[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2016 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 40
Protection of Environment
________________________
Parts 723 to 789
Revised as of July 1, 2016
Containing a codification of documents of general
applicability and future effect
As of July 1, 2016
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
As of July 1, 2016
Title 40, Parts 700 to 789
Revised as of July 1, 2015
Is Replaced by
Title 40, Parts 700 to 722
and
Parts 723 to 789
[[Page v]]
Table of Contents
Page
Explanation................................................. vii
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 403
Alphabetical List of Agencies Appearing in the CFR...... 423
List of CFR Sections Affected........................... 433
[[Page vi]]
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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.
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[[Page vii]]
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
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evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
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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 viii]]
Many agencies have begun publishing numerous OMB control numbers as
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``[RESERVED]'' TERMINOLOGY
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(a) The incorporation will substantially reduce the volume of
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(b) The matter incorporated is in fact available to the extent
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(c) The incorporating document is drafted and submitted for
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CFR INDEXES AND TABULAR GUIDES
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and Finding Aids. This volume contains the Parallel Table of Authorities
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alphabetical list of agencies publishing in the CFR are also included in
this volume.
[[Page ix]]
An index to the text of ``Title 3--The President'' is carried within
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available at www.ecfr.gov.
Oliver A. Potts,
Director,
Office of the Federal Register.
July 1, 2016.
[[Page xi]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty-seven
volumes. The parts in these volumes are arranged in the following order:
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
60.499) , part 60 (60.500-end of part 60, sections), part 60
(Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63
(63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts
72-79, part 80, part 81, parts 82-86, parts 87-95, parts 96-99, parts
100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-265,
parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts 700-
722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to
end. The contents of these volumes represent all current regulations
codified under this title of the CFR as of July 1, 2016.
Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. Regulations issued by the Council on Environmental
Quality, including an Index to Parts 1500 through 1508, appear in the
volume containing parts 1060 to end. The OMB control numbers for title
40 appear in Sec. 9.1 of this chapter.
For this volume, Ann Worley was Chief Editor. The Code of Federal
Regulations publication program is under the direction of John Hyrum
Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 723 to 789)
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Part
chapter i--Environmental Protection Agency (Continued)...... 723
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 65 FR
47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001.
SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT
Part Page
723 Premanufacture notification exemptions...... 5
725 Reporting requirements and review processes
for microorganisms...................... 27
745 Lead-based paint poisoning prevention in
certain residential structures.......... 73
747 Metalworking fluids......................... 140
749 Water treatment chemicals................... 145
750 Procedures for rulemaking under section 6 of
the Toxic Substances Control Act........ 148
761 Polychlorinated biphenyls (PCBs)
manufacturing, processing, distribution
in commerce, and use prohibitions....... 163
763 Asbestos.................................... 294
766 Dibenzo-para-dioxins/dibenzofurans.......... 389
767-789
[Reserved]
[[Page 5]]
SUBCHAPTER R_TOXIC SUBSTANCES CONTROL ACT
PART 723_PREMANUFACTURE NOTIFICATION EXEMPTIONS--Table of Contents
Subpart A [Reserved]
Subpart B_Specific Exemptions
Sec.
723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
723.175 Chemical substances used in or for the manufacture or processing
of instant photographic and peel-apart film articles.
723.250 Polymers.
Authority: 15 U.Sec. 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.Sec. 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.Sec. 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.Sec. 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.Sec. 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 or import the new
chemical substance for commercial purposes, other than in small
quantities solely for research and development, under the terms of this
section.
(B) The manufacturer is familiar with the terms of this section and
will comply with those terms.
(C) The new chemical substance for which the notice is submitted
meets all applicable exemption conditions.
(D) For substances manufactured under paragraph (c)(1) of this
section, the manufacturer intends to commence manufacture of the
exempted substance for commercial purposes within 1 year of the date of
the expiration of the 30-day review period.
(xii) Sanitized copy of notice. (A) The manufacturer must make all
claims of confidentiality in accordance with paragraph (l) of this
section. If any information is claimed confidential, the manufacturer
must submit a second copy of the notice, with all information claimed as
confidential deleted, in accordance with paragraph (l)(3) of this
section.
(B) If the manufacturer does not provide the second copy, the
submission will be considered incomplete.
(3) Incomplete notices. If EPA receives a submission which does not
include all of the information required under this paragraph (e) of this
section, the submission will be determined to be incomplete by EPA. When
a submission for a new chemical substance has been determined to be
incomplete, a manufacturer reapplying for an exemption for the new
chemical substance must submit a new exemption notice containing all the
information required under this paragraph (e) of this section including
a certification page containing an original dated signature; partial
submissions sent to EPA to supplement notices declared incomplete will
not be accepted. Photocopied pages from previously submitted exemption
forms will be accepted provided that the certifications page contains an
original dated signature.
(f) Multiple exemption holders. (1) A manufacturer who intends to
manufacture a substance for which an exemption under this section was
previously approved may apply for an exemption under paragraph (c)(1) or
(c)(2) of this section; however, EPA will not approve any subsequent
exemption application under paragraph (c)(1) of this section unless it
can determine that the potential human exposure to, and environmental
release of, the new chemical substance at the higher aggregate
production volume will not present an unreasonable risk of injury to
human health or the environment.
(2)(i) If EPA proposes to deny an exemption application for a
substance for which another manufacturer currently holds an exemption,
and that proposed denial is based exclusively on the cumulative human
exposure or environmental release of the substance which precludes the
EPA from determining that the subsequent applicant's activities will not
present an unreasonable risk of injury to human health or the
environment, the EPA will notify the first exemption holder that it
must, within 21 days of its receipt of EPA's notice, either:
(A) Provide a new certification that it has commenced, or that it
will commence, manufacture of the new chemical substance under this
section within 1 year of the expiration of its exemption review period;
or
(B) Withdraw its exemption for the new chemical substance.
(ii) If the first exemption holder does not respond to the EPA's
notice under paragraph (f)(2)(i) of this section within the prescribed
time period, EPA shall issue a notice of ineligibility to the first
exemption holder under the
[[Page 9]]
provisions of paragraph (h)(2) of this section.
(g) Review period. (1) EPA will review the notice submitted under
paragraph (e) of this section to determine whether manufacture of the
new chemical substance is eligible for the exemption. The review period
will end 30 days after receipt of the notice by the TSCA Document
Control Officer. To provide additional time to address any unresolved
issues concerning an exemption application, the exemption applicant may,
at any time during the review period, request a suspension of the review
period pursuant to the provisions of Sec. 720.75(b) of this chapter.
(2) Upon expiration of the 30-day review period, if EPA has taken no
action, the manufacturer may consider its exemption approved and begin
to manufacture the new chemical substance under the terms described in
its notice and in this section.
(h) Notice of ineligibility--(1) During the review period. If the
EPA determines during the review period that manufacture of the new
chemical substance does not meet the terms of this section or that there
are issues concerning toxicity or exposure that require further review
which cannot be accomplished within the 30-day review period, EPA will
notify the manufacturer by telephone that the substance is not eligible.
This telephone notification will subsequently be confirmed by certified
letter that identifies the reasons for the ineligibility determination.
The manufacturer may not begin manufacture of the new chemical substance
without complying with section 5(a)(1) of the Act or submitting a new
notice under paragraph (e) of this section that satisfies EPA's
concerns.
(2) After the review period. (i)(A) If at any time after the review
period specified in paragraph (g) of this section the Assistant
Administrator for the Office of Chemical Safety and Pollution Prevention
(``the Assistant Administrator'') makes a preliminary determination that
manufacture of the new chemical substance does not meet the terms of
this section, the Assistant Administrator will notify the manufacturer
by certified letter that EPA believes that the new chemical substance
does not meet the terms of the section.
(B) The manufacturer may continue to manufacture, process,
distribute in commerce, and use the substance after receiving the notice
under paragraph (h)(2)(i)(A) of this section if the manufacturer was
manufacturing, processing, distributing in commerce, or using the
substance at the time of the notification and if the manufacturer
submits objections or an explanation under paragraph (h)(2)(ii) of this
section. Manufacturers not manufacturing, processing, distributing in
commerce, or using the substance at the time of the notification may not
begin manufacture until EPA makes its final determination under
paragraph (h)(2)(iii) of this section.
(ii) A manufacturer who has received notice under paragraph
(h)(2)(i)(A) of this section may submit, within 15 days of receipt of
written notification, detailed objections to the determination or an
explanation of its diligence and good faith efforts in attempting to
comply with the terms of this section.
(iii) The Assistant Administrator will consider any objections or
explanation submitted under paragraph (h)(2)(ii) of this section and
will make a final determination. The Assistant Administrator will notify
the manufacturer of the final determination by telephone within 15 days
of receipt of the objections or explanation, and subsequently by
certified letter.
(iv) If the Assistant Administrator determines that manufacture of
the new chemical substance meets the terms of this section, the
manufacturer may continue or resume manufacture, processing,
distribution in commerce, and use in accordance with the terms of this
section.
(v) If the Assistant Administrator determines that manufacture of
the new chemical substance does not meet the terms of this section and
that the manufacturer did not act with due diligence and in good faith
to meet the terms of this section, the manufacturer must cease any
continuing manufacture, processing, distribution in commerce, and use of
the new chemical substance within 7 days of the written notification
under paragraph (h)(2)(iii) of this section. The manufacturer may not
resume manufacture, processing, distribution in commerce, and use of
[[Page 10]]
the new chemical substance until it submits a notice under section
5(a)(1) of the Act and part 720 of this chapter and the notice review
period has ended.
(vi) If the Assistant Administrator determines that manufacture of
the new chemical substance does not meet the terms of this section and
that the manufacturer acted with due diligence and in good faith to meet
the terms of this section, the manufacturer may continue manufacture,
processing, distribution in commerce, and use of the new chemical
substance if:
(A) It was actually manufacturing, processing, distributing in
commerce, or using the chemical substance at the time it received the
notification specified in paragraph (h)(2)(i)(A) of this section.
(B) It submits a notice on the new chemical substance under section
5(a)(1) of the Act and part 720 of this chapter within 15 days of
receipt of the written notification under paragraph (h)(2)(iii) of this
section. Such manufacture, processing, distribution in commerce, and use
may continue unless EPA takes action under section 5(e) or 5(f) of the
Act.
(3) Action under this paragraph does not preclude action under
sections 7, 15, 16, or 17 of the Act.
(i) Additional information. If the manufacturer of a new chemical
substance under the terms of this exemption obtains test data or other
information indicating that the new chemical substance may not qualify
under terms of this section, the manufacturer must submit these data or
information to EPA within 15 working days of receipt of the information.
If, during the notice review period specified in paragraph (g) of this
section, the submitter obtains possession, control, or knowledge of new
information that materially adds to, changes, or otherwise makes
significantly more complete the information included in the notice, the
submitter must send that information to the address listed on the notice
form within 10 days of receiving the new information, but no later than
5 days before the end of the notice review period. The new submission
must clearly identify the submitter and the exemption notice to which
the new information is related. If the new information becomes available
during the last 5 days of the notice review period, the submitter must
immediately inform its EPA contact for that notice by telephone.
(j) Changes in manufacturing site, use, human exposure and
environmental release controls, and certain manufacturing volumes. (1)
Except as provided in paragraph (j)(6) of this section, chemical
substances manufactured under this section must be manufactured at the
site or sites described, for the uses described, and under the human
exposure and environmental release controls described in the exemption
notice under paragraph (e) of this section.
(2) Where the manufacturer lists a specific physical form in which
the new chemical substance will be manufactured, processed, and/or used,
the manufacturer must continue manufacturing, processing, and/or using
the new chemical substance in either the same physical form described in
the notice under paragraph (e), or in a physical form which will not
increase the human exposure to or environmental release of the new
chemical substance over those exposures or releases resulting from the
specified physical form (e.g., a manufacturer which specifies that the
new chemical substance will be produced in a non-volatile liquid form
generally may not change to a respirable powder form).
(3) The annual production volume of chemical substances manufactured
under paragraph (c)(1) of this section for which the manufacturer
designated a binding annual production volume pursuant to paragraph
(e)(2)(vi) of this section must not exceed that designated volume.
(4) Any person who manufactures a new chemical substance under
paragraph (c)(1) or (c)(2) of this section must comply with the
provisions of this section, including submission of a new notice under
paragraph (e) of this section, before:
(i) Manufacturing the new chemical substance at a site that was not
approved in a previous exemption notice for the substance, except as
provided in paragraph (j)(6) of this section.
[[Page 11]]
(ii) Manufacturing the new chemical substance for a use that was not
approved in a previous exemption notice for the substance.
(iii) Manufacturing the new chemical substance without employing the
human exposure and environmental release controls approved in a previous
exemption notice for the substance.
(iv) Manufacturing the new chemical substance in a physical form
different than that physical form approved in a previous exemption
notice for the substance and which form may increase the human exposure
to, or environmental release of, the new chemical substance over those
exposures or releases resulting from the physical form approved in the
previous notice.
(v) Manufacturing the chemical substance in annual production
volumes above any volume designated by the manufacturer as binding under
paragraph (e)(2)(vi) of this section in a previous exemption notice for
the substance.
(5) In an exemption notice informing EPA of a change in site, use,
or worker protection, or environmental release controls, the
manufacturer is not required to provide all of the same information
submitted to EPA in a previous exemption notice for that chemical
substance. The new exemption notice, however, must indicate the identity
of the new chemical substance; the manufacturer's name; the name and
telephone number of a technical contact; and location of the new site,
new worker protection or environmental release controls, and new use
information. The notice must also include the EPA-designated exemption
number assigned to the previous notice and a new certification by the
manufacturer, as described in paragraph (e)(2)(xi) of this section.
(6)(i) A manufacturer may, without submitting a new notice,
manufacture the new chemical substance at a site not listed in its
exemption application under the following conditions:
(A) the magnitude, frequency, and duration of exposure of individual
workers to the new chemical substance at the new manufacturing site is
equal to, or less than, the magnitude, frequency, and duration of
exposure of the individual workers to the new chemical substance at the
manufacturing site for which the EPA performed its original risk-
assessment pursuant to the original exemption notice; and
(B) Either (1) at the new manufacturing site, the manufacturer does
not release to surface waters any of the new chemical substance, or any
waste streams containing the new chemical substance; or (2) at the new
manufacturing site, the manufacturer maintains surface water
concentrations of the chemical substance, resulting from direct or
indirect discharges from the manufacturing site, at or below 1 part per
billion, or at or below an alternative concentration level approved by
the Agency in writing or under the procedures described in paragraph
(c)(2)(iii) of this section, using the water concentration calculation
method described at 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.Sec. 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.Sec. C. 2614).
(3) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.Sec. 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.Sec. C. 2606) or section 17 of the Act (15 U.Sec. C. 1616).
[60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62
FR 17932, Apr. 11, 1997; 64 FR 31989, June 15, 1999; 71 FR 33642, June
12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012; 78 FR
72828, Dec. 4, 2013; 80 FR 42746, July 20, 2015]
Sec. 723.175 Chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles.
(a) Purpose and scope. (1) This section grants an exemption from the
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic
Substances Control Act (15 U.Sec. C. 2604(a)(1)(A)) for the manufacture and
processing of new chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles. This
section does not apply to microorganisms subject to part 725 of this
chapter.
(2) To manufacture a new chemical substance under the terms of this
exemption, a manufacturer of instant photographic or peel-apart film
articles must:
(i) Submit an exemption notice when manufacture begins under
paragraph (i) of this section.
(ii) Comply with certain requirements to limit exposure to the new
chemical substance under paragraphs (e), (f), (g), and (h) of this
section.
(iii) Comply with all recordkeeping requirements under paragraph (j)
of this section.
(b) Definitions--(1) Act means the Toxic Substances Control Act (15
U.Sec. C. 2601 et seq.).
(2) An article is a manufactured item (i) which is formed to a
specific shape or design during manufacture, (ii) which has end use
function(s) dependent in whole or in part upon its shape or design
during end use, and (iii) which has either no change of chemical
composition during its end use or only those changes of composition
which have no commercial purpose separate from that of the article and
that may occur as described in Sec. 710.2 of this chapter except that
fluids and particles are not considered articles regardless of shape or
design.
[[Page 14]]
(3) The terms byproduct, EPA, impurities, person, and site have the
same meanings as in Sec. 710.3 of this chapter.
(4) The term category of chemical substances has the same meaning as
in section 26(c)(2) of the Act (15 U.Sec. 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.Sec. 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.Sec. C. 2604).
(8) The term instant photographic film article means a self-
developing photographic film article designed so that all the chemical
substances contained in the article, including the chemical substances
required to process the film, remain sealed during distribution and use.
(9) Intermediate means any chemical substance which is consumed in
whole or in part in a chemical reaction(s) used for the intentional
manufacture of another chemical substance.
(10) Known to or reasonably ascertainable means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know, our could obtain without unreasonable burden or cost.
(11) The term peel-apart film article means a self-developing
photographic film article consisting of a positive image receiving
sheet, a light sensitive negative sheet, and a sealed reagent pod
containing a developer reagent and designed so that all the chemical
substances required to develop or process the film will not remain
sealed within the article during and after the development of the film.
(12) Photographic article means any article which will become a
component of an instant photographic or peel-apart film article.
(13) Special production area means a demarcated area within which
all manufacturing, processing, and use of a new chemical substance takes
place, except as provided in paragraph (f) of this section, in
accordance with the requirements of paragraph (e) of this section.
(14) Test data means:
(i) Data from a formal or informal study, test, experiment, recorded
observation, monitoring, or measurement.
(ii) Information concerning the objectives, experimental methods and
materials, protocols, results, data analyses (including risk
assessments), and conclusions from a study, test, experiment, recorded
observation, monitoring, or measurement.
(15) Used in or for the manufacturing or processing of an instant
photographic or peel-apart film article, when used to describe
activities involving a new chemical substance, means the new chemical
substance (i) is included in the article, or (ii) is an intermediate to
a chemical substance included in the article or is one of a series of
intermediates used to manufacture a chemical substance included in the
article.
(16) Wet mixture means a water or organic solvent-based suspension,
solution, dispersion, or emulsion used in the manufacture of an instant
photographic or peel-apart film article.
(c) Exemption category. The exemption category includes new chemical
substances used in or for the manufacture or processing of instant
photographic or peel-apart film articles which are manufactured and
processed under the terms of this section.
(d) Applicability. This exemption applies only to manufacturers of
instant photographic or peel-apart film articles who:
(1) Manufacture the new chemical substances used in or for the
manufacture or processing of the instant photographic or peel-apart film
articles.
(2) Limit manufacture and processing of a new chemical substance to
the site(s) listed in the exemption notice for that new chemical
substance submitted under paragraph (i) of this section.
[[Page 15]]
(3) Comply with the requirements of paragraphs (e), (f), (g), (h),
and (j) of this section.
(4) Do not distribute in commerce or use a peel-apart film article
containing a new chemical substance until submission of a premanufacture
notice under section 5(a)(1)(A) of the Act (15 U.Sec. 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.Sec. 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 (2)(ii) of this section.
(B) When suitable sampling and analytic methods do not exist,
compliance with the exposure limits of paragraph (e)(1) and the
requirements of paragraph (e)(10) of this section must be determined by
an evaluation of monitoring data developed for a surrogate chemical
substance possessing comparable physical-chemical properties under
similar manufacturing and processing conditions.
(ii) Monitoring methods. A suitable air sampling method must permit
personal or fixed location sampling by conventional collection methods.
A suitable analytic method must have adequate sensitivity for the volume
of sample available and be specific for the new chemical substance being
monitored. If chemical-specific monitoring methods are not available,
nonspecific methods may be used if the concentration of the new chemical
substance is assumed to be the total concentration of chemical
substances monitored.
(iii) Monitoring frequency. (A) When suitable air sampling and
analytical procedures are available, monitoring must be done in each
special production area during the first three 8-hour work shifts
involving the manufacture or processing of each new chemical substance.
Thereafter, monitoring must be done in each special production area for
at least one 8-hour period per month, during a production run in which
the new chemical substance is manufactured or processed. Samples must be
of such frequency and pattern as to represent with reasonable accuracy
the mean level and maximum 30-
[[Page 16]]
minute level of employee exposure during an 8-hour work shift. In
monitoring for an 8-hour work shift or the equivalent, samples must be
collected periodically or continuously for the duration of the 8-hour
work shift. Samples must be taken during a period which is likely to
represent the maximum employee exposure.
(B) If the manufacturer demonstrates compliance with the exposure
limits for 3 consecutive months, further monitoring of the identical
process must be performed only every 6 months thereafter, unless there
is a significant change in the process, process design, or equipment. If
there is such a change, the manufacturer must begin monitoring again
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
(iv) Location of monitoring. Air samples must be taken so as to
ensure that the samples adequately represent the ambient air
concentration of a new chemical substance present in each worker's
breathing zone.
(4) Engineering controls and exposure safeguards. Engineering
controls such as, but not limited to, isolation, enclosure, local
exhaust ventilation, and dust collection must be used to ensure
compliance with the exposure limits prescribed in paragraphs (e)(1) or
(e)(2)(ii) of this section.
(5) Training, hygiene, and work practices--(i) Training. No employee
may enter a special production area before the completion of a training
program. The training program must be adapted to the individual
circumstances of the manufacturer and must address: The known physical-
chemical and toxicological properties of the chemical substances handled
in the area; procedures for using and maintaining respirators and other
personal safeguards; applicable principles of hygiene; special handling
procedures designed to limit personal exposure to, and inadvertent
release of, chemical substances; and procedures for responding to
emergencies or spills.
(ii) Hygiene. Appropriate standards of hygiene must be observed by
all employees handling a new chemical substance in manufacturing,
processing, or transfer operations. The manufacturer must provide
appropriate facilities for employee changing and wash-up. Food,
beverages, tobacco products, and cosmetics must not be allowed in
special production areas.
(iii) Work practices. Operating procedures such as those related to
chemical weighing and filtering, or the charging, discharging and clean-
up of process equipment, must be designed and conducted to ensure
compliance with the exposure limits prescribed in paragraph (e)(1) or
(e)(2)(ii) of this section. Written procedures and all materials
necessary for responding to emergency situations must be immediately
accessible to all employees in a special production area. Any spill or
unanticipated emission must be controlled by specially trained personnel
using the equipment and protective clothing described in paragraph
(e)(6) of this section.
(6) Personal protection devices. All workers engaged in the
manufacture and processing of a new chemical substance in the special
production area must wear suitable protective clothing or equipment,
such as chemical-resistant coveralls, protective eyewear, and gloves.
(7) Caution signs. Each special production area must be clearly
posted with signs identifying the area as a special production area
where new chemical substances are manufactured and processed under
controlled conditions. Each sign must clearly restrict entry into the
special production area to qualified personnel who are properly trained
and equipped with appropriate personal exposure safeguards.
(8) Removal for storage or transportation. A new chemical substance
that is not incorporated into a wet mixture, photographic article, or
instant photographic or peel-apart film article may be removed from the
special production area for purposes of storage between operational
steps or for purposes of transportation to another special production
area. Such storage or transportation must be conducted in a manner that
limits worker and environmental exposure through the use of engineering
controls, training, hygiene, work practices, and personal protective
devices appropriate to the chemical substance in question.
[[Page 17]]
(9) Labeling. (i) Any new chemical substance removed from a special
production area or stored or transported between operational steps must
be clearly labeled. The label must show the identity of the new chemical
substance or an appropriate identification code, a statement of any
known hazards associated with it, a list of special handling
instructions, first aid information, spill control directions, and where
applicable, the appropriate U.Sec. Department of Transportation notations.
(ii) No label is required if the new chemical substance has been
incorporated into a photographic article, or if it is contained in a
sealed reaction vessel or pipeline, or if it has been incorporated into
an instant photographic or peel-apart film article.
(10) Areas immediately adjacent to the special production area. The
ambient air concentration of the new chemical substance in areas
immediately adjacent to the special production area must not exceed the
exposure limit established in paragraph (e)(2)(ii) of this section for
waiver of respirator protection within the special production area.
Periodic monitoring in accordance with paragraph (e)(3) of this section
must be performed in immediately adjacent areas where it is reasonable
to expect a risk of inhalation exposure.
(f) Conditions of processing outside the special production area. A
wet mixture may be incorporated into a photographic article or an
instant photographic or peel-apart film article outside the special
production area under the conditions listed in this paragraph:
(1) Engineering controls and exposure safeguards. Engineering
controls must limit the exposure to a new chemical substance contained
in a wet mixture.
(2) Training, hygiene and work practices--(i) Training. Training of
employees involved in the handling of wet mixtures containing a new
chemical substance must be adapted to the individual circumstances of
the employees' activities and must address: Procedures for using
personal exposure safeguards, applicable principles of hygiene, handling
procedures designed to limit personal exposure, and procedures for
responding to emergencies and spills.
(ii) Hygiene. Appropriate standards of hygiene that limit exposure
must be observed by all employees handling wet mixtures that contain new
chemical substances.
(iii) Work practices. Work practices and operating procedures must
be designed to limit exposure to any new chemical substance contained in
wet mixtures. Any spills or unanticipated releases of a wet mixture must
be controlled by trained personnel wearing appropriate protective
clothing or equipment such as gloves, eye protection, and, where
necessary, respirators or chemically imprevious clothing.
(3) Personal protection devices. All workers engaged in the
processing of a wet mixture containing a new chemical substance must
wear suitable protective clothing or equipment such as coveralls,
protective eyewear, respirators, and gloves.
(g) Incorporation of photographic articles into instant photographic
and peel-apart film articles. A photographic article may be incorporated
into the instant photographic or peel-apart film article outside the
special production area. The manufacturer must take measures to limit
worker and environmental exposure to new chemcial substances during
these operations using engineering controls, training, hygiene, work
practices, and personal protective devices.
(h) Environmental release and waste treatment--(1) Release to land.
Process waste from manufacturing and processing operations in the
special production area that contain a new chemical substance are
considered to be hazardous waste and must be handled in accordance with
the requirements of parts 262 through 267 and parts 122 and 124 of this
chapter.
(2) Release to water. All wastewater or discharge which contain the
new chemcial subtance must be appropriately pretreated before release to
a Publicly Owned Treatment Works (POTW) or other receiving body of
water. In the case of release to a POTW, the pretreatment must prevent
structural damage to, obstruction of, or interference with the operation
of the POTW. The treatment of direct release to a receiving body of
water must be appropriate for the new chemical
[[Page 18]]
substance's physical-chemical properties and potential toxicity.
(3) Release to air. All process emissions released to the air which
contain the new chemical substance must be vented through control
devices appropriate for the new chemical substance's physical-chemical
properties and potential toxicity.
(i) Exemption notice. An exemption notices must be submitted to EPA
when manufacture of the new chemical substance begins.
(1) Contents of exemption notice. The exemption notice must include
the following information:
(i) Manufacturer and sites. The notice must identify the
manufacturer and the sites and locations where the new chemical
substance and the instant photographic or peel-apart film articles will
be manufactured and processed.
(ii) Chemical identification. The notice must identify the new
chemical substance as follows:
(A) Class 1 substances. For chemical substances whose composition
can be represented by a definite structural disagram (Class 1
substances), the notice must provide the chemical name (preferably CAS
or IUPAC nomenclature), the molecular formula, CAS Registry Number (if
available), known synonyms (including trade names), and a structural
diagram.
(B) Class 2 substances. For chemical substances that cannot be fully
represented by a structural diagram, (Class 2 substances), the notice
must provide the chemical name, the molecular formula, the CAS Registry
Number (if available), and known synonyms (including trade names). The
notice must identify the immediate precursors and reactants by name and
CAS Registry Number (if available). The notice must include a partial or
incomplete structural diagram, if available.
(C) Polymers. For a polymer, the notice must indentify monomers and
other reactants used in the manufacture of the polymer by chemical name
and CAS Registry Number. The notice must indicate the amount of each
monomer used (by weight percent of total monomer); the maximum residual
of each monomer present in the polymer; and a partial or incomplete
structural diagram, if available. The notice must indicate the number
average molecular weight of the polymer and characterize the anticipated
low molecular weight species. The notice must include this information
for each typical average molecular weight composition of the polymer to
be manufactured.
(iii) Impurities. The notice must identify the impurities that can
be reasonably anticipated to be present in the new chemcial substance
when manufactured under the exemption by name and CAS Registry Number,
by class of substances, or by process or source. The notice also must
estimate the maximum percent (by weight) of each impurity in the new
chemical substance and the percent of unknown impurities present.
(iv) Physical-chemical properties. The notice must describe the
physical-chemical properties of the new chemical substance. Where
specific physical-chemical data are not available, reasonable estimates
and the techniques used to develop these estimates must be provided.
(v) Byproducts. The notice must identify the name, CAS Registry
number (if available), and the volume of each byproduct that would be
manufactured during manufacture of the new chemical substance.
(vi) Production volume. The notice must include an estimate of the
anticipated maximum annual production volume.
(vii) Test data. The notice must include all information and test
data on the new chemical substance's health and environmental effects
that are known to or reasonably ascertainable by the manufacturer.
(viii) Identity of the article. The notice must identify and
describe the instant photographic film article(s) or peel-apart film
article(s) that will contain the new chemical substance.
(ix) Release to water. The notice must include a description of the
methods used to control and treat wastewater or discharge released to a
POTW or other receiving body of water. The notice must also identify the
POTW or receiving body of water.
(x) Certification. The manufacturer must certify in the notice that
it is familiar with the terms of the exemption
[[Page 19]]
and that the manufacture, processing, distribution, use, and disposal of
the new chemical substance will comply with those terms.
(2) Duplication of information in premanufacture notice. If a
manufacturer who submits an exemption notice under this paragraph has
already submitted, or simultaneously submits, a premanufacture notice
under section 5(a)(1)(A) of the Act for the new chemical substance, it
may, in lieu of submitting the information required by this paragraph,
reference the required information to the extent it is included in the
premanufacture notice. At a minimum, the exemption notice must identify
the manufacturer and the new chemical substance, and contain the
certification required by paragraph (i)(1)(x) of this section.
(3) Address. The exemption notice must be addressed to the Document
Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics
(OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
(j) Recordkeeping. (1) Manufacturers of a new chemical substance
under this exemption must keep the following records for 30 years from
the final date of manufacture.
(i) Production records. Each manufacturer must maintain records of
the annual production volume of each new chemical substance manufactured
under the terms of the exemption. This record must indicate when
manufacture of the new chemical substance began.
(ii) Exposure monitoring records. Manufacturers must maintain an
accurate record of all monitoring required by this section. Monitoring
records may be adapted to the individual circumstances of the
manufacturer but, at a minimum, must contain the following information:
The chemical identity of the new chemical substance, date of the
monitoring, the actual monitoring data for each monitoring location and
sampling, and a reference to or description of the collection and
analytic techniques. If the manufacturer does not monitor, the
manufacturer must maintain a record of the reasons for not monitoring
and the methods used to determine compliance with the exposure limits of
paragraph (e)(1) of this section.
(iii) Training and exposure records. For each employee engaged in
the manufacture or processing of a new chemical substance, the company
must develop and maintain a record of the worker's participation in
required training. This record must also demonstrate the regular use of
personal exposure safeguards, including the results of any personal
exposure monitoring, the results of the quantitative fit test for the
worker's personal respirator, and any additional information related to
the worker's occupational exposure.
(iv) Treatment records. Manufacturers who release treated wastewater
or discharge containing a new chemical substance to a POTW or other
receiving body of water must maintain records of the method of
treatment.
(2) The manufacturer must make the records listed in paragraph
(j)(1) of this section available to EPA upon written request by the
Director of the Office of Pollution Prevention and Toxics. The
manufacturer must provide these records within 15 working days of
receipt of this request.
(k) Confidentiality. If the manufacturer submits information under
paragraph (i) or (j) of this section which it claims to be confidential
business information, the manufacturer must clearly identify the
information at the time of submission to the Agency by bracketing,
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or
some other appropriate designation. Any information so identified will
be treated in accordance with the procedures in part 2 of this chapter.
Any information not claimed confidential at the time of submission will
be made available to the public without further notice to the submitter.
(l) Amendment and repeal. (1) EPA may amend or repeal any term of
this exemption if it determines that the manufacture, processing,
distribution, use, and disposal of new chemical substances under the
terms of the exemption may present an unreasonable risk of injury to
health or the environment. EPA also may amend this exemption to enlarge
the exemption category or to reduce the restrictions or conditions of
the exemption.
[[Page 20]]
(2) As required by section 5(h)(4) of the Act, EPA will amend or
repeal the substantive terms of an exemption granted under this part
only by the formal rulemaking procedures described in section 6(c)(2)
and (3) of the Act (15 U.Sec. 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.Sec. 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.Sec. C. 2614).
(3) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.Sec. 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.Sec. C. 2616).
[47 FR 24317, June 4, 1982, as amended at 53 FR 12523, Apr. 15, 1988; 60
FR 34465, July 3, 1995; 62 FR 17932, Apr. 11, 1997; 68 FR 906, Jan. 7,
2003; 71 FR 33642, June 12, 2006]
Sec. 723.250 Polymers.
(a) Purpose and scope. (1) This section grants an exemption from
certain of the premanufacture notice requirements of section 5(a)(1)(A)
of the Toxic Substances Control Act (15 U.Sec. 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.Sec. C. 2602, the following definitions apply to this part.
Act means the Toxic Substances Control Act (15 U.Sec. 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.Sec. C. 2625).
Cationic polymer means a polymer that contains a net positively
charged atom(s) or associated groups of atoms covalently linked to its
polymer molecule.
Chemical substance, Director, EPA, importer, impurity, Inventory,
known to or reasonably ascertainable, manufacture, manufacturer,
mixture, new chemical, person, possession or control, process and test
data have the same meanings as in Sec. 720.3 of this chapter.
Equivalent weight of a functional group means the ratio of the
molecular weight to the number of occurrences of that functional group
in the molecule. It is the weight of substance that contains one
formula-weight of the functional group.
Fluorotelomers means the products of telomerization, which is the
reaction of a telogen (such as pentafluoroethyl iodide) with an
ethylenic compound (such as tetrafluoroethylene) to form low molecular
weight polymeric compounds, which contain an array of saturated carbon
atoms covalently bonded to each other (C-C bonds) and to fluorine atoms
(C-F bonds). This array is predominantly a straight chain, and depending
on the telogen used produces a compound having an even number of carbon
atoms. However, the carbon
[[Page 21]]
chain length of the fluorotelomer varies widely. The perfluoroalkyl
groups formed by this process are usually, but do not have to be,
connected to the polymer through a functionalized ethylene group as
indicated by the following structural diagram: (Rf-
CH2CH2-Anything).
Internal monomer unit means a monomer unit that is covalently bonded
to at least two other molecules. Internal monomer units of polymer
molecules are chemically derived from monomer molecules that have formed
covalent bonds between two or more other monomer molecules or other
reactants.
Monomer means a chemical substance that is capable of forming
covalent bonds with two or more like or unlike molecules under the
conditions of the relevant polymer-forming reaction used for the
particular process.
Monomer Unit means the reacted form of the monomer in a polymer.
Number-average molecular weight means the arithmetic average (mean)
of the molecular weight of all molecules in a polymer.
Oligomer means a polymer molecule consisting of only a few monomer
units (dimer, trimer, tetramer)
Other reactant means a molecule linked to one or more sequences of
monomer units but which, under the relevant reaction conditions used for
the particular process, cannot become a repeating unit in the polymer
structure.
Perfluoroalkyl carboxylate (PFAC) means a group of saturated carbon
atoms covalently bonded to each other in a linear, branched, or cyclic
array and covalently bonded to a carbonyl moiety and where all carbon-
hydrogen (C-H) bonds have been replaced with carbon-fluorine (C-F)
bonds. The carbonyl moiety is also covalently bonded to a hetero atom,
typically, but not necessarily oxygen (O) or nitrogen (N).
Perfluoroalkyl sulfonate (PFAS) means a group of saturated carbon
atoms covalently bonded to each other in a linear, branched, or cyclic
array and covalently bonded to a sulfonyl moiety and where all carbon -
hydrogen (C-H) bonds have been replaced with carbon - fluorine (C-F)
bonds. The sulfonyl moiety is also covalently bonded to a hetero atom,
typically, but not necessarily oxygen (O) or nitrogen (N).
Polyester means a chemical substance that meets the definition of
polymer and whose polymer molecules contain at least two carboxylic acid
ester linkages, at least one of which links internal monomer units
together.
Polymer means a chemical substance consisting of molecules
characterized by the sequence of one or more types of monomer units and
comprising a simple weight majority of molecules containing at least 3
monomer units which are covalently bound to at least one other monomer
unit or other reactant and which consists of less than a simple weight
majority of molecules of the same molecular weight. Such molecules must
be distributed over a range of molecular weights wherein differences in
the molecular weight are primarily attributable to differences in the
number of monomer units. In the context of this definition, sequence
means that the monomer units under consideration are covalently bound to
one another and form a continuous string within the molecule,
uninterrupted by units other than monomer units.
Polymer molecule means a molecule which contains a sequence of at
least 3 monomer units which are covalently bound to at least one other
monomer unit or other reactant.
Reactant means a chemical substance that is used intentionally in
the manufacture of a polymer to become chemically a part of the polymer
composition.
Reactive functional group means an atom or associated group of atoms
in a chemical substance that is intended or can reasonably be
anticipated to undergo further chemical reaction.
Reasonably anticipated means that a knowledgeable person would
expect a given physical or chemical composition or characteristic to
occur based on such factors as the nature of the precursors used to
manufacture the polymer, the type of reaction, the type of manufacturing
process, the products produced in polymerization, the intended uses of
the substance, or associated use conditions.
[[Page 22]]
(c) Applicability. This section applies to manufacturers of new
chemical substances that otherwise must submit a premanufacture notice
to EPA under Sec. 720.22 of this chapter. New substances are eligible
for exemption under this section if they meet the definition of
``polymer'' in paragraph (b) of this section, and the criteria in
paragraph (e) of this section, and if they are not excluded from the
exemption under paragraph (d) of this section.
(d) Polymers that cannot be manufactured under this section--(1)
Cationic polymers. A polymer cannot be manufactured under this section
if the polymer is a cationic polymer as defined under paragraph (b) of
this section or if the polymer is reasonably anticipated to become a
cationic polymer in a natural aquatic environment (e.g., rivers, lakes)
unless:
(i) The polymer is a solid material that is not soluble or
dispersible in water and will be used only in the solid phase (e.g.,
polymers that will be used as ion exchange beads), or
(ii) The combined (total) functional group equivalent weight of
cationic groups in the polymer is equal to or greater than 5,000.
(2) Elemental limitations. (i) A polymer manufactured under this
section must contain as an integral part of its composition at least two
of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and
sulfur.
(ii) A polymer cannot be manufactured under this section if it
contains as an integral part of its composition, except as impurities,
any elements other than the following:
(A) The elements listed in paragraph (d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum, potassium, calcium, chlorine,
bromine, and iodine as the monatomic counterions Na = ,
Mg = 2, Al = 3, K = ,
Ca = 2, Cl-, Br-, or I-.
(C) Fluorine, chlorine, bromine, and iodine covalently bound to
carbon.
(D) Less than 0.20 weight percent of any combination of the atomic
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel,
copper, zinc, tin, and zirconium.
(3) Polymers which degrade, decompose, or depolymerize. A polymer
cannot be manufactured under this section if the polymer is designed or
is reasonably anticipated to substantially degrade, decompose, or
depolymerize, including those polymers that could substantially
decompose after manufacture and use, even though they are not actually
intended to do so. For the purposes of this section, degradation,
decomposition, or depolymerization mean those types of chemical change
that convert a polymeric substance into simpler, smaller substances,
through processes including but not limited to oxidation, hydrolysis,
attack by solvents, heat, light, or microbial action.
(4) Polymers manufactured or imported from monomers and reactants
not on the TSCA Chemical Substance Inventory. A polymer cannot be
manufactured under this section if the polymer being manufactured or
imported is prepared from monomers and/or other reactants (that are
either charged to the reaction vessel or incorporated in the polymer at
levels of greater than 2 weight percent) that are not already included
on the TSCA Chemical Substance Inventory or manufactured under an
applicable TSCA section 5 exemption.
(5) Water absorbing polymers with number average molecular weight
(MW) 10,000 and greater. A polymer cannot be manufactured under this
section if the polymer being manufactured or imported is a water
absorbing polymer and has a number average MW greater than or equal to
10,000 daltons. For purposes of this section, a water-absorbing polymer
is a polymeric substance that is capable of absorbing its weight of
water.
(6) Polymers which contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length. Except as provided in
paragraph (d)(6)(i), after February 26, 2010, a polymer cannot be
manufactured under this section if the polymer contains as an integral
part of its composition, except as impurities, one or more of the
following perfluoroalkyl moieties consisting of a CF3- or longer chain
length: Perfluoroalkyl sulfonates (PFAS), perfluoroalkyl carboxylates
(PFAC), fluorotelomers, or perfluoroalkyl moieties that are covalently
bound to either a carbon or sulfur atom where the carbon or sulfur atom
is an integral part of the polymer molecule.
[[Page 23]]
(i) Any polymer that has been manufactured previously in full
compliance with the requirements of this section prior to February 26,
2010 may no longer be manufactured under this section after January 27,
2012.
(ii) [Reserved]
(e) Exemption criteria. To be manufactured under this section, the
polymer must meet one of the following criteria:
(1) Polymers with number average MW greater than or equal to 1,000
and less than 10,000 daltons (and oligomer content less than 10 percent
below MW 500 and less than 25 percent below MW 1,000). (i) The polymer
must have a number average MW greater than or equal to 1,000 and less
than 10,000 daltons and contain less than 10 percent oligomeric material
below MW 500 and less than 25 percent oligomeric material below MW
1,000.
(ii) The polymer cannot contain reactive functional groups unless it
meets one of the following criteria:
(A) The polymer contains only the following reactive functional
groups: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated
olefinic groups that are considered ``ordinary,''(i.e., not specially
activated either by being part of a larger functional group, such as a
vinyl ether, or by other activating influences, e.g., strongly electron-
withdrawing sulfone group with which the olefinic groups interact),
butenedioic acid groups, those conjugated olefinic groups contained in
naturally-occurring fats, oils, and carboxylic acids, blocked
isocyanates (including ketoxime-blocked isocyanates), thiols,
unconjugated nitrile groups, and halogens (except that reactive halogen-
containing groups such as benzylic or allylichalides cannot be
included).
(B) The polymer has a combined (total) reactive group equivalent
weight greater than or equal to 1,000 for the following reactive
functional groups: acidhalides; acid anhydrides; aldehydes, hemiacetals;
methylolamides,- amines or,- ureas; alkoxysilanes with alkoxy greater
than C2-alkoxysilanes; allyl ethers; conjugated olefins;
cyanates; epoxides; imines; or unsubstituted positions ortho or para to
phenolic hydroxyl; or
(C) If any reactive functional groups not included in paragraph
(e)(1)(ii)(A) and (B) of this section are present, the combined (total)
reactive group equivalent weight, including any groups listed in
paragraph (e)(1)(ii)(B), is greater than or equal to 5,000.
(2) Polymers with number average MW greater than or equal to 10,000
(and oligomer content less than 2 percent below MW 500 and less than 5
percent below MW 1,000) . The polymer must have a number average MW
greater than or equal to 10,000 daltons and contain less than 2 percent
oligomeric material below MW 500 and less than 5 percent oligomeric
material below MW 1000.
(3) Polyester polymers. The polymer is a polyester as defined in
paragraph (b) of this section and is manufactured solely from one or
more of the reactants in the following table 1:
Table 1--List of Reactants From Which Polyester May be Made
------------------------------------------------------------------------
Reactant CAS No.
------------------------------------------------------------------------
Monobasic Acids and Natural Oils
Benzoic acid............................. 65-85-0
Canola oil............................... 120962-03-0
Coconut oil.............................. 8001-31-8*
Corn oil................................. 8001-30-7*
Cottonseed oil........................... 8001-29-4*
Dodecanoic acid.......................... 143-07-7
Fats and glyceridic oils, anchovy........ 128952-11-4*
Fats and glyceridic oils, babassu........ 91078-92-1*
Fats and glyceridic oils, herring........ 68153-06-0*
Fats and glyceridic oils, menhaden....... 8002-50-4*
Fats and glyceridic oils, sardine........ 93334-41-9*
Fats and glyceridic oils, oiticica....... 8016-35-1*
Fatty acids,C16-18 and C18-unsatd........ 67701-08-0*
Fatty acids, castor-oil.................. 61789-44-4*
Fatty acids, coco........................ 61788-47-4*
Fatty acids, dehydrated castor-oil....... 61789-45-5*
Fatty acids, linseed oil................. 68424-45-3*
Fatty acids, safflower oil...............
[[Page 24]]
Fatty acids, soya........................ 68308-53-2*
Fatty acids, sunflower oil............... 84625-38-7*
Fatty acids, sunflower-oil, conjugated... 68953-27-5*
Fatty acids, tall-oil.................... 61790-12-3*
Fatty acids, tall-oil, conjugated*.......
Fatty acids, vegetable oil............... 61788-66-7*
Glycerides, C16-18 and C18-unsatd........ 67701-30-8*
Heptanoic acid........................... 111-14-8
Hexanoic acid............................ 142-62-1
Hexanoic acid, 3,3,5-trimethyl-.......... 3302-10-1
Linseed oil.............................. 8001-26-1*
Linseed oil, oxidized.................... 68649-95-6*
Nonanoic acid............................ 112-05-0
Oils, Cannabis*..........................
Oils, palm kernel........................ 8023-79-8*
Oils, perilla............................ 68132-21-8*
Oils, walnut............................. 8024-09-7
Safflower oil............................ 8001-23-8*
Soybean oil.............................. 8001-22-7*
Sunflower oil............................ 8001-21-6*
Tung oil................................. 8001-20-5*
Di and Tri Basic Acids:
1,2-Benzenedicarboxylic acid............. 88-99-3
1,3-Benzenedicarboxylic acid............. 121-91-5
1,3-Benzenedicarboxylic acid, dimethyl 1459-93-4
ester.
1,4-Benzenedicarboxylic acid............. 100-21-0
1,4-Benzenedicarboxylic acid, diethyl 636-09-9
ester.
1,4-Benzenedicarboxylic acid, dimethyl 120-61-6
ester.
1,2,4-Benzenetricarboxylic acid.......... 528-44-9
Butanedioic acid......................... 110-15-6
Butanedioic acid, diethyl ester.......... 123-25-1
Butanedioic acid, dimethyl ester......... 106-65-0
2-Butenedioic acid (E)-.................. 110-17-8
Decanedioic acid......................... 111-20-6
Decanedioic acid, diethyl ester.......... 110-40-7
Decanedioic acid, dimethyl ester......... 106-79-6
Dodecanedioic acid....................... 693-23-2
Fatty acids, C18-unsatd., dimers......... 61788-89-4*
Heptanedioic acid........................ 111-16-0
Heptanedioic acid, dimethyl ester........ 1732-08-7
Hexanedioic acid......................... 124-04-9
Hexanedioic acid, dimethyl ester......... 627-93-0
Hexanedioic acid, diethyl ester.......... 141-28-6
Nonanedioic acid......................... 123-99-9
Nonanedioic acid, dimethyl ester......... 1732-10-1
Nonanedioic acid, diethyl ester.......... 624-17-9
Octanedioic acid......................... (505-48-6)
Octanedioic acid, dimethyl ester......... 1732-09-8
Pentanedioic acid........................ (110-94-1)
Pentanedioic acid, dimethyl ester........ 1119-40-0
Pentanedioic acid, diethyl ester......... 818-38-2
Undecanedioic acid....................... 1852-04-6
Polyols
1,3-Butanediol........................... 107-88-0
1,4-Butanediol........................... 110-63-4
1,4-Cyclohexanedimethanol................ 105-08-8
1,2-Ethanediol........................... 107-21-1
Ethanol, 2,2'-oxybis-.................... 111-46-6
1,6-Hexanediol........................... 629-11-8
1,3-Pentanediol, 2,2,4-trimethyl-........ 144-19-4
1,2-Propanediol,......................... 57-55-6
1,3-Propanediol, 2,2-bis(hydroxymethyl)-. 115-77-5
1,3-Propanediol, 2,2-dimethyl-........... 126-30-7
1,3-Propanediol, 2-ethyl-2- 77-99-6
(hydroxymethyl)-.
1,3-Propanediol, 2-(hydroxymethyl)-2- 77-85-0
methyl-.
1,3-propanediol, 2-methyl................ 2163-42-0
1,2,3-Propanetriol....................... 56-81-5
1,2,3-Propanetriol, homopolymer.......... 25618-55-7
2-Propen-1-ol, polymer with 25119-62-4
ethenylbenzene.
Modifiers
Acetic acid, 2,2'-oxybis-................ 110-99-6
[[Page 25]]
1-Butanol................................ 71-36-3**
Cyclohexanol............................. 108-93-0
Cyclohexanol, 4,4'-(1- 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 the exemption are not allowed at any level.
(2) A representative structural diagram, if possible.
(h) Certification. To manufacture a substance under the terms of
this section, a manufacturer must as of the date of first manufacture,
make the following certification statements and maintain them in
accordance with paragraph (j) of this section:
(1) The substance is manufactured or imported for a commercial
purpose other than for research and development.
(2) All information in the certification is truthful.
(3) The new chemical substance meets the definition of a polymer, is
not specifically excluded from the exemption in paragraph (d) of this
section, and meets the conditions of the exemption in paragraph (e) of
this section.
(i) Exemptions granted under superseded regulations. Manufacturers
granted exemptions under the superseded requirements of Sec. 723.250
(as in effect on
[[Page 26]]
May 26, 1995) shall either continue to comply with those requirements or
follow all procedural and recordkeeping requirements pursuant to this
section. If an exemption holder continues to follow the superseded
regulations, the Notice of Commencement requirements apply and the
exempt polymer will continue to be listed on the Inventory with
exclusion criteria and exemption category restrictions on residual
monomer/reactant and low molecular weight species content limitations.
(j) Recordkeeping. (1) A manufacturer of a new polymer under
paragraphs (e) of this section, must retain the records described in
this paragraph at the manufacturing site for a period of 5 years from
the date of commencement of manufacture or import.
(2) The records must include the following to demonstrate compliance
with the terms of this section:
(i) Chemical identity information as required in paragraph (g) of
this section.
(ii) Information to demonstrate that the new polymer is not
specifically excluded from the exemption.
(iii) Records of production volume for the first 3 years of
manufacture and the date of commencement of manufacture.
(iv) Information to demonstrate that the new polymer meets the
exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this
section.
(v) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the number-average MW
exemption criteria in paragraphs (e)(1) or (e)(2) of this section. The
analytical tests may include gel permeation chromatography (GPC).vapor
pressure osmometry (VPO), or other such tests which will demonstrate
that the polymer meets the number-average MW criterion.
(vi) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the criteria in
paragraphs (e)(1) or (e)(2) of this section, meets the low MW content
criteria in paragraphs (e)(1) or (e)(2) of this section.
(vii) If applicable, analytical data, or theoretical calculations
(if it can be documented that an analytical determination cannot be made
or is not necessary) required in paragraph (g) of this section for
determining monomers or reactants charged to the reaction vessel at
greater than 2 weight percent but incorporated at 2 weight percent or
less in the manufactured polymer.
(viii) The certification statements as required under paragraph (h)
of this section.
(3) The manufacturer must submit the records listed in paragraph
(j)(2) of this section to EPA upon written request by EPA. The
manufacturer must provide these records within 15 working days of
receipt of this request. In addition, any person who manufactures a new
chemical substance under the terms of this section, upon request of EPA,
must permit such person at all reasonable times to have access to and to
copy these records.
(k) Submission of information. Information submitted to EPA under
this section must be sent in writing to: TSCA Document Control Officer,
(7407), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(l) Compliance. (1) A person who manufactures or imports a new
chemical substance and fails to comply with any provision of this
section is in violation of section 15 of the Act (15 U.Sec. 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.Sec. 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.Sec. 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.Sec. C.
2614).
(5) Violators may be subject to the civil and criminal penalties in
section
[[Page 27]]
16 of the Act (15 U.Sec. 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.Sec. C. 2606) or section 17 of the Act (15 U.Sec. C. 2616).
(m) Inspections. EPA will conduct inspections under section 11 of
the Act to assure compliance with section 5 and this section, to verify
that information submitted to EPA under this section is true and
correct, and to audit data submitted to EPA under this section.
(n) Confidentiality. If a manufacturer submits information to EPA
under this section which the manufacturer claims to be confidential
business information, the manufacturer must clearly identify the
information at the time of submission to EPA by bracketing, circling, or
underlining it and stamping it with ``CONFIDENTIAL'' or some other
appropriate designation. Any information so identified will be treated
in accordance with the procedures in 40 CFR part 2. Any information not
claimed confidential at the time of submission may be made available to
the public without further notice.
[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, Apr. 11, 1997;
75 FR 4305, Jan. 27, 2010]
PART 725_REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
Subpart A_General Provisions and Applicability
Sec.
725.1 Scope and purpose.
725.3 Definitions.
725.8 Coverage of this part.
725.12 Identification of microorganisms for Inventory and other listing
purposes.
725.15 Determining applicability when microorganism identity or use is
confidential or uncertain.
725.17 Consultation with EPA.
Subpart B_Administrative Procedures
725.20 Scope and purpose.
725.25 General administrative requirements.
725.27 Submissions.
725.28 Notice that submission is not required.
725.29 EPA acknowledgement of receipt of submission.
725.32 Errors in the submission.
725.33 Incomplete submissions.
725.36 New information.
725.40 Notice in the Federal Register.
725.50 EPA review.
725.54 Suspension of the review period.
725.56 Extension of the review period.
725.60 Withdrawal of submission by the submitter.
725.65 Recordkeeping.
725.67 Applications to exempt new microorganisms from this part.
725.70 Compliance.
725.75 Inspections.
Subpart C_Confidentiality and Public Access to Information
725.80 General provisions for confidentiality claims.
725.85 Microorganism identity.
725.88 Uses of a microorganism.
725.92 Data from health and safety studies of microorganisms.
725.94 Substantiation requirements.
725.95 Public file.
Subpart D_Microbial Commercial Activities Notification Requirements
725.100 Scope and purpose.
725.105 Persons who must report.
725.110 Persons not subject to this subpart.
725.150 Procedural requirements for this subpart.
725.155 Information to be included in the MCAN.
725.160 Submission of health and environmental effects data.
725.170 EPA review of the MCAN.
725.190 Notice of commencement of manufacture or import.
Subpart E_Exemptions for Research and Development Activities
725.200 Scope and purpose.
725.205 Persons who may report under this subpart.
725.232 Activities subject to the jurisdiction of other Federal programs
or agencies.
725.234 Activities conducted inside a structure.
725.235 Conditions of exemption for activities conducted inside a
structure.
725.238 Activities conducted outside a structure.
725.239 Use of specific microorganisms in activities conducted outside a
structure.
[[Page 28]]
725.250 Procedural requirements for the TERA.
725.255 Information to be included in the TERA.
725.260 Submission of health and environmental effects data.
725.270 EPA review of the TERA.
725.288 Revocation or modification of TERA approval.
Subpart F_Exemptions for Test Marketing
725.300 Scope and purpose.
725.305 Persons who may apply under this subpart.
725.350 Procedural requirements for this subpart.
725.355 Information to be included in the TME application.
725.370 EPA review of the TME application.
Subpart G_General Exemptions for New Microorganisms
725.400 Scope and purpose.
725.420 Recipient microorganisms.
725.421 Introduced genetic material.
725.422 Physical containment and control technologies.
725.424 Requirements for the Tier I exemption.
725.426 Applicability of the Tier I exemption.
725.428 Requirements for the Tier II exemption.
725.450 Procedural requirements for the Tier II exemption.
725.455 Information to be included in the Tier II exemption request.
725.470 EPA review of the Tier II exemption request.
Subparts H-K [Reserved]
Subpart L_Additional Procedures for Reporting on Significant New Uses of
Microorganisms
725.900 Scope and purpose.
725.910 Persons excluded from reporting significant new uses.
725.912 Exemptions.
725.920 Exports and imports.
725.950 Additional recordkeeping requirements.
725.975 EPA approval of alternative control measures.
725.980 Expedited procedures for issuing significant new use rules for
microorganisms subject to section 5(e) orders.
725.984 Modification or revocation of certain notification requirements.
Subpart M_Significant New Uses for Specific Microorganisms
725.1000 Scope.
725.1075 Burkholderia cepacia complex.
Authority: 15 U.Sec. 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,
[[Page 29]]
for which compliance with MCAN requirements is required. The TERA
exemptions are for R&D activities subject to other Federal agencies or
programs (see Sec. 725.232), certain kinds of contained R&D activities
(see Sec. 725.234), and R&D activities using certain listed
microorganisms (see Sec. 725.238).
(d) New microorganisms will be added to the Inventory established
under section 8 of TSCA once a MCAN has been received, the MCAN review
period has expired, and EPA receives a Notice of Commencement (NOC)
indicating that manufacture or importation has actually begun. New
microorganisms approved for use under a TERA will not be added to the
Inventory until a MCAN has been received, the MCAN review period has
expired, and EPA has received an NOC.
Sec. 725.3 Definitions.
Definitions in section 3 of the Act (15 U.Sec. 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.
Genome means the sum total of chromosomal and extrachromosomal
genetic material of an isolate and any descendants derived under pure
culture conditions from that isolate.
Health and safety study of a microorganism or health and safety
study means any study of any effect of a microorganism or microbial
mixture on health or the environment or on both, including underlying
data and epidemiological studies, studies of occupational exposure to a
microorganism or microbial mixture, toxicological, clinical, and
ecological, or other studies of a microorganism or microbial mixture,
and any test performed under the Act. Microorganism identity is always
part of a health and safety study of a microorganism.
(1) It is intended that the term ``health and safety study of a
microorganism'' be interpreted broadly. Not only is information which
arises as a result of a formal, disciplined study included, but other
information relating to the effects of a microorganism or microbial
mixture on health or the environment is also included. Any data that
bear on the effects of a microorganism on health or the environment
would be included.
(2) Examples include:
(i) Tests for ecological or other environmental effects on
invertebrates, fish, or other animals, and plants, including: Acute
toxicity tests, chronic toxicity tests, critical life stage tests,
behavioral tests, algal growth tests, seed germination tests, plant
growth or damage tests, microbial function tests, bioconcentration or
bioaccumulation tests, and model ecosystem (microcosm) studies.
(ii) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; dermatoxicity; cumulative, additive, and synergistic
effects; and acute, subchronic, and chronic effects.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular microorganism or
microbial mixture on the environment, including surveys, tests, and
studies of: Survival and transport in air, water, and soil; ability to
exchange genetic material with other microorganisms, ability to colonize
human or animal guts, and ability to colonize plants.
[[Page 30]]
(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a microorganism.
(v) Any assessments of risk to health and the environment resulting
from the manufacture, processing, distribution in commerce, use, or
disposal of the microorganism.
Inactivation means that living microorganisms are rendered
nonviable.
Institutional Biosafety Committee means the committees described in
the NIH Guidelines in section IV.B.2.
Intergeneric microorganism means a microorganism that is formed by
the deliberate combination of genetic material originally isolated from
organisms of different taxonomic genera.
(1) The term ``intergeneric microorganism'' includes a microorganism
which contains a mobile genetic element which was first identified in a
microorganism in a genus different from the recipient microorganism.
(2) The term ``intergeneric microorganism'' does not include a
microorganism which contains introduced genetic material consisting of
only well-characterized, non-coding regulatory regions from another
genus.
Introduced genetic material means genetic material that is added to,
and remains as a component of, the genome of the recipient.
Manufacture, import, or process for commercial purposes means:
(1) To import, produce, manufacture, or process with the purpose of
obtaining an immediate or eventual commercial advantage for the
manufacturer, importer, or processor, and includes, among other things,
``manufacture'' or ``processing'' of any amount of a microorganism or
microbial mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research
and development or as an intermediate.
(2) The term also applies to substances that are produced
coincidentally during the manufacture, processing, use, or disposal of
another microorganism or microbial mixture, including byproducts that
are separated from that other microorganism or microbial mixture and
impurities that remain in that microorganism or microbial mixture.
Byproducts and impurities without separate commercial value are
nonetheless produced for the purpose of obtaining a commercial
advantage, since they are part of the manufacture or processing of a
microorganism for commercial purposes.
Microbial commercial activity notice or MCAN means a notice for
microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act
in accordance with subpart D of this part.
Microbial mixture means any combination of microorganisms or
microorganisms and other chemical substances, if the combination does
not occur in nature and is not an article.
Microorganism means an organism classified, using the 5-kingdom
classification system of Whittacker, in the kingdoms Monera (or
Procaryotae), Protista, Fungi, and the Chlorophyta and the Rhodophyta of
the Plantae, and a virus or virus-like particle.
Mobile genetic element or MGE means an element of genetic material
that has the ability to move genetic material within and between
organisms. ``Mobile genetic elements'' include all plasmids, viruses,
transposons, insertion sequences, and other classes of elements with
these general properties.
New microorganism means a microorganism not included on the
Inventory.
NIH Guidelines means the National Institutes of Health (NIH)
``Guidelines for Research Involving Recombinant DNA Molecules'' (July 5,
1994).
Non-coding regulatory region means a segment of introduced genetic
material for which:
(1) The regulatory region and any inserted flanking nucleotides do
not code for protein, peptide, or functional ribonucleic acid molecules.
(2) The regulatory region solely controls the activity of other
regions that code for protein or peptide molecules or act as recognition
sites for the initiation of nucleic acid or protein synthesis.
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or analysis
or research on, or analysis of, such substance or another substance,
including such research or analysis for development of a product'')
[[Page 31]]
means quantities of a microorganism manufactured, imported, or processed
or proposed to be manufactured, imported, or processed solely for
research and development that meet the requirements of Sec. 725.234.
Structure means a building or vessel which effectively surrounds and
encloses the microorganism and includes features designed to restrict
the microorganism from leaving.
Submission means any MCAN or exemption request submitted to EPA
under this part.
Technically qualified individual means a person or persons:
(1) Who, because of education, training, or experience, or a
combination of these factors, is capable of understanding the health and
environmental risks associated with the microorganism which is used
under his or her supervision,
(2) Who is responsible for enforcing appropriate methods of
conducting scientific experimentation, analysis, or microbiological
research to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances
related to the procurement, storage, use, and disposal of the
microorganism as may be appropriate or required within the scope of
conducting a research and development activity.
TSCA Experimental Release Application or TERA means an exemption
request for a research and development activity, which is not eligible
for a full exemption from reporting under Sec. 725.232, 725.234, or
725.238, submitted to EPA in accordance with subpart E of this part.
Well-characterized for introduced genetic material means that the
following have been determined:
(1) The function of all of the products expressed from the
structural gene(s).
(2) The function of sequences that participate in the regulation of
expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and
their associated functions, where associated nucleotide sequences are
those sequences needed to move genetic material including linkers,
homopolymers, adaptors, transposons, insertion sequences, and
restriction enzyme sites.
Sec. 725.8 Coverage of this part.
(a) Microorganisms subject to this part. Only microorganisms which
are manufactured, imported, or processed for commercial purposes, as
defined in Sec. 725.3, are subject to the requirements of this part.
(b) Microorganisms automatically included on the Inventory.
Microorganisms that are not intergeneric are automatically included on
the Inventory.
(c) Microorganisms not subject to this part. The following
microorganisms are not subject to this part, either because they are not
subject to jurisdiction under the Act or are not subject to reporting
under section 5 of the Act.
(1) Any microorganism which would be excluded from the definition of
``chemical substance'' in section 3 of the Act and Sec. 720.3(e) of
this chapter.
(2) Any microbial mixture as defined in Sec. 725.3. This exclusion
applies only to a microbial mixture as a whole and not to any
microorganisms and other chemical substances which are part of the
microbial mixture.
(3) Any microorganism that is manufactured and processed solely for
export if the following conditions are met:
(i) The microorganism is labeled in accordance with section
12(a)(1)(B) of the Act, when the microorganism is distributed in
commerce.
(ii) The manufacturer and processor can document at the commencement
of manufacturing or processing that the person to whom the microorganism
will be distributed intends to export it or process it solely for export
as defined in Sec. 721.3 of this chapter.
Sec. 725.12 Identification of microorganisms for Inventory and other
listing purposes.
To identify and list microorganisms on the Inventory, both taxonomic
designations and supplemental information will be used. The supplemental
information required in paragraph (b) of this section will be used to
specifically describe an individual microorganism on the Inventory.
Submitters must provide the supplemental information required by
paragraph (b) of this section to the extent necessary to enable a
microorganism to be accurately and
[[Page 32]]
unambiguously identified on the Inventory.
(a) Taxonomic designation. The taxonomic designation of a
microorganism must be provided for the donor organism and the recipient
microorganism to the level of strain, as appropriate. These designations
must be substantiated by a letter from a culture collection, literature
references, or the results of tests conducted for the purpose of
taxonomic classification. Upon EPA's request to the submitter, data
supporting the taxonomic designation must be provided to EPA. The
genetic history of the recipient microorganism should be documented back
to the isolate from which it was derived.
(b) Supplemental information. The supplemental information described
in paragraphs (b)(1) and (b)(2) of this section is required to the
extent that it enables a microorganism to be accurately and
unambiguously identified.
(1) Phenotypic information. Phenotypic information means pertinent
traits that result from the interaction of a microorganism's genotype
and the environment in which it is intended to be used and may include
intentionally added biochemical and physiological traits.
(2) Genotypic information. Genotypic information means the pertinent
and distinguishing genotypic characteristics of a microorganism, such as
the identity of the introduced genetic material and the methods used to
construct the reported microorganism. This also may include information
on the vector construct, the cellular location, and the number of copies
of the introduced genetic material.
Sec. 725.15 Determining applicability when microorganism identity or
use is confidential or uncertain.
(a) Consulting EPA. Persons intending to conduct activities
involving microorganisms may determine their obligations under this part
by consulting the Inventory or the microorganisms and uses specified in
Sec. 725.239 or in subpart M of this part. This section establishes
procedures for EPA to assist persons in determining whether the
microorganism or the use is listed on the Inventory, in Sec. 725.239 or
in subpart M of this part.
(1) Confidential identity or use. In some cases it may not be
possible to directly determine if a specific microorganism is listed,
because portions of that entry may contain generic information to
protect confidential business information (CBI). If any portion of the
microorganism's identity or use has been claimed as CBI, that portion
does not appear on the public version of the Inventory, in Sec. 725.239
or in subpart M of this part. Instead, it is contained in a confidential
version held in EPA's Confidential Business Information Center (CBIC).
The public versions contain generic information which masks the
confidential business information. A person who intends to conduct an
activity involving a microorganism or use whose entry is described with
generic information will need to inquire of EPA whether the unreported
microorganism or use is on the confidential version.
(2) Uncertain microorganism identity. The current state of
scientific knowledge leads to some imprecision in describing a
microorganism. As the state of knowledge increases, EPA will be
developing policies to determine whether one microorganism is equivalent
to another. Persons intending to conduct activities involving
microorganisms may inquire of EPA whether the microorganisms they intend
to manufacture (including import) or process are equivalent to specific
microorganisms described on the Inventory, in Sec. 725.239, or in
subpart M of this part.
(b) Requirement of bona fide intent. (1) EPA will answer the
inquiries described in paragraph (a) of this section only if the Agency
determines that the person has a bona fide intent to conduct the
activity for which reporting is required or for which any exemption may
apply.
(2) To establish a bona fide intent to manufacture (including
import) or process a microorganism, the person who proposes to
manufacture (including import) or process the microorganism must submit
the request to EPA via CDX. Prior to submission to EPA via CDX, such
bona fide intents to manufacture (including import) or process must be
generated and completed using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how
[[Page 33]]
to access the e-PMN software. A bona fide intent to manufacture
(including import) or process must contain the following information:
(i) Taxonomic designations and supplemental information required by
Sec. 725.12.
(ii) A signed statement certifying that the submitter intends to
manufacture (including import) or process the microorganism for
commercial purposes.
(iii) A description of research and development activities conducted
with the microorganism to date, demonstration of the submitter's ability
to produce or obtain the microorganism from a foreign manufacturer, and
the purpose for which the person will manufacture (including import) or
process the microorganism.
(iv) An indication of whether a related microorganism was previously
reviewed by EPA to the extent known by the submitter.
(v) A specific description of the major intended application or use
of the microorganism.
(c) If an importer or processor cannot provide all the information
required by paragraph (b) of this section, because it is claimed as
confidential business information by its foreign manufacturer or
supplier, the foreign manufacturer or supplier may supply the
information directly to EPA.
(d) EPA will review the information submitted by the manufacturer
(including importer) or processor under this paragraph to determine
whether that person has shown a bona fide intent to manufacture
(including import) or process the microorganism. If necessary, EPA will
compare this information to the information requested for the
confidential microorganism under Sec. 725.85(b)(3)(iii).
(e) In order for EPA to make a conclusive determination of the
microorganism's status, the proposed manufacturer (including importer)
or processor must show a bona fide intent to manufacture (including
import) or process the microorganism and must provide sufficient
information to establish identity unambiguously. After sufficient
information has been provided, EPA will inform the manufacturer
(including importer) or processor whether the microorganism is subject
to this part and if so, which sections of this part apply.
(f) If the microorganism is found on the confidential version of the
Inventory, in Sec. 725.239 or in subpart M of this part, EPA will
notify the person(s) who originally reported the microorganism that
another person (whose identity will remain confidential, if so
requested) has demonstrated a bona fide intent to manufacture (including
import) or process the microorganism and therefore was told that the
microorganism is on the Inventory, in Sec. 725.239, or in subpart M of
this part.
(g) A disclosure to a person with a bona fide intent to manufacture
(including import) or process a particular microorganism that the
microorganism is on the Inventory, in Sec. 725.239, or in subpart M of
this part will not be considered a public disclosure of confidential
business information under section 14 of the Act.
(h) EPA will answer an inquiry on whether a particular microorganism
is subject to this part within 30 days after receipt of a complete
submission under paragraph (b) of this section.
[62 FR 17932, Apr. 11, 1997, as amended at 80 FR 42747, July 20, 2015]
Sec. 725.17 Consultation with EPA.
Persons may consult with EPA, either in writing or by telephone,
about their obligations under this part. Written consultation is
preferred. Written inquiries should be sent to the following address:
Environmental Assistance Division (7408), Office of Pollution Prevention
and Toxics, U.Sec. Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice
Consultation. Persons wishing to consult with EPA by telephone should
call (202) 554-1404; hearing impaired TDD (202) 554-0551 or e-mail:
[email protected].
Subpart B_Administrative Procedures
Sec. 725.20 Scope and purpose.
This subpart describes general administrative procedures applicable
to
[[Page 34]]
all persons who submit MCANs and exemption requests to EPA under section
5 of the Act for microorganisms.
Sec. 725.25 General administrative requirements.
(a) General. (1) Each person who is subject to the notification
provisions of this part must complete, sign, and submit a MCAN or
exemption request containing the information as required for the
appropriate submission under this part. Except as otherwise provided,
each submission must include all referenced attachments. All information
in the submission (unless certain attachments appear in the open
scientific literature) must be in English. All information submitted
must be true and correct.
(2) In addition to specific information required, the submitter
should submit all information known to or reasonably ascertainable by
the submitter that would permit EPA to make a reasoned evaluation of the
human health and environmental effects of the microorganism and any
microbial mixture or article that may contain the microorganism.
(b) Certification. Persons submitting MCANs and exemption requests
to EPA under this part, and material related to their reporting
obligations under this part, must attach the following statement to any
information submitted to EPA. This statement must be signed and dated by
an authorized official of the submitter:
I certify that to the best of my knowledge and belief: The company
named in this submission intends to manufacture, import, or process for
a commercial purpose, other than in small quantities solely for research
and development, the microorganism identified in this submission. All
information provided in this submission is complete and truthful as of
the date of submission. I am including with this submission all test
data in my possession or control and a description of all other data
known to or reasonably ascertainable by me as required by 40 CFR 725.160
or 725.260.
(c) Where to submit information under this part. MCANs and exemption
requests, and any support documents related to these submissions, may
only be submitted in a manner set forth in this paragraph. MCANs and
exemption requests, and any related support documents, must be
generated, completed, and submitted to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software.
(d) General requirements for submission of data. (1) Submissions
under this part must include the information described in Sec. 725.155,
725.255, 725.355, or 725.455, as appropriate, to the extent such
information is known to or reasonably ascertainable by the submitter.
(2) In accordance with Sec. 725.160 or 725.260, as appropriate, the
submission must also include any test data in the submitter's possession
or control and descriptions of other data which are known to or
reasonably ascertainable by the submitter and which concern the health
and environmental effects of the microorganism.
(e) Agency or joint submissions. (1) A manufacturer or importer may
designate an agent to assist in submitting the MCAN. If so, only the
manufacturer or importer, and not the agent, signs the certification on
the form.
(2) A manufacturer or importer may authorize another person, (e.g.,
a supplier or a toll manufacturer) to report some of the information
required in the MCAN to EPA on its behalf. The manufacturer or importer
should indicate in a cover letter accompanying the MCAN which
information will be supplied by another person and identify that other
person as a joint submitter where indicated in their MCAN. The other
person supplying information (i.e., the joint submitter) may submit the
information to EPA either in the MCAN or a Letter of Support, except
that if the joint submitter is not incorporated, licensed, or doing
business in the United States, the joint submitter must submit the
information to EPA in a Letter of Support only, rather than the MCAN.
The joint submitter must indicate in the MCAN or Letter of Support the
identity of the manufacturer or importer. Any person who submits the
MCAN or Letter of Support for a joint submission must sign and certify
the MCAN or Letter of Support.
(3) If EPA receives a submission which does not include the
information required, which the submitter indicates that it has
authorized another person to provide, the review period will not
[[Page 35]]
begin until EPA receives all of the required information.
(f) Microorganisms subject to a section 4 test rule. (1) Except as
provided in paragraph (f)(3) of this section, if a person intends to
manufacture or import a new microorganism which is subject to the
notification requirements of this part, and the microorganism is subject
to a test rule promulgated under section 4 of the Act before the notice
is submitted, section 5(b)(1) of the Act requires the person to submit
the test data required by the testing rule with the notice. The person
must submit the data in the form and manner specified in the test rule
and in accordance with Sec. 725.160. If the person does not submit the
test data, the submission is incomplete and EPA will follow the
procedures in Sec. 725.33.
(2) If EPA has granted the submitter an exemption under section 4(c)
of the Act from the requirement to conduct tests and submit data, the
person may not file a MCAN or TERA until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c)
of the Act and if another person previously has submitted the test data
to EPA, the exempted person may either submit the test data or provide
the following information as part of the notice:
(i) The name, title, and address of the person who submitted the
test data to EPA.
(ii) The date the test data were submitted to EPA.
(iii) A citation for the test rule.
(iv) A description of the exemption and a reference identifying it.
(g) Microorganisms subject to a section 5(b)(4) rule. (1) If a
person:
(i) Intends to manufacture or import a microorganism which is
subject to the notification requirements of this part and which is
subject to a rule issued under section 5(b)(4) of the Act; and
(ii) Is not required by a rule issued under section 4 of the Act to
submit test data for the microorganism before the filing of a
submission, the person must submit to EPA data described in paragraph
(g)(2) of this section at the time the submission is filed.
(2) Data submitted under paragraph (g)(1) of this section must be
data which the person submitting the notice believes show that the
manufacture, processing, distribution in commerce, use, and disposal of
the microorganism, or any combination of such activities, will not
present an unreasonable risk of injury to health or the environment.
(h) Data that need not be submitted. Specific data requirements are
listed in subparts D, E, F, G, and L of this part. The following is a
list of data that need not be submitted under this part:
(1) Data previously submitted to EPA. (i) A person need not submit
any data previously submitted to EPA with no claims of confidentiality
if the new submission includes: the office or person to whom the data
were submitted; the date of submission; and, if appropriate, a standard
literature citation as specified in Sec. 725.160(a)(3)(ii).
(ii) For data previously submitted to EPA with a claim of
confidentiality, the person must resubmit the data with the new
submission and any claim of confidentiality, under Sec. 725.80.
(2) Efficacy data. This part does not require submission of any data
related solely to product efficacy. However, including efficacy data
will improve EPA's ability to assess the benefits of the use of the
microorganism. This does not exempt a person from submitting any of the
data specified in Sec. 725.160 or 725.260.
(3) Non-U.Sec. exposure data. This part does not require submission of
any data which relates only to exposure of humans or the environment
outside the United States. This does not exclude nonexposure data such
as data on health effects (including epidemiological studies),
ecological effects, physical and chemical properties, or environmental
fate characteristics.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Sec. 725.27 Submissions.
Each person who is required to submit information under this part
must submit the information in the form and manner set forth in the
appropriate subpart.
(a) Requirements specific to MCANs are described in Sec. Sec.
725.150 through 725.160.
[[Page 36]]
(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, 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.Sec. mail to the submitter that identifies the number
assigned to each MCAN or exemption request and the date on which the
review period begins. The review period will begin on the date the MCAN
or exemption request is received by the Office of Pollution Prevention
and Toxics Document Control Officer.
(b) The acknowledgement does not constitute a finding by EPA that
the submission is in compliance with this part.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010]
Sec. 725.32 Errors in the submission.
(a) Within 30 days of receipt of the submission, EPA may request
that the submitter remedy errors in the submission. The following are
examples of such errors:
(1) Failure to date the submission.
(2) Typographical errors that cause data to be misleading or answers
to any questions to be unclear.
(3) Contradictory information.
(4) Ambiguous statements or information.
(b) In the request to correct the submission, EPA will explain the
action which the submitter must take to correct the submission.
(c) If the submitter fails to correct the submission within 15 days
of receipt of the request, EPA may extend the review period.
Sec. 725.33 Incomplete submissions.
(a) A submission under this part is not complete, and the review
period does not begin, if:
(1) The wrong person files the submission.
(2) The submitter does not attach and sign the certification
statement as required by Sec. 725.25(b).
(3) Some or all of the information in the submission or any
attachments are not in English, except for published scientific
literature.
(4) The submitter does not provide information that is required by
sections 5(d)(1)(B) and (C) of the Act and Sec. 725.160 or 725.260, as
appropriate.
(5) The submitter does not provide information required by Sec.
725.25, Sec. 725.155, Sec. 725.255, Sec. 725.355, or Sec. 725.455,
as appropriate, or indicate that it is not known to or reasonably
ascertainable by the submitter.
(6) The submitter has asserted confidentiality claims and has failed
to:
(i) Submit a second copy of the submission with all confidential
information deleted for the public file, as required by Sec.
725.80(b)(2).
(ii) Comply with the substantiation requirements as described in
Sec. 725.94.
(7) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by Sec. 725.25(f).
(8) The submitter does not submit data which the submitter believes
show that the microorganism will not present an unreasonable risk of
injury to health or the environment, if EPA has listed the microorganism
under section 5(b)(4) of the Act, as required in Sec. 725.25(g).
(9) For MCANs, the submitter does not remit the fees required by
Sec. 700.45(b)(1) or (b)(2)(vi) of this chapter.
[[Page 37]]
(10) The submitter does not include an identifying number and a
payment identity number as required by Sec. 700.45(e)(3) of this
chapter.
(11) The submitter does not submit the notice in the manner set
forth in Sec. 725.25(c).
(b)(1) If EPA receives an incomplete submission under this part, the
Director, or a designee, will notify the submitter within 30 days of
receipt that the submission is incomplete and that the review period
will not begin until EPA receives a complete submission.
(2) If EPA obtains additional information during the review period
for any submission that indicates the original submission was
incomplete, the Director, or a designee, may declare the submission
incomplete within 30 days after EPA obtains the additional information
and so notify the submitter.
(c) The notification that a submission is incomplete under paragraph
(b) of this section will include:
(1) A statement of the basis of EPA's determination that the
submission is incomplete.
(2) The requirements for correcting the incomplete submission.
(3) Information on procedures under paragraph (d) of this section
for filing objections to the determination or requesting modification of
the requirements for completing the submission.
(d) Within 10 days after receipt of notification by EPA that a
submission is incomplete, the submitter may file written objections
requesting that EPA accept the submission as complete or modify the
requirements necessary to complete the submission.
(e)(1) EPA will consider the objections filed by the submitter. The
Director, or a designee, will determine whether the submission was
complete or incomplete, or whether to modify the requirements for
completing the submission. EPA will notify the submitter in writing of
EPA's response within 10 days of receiving the objections.
(2) If the Director, or a designee, determines, in response to the
objection, that the submission was complete, the review period will be
deemed suspended on the date EPA declared the submission incomplete, and
will resume on the date that the submission is declared complete. The
submitter need not correct the submission as EPA originally requested.
If EPA can complete its review within the review period beginning on the
date of the submission, the Director, or a designee, may inform the
submitter that the running of the review period will resume on the date
EPA originally declared it incomplete.
(3) If the Director, or a designee, modifies the requirements for
completing the submission or concurs with EPA's original determination,
the review period will begin when EPA receives a complete submission.
(f) If EPA discovers at any time that a person submitted materially
false or misleading statements in information submitted under this part,
EPA may find that the submission was incomplete from the date it was
submitted, and take any other appropriate action.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010]
Sec. 725.36 New information.
(a) During the review period, if a submitter possesses, controls, or
knows of new information that materially adds to, changes, or otherwise
makes significantly more complete the information included in the MCAN
or exemption request, the submitter must send that information within 10
days of receiving the new information, but no later than 5 days before
the end of the review period. The new information must be sent in the
same manner the original notice or exemption was sent, as described in
Sec. 725.25(c)(1), (c)(2), and (c)(3).
(b) The new submission must clearly identify the submitter, the MCAN
or exemption request to which the new information is related, and the
number assigned to that submission by EPA, if known to the submitter.
(c) If the new information becomes available during the last 5 days
of the review period, the submitter must immediately inform the EPA
contact for that submission by telephone of the new information.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010]
[[Page 38]]
Sec. 725.40 Notice in the Federal Register.
(a) Filing of Federal Register notice. After EPA receives a MCAN or
an exemption request under this part, EPA will issue a notice in the
Federal Register including the information specified in paragraph (b) of
this section.
(b) Contents of notice. (1) In the public interest, the specific
microorganism identity listed in the submission will be published in the
Federal Register unless the submitter has claimed the microorganism
identity confidential. If the submitter claims confidentiality, a
generic name will be published in accordance with Sec. 725.85.
(2) The categories of use of the microorganism will be published as
reported in the submission unless this information is claimed
confidential. If confidentiality is claimed, the generic information
which is submitted under Sec. 725.88 will be published.
(3) A list of information submitted in accordance with Sec.
725.160(a), Sec. 725.255, Sec. 725.260, Sec. 725.355, or Sec.
725.455, as appropriate, will be published.
(4) The submitter's identity will be published, unless the submitter
has claimed it confidential.
(c) Publication of exemption decisions. Following the expiration of
the appropriate review period for the exemption request, EPA will issue
a notice in the Federal Register indicating whether the request has been
approved or denied and the reasons for the decision.
Sec. 725.50 EPA review.
(a) MCANs. The review period specified in section 5(a) of the Act
for MCANs runs for 90 days from the date the Document Control Officer
receives a complete submission, or the date EPA determines the
submission is complete under Sec. 725.33, unless the Agency extends the
review period under section 5(c) of the Act and Sec. 725.56.
(b) Exemption requests. The review period starts on the date the
Document Control Officer receives a complete exemption request, or the
date EPA determines the request is complete under Sec. 725.33, unless
the Agency extends the review period under Sec. 725.56. The review
periods for exemption requests run as follows:
(1) TERAs. The review period for TERAs is 60 days.
(2) TMEs. The review period for TMEs is 45 days.
(3) Tier II exemption requests. The review period for Tier II
exemption requests is 45 days.
Sec. 725.54 Suspension of the review period.
(a) A submitter may voluntarily suspend the running of the review
period if the Director, or a designee, agrees. If the Director does not
agree, the review period will continue to run, and EPA will notify the
submitter. A submitter may request a suspension at any time during the
review period. The suspension must be for a specified period of time.
(b)(1) Request for suspension. A request for suspension may only be
submitted in a manner set forth in this paragraph. The request for
suspension also may be made orally, including by telephone, to the
submitter's EPA contact for that notice, subject to paragraph (c) of
this section.
(2) Submission of suspension notices. EPA will accept requests for
suspension only if submitted in accordance with this paragraph. Requests
for suspension, must be generated, completed, and submitted to EPA (via
CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for information
on how to obtain e-PMN software.
(c) An oral request for suspension may be granted by EPA for a
maximum of 15 days only. Requests for longer suspension must only be
submitted in the manner set forth in this paragraph.
(d) If the submitter has not made a previous oral request, the
running of the notice review period is suspended as of the date of
receipt of the CDX submission by EPA.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Sec. 725.56 Extension of the review period.
(a) At any time during the review period, EPA may unilaterally
determine that good cause exists to extend the review period specified
for MCANs, or the exemption requests.
(b) If EPA makes such a determination, EPA:
[[Page 39]]
(1) Will notify the submitter that EPA is extending the review
period for a specified length of time and state the reasons for the
extension.
(2) For MCANs, EPA may issue a notice for publication in the Federal
Register which states that EPA is extending the review period and gives
the reasons for the extension.
(c) The total period of the extension may be for a period of up to
the same length of time as specified for each type of submission in
Sec. 725.50. If the initial extension is for less than the total time
allowed, EPA may make additional extensions. However, the sum of the
extensions may not exceed the total allowed.
(d) The following are examples of situations in which EPA may find
that good cause exists for extending the review period:
(1) EPA has reviewed the submission and is seeking additional
information.
(2) EPA has received significant additional information during the
review period.
(3) The submitter has failed to correct a submission after receiving
EPA's request under Sec. 725.32.
(4) EPA has reviewed the submission and determined that there is a
significant possibility that the microorganism will be regulated under
section 5(e) or section 5(f) of the Act, but EPA is unable to initiate
regulatory action within the initial review period.
Sec. 725.60 Withdrawal of submission by the submitter.
(a)(1) Withdrawal of notice by the submitter. A submitter may
withdraw a notice during the notice review period by submitting a
statement of withdrawal in a manner set forth in this paragraph. The
withdrawal is effective upon receipt of the CDX submission by EPA.
(2) Submission of withdrawal notices. EPA will accept statements of
withdrawal only if submitted in accordance with this paragraph.
Statements of withdrawal must be generated, completed, and submitted to
EPA (via CDX) using e-PMN software. See 40 CFR 720.40(a)(2)(ii) for
information on how to obtain e-PMN software.
(b) If a manufacturer, importer, or processor who withdrew a
submission later resubmits a submission for the same microorganism, a
new review period begins.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Sec. 725.65 Recordkeeping.
(a) General provisions. (1) Any person who submits a notice under
this part must retain documentation of information in the submission,
including:
(i) Any data in the submitter's possession or control; and
(ii) Records of production volume for the first 3 years of
manufacture, import, or processing.
(2) Any person who submits a notice under this part must retain
documentation of the date of commencement of testing, manufacture,
import, or processing.
(3) Any person who is exempt from some or all of the reporting
requirements of this part must retain documentation that supports the
exemption.
(4) All information required by this section must be retained for 3
years from the date of commencement of each activity for which records
are required under this part.
(b) Specific requirements. In addition to the requirements of
paragraph (a) of this section, specific recordkeeping requirements
included in certain subparts must also be followed.
(1) Additional recordkeeping requirements for activities conducted
inside a structure are set forth in Sec. 725.235(h).
(2) Additional recordkeeping requirements for TERAs are set forth in
Sec. 725.250(f).
(3) Additional recordkeeping requirements for TMEs are set forth in
Sec. 725.350(c).
(4) Additional recordkeeping requirements for Tier I exemptions
under subpart G of this part are set forth in Sec. 725.424(a)(5).
(5) Additional recordkeeping requirements for Tier II exemptions
under subpart G of this part are set forth in Sec. 725.450(d).
(6) Additional recordkeeping requirements for significant new uses
of microorganisms reported under subpart L of this part are set forth in
Sec. 725.850. Recordkeeping requirements may also be included when a
microorganism and
[[Page 40]]
significant new use are added to subpart M of this part.
Sec. 725.67 Applications to exempt new microorganisms from this part.
(a) Submission. (1) Any manufacturer or importer of a new
microorganism may request, under TSCA section 5(h)(4), an exemption, in
whole or in part, from this part by sending a Letter of Application in
the manner set forth in Sec. 725.25(c).
(2) General provisions. The Letter of Application should provide
information to show that any activities affected by the requested
exemption will not present an unreasonable risk of injury to health or
the environment. This information should include data described in the
following paragraphs.
(i) The effects of the new microorganism on health and the
environment.
(ii) The magnitude of exposure of human beings and the environment
to the new microorganism.
(iii) The benefits of the new microorganism for various uses and the
availability of substitutes for such uses.
(iv) The reasonably ascertainable economic consequences of granting
or denying the exemption, including effects on the national economy,
small business, and technological innovation.
(3) Specific requirements. In addition to the requirements of
paragraph (a)(2) of this section, the specific information requirements
of the relevant subpart under which the exemption is sought should be
met.
(i) Exemption from MCAN reporting under subpart D. Information
requirements are set forth in 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
[[Page 41]]
national economy, small business, technological innovation, the
environment, and public health.
(2) Grant of the exemption. The exemption will be granted if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the new microorganism will not present an
unreasonable risk of injury to health or the environment.
(3) Denial of the exemption. The exemption will be denied if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the determination described in paragraph
(c)(2) of this section cannot be made. A final decision terminating the
rulemaking proceeding will be published in the Federal Register.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 77
FR 46292, Aug. 3, 2012]
Sec. 725.70 Compliance.
(a) Failure to comply with any provision of this part is a violation
of section 15 of the Act (15 U.Sec. 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.Sec. 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.Sec. 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.Sec. C.
2614).
(f) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.Sec. 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.Sec. C. 2606) or section 17 of the Act (15 U.Sec. C. 2616).
Sec. 725.75 Inspections.
EPA will conduct inspections under section 11 of the Act to assure
compliance with section 5 of the Act and this part, to verify that
information required by EPA under this part is true and correct, and to
audit data submitted to EPA under this part.
Subpart C_Confidentiality and Public Access to Information
Sec. 725.80 General provisions for confidentiality claims.
(a) A person may assert a claim of confidentiality for any
information submitted to EPA under this part. However,
(1) Any person who asserts a claim of confidentiality for portions
of the specific microorganism identity must provide the information as
described in Sec. 725.85.
(2) Any person who asserts a claim of confidentiality for a use of a
microorganism must provide the information as described in Sec. 725.88.
(3) Any person who asserts a claim of confidentiality for
information contained in a health and safety study of a microorganism
must provide the information described in Sec. 725.92.
(b) Any claim of confidentiality must accompany the information when
it is submitted to EPA.
(1) When a person submits any information under this part, including
any attachments, for which claims of confidentiality are made, the
claim(s) must be asserted by circling the specific information which is
claimed and marking the page on which that information appears with an
appropriate designation such as ``trade secret,'' ``TSCA CBI,'' or
``confidential business information.''
[[Page 42]]
(2) If any information is claimed confidential, the person must
submit two copies of the document including the claimed information.
(i) One copy of the document must be complete. In that copy, the
submitter must mark the information which is claimed as confidential in
the manner prescribed in paragraph (b)(1) of this section.
(ii) The second copy must be complete except that all information
claimed as confidential in the first copy must be deleted. EPA will
place the second copy in the public file.
(iii) If the submitter does not provide the second copy, the
submission is incomplete and the review period does not begin to run
until EPA receives the second copy, in accordance with Sec. 725.33.
(iv) Any information contained within the copy submitted under
paragraph (b)(2)(ii) of this section which has been in the public file
for more than 30 days will be presumed to be in the public domain,
notwithstanding any assertion of confidentiality made under this
section.
(3) A person who submits information to EPA under this part must
reassert a claim of confidentiality and substantiate the claim each time
the information is submitted to EPA.
(c) Any person asserting a claim of confidentiality under this part
must substantiate each claim in accordance with the requirements in
Sec. 725.94.
(d) EPA will disclose information that is subject to a claim of
confidentiality asserted under this section only to the extent permitted
by the Act, this subpart, and part 2 of this title.
(e) If a submitter does not assert a claim of confidentiality for
information at the time it is submitted to EPA, EPA may make the
information public and place it in the public file without further
notice to the submitter.
Sec. 725.85 Microorganism identity.
(a) Claims applicable to the period prior to commencement of
manufacture or import for general commercial use--(1) When to make a
claim. (i) A person who submits information to EPA under this part may
assert a claim of confidentiality for portions of the specific
microorganism identity at the time of submission of the information.
This claim will apply only to the period prior to the commencement of
manufacture or import for general commercial use.
(ii) A person who submits information to EPA under this part must
reassert a claim of confidentiality and substantiate the claim each time
the information is submitted to EPA. For example, if a person claims
certain information confidential in a TERA submission and wishes the
same information to remain confidential in a subsequent TERA or MCAN
submission, the person must reassert and resubstantiate the claim in the
subsequent submission.
(2) Assertion of claim. (i) A submitter may assert a claim of
confidentiality only if the submitter believes that public disclosure
prior to commencement of manufacture or import for general commercial
use of the fact that anyone is initiating research and development
activities pertaining to the specific microorganism or intends to
manufacture or import the specific microorganism for general commercial
use would reveal confidential business information. Claims must be
substantiated in accordance with the requirements of Sec. 725.94(a).
(ii) If the submission includes a health and safety study concerning
the microorganism and if the claim for confidentiality with respect to
the specific identity is denied in accordance with Sec. 725.92(c), EPA
will deny a claim asserted under paragraph (a) of this section.
(3) Development of generic name. Any person who asserts a claim of
confidentiality for portions of the specific microorganism identity
under this paragraph must provide one of the following items at the time
the submission is filed:
(i) The generic name which was accepted by EPA in the prenotice
consultation conducted under paragraph (a)(4) of this section.
(ii) One generic name that is only as generic as necessary to
protect the confidential identity of the particular microorganism. The
name should reveal the specific identity to the maximum extent possible.
The generic
[[Page 43]]
name will be subject to EPA review and approval.
(4) Determination by EPA. (i) Any person who intends to assert a
claim of confidentiality for the specific identity of a new
microorganism may seek a determination by EPA of an appropriate generic
name for the microorganism before filing a submission. For this purpose,
the person should submit to EPA:
(A) The specific identity of the microorganism.
(B) A proposed generic name(s) which is only as generic as necessary
to protect the confidential identity of the new microorganism. The
name(s) should reveal the specific identity of the microorganism to the
maximum extent possible.
(ii) Within 30 days, EPA will inform the submitter either that one
of the proposed generic names is adequate or that none is adequate and
further consultation is necessary.
(5) Use of generic name. If a submitter claims microorganism
identity as confidential under paragraph (a) of this section, and if the
submitter complies with paragraph (a)(2) of this section, EPA will issue
for publication in the Federal Register notice described in Sec. 725.40
the generic name proposed by the submitter or one agreed upon by EPA and
the submitter.
(b) Claims applicable to the period after commencement of
manufacture or import for general commercial use--(1) Maintaining claim.
Any claim of confidentiality under paragraph (a) of this section is
applicable only until the microorganism is manufactured or imported for
general commercial use and becomes eligible for inclusion on the
Inventory. To maintain the confidential status of the microorganism
identity when the microorganism is added to the Inventory, a submitter
must reassert the confidentiality claim and substantiate the claim in
the notice of commencement of manufacture required under Sec. 725.190.
(i) A submitter may not claim the microorganism identity
confidential for the period after commencement of manufacture or import
for general commercial use unless the submitter claimed the
microorganism identity confidential under paragraph (a) of this section
in the MCAN submitted for the microorganism.
(ii) A submitter may claim the microorganism identity confidential
for the period after commencement of manufacture or import for general
commercial use if the submitter did not claim the microorganism identity
confidential under paragraph (a) of this section in any TERA submitted
for the microorganism, but subsequently did claim microorganism identity
confidential in the MCAN submitted for the microorganism.
(2) Assertion of claim. (i) A person who believes that public
disclosure of the fact that anyone manufactures or imports the
microorganism for general commercial use would reveal confidential
business information may assert a claim of confidentiality under
paragraph (b) of this section.
(ii) If the notice includes a health and safety study concerning the
new microorganism, and if the claim for confidentiality with respect to
the microorganism identity is denied in accordance with Sec. 725.92(c),
EPA will deny a claim asserted under paragraph (b) of this section.
(3) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must:
(i) Comply with the requirements of paragraph (a)(3) of this section
regarding submission of a generic name.
(ii) Agree that EPA may disclose to a person with a bona fide intent
to manufacture or import the microorganism the fact that the particular
microorganism is included on the confidential Inventory for purposes of
notification under section 5(a)(1)(A) of the Act.
(iii) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by Sec.
725.12.
(iv) Provide a detailed written substantiation of the claim, in
accordance with the requirements of Sec. 725.94(b).
(4) Denial of claim. If the submitter does not meet the requirements
of paragraph (b) of this section, EPA will deny the claim of
confidentiality.
(5) Acceptance of claim. (i) EPA will publish a generic name on the
public Inventory if:
[[Page 44]]
(A) The submitter asserts a claim of confidentiality in accordance
with this paragraph.
(B) No claim for confidentiality of the microorganism identity as
part of a health and safety study has been denied in accordance with
part 2 of this title or Sec. 725.92.
(ii) Publication of a generic name on the public Inventory does not
create a category for purposes of the Inventory. Any person who has a
bona fide intent to manufacture or import a microorganism which is
described by a generic name on the public Inventory may submit an
inquiry to EPA under Sec. 725.15(b) to determine whether the particular
microorganism is included on the confidential Inventory.
(iii) Upon receipt of a request described in Sec. 725.15(b), EPA
may require the submitter who originally asserted confidentiality for a
microorganism to submit to EPA the information listed in paragraph
(b)(3)(iii) of this section.
(iv) Failure to submit any of the information required under
paragraph (b)(3)(iii) of this section within 10 calendar days of receipt
of a request by EPA under paragraph (b) of this section will constitute
a waiver of the original submitter's confidentiality claim. In this
event, EPA may place the specific microorganism identity on the public
Inventory without further notice to the original submitter.
(6) Use of generic name on the public Inventory. If a submitter
asserts a claim of confidentiality under paragraph (b) of this section,
EPA will examine the generic microorganism name proposed by the
submitter.
(i) If EPA determines that the generic name proposed by the
submitter is only as generic as necessary to protect the confidential
identity of the particular microorganism, EPA will place that generic
name on the public Inventory.
(ii) If EPA determines that the generic name proposed by the
submitter is more generic than necessary to protect the confidential
identity, EPA will propose in writing, for review by the submitter, an
alternative generic name that will reveal the identity of the
microorganism to the maximum extent possible.
(iii) If the generic name proposed by EPA is acceptable to the
submitter, EPA will place that generic name on the public Inventory.
(iv) If the generic name proposed by EPA is not acceptable to the
submitter, the submitter must explain in detail why disclosure of that
generic name would reveal confidential business information and propose
another generic name which is only as generic as necessary to protect
the confidential identity of the microorganism. If EPA does not receive
a response from the submitter within 30 days after the submitter
receives the proposed name, EPA will place EPA's chosen generic name on
the public Inventory. If the submitter does provide the information
requested, EPA will review the response. If the submitter's proposed
generic name is acceptable, EPA will publish that generic name on the
public Inventory. If the submitter's proposed generic name is not
acceptable, EPA will notify the submitter of EPA's choice of a generic
name. Thirty days after this notification, EPA will place the chosen
generic name on the public Inventory.
Sec. 725.88 Uses of a microorganism.
(a) Assertion of claim. A person who submits information to EPA
under this part on the categories or proposed categories of use of a
microorganism may assert a claim of confidentiality for this
information.
(b) Requirements for claim. A submitter that asserts such a claim
must:
(1) Report the categories or proposed categories of use of the
microorganism.
(2) Provide, in nonconfidential form, a description of the uses that
is only as generic as necessary to protect the confidential business
information. The generic use description will be included in the Federal
Register notice described in Sec. 725.40.
(c) Generic use description. The person must submit the information
required by paragraph (b) of this section by describing the uses as
precisely as possible, without revealing the information which is
claimed confidential, to disclose as much as possible how the use may
result in human exposure to the microorganism or its release to the
environment.
[[Page 45]]
Sec. 725.92 Data from health and safety studies of microorganisms.
(a) Information other than specific microorganism identity. Except
as provided in paragraph (b) of this section, EPA will deny any claim of
confidentiality with respect to information included in a health and
safety study of a microorganism, unless the information would disclose
confidential business information concerning:
(1) Processes used in the manufacture or processing of a
microorganism.
(2) Information which is not in any way related to the effects of a
microorganism on health or the environment, such as, the name of the
submitting company, cost or other financial data, product development or
marketing plans, and advertising plans, for which the person submits a
claim of confidentiality in accordance with Sec. 725.80.
(b) Microorganism identity--(1) Claims applicable to the period
prior to commencement of manufacture or import for general commercial
use. A claim of confidentiality for the period prior to commencement of
manufacture or import for general commercial use for the specific
identity of a microorganism for which a health and safety study was
submitted must be asserted in conjunction with a claim asserted under
Sec. 725.85(a). The submitter must substantiate each claim in
accordance with the requirements of Sec. 725.94(a).
(2) Claims applicable to the period after commencement of
manufacture or import for general commercial use. To maintain the
confidential status of the specific identity of a microorganism for
which a health and safety study was submitted after commencement of
manufacture or import for general commercial use, the claim must be
reasserted and substantiated in conjunction with a claim under Sec.
725.85(b). The submitter must substantiate each claim in accordance with
the requirements of Sec. 725.94(b).
(c) Denial of confidentiality claim. EPA will deny a claim of
confidentiality for microorganism identity under paragraph (b) of this
section, unless:
(1) The information would disclose processes used in the manufacture
or processing of a microorganism.
(2) The microorganism identity is not necessary to interpret a
health and safety study.
(d) Use of generic names. When EPA discloses a health and safety
study containing a microorganism identity, which the submitter has
claimed confidential, and if the Agency has not denied the claim under
paragraph (c) of this section, EPA will identify the microorganism by
the generic name selected under Sec. 725.85.
Sec. 725.94 Substantiation requirements.
(a) Claims applicable to the period prior to commencement of
manufacture or import for general commercial use--(1) MCAN, TME, Tier I
certification, and Tier II exemption request requirements. Any person
who submits a MCAN, TME, Tier I certification, or Tier II exemption
request should strictly limit confidentiality claims to that information
which is confidential and proprietary to the business.
(i) If any information in the submission is claimed as confidential
business information, the submitter must substantiate each claim by
submitting written answers to the questions in paragraphs (c), (d), and
(e) of this section at the time the person submits the information.
(ii) If the submitter does not provide written substantiation as
required in paragraph (a)(1)(i) of this section, the submission will be
considered incomplete and the review period will not begin in accordance
with Sec. 725.33.
(2) TERA requirements. Any person who submits a TERA, should
strictly limit confidentiality claims to that information which is
confidential and proprietary to the business. If any information in such
a submission is claimed as confidential business information, the
submitter must have available for each of those claims, and agree to
furnish to EPA upon request, written answers to the questions in
paragraphs (d) and (e) of this section.
(b) Claims applicable to the period after commencement of
manufacture or import for general commercial use. (1) If a submitter
claimed portions of the microorganism identity confidential in the MCAN
and wants the identity to be listed on the confidential Inventory,
[[Page 46]]
the claim must be reasserted and substantiated at the time the Notice of
Commencement (NOC) is submitted under Sec. 725.190. Otherwise, EPA will
list the specific microorganism identity on the public Inventory.
(2) The submitter must substantiate the claim for confidentiality of
the microorganism identity by answering all of the questions in
paragraphs (c), (d), and (e) in this section. In addition, the following
questions must be answered:
(i) What harmful effects to the company's or institution's
competitive position, if any, would result if EPA publishes on the
Inventory the identity of the microorganism? How could a competitor use
such information given the fact that the identity of the microorganism
otherwise would appear on the TSCA Inventory with no link between the
microorganism and the company or institution? How substantial would the
harmful effects of disclosure be? What is the causal relationship
between the disclosure and the harmful effects?
(ii) Has the identity of the microorganism been kept confidential to
the extent that competitors do not know it is being manufactured or
imported for general commercial use by anyone?
(c) General questions. The following questions must be answered in
detail for each confidentiality claim:
(1) For what period of time is a claim of confidentiality being
asserted? If the claim is to extend until a certain event or point in
time, indicate that event or time period. Explain why the information
should remain confidential until such point.
(2) Briefly describe any physical or procedural restrictions within
the company or institution relating to the use and storage of the
information claimed as confidential. What other steps, if any, apply to
use or further disclosure of the information?
(3) Has the information claimed as confidential been disclosed to
individuals outside of the company or institution? Will it be disclosed
to such persons in the future? If so, what restrictions, if any, apply
to use or further disclosure of the information?
(4) Does the information claimed as confidential appear, or is it
referred to, in any of the following questions? If the answer is yes to
any of these questions, indicate where the information appears and
explain why it should nonetheless be treated as confidential.
(i) Advertising or promotional materials for the microorganism or
the resulting end product?
(ii) Material safety data sheets or other similar materials for the
microorganism or the resulting end product?
(iii) Professional or trade publications?
(iv) Any other media available to the public or to competitors?
(v) Patents?
(vi) Local, State, or Federal agency public files?
(5) Has EPA, another Federal agency, a Federal court, or a State
made any confidentiality determination regarding the information claimed
as confidential? If so, provide copies of such determinations.
(6) For each type of information claimed confidential, describe the
harm to the company's or institution's competitive position that would
result if this information were disclosed. Why would this harm be
substantial? How could a competitor use such information? What is the
causal connection between the disclosure and harm?
(7) If EPA disclosed to the public the information claimed as
confidential, how difficult would it be for the competitor to enter the
market for the resulting product? Consider such constraints as capital
and marketing cost, specialized technical expertise, or unusual
processes.
(d) Microorganism identity and production method. If confidentiality
claims are asserted for the identity of the microorganism or information
on how the microorganism is produced, the following questions must be
answered:
(1) Has the microorganism or method of production been patented in
the U.Sec. or elsewhere? If so, why is confidentiality necessary?
(2) Does the microorganism leave the site of production or testing
in a form which is accessible to the public or to competitors? What is
the cost to a competitor, in time and money, to develop appropriate use
conditions? What factors facilitate or impede product analysis?
[[Page 47]]
(3) For each additional type of information claimed as confidential,
explain what harm would result from disclosure of each type of
information if the identity of the microorganism were to remain
confidential.
(e) Health and safety studies of microorganisms. If confidentiality
claims are asserted for information in a health or safety study of a
microorganism, the following questions must be answered:
(1) Would the disclosure of the information claimed confidential
reveal: confidential process information, or information unrelated to
the effects of the microorganism on health and the environment. Describe
the causal connection between the disclosure and harm.
(2) Does the company or institution assert that disclosure of the
microorganism identity is not necessary to interpret any health and
safety studies which have been submitted? If so, explain how a less
specific identity would be sufficient to interpret the studies.
Sec. 725.95 Public file.
All information submitted, including any health and safety study of
a microorganism and other supporting documentation, will become part of
the public file for that submission, unless such materials are claimed
confidential. In addition, EPA may add materials to the public file,
unless such materials are claimed confidential. Publically available
docket materials are available at the addresses in Sec. 700.17(b)(1)
and (2) of this chapter
[62 FR 17932, Apr. 11, 1997, 77 FR 46292, Aug. 3, 2012]
Subpart D_Microbial Commercial Activities Notification Requirements
Sec. 725.100 Scope and purpose.
(a) This subpart establishes procedures for submission of a notice
to EPA under section 5(a) of the Act for persons who manufacture,
import, or process microorganisms for commercial purposes. This notice
is called a Microbial Commercial Activity Notice (MCAN). It is expected
that MCANs will in general only be submitted for microorganisms intended
for general commercial use. Persons who manufacture, import, or process
a microorganism in small quantities solely for research and development
as defined in Sec. 725.3 are not required to submit a notice to EPA.
Persons who manufacture, import, or process a microorganism for research
and development activities that do not fit the definition of small
quantities solely for research and development may nonetheless qualify
for more limited reporting requirements in subpart E, including the TERA
which can be used for review of research and development involving
environmental release.
(b) Persons subject to MCAN submission are described in Sec.
725.105.
(c) Exclusions and exemptions specific to MCAN submissions are
described in Sec. 725.110.
(d) Submission requirements applicable specifically to MCANs are
described at Sec. 725.150.
(e) Data requirements for MCANs are set forth in 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
[[Page 48]]
United States for commercial purposes a new microorganism. Exclusions
are described in Sec. 725.110.
(2) When several persons are involved in an import transaction, the
MCAN must be submitted by the principal importer. If no one person fits
the principal importer definition in a particular transaction, the
importer should contact EPA to determine who must submit the MCAN for
that transaction.
(3) Except as otherwise provided in paragraph (b)(4) of this
section, the provisions of this subpart D apply to each person who
submits a MCAN for a new microorganism which such person intends to
import for a commercial purpose. In addition, each importer must comply
with paragraph (b)(4) of this section.
(4) EPA will hold the principal importer, or the importer that EPA
determines must submit the MCAN when there is no principal importer
under paragraph (b)(2) of this section, liable for complying with this
part, for completing the MCAN, and for the completeness and truthfulness
of all information which it submits.
(c) Manufacturers, importers, or processors of microorganisms for a
significant new use. MCAN submission is required for any person who
intends to manufacture, import, or process for commercial purposes a
microorganism identified as having one or more significant new uses in
subpart M of this part, and who intends either to engage in a designated
significant new use of the microorganism or intends to distribute it in
commerce. Persons excluded from reporting on significant new uses of
microorganisms and additional procedures for reporting are described in
subpart L of this part.
Sec. 725.110 Persons not subject to this subpart.
Persons are not subject to the requirements of this subpart for the
following activities:
(a) Manufacturing, importing, or processing solely for research and
development microorganisms that meet the requirements for an exemption
under subpart E of this part.
(b) Manufacturing, importing, or processing microorganisms for test
marketing activities which have been granted an exemption under subpart
F of this part.
(c) Manufacturing or importing new microorganisms under the
conditions of a Tier I or Tier II exemption under subpart G of this
part.
Sec. 725.150 Procedural requirements for this subpart.
General requirements for all MCANs under this part are contained in
subparts A through C of this part. In addition, the following
requirements apply to MCANs submitted under this subpart:
(a) When to submit a MCAN. A MCAN must be submitted at least 90
calendar days prior to manufacturing or importing a new microorganism
and at least 90 calendar days prior to manufacturing, importing, or
processing a microorganism for a significant new use.
(b) Section 5(b) of the Act. The submitter must comply with any
applicable requirement of section 5(b) of the Act for the submission of
test data.
(c) Contents of a MCAN. Each person who submits a MCAN under this
subpart must provide the information and test data described in
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
[[Page 49]]
on its effects on humans, animals, plants, and other microorganisms, and
in the environment. The information to be submitted under this subpart
includes the information listed in paragraphs (c) through (h) of this
section relating to the manufacture, processing, distribution in
commerce, use, and disposal of the new microorganism.
(c) Submitter identification. (1) The name and headquarters address
of the submitter.
(2) The name, address, and office telephone number (including area
code) of the principal technical contact representing the submitter.
(d) Microorganism identity information. Persons must submit
sufficient information to allow the microorganism to be accurately and
unambiguously identified for listing purposes as required by Sec.
725.12.
(1) Description of the recipient microorganism and the new
microorganism. (i) Data substantiating the taxonomy of the recipient
microorganism and the new microorganism to the level of strain, as
appropriate. In lieu of data, EPA will accept a letter from a culture
collection substantiating taxonomy, provided EPA, upon request to the
submitter, may have access to the data supporting the taxonomic
designation.
(ii) Information on the morphological and physiological features of
the new microorganism.
(iii) Other specific data by which the new microorganism may be
uniquely identified for Inventory purposes.
(2) Genetic construction of the new microorganism. (i) Data
substantiating the taxonomy of the donor organism(s). In lieu of data,
EPA will accept a letter from a culture collection substantiating
taxonomy, provided EPA, upon request to the submitter, may have access
to the data supporting the taxonomic designation.
(ii) Description of the traits for which the new microorganism has
been selected or developed and other traits known to have been added or
modified.
(iii) A detailed description of the genetic construction of the new
microorganism, including the technique used to modify the microorganism
(e.g., fusion of cells, injection of DNA, electroporation or chemical
poration, or methods used for induced mutation and selection). The
description should include, for example, a description of the introduced
genetic material, including any regulatory sequences and structural
genes and the products of those genes; how the introduced genetic
material is expected to affect behavior of the recipient; expression,
alteration, and stability of the introduced genetic material; methods
for vector construction and introduction; and a description of the
regulatory and structural genes that are components of the introduced
genetic material, including genetic maps of the introduced sequences.
(3) Phenotypic and ecological characteristics. (i) Habitat,
geographical distribution, and source of the recipient microorganism.
(ii) Survival and dissemination under relevant environmental
conditions including a description of methods for detecting the new or
recipient microorganism(s) in the environment and the sensitivity limit
of detection for these techniques.
(iii) A description of anticipated biological interactions with and
effects on target organisms and other organisms such as competitors,
prey, hosts, symbionts, parasites, and pathogens; a description of host
range; a description of pathogenicity, infectivity, toxicity, virulence,
or action as a vector of pathogens; and capacity for genetic transfer
under laboratory and relevant environmental conditions.
(iv) A description of anticipated involvement in biogeochemical or
biological cycling processes, involvement in rate limiting steps in
mineral or nutrient cycling, or involvement in inorganic compounds
cycling (such as possible sequestration or transformation of heavy
metals).
(e) Byproducts. A description of the byproducts resulting from the
manufacture, processing, use, and disposal of the new microorganism.
(f) Total production volume. The estimated maximum amount of the new
microorganism intended to be manufactured or imported during the first
year of production and the estimated maximum amount to be manufactured
or imported during any consecutive 12-month period during the first 3
years of production. This estimate may be by
[[Page 50]]
weight or volume and should include an estimation of viability (i.e.,
viable cells per unit volume or colony forming units per unit dry
weight).
(g) Use information. A description of intended categories of use by
function and application, the estimated percent of production volume
devoted to each category of use, and the percent of the new
microorganism in the formulation for each commercial or consumer use.
(h) Worker exposure and environmental release. (1) For sites
controlled by the submitter:
(i) The identity of sites where the new microorganism will be
manufactured, processed, or used. For purposes of this section, the site
for a person who imports a new microorganism is the site of the
operating unit within the person's organization which is directly
responsible for importing the new microorganism and which controls the
import transaction. The import site may in some cases be the
organization's headquarters office in the United States.
(ii) A process description of each manufacture, processing, and use
operation, which includes a diagram of the major unit operations and
conversions, the identity and entry point of all feedstocks, and the
identity of any possible points of release of the new microorganism from
the process, including a description of all controls, including
engineering controls, used to prevent such releases.
(iii) Worker exposure information, including worker activities,
physical form of process streams which contain the new microorganism to
which workers may be exposed, the number of workers, and the duration of
activities.
(iv) Information on release of the new microorganism to the
environment, including the quantity and media of release and type of
control technology used.
(v) A narrative description of the intended transport of the new
microorganism, including the means of transport, containment methods to
be used during transport, and emergency containment procedures to be
followed in case of accidental release.
(vi) Procedures for disposal of any articles, waste, clothing, or
other equipment involved in the activity, including procedures for
inactivation of the new microorganism, containment, disinfection, and
disposal of contaminated items.
(2) For sites not controlled by the submitter, a description of each
type of processing and use operation involving the new microorganism,
including identification of the estimated number of processing or use
sites, situations in which worker exposure to and/or environmental
release of the new microorganism will occur, the number of workers
exposed and the duration of exposure; procedures for transport of the
new microorganism and for disposal, including procedures for
inactivation of the new microorganism; and control measures which limit
worker exposure and environmental release.
Sec. 725.160 Submission of health and environmental effects data.
(a) Test data on the new microorganism in the possession or control
of the submitter. (1) Except as provided in Sec. 725.25(h), and in
addition to the information required by Sec. 725.155(d)(3), each MCAN
must contain all test data in the submitter's possession or control
which are related to the effects on health or the environment of any
manufacture, processing, distribution in commerce, use, or disposal of
the new microorganism or any microbial mixture or article containing the
new microorganism, or any combination of such activities. This includes
test data concerning the new microorganism in a pure culture or
formulated form as used or as intended to be used in one of the
activities listed above.
(2) A full report or standard literature citation must be submitted
for the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test data related to human exposure to
or environmental release of the new microorganism.
(3)(i) If the data do not appear in the open scientific literature,
the submitter must provide a full report. A full report includes the
experimental
[[Page 51]]
methods and materials, results, discussion and data analysis,
conclusions, references, and the name and address of the laboratory that
developed the data.
(ii) If the data appear in the open scientific literature, the
submitter need only provide a standard literature citation. A standard
literature citation includes author, title, periodical name, date of
publication, volume, and page numbers.
(4)(i) If a study, report, or test is incomplete when a person
submits a MCAN, the submitter must identify the nature and purpose of
the study; name and address of the laboratory developing the data;
progress to date; types of data collected, significant preliminary
results; and anticipated completion date.
(ii) If a test or experiment is completed before the MCAN review
period ends, the person must submit the study, report, or test, as
specified in paragraph (a)(3)(i) of this section, to the address listed
in Sec. 725.25(c) within 10 days of receiving it, but no later than 5
days before the end of the review period. If the test or experiment is
completed during the last 5 days of the review period, the submitter
must immediately inform its EPA contact for that submission by
telephone.
(5) For test data in the submitter's possession or control which are
not listed in paragraph (a)(2) of this section, a person is not required
to submit a complete report. The person must submit a summary of the
data. If EPA so requests, the person must submit a full report within 10
days of the request, but no later than 5 days before the end of the
review period.
(6) All test data described under paragraph (a) of this section are
subject to these requirements, regardless of their age, quality, or
results.
(b) Other data concerning the health and environmental effects of
the new microorganism that are known to or reasonably ascertainable by
the submitter. (1) Except as provided in Sec. 725.25(h), and in
addition to the information required by Sec. 725.155(c)(3), any person
who submits a MCAN must describe the following data, including any data
from a health and safety study of a microorganism, if the data are
related to effects on health or the environment of any manufacture,
processing, distribution in commerce, use, or disposal of the
microorganism, of any microbial mixture or article containing the new
microorganism, or of any combination of such activities:
(i) Any data, other than test data, in the submitter's possession or
control.
(ii) Any data, including test data, which are not in the submitter's
possession or control, but which are known to or reasonably
ascertainable by the submitter. For the purposes of this section, data
are known to or reasonably ascertainable by the submitter if the data
are known to any of its employees or other agents who are associated
with the research and development, test marketing, or commercial
marketing of the microorganism.
(2) Data that must be described include data concerning the new
microorganism in a pure culture or formulated form as used or as
intended to be used in one of the activities listed in paragraph (b)(1)
of this section.
(3) The description of data reported under paragraph (b) of this
section must include:
(i) If the data appear in the open scientific literature, a standard
literature citation, which includes the author, title, periodical name,
date of publication, volume, and pages.
(ii) If the data are not available in the open scientific
literature, a description of the type of data and summary of the
results, if available, and the names and addresses of persons the
submitter believes may have possession or control of the data.
(4) All data described in paragraph (b) of this section are subject
to these requirements, regardless of their age, quality, or results; and
regardless of whether they are complete at the time the MCAN is
submitted.
Sec. 725.170 EPA review of the MCAN.
General procedures for review of all submissions under this part are
contained in 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
[[Page 52]]
Officer for the Office of Pollution Prevention and Toxics receives a
complete MCAN, or the date EPA determines the MCAN is complete under
Sec. 725.33, unless the Agency extends the period under section 5(c) of
the Act and Sec. 725.56.
(b) Notice of expiration of MCAN review period. (1) EPA will notify
the submitter that the MCAN review period has expired or that EPA has
completed its review of the MCAN. Expiration of the review period does
not constitute EPA approval or certification of the new microorganism,
and does not mean that EPA may not take regulatory action against the
microorganism in the future.
(2) After expiration of the MCAN review period, in the absence of
regulatory action by EPA under section 5(e), 5(f), or 6(a) of the Act,
the submitter may manufacture or import the microorganism even if the
submitter has not received notice of expiration.
(3) Early notification that EPA has completed its review does not
permit commencement of manufacture or import prior to the expiration of
the 90-day MCAN review period.
(c) No person submitting a MCAN in response to the requirements of
this subpart may manufacture, import, or process a microorganism subject
to this subpart until the review period, including all extensions and
suspensions, has expired.
Sec. 725.190 Notice of commencement of manufacture or import.
(a) Applicability. Any person who commences the manufacture or
import of a new microorganism for nonexempt, commercial purposes for
which that person previously submitted a section 5(a) notice under this
part must submit a notice of commencement (NOC) of manufacture or
import.
(b) When to report. (1) If manufacture or import for nonexempt,
commercial purposes begins on or after May 27, 1997, the submitter must
submit the NOC to EPA no later than 30 calendar days after the first day
of such manufacture or import.
(2) If manufacture or import for nonexempt, commercial purposes
began or will begin before May 27, 1997, the submitter must submit the
NOC by May 27, 1997.
(3) Submission of an NOC prior to the commencement of manufacture or
import is a violation of section 15 of the Act.
(c) Information to be reported. The NOC must contain the following
information: Specific microorganism identity, MCAN number, and the date
when manufacture or import commences. If the person claimed
microorganism identity confidential in the MCAN, and wants the identity
to be listed on the confidential Inventory, the claim must be reasserted
and resubstantiated in accordance with Sec. 725.85(b). Otherwise, EPA
will list the specific microorganism identity on the public Inventory.
(d) How to submit. All notices of commencement must be generated,
completed, and submitted to EPA (via CDX) using e-PMN software. See 40
CFR 720.40(a)(2)(ii) for information on how to obtain e-PMN software.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Subpart E_Exemptions for Research and Development Activities
Sec. 725.200 Scope and purpose.
(a) This subpart describes exemptions from the reporting
requirements under subpart D of this part for research and development
activities involving microorganisms.
(b) In lieu of complying with subpart D of this part, persons
described in Sec. 725.205 may submit a TSCA Experimental Release
Application (TERA) for research and development activities involving
microorganisms or otherwise comply with this subpart.
(c) Exemptions from part 725 are provided at 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.
[[Page 53]]
Sec. 725.205 Persons who may report under this subpart.
(a) Commercial research and development activities involving new
microorganisms or significant new uses of microorganisms are subject to
reporting under this part unless they qualify for an exemption under
this part.
(b) Commercial purposes for research and development means that the
activities are conducted with the purpose of obtaining an immediate or
eventual commercial advantage for the researcher and would include:
(1) All research and development activities which are funded
directly, in whole or in part, by a commercial entity regardless of who
is actually conducting the research. Indications that the research and
development activities are funded directly, in whole or in part, may
include, but are not limited to:
(i) Situations in which a commercial entity contracts directly with
a university or researcher; or
(ii) Situations in which a commercial entity gives a conditional
grant where the commercial entity holds patent rights, or establishes a
joint venture where the commercial entity holds patent or licensing
rights; or
(iii) Any other situation in which the commercial entity intends to
obtain an immediate or eventual commercial advantage for the commercial
entity and/or the researcher.
(2) Research and development activities that are not funded directly
by a commercial entity, if the researcher intends to obtain an immediate
or eventual commercial advantage. Indications that the researcher
intends to obtain an immediate or eventual commercial advantage may
include, but are not limited to:
(i) The research is directed toward developing a commercially viable
improvement of a product already on the market; or
(ii) The researcher has sought or is seeking commercial funding for
the purpose of developing a commercial application; or
(iii) The researcher or university has sought or is seeking a patent
to protect a commercial application which the research is developing; or
(iv) Other evidence that the researcher is aware of a commercial
application for the research and has directed the research toward
developing that application.
(c) Certain research and development activities involving
microorganisms subject to jurisdiction under the Act are exempt from
reporting under this part. A person conducting research and development
activities which meet the conditions for the exemptions described in
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.
[[Page 54]]
(c)(1) The person receives research funds from another Federal
agency, and the funds are awarded on the condition that the research
will be conducted in accordance with the relevant portions of the NIH
Guidelines, or
(2) A Federal agency or program otherwise imposes the legally
binding requirement that the research is to be conducted in accordance
with relevant portions of the NIH Guidelines.
Sec. 725.234 Activities conducted inside a structure.
A person who manufactures, imports, or processes a microorganism is
not subject to the reporting requirements under subpart D of this part
if all of the following conditions are met:
(a) The microorganism is manufactured, imported, or processed solely
for research and development activities.
(b) The microorganism is used by, or directly under the supervision
of, a technically qualified individual, as defined in Sec. 725.3. The
technically qualified individual must maintain documentation of the
procedures selected to comply with paragraph (d) of this section and
must ensure that the procedures are used.
(c) There is no intentional testing of a microorganism outside of a
structure, as structure is defined in Sec. 725.3.
(d) Containment and/or inactivation controls. (1) Selection and use
of containment and/or inactivation controls inside a structure for a
particular microorganism shall take into account the following:
(i) Factors relevant to the organism's ability to survive in the
environment.
(ii) Potential routes of release in air, solids and liquids; in or
on waste materials and equipment; in or on people, including maintenance
and custodial personnel; and in or on other organisms, such as insects
and rodents.
(iii) Procedures for transfer of materials between facilities.
(2) The technically qualified individual's selection of containment
and/or inactivation controls shall be approved and certified by an
authorized official (other than the TQI) of the institution that is
conducting the test prior to the commencement of the test.
(3) Records shall be developed and maintained describing the
selection and use of containment and/or inactivation controls, as
specified in Sec. 725.235(c). These records, which must be maintained
at the location where the research and development activity is being
conducted, shall be submitted to EPA upon written request and within the
time frame specified in EPA's request.
(4) Subsequent to EPA review of records in accordance with paragraph
(d)(3) of this section, changes to the containment/inactivation controls
selected under paragraph (d)(1) of this section must be made upon EPA
order. Failure to comply with EPA's order shall result in automatic loss
of eligibility for an exemption under this section.
(e) The manufacturer, importer, or processor notifies all persons in
its employ or to whom it directly distributes the microorganism, who are
engaged in experimentation, research, or analysis on the microorganism,
including the manufacture, processing, use, transport, storage, and
disposal of the microorganism associated with research and development
activities, of any risk to health, identified under Sec. 725.235(a),
which may be associated with the microorganism. The notification must be
made in accordance with Sec. 725.235(b).
Sec. 725.235 Conditions of exemption for activities conducted inside
a structure.
(a) Determination of risks. To determine whether notification under
Sec. 725.234(e) is required, the manufacturer, importer, or processor
must do one of the following:
(1) For research conducted in accordance with the NIH Guidelines,
the manufacturer, importer, or processor must meet the conditions laid
out at IV-B-4-d of the NIH Guidelines; or
(2) For all other research conducted in accordance with Sec.
725.234, the manufacturer, importer, or processor must review and
evaluate the following information to determine whether there is reason
to believe there is any risk to health which may be associated with the
microorganism:
(i) Information in its possession or control concerning any
significant adverse reaction of persons exposed to
[[Page 55]]
the microorganism which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer, importer, or
processor by a supplier or any other person concerning a health risk
believed to be associated with the microorganism.
(iii) Health and environmental effects data in its possession or
control concerning the microorganism.
(iv) Information on health effects which accompanies any EPA rule or
order issued under TSCA section 4, 5, or 6 of the Act that applies to
the microorganism and of which the manufacturer, importer, or processor
has knowledge.
(b) Notification to employees and others. (1) The manufacturer,
importer, or processor must notify the persons identified in Sec.
725.234(e) by means of a container labeling system, conspicuous
placement of notices in areas where exposure may occur, written
notification to each person potentially exposed, or any other method of
notification which adequately informs persons of health risks which the
manufacturer, importer, or processor has reason to believe may be
associated with the microorganism, as determined under paragraph (a) of
this section.
(2) If the manufacturer, importer, or processor distributes a
microorganism manufactured, imported, or processed under this section to
persons not in its employ, the manufacturer, importer, or processor must
in written form:
(i) Notify those persons that the microorganism is to be used only
for research and development purposes and the requirements of Sec.
725.234 are to be met.
(ii) Provide the notice of health risks specified in paragraph
(b)(1) of this section.
(3) The adequacy of any notification under this section is the
responsibility of the manufacturer, importer, or processor.
(c) Recordkeeping. (1) For research conducted in accordance with the
NIH Guidelines, a person who manufactures, imports, or processes a
microorganism under this section must retain the following records:
(i) Documentation that the NIH Guidelines have been adhered to. Such
documentation shall include:
(A) For experiments subject to Institutional Biosafety Committee
review, or notification simultaneous with initiation of the experiment,
the information submitted for review or notification, along with
standard laboratory records, shall satisfy the recordkeeping
requirements specified in Sec. 725.234(d)(3).
(B) For experiments exempt from Institutional Biosafety Committee
review or notification simultaneous with initiation of the experiment,
documentation of the exemption, along with standard laboratory records,
shall satisfy the recordkeeping requirement specified in Sec.
725.234(d)(3).
(ii) Documentation of how the following requirements are satisfied
under the NIH Guidelines:
(A) Copies or citations to information reviewed and evaluated to
determine the need to make any notification of risk.
(B) Documentation of the nature and method of notification of risk,
including copies of any labels or written notices used.
(C) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of the microorganism, the amount distributed,
and copies of the notifications required.
(2) For all other research conducted in accordance with Sec.
725.234, a person who manufacturers, imports, or processes a
microorganism under this section, must maintain the following records:
(i) Records describing selection and use of containment and/or
inactivation controls required by Sec. 725.234(d)(3) and certification
by an authorized official required by Sec. 725.234(d)(2) for each
microorganism.
(ii) Copies or citations to information reviewed and evaluated under
paragraph (a) of this section to determine the need to make any
notification of risk.
(iii) Documentation of the nature and method of notification under
paragraph (b)(1) of this section, including copies of any labels or
written notices used.
(iv) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of
[[Page 56]]
the microorganism, the amount distributed, and copies of the
notifications required under paragraph (b)(2) of this section.
Sec. 725.238 Activities conducted outside a structure.
(a) Exemption. (1) Research and development activities involving
intentional testing in the environment of certain microorganisms listed
in Sec. 725.239 may be conducted without prior review by EPA if all of
the conditions of this section and Sec. 725.239 are met.
(2) The research and development activity involving a microorganism
listed in Sec. 725.239 must be conducted by, or directly under the
supervision of, a technically qualified individual, as defined in Sec.
725.3.
(b) Certification. To be eligible for the exemption under this
section, a manufacturer or importer must submit to EPA prior to
initiation of the activity a document signed by an authorized official
containing the following information:
(1) Name, address, and telephone number of the manufacturer or
importer.
(2) Location, estimated duration, and planned start date of the
test.
(3) Certification of the following:
(i) Compliance with the conditions of the exemption specified for
the microorganism in Sec. 725.239.
(ii) If state and/or local authorities have been notified of the
activity, evidence of notification.
(c) Recordkeeping. Persons who conduct research and development
activities under this section must comply with the recordkeeping
requirements of Sec. 725.65 and retain documentation that supports
their compliance with the requirements of this section and the specific
requirements for the microorganism listed in Sec. 725.239.
Sec. 725.239 Use of specific microorganisms in activities conducted
outside a structure.
(a) Bradyrhizobium japonicum. To qualify for an exemption under this
section, all of the following conditions must be met for a test
involving Bradyrhizobium japonicum:
(1) Characteristics of recipient microorganism. The recipient
microorganism is limited to strains of Bradyrhizobium japonicum.
(2) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in Sec. 725.421(c).
(ii) The introduced genetic material must consist only of the
following components:
(A) The structural gene(s) of interest, which have the following
limitations:
(1) For structural genes encoding marker sequences, the gene is
limited to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.
(2) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.
(B) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.
(ii) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Bradyrhizobium japonicum.
(b) Rhizobium meliloti. To qualify for an exemption under this
section, all of the following conditions must be met for a test
involving Rhizobium meliloti:
(1) Characteristics of recipient microorganism. The recipient
microorganism is limited to strains of Rhizobium meliloti.
(2) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in Sec. 725.421(c) of
this part.
(ii) The introduced genetic material must consist only of the
following components:
(A) The structural gene(s) of interest, which have the following
limitations:
(1) For structural genes encoding marker sequences, the gene is
limited
[[Page 57]]
to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.
(2) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.
(B) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.
(ii) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Rhizobium meliloti.
Sec. 725.250 Procedural requirements for the TERA.
General requirements for all submissions under this part are
contained in subparts A through C of this part. In addition, the
following requirements apply to TERAs submitted under this subpart:
(a) When to submit the TERA. Each person who is eligible to submit a
TERA under this subpart must submit the TERA at least 60 calendar days
before the person intends to initiate the proposed research and
development activity.
(b) Contents of the TERA. Each person who submits a TERA under this
subpart must provide the information and test data described in
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 terms of the TERA
approval, as well as the conditions described in the TERA.
(f) Recordkeeping. Persons submitting a TERA must comply with the
recordkeeping requirements of Sec. 725.65. In addition, the following
requirements apply to TERAs:
(1) Each person submitting a TERA under this part must retain
documentation of information contained in the TERA for a period of 3
years from the date that the results of the study are submitted to the
Agency.
(2) Summaries of all data, conclusions, and reports resulting from
the conduct of the research and development activity under the TERA must
be submitted to the EPA address identified in Sec. 725.25(c) within 1
year of the termination of the activity.
Sec. 725.255 Information to be included in the TERA.
(a) To review a TERA, EPA must have sufficient information to permit
a reasoned evaluation of the health and environmental effects of the
planned test in the environment. The person seeking EPA approval must
submit all information known to or reasonably ascertainable by the
submitter on the microorganism(s) and the research and development
activity, including information not listed in paragraphs (c), (d), and
(e) of this section that the person believes will be useful for EPA's
risk assessment. The TERA must be in writing and must include at least
the information described in the following paragraphs.
(b) When specific information is not submitted, an explanation of
why such information is not available or not applicable must be
included.
[[Page 58]]
(c) Persons applying for a TERA, must include the submitter
identification and microorganism identity information required for MCANs
in Sec. 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TERA must submit phenotypic and
ecological characteristics information required in Sec. 725.155(d)(3)
as it relates directly to the conditions of the proposed research and
development activity.
(e) Persons applying for a TERA must also submit the following
information about the proposed research and development activity:
(1) A detailed description of the proposed research and development
activity. (i) The objectives and significance of the activity and a
rationale for testing the microorganisms in the environment.
(ii) Number of microorganisms released (including viability per
volume if applicable) and the method(s) of application or release.
(iii) Characteristics of the test site(s), including location,
geographical, physical, chemical, and biological features, proximity to
human habitation or activity, and description of site characteristics
that would influence dispersal or confinement.
(iv) Target organisms (if the microorganism(s) to be tested has an
intended target), including identification of each target organism and
anticipated mechanism and result of interaction.
(v) Planned start date and duration of each activity.
(vi) If State and/or local authorities have been notified of the
activity, evidence of notification.
(2) Information on monitoring, confinement, mitigation, and
emergency termination procedures. (i) Confinement procedures for the
activity, access and security measures, and procedures for routine
termination of the activity.
(ii) Mitigation and emergency procedures.
(iii) Measures to detect and control potential adverse effects.
(iv) Name of principal investigator and chief of site personnel
responsible for emergency procedures.
(v) Personal protective equipment, engineering controls, and
procedures to be followed to minimize dispersion of the microorganism(s)
by people, machinery, or equipment.
(vi) Procedures for disposal of any articles, waste, clothing,
machinery, or other equipment involved in the experimental release,
including methods for inactivation of the microorganism(s), containment,
disinfection, and disposal of contaminated items.
Sec. 725.260 Submission of health and environmental effects data.
Each TERA must contain all available data concerning actual or
potential effects on health or the environment of the new microorganism
that are in the possession or control of the submitter and a description
of other data known to or reasonably ascertainable by the submitter that
will permit a reasoned evaluation of the planned test in the
environment. The data must be reported in the manner described in Sec.
725.160(a)(3) and (b)(3).
Sec. 725.270 EPA review of the TERA.
General procedures for review of all submissions under this part are
contained in 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
[[Page 59]]
approved and that the submitter can proceed with the proposed research
and development activity described in the TERA.
(3) EPA may include requirements and conditions in its approval of
the TERA that would be stated in the TERA approval under paragraph (c)
of this section.
(4) If EPA concludes that it cannot determine that the proposed
research and development activity described in the TERA will not present
an unreasonable risk of injury to health or the environment, EPA will
deny the TERA and will provide reasons for the denial in writing.
(c) TERA approval. (1) A TERA approval issued by EPA under this
section is legally binding on the TERA submitter.
(2) When EPA approves a TERA, the submitter must conduct the
research and development activity only as described in the TERA and in
accordance with any requirements and conditions prescribed by EPA in its
approval of the TERA.
(3) Any person who fails to conduct the research and development
activity as described in the TERA and in accordance with any
requirements and conditions prescribed by EPA in its approval of the
TERA under this section, shall be in violation of sections 5 and 15 of
the Act and be subject to civil and criminal penalties under section 16
of the Act.
Sec. 725.288 Revocation or modification of TERA approval.
(a) Significant questions about risk. (1) If, after approval of a
TERA under this subpart, EPA receives information which raises
significant questions about EPA's determination that the activity does
not present an unreasonable risk of injury to health or the environment,
EPA will notify the submitter in writing of those questions.
(2) The submitter may, within 10 days of receipt of EPA's notice,
provide in writing additional information or arguments concerning the
significance of the questions and whether EPA should modify or revoke
the approval of the TERA.
(3) After considering any such information and arguments, EPA will
decide whether to change its determination regarding approval of the
TERA.
(i) If EPA determines that the activity will not present an
unreasonable risk of injury to health or the environment, it will notify
the submitter in writing. To make this finding, EPA may prescribe
additional conditions which must be followed by the submitter.
(ii) If EPA determines that it can no longer conclude that the
activity will not present an unreasonable risk of injury to health or
the environment, it will notify the submitter in writing that EPA is
revoking its approval and state its reasons. In that event, the
submitter must terminate the research and development activity within 48
hours of receipt of the notice in accordance with directions provided by
EPA in the notice.
(b) Evidence of unreasonable risk. (1) If, after approval of a TERA
under this subpart, EPA determines that the proposed research and
development activity will present an unreasonable risk of injury to
health or the environment, EPA will notify the submitter in writing and
state its reasons.
(2) In the notice, EPA may prescribe additional safeguards to
address or reduce the risk, or may instruct the submitter to suspend the
research and development activities.
(3) Within 48 hours, the submitter must implement the instructions
contained in the notice. The submitter may then submit additional
information or arguments concerning the matters raised by EPA and
whether EPA should modify or revoke the approval of the TERA in
accordance with paragraph (a)(2) of this section.
(4) EPA will consider the information and arguments in accordance
with paragraph (a)(3) of this section.
(5) Following consideration of the information and arguments under
paragraph (a)(3) of this section, if EPA notifies the submitter that the
R&D activity must be suspended or terminted, the submitter may resume
the activity only upon written notice from EPA that EPA has approved
resumption of the activity. In approving resumption of an activity, EPA
may prescribe additional conditions which must be followed by the
submitter.
[[Page 60]]
(c) Modifications. If, after approval of a TERA under this subpart,
the submitter concludes that it is necessary to alter the conduct of the
research and development activity in a manner which would result in the
activity being different from that described in the TERA agreement and
any conditions EPA prescribed in its approval, the submitter must inform
the EPA contact for the TERA and may not modify the activity without the
approval of EPA.
Subpart F_Exemptions for Test Marketing
Sec. 725.300 Scope and purpose.
(a) This subpart describes exemptions from the reporting
requirements under subpart D of this part for test marketing activities
involving microorganisms.
(b) In lieu of complying with subpart D of this part, persons
described in Sec. 725.305 may submit an application for a test
marketing exemption (TME).
(c) Submission requirements specific for TME applications are
described at Sec. 725.350.
(d) Data requirements for TME applications are set forth in Sec.
725.355.
(e) EPA review procedures specific for TMEs are set forth in Sec.
725.370.
(f) Subparts A through C of this part apply to any submission under
this subpart.
Sec. 725.305 Persons who may apply under this subpart.
A person identified in this section may apply for a test marketing
exemption. EPA may grant the exemption if the person demonstrates that
the microorganism will not present an unreasonable risk of injury to
health or the environment as a result of the test marketing. A person
may apply under this subpart for the following test marketing
activities:
(a) A person who intends to manufacture or import for commercial
purposes a new microorganism.
(b) A person who intends to manufacture, import, or process for
commercial purposes a microorganism identified in subpart M of this part
for a significant new use.
Sec. 725.350 Procedural requirements for this subpart.
General requirements for all submissions under this part are
contained in subparts A through C of this part. In addition, the
following requirements apply to applications submitted under this
subpart:
(a) Prenotice consultation. EPA strongly suggests that for a TME,
the applicant contact EPA for a prenotice consultation regarding
eligibility for a TME.
(b) When to submit a TME application. Each person who is eligible to
apply for a TME under this subpart must submit the application at least
45 calendar days before the person intends to commence the test
marketing activity.
(c) Recordkeeping. Each person who is granted a TME must comply with
the recordkeeping requirements of Sec. 725.65. In addition, any person
who obtains a TME must retain documentation of compliance with any
restrictions imposed by EPA when it grants the TME. This information
must be retained for 3 years from the final date of manufacture or
import under the exemption.
Sec. 725.355 Information to be included in the TME application.
(a) To review a TME application, EPA must have sufficient
information to permit a reasoned evaluation of the health and
environmental effects of the planned test marketing activity. The person
seeking EPA approval must submit all information known to or reasonably
ascertainable by the person on the microorganism and the test marketing
activity, including information not listed in paragraphs (c), (d), and
(e) of this section that the person believes will demonstrate that the
microorganism will not present an unreasonable risk of injury to health
or the environment as a result of the test marketing. The TME
application must be in writing and must include at least the information
described in paragraphs (b), (c), (d), and (e) of this section.
(b) When specific information is not submitted, an explanation of
why such information is not available or not applicable must be
included.
(c) Persons applying for a TME must submit the submitter
identification
[[Page 61]]
and microorganism identity information required for MCANs in Sec.
725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TME must submit phenotypic and ecological
characteristics information required in Sec. 725.155(d)(3) as it
relates directly to the conditions of the proposed test marketing
activity.
(e) Persons applying for a TME must also submit the following
information about the proposed test marketing activity:
(1) Proposed test marketing activity. (i) The maximum quantity of
the microorganism which the applicant will manufacture or import for
test marketing.
(ii) The maximum number of persons who may be provided the
microorganism during test marketing.
(iii) The maximum number of persons who may be exposed to the
microorganism as a result of test marketing, including information
regarding duration and route of such exposures.
(iv) A description of the test marketing activity, including its
duration and how it can be distinguished from full-scale commercial
production and research and development activities.
(2) Health and environmental effects data. All existing data
regarding health and environmental effects of the microorganism must be
reported in accordance with Sec. 725.160.
Sec. 725.370 EPA review of the TME application.
General procedures for review of all submissions under this part are
contained in 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.
(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.
Sec. 725.421 Introduced genetic material.
For a new microorganism to qualify for either exemption under this
subpart, introduced genetic material must meet all of the criteria
listed in this section.
[[Page 62]]
(a) Limited in size. The introduced genetic material must consist
only of the following:
(1) The structural gene(s) of interest.
(2) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(3) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(4) The nucleotide sequences needed for vector transfer.
(5) The nucleotide sequences needed for vector maintenance.
(b) Well-characterized. For introduced genetic material, well-
characterized means that the following have been determined:
(1) The function of all of the products expressed from the
structural gene(s).
(2) The function of sequences that participate in the regulation of
expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and
their associated functions, where associated nucleotide sequences are
those sequences needed to move genetic material including linkers,
homopolymers, adaptors, transposons, insertion sequences, and
restriction enzyme sites.
(c) Poorly mobilizable. The ability of the introduced genetic
material to be transferred and mobilized is inactivated, with a
resulting frequency of transfer of less than 10-8 transfer
events per recipient.
(d) Free of certain sequences. (1) The introduced genetic material
must not contain a functional portion of any of the toxin-encoding
sequences described in this paragraph (d).
(i) For the purposes of this section, a functional portion of a
toxin-encoding sequence means any sequence which codes for a polypeptide
that has one of the following effects:
(A) It directly or indirectly contributes to toxic effects in
humans. Directly contributes to toxic effects in humans means those
sequences encoding polypeptides that have direct toxicity to target
cells. An example of a sequence which directly contributes to toxic
effects in humans is one which encodes the portion of diphtheria toxin,
listed in paragraph (d)(2) of this section, capable of interacting with
elongation factor 2, leading to inhibition of protein synthesis in
target respiratory, heart, kidney, and nerve tissues. Indirectly
contributes to toxic effects in humans means a sequence whose encoded
polypeptide is not directly toxic to target cells, yet still adversely
affects humans. An example of a sequence which indirectly contributes to
toxic effects is the sequence which encodes the portion of the botulinum
toxin, listed in paragraph (d)(3) of this section, capable of blocking
the release of acetylcholine from gangliosides. Botulinum toxin affects
neuromuscular junctions by its blockage of acetylcholine release,
leading to irreversible relaxation of muscles and respiratory arrest.
(B) It binds a toxin or toxin precursor to target human cells.
(C) It facilitates intracellular transport of a toxin in target
human cells.
(ii) While these toxins are listed (with synonyms in parentheses) in
paragraphs (d)(2) through (d)(7) of this section according to the source
organism, it is use of the nucleotide sequences that encode the toxins
that is being restricted and not the use of the source organisms. The
source organisms are listed to provide specificity in identification of
sequences whose use is restricted. Although similar or identical
sequences may be isolated from organisms other than those listed below
in paragraphs (d)(2) through (d)(7) of this section, these comparable
toxin sequences, regardless of the organism from which they are derived,
must not be included in the introduced genetic material.
(2) Sequences for protein synthesis inhibitor.
Sequence Source Toxin Name
Corynebacterium diphtheriae & C. ulcerans Diphtheria toxin
Pseudomonas aeruginosa Exotoxin A
Shigella dysenteriae Shigella toxin (Shiga toxin,
Shigella dysenteriae type I
toxin, Vero cell toxin)
Abrus precatorius, seeds Abrin
Ricinus communis, seeds Ricin
(3) Sequences for neurotoxins.
Sequence Source Toxin Name
Clostridium botulinum Neurotoxins A, B, C1, D, E,
F, G (Botulinum toxins,
botulinal toxins)
[[Page 63]]
Clostridium tetani Tetanus toxin
(tetanospasmin)
Proteus mirabilis Neurotoxin
Staphylococcus aureus Alpha toxin (alpha lysin)
Yersinia pestis Murine toxin
Snake toxins ............................
Bungarus caeruleus Caeruleotoxin
Bungarus multicinctus Beta-bungarotoxin
(phospholipase)
Crotalus spp. Crotoxin (phospholipase)
Dendroaspis viridis Neurotoxin
Naja naja varieties Neurotoxin
Notechia scutatus Notexin (phospholipase)
Oxyuranus scutellatus Taipoxin
Invertebrate toxins
Chironex fleckeri Neurotoxin
Androctnus australis Neurotoxin
Centruroides sculpturatus Neurotoxin
(4) Sequences for oxygen labile cytolysins.
Sequence Source Toxin Name
Bacillus alve Alveolysin
Bacillus cereus Cereolysin
Bacillus laterosporus Laterosporolysin
Bacillus thuringiensis Thuringiolysin
Clostridium bifermentans Lysin
Clostridium botulinum Lysin
Clostridium caproicum Lysin
Clostridium chauvoei Delta-toxin
Clostridium histolyticum Epsilon-toxin
Clostridium novyi Gamma-toxin
Clostridium oedematiens Delta-toxin
Clostridium perfringens Theta-toxin (Perfringolysin)
Clostridium septicum Delta-toxin
Clostridium sordellii Lysin
Clostridium tetani Tetanolysin
Listeria monocytogenes Listeriolysin (A B)
Streptococcus pneumoniae Pneumolysin
Streptococcus pyogene Streptolysin O (SLO)
(5) Sequences for toxins affecting membrane function.
Sequence Source Toxin Name
Bacillus anthracis Edema factor (Factors I II);
Lethal factor (Factors II
III)
Bacillus cereus Enterotoxin (diarrheagenic
toxin, mouse lethal factor)
Bordetella pertussis Adenylate cyclase (Heat-
labile factor); Pertussigen
(pertussis toxin, islet
activating factor,
histamine sensitizing
factor, lymphocytosis
promoting factor)
Clostridium botulinum C2 toxin
Clostridium difficile Enterotoxin (toxin A)
Clostridium perfringens Beta-toxin; Delta-toxin
Escherichia coli & other Heat-labile enterotoxins
Enterobacteriaceae spp. (LT); Heat-stable
enterotoxins (STa, ST1
subtypes ST1a ST1b; also
STb, STII)
Legionella pneumophila Cytolysin
Vibrio cholerae & Vibrio mimicus Cholera toxin (choleragen)
(6) Sequences that affect membrane integrity.
Sequence Source Toxin Name
Clostridium bifermentans & other Lecithinase
Clostridium spp
Clostridium perfringens Alpha-toxin (phospholipase
C, lecithinase);
Enterotoxin
Corynebacterium pyogenes & other Cytolysin (phospholipase C),
Corynebacterium spp. Ovis toxin
(sphingomyelinase D)
Staphylococcus aureus Beta-lysin (beta toxin)
(7) Sequences that are general cytotoxins.
Sequence Source Toxin Name
Adenia digitata Modeccin
Aeromonas hydrophila Aerolysin (beta-lysin,
cytotoxic lysin)
Clostridium difficile Cytotoxin (toxin B)
Clostridium perfringens Beta-toxin; Epsilon-toxin;
Kappa-toxin
Escherichia coli & other Cytotoxin (Shiga-like toxin,
Enterobacteriaceae spp. Vero cell toxin)
Pseudomonas aeruginosa Proteases
Staphylococcus aureus Gamma lysin (Gamma toxin);
Enterotoxins (SEA, SEB,
SEC, SED SEE); Pyrogenic
exotoxins A B; Toxic shock
syndrome toxins (TSST-1)
Staphylococcus aureus & Pseudomonas Leucocidin (leukocidin,
aeruginosa cytotoxin)
Streptococcus pyogenes Streptolysin S (SLS);
Erythrogenic toxins
(scarlet fever toxins,
pyrogenic exotoxins)
Yersinia enterocolitica Heat-stable enterotoxins
(ST)
Sec. 725.422 Physical containment and control technologies.
The manufacturer must meet all of the following criteria for
physical containment and control technologies for any facility in which
the new microorganism will be used for a Tier I exemption; these
criteria also serve as guidance for a Tier II exemption.
(a) Use a structure that is designed and operated to contain the new
microorganism.
(b) Control access to the structure.
(c) Provide written, published, and implemented procedures for the
safety of personnel and control of hygiene.
(d) Use inactivation procedures demonstrated and documented to be
effective against the new microorganism contained in liquid and solid
wastes prior to disposal of the wastes. The inactivation procedures must
reduce viable microbial populations by at least 6 logs in liquid and
solid wastes.
(e) Use features known to be effective in minimizing viable
microbial populations in aerosols and exhaust gases released from the
structure, and document use of such features.
[[Page 64]]
(f) Use systems for controlling dissemination of the new
microorganism through other routes, and document use of such features.
(g) Have in place emergency clean-up procedures.
Sec. 725.424 Requirements for the Tier I exemption.
(a) Conditions of exemption. The manufacture or import of a new
microorganism for commercial purposes is not subject to review under
this part if all of the following conditions are met for all activities
involving the new microorganism:
(1) The recipient microorganism is listed in and meets any
requirements specified in Sec. 725.420.
(2) The introduced genetic material meets the criteria under Sec.
725.421.
(3) The physical containment and control technologies of any
facility in which the microorganism will be manufactured, processed, or
used meet the criteria under Sec. 725.422.
(4) The manufacturer or importer submits a certification described
in paragraph (b) of this section to EPA at least 10 days before
commencing initial manufacture or import of a new microorganism derived
from a recipient microorganism listed in Sec. 725.420.
(5) The manufacturer or importer complies with the recordkeeping
requirements of Sec. 725.65 and maintains records for the initial and
subsequent uses of the new microorganism that verify compliance with the
following:
(i) The certifications made in paragraph (b) of this section.
(ii) All the eligibility criteria for the Tier I exemption including
the criteria for the recipient microorganism, the introduced genetic
material, the physical containment and control technologies.
(b) Certification. To be eligible for the Tier I exemption under
this subpart, the manufacturer or importer must submit to EPA a document
signed by a responsible company official containing the information
listed in this paragraph.
(1) Name and address of manufacturer or importer.
(2) Date when manufacture or import is expected to begin.
(3) The identification (genus, species) of the recipient
microorganism listed in Sec. 725.420 which is being used to create the
new microorganism which will be used under the conditions of the Tier I
exemption.
(4) Certification of the following:
(i) Compliance with the introduced genetic material criteria
described in Sec. 725.421.
(ii) Compliance with the containment requirements described in Sec.
725.422, including the provision in paragraph (a)(3) of this section.
(5) The site of waste disposal and the type of permits for disposal,
the permit numbers and the institutions issuing the permits.
(6) The certification statement required in Sec. 725.25(b).
Certification of submission of test data is not required for the Tier I
exemption.
Sec. 725.426 Applicability of the Tier I exemption.
The Tier I exemption under Sec. 725.424 applies only to a
manufacturer or importer of a new microorganism that certifies that the
microorganism will be used in all cases in compliance with 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.
[[Page 65]]
Sec. 725.450 Procedural requirements for the Tier II exemption.
General requirements for all submissions under this part are
contained in Sec. 725.25. In addition, the following requirements apply
to requests submitted under this subpart:
(a) Prenotice consultation. EPA strongly suggests that for a Tier II
exemption, the submitter contact the Agency for a prenotice consultation
regarding eligibility for the exemption.
(b) When to submit the Tier II exemption request. Each person who is
eligible to submit a Tier II exemption request under this subpart must
submit the request at least 45 calendar days before the person intends
to commence manufacture or import.
(c) Contents of the Tier II exemption request. Each person who
submits a request under this subpart must provide the information
described in 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.
(2) The name, address, and office telephone number (including area
code) of the principal technical contact representing the submitter.
(b) Microorganism identity information. (1) Identification (genus,
species, and strain) of the recipient microorganism. Genus, species
designation should be substantiated by a letter from a culture
collection or a brief summary of the results of tests conducted for
taxonomic identification.
(2) Type of genetic modification and the function of the introduced
genetic material.
(3) Site of insertion.
(4) Certification of compliance with the introduced genetic material
criteria described in Sec. 725.421.
(c) Production volume. Production volume, including total liters per
year, and the maximum cell concentration achieved during the production
process.
(d) Process and containment information. (1) A description of the
process including the following:
(i) Identity and location of the manufacturing site(s).
(ii) Process flow diagram illustrating the production process,
including downstream separations, and indicating the containment
envelope around the appropriate equipment.
(iii) Identities and quantities of feedstocks.
(iv) Sources and quantities of potential releases to both the
workplace and environment, and a description of engineering controls,
inactivation procedures, and other measures which will reduce worker
exposure and environmental releases.
(v) A description of procedures which will be undertaken to prevent
fugitive emissions, i.e. leak detection and repair program.
(vi) A description of procedures/safeguards to prevent and mitigate
accidental releases to the workplace and the environment.
(2) Certification of those elements of the containment criteria
described in Sec. 725.422 with which the manufacturer is in compliance,
including stating by number the elements with which the manufacturer is
in full compliance.
(e) The site of waste disposal and the type of permits for disposal,
the permit
[[Page 66]]
numbers and the institutions issuing the permits.
(f) The certification statement required in Sec. 725.25(b).
Certification of submission of test data is not required for the Tier II
exemption.
Sec. 725.470 EPA review of the Tier II exemption request.
General procedures for review of all submissions under this part are
contained in 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.
(3) If the request is denied, the manufacturer or importer may
submit the information necessary to constitute a MCAN under subpart D of
this part.
(e) Approval or denial of the Tier II exemption request. (1) No
later than 45 days after EPA receives a request, the Agency will either
approve or deny the request.
(2) In approving a request, EPA may impose any restrictions
necessary to ensure that the microorganism will not present an
unreasonable risk of injury to health and the environment as a result of
general commercial use.
(f) EPA may seek to enjoin the manufacture or import of a
microorganism in violation of this subpart, or act to seize any
microorganism manufactured or imported in violation of this section or
take other actions under the authority of sections 7 or 17 of the Act.
(g) A manufacturer or importer may only proceed after receipt of EPA
approval.
Subparts H-K [Reserved]
Subpart L_Additional Procedures for Reporting on Significant New Uses of
Microorganisms
Sec. 725.900 Scope and purpose.
(a) This subpart describes additional provisions governing
submission of MCANs for microorganisms subject to significant new use
rules identified in subpart M of this part.
(b) Manufacturers, importers, and processors described in Sec.
725.105(c) must submit a MCAN under subpart D of this part for
significant new uses of microorganisms described in subpart M of this
part, unless they are excluded under Sec. 725.910 or Sec. 725.912.
(c) Section 725.920 discusses exports and imports.
(d) Additional recordkeeping requirements specific to significant
new uses of microorganisms are described in Sec. 725.950.
(e) Section 725.975 describes how EPA will approve alternative means
of complying with significant new use requirements designated in subpart
M of this part.
[[Page 67]]
(f) Expedited procedures for promulgating significant new use
requirements under subpart M of this part for microorganisms subject to
section 5(e) orders are discussed in 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 in the specific section in subpart M of this part.
(b) The manufacturer, importer, or processor described in paragraph
(a) of this section must submit a MCAN under subpart D of this part, if
such person has knowledge at the time of commercial distribution of the
microorganism identified in the specific section in subpart M of this
part that a recipient intends to engage in a designated significant new
use of that microorganism without submitting a MCAN under this part.
(c) A person who processes a microorganism identified in a specific
section in subpart M of this part for a significant new use of that
microorganism is not required to submit a MCAN if that person can
document each of the following:
(1) That the person does not know the specific microorganism
identity of the microorganism being processed, and
(2) That the person is processing the microorganism without
knowledge that the microorganism is identified in subpart M of this
part.
(d)(1) If at any time after commencing distribution in commerce of a
microorganism identified in a specific section in subpart M of this
part, a person who manufactures, imports, or processes a microorganism
described in subpart M of this part and distributes it in commerce has
knowledge that a recipient of the microorganism is engaging in a
significant new use of that microorganism designated in that section
without submitting a MCAN under this part, the person is required to
cease supplying the microorganism to that recipient and to submit a MCAN
for that microorganism and significant new use, unless the person is
able to document each of the following:
(i) That the person has notified the recipient and EPA enforcement
authorities (at the address in paragraph (d)(1)(iii) of this section),
in writing within 15 working days of the time the person develops
knowledge that the recipient is engaging in a significant new use, that
the recipient is engaging in a significant new use without submitting a
MCAN.
[[Page 68]]
(ii) That, within 15 working days of notifying the recipient as
described in paragraph (d)(1)(i) of this section, the person received
from the recipient, in writing, a statement of assurance that the
recipient is aware of the terms of the applicable section in subpart M
of this part and will not engage in the significant new use.
(iii) That the person has promptly provided EPA enforcement
authorities with a copy of the recipient's statement of assurance
described in paragraph (d)(1)(ii) of this section. The copy must be sent
to the Director, Office of Compliance (2221A), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(2) If EPA notifies the manufacturer, importer, or processor that
the recipient is engaging in a significant new use after providing the
statement of assurance described in paragraph (d)(1)(ii) of this section
and without submitting a MCAN under this part, the manufacturer,
importer, or processor shall immediately cease distribution to that
recipient until the manufacturer, importer, or processor or the
recipient has submitted a MCAN under this part and the MCAN review
period has ended.
(3) If, after receiving a statement of assurance from a recipient
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or
processor has knowledge that the recipient is engaging in a significant
new use without submitting a MCAN under this part, the manufacturer,
importer, or processor must immediately cease distributing the
microorganism to that recipient and notify EPA enforcement authorities
at the address identified in paragraph (d)(1)(iii) of this section. The
manufacturer, importer, or processor may not resume distribution to that
recipient until any one of the following has occurred:
(i) The manufacturer, importer, or processor has submitted a MCAN
under this part and the MCAN review period has ended.
(ii) The recipient has submitted a MCAN under this part and the MCAN
review period has ended.
(iii) The manufacturer, importer, or processor has received notice
from EPA enforcement authorities that it may resume distribution to that
recipient.
Sec. 725.912 Exemptions.
Persons identified in Sec. 725.105(c) are not required to submit a
MCAN under subpart D of this part for a microorganism identified in
subpart M of this part, unless otherwise specified in a specific section
in subpart M, if:
(a) The person submits a MCAN for the microorganism prior to the
promulgation date of the section in subpart M of this part which
identifies the microorganism, and the person receives written
notification of compliance from EPA prior to the effective date of such
section. The MCAN submitter must comply with any applicable requirement
of section 5(b) of the Act. The MCAN must include the information and
test data specified in section 5(d)(1) of the Act. For purposes of this
exemption, the specific section in subpart M of this part which
identifies the microorganism and 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.
[[Page 69]]
Sec. 725.920 Exports and imports.
(a) Exports. Persons who intend to export a microorganism identified
in subpart M of this part, or in any proposed rule which would amend
subpart M of this part, are subject to the export notification
provisions of section 12(b) of the Act. The regulations that interpret
section 12(b) appear at part 707 of this chapter.
(b) Imports. Persons who import a substance identified in a specific
section in subpart M of this part are subject to the import
certification requirements under section 13 of the Act, which are
codified at 19 CFR 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.
Sec. 725.975 EPA approval of alternative control measures.
(a) In certain sections of subpart M of this part, significant new
uses for the identified microorganisms are described as the failure to
establish and implement programs providing for the use of either:
specific measures to control worker exposure to or release of
microorganisms which are identified in such sections, or alternative
measures to control worker exposure or environmental release which EPA
has determined provide substantially the same degree of protection as
the specified control measures. Persons who manufacture, import, or
process a microorganism identified in such sections and who intend to
employ alternative measures to control worker exposure or environmental
release must submit a request to EPA for a determination of equivalency
before commencing manufacture, import, or processing involving the
alternative control measures.
(b) Persons submitting a request for a determination of equivalency
to EPA under this part must submit the request to EPA (via CDX) using e-
PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to
obtain e-PMN software. Support documents related to these requests must
also be submitted to EPA via CDX using e-PMN software. A request for a
determination of equivalency must contain:
(1) The name of the submitter.
(2) The specific identity of the microorganism.
(3) The citation for the specific section in subpart M of this part
which pertains to the microorganism for which the request is being
submitted.
(4) A detailed description of the activities involved.
(5) The specifications of the alternative worker exposure control
measures or environmental release control measures.
(6) A detailed analysis explaining why such alternative control
measures provide substantially the same degree of protection as the
specific control measures identified in the specific section in subpart
M of this part which
[[Page 70]]
pertains to the microorganism for which the request is being submitted.
(7) The data and information described in 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.
(2) If EPA determines that significant new use notifications
requirements are not needed for a microorganism that is subject to a
final order issued under section 5(e) of the Act, EPA will issue a
notice in the Federal Register explaining why the significant new use
requirements are not needed.
(b) Designation of requirements. (1) The significant new use
notification and other specific requirements will be based on and be
consistent with the provisions included in the final order issued for
the microorganism under section 5(e) of the Act. EPA may also designate
additional activities as significant new uses which will be subject to
notification.
(2) Significant new use requirements and other specific requirements
designated under this section will be listed in subpart M of this part.
For each microorganism, subpart M of this part will identify:
(i) The microorganism name.
(ii) The activities designated as significant new uses.
(iii) Other specific requirements applicable to the microorganism,
including recordkeeping requirements or any other requirements included
in the final section 5(e) order.
(c) Procedures for issuing significant new use rules--(1) Possible
processes. EPA will issue significant new use rules (SNURs) under this
section by one of the following three processes: direct final
rulemaking, interim final rulemaking, or notice and comment rulemaking.
EPA will use the direct final rulemaking process to issue significant
new use rules unless it determines that, in a particular case, one of
the other processes is more appropriate.
(2) Notice in the Federal Register. Federal Register documents
issued to propose or establish significant new uses under this section
will contain the following:
(i) The microorganism identity or, if its specific identity is
claimed confidential, an appropriate generic microorganism name and an
accession number assigned by EPA.
(ii) The MCAN number.
[[Page 71]]
(iii) A summary of EPA's findings under section 5(e)(1)(A) of the
Act for the final order issued under section 5(e).
(iv) Designation of the significant new uses subject to, or proposed
to be subject to, notification and any other applicable requirements.
(v) Any modification of subpart L of this part applicable to the
specific microorganism and significant new uses.
(vi) If the Federal Register document establishes a final rule, or
notifies the public that a final rule will not be issued after public
comment has been received, the document will describe comments received
and EPA's response.
(3) Direct final rulemaking. (i) EPA will use direct final
rulemaking to issue a significant new use rule, when specific
requirements will be based on and be consistent with the provisions
included in the final order issued for the microorganism under section
5(e) of the Act. EPA will issue a final rule in the Federal Register
following its decision to develop a significant new use rule under this
section for a specific new microorganism.
(ii) The Federal Register document will state that, unless written
notice is received by EPA within 30 days of publication that someone
wishes to submit adverse or critical comments, the rule will be
effective 60 days from the date of publication. The written notice of
intent to submit adverse or critical comments should state which SNUR(s)
will be the subject of the adverse or critical comments, if several
SNURs are established through the direct final rule. If notice is
received within 30 days that someone wishes to submit adverse or
critical comments, the section(s) of the direct final rule containing
the SNUR(s) for which a notice of intent to comment was received will be
withdrawn by EPA issuing a document in the final rule section of the
Federal Register, and a proposal will be published in the proposed rule
section of the Federal Register. The proposal will establish a 30-day
comment period.
(iii) If EPA, having considered any timely comments submitted in
response to the proposal, decides to establish notification requirements
under this section, EPA will issue a final rule adding the microorganism
to subpart M of this part and designating the significant new uses
subject to notification.
(4) Interim final rulemaking. (i) EPA will use the interim final
rulemaking procedure to issue a significant new use rule, when specific
requirements will be based on and be consistent with the provisions
included in the final order issued for the microorganism under section
5(e) of the Act. The Agency will issue an interim final rule in the
Federal Register following its decision to develop a significant new use
rule for a specific new microorganism. The document will state EPA's
reasons for using the interim final rulemaking procedure.
(A) The significant new use rule will take effect on the date of
publication.
(B) Persons will be given 30 days from the date of publication to
submit comments.
(ii) Interim final rules issued under this section shall cease to be
in effect 180 days after publication unless, within the 180-day period,
EPA issues a final rule in the Federal Register responding to any
written comments received during the 30-day comment period specified in
paragraph (c)(4)(i)(B) of this section and promulgating final
significant new use notification requirements and other requirements for
the microorganism.
(5) Notice and comment rulemaking. (i) EPA will use a notice and
comment procedure to issue a significant new use rule, when EPA is
designating additional activities which are not provisions included in
the final order issued for the microorganism under section 5(e) of the
Act as significant new uses which will be subject to notification. EPA
will issue a proposal in the Federal Register following its decision to
develop a significant new use rule under this section for a specific new
microorganism. Persons will be given 30 days to comment on whether EPA
should establish notification requirements for the microorganism under
this part.
(ii) If EPA, having considered any timely comments, decides to
establish notification requirements under this
[[Page 72]]
section, EPA will issue a final rule adding the microorganism to subpart
M of this part and designating the significant new uses subject to
notification.
(d) Schedule for issuing significant new use rules. (1) Unless EPA
determines that a significant new use rule should not be issued under
this section, EPA will issue a proposed rule, a direct final rule, or an
interim final rule within 180 days of receipt of a valid notice of
commencement under Sec. 725.190.
(2) If EPA receives adverse or critical significant comments
following publication of a proposed or interim final rule, EPA will
either withdraw the rule or issue a final rule addressing the comments
received.
Sec. 725.984 Modification or revocation of certain notification
requirements.
(a) Criteria for modification or revocation. EPA may at any time
modify or revoke significant new use notification requirements for a
microorganism which has been added to subpart M of this part using the
procedures of Sec. 725.980. Such action may be taken under this section
if EPA makes one of the following determinations, unless other
information shows that the requirements should be retained:
(1) Test data or other information obtained by EPA provide a
reasonable basis for concluding that activities designated as
significant new uses of the microorganism will not present an
unreasonable risk of injury to health or the environment.
(2) EPA has promulgated a rule under section 4 or 6 of the Act, or
EPA or another agency has taken action under another law, for the
microorganism that eliminates the need for significant new use
notification under section 5(a)(2) of the Act.
(3) EPA has received MCANs for some or all of the activities
designated as significant new uses of the microorganism and, after
reviewing such MCANs, concluded that there is no need to require
additional notice from persons who propose to engage in identical or
similar activities.
(4) EPA has examined new information, or has reexamined the test
data or other information supporting its finding under section
5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no
longer exists for the findings that activities involving the
microorganism may present an unreasonable risk of injury to health or
the environment required under section 5(e)(1)(A) of the Act.
(5) Certain activities involving the microorganism have been
designated as significant new uses pending the completion of testing,
and adequate test data developed in accordance with applicable
procedures and criteria have been submitted to EPA.
(b) Procedures for limitation or revocation. Modification or
revocation of significant new use notification requirements for a
microorganism that has been added to subpart M of this part using the
procedures described in Sec. 725.980 may occur either at EPA's
initiative or in response to a written request.
(1) Any affected person may request modification or revocation of
significant new use notification requirements for a microorganism that
has been added to subpart M of this part using the procedures described
in Sec. 725.980. The request must be accompanied by information
sufficient to support the request. Persons submitting a request to EPA
under this part must submit the request to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software. Support documents related to these requests must also be
submitted to EPA via CDX using e-PMN software.
(2) The Director, or a designee, will consider the request, make a
determination whether to initiate rulemaking to modify the requirements,
and notify the requester of that determination by certified letter. If
the request is denied, the letter will explain why EPA has concluded
that the significant new use notification requirements for that
microorganism should remain in effect.
(3) If EPA concludes that significant new use notification
requirements for a microorganism should be limited or revoked, EPA will
propose the changes in a notice in the Federal Register,
[[Page 73]]
briefly describe the grounds for the action, and provide interested
parties an opportunity to comment.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Subpart M_Significant New Uses for Specific Microorganisms
Sec. 725.1000 Scope.
This subpart identifies uses of microorganisms which EPA has
determined to be significant new uses under the authority of section
5(a)(2) of the Toxic Substances Control Act.
Sec. 725.1075 Burkholderia cepacia complex.
(a) Microorganism and significant new uses subject to reporting. (1)
The microorganisms identified as the Burkholderia cepacia complex
defined as containing the following nine species, Burkholderia cepacia,
Burkholderia multivorans, Burkholderia stabilis, Burkholderia
vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia,
Burkholderia cepacia genomovar VIII (Burkholderia anthina), and
Burkholderia cepacia genomovars III and VI are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new use is any use other than research and
development in the degradation of chemicals via injection into
subsurface groundwater.
(b) [Reserved]
[68 FR 35320, June 13, 2003]
PART 745_LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL
STRUCTURES--Table of Contents
Subparts A-C [Reserved]
Subpart D_Lead-Based Paint Hazards
Sec.
745.61 Scope and applicability.
745.63 Definitions.
745.65 Lead-based paint hazards.
Subpart E_Residential Property Renovation
745.80 Purpose.
745.81 Effective dates.
745.82 Applicability.
745.83 Definitions.
745.84 Information distribution requirements.
745.85 Work practice standards.
745.86 Recordkeeping and reporting requirements.
745.87 Enforcement and inspections.
745.88 Recognized test kits.
745.89 Firm certification.
745.90 Renovator certification and dust sampling technician
certification.
745.91 Suspending, revoking, or modifying an individual's or firm's
certification.
745.92 Fees for the accreditation of renovation and dust sampling
technician training and the certification of renovation firms.
Subpart F_Disclosure of Known Lead-Based Paint and/or Lead-Based Paint
Hazards Upon Sale or Lease of Residential Property
745.100 Purpose.
745.101 Scope and applicability.
745.102 Effective dates.
745.103 Definitions.
745.107 Disclosure requirements for sellers and lessors.
745.110 Opportunity to conduct an evaluation.
745.113 Certification and acknowledgment of disclosure.
745.115 Agent responsibilities.
745.118 Enforcement.
745.119 Impact on State and local requirements.
Subparts G-K [Reserved]
Subpart L_Lead-Based Paint Activities
745.220 Scope and applicability.
745.223 Definitions.
745.225 Accreditation of training programs: target housing and child-
occupied facilities.
745.226 Certification of individuals and firms engaged in lead-based
paint activities: target housing and child-occupied
facilities.
745.227 Work practice standards for conducting lead-based paint
activities: target housing and child-occupied facilities.
745.228 Accreditation of training programs: public and commercial
buildings, bridges and superstructures. [Reserved]
745.229 Certification of individuals and firms engaged in lead-based
paint activities: public and commercial buildings, bridges and
superstructures. [Reserved]
745.230 Work practice standards for conducting lead-based paint
activities: public and commercial buildings, bridges and
superstructures. [Reserved]
745.233 Lead-based paint activities requirements.
745.235 Enforcement.
[[Page 74]]
745.237 Inspections.
745.238 Fees for accreditation and certification of lead-based paint
activities.
745.239 Effective dates.
Subparts M-P [Reserved]
Subpart Q_State and Indian Tribal Programs
745.320 Scope and purpose.
745.323 Definitions.
745.324 Authorization of State or Tribal programs.
745.325 Lead-based paint activities: State and Tribal program
requirements.
745.326 Renovation: State and Tribal program requirements.
745.327 State or Indian Tribal lead-based paint compliance and
enforcement programs.
745.339 Effective date.
Authority: 15 U.Sec. C. 2605, 2607, 2681-2692 and 42 U.Sec. C. 4852d.
Source: 61 FR 9085, Mar. 6, 1996, unless otherwise noted.
Subparts A-C [Reserved]
Subpart D_Lead-Based Paint Hazards
Source: 66 FR 1237, Jan. 5, 2001, unless otherwise noted.
Sec. 745.61 Scope and applicability.
(a) This subpart identifies lead-based paint hazards.
(b) The standards for lead-based paint hazards apply to target
housing and child-occupied facilities.
(c) Nothing in this subpart requires the owner of property(ies)
subject to these standards to evaluate the property(ies) for the
presence of lead-based paint hazards or take any action to control these
conditions if one or more of them is identified.
Sec. 745.63 Definitions.
The following definitions apply to part 745.
Arithmetic mean means the algebraic sum of data values divided by
the number of data values (e.g., the sum of the concentration of lead in
several soil samples divided by the number of samples).
Chewable surface means an interior or exterior surface painted with
lead-based paint that a young child can mouth or chew. A chewable
surface is the same as an ``accessible surface'' as defined in 42 U.Sec. C.
4851b(2)). Hard metal substrates and other materials that cannot be
dented by the bite of a young child are not considered chewable.
Common area group means a group of common areas that are similar in
design, construction, and function. Common area groups include, but are
not limited to hallways, stairwells, and laundry rooms.
Concentration means the relative content of a specific substance
contained within a larger mass, such as the amount of lead (in
micrograms per gram or parts per million by weight) in a sample of dust
or soil.
Deteriorated paint means any interior or exterior paint or other
coating that is peeling, chipping, chalking or cracking, or any paint or
coating located on an interior or exterior surface or fixture that is
otherwise damaged or separated from the substrate.
Dripline means the area within 3 feet surrounding the perimeter of a
building.
Friction surface means an interior or exterior surface that is
subject to abrasion or friction, including, but not limited to, certain
window, floor, and stair surfaces.
Impact surface means an interior or exterior surface that is subject
to damage by repeated sudden force such as certain parts of door frames.
Interior window sill means the portion of the horizontal window
ledge that protrudes into the interior of the room.
Lead-based paint hazard means hazardous lead-based paint, dust-lead
hazard or soil-lead hazard as identified in Sec. 745.65.
Loading means the quantity of a specific substance present per unit
of surface area, such as the amount of lead in micrograms contained in
the dust collected from a certain surface area divided by the surface
area in square feet or square meters.
Mid-yard means an area of a residential yard approximately midway
between the dripline of a residential building and the nearest property
boundary or between the driplines of a residential building and another
building on the same property.
[[Page 75]]
Play area means an area of frequent soil contact by children of less
than 6 years of age as indicated by, but not limited to, such factors
including the following: the presence of play equipment (e.g.,
sandboxes, swing sets, and sliding boards), toys, or other children's
possessions, observations of play patterns, or information provided by
parents, residents, care givers, or property owners.
Residential building means a building containing one or more
residential dwellings.
Room means a separate part of the inside of a building, such as a
bedroom, living room, dining room, kitchen, bathroom, laundry room, or
utility room. To be considered a separate room, the room must be
separated from adjoining rooms by built-in walls or archways that extend
at least 6 inches from an intersecting wall. Half walls or bookcases
count as room separators if built-in. Movable or collapsible partitions
or partitions consisting solely of shelves or cabinets are not
considered built-in walls. A screened in porch that is used as a living
area is a room.
Soil sample means a sample collected in a representative location
using ASTM E1727, ``Standard Practice for Field Collection of Soil
Samples for Lead Determination by Atomic Spectrometry Techniques,'' or
equivalent method.
Weighted arithmetic mean means the arithmetic mean of sample results
weighted by the number of subsamples in each sample. Its purpose is to
give influence to a sample relative to the surface area it represents. A
single surface sample is comprised of a single subsample. A composite
sample may contain from two to four subsamples of the same area as each
other and of each single surface sample in the composite. The weighted
arithmetic mean is obtained by summing, for all samples, the product of
the sample's result multiplied by the number of subsamples in the
sample, and dividing the sum by the total number of subsamples contained
in all samples. For example, the weighted arithmetic mean of a single
surface sample containing 60 [micro]g/ft\2\, 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 40 [micro]g/ft\2\
[[Page 76]]
on floors or 250 [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.
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.Sec. C. 2682 and 2686) and
applies to all renovations performed for compensation in target housing
and child-occupied facilities. The purpose of this subpart is to ensure
the following:
(a) Owners and occupants of target housing and child-occupied
facilities receive information on lead-based paint hazards before these
renovations begin; and
(b) Individuals performing renovations regulated in accordance with
Sec. 745.82 are properly trained; renovators and firms performing these
renovations are certified; and the work practices in Sec. 745.85 are
followed during these renovations.
[73 FR 21758, Apr. 22, 2008]
Sec. 745.81 Effective dates.
(a) Training, certification and accreditation requirements and work
practice standards. The training, certification and accreditation
requirements and work practice standards in this subpart are applicable
in any State or Indian Tribal area that does not have a renovation
program that is authorized under subpart Q of this part. The training,
certification and accreditation requirements and work practice standards
in this subpart will become effective as follows:
(1) Training programs. Effective June 23, 2008, no training program
may provide, offer, or claim to provide training or refresher training
for EPA certification as a renovator or a dust sampling technician
without accreditation from EPA under Sec. 745.225. Training programs
may apply for accreditation under Sec. 745.225 beginning April 22,
2009.
(2) Firms. (i) Firms may apply for certification under Sec. 745.89
beginning October 22, 2009.
(ii) On or after April 22, 2010, no firm may perform, offer, or
claim to perform renovations without certification from EPA under Sec.
745.89 in target housing or child-occupied facilities, unless the
renovation qualifies for one of the exceptions identified in Sec.
745.82(a) or (c).
(3) Individuals. On or after April 22, 2010, all renovations must be
directed by renovators certified in accordance with Sec. 745.90(a) and
performed by certified renovators or individuals trained in accordance
with Sec. 745.90(b)(2) in target housing or child-occupied facilities,
unless the renovation qualifies for one of the exceptions identified in
Sec. 745.82(a) or (c).
(4) Work practices. (i) On or after April 22, 2010 and before July
6, 2010 all renovations must be performed in accordance with the work
practice standards in Sec. 745.85 and the associated recordkeeping
requirements in Sec. 745.86 (b)(6) in target housing or child-occupied
facilities, unless the renovation qualifies for one of the exceptions
identified in Sec. 745.82(a). This does not apply to renovations in
target housing for which
[[Page 77]]
the firm performing the renovation has obtained a statement signed by
the owner that the renovation will occur in the owner's residence, no
child under age 6 resides there, the housing is not a child-occupied
facility, and the owner acknowledges that the work practices to be used
during the renovation will not necessarily include all of the lead-safe
work practices contained in EPA's renovation, repair, and painting rule.
For the purposes of this section, a child resides in the primary
residence of his or her custodial parents, legal guardians, and foster
parents. A child also resides in the primary residence of an informal
caretaker if the child lives and sleeps most of the time at the
caretaker's residence.
(ii) On or after July 6, 2010, all renovations must be performed in
accordance with the work practice standards in Sec. 745.85 and the
associated recordkeeping requirements in Sec. 745.86(b)(1) and (b)(6)
in target housing or child-occupied facilities, unless the renovation
qualifies for the exception identified in Sec. 745.82(a).
(5) The suspension and revocation provisions in Sec. 745.91 are
effective April 22, 2010.
(b) Renovation-specific pamphlet. Before December 22, 2008,
renovators or firms performing renovations in States and Indian Tribal
areas without an authorized program may provide owners and occupants
with either of the following EPA pamphlets: Protect Your Family From
Lead in Your Home or Renovate Right: Important Lead Hazard Information
for Families, Child Care Providers and Schools. After that date,
Renovate Right: Important Lead Hazard Information for Families, Child
Care Providers and Schools must be used exclusively.
(c) Pre-Renovation Education Rule. With the exception of the
requirement to use the pamphlet entitled Renovate Right: Important Lead
Hazard Information for Families, Child Care Providers and Schools, the
provisions of the Pre-Renovation Education Rule in this subpart have
been in effect since June 1999.
[73 FR 21758, Apr. 22, 2008, as amended at 75 FR 24818, May 6, 2010]
Sec. 745.82 Applicability.
(a) This subpart applies to all renovations performed for
compensation in target housing and child-occupied facilities, except for
the following:
(1) Renovations in target housing or child-occupied facilities in
which a written determination has been made by an inspector or risk
assessor (certified pursuant to either Federal regulations at Sec.
745.226 or a State or Tribal certification program authorized pursuant
to Sec. 745.324) that the components affected by the renovation are
free of paint or other surface coatings that contain lead equal to or in
excess of 1.0 milligrams/per square centimeter (mg/cm\2\) or 0.5% by
weight, where the firm performing the renovation has obtained a copy of
the determination.
(2) Renovations in target housing or child-occupied facilities in
which a certified renovator, using an EPA recognized test kit as defined
in Sec. 745.83 and following the kit manufacturer's instructions, has
tested each component affected by the renovation and determined that the
components are free of paint or other surface coatings that contain lead
equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the
components make up an integrated whole, such as the individual stair
treads and risers of a single staircase, the renovator is required to
test only one of the individual components, unless the individual
components appear to have been repainted or refinished separately.
(3) Renovations in target housing or child-occupied facilities in
which a certified renovator has collected a paint chip sample from each
painted component affected by the renovation and a laboratory recognized
by EPA pursuant to section 405(b) of TSCA as being capable of performing
analyses for lead compounds in paint chip samples has determined that
the samples are free of paint or other surface coatings that contain
lead equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the
components make up an integrated whole, such as the individual stair
treads and risers of a single staircase, the renovator is required to
test only one of the individual components, unless the individual
components appear to have
[[Page 78]]
been repainted or refinished separately.
(b) The information distribution requirements in Sec. 745.84 do not
apply to emergency renovations, which are renovation activities that
were not planned but result from a sudden, unexpected event (such as
non-routine failures of equipment) that, if not immediately attended to,
presents a safety or public health hazard, or threatens equipment and/or
property with significant damage. Interim controls performed in response
to an elevated blood lead level in a resident child are also emergency
renovations. Emergency renovations other than interim controls are also
exempt from the warning sign, containment, waste handling, training, and
certification requirements in 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 include, but are not limited to, day care centers, preschools and
kindergarten classrooms. Child-occupied facilities may be located in
target housing or in public or commercial buildings. With respect to
common areas in public or commercial buildings that contain child-
occupied facilities, the child-occupied facility encompasses only those
common areas that are routinely used by children under age 6, such as
restrooms and cafeterias. Common areas that children under age 6 only
pass through, such as hallways, stairways, and garages are not included.
In addition, with respect to exteriors of public or commercial buildings
that contain child-occupied facilities, the child-occupied facility
encompasses only the exterior sides of the building that are immediately
adjacent to the child-occupied facility or the common areas routinely
used by children under age 6.
Cleaning verification card means a card developed and distributed,
or otherwise approved, by EPA for the purpose of determining, through
comparison of wet and dry disposable cleaning cloths with the card,
whether post-renovation cleaning has been properly completed.
Component or building component means specific design or structural
elements or fixtures of a building or residential dwelling that are
distinguished from each other by form, function, and location. These
include, but are not limited to, interior components such as: Ceilings,
crown molding, walls, chair rails, doors, door trim, floors, fireplaces,
radiators and other heating units, shelves, shelf supports, stair
treads, stair risers, stair stringers, newel posts, railing caps,
balustrades, windows and trim (including sashes, window heads, jambs,
sills or stools and troughs), built in cabinets, columns, beams,
bathroom vanities, counter tops, and air conditioners; and exterior
components such as: Painted roofing, chimneys, flashing, gutters and
downspouts, ceilings, soffits, fascias, rake boards, cornerboards,
bulkheads, doors and door trim, fences, floors, joists, lattice work,
railings and railing caps, siding, handrails, stair risers and treads,
stair stringers, columns, balustrades, windowsills or stools and
troughs, casings, sashes and wells, and air conditioners.
Dry disposable cleaning cloth means a commercially available dry,
electrostatically charged, white disposable
[[Page 79]]
cloth designed to be used for cleaning hard surfaces such as uncarpeted
floors or counter tops.
Firm means a company, partnership, corporation, sole proprietorship
or individual doing business, association, or other business entity; a
Federal, State, Tribal, or local government agency; or a nonprofit
organization.
HEPA vacuum means a vacuum cleaner which has been designed with a
high-efficiency particulate air (HEPA) filter as the last filtration
stage. A HEPA filter is a filter that is capable of capturing
particulates of 0.3 microns with 99.97% efficiency. The vacuum cleaner
must be designed so that all the air drawn into the machine is expelled
through the HEPA filter with none of the air leaking past it. HEPA
vacuums must be operated and maintained in accordance with the
manufacturer's instructions.
Interim controls means a set of measures designed to temporarily
reduce human exposure or likely exposure to lead-based paint hazards,
including specialized cleaning, repairs, maintenance, painting,
temporary containment, ongoing monitoring of lead-based paint hazards or
potential hazards, and the establishment and operation of management and
resident education programs.
Minor repair and maintenance activities are activities, including
minor heating, ventilation or air conditioning work, electrical work,
and plumbing, that disrupt 6 square feet or less of painted surface per
room for interior activities or 20 square feet or less of painted
surface for exterior activities where none of the work practices
prohibited or restricted by Sec. 745.85(a)(3) are used and where the
work does not involve window replacement or demolition of painted
surface areas. When removing painted components, or portions of painted
components, the entire surface area removed is the amount of painted
surface disturbed. Jobs, other than emergency renovations, performed in
the same room within the same 30 days must be considered the same job
for the purpose of determining whether the job is a minor repair and
maintenance activity.
Painted surface means a component surface covered in whole or in
part with paint or other surface coatings.
Pamphlet means the EPA pamphlet titled Renovate Right: Important
Lead Hazard Information for Families, Child Care Providers and Schools
developed under section 406(a) of TSCA for use in complying with section
406(b) of TSCA, or any State or Tribal pamphlet approved by EPA pursuant
to 40 CFR 745.326 that is developed for the same purpose. This includes
reproductions of the pamphlet when copied in full and without revision
or deletion of material from the pamphlet (except for the addition or
revision of State or local sources of information). Before December 22,
2008, the term ``pamphlet'' also means any pamphlet developed by EPA
under section 406(a) of TSCA or any State or Tribal pamphlet approved by
EPA pursuant to Sec. 745.326.
Person means any natural or judicial person including any
individual, corporation, partnership, or association; any Indian Tribe,
State, or political subdivision thereof; any interstate body; and any
department, agency, or instrumentality of the Federal Government.
Recognized test kit means a commercially available kit recognized by
EPA under Sec. 745.88 as being capable of allowing a user to determine
the presence of lead at levels equal to or in excess of 1.0 milligrams
per square centimeter, or more than 0.5% lead by weight, in a paint
chip, paint powder, or painted surface.
Renovation means the modification of any existing structure, or
portion thereof, that results in the disturbance of painted surfaces,
unless that activity is performed as part of an abatement as defined by
this part (40 CFR 745.223). The term renovation includes (but is not
limited to): The removal, modification or repair of painted surfaces or
painted components (e.g., modification of painted doors, surface
restoration, window repair, surface preparation activity (such as
sanding, scraping, or other such activities that may generate paint
dust)); the removal of building components (e.g., walls, ceilings,
plumbing, windows); weatherization projects (e.g., cutting holes in
[[Page 80]]
painted surfaces to install blown-in insulation or to gain access to
attics, planing thresholds to install weather-stripping), and interim
controls that disturb painted surfaces. A renovation performed for the
purpose of converting a building, or part of a building, into target
housing or a child-occupied facility is a renovation under this subpart.
The term renovation does not include minor repair and maintenance
activities.
Renovator means an individual who either performs or directs workers
who perform renovations. A certified renovator is a renovator who has
successfully completed a renovator course accredited by EPA or an EPA-
authorized State or Tribal program.
Training hour means at least 50 minutes of actual learning,
including, but not limited to, time devoted to lecture, learning
activities, small group activities, demonstrations, evaluations, and
hands-on experience.
Wet disposable cleaning cloth means a commercially available, pre-
moistened white disposable cloth designed to be used for cleaning hard
surfaces such as uncarpeted floors or counter tops.
Vertical containment means a vertical barrier consisting of plastic
sheeting or other impermeable material over scaffolding or a rigid
frame, or an equivalent system of containing the work area. Vertical
containment is required for some exterior renovations but it may be used
on any renovation.
Wet mopping system means a device with the following
characteristics: A long handle, a mop head designed to be used with
disposable absorbent cleaning pads, a reservoir for cleaning solution,
and a built-in mechanism for distributing or spraying the cleaning
solution onto a floor, or a method of equivalent efficacy.
Work area means the area that the certified renovator establishes to
contain the dust and debris generated by a renovation.
[63 FR 29919, June 1, 1998, as amended at 73 FR 21758, Apr. 22, 2008; 76
FR 47938, Aug. 5, 2011]
Sec. 745.84 Information distribution requirements.
(a) Renovations in dwelling units. No more than 60 days before
beginning renovation activities in any residential dwelling unit of
target housing, the firm performing the renovation must:
(1) Provide the owner of the unit with the pamphlet, and comply with
one of the following:
(i) Obtain, from the owner, a written acknowledgment that the owner
has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(2) In addition to the requirements in paragraph (a)(1) of this
section, if the owner does not occupy the dwelling unit, provide an
adult occupant of the unit with the pamphlet, and comply with one of the
following:
(i) Obtain, from the adult occupant, a written acknowledgment that
the occupant has received the pamphlet; or certify in writing that a
pamphlet has been delivered to the dwelling and that the firm performing
the renovation has been unsuccessful in obtaining a written
acknowledgment from an adult occupant. Such certification must include
the address of the unit undergoing renovation, the date and method of
delivery of the pamphlet, names of the persons delivering the pamphlet,
reason for lack of acknowledgment (e.g., occupant refuses to sign, no
adult occupant available), the signature of a representative of the firm
performing the renovation, and the date of signature.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(b) Renovations in common areas. No more than 60 days before
beginning renovation activities in common areas of multi-unit target
housing, the firm performing the renovation must:
(1) Provide the owner with the pamphlet, and comply with one of the
following:
(i) Obtain, from the owner, a written acknowledgment that the owner
has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(2) Comply with one of the following. (i) Notify in writing, or
ensure written notification of, each affected unit and make the pamphlet
available upon request prior to the start of renovation. Such
notification shall be accomplished by distributing written notice to
each affected unit. The notice shall
[[Page 81]]
describe the general nature and locations of the planned renovation
activities; the expected starting and ending dates; and a statement of
how the occupant can obtain the pamphlet and a copy of the records
required by Sec. 745.86(c) and (d), at no cost to the occupants, or
(ii) While the renovation is ongoing, post informational signs
describing the general nature and locations of the renovation and the
anticipated completion date. These signs must be posted in areas where
they are likely to be seen by the occupants of all of the affected
units. The signs must be accompanied by a posted copy of the pamphlet or
information on how interested occupants can review a copy of the
pamphlet or obtain a copy from the renovation firm at no cost to
occupants. The signs must also include information on how interested
occupants can review a copy of the records required by Sec. 745.86(c)
and (d) or obtain a copy from the renovation firm at no cost to the
occupants.
(3) Prepare, sign, and date a statement describing the steps
performed to notify all occupants of the intended renovation activities
and to provide the pamphlet.
(4) If the scope, locations, or expected starting and ending dates
of the planned renovation activities change after the initial
notification, and the firm provided written initial notification to each
affected unit, the firm performing the renovation must provide further
written notification to the owners and occupants providing revised
information on the ongoing or planned activities. This subsequent
notification must be provided before the firm performing the renovation
initiates work beyond that which was described in the original notice.
(c) Renovations in child-occupied facilities. No more than 60 days
before beginning renovation activities in any child-occupied facility,
the firm performing the renovation must:
(1)(i) Provide the owner of the building with the pamphlet, and
comply with one of the following:
(A) Obtain, from the owner, a written acknowledgment that the owner
has received the pamphlet.
(B) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(ii) If the child-occupied facility is not the owner of the
building, provide an adult representative of the child-occupied facility
with the pamphlet, and comply with one of the following:
(A) Obtain, from the adult representative, a written acknowledgment
that the adult representative has received the pamphlet; or certify in
writing that a pamphlet has been delivered to the facility and that the
firm performing the renovation has been unsuccessful in obtaining a
written acknowledgment from an adult representative. Such certification
must include the address of the child-occupied facility undergoing
renovation, the date and method of delivery of the pamphlet, names of
the persons delivering the pamphlet, reason for lack of acknowledgment
(e.g., representative refuses to sign), the signature of a
representative of the firm performing the renovation, and the date of
signature.
(B) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(2) Provide the parents and guardians of children using the child-
occupied facility with the pamphlet, information describing the general
nature and locations of the renovation and the anticipated completion
date, and information on how interested parents or guardians of children
frequenting the child-occupied facility can review a copy of the records
required by Sec. 745.86(c) and (d) or obtain a copy from the renovation
firm at no cost to the occupants by complying with one of the following:
(i) Mail or hand-deliver the pamphlet and the renovation information
to each parent or guardian of a child using the child-occupied facility.
(ii) While the renovation is ongoing, post informational signs
describing the general nature and locations of the renovation and the
anticipated completion date. These signs must be posted in areas where
they can be seen by the parents or guardians of the children frequenting
the child-occupied facility. The signs must be accompanied by a posted
copy of the pamphlet or information on how interested parents or
guardians of children frequenting the child-occupied facility can review
a
[[Page 82]]
copy of the pamphlet or obtain a copy from the renovation firm at no
cost to the parents or guardians. The signs must also include
information on how interested parents or guardians of children
frequenting the child-occupied facility can review a copy of the records
required by Sec. 745.86(c) and (d) or obtain a copy from the renovation
firm at no cost to the parents or guardians.
(3) The renovation firm must prepare, sign, and date a statement
describing the steps performed to notify all parents and guardians of
the intended renovation activities and to provide the pamphlet.
(d) Written acknowledgment. The written acknowledgments required by
paragraphs (a)(1)(i), (a)(2)(i), (b)(1)(i), (c)(1)(i)(A), and
(c)(1)(ii)(A) of this section must:
(1) Include a statement recording the owner or occupant's name and
acknowledging receipt of the pamphlet prior to the start of renovation,
the address of the unit undergoing renovation, the signature of the
owner or occupant as applicable, and the date of signature.
(2) Be either a separate sheet or part of any written contract or
service agreement for the renovation.
(3) Be written in the same language as the text of the contract or
agreement for the renovation or, in the case of non-owner occupied
target housing, in the same language as the lease or rental agreement or
the pamphlet.
[63 FR 29919, June 1, 1998. Redesignated and amended at 73 FR 21760,
Apr. 22, 2008; 75 FR 24818, May 6, 2010]
Sec. 745.85 Work practice standards.
(a) Standards for renovation activities. Renovations must be
performed by certified firms using certified renovators as directed in
Sec. 745.89. The responsibilities of certified firms are set forth in
Sec. 745.89(d) and the responsibilities of certified renovators are set
forth in Sec. 745.90(b).
(1) Occupant protection. Firms must post signs clearly defining the
work area and warning occupants and other persons not involved in
renovation activities to remain outside of the work area. To the extent
practicable, these signs must be in the primary language of the
occupants. These signs must be posted before beginning the renovation
and must remain in place and readable until the renovation and the post-
renovation cleaning verification have been completed. If warning signs
have been posted in accordance with 24 CFR 35.1345(b)(2) or 29 CFR
1926.62(m), additional signs are not required by this section.
(2) Containing the work area. Before beginning the renovation, the
firm must isolate the work area so that no dust or debris leaves the
work area while the renovation is being performed. In addition, the firm
must maintain the integrity of the containment by ensuring that any
plastic or other impermeable materials are not torn or displaced, and
taking any other steps necessary to ensure that no dust or debris leaves
the work area while the renovation is being performed. The firm must
also ensure that containment is installed in such a manner that it does
not interfere with occupant and worker egress in an emergency.
(i) Interior renovations. The firm must:
(A) Remove all objects from the work area, including furniture,
rugs, and window coverings, or cover them with plastic sheeting or other
impermeable material with all seams and edges taped or otherwise sealed.
(B) Close and cover all ducts opening in the work area with taped-
down plastic sheeting or other impermeable material.
(C) Close windows and doors in the work area. Doors must be covered
with plastic sheeting or other impermeable material. Doors used as an
entrance to the work area must be covered with plastic sheeting or other
impermeable material in a manner that allows workers to pass through
while confining dust and debris to the work area.
(D) Cover the floor surface, including installed carpet, with taped-
down plastic sheeting or other impermeable material in the work area 6
feet beyond the perimeter of surfaces undergoing renovation or a
sufficient distance to contain the dust, whichever is greater. Floor
containment measures may stop at the edge of the vertical barrier when
using a vertical containment system consisting of impermeable barriers
[[Page 83]]
that extend from the floor to the ceiling and are tightly sealed at
joints with the floor, ceiling and walls.
(E) Use precautions to ensure that all personnel, tools, and other
items, including the exteriors of containers of waste, are free of dust
and debris before leaving the work area.
(ii) Exterior renovations. The firm must:
(A) Close all doors and windows within 20 feet of the renovation. On
multi-story buildings, close all doors and windows within 20 feet of the
renovation on the same floor as the renovation, and close all doors and
windows on all floors below that are the same horizontal distance from
the renovation.
(B) Ensure that doors within the work area that will be used while
the job is being performed are covered with plastic sheeting or other
impermeable material in a manner that allows workers to pass through
while confining dust and debris to the work area.
(C) Cover the ground with plastic sheeting or other disposable
impermeable material extending 10 feet beyond the perimeter of surfaces
undergoing renovation or a sufficient distance to collect falling paint
debris, whichever is greater, unless the property line prevents 10 feet
of such ground covering. Ground containment measures may stop at the
edge of the vertical barrier when using a vertical containment system.
(D) If the renovation will affect surfaces within 10 feet of the
property line, the renovation firm must erect vertical containment or
equivalent extra precautions in containing the work area to ensure that
dust and debris from the renovation does not contaminate adjacent
buildings or migrate to adjacent properties. Vertical containment or
equivalent extra precautions in containing the work area may also be
necessary in other situations in order to prevent contamination of other
buildings, other areas of the property, or adjacent buildings or
properties.
(3) Prohibited and restricted practices. The work practices listed
below are prohibited or restricted during a renovation as follows:
(i) Open-flame burning or torching of painted surfaces is
prohibited.
(ii) The use of machines designed to remove paint or other surface
coatings through high speed operation such as sanding, grinding, power
planing, needle gun, abrasive blasting, or sandblasting, is prohibited
on painted surfaces unless such machines have shrouds or containment
systems and are equipped with a HEPA vacuum attachment to collect dust
and debris at the point of generation. Machines must be operated so that
no visible dust or release of air occurs outside the shroud or
containment system.
(iii) Operating a heat gun on painted surfaces is permitted only at
temperatures below 1,100 degrees Fahrenheit.
(4) Waste from renovations--(i) Waste from renovation activities
must be contained to prevent releases of dust and debris before the
waste is removed from the work area for storage or disposal. If a chute
is used to remove waste from the work area, it must be covered.
(ii) At the conclusion of each work day and at the conclusion of the
renovation, waste that has been collected from renovation activities
must be stored under containment, in an enclosure, or behind a barrier
that prevents release of dust and debris out of the work area and
prevents access to dust and debris.
(iii) When the firm transports waste from renovation activities, the
firm must contain the waste to prevent release of dust and debris.
(5) Cleaning the work area. After the renovation has been completed,
the firm must clean the work area until no dust, debris or residue
remains.
(i) Interior and exterior renovations. The firm must:
(A) Collect all paint chips and debris and, without dispersing any
of it, seal this material in a heavy-duty bag.
(B) Remove the protective sheeting. Mist the sheeting before folding
it, fold the dirty side inward, and either tape shut to seal or seal in
heavy-duty bags. Sheeting used to isolate contaminated rooms from non-
contaminated rooms must remain in place until after the cleaning and
removal of other sheeting. Dispose of the sheeting as waste.
[[Page 84]]
(ii) Additional cleaning for interior renovations. The firm must
clean all objects and surfaces in the work area and within 2 feet of the
work area in the following manner, cleaning from higher to lower:
(A) Walls. Clean walls starting at the ceiling and working down to
the floor by either vacuuming with a HEPA vacuum or wiping with a damp
cloth.
(B) Remaining surfaces. Thoroughly vacuum all remaining surfaces and
objects in the work area, including furniture and fixtures, with a HEPA
vacuum. The HEPA vacuum must be equipped with a beater bar when
vacuuming carpets and rugs.
(C) Wipe all remaining surfaces and objects in the work area, except
for carpeted or upholstered surfaces, with a damp cloth. Mop uncarpeted
floors thoroughly, using a mopping method that keeps the wash water
separate from the rinse water, such as the 2-bucket mopping method, or
using a wet mopping system.
(b) Standards for post-renovation cleaning verification--(1)
Interiors. (i) A certified renovator must perform a visual inspection to
determine whether dust, debris or residue is still present. If dust,
debris or residue is present, these conditions must be removed by re-
cleaning and another visual inspection must be performed.
(ii) After a successful visual inspection, a certified renovator
must:
(A) Verify that each windowsill in the work area has been adequately
cleaned, using the following procedure.
(1) Wipe the windowsill with a wet disposable cleaning cloth that is
damp to the touch. If the cloth matches or is lighter than the cleaning
verification card, the windowsill has been adequately cleaned.
(2) If the cloth does not match and is darker than the cleaning
verification card, re-clean the windowsill as directed in paragraphs
(a)(5)(ii)(B) and (a)(5)(ii)(C) of this section, then either use a new
cloth or fold the used cloth in such a way that an unused surface is
exposed, and wipe the surface again. If the cloth matches or is lighter
than the cleaning verification card, that windowsill has been adequately
cleaned.
(3) If the cloth does not match and is darker than the cleaning
verification card, wait for 1 hour or until the surface has dried
completely, whichever is longer.
(4)After waiting for the windowsill to dry, wipe the windowsill with
a dry disposable cleaning cloth. After this wipe, the windowsill has
been adequately cleaned.
(B) Wipe uncarpeted floors and countertops within the work area with
a wet disposable cleaning cloth. Floors must be wiped using an
application device with a long handle and a head to which the cloth is
attached. The cloth must remain damp at all times while it is being used
to wipe the surface for post-renovation cleaning verification. If the
surface within the work area is greater than 40 square feet, the surface
within the work area must be divided into roughly equal sections that
are each less than 40 square feet. Wipe each such section separately
with a new wet disposable cleaning cloth. If the cloth used to wipe each
section of the surface within the work area matches the cleaning
verification card, the surface has been adequately cleaned.
(1) If the cloth used to wipe a particular surface section does not
match the cleaning verification card, re-clean that section of the
surface as directed in paragraphs (a)(5)(ii)(B) and (a)(5)(ii)(C) of
this section, then use a new wet disposable cleaning cloth to wipe that
section again. If the cloth matches the cleaning verification card, that
section of the surface has been adequately cleaned.
(2) If the cloth used to wipe a particular surface section does not
match the cleaning verification card after the surface has been re-
cleaned, wait for 1 hour or until the entire surface within the work
area has dried completely, whichever is longer.
(3) After waiting for the entire surface within the work area to
dry, wipe each section of the surface that has not yet achieved post-
renovation cleaning verification with a dry disposable cleaning cloth.
After this wipe, that section of the surface has been adequately
cleaned.
(iii) When the work area passes the post-renovation cleaning
verification, remove the warning signs.
[[Page 85]]
(2) Exteriors. A certified renovator must perform a visual
inspection to determine whether dust, debris or residue is still present
on surfaces in and below the work area, including windowsills and the
ground. If dust, debris or residue is present, these conditions must be
eliminated and another visual inspection must be performed. When the
area passes the visual inspection, remove the warning signs.
(c) Optional dust clearance testing. Cleaning verification need not
be performed if the contract between the renovation firm and the person
contracting for the renovation or another Federal, State, Territorial,
Tribal, or local law or regulation requires:
(1) The renovation firm to perform dust clearance sampling at the
conclusion of a renovation covered by this subpart.
(2) The dust clearance samples are required to be collected by a
certified inspector, risk assessor or dust sampling technician.
(3) The renovation firm is required to re-clean the work area until
the dust clearance sample results are below the clearance standards in
Sec. 745.227(e)(8) or any applicable State, Territorial, Tribal, or
local standard.
(d) Activities conducted after post-renovation cleaning
verification. Activities that do not disturb paint, such as applying
paint to walls that have already been prepared, are not regulated by
this subpart if they are conducted after post-renovation cleaning
verification has been performed.
[73 FR 21761, Apr. 22, 2008, as amended at 76 FR 47938, Aug. 5, 2011]
Sec. 745.86 Recordkeeping and reporting requirements.
(a) Firms performing renovations must retain and, if requested, make
available to EPA all records necessary to demonstrate compliance with
this subpart for a period of 3 years following completion of the
renovation. This 3-year retention requirement does not supersede longer
obligations required by other provisions for retaining the same
documentation, including any applicable State or Tribal laws or
regulations.
(b) Records that must be retained pursuant to paragraph (a) of this
section shall include (where applicable):
(1) Records or reports certifying that a determination had been made
that lead-based paint was not present on the components affected by the
renovation, as described in Sec. 745.82(a). These records or reports
include:
(i) Reports prepared by a certified inspector or certified risk
assessor (certified pursuant to either Federal regulations at Sec.
745.226 or an EPA-authorized State or Tribal certification program).
(ii) Records prepared by a certified renovator after using EPA-
recognized test kits, including an identification of the manufacturer
and model of any test kits used, a description of the components that
were tested including their locations, and the result of each test kit
used.
(iii) Records prepared by a certified renovator after collecting
paint chip samples, including a description of the components that were
tested including their locations, the name and address of the NLLAP-
recognized entity performing the analysis, and the results for each
sample.
(2) Signed and dated acknowledgments of receipt as described in
Sec. 745.84(a)(1)(i), (a)(2)(i), (b)(1)(i), (c)(1)(i)(A), and
(c)(1)(ii)(A).
(3) Certifications of attempted delivery as described in Sec.
745.84(a)(2)(i) and (c)(1)(ii)(A).
(4) Certificates of mailing as described in Sec. 745.84(a)(1)(ii),
(a)(2)(ii), (b)(1)(ii), (c)(1)(i)(B), and (c)(1)(ii)(B).
(5) Records of notification activities performed regarding common
area renovations, as described in Sec. 745.84(b)(3) and (b)(4), and
renovations in child-occupied facilities, as described in Sec.
745.84(c)(2).
(6) Documentation of compliance with the requirements of Sec.
745.85, including documentation that a certified renovator was assigned
to the project, that the certified renovator provided on-the-job
training for workers used on the project, that the certified renovator
performed or directed workers who performed all of the tasks described
in Sec. 745.85(a), and that the certified renovator performed the post-
[[Page 86]]
renovation cleaning verification described in Sec. 745.85(b). If the
renovation firm was unable to comply with all of the requirements of
this rule due to an emergency as defined in Sec. 745.82, the firm must
document the nature of the emergency and the provisions of the rule that
were not followed. This documentation must include a copy of the
certified renovator's training certificate, and a certification by the
certified renovator assigned to the project that:
(i) Training was provided to workers (topics must be identified for
each worker).
(ii) Warning signs were posted at the entrances to the work area.
(iii) If test kits were used, that the specified brand of kits was
used at the specified locations and that the results were as specified.
(v) The work area was contained by:
(A) Removing or covering all objects in the work area (interiors).
(B) Closing and covering all HVAC ducts in the work area
(interiors).
(C) Closing all windows in the work area (interiors) or closing all
windows in and within 20 feet of the work area (exteriors).
(D) Closing and sealing all doors in the work area (interiors) or
closing and sealing all doors in and within 20 feet of the work area
(exteriors).
(E) Covering doors in the work area that were being used to allow
passage but prevent spread of dust.
(F) Covering the floor surface, including installed carpet, with
taped-down plastic sheeting or other impermeable material in the work
area 6 feet beyond the perimeter of surfaces undergoing renovation or a
sufficient distance to contain the dust, whichever is greater
(interiors) or covering the ground with plastic sheeting or other
disposable impermeable material anchored to the building extending 10
feet beyond the perimeter of surfaces undergoing renovation or a
sufficient distance to collect falling paint debris, whichever is
greater, unless the property line prevents 10 feet of such ground
covering, weighted down by heavy objects (exteriors).
(G) Installing (if necessary) vertical containment to prevent
migration of dust and debris to adjacent property (exteriors).
(iv) If paint chip samples were collected, that the samples were
collected at the specified locations, that the specified NLLAP-
recognized laboratory analyzed the samples, and that the results were as
specified.
(vi) Waste was contained on-site and while being transported off-
site.
(vii) The work area was properly cleaned after the renovation by:
(A) Picking up all chips and debris, misting protective sheeting,
folding it dirty side inward, and taping it for removal.
(B) Cleaning the work area surfaces and objects using a HEPA vacuum
and/or wet cloths or mops (interiors).
(viii) The certified renovator performed the post-renovation
cleaning verification (the results of which must be briefly described,
including the number of wet and dry cloths used).
(c)(1) When the final invoice for the renovation is delivered or
within 30 days of the completion of the renovation, whichever is
earlier, the renovation firm must provide information pertaining to
compliance with this subpart to the following persons:
(i) The owner of the building; and, if different,
(ii) An adult occupant of the residential dwelling, if the
renovation took place within a residential dwelling, or an adult
representative of the child-occupied facility, if the renovation took
place within a child-occupied facility.
(2) When performing renovations in common areas of multi-unit target
housing, renovation firms must post the information required by this
subpart or instructions on how interested occupants can obtain a copy of
this information. This information must be posted in areas where it is
likely to be seen by the occupants of all of the affected units.
(3) The information required to be provided by paragraph (c) of this
section may be provided by completing the sample form titled ``Sample
Renovation Recordkeeping Checklist'' or a similar form containing the
test kit information required by Sec. 745.86(b)(1)(ii) and the training
and work practice compliance information required by Sec. 745.86(b)(6).
[[Page 87]]
(d) If dust clearance sampling is performed in lieu of cleaning
verification as permitted by Sec. 745.85(c), the renovation firm must
provide, when the final invoice for the renovation is delivered or
within 30 days of the completion of the renovation, whichever is
earlier, a copy of the dust sampling report to:
(1) The owner of the building; and, if different,
(2) An adult occupant of the residential dwelling, if the renovation
took place within a residential dwelling, or an adult representative of
the child-occupied facility, if the renovation took place within a
child-occupied facility.
(3) When performing renovations in common areas of multi-unit target
housing, renovation firms must post these dust sampling reports or
information on how interested occupants of the housing being renovated
can obtain a copy of the report. This information must be posted in
areas where they are likely to be seen by the occupants of all of the
affected units.
[73 FR 21761, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76
FR 47939, Aug. 5, 2011]
Sec. 745.87 Enforcement and inspections.
(a) Failure or refusal to comply with any provision of this subpart
is a violation of TSCA section 409 (15 U.Sec. 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.Sec. 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.Sec. C. 2610) is a violation of
sections 15 and 409 (15 U.Sec. C. 2614 and 2689).
(d) Violators may be subject to civil and criminal sanctions
pursuant to TSCA section 16 (15 U.Sec. 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.Sec. C. 2610) to ensure
compliance with this subpart.
[63 FR 29919, June 1, 1998, as amended at 73 FR 21763, Apr. 22, 2008]
Sec. 745.88 Recognized test kits.
(a) Effective June 23, 2008, EPA recognizes the test kits that have
been determined by National Institute of Standards and Technology
research to meet the negative response criteria described in paragraph
(c)(1) of this section. This recognition will last until EPA publicizes
its recognition of the first test kit that meets both the negative
response and positive response criteria in paragraph (c) of this
section.
(b) No other test kits will be recognized until they are tested
through EPA's Environmental Technology Verification Program or other
equivalent EPA approved testing program.
(1) Effective September 1, 2008, to initiate the testing process, a
test kit manufacturer must submit a sufficient number of kits, along
with the instructions for using the kits, to EPA. The test kit
manufacturer should first visit the following website for information on
where to apply: http://www.epa.gov/etv/howtoapply.html.
(2) After the kit has been tested through the Environmental
Technology Verification Program or other equivalent approved EPA testing
program, EPA will review the report to determine whether the required
criteria have been met.
(3) Before September 1, 2010, test kits must meet only the negative
response criteria in paragraph (c)(1) of this section. The recognition
of kits that meet only this criteria will last until EPA publicizes its
recognition of the first test kits that meets both of the criteria in
paragraph (c) of this section.
(4) After September 1, 2010, test kits must meet both of the
criteria in paragraph (c) of this section.
(5) If the report demonstrates that the kit meets the required
criteria, EPA will issue a notice of recognition to the kit
manufacturer, provide them with the report, and post the information on
EPA's website.
(6) If the report demonstrates that the kit does not meet the
required criteria, EPA will notify the kit manufacturer and provide them
with the report.
(c) Response criteria--(1) Negative response criteria. For paint
containing lead at or above the regulated level, 1.0
[[Page 88]]
mg/cm\2\ or 0.5% by weight, a demonstrated probability (with 95%
confidence) of a negative response less than or equal to 5% of the time.
(2) Positive response criteria. For paint containing lead below the
regulated level, 1.0 mg/cm\2\ or 0.5% by weight, a demonstrated
probability (with 95% confidence) of a positive response less than or
equal to 10% of the time.
[73 FR 21763, Apr. 22, 2008]
Sec. 745.89 Firm certification.
(a) Initial certification. (1) Firms that perform renovations for
compensation must apply to EPA for certification to perform renovations
or dust sampling. To apply, a firm must submit to EPA a completed
``Application for Firms,'' signed by an authorized agent of the firm,
and pay at least the correct amount of fees. If a firm pays more than
the correct amount of fees, EPA will reimburse the firm for the excess
amount.
(2) After EPA receives a firm's application, EPA will take one of
the following actions within 90 days of the date the application is
received:
(i) EPA will approve a firm's application if EPA determines that it
is complete and that the environmental compliance history of the firm,
its principals, or its key employees does not show an unwillingness or
inability to maintain compliance with environmental statutes or
regulations. An application is complete if it contains all of the
information requested on the form and includes at least the correct
amount of fees. When EPA approves a firm's application, EPA will issue
the firm a certificate with an expiration date not more than 5 years
from the date the application is approved. EPA certification allows the
firm to perform renovations covered by this section in any State or
Indian Tribal area that does not have a renovation program that is
authorized under subpart Q of this part.
(ii) EPA will request a firm to supplement its application if EPA
determines that the application is incomplete. If EPA requests a firm to
supplement its application, the firm must submit the requested
information or pay the additional fees within 30 days of the date of the
request.
(iii) EPA will not approve a firm's application if the firm does not
supplement its application in accordance with paragraph (a)(2)(ii) of
this section or if EPA determines that the environmental compliance
history of the firm, its principals, or its key employees demonstrates
an unwillingness or inability to maintain compliance with environmental
statutes or regulations. EPA will send the firm a letter giving the
reason for not approving the application. EPA will not refund the
application fees. A firm may reapply for certification at any time by
filing a new, complete application that includes the correct amount of
fees.
(b) Re-certification. To maintain its certification, a firm must be
re-certified by EPA every 5 years.
(1) Timely and complete application. To be re-certified, a firm must
submit a complete application for re-certification. A complete
application for re-certification includes a completed ``Application for
Firms'' which contains all of the information requested by the form and
is signed by an authorized agent of the firm, noting on the form that it
is submitted as a re-certification. A complete application must also
include at least the correct amount of fees. If a firm pays more than
the correct amount of fees, EPA will reimburse the firm for the excess
amount.
(i) An application for re-certification is timely if it is
postmarked 90 days or more before the date the firm's current
certification expires. If the firm's application is complete and timely,
the firm's current certification will remain in effect until its
expiration date or until EPA has made a final decision to approve or
disapprove the re-certification application, whichever is later.
(ii) If the firm submits a complete re-certification application
less than 90 days before its current certification expires, and EPA does
not approve the application before the expiration date, the firm's
current certification will expire and the firm will not be able to
conduct renovations until EPA approves its re-certification application.
(iii) If the firm fails to obtain recertification before the firm's
current certification expires, the firm must not perform renovations or
dust sampling
[[Page 89]]
until it is certified anew pursuant to paragraph (a) of this section.
(2) EPA action on an application. After EPA receives a firm's
application for re-certification, EPA will review the application and
take one of the following actions within 90 days of receipt:
(i) EPA will approve a firm's application if EPA determines that it
is timely and complete and that the environmental compliance history of
the firm, its principals, or its key employees does not show an
unwillingness or inability to maintain compliance with environmental
statutes or regulations. When EPA approves a firm's application for re-
certification, EPA will issue the firm a new certificate with an
expiration date 5 years from the date that the firm's current
certification expires. EPA certification allows the firm to perform
renovations or dust sampling covered by this section in any State or
Indian Tribal area that does not have a renovation program that is
authorized under subpart Q of this part.
(ii) EPA will request a firm to supplement its application if EPA
determines that the application is incomplete.
(iii) EPA will not approve a firm's application if it is not
received or is not complete as of the date that the firm's current
certification expires, or if EPA determines that the environmental
compliance history of the firm, its principals, or its key employees
demonstrates an unwillingness or inability to maintain compliance with
environmental statutes or regulations. EPA will send the firm a letter
giving the reason for not approving the application. EPA will not refund
the application fees. A firm may reapply for certification at any time
by filing a new application and paying the correct amount of fees.
(c) Amendment of certification. A firm must amend its certification
within 90 days of the date a change occurs to information included in
the firm's most recent application. If the firm fails to amend its
certification within 90 days of the date the change occurs, the firm may
not perform renovations or dust sampling until its certification is
amended.
(1) To amend a certification, a firm must submit a completed
``Application for Firms,'' signed by an authorized agent of the firm,
noting on the form that it is submitted as an amendment and indicating
the information that has changed. The firm must also pay at least the
correct amount of fees.
(2) If additional information is needed to process the amendment, or
the firm did not pay the correct amount of fees, EPA will request the
firm to submit the necessary information or fees. The firm's
certification is not amended until the firm complies with the request.
(3) Amending a certification does not affect the certification
expiration date.
(d) Firm responsibilities. Firms performing renovations must ensure
that:
(1) All individuals performing renovation activities on behalf of
the firm are either certified renovators or have been trained by a
certified renovator in accordance with Sec. 745.90.
(2) A certified renovator is assigned to each renovation performed
by the firm and discharges all of the certified renovator
responsibilities identified in Sec. 745.90.
(3) All renovations performed by the firm are performed in
accordance with the work practice standards in Sec. 745.85.
(4) The pre-renovation education requirements of Sec. 745.84 have
been performed.
(5) The recordkeeping requirements of Sec. 745.86 are met.
[73 FR 21764, Apr. 22, 2008]
Sec. 745.90 Renovator certification and dust sampling technician
certification.
(a) Renovator certification and dust sampling technician
certification. (1) To become a certified renovator or certified dust
sampling technician, an individual must successfully complete the
appropriate course accredited by EPA under Sec. 745.225 or by a State
or Tribal program that is authorized under subpart Q of this part. The
course completion certificate serves as proof of certification. EPA
renovator certification allows the certified individual to perform
renovations covered by this section in any State or Indian Tribal area
that does not have a renovation program that is authorized under subpart
Q of this part. EPA dust
[[Page 90]]
sampling technician certification allows the certified individual to
perform dust clearance sampling under Sec. 745.85(c) in any State or
Indian Tribal area that does not have a renovation program that is
authorized under subpart Q of this part.
(2) Individuals who have successfully completed an accredited
abatement worker or supervisor course, or individuals who successfully
completed an EPA, HUD, or EPA/HUD model renovation training course
before October 4, 2011 may take an accredited refresher renovator
training course that includes hands-on training in lieu of the initial
renovator training course to become a certified renovator.
(3) Individuals who have successfully completed an accredited lead-
based paint inspector or risk assessor course October 4, 2011 may take
an accredited refresher dust sampling technician course in lieu of the
initial training to become a certified dust sampling technician.
Individuals who are currently certified as lead-based paint inspectors
or risk assessors may act as certified dust sampling technicians without
further training.
(4) To maintain renovator certification or dust sampling technician
certification, an individual must complete a renovator or dust sampling
technician refresher course accredited by EPA under Sec. 745.225 or by
a State or Tribal program that is authorized under subpart Q of this
part within 5 years of the date the individual completed the initial
course described in paragraph (a)(1) of this section. If the individual
does not complete a refresher course within this time, the individual
must re-take the initial course to become certified again. Individuals
who complete a renovator course accredited by EPA or an EPA authorized
program on or before March 31, 2010, must complete a renovator refresher
course accredited by EPA or an EPA authorized program on or before March
31, 2016, to maintain renovator certification. Individuals who completed
a renovator course accredited by EPA or an EPA authorized program
between April 1, 2010 and March 31, 2011, will have one year added to
their original 5-year certification. Individuals who take a renovator
refresher course that does not include hands-on training will be
certified for 3 years from the date they complete the training.
Individuals who take a refresher training course that includes hands-on
training will be certified for 5 years. Individuals who take the
renovator refresher without hands-on training must, for their next
refresher course, take a refresher course that includes hands-on
training to maintain renovator certification.
(b) Renovator responsibilities. Certified renovators are responsible
for ensuring compliance with Sec. 745.85 at all renovations to which
they are assigned. A certified renovator:
(1) Must perform all of the tasks described in Sec. 745.85(b) and
must either perform or direct workers who perform all of the tasks
described in Sec. 745.85(a).
(2) Must provide training to workers on the work practices required
by Sec. 745.85(a) that they will be using in performing their assigned
tasks.
(3) Must be physically present at the work site when the signs
required by Sec. 745.85(a)(1) are posted, while the work area
containment required by Sec. 745.85(a)(2) is being established, and
while the work area cleaning required by Sec. 745.85(a)(5) is
performed.
(4) Must regularly direct work being performed by other individuals
to ensure that the work practices required by Sec. 745.85(a) are being
followed, including maintaining the integrity of the containment
barriers and ensuring that dust or debris does not spread beyond the
work area.
(5) Must be available, either on-site or by telephone, at all times
that renovations are being conducted.
(6) When requested by the party contracting for renovation services,
must use an acceptable test kit to determine whether components to be
affected by the renovation contain lead-based paint.
(7) Must have with them at the work site copies of their initial
course completion certificate and their most recent refresher course
completion certificate.
(8) Must prepare the records required by Sec. 745.86(b)(1)(ii) and
(6).
(c) Dust sampling technician responsibilities. When performing
optional dust clearance sampling under
[[Page 91]]
Sec. 745.85(c), a certified dust sampling technician:
(1) Must collect dust samples in accordance with Sec.
745.227(e)(8), must send the collected samples to a laboratory
recognized by EPA under TSCA section 405(b), and must compare the
results to the clearance levels in accordance with Sec. 745.227(e)(8).
(2) Must have with them at the work site copies of their initial
course completion certificate and their most recent refresher course
completion certificate.
[73 FR 21765, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76
FR 47939, Aug. 5, 2011; 80 FR 20446, Apr. 16, 2015; 81 FR 7995, Feb. 17,
2016]
Sec. 745.91 Suspending, revoking, or modifying an individual's or
firm's certification.
(a)(1) Grounds for suspending, revoking, or modifying an
individual's certification. EPA may suspend, revoke, or modify an
individual's certification if the individual fails to comply with
Federal lead-based paint statutes or regulations. EPA may also suspend,
revoke, or modify a certified renovator's certification if the renovator
fails to ensure that all assigned renovations comply with Sec. 745.85.
In addition to an administrative or judicial finding of violation,
execution of a consent agreement in settlement of an enforcement action
constitutes, for purposes of this section, evidence of a failure to
comply with relevant statutes or regulations.
(2) Grounds for suspending, revoking, or modifying a firm's
certification. EPA may suspend, revoke, or modify a firm's certification
if the firm:
(i) Submits false or misleading information to EPA in its
application for certification or re-certification.
(ii) Fails to maintain or falsifies records required in Sec.
745.86.
(iii) Fails to comply, or an individual performing a renovation on
behalf of the firm fails to comply, with Federal lead-based paint
statutes or regulations. In addition to an administrative or judicial
finding of violation, execution of a consent agreement in settlement of
an enforcement action constitutes, for purposes of this section,
evidence of a failure to comply with relevant statutes or regulations.
(b) Process for suspending, revoking, or modifying certification.
(1) Prior to taking action to suspend, revoke, or modify an individual's
or firm's certification, EPA will notify the affected entity in writing
of the following:
(i) The legal and factual basis for the proposed suspension,
revocation, or modification.
(ii) The anticipated commencement date and duration of the
suspension, revocation, or modification.
(iii) Actions, if any, which the affected entity may take to avoid
suspension, revocation, or modification, or to receive certification in
the future.
(iv) The opportunity and method for requesting a hearing prior to
final suspension, revocation, or modification.
(2) If an individual or firm requests a hearing, EPA will:
(i) Provide the affected entity an opportunity to offer written
statements in response to EPA's assertions of the legal and factual
basis for its proposed action.
(ii) Appoint an impartial official of EPA as Presiding Officer to
conduct the hearing.
(3) The Presiding Officer will:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of
the request for a hearing.
(ii) Consider all relevant evidence, explanation, comment, and
argument submitted.
(iii) Notify the affected entity in writing within 90 days of
completion of the hearing of his or her decision and order. Such an
order is a final agency action which may be subject to judicial review.
The order must contain the commencement date and duration of the
suspension, revocation, or modification.
(4) If EPA determines that the public health, interest, or welfare
warrants immediate action to suspend the certification of any individual
or firm prior to the opportunity for a hearing, it will:
(i) Notify the affected entity in accordance with paragraph
(b)(1)(i) through (b)(1)(iii) of this section, explaining why it is
necessary to suspend the entity's certification before an opportunity
for a hearing.
[[Page 92]]
(ii) Notify the affected entity of its right to request a hearing on
the immediate suspension within 15 days of the suspension taking place
and the procedures for the conduct of such a hearing.
(5) Any notice, decision, or order issued by EPA under this section,
any transcript or other verbatim record of oral testimony, and any
documents filed by a certified individual or firm in a hearing under
this section will be available to the public, except as otherwise
provided by section 14 of TSCA or by part 2 of this title. Any such
hearing at which oral testimony is presented will be open to the public,
except that the Presiding Officer may exclude the public to the extent
necessary to allow presentation of information which may be entitled to
confidential treatment under section 14 of TSCA or part 2 of this title.
(6) EPA will maintain a publicly available list of entities whose
certification has been suspended, revoked, modified, or reinstated.
(7) Unless the decision and order issued under paragraph (b)(3)(iii)
of this section specify otherwise:
(i) An individual whose certification has been suspended must take a
refresher training course (renovator or dust sampling technician) in
order to make his or her certification current.
(ii) An individual whose certification has been revoked must take an
initial renovator or dust sampling technician course in order to become
certified again.
(iii) A firm whose certification has been revoked must reapply for
certification after the revocation ends in order to become certified
again. If the firm's certification has been suspended and the suspension
ends less than 5 years after the firm was initially certified or re-
certified, the firm does not need to do anything to re-activate its
certification.
[73 FR 21765, Apr. 22, 2008]
Sec. 745.92 Fees for the accreditation of renovation and dust sampling
technician training and the certification of renovation firms.
(a) Persons who must pay fees. Fees in accordance with paragraph (b)
of this section must be paid by:
(1) Training programs--(i) Non-exempt training programs. All non-
exempt training programs applying to EPA for the accreditation and re-
accreditation of training programs in one or more of the following
disciplines: Renovator, dust sampling technician.
(ii) Exemption. No fee shall be imposed on any training program
operated by a State, federally recognized Indian Tribe, local
government, or non-profit organization. This exemption does not apply to
the certification of firms or individuals.
(2) Firms. All firms applying to EPA for certification and re-
certification to conduct renovations.
(b) Fee amounts--(1) Certification and accreditation fees. Initial
and renewal certification and accreditation fees are specified in the
following table:
------------------------------------------------------------------------
Re-accreditation
(every 4 years,
Training Program Accreditation see 40 CFR
745.225(f)(1) for
details)
------------------------------------------------------------------------
Initial Renovator or Dust $560 $340
Sampling Technician Course
------------------------------------------------------------------------
Refresher Renovator or Dust $400 $310
Sampling Technician Course
------------------------------------------------------------------------
Renovation Firm Certification Re-certification
(every 5 years
see 40 CFR
745.89(b))
------------------------------------------------------------------------
Firm $300 $300
Combined Renovation and Lead- $550 $550
based Paint Activities Firm
Application
Combined Renovation and Lead- $20 $20
based Paint Activities Tribal
Firm Application
Tribal Firm $20 $20
------------------------------------------------------------------------
[[Page 93]]
(2) Lost certificate. A $15 fee will be charged for the replacement
of a firm certificate.
(c) Certificate replacement. Firms seeking certificate replacement
must:
(1) Complete the applicable portions of the ``Application for
Firms'' in accordance with the instructions provided.
(2) Submit the application and a payment of $15 in accordance with
the instructions provided with the application package.
(3) Accreditation or certification amendments. No fee will be
charged for accreditation or certification amendments.
(d) Failure to remit fees. (1) EPA will not provide certification,
re-certification, accreditation, or re-accreditation for any firm or
training program that does not remit fees described in paragraph (b) of
this section in accordance with the procedures specified in 40 CFR
745.89.
(2) EPA will not replace a certificate for any firm that does not
remit the $15 fee in accordance with the procedures specified in
paragraph (c) of this section.
[74 FR 11869, Mar. 20, 2009, as amended at 76 FR 47939, Aug. 5, 2011]
Subpart F_Disclosure of Known Lead-Based Paint and/or Lead-Based Paint
Hazards Upon Sale or Lease of Residential Property
Sec. 745.100 Purpose.
This subpart implements the provisions of 42 U.Sec. C. 4852d, which
impose certain requirements on the sale or lease of target housing.
Under this subpart, a seller or lessor of target housing shall disclose
to the purchaser or lessee the presence of any known lead-based paint
and/or lead-based paint hazards; provide available records and reports;
provide the purchaser or lessee with a lead hazard information pamphlet;
give purchasers a 10-day opportunity to conduct a risk assessment or
inspection; and attach specific disclosure and warning language to the
sales or leasing contract before the purchaser or lessee is obligated
under a contract to purchase or lease target housing.
Sec. 745.101 Scope and applicability.
This subpart applies to all transactions to sell or lease target
housing, including subleases, with the exception of the following:
(a) Sales of target housing at foreclosure.
(b) Leases of target housing that have been found to be lead-based
paint free by an inspector certified under the Federal certification
program or under a federally accredited State or tribal certification
program. Until a Federal certification program or federally accredited
State certification program is in place within the State, inspectors
shall be considered qualified to conduct an inspection for this purpose
if they have received certification under any existing State or tribal
inspector certification program. The lessor has the option of using the
results of additional test(s) by a certified inspector to confirm or
refute a prior finding.
(c) Short-term leases of 100 days or less, where no lease renewal or
extension can occur.
(d) Renewals of existing leases in target housing in which the
lessor has previously disclosed all information required under Sec.
745.107 and where no new information described in Sec. 745.107 has come
into the possession of the lessor. For the purposes of this paragraph,
renewal shall include both renegotiation of existing lease terms and/or
ratification of a new lease.
Sec. 745.102 Effective dates.
The requirements in this subpart take effect in the following
manner:
(a) For owners of more than four residential dwellings, the
requirements shall take effect on September 6, 1996.
(b) For owners of one to four residential dwellings, the
requirements shall take effect on December 6, 1996.
Sec. 745.103 Definitions.
The following definitions apply to this subpart.
The Act means the Residential Lead-Based Paint Hazard Reduction Act
of 1992, 42 U.Sec. C. 4852d.
Agent means any party who enters into a contract with a seller or
lessor,
[[Page 94]]
including any party who enters into a contract with a representative of
the seller or lessor, for the purpose of selling or leasing target
housing. This term does not apply to purchasers or any purchaser's
representative who receives all compensation from the purchaser.
Available means in the possession of or reasonably obtainable by the
seller or lessor at the time of the disclosure.
Common area means a portion of a building generally accessible to
all residents/users including, but not limited to, hallways, stairways,
laundry and recreational rooms, playgrounds, community centers, and
boundary fences.
Contract for the purchase and sale of residential real property
means any contract or agreement in which one party agrees to purchase an
interest in real property on which there is situated one or more
residential dwellings used or occupied, or intended to be used or
occupied, in whole or in part, as the home or residence of one or more
persons.
EPA means the Environmental Protection Agency.
Evaluation means a risk assessment and/or inspection.
Foreclosure means any of the various methods, statutory or
otherwise, known in different jurisdictions, of enforcing payment of a
debt, by the taking and selling of real property.
Housing for the elderly means retirement communities or similar
types of housing reserved for households composed of one or more persons
62 years of age or more at the time of initial occupancy.
HUD means the U.Sec. 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.Sec. C. 4822], and
(2) The provision of a report explaining the results of the
investigation.
Lead-based paint means paint or other surface coatings that contain
lead equal to or in excess of 1.0 milligram per square centimeter or 0.5
percent by weight.
Lead-based paint free housing means target housing that has been
found to be free of paint or other surface coatings that contain lead
equal to or in excess of 1.0 milligram per square centimeter or 0.5
percent by weight.
Lead-based paint hazard means any condition that causes exposure to
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible
surfaces, friction surfaces, or impact surfaces that would result in
adverse human health effects as established by the appropriate Federal
agency.
Lessee means any entity that enters into an agreement to lease,
rent, or sublease target housing, including but not limited to
individuals, partnerships, corporations, trusts, government agencies,
housing agencies, Indian tribes, and nonprofit organizations.
Lessor means any entity that offers target housing for lease, rent,
or sublease, including but not limited to individuals, partnerships,
corporations, trusts, government agencies, housing agencies, Indian
tribes, and nonprofit organizations.
Owner means any entity that has legal title to target housing,
including but not limited to individuals, partnerships, corporations,
trusts, government agencies, housing agencies, Indian tribes, and
nonprofit organizations, except where a mortgagee holds legal title to
property serving as collateral for a mortgage loan, in which case the
owner would be the mortgagor.
Purchaser means an entity that enters into an agreement to purchase
an interest in target housing, including but not limited to individuals,
partnerships, corporations, trusts, government agencies, housing
agencies, Indian tribes, and nonprofit organizations.
Reduction means measures designed to reduce or eliminate human
exposure to lead-based paint hazards through methods including interim
controls and abatement.
Residential dwelling means:
(1) A single-family dwelling, including attached structures such as
porches and stoops; or
(2) A single-family dwelling unit in a structure that contains more
than one separate residential dwelling unit, and
[[Page 95]]
in which each such unit is used or occupied, or intended to be used or
occupied, in whole or in part, as the residence of one or more persons.
Risk assessment means an on-site investigation to determine and
report the existence, nature, severity, and location of lead-based paint
hazards in residential dwellings, including:
(1) Information gathering regarding the age and history of the
housing and occupancy by children under age 6;
(2) Visual inspection;
(3) Limited wipe sampling or other environmental sampling
techniques;
(4) Other activity as may be appropriate; and
(5) Provision of a report explaining the results of the
investigation.
Secretary means the Secretary of Housing and Urban Development.
Seller means any entity that transfers legal title to target
housing, in whole or in part, in return for consideration, including but
not limited to individuals, partnerships, corporations, trusts,
government agencies, housing agencies, Indian tribes, and nonprofit
organizations. The term ``seller'' also includes:
(1) An entity that transfers shares in a cooperatively owned
project, in return for consideration; and
(2) An entity that transfers its interest in a leasehold, in
jurisdictions or circumstances where it is legally permissible to
separate the fee title from the title to the improvement, in return for
consideration.
Target housing means any housing constructed prior to 1978, except
housing for the elderly or persons with disabilities (unless any child
who is less than 6 years of age resides or is expected to reside in such
housing) or any 0-bedroom dwelling.
TSCA means the Toxic Substances Control Act, 15 U.Sec. C. 2601.
0-bedroom dwelling means any residential dwelling in which the
living area is not separated from the sleeping area. The term includes
efficiencies, studio apartments, dormitory housing, military barracks,
and rentals of individual rooms in residential dwellings.
Sec. 745.107 Disclosure requirements for sellers and lessors.
(a) The following activities shall be completed before the purchaser
or lessee is obligated under any contract to purchase or lease target
housing that is not otherwise an exempt transaction pursuant to Sec.
745.101. Nothing in this section implies a positive obligation on the
seller or lessor to conduct any evaluation or reduction activities.
(1) The seller or lessor shall provide the purchaser or lessee with
an EPA-approved lead hazard information pamphlet. Such pamphlets include
the EPA document entitled Protect Your Family From Lead in Your Home
(EPA 747-K-94-001) or an equivalent pamphlet that has been
approved for use in that State by EPA.
(2) The seller or lessor shall disclose to the purchaser or lessee
the presence of any known lead-based paint and/or lead-based paint
hazards in the target housing being sold or leased. The seller or lessor
shall also disclose any additional information available concerning the
known lead-based paint and/or lead-based paint hazards, such as the
basis for the determination that lead-based paint and/or lead-based
paint hazards exist, the location of the lead-based paint and/or lead-
based paint hazards, and the condition of the painted surfaces.
(3) The seller or lessor shall disclose to each agent the presence
of any known lead-based paint and/or lead-based paint hazards in the
target housing being sold or leased and the existence of any available
records or reports pertaining to lead-based paint and/or lead-based
paint hazards. The seller or lessor shall also disclose any additional
information available concerning the known lead-based paint and/or lead-
based paint hazards, such as the basis for the determination that lead-
based paint and/or lead-based paint hazards exist, the location of the
lead-based paint and/or lead-based paint hazards, and the condition of
the painted surfaces.
(4) The seller or lessor shall provide the purchaser or lessee with
any records or reports available to the seller or lessor pertaining to
lead-based paint and/or lead-based paint hazards in the target housing
being sold or
[[Page 96]]
leased. This requirement includes records or reports regarding common
areas. This requirement also includes records or reports regarding other
residential dwellings in multifamily target housing, provided that such
information is part of an evaluation or reduction of lead-based paint
and/or lead-based paint hazards in the target housing as a whole.
(b) If any of the disclosure activities identified in paragraph (a)
of this section occurs after the purchaser or lessee has provided an
offer to purchase or lease the housing, the seller or lessor shall
complete the required disclosure activities prior to accepting the
purchaser's or lessee's offer and allow the purchaser or lessee an
opportunity to review the information and possibly amend the offer.
Sec. 745.110 Opportunity to conduct an evaluation.
(a) Before a purchaser is obligated under any contract to purchase
target housing, the seller shall permit the purchaser a 10-day period
(unless the parties mutually agree, in writing, upon a different period
of time) to conduct a risk assessment or inspection for the presence of
lead-based paint and/or lead-based paint hazards.
(b) Not withstanding paragraph (a) of this section, a purchaser may
waive the opportunity to conduct the risk assessment or inspection by so
indicating in writing.
Sec. 745.113 Certification and acknowledgment of disclosure.
(a) Seller requirements. Each contract to sell target housing shall
include an attachment containing the following elements, in the language
of the contract (e.g., English, Spanish):
(1) A Lead Warning Statement consisting of the following language:
Every purchaser of any interest in residential real property on
which a residential dwelling was built prior to 1978 is notified that
such property may present exposure to lead from lead-based paint that
may place young children at risk of developing lead poisoning. Lead
poisoning in young children may produce permanent neurological damage,
including learning disabilities, reduced intelligence quotient,
behavioral problems, and impaired memory. Lead poisoning also poses a
particular risk to pregnant women. The seller of any interest in
residential real property is required to provide the buyer with any
information on lead-based paint hazards from risk assessments or
inspections in the seller's possession and notify the buyer of any known
lead-based paint hazards. A risk assessment or inspection for possible
lead-based paint hazards is recommended prior to purchase.
(2) A statement by the seller disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being
sold or indicating no knowledge of the presence of lead-based paint and/
or lead-based paint hazards. The seller shall also provide any
additional information available concerning the known lead-based paint
and/or lead-based paint hazards, such as the basis for the determination
that lead-based paint and/or lead-based paint hazards exist, the
location of the lead-based paint and/or lead-based paint hazards, and
the condition of the painted surfaces.
(3) A list of any records or reports available to the seller
pertaining to lead-based paint and/or lead-based paint hazards in the
housing that have been provided to the purchaser. If no such records or
reports are available, the seller shall so indicate.
(4) A statement by the purchaser affirming receipt of the
information set out in paragraphs (a)(2) and (a)(3) of this section and
the lead hazard information pamphlet required under 15 U.Sec. 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.Sec. C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with
the requirements of this subpart.
(7) The signatures of the sellers, agents, and purchasers certifying
to the accuracy of their statements to the best of their knowledge,
along with the dates of signature.
[[Page 97]]
(b) Lessor requirements. Each contract to lease target housing shall
include, as an attachment or within the contract, the following
elements, in the language of the contract (e.g., English, Spanish):
(1) A Lead Warning Statement with the following language:
Housing built before 1978 may contain lead-based paint. Lead from
paint, paint chips, and dust can pose health hazards if not managed
properly. Lead exposure is especially harmful to young children and
pregnant women. Before renting pre-1978 housing, lessors must disclose
the presence of lead-based paint and/or lead-based paint hazards in the
dwelling. Lessees must also receive a federally approved pamphlet on
lead poisoning prevention.
(2) A statement by the lessor disclosing the presence of known lead-
based paint and/or lead-based paint hazards in the target housing being
leased or indicating no knowledge of the presence of lead-based paint
and/or lead-based paint hazards. The lessor shall also disclose any
additional information available concerning the known lead-based paint
and/or lead-based paint hazards, such as the basis for the determination
that lead-based paint and/or lead-based paint hazards exist, the
location of the lead-based paint and/or lead-based paint hazards, and
the condition of the painted surfaces.
(3) A list of any records or reports available to the lessor
pertaining to lead-based paint and/or lead-based paint hazards in the
housing that have been provided to the lessee. If no such records or
reports are available, the lessor shall so indicate.
(4) A statement by the lessee affirming receipt of the information
set out in paragraphs (b)(2) and (b)(3) of this section and the lead
hazard information pamphlet required under 15 U.Sec. 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.Sec. C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with
the requirements of this subpart.
(6) The signatures of the lessors, agents, and lessees, certifying
to the accuracy of their statements, to the best of their knowledge,
along with the dates of signature.
(c) Retention of Certification and Acknowledgment Information.
(1) The seller, and any agent, shall retain a copy of the completed
attachment required under paragraph (a) of this section for no less than
3 years from the completion date of the sale. The lessor, and any agent,
shall retain a copy of the completed attachment or lease contract
containing the information required under paragraph (b) of this section
for no less than 3 years from the commencement of the leasing period.
(2) This recordkeeping requirement is not intended to place any
limitations on civil suits under the Act, or to otherwise affect a
lessee's or purchaser's rights under the civil penalty provisions of 42
U.Sec. 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
[[Page 98]]
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.Sec. 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.Sec. 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.Sec. C. 4852d(b)(5) and of TSCA section 409 (15 U.Sec. C. 2689).
(f) Violators may be subject to civil and criminal sanctions
pursuant to TSCA section 16 (15 U.Sec. C. 2615) for each violation. For
purposes of enforcing this subpart, the penalty for each violation
applicable under 15 U.Sec. C. 2615 shall not be more than $11,000 for all
violations occuring after July 28, 1997; all violations occuring on or
prior to that date are subject to a penalty not more than $10,000.
[61 FR 9085, Mar. 6, 1996, as amended at 62 FR 35041, June 27, 1997]
Sec. 745.119 Impact on State and local requirements.
Nothing in this subpart shall relieve a seller, lessor, or agent
from any responsibility for compliance with State or local laws,
ordinances, codes, or regulations governing notice or disclosure of
known lead-based paint or lead-based paint hazards. Neither HUD nor EPA
assumes any responsibility for ensuring compliance with such State or
local requirements.
Subparts G-K [Reserved]
Subpart L_Lead-Based Paint Activities
Source: 61 FR 45813, Aug. 29, 1996, unless otherwise noted.
Sec. 745.220 Scope and applicability.
(a) This subpart contains procedures and requirements for the
accreditation of training programs for lead-based paint activities and
renovations, procedures and requirements for the certification of
individuals and firms engaged in lead-based paint activities, and work
practice standards for performing such activities. This subpart also
requires that, except as discussed below, all lead-based paint
activities, as defined in this subpart, be performed by certified
individuals and firms.
(b) This subpart applies to all individuals and firms who are
engaged in lead-based paint activities as defined in Sec. 745.223,
except persons who perform these activities within residential dwellings
that they own, unless the residential dwelling is occupied by a person
or persons other than the owner or the owner's immediate family while
these activities are being performed, or a child residing in the
building has been identified as having an elevated blood lead level.
This subpart applies only in those States or Indian Country that do not
have an authorized State or Tribal program pursuant to Sec. 745.324 of
subpart Q.
(c) Each department, agency, and instrumentality of the executive,
legislative, and judicial branches of the Federal Government having
jurisdiction over any property or facility, or engaged in any activity
resulting, or which may result, in a lead-based paint hazard, and each
officer, agent, or employee thereof shall be subject to, and comply
with, all Federal, State, interstate, and local requirements, both
substantive and procedural, including the requirements of this subpart
regarding lead-based paint, lead-based
[[Page 99]]
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 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
[[Page 100]]
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 maximum amount of lead
permitted in dust on a surface following completion of an abatement
activity.
Common area means a portion of a building that is generally
accessible to all occupants. Such an area may include, but is not
limited to, hallways, stairways, laundry and recreational rooms,
playgrounds, community centers, garages, and boundary fences.
Component or building component means specific design or structural
elements or fixtures of a building, residential dwelling, or child-
occupied facility that are distinguished from each other by form,
function, and location. These include, but are not limited to, interior
components such as: ceilings, crown molding, walls, chair rails, doors,
door trim, floors, fireplaces, radiators and other heating units,
shelves, shelf supports, stair treads, stair risers, stair stringers,
newel posts, railing caps, balustrades, windows and trim (including
sashes, window heads, jambs, sills or stools and troughs), built in
cabinets, columns, beams, bathroom vanities, counter tops, and air
conditioners; and exterior components such as: painted roofing,
chimneys, flashing, gutters and downspouts, ceilings, soffits, fascias,
rake boards, cornerboards, bulkheads, doors and door trim, fences,
floors, joists, lattice work, railings and railing caps, siding,
handrails, stair risers and treads, stair stringers, columns,
balustrades, window sills or stools and troughs, casings, sashes and
wells, and air conditioners.
Containment means a process to protect workers and the environment
by controlling exposures to the lead-contaminated dust and debris
created during an abatement.
Course agenda means an outline of the key topics to be covered
during a training course, including the time allotted to teach each
topic.
Course test means an evaluation of the overall effectiveness of the
training which shall test the trainees' knowledge and retention of the
topics covered during the course.
Course test blue print means written documentation identifying the
proportion of course test questions devoted to each major topic in the
course curriculum.
Deteriorated paint means paint that is cracking, flaking, chipping,
peeling, or otherwise separating from the substrate of a building
component.
Discipline means one of the specific types or categories of lead-
based paint activities identified in this subpart for which individuals
may receive training from accredited programs and become certified by
EPA. For example, ``abatement worker'' is a discipline.
Distinct painting history means the application history, as
indicated by its visual appearance or a record of application, over
time, of paint or other surface coatings to a component or room.
[[Page 101]]
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-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
[[Page 102]]
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 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.
[[Page 103]]
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]
Sec. 745.225 Accreditation of training programs: target housing and
child occupied facilities.
(a) Scope. (1) A training program may seek accreditation to offer
courses in any of the following disciplines: Inspector, risk assessor,
supervisor, project designer, abatement worker, renovator, and dust
sampling technician. A training program may also seek accreditation to
offer refresher courses for each of the above listed disciplines.
(2) Training programs may first apply to EPA for accreditation of
their lead-based paint activities courses or refresher courses pursuant
to this section on or after August 31, 1998. Training programs may first
apply to EPA for accreditation of their renovator or dust sampling
technician courses or refresher courses pursuant to this section on or
after April 22, 2009.
(3) A training program must not provide, offer, or claim to provide
EPA- accredited lead-based paint activities courses without applying for
and receiving accreditation from EPA as required under paragraph (b) of
this section on or after March 1, 1999. A training program must not
provide, offer, or claim to provide EPA-accredited renovator or dust
sampling technician courses without applying for and receiving
accreditation from EPA as required under paragraph (b) of this section
on or after June 23, 2008.
(4) Accredited training programs, training program managers, and
principal instructors must comply with all of the requirements of this
section including approved terms of the application and all of the
requirements and limitations specified in any accreditation documents
issued to training programs.
(b) Application process. The following are procedures a training
program must follow to receive EPA accreditation to offer lead-based
paint activities courses, renovator courses, or dust sampling technician
courses:
(1) A training program seeking accreditation shall submit a written
application to EPA containing the following information:
(i) The training program's name, address, and telephone number.
(ii) A list of courses for which it is applying for accreditation.
For the purposes of this section, courses taught in different languages
and electronic learning courses are considered different courses, and
each must independently meet the accreditation requirements.
(iii) The name and documentation of the qualifications of the
training program manager.
(iv) The name(s) and documentation of qualifications of any
principal instructor(s).
(v) A statement signed by the training program manager certifying
that the training program meets the requirements established in
paragraph (c) of this section. If a training program uses EPA-
recommended model training materials, or training materials approved by
a State or Indian Tribe that has been authorized by EPA under subpart Q
of this part, the training program manager shall include a statement
certifying that, as well.
(vi) If a training program does not use EPA-recommended model
training materials, its application for accreditation shall also
include:
(A) A copy of the student and instructor manuals, or other materials
to be used for each course.
(B) A copy of the course agenda for each course.
(C) When applying for accreditation of a course in a language other
than English, a signed statement from a qualified, independent
translator that they had compared the course to the English language
version and found the translation to be accurate.
[[Page 104]]
(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
(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
[[Page 105]]
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 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
[[Page 106]]
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 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.
[[Page 107]]
(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.Sec. Postal Service, fax, commercial delivery service, or hand delivery
(persons submitting notification by U.Sec. 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.
[[Page 108]]
(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.Sec.
Postal Service, fax, commercial delivery service, or hand delivery
(persons submitting notification by U.Sec. Postal Service are reminded
that they should allow 3 additional business days for delivery in order
to ensure that EPA receives the notification by the required date).
Instructions and sample forms can be obtained from the NLIC at 1-800-
424-LEAD (5323), or on the Internet at http://www.epa.gov/lead.
(d) Minimum training curriculum requirements. A training program
accredited by EPA to offer lead-based paint courses in the specific
disciplines listed in this paragraph (d) must ensure that its courses of
study include, at a minimum, the following course topics.
(1) Inspector. Instruction in the topics described in paragraphs
(d)(1)(iv), (v), (vi), and (vii) of this section must be included in the
hands-on portion of the course.
(i) Role and responsibilities of an inspector.
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State, and local
regulations and guidance that pertains to lead-based paint and lead-
based paint activities.
(iv) Lead-based paint inspection methods, including selection of
rooms and components for sampling or testing.
(v) Paint, dust, and soil sampling methodologies.
(vi) Clearance standards and testing, including random sampling.
(vii) Preparation of the final inspection report.
(viii) Recordkeeping.
(2) Risk assessor. Instruction in the topics described in paragraphs
(d)(2)(iv), (vi), and (vii) of this section must be included in the
hands-on portion of the course.
(i) Role and responsibilities of a risk assessor.
(ii) Collection of background information to perform a risk
assessment.
(iii) Sources of environmental lead contamination such as paint,
surface dust and soil, water, air, packaging, and food.
(iv) Visual inspection for the purposes of identifying potential
sources of lead-based paint hazards.
(v) Lead hazard screen protocol.
(vi) Sampling for other sources of lead exposure.
(vii) Interpretation of lead-based paint and other lead sampling
results, including all applicable Federal or State guidance or
regulations pertaining to lead-based paint hazards.
(viii) Development of hazard control options, the role of interim
controls, and operations and maintenance activities to reduce lead-based
paint hazards.
(ix) Preparation of a final risk assessment report.
(3) Supervisor. Instruction in the topics described in paragraphs
(d)(3)(v), (vii), (viii), (ix), and (x) of this section must be included
in the hands-on portion of the course.
(i) Role and responsibilities of a supervisor.
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State, and local
regulations and
[[Page 109]]
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.
(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.
[[Page 110]]
(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, 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.
[[Page 111]]
(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 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.
[[Page 112]]
(2) In addition to an administrative or judicial finding of
violation, execution of a consent agreement in settlement of an
enforcement action constitutes, for purposes of this section, evidence
of a failure to comply with relevant statutes or regulations.
(h) Procedures for suspension, revocation or modification of
training program accreditation. (1) Prior to taking action to suspend,
revoke, or modify the accreditation of a training program, EPA shall
notify the affected entity in writing of the following:
(i) The legal and factual basis for the suspension, revocation, or
modification.
(ii) The anticipated commencement date and duration of the
suspension, revocation, or modification.
(iii) Actions, if any, which the affected entity may take to avoid
suspension, revocation, or modification, or to receive accreditation in
the future.
(iv) The opportunity and method for requesting a hearing prior to
final EPA action to suspend, revoke or modify accreditation.
(v) Any additional information, as appropriate, which EPA may
provide.
(2) If a hearing is requested by the accredited training program,
EPA shall:
(i) Provide the affected entity an opportunity to offer written
statements in response to EPA's assertions of the legal and factual
basis for its proposed action, and any other explanations, comments, and
arguments it deems relevant to the proposed action.
(ii) Provide the affected entity such other procedural opportunities
as EPA may deem appropriate to ensure a fair and impartial hearing.
(iii) Appoint an official of EPA as Presiding Officer to conduct the
hearing. No person shall serve as Presiding Officer if he or she has had
any prior connection with the specific matter.
(3) The Presiding Officer appointed pursuant to paragraph (h)(2) of
this section shall:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of
the request for a hearing.
(ii) Consider all relevant evidence, explanation, comment, and
argument submitted.
(iii) Notify the affected entity in writing within 90 days of
completion of the hearing of his or her decision and order. Such an
order is a final agency action which may be subject to judicial review.
(4) If EPA determines that the public health, interest, or welfare
warrants immediate action to suspend the accreditation of any training
program prior to the opportunity for a hearing, it shall:
(i) Notify the affected entity of its intent to immediately suspend
training program accreditation for the reasons listed in paragraph
(g)(1) of this section. If a suspension, revocation, or modification
notice has not previously been issued pursuant to paragraph (g)(1) of
this section, it shall be issued at the same time the emergency
suspension notice is issued.
(ii) Notify the affected entity in writing of the grounds for the
immediate suspension and why it is necessary to suspend the entity's
accreditation before an opportunity for a suspension, revocation or
modification hearing.
(iii) Notify the affected entity of the anticipated commencement
date and duration of the immediate suspension.
(iv) Notify the affected entity of its right to request a hearing on
the immediate suspension within 15 days of 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.
[[Page 113]]
(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.
(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,
[[Page 114]]
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.
(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
[[Page 115]]
(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:
(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
[[Page 116]]
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
(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
[[Page 117]]
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 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
[[Page 118]]
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 with the appropriate requirements below.
(3) Documented methodologies that are appropriate for this section
are found in the following: The U.Sec. 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
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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
(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:
[[Page 120]]
(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 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
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each certified risk assessor if applicable.
(viii) Name, address, and telephone number of each recognized
laboratory conducting analysis of collected samples.
(ix) Results of the visual inspection.
(x) Testing method and sampling procedure for paint analysis
employed.
(xi) Specific locations of each painted component tested for the
presence of lead.
(xii) All data collected from on-site testing, including quality
control data and, if used, the serial number of any XRF device.
(xiii) All results of laboratory analysis on collected paint, soil,
and dust samples.
(xiv) Any other sampling results.
(xv) Any background information collected pursuant to paragraph
(d)(3) of this section.
(xvi) To the extent that they are used as part of the lead-based
paint hazard determination, the results of any previous inspections or
analyses for the presence of lead-based paint, or other assessments of
lead-based paint-related hazards.
(xvii) A description of the location, type, and severity of
identified lead-based paint hazards and any other potential lead
hazards.
(xviii) A description of interim controls and/or abatement options
for each identified lead-based paint hazard and a suggested
prioritization for addressing each hazard. If the use of an encapsulant
or enclosure is recommended, the report shall recommend a maintenance
and monitoring schedule for the encapsulant or enclosure.
(e) Abatement. (1) An abatement shall be conducted only by an
individual certified by EPA, and if conducted, shall be conducted
according to the procedures in this paragraph.
(2) A certified supervisor is required for each abatement project
and shall be onsite during all work site preparation and during the
post-abatement cleanup of work areas. At all other times when abatement
activities are being conducted, the certified supervisor shall be onsite
or available by telephone, pager or answering service, and able to be
present at the work site in no more than 2 hours.
(3) The certified supervisor and the certified firm employing that
supervisor shall ensure that all abatement activities are conducted
according to the requirements of this section and all other Federal,
State and local requirements.
(4) 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.
[[Page 122]]
(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.Sec. Postal Service, fax, commercial
delivery service, or hand delivery (persons submitting notification by
U.Sec. Postal Service are reminded that they should allow 3 additional
business days for delivery in order to ensure that EPA receives the
notification by the required date). Instructions and sample forms can be
obtained from the NLIC at 1-800-424-LEAD(5323), or on the Internet at
http://www.epa.gov/lead.
(viii) Lead-based paint abatement activities shall not begin on a
date, or at a location other than that specified in either an original
or updated notification, in the event of changes to the original
notification.
(ix) No firm or individual shall engage in lead-based paint
abatement activities, as defined in Sec. 745.223, prior to notifying
EPA of such activities according to the requirements of this paragraph.
(5) A written occupant protection plan shall be developed for all
abatement projects and shall be prepared according to the following
procedures:
(i) The occupant protection plan shall be unique to each residential
dwelling or child-occupied facility and be developed prior to the
abatement. The occupant protection plan shall describe the measures and
management procedures that will be taken during the abatement to protect
the building occupants from exposure to any lead-based paint hazards.
(ii) A certified supervisor or project designer shall prepare the
occupant protection plan.
(6) The work practices listed below shall be restricted during an
abatement as follows:
(i) Open-flame burning or torching of lead-based paint is
prohibited;
(ii) Machine sanding or grinding or abrasive blasting or
sandblasting of lead-based paint is prohibited unless used with High
Efficiency Particulate Air (HEPA) exhaust control which removes
particles of 0.3 microns or larger
[[Page 123]]
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 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
[[Page 124]]
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 40 [micro]g/ft\2\
for floors, 250 [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/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
[[Page 125]]
(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 40 [micro]g/ft\2\ for floors and 250 [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]
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. Sec.
745.225, 745.226, 745.227, or 745.233 is a prohibited act under sections
15 and 409 of TSCA (15 U.Sec. C. 2614, 2689).
(b) Failure or refusal to establish, maintain, provide, copy, or
permit access to records or reports as required by Sec. Sec. 745.225,
745.226, or 745.227 is a prohibited act under sections 15 and 409 of
TSCA (15 U.Sec. 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.Sec. C. 2610) is a prohibited
act under sections 15 and 409 of TSCA (15 U.Sec. 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
[[Page 126]]
committed a prohibited act under sections 15 and 409 of TSCA (15 U.Sec. 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.Sec. 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.Sec. C. 2610) to ensure compliance with this
subpart.
Sec. 745.238 Fees for accreditation and certification of lead-based
paint activities.
(a) Purpose. To establish and impose fees for certified individuals
and firms engaged in lead-based paint activities and persons operating
accredited training programs under section 402(a) of the Toxic
Substances Control Act (TSCA).
(b) Persons who must pay fees. Fees in accordance with paragraph (c)
of this section must be paid by:
(1) Training programs. (i) All non-exempt training programs applying
to EPA for the accreditation and re-accreditation of training programs
in one or more of the following disciplines: inspector, risk assessor,
supervisor, project designer, abatement worker.
(ii) Exemptions. No fee shall be imposed on any training program
operated by a State, federally recognized Indian Tribe, local
government, or nonprofit organization. This exemption does not apply to
the certification of firms or individuals.
(2) Firms and individuals. All firms and individuals seeking
certification and re-certification from EPA to engage in lead-based
paint activities in one or more of the following disciplines: inspector,
risk assessor, supervisor, project designer, abatement worker.
(c) Fee amounts--(1) Certification and accreditation fees. Initial
and renewal certification and accreditation fees are specified in the
following table:
------------------------------------------------------------------------
Re-accreditation
(every 4 years,
Training Program Accreditation see 40 CFR
745.225(f)(1) for
details)
------------------------------------------------------------------------
Initial Course ..................
Inspector....................... $870.............. $620
Risk assessor................... $870.............. $620
Supervisor...................... $870.............. $620
Worker.......................... $870.............. $620
Project Designer................ $870.............. $620
------------------------------------------------------------------------
Refresher Course ..................
Inspector....................... $690.............. $580
Risk assessor................... $690.............. $580
Supervisor...................... $690.............. $580
Worker.......................... $690.............. $580
Project Designer................ $690.............. $580
------------------------------------------------------------------------
Lead-based Paint Activities-- Certification Re-certification
Individual (every 3 years,
see 40 CFR
745.226(e)(1) for
details)
------------------------------------------------------------------------
Inspector $410 $410
Risk assessor................... $410.............. $410
Supervisor...................... $410.............. $410
Worker.......................... $310.............. $310
Project designer................ $410.............. $410
Tribal certification (each $10............... $10
discipline).
------------------------------------------------------------------------
Lead-based Paint Activities-- Certification Re-certification
Firm (every 3 years,
see 40 CFR
745.226(f)(7) for
details)
------------------------------------------------------------------------
Firm $550 $550
Combined Renovation and Lead- $550 $550
based Paint Activities Firm
Application
[[Page 127]]
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.''
(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:
[[Page 128]]
(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 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.Sec. 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.
[[Page 129]]
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 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.
[[Page 130]]
(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.
(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.
[[Page 131]]
(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 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.
[[Page 132]]
(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.
(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
[[Page 133]]
(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
(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.
[[Page 134]]
(v) The certified abatement contractor or the firm retains
appropriate records.
(e) The State or Indian Tribe must demonstrate that it has standards
for identifying lead-based paint hazards and clearance standards for
dust, that are at least as protective as the standards in Sec. 745.227
as amended on February 5, 2001. A State or Indian Tribe with such a
section 402 program approved before February 5, 2003 shall make this
demonstration no later than the first report submitted pursuant to Sec.
745.324(h) on or after February 5, 2003. A State or Indian Tribe with
such a program submitted but not approved before February 5, 2003 may
make this demonstration by amending its application or in its first
report submitted pursuant to Sec. 745.324(h). A State or Indian Tribe
submitting its program on or after February 5, 2003 shall make this
demonstration in its application.
[61 FR 45825, Aug. 29, 1996, as amended at 66 FR 1240, Jan. 5, 2001]
Sec. 745.326 Renovation: State and Tribal program requirements.
(a) Program elements. To receive authorization from EPA, a State or
Tribal program must contain the following program elements:
(1) For pre-renovation education programs, procedures and
requirements for the distribution of lead hazard information to owners
and occupants of target housing and child-occupied facilities before
renovations for compensation.
(2) For renovation training, certification, accreditation, and work
practice standards programs:
(i) Procedures and requirements for the accreditation of renovation
and dust sampling technician training programs. A State and Tribal
program is not required to include procedures and requirements for the
dust sampling technician training discipline if the State or Tribal
program requires dust sampling to be performed by a certified lead-based
paint inspector or risk assessor.
(ii) Procedures and requirements for accredited initial and
refresher training for renovators and dust sampling technicians and on-
the-job training for other individuals who perform renovations.
(iii) Procedures and requirements for the certification of
individuals and/or firms.
(iv) Requirements that all renovations be conducted by appropriately
certified individuals and/or firms.
(v) Work practice standards for the conduct of renovations.
(3) For all renovation programs, development of the appropriate
infrastructure or government capacity to effectively carry out a State
or Tribal program.
(b) Pre-renovation education. To be considered at least as
protective as the Federal program, the State or Tribal program must:
(1) Establish clear standards for identifying renovation activities
that trigger the information distribution requirements.
(2) Establish procedures for distributing the lead hazard
information to owners and occupants of housing and child-occupied
facilities prior to renovation activities.
(3) Require that the information to be distributed include either
the pamphlet titled Renovate Right: Important Lead Hazard Information
for Families, Child Care Providers and Schools, developed by EPA under
section 406(a) of TSCA, or an alternate pamphlet or package of lead
hazard information that has been submitted by the State or Tribe,
reviewed by EPA, and approved by EPA for that State or Tribe. Such
information must contain renovation-specific information similar to that
in Renovate Right: Important Lead Hazard Information for Families, Child
Care Providers and Schools, must meet the content requirements
prescribed by section 406(a) of TSCA, and must be in a format that is
readable to the diverse audience of housing and child-occupied facility
owners and occupants in that State or Tribe.
(i) A State or Tribe with a pre-renovation education program
approved before June 23, 2008, must demonstrate that it meets the
requirements of this section no later than the first report that it
submits pursuant to Sec. 745.324(h) on or after April 22, 2009.
(ii) A State or Tribe with an application for approval of a pre-
renovation
[[Page 135]]
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:
(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)
[[Page 136]]
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 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
[[Page 137]]
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, 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:
[[Page 138]]
(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.
(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
[[Page 139]]
lead-based paint compliance and enforcement program. The State or Tribal
program must have access to the facilities and equipment necessary to
perform sampling and laboratory analysis as needed. This laboratory
facility must be a recognized laboratory as defined at Sec. 745.223, or
the State or Tribal program must implement a quality assurance program
that ensures appropriate quality of laboratory personnel and protects
the integrity of analytical data.
(4) Tracking tips and complaints. A State or Tribal lead-based paint
compliance and enforcement program must demonstrate the ability to
process and react to tips and complaints or other information indicating
a violation.
(5) Targeting inspections. A State or Tribal lead-based paint
compliance and enforcement program must demonstrate the ability to
target inspections to ensure compliance with the lead-based paint
program requirements. Such targeting must include a method for obtaining
and using notifications of commencement of abatement activities.
(6) Follow up to inspection reports. A State or Tribal lead-based
paint compliance and enforcement program must demonstrate the ability to
reasonably, and in a timely manner, process and follow-up on inspection
reports and other information generated through enforcement-related
activities associated with a lead-based paint program. The State or
Tribal program must be in a position to ensure correction of violations
and, as appropriate, effectively develop and issue enforcement remedies/
responses to follow up on the identification of violations.
(7) Compliance monitoring and enforcement. A State or Tribal lead-
based paint compliance and enforcement program must demonstrate, in its
application for approval, that it is in a position to implement a
compliance monitoring and enforcement program. Such a compliance
monitoring and enforcement program must ensure correction of violations,
and encompass either planned and/or responsive lead-based paint
compliance inspections and development/issuance of State or Tribal
enforcement responses which are appropriate to the violations.
(d) Summary on Progress and Performance. The Summary on Progress and
Performance described below is part of the required elements for the
compliance and enforcement program portion of a State or Tribal lead-
based paint program. A State or Tribal lead-based paint compliance and
enforcement program must submit to the appropriate EPA Regional
Administrator a report 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)
[[Page 140]]
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.Sec. 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.Sec. C.
2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(1) The terms Act, article, chemical substance, commerce, importer,
impurity, Inventory, manufacturer, person, process, processor, and small
quantities solely for research and development have the same meaning as
in Sec. 720.3 of this chapter.
(2) Metalworking fluid means a liquid of any viscosity or color
containing intentionally added water used in metal machining operations
for the purpose of cooling, lubricating, or rust inhibition.
(3) Nitrosating agent means any substance that has the potential to
transfer a nitrosyl group (-NO) to a primary, secondary, or tertiary
amine to form the corresponding nitrosamine.
(4) Process or distribute in commerce solely for export means to
process or distribute in commerce solely for export from the United
States under the following restrictions on domestic activity:
(i) Processing must be performed at sites under the control of the
processor.
(ii) Distribution in commerce is limited to purposes of export.
(iii) The processor or distributor may not use the substance except
in small quantities solely for research and development.
(c) Use limitations. (1) Any person producing a metalworking fluid,
or a product which could be used in or as a metalworking fluid, which
includes as one of its components P-84-529, is prohibited from adding
any nitrosating agent to the metalworking fluid or product.
(2) Any person using as a metalworking fluid a product containing P-
84-529 is prohibited from adding any nitrosating agent to the product.
(d) Warnings and instructions. (1) Any person who distributes in
commerce P-84-529 in a metalworking fluid, or in any form in which it
could be used as a component of a metalworking fluid, must send to each
recipient of P-84-529 and confirm receipt in writing prior to the first
shipment to that person:
(i) A letter that includes the following statements:
[[Page 141]]
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 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.Sec. 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.Sec. 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.Sec. C. 2614].
(4) Violators may be subject to the civil and criminal penalties in
section
[[Page 142]]
16 of the Act [15 U.Sec. 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.Sec. 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.Sec. C.
2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(1) The terms Act, article, chemical substance, commerce, importer,
impurity, Inventory, manufacturer, person, process, processor, and small
quantities solely for research and development, have the same meaning as
in Sec. 720.3 of this chapter.
(2) Metalworking fluid means a liquid of any viscosity or color
containing intentionally added water used in metal machining operations
for the purpose of cooling, lubricating, or rust inhibition.
(3) Nitrosating agent means any substance that has the potential to
transfer a nitrosyl group (--NO) to a primary, secondary, or tertiary
amine to form the corresponding nitrosamine.
(4) Process or distribute in commerce solely for export means to
process or distribute in commerce solely for export from the United
States under the following restrictions on domestic activity:
(i) Processing must be performed at sites under the control of the
processor.
(ii) Distribution in commerce is limited to purposes of export.
(iii) The processor or distributor may not use the substance except
in small quantities solely for research and development.
(c) Use limitations. (1) Any person producing a metalworking fluid,
or a product which could be used in or as a metalworking fluid, which
includes as one of its components P-84-310, is prohibited from adding
any nitrosating agent to the metalworking fluid or product.
(2) A person using as a metalworking fluid a product containing P-
84-310 is prohibited from adding any nitrosating agent to the product.
(d) Warnings and instructions. (1) Any person who distributes in
commerce P-84-310 in a metalworking fluid, or in any form in which it
could be used as a component of a metalworking fluid, must send to each
recipient of P-84-310 and confirm receipt in writing prior to the first
shipment to that person:
(i) A letter that includes the following statements: A substance,
identified generically as a triethanolamine salt of a substituted
organic acid, contained in the product (insert distributor's trade name
or other identifier for product containing P-84-310) has been regulated
by the Environmental Protection Agency, at 40 CFR 747.195, as published
in the Federal Register of June 14, 1984. A copy of the regulation is
enclosed. The regulation prohibits the addition of any nitrosating
agent, including nitrites, to the triethanolamine salt of a substituted
organic acid, when the substance is or could be used in metalworking
fluids. The addition of nitrites or other nitrosating agents to this
substance leads to formation of a substance known to cause cancer in
laboratory animals. The triethanolamine salt of a substituted organic
acid has been specifically designed to be used without nitrites. Consult
the enclosed regulation for further information.
(ii) A copy of this Sec. 747.195.
(2)(i) Any person who distributes in commerce a metalworking fluid
containing P-84-310 must affix a label to each container containing the
fluid.
(ii) The label shall contain a warning statement which shall consist
only of the following language:
[[Page 143]]
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.
(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.Sec. 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.Sec. 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.Sec. 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.Sec. 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,
[[Page 144]]
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 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.
[[Page 145]]
(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.Sec. 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.Sec. 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.Sec. C. 2614).
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.Sec. 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.Sec. C. 2605 or 2616).
[49 FR 2772, Jan. 23, 1984]
PART 749_WATER TREATMENT CHEMICALS--Table of Contents
Subparts A-C [Reserved]
Subpart D_Air Conditioning and Cooling Systems
Sec.
749.68 Hexavalent chromium-based water treatment chemicals in cooling
systems.
Authority: 15 U.Sec. 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,
[[Page 146]]
15 U.Sec. 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.Sec. 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.
(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
[[Page 147]]
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 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.Sec. 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.Sec. C. 2614).
(3) Failure or refusal to permit entry or inspection as required by
section 11 of the Act (15 U.Sec. C. 2610) is a violation of section 15 of
the Act (15 U.Sec. C. 2614).
[[Page 148]]
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.Sec. C. 2615) for each violation.
(k) Inspections. EPA will conduct inspections under section 11 of
the Act (15 U.Sec. C. 2610) to ensure compliance with this section.
[55 FR 240, Jan. 3, 1990, as amended at 59 FR 42773, Aug. 19, 1994]
PART 750_PROCEDURES FOR RULEMAKING UNDER SECTION 6 OF THE TOXIC SUBSTANCES
CONTROL ACT--Table of Contents
Subpart A_Procedures for Rulemaking Under Section 6 of the Toxic
Substances Control Act
Sec.
750.1 Applicability.
750.2 Notice of proposed rulemaking.
750.3 Record.
750.4 Public comments.
750.5 Subpoenas.
750.6 Participation in informal hearing.
750.7 Conduct of legislative hearing.
750.8 Cross-examination.
750.9 Final rule.
Appendix A to Subpart A of Part 750
Subpart B_Interim Procedural Rules for Manufacturing Exemptions
750.10 Applicability.
750.11 Filing of petitions for exemption.
750.12 Consolidation of rulemakings.
750.13 Notice of proposed rulemaking.
750.14 Record.
750.15 Public comments.
750.16 Confidentiality.
750.17 Subpoenas.
750.18 Participation in informal hearing.
750.19 Conduct of informal hearing.
750.20 Cross-examination.
750.21 Final rule.
Subpart C_Interim Procedural Rules for Processing and Distribution in
Commerce Exemptions
750.30 Applicability.
750.31 Filing of petitions for exemption.
750.32 Consolidation of rulemaking.
750.33 Notice of proposed rulemaking.
750.34 Record.
750.35 Public comments.
750.36 Confidentiality.
750.37 Subpoenas.
750.38 Participation in informal hearing.
750.39 Conduct of informal hearing.
750.40 Cross-examination.
750.41 Final rule.
Authority: 15 U.Sec. C. 2605.
Subpart A_Procedures for Rulemaking Under Section 6 of the Toxic
Substances Control Act
Source: 42 FR 61259, Dec. 2, 1977, unless otherwise noted.
Sec. 750.1 Applicability.
This part applies to all rulemakings under authority of section 6 of
the Toxic Substances Control Act (TSCA), 15 U.Sec. C. 2605.
Sec. 750.2 Notice of proposed rulemaking.
(a) Each rulemaking becomes subject to this part with the
publication of a Notice of Proposed Rulemaking in the Federal Register.
A proceeding under section 6 of the Toxic Substances Control Act may
begin, as appropriate, with the publication in the Federal Register of a
Notice of Proposed Rulemaking, an Advance Notice of Proposed Rulemaking,
or notice of other action, such as a formal regulatory investigation
designed to lead to issuance of rules within a reasonable time.
(b) Each such notice shall contain:
(1) A draft finding that there is a reasonable basis to conclude
that the manufacture, processing, distribution in commerce, use or
disposal of the chemical substance(s) or mixture(s) at issue, or any
combination of such activities, presents or will present an unreasonable
risk of injury to health or the environment.
(2) A Notice of Proposed Rulemaking stating with particularity the
reasons for the proposed rule together with a statement why the proposed
rule protects adequately against the risk(s) involved using the least
burdensome requirements authorized by TSCA.
(3) Either the draft text of the proposed rule (which may include
alternative approaches among which a final choice has not yet been made)
or a description of the approaches and provisions being considered for
inclusion in the rule, or some combination of the above.
(4) Except for rules published under authority of section 6(e), a
draft statement with respect to:
[[Page 149]]
(i) The effects of the substance(s) or mixture(s) at issue on health
and the magnitude of the exposure of human beings to such substance(s)
or mixture(s);
(ii) The effects of the substance(s) or mixture(s) at issue on the
environment and the magnitude of the exposure of the environment to such
substance(s) or mixture(s).
(iii) The benefits of the substance(s) or mixture(s) at issue for
various uses and the availability of substitutes for such uses; and
(iv) The reasonably ascertainable economic consequences of the rule,
after consideration of the effect on the national economy, small
business, technological innovation, the environment, and public health.
(v) Major impacts of alternatives to the proposed rule shall also be
analyzed.
(5) In cases where the administrator, in his or her discretion,
determines that a risk of injury to health or the environment could be
eliminated or reduced to a sufficient extent by actions taken under a
Federal law (or laws) other than TSCA administered in whole or in part
by the Administrator, a finding that it is in the public interest to
proceed against such risk under TSCA. Any such finding shall be
accompanied by a brief statement discussing:
(i) All relevant aspects of the risk;
(ii) A comparison of the estimated costs of complying with actions
taken under TSCA and under such other law (or laws); and
(iii) The relative efficiency of actions under TSCA and under such
other law (or laws) to protect against risk of injury.
Two or more or all of the statements required above may be combined in
the same narrative for efficiency of exposition as long as each of the
required points is discussed. Any statement required by this paragraph
may reference other documents which are not published in the Federal
Register. All such referenced documents shall be included in the
rulemaking record. Either the statements required by this paragraph or
the documents they reference shall contain a discussion of the factual,
analytical, policy and legal considerations behind the agency decision
to issue the proposed rule in the form chosen. A brief summary of these
considerations shall be included in the preamble in any case. All
factual materials and each analytical methodology seriously considered
shall be fully disclosed. Significant areas of uncertainty known to the
Agency under each heading shall be identified, and the manner in which
the Agency intends to deal with them shall be specified.
(c) In addition to the material required under paragraph (b) of this
section, each notice of proposed rulemaking shall contain:
(1) A statement of the time and place at which the informal hearing
required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent
these are not specified, a statement that they will be specified later
in a separate Federal Register notice Provided, That Federal Register
notice of the date and city at which any informal hearing shall begin
shall be given at least 30 days in advance;
(2) A statement identifying the place at which the official record
of the rulemaking is located, the hours during which it will be open for
public inspection, the documents contained in it as of the date the
notice of proposed rulemaking was issued, and a statement of the
approximate times at which additional materials such as public comments,
hearing transcripts, and agency studies in progress will be added to the
record. If any material other than public comments or material generated
by a hearing is added to the record after publication of the notice
required by this section, and notice of its future addition was not
given at the time of that initial publication, a separate Federal
Register notice announcing its addition to the record and inviting
comment shall be published;
(3) The due date for public comments, which shall be at least two
weeks prior to the informal hearing for main comments and no more than
two weeks after the informal hearing for reply comments;
(4) The name, address and office telephone number of the Record and
Hearing Clerk for the rulemaking in question; and
[[Page 150]]
(5) A nonbinding target date for issuing the final rule.
[42 FR 61259, Dec. 2, 1977, as amended at 54 FR 21623, May 19, 1989]
Sec. 750.3 Record.
(a) No later than the date of proposal of a rule subject to this
part, a rulemaking record for that rule shall be established. It shall
consist of a separate identified filing space containing:
(1) All documents required by Sec. 750.2(b);
(2) All documents cited in the documents required by Sec. 750.2(b);
(3) All public comments timely received;
(4) All public hearing transcripts;
(5) All material received during an informal hearing and accepted
for the record of that hearing; and
(6) Any other information which the Administrator considers to be
relevant to such rule and which the Administrator identified, on or
before the date of the promulgation of the rule, in a notice published
in the Federal Register.
All material in the record shall be appropriately indexed. Each record
shall be available for public inspection during normal Agency business
hours. Appropriate arrangements allowing members of the public to copy
record materials that do not risk the permanent loss of such materials
shall be made. All material required to be included in the record shall
be added to the record as soon as feasible after its receipt by the
Agency.
(b) The Record and Hearing Clerk for each rulemaking shall be
responsible for Agency compliance with the requirements of paragraph (a)
of this section.
Sec. 750.4 Public comments.
(a) Main comments shall be postmarked or received no later than the
time specified in the Notice of Proposed Rulemaking and shall contain
all comments on and criticisms of that Notice by the commenting person,
based on information which is or reasonably could have been available to
that person at the time.
(b) Reply comments shall be postmarked or received no later than two
weeks after the close of all informal hearings on the proposed rule and
shall be restricted to comments on:
(1) Other comments;
(2) Material in the hearing record; and
(3) Material which was not and could not reasonably have been
available to the commenting party a sufficient time before main comments
were due.
(c) Extensions of the time for filing comments may be granted in
writing by the Record and Hearing Clerk. Application for an extension
shall be made in writing. Comments submitted after the comment period
and all extensions of it have expired need not be added to the
rulemaking record and need not be considered in decisions concerning the
rule. Unless the Notice of Proposed Rulemaking states otherwise, four
copies of all comments shall be submitted.
Sec. 750.5 Subpoenas.
(a) Where necessary, subpoenas requiring the production of
documentary material, the attendance of persons at the hearing, or
responses to written questions may be issued. Subpoenas may be issued
either upon request as provided in paragraph (b) of this section or by
EPA on its own motion.
(b) All subpoena requests shall be in writing. Hearing participants
may request the issuance of subpoenas as follows:
(1) Subpoenas for the attendance of persons, and for the production
of documents or responses to questions at the legislative hearing may be
requested at any time up to the deadline for filing main comments.
(2) Subpoenas for production of documents or answers to questions
after the legislative hearing may be requested at any time between the
beginning of the legislative hearing and the deadline for submitting
reply comments.
(c) EPA will rule on all subpoena requests filed under paragraph
(b)(1) of this section no later than the beginning of the legislative
hearing. Such requests may be granted, denied, or deferred. EPA will
rule on all subpoena requests filed under paragraph (b)(2) of this
section and all deferred subpoena requests filed under paragraph (b)(1)
of
[[Page 151]]
this section no later than the promulgation of the final rule. Such
requests shall be either granted or denied.
Sec. 750.6 Participation in informal hearing.
(a) Each person or organization desiring to participate in the
informal hearing required by section 6(c)(2)(C) of TSCA shall file a
written request to so participate with the Record and Hearing Clerk
which shall be postmarked or received no later than three weeks prior to
the scheduled start of such hearing. The request shall include:
(1) A brief statement of the interest of the person or organization
in the proceeding;
(2) A brief outline of the points to be addressed;
(3) An estimate of the time required; and
(4) If the request comes from an organization, a nonbinding list of
the persons to take part in the presentation. Organizations are
requested to bring with them, to the extent possible, employees with
individual expertise in and responsibility for each of the areas to be
addressed. No organization not filing main comments in the rulemaking
will be allowed to participate at the hearing, unless a waiver of this
requirement is granted in writing by the Record and Hearing Clerk or the
organization is appearing at the request of EPA or under subpoena.
(b) No later than one week prior to the start of the hearing, the
Record and Hearing Clerk shall make a hearing schedule publicly
available and mail or deliver it to each of the persons who requested to
appear at the hearing. This schedule shall be subject to change during
the course of the hearing at the discretion of those presiding over it.
(c) Opening statements should be brief, and restricted either to
points that could not have been made in main comments, or to emphasizing
points which are made in main comments, but which the participant
believes can be more forcefully urged in the hearing context.
Sec. 750.7 Conduct of legislative hearing.
(a) A panel of EPA employees shall preside at each hearing conducted
under section 6(c)(2)(C) of TSCA. In appropriate cases other Executive
Branch employees may also sit with and assist the panel. The membership
of the panel may change as different topics arise during the hearing. In
general, the panel membership will consist of agency employees with
special responsibility for the final rule or special expertise in the
topics under discussion. One member of the panel shall be named to chair
the proceedings and shall attend throughout the hearing, unless
unavoidably prevented by sickness or similar personal circumstances.
(b) The panel may question any individual or group participating in
the hearing on any subject relating to the rulemaking. Cross-examination
by others will normally not be permitted at this stage. It may be
granted in compelling circumstances at the sole discretion of the
hearing panel. However, persons in the hearing audience may submit
questions in writing for the hearing panel to ask the participants, and
the hearing panel may, at their discretion, ask these questions.
(c) Participants in the hearing may submit additional material for
the hearing record and shall submit such additional material as the
hearing panel may request. All such submissions shall become part of the
record of the hearing. A verbatim transcript of the hearing shall be
made.
Sec. 750.8 Cross-examination.
(a) After the close of the legislative hearing conducted under Sec.
750.7, any participant in that hearing may submit a written request for
cross-examination. The request shall be received by EPA within one week
after a full transcript of the legislative hearing becomes available and
shall specify:
(1) The disputed issue(s) of material fact as to which cross-
examination is requested. This shall include an explanation of why the
questions at issue are ``factual'', rather than of an analytical or
policy nature, the extent to which they are in ``dispute'' in the light
of the record made thus far, and the extent to which and why they can
reasonably be considered ``material'' to the decision on the final rule;
and
(2) The person(s) the participant desires to cross-examine, and an
estimate
[[Page 152]]
of the time necessary. This shall include a statement by the cross-
examination requested can be expected to result in ``full and true
disclosure'' resolving the issue of material fact involved.
(b) Within one week after receipt of all requests for cross-
examination under paragraph (a) of this section the hearing panel shall
rule on them. The ruling shall be served by the Record and Hearing Clerk
on all participants who have requested cross-examination and shall be
inserted in the record. Written notice of the ruling shall be given to
all persons requesting cross-examination and all persons to be cross-
examined. The ruling shall specify:
(1) The issues as to which cross-examination is granted,
(2) The persons to be cross-examined on each issue,
(3) The persons to be allowed to conduct cross-examination, and
(4) Time limits for the examination of each witness by each cross-
examiner.
In issuing this ruling, the panel may determine that one or more
participants who have requested cross-examination have the same or
similar interests and should be required to choose a single
representative for purposes of cross-examination. In such a case the
order shall simply assign time for cross-examination by that single
representative without identifying the representative further. Subpoenas
for witnesses may be issued where necessary.
(c) Within one week after the insertion into the record of the
ruling under paragraph (b) of this section, the hearing at which the
cross-examination will be conducted shall commence. One or more members
of the original panel shall preside for the Agency. The panel shall have
authority to conduct cross-examination on behalf of any participant,
although as a general rule this right will not be exercised. The panel
shall also have authority to modify the governing ruling in any respect
and to make new rulings on group representation under section 6(c)(3)(C)
of TSCA. A verbatim transcript of the hearing shall be made.
(d)(1) No later than the time set for requesting cross-examination,
a hearing participant may request that other alternative methods of
clarifying the record (such as informal conferences or the submittal of
additional information) be used. Such requests may be submitted either
in lieu of cross-examination requests, or in conjunction with them.
(2) The panel in passing on a cross-examination request may as a
precondition to ruling on its merits require that alternative means of
clarifying the record be used whether or not that has been requested
under paragraph (d)(1) of this section. In such a case the results of
the use of such alternative means shall be made available to the person
requesting cross-examination of a one-week comment period, and the panel
shall make a final ruling on cross-examination within one week
thereafter.
(e) Waivers or extensions of any deadline in this section applicable
to persons other than EPA may be granted on the record of the hearing by
the person chairing it or in writing by the Record and Hearing Clerk.
Sec. 750.9 Final rule.
(a) As soon as feasible after the deadline for submittal of reply
comments, the Agency shall issue a final rule. Final versions of the
statements required by paragraph (b) of Sec. 750.2 shall be published
in the Federal Register together with the final rule. The Agency shall
also publish at that time:
(1) A list of all material added to the record (other than public
comments and material from the hearing record) which has not previously
been listed in a Federal Register document, and
(2) The effective date of the rule.
(b) [Reserved]
Sec. Appendix A to Subpart A of Part 750
To assist in reading the regulations set forth above, this appendix
sets forth the principal stages through which rules promulgated under
section 6 of TSCA will pass.
The second column gives the relationship that one date bears to
another whenever that relationship is specified in the regulations, and
cites the governing provision. The third column contains estimates of
the time that a typical rulemaking is likely to require to
[[Page 153]]
reach and complete each stage of these proceedings. In drawing up this
third column, we have assumed that 60 days will be allowed for the
submission of main comments; that the legislative phase of the informal
hearing will take two weeks, and that cross-examination will take four
days. Since these are only estimates, in any given rulemaking shorter or
longer times may actually be required for each of these stages.
------------------------------------------------------------------------
Estimated
total
Stage Timing in relation to time
other stages elapsed
(days)
------------------------------------------------------------------------
Proposed regulation................. Sec. 750.2.............
Requests to participate in informal 3 weeks prior to 53
hearing due. beginning of hearing
(Sec. 750.2(a)).
Main comments due................... 2 weeks prior to 60
beginning of hearing
(Sec. 750.2(c)(3)).
Begin informal hearing.............. ....................... 74
End legislative hearing............. ....................... 88
Requests for cross-examination due.. 1 week after end of 95
legislative hearing
(Sec. 750.8(a)).
Ruling on cross-examination requests 1 week after requests 102
are due (Sec.
750.8(b)).
Cross-examination begins............ 1 week afer ruling on 109
cross-examination
requests (Sec.
750.8(c)).
Cross-examination ends; informal ....................... 113
hearing ends.
Reply comments due.................. 2 weeks after end of 127
informal hearing (Sec.
750.4(b)).
------------------------------------------------------------------------
Subpart B_Interim Procedural Rules for Manufacturing Exemptions
Source: 43 FR 50905, Nov. 1, 1978, unless otherwise noted.
Sec. 750.10 Applicability.
Sections 750.10-750.21 apply to all rulemakings under authority of
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.Sec. C.
2605(e)(3)(B) with respect to petitions filed pursuant to Sec.
750.11(a) of this part.
Sec. 750.11 Filing of petitions for exemption.
(a) Who may file. Any person seeking an exemption from the PCB
manufacturing ban imposed by section 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.
[[Page 154]]
(d) Request for further information. The Agency reserves the right
to request further information as to each petition prior to or after
publication of the notice of proposed rulemaking required by Sec.
750.13.
(e) Renewal requests. (1) Any petitioner who has been granted an
exemption under section 6(e)(3)(B) of TSCA, on or after May 25, 1994,
and who seeks to renew that exemption without changing its terms, must
submit a letter by certified mail to EPA requesting that the exemption
be granted for the following year.
(i) This letter must contain a certification by the petitioner that
the type of activities, the procedures for handling the PCBs, the amount
of PCBs handled, and any other aspect of the exemption have not changed
from the original exemption petition request.
(ii) This letter must be received by EPA at least 6 months prior to
the expiration of the existing exemption.
(iii) If a petitioner fails to make a submission or the submission
is not timely under this section, the exemption will expire 1 year from
the effective date of granting that exemption.
(iv) EPA will address a timely submission of a renewal request by
rulemaking and either grant or deny the request.
(2) Any petitioner who has been granted an exemption on or after May
25, 1994, and who seeks to increase the amount of PCBs handled or to
change the type of activities, the procedures for handling the PCBs, and
any other aspect of their existing exemption must submit a new exemption
petition to EPA. The existing exemption activity may continue until the
new submission is addressed by rulemaking, provided the activity
conforms to the terms of the current exemption approved by EPA, and the
petitioner complies with the conditions of paragraph (e)(1) of this
section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B)
exemption in a rule prior to May 25, 1994, and who seeks to increase the
amount of PCBs handled or to change the type of activities, the
procedures for handling the PCBs, and any other aspect of their existing
exemption must submit a new exemption petition to EPA. The existing
exemption activity may continue until the new submission is addressed by
rulemaking, provided the activity conforms to the terms of the original
exemption approved by EPA.
[43 FR 50905, Nov. 1, 1978, as amended at 53 FR 12524, Apr. 15, 1988; 59
FR 16998, Apr. 11, 1994; 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. The notice shall also be subject to
Sec. 750.2(c) with the exceptions (1) that the clause ``in addition to
the material required under paragraph (b)'' is eliminated; and (2) that
Sec. 750.2(c)(3) is changed to read:
The due date for public comments, which shall be (1) thirty days
after publication of the notice of proposed rulemaking for main comments
and (2) one week after the close of the informal hearing for reply
comments.
[43 FR 50905, Nov. 1, 1978, as amended at 59 FR 16998, Apr. 11, 1994]
Sec. 750.14 Record.
Section 750.3 shall be applicable with the exception that the words
``Sec. 750.11(c)'' are substituted for ``Sec. 750.2(b)'' in Sec.
750.3(a)(1) and (2).
[43 FR 50905, Nov. 1, 1978, as amended at 59 FR 16998, Apr. 11, 1994]
Sec. 750.15 Public comments.
Section 750.4 shall be applicable with the exception that the time
period in Sec. 750.4(b) is shortened to 1 week.
Sec. 750.16 Confidentiality.
The Agency encourages the submission of nonconfidential information
by
[[Page 155]]
petitioners and commenters. The Agency does not wish to have unnecessary
restrictions on access to the rulemaking record. However, if a
petitioner or commenter believes that he can only state his position
through the use of information claimed to be confidential, he may submit
it. Such information must be separately submitted for the rulemaking
record and marked ``confidential'' by the submitter. For the information
claimed to be confidential, the Agency will list only the date and the
name and address of the petitioner or commenter in the public file,
noting that the petitioner or commenter has requested confidential
treatment. The information claimed to be confidential will be placed in
a confidential file. A petitioner must also file a nonconfidential
petition with a nonconfidential summary of the confidential information
to be placed in the public file. Similarly, a commenter must supply a
nonconfidential summary of the information claimed to be confidential to
be placed in the public file. Any information not marked as confidential
will be placed in the public file. Information marked confidential will
be treated in accordance with the procedures in part 2, subpart B of
this title.
Sec. 750.17 Subpoenas.
Section 750.5 shall be applicable.
Sec. 750.18 Participation in informal hearing.
(a) Each person or organization desiring to participate in the
informal hearing required by section 6(c)(2)(C) of TSCA shall file a
written request to so participate with the record and hearing clerk
which shall be received no later than 7 days prior to the scheduled
start of the hearing. The hearing shall begin 7 days after the close of
the 30-day comment period or as soon thereafter as practicable.
(b) With the exception of the first sentence in Sec. 750.6(a),
Sec. 750.6 shall be applicable with the further exception that the time
period in Sec. 750.6(b) is shortened to no later than 3 days prior to
the start of the hearing.
Sec. 750.19 Conduct of informal hearing.
Section 750.7 shall be applicable with the addition of the following
sentence at the end of Sec. 750.7(c):
Participants shall be allowed to designate testimony from prior EPA
informal rulemaking hearings concerning PCB's under TSCA. The hearing
panel may reject repetitive testimony previously presented at such
hearings.
Sec. 750.20 Cross-examination.
Section 750.8 shall be applicable.
Sec. 750.21 Final rule.
(a) As soon as feasible after the deadline for submittal of reply
comments, the Agency shall issue a final rule. The Agency shall also
publish at that time:
(1) A list of all material added to the record (other than public
comments and material from the hearing record) which has not previously
been listed in a Federal Register document, and
(2) The effective date of the rule.
(b) EPA will grant or deny petitions under section 6(e)(3)(B) of
TSCA submitted pursuant to Sec. 750.11. EPA will act on such petitions
subsequent to opportunity for an informal hearing pursuant to this rule.
(c) In determining whether to grant an exemption to the PCB ban, the
Agency shall apply the two standards enunciated in section 6(e)(3)(B) of
TSCA.
[43 FR 50905, Nov. 1, 1978, as amended at 72 FR 57238, Oct. 9, 2007]
Subpart C_Interim Procedural Rules for Processing and Distribution in
Commerce Exemptions
Source: 44 FR 31560, Mar. 31, 1979, unless otherwise noted.
Sec. 750.30 Applicability.
Sections 750.30-750.41 apply to all rulemakings under authority of
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.Sec. C.
2605(e)(3)(B) with respect to petitions for PCB processing and
distribution in commerce exemptions filed pursuant to Sec. 750.31(a) of
this part.
[[Page 156]]
Sec. 750.31 Filing of petitions for exemption.
(a) Who may file. Any person seeking an exemption from the PCB
processing and distribution in commerce prohibitions imposed by section
6(e)(3)(A)(ii) of TSCA may file a petition for exemption. Petitions must
be submitted on an individual basis for each processor, distributor,
seller or individual affected by the 1979 processing and distribution in
commerce prohibitions, except as described in paragraphs (a) (1) through
(9) of this section.
(1) Processing and distribution in commerce of PCB-contaminated
transformer dielectric fluid. Persons who process or distribute in
commerce dielectric fluid containing 50 ppm or greater PCB (but less
than 500 ppm PCB) for use in PCB-Contaminated Transformers may submit a
single consolidated petition on behalf of any number of petitioners. The
name and address of each petitioner must be stated in the petition.
(2) Contaminated substances and mixtures--processing. Persons who
process the same chemical substance or the same mixture containing 50
ppm or greater PCB as an impurity or contaminant may submit a
consolidated petition if the chemical substance or mixture is processed
for the same use by each person represented by the petition. For
example, persons who process a PCB-contaminated pigment into printing
inks may combine their petitions into one petition. The name and address
of each petitioner must be stated in the petition.
(3) Contaminated substances and mixtures--distribution in commerce.
Persons who distribute in commerce the same chemical substance or the
same mixture containing 50 ppm or greater PCB as an impurity or
contaminant may submit a consolidated petition if the chemical substance
or mixture is distributed in commerce for a common use. Such a petition
is not required to name each person who distributes in commerce the
chemical substance or mixture.
(4) PCB capacitor distribution for purposes of repair. Persons who
distribute in commerce PCB capacitors for servicing (repair) of PCB
Equipment may submit a single consolidated petition on behalf of any
number of petitioners engaged in such distribution in commerce for
purposes of repair. The name of each petitioner need not be stated in
the petition.
(5) Small quantities for research and development. Persons who
process or distribute in commerce small quantities of PCBs for research
and development may submit a single consolidated petition. The name and
address of each petitioner must be stated in the petition.
(6) Microscopy. Persons who process or distribute in commerce PCBs
for use as a mounting medium in microscopy may submit a single
consolidated petition on behalf of any number of petitioners. The name
and address of each petitioner must be stated in the petition.
(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.
[[Page 157]]
(9) Distribution of PCB Equipment. Distributors in commerce of PCB
Equipment may submit a consolidated petition on behalf of persons who
distribute in commerce PCB Equipment of one type (such as air
conditioners). The petition is not required to name the persons who
distribute in commerce the affected PCB Equipment.
(b) Where to file. All petitions pertaining to:
(1) PCB use, which includes storage for use or reuse, manufacture,
processing related to manufacture and use, and distribution in commerce
related to use or processing for use, must be submitted to: OPPT
Document Control Officer (7407T), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
(2) PCB disposal, which includes cleanup, storage for disposal,
processing related to disposal, distribution in commerce related to
disposal or processing for disposal, and decontamination, must be
submitted to: Document Control Officer, Office of Resource Conservation
and Recovery (5305P), Environmental Protection Agency, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460-0001.
(c) Content of petition. Each petition must contain the following:
(1) Name, address and telephone number of petitioner. See also
paragraphs (a) (1) through (9) of this section for additional
identification requirements applicable to certain consolidated
petitions.
(2) Description of PCB processing or distribution in commerce
exemption requested, including a description of the chemical substances,
mixtures or items to be processed or distributed in commerce and, if
processing is involved, the nature of the processing.
(3) For processing petitions, location(s) of sites requiring
exemption.
(4) Length of time requested for exemption (maximum length of
exemption is one year).
(5) Estimated amount of PCBs (by pound and/or volume) to be
processed, distributed in commerce, or used during requested exemption
period and the manner of release of PCBs into the environment associated
with such processing, distribution in commerce, or use. Where the PCB
concentration is less than 500 ppm, both the total liquid volume and the
total PCB volume must be provided.
(6) The basis for the petitioner's contention that under section
6(e)(3)(B)(i) of TSCA ``an unreasonable risk of injury to health or
environment would not result'' from the granting of the petition for
exemption.
(7) The basis for the petitioner's contention that under section
6(e)(3)(B)(ii) ``good faith efforts have been made to develop a chemical
substance which does not present an unreasonable risk of injury to
health or the environment and which may be substituted for'' the PCB.
(8) Quantification of the reasonably ascertainable economic
consequences of denying the petition for exemption and an explanation of
the manner of computation.
(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.
[[Page 158]]
(iii) Persons filing petitions under paragraphs (a)(2) (Contaminated
Substances and Mixtures-Processing) and (a)(3) (Contaminated Substances
and Mixtures-Distribution in Commerce) must also provide a justification
for the class grouping selected and a description of the uses and the
human and environmental exposure associated with each use of the PCB-
contaminated chemical substance or mixture for which an exemption is
sought. Information may be provided on a group basis, except that the
information required by paragraphs (c)(1), (c)(3) and (c)(5) of this
section, must be provided for each person represented by a petition
under paragraph (a)(2) of this section.
(iv) Persons filing petitions under paragraph (a)(4) of this section
(PCB Capacitor Distribution for Purposes of Repair) must also provide an
estimate of the expected total number of PCB Capacitors to be
distributed in commerce under the requested exemption. All information
may be provided on a group basis.
(v) Persons filing petitions under paragraphs (a) (7) and (8) of
this section (Processing of PCB Articles into PCB Equipment and
Processing of PCB Equipment into Other PCB Equipment) must provide a
description of each type of PCB Equipment (including the amount of PCBs
by poundage and/or volume in the PCB Equipment) to be processed and/or
distributed in commerce under the exemption, the number of each type of
equipment expected to be processed and/or distributed in commerce, and
the approximate number of distributors or further processors covered by
the petition. All information may be provided on a group basis. However,
in the case of a petition under paragraph (a)(7) of this section, the
processor of PCB Articles into PCB Equipment must be identified in the
petition. In the case of a petition under paragraph (a)(8) of this
section, the processor of PCB Equipment who files the petition must be
identified.
(vi) Persons filing petitions under paragraph (a)(9) of this section
(Distribution of PCB Equipment) must provide a description of each type
of PCB Equipment (including the amount of PCBs by poundage and/or volume
in the PCB Equipment) to be distributed in commerce under the exemption,
the number of each type of equipment to be distributed in commerce, and
the approximate number of distributors covered by the petition. All
information may be provided on a group basis.
(vii) Persons filing petitions under paragraphs (a) (5) and (6) of
this section must provide the information required by paragraphs (c) (1)
through (8) of this section for each petitioner named in the petition.
(d) EPA reserves the right to request further information as to each
petition where necessary to determine whether the petition meets the
statutory tests of section 6(e)(3)(B) of TSCA prior to or after
publication of the notice of proposed rulemaking required by Sec.
750.33 of these rules.
(e) Renewal requests. (1) Any petitioner who has been granted an
exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on
or after May 25, 1994, and who seeks to renew that exemption without
changing its terms, must submit a letter by certified mail to EPA
requesting that the exemption be granted for the following year.
(i) This letter must contain a certification by the petitioner that
the type 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
[[Page 159]]
to EPA. The existing exemption activity may continue until the new
submission is addressed by rulemaking, provided the activity conforms to
the terms of the current exemption approved by EPA, and the petitioner
complies with the conditions of paragraph (e)(1) of this section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B)
exemption in a rule prior to May 25, 1994, and who seeks to increase the
amount of PCBs handled or to change the type of activities, the
procedures for handling the PCBs, and any other aspect of their existing
exemption must submit a new exemption petition to EPA. The existing
exemption activity may continue until the new submission is addressed by
rulemaking, provided the activity conforms to the terms of the original
exemption approved by EPA.
[44 FR 31560, Mar. 31, 1979, as amended at 53 FR 12524, Apr. 15, 1988;
59 FR 16998, Apr. 11, 1994; 63 FR 35436, June 29, 1998; 72 FR 57238,
Oct. 9, 2007; 74 FR 30232, June 25, 2009]
Sec. 750.32 Consolidation of rulemaking.
All petitions received pursuant to Sec. 750.31(a) will be
consolidated into one rulemaking with one informal hearing held on all
petitions.
Sec. 750.33 Notice of proposed rulemaking.
Rulemaking for PCB processing and distribution in commerce
exemptions filed pursuant to Sec. 750.31(a) will begin with the
publication of a Notice of Proposed Rulemaking in the Federal Register.
Each notice will contain:
(a) A summary of the information required in Sec. 750.31(d);
(b) A statement of the time and place at which the informal hearing
required by section 6(c)(2)(C) of TSCA shall begin, or, to the extent
these are not specified, a statement that they will be specified later
in a separate Federal Register notice provided that Federal Register
notice of the date and city at which any informal hearing shall begin
will be given at least 30 days in advance;
(c) A statement identifying the place at which the official record
of the rulemaking is located, the hours during which it will be open for
public inspection, the documents contained in it as of the date the
Notice of Proposed Rulemaking was issued, and a statement of the
approximate times at which additional materials such as public comments,
hearing transcripts, and Agency studies in progress will be added to the
record. If any material other than public comments or material generated
by a hearing is added to the record after publication of the notice
required by this action, and notice of its future addition was not given
at the time of that initial publication, a separate Federal Register
notice announcing its addition to the record and inviting comment will
be published;
(d) The due date for public comments, which will be (1) 30 days
after publication of the notice of proposed rulemaking for main comments
and (2) one week after the informal hearing for reply comments;
(e) The name, address, and office telephone number of the Record
Clerk and the Hearing Clerk for the rulemaking in question; and
(f) A nonbinding target date for issuing the final rule.
Sec. 750.34 Record.
(a) No later than the date of proposal of a rule subject to this
subpart, a rulemaking record for that rule will be established. It will
consist of a separate identified filing space containing:
(1) All documents required by Sec. 750.31(d);
(2) All public comments timely received;
(3) All public hearing transcripts;
(4) All material received during an informal hearing and accepted
for the record of that hearing; and
(5) Any other information that EPA considers to be relevant to such
rule and that EPA identified, on or before the date of the promulgation
of the rule, in a notice published in the Federal Register.
(b) All material in the record will be appropriately indexed. Each
record will be available for public inspection during normal EPA
business hours. Appropriate arrangements allowing members of the public
to copy record materials that do not risk the permanent loss of such
materials will be made. All material required to be included in the
record will be added to the record as
[[Page 160]]
soon as feasible after its receipt by EPA.
(c) The Record Clerk for each rulemaking will be responsible for EPA
compliance with the requirements of paragraph (a) of this section.
[44 FR 31560, Mar. 31, 1979, as amended at 72 FR 57238, Oct. 9, 2007]
Sec. 750.35 Public comments.
(a) Main comments must be postmarked or received no later than the
time specified in the Notice of Proposed Rulemaking and must contain all
comments on and criticisms of that Notice by the commenting person,
based on information which is or reasonably could have been available to
that person at the time.
(b) Reply comments must be postmarked or received no later than one
week after the close of all informal hearings on the proposed rule and
must be restricted to comments on:
(1) Other comments;
(2) Material in the hearing record; and
(3) Material which was not and could not reasonably have been
available to the commenting party a sufficient time before main comments
were due.
(c) Extensions of the time for filing comments may be granted in
writing by the Hearing Chairman. Application for an extension must be
made in writing. Comments submitted after the comment period and all
extensions of it have expired need not be added to the rulemaking record
and need not be considered in decisions concerning the rule.
(d) Unless the Notice of Proposed Rulemaking states otherwise, four
copies of all comments must be submitted.
Sec. 750.36 Confidentiality.
EPA encourages the submission of non-confidential information by
petitioners and commentors. EPA does not wish to have unnecessary
restrictions on access to the rulemaking record. However, if a
petitioner or commentor believes that he can only state his position
through the use of information claimed to be confidential, he may submit
it. Such information must be separately submitted for the rulemaking
record and marked ``confidential'' by the submitter. For the information
claimed to be confidential, EPA will list only the date and the name and
address of the petitioner or commentor in the public file, noting that
the petitioner or commentor has requested confidential treatment. The
information claimed to be confidential will be placed in a confidential
file. A petitioner must also file a non-confidential petition with a
non-confidential summary of the confidential information to be placed in
the public file. Similarly, a commentor must supply a non-confidential
summary of the information claimed to be confidential to be placed in
the public file. Any information not marked as confidential will be
placed in the public file. Information marked confidential will be
treated in accordance with the procedures in part 2, subpart B of this
title.
Sec. 750.37 Subpoenas.
(a) Where necessary, subpoenas requiring the production of
documentary material, the attendance of persons at the hearing, or
responses to written questions may be issued. Subpoenas may be issued
either upon request as provided in paragraph (b) of this section or by
EPA on its own motion.
(b) All subpoena requests must be in writing. Hearing participants
may request the issuance of subpoenas as follows:
(1) Subpoenas for the attendance of persons or for the production of
documents or responses to questions at the legislative hearing may be
requested at any time up to the deadline for filing main comments.
(2) Subpoenas for production of documents or answers to questions
after the legislative hearing may be requested at any time between the
beginning of the legislative hearing and the deadline for submitting
reply comments.
(c) EPA will rule on all subpoena requests filed under paragraph
(b)(1) of this section no later than the beginning of the informal
hearing. Such requests may be granted, denied, or deferred. EPA will
rule on all subpoena requests filed under paragraph (b)(2) of this
section and all deferred subpoena requests filed under paragraph (b)(1)
of this section no later than the promulgation of the final rule. Such
requests will be either granted or denied.
[[Page 161]]
Sec. 750.38 Participation in informal hearing.
(a) Each person or organization desiring to participate in the
informal hearing required by section 6(c)(2)(C) of TSCA must file a
written request to participate with the Hearing Clerk. This request must
be received no later than seven days prior to the scheduled start of the
hearing. The hearing will begin seven days after the close of the thirty
day comment period or as soon thereafter as practicable. The request
must include:
(1) A brief statement of the interest of the person or organization
in the proceeding;
(2) A brief outline of the points to be addressed;
(3) An estimate of the time required; and
(4) If the request comes from an organization, a nonbinding list of
the persons to take part in the presentation. Organizations are
requested to bring with them, to the extent possible, employees with
individual expertise in and responsibility for each of the areas to be
addressed. No organization not filing main comments in the rulemaking
will be allowed to participate at the hearing, unless a waiver of this
requirement is granted in writing by the Hearing Chairman or the
organization is appearing at the request of EPA or under subpoena.
(b) No later than three days prior to the start of the hearing, the
Hearing Clerk will make a hearing schedule publicly available and mail
or deliver it to each of the persons who requested to appear at the
hearing. This schedule will be subject to change during the course of
the hearing at the discretion of those presiding over it.
(c) Opening statements should be brief, and restricted either to
points that could not have been made in main comments or to emphasizing
points which are made in main comments, but which the participant
believes can be more forcefully urged in the hearing context.
Sec. 750.39 Conduct of informal hearing.
(a) A panel of EPA employees shall preside at each hearing conducted
under section 6(c)(2)(C) of TSCA. In appropriate cases, other Executive
Branch employees may also sit with and assist the panel. The membership
of the panel may change as different topics arise during the hearing. In
general, the panel membership will consist of EPA employees with special
responsibility for the final rule or special expertise in the topics
under discussion. One member of the panel will be named to chair the
proceedings and will attend throughout the hearing, unless unavoidably
prevented by sickness or similar personal circumstances.
(b) The panel may question any individual or group participating in
the hearing on any subject relating to the rulemaking. Cross-examination
by others will normally not be permitted at this stage. It may be
granted in compelling circumstances at the sole discretion of the
hearing panel. However, persons in the hearing audience may submit
questions in writing for the hearing panel to ask the participants, and
the hearing panel may, at their discretion, ask these questions.
(c) Participants in the hearing may submit additional material for
the hearing record and shall submit such additional material as the
hearing panel may request. All such submissions will become part of the
record of the hearing. A verbatim transcript of the hearing shall be
made. Participants will be allowed to designate testimony from prior EPA
informal rulemaking hearings concerning PCBs under TSCA. The hearing
panel may reject repetitive testimony previously presented at such
hearings.
Sec. 750.40 Cross-examination.
(a) After the close of the informal hearing conducted under Sec.
750.39, any participant in that hearing may submit a written request for
cross-examination. The request must be received by EPA within one week
after a full transcript of the informal hearing becomes available and
must specify:
(1) The disputed issue(s) of material fact as to which cross-
examination is requested. This must include an explanation of why the
questions at issue are ``factual'', rather than of an analytical or
policy nature, the extent to which they are in ``dispute'' in the light
of the record made thus far, and the extent to which and why they can
[[Page 162]]
reasonably be considered ``material'' to the decision on the final rule;
and
(2) The person(s) the participant desires to cross-examine, and an
estimate of the time necessary. This must include a statement as to how
the cross-examination requested can be expected to result in ``full and
true disclosure'' resolving the issue of material fact involved.
(b) Within one week after receipt of all requests for cross-
examination under paragraph (a), the hearing panel will rule on them.
The ruling will be served by the Hearing Clerk on all participants who
have requested cross-examination and will be inserted in the record.
Written notice of the ruling will be given to all persons requesting
cross-examination and all persons to be cross-examined. The ruling will
specify:
(1) The issues as to which cross-examination is granted;
(2) The persons to be cross-examined on each issue;
(3) The persons to be allowed to conduct cross-examination; and
(4) Time limits for the examination of each witness by each cross-
examiner.
(c) In issuing this ruling, the panel may determine that one or more
participants who have requested cross-examination have the same or
similar interests and should be required to choose a single
representative for purposes of cross-examination by that single
representative without identifying the representative further. Subpoenas
for witnesses may be issued where necessary.
(d) Within one week after the insertion into the record of the
ruling under paragraph (b) of this section, the hearing at which the
cross-examination will be conducted will begin. One or more members of
the original panel will preside for EPA. The panel will have authority
to conduct cross-examination on behalf of any participant, although as a
general rule this right will not be exercised. The panel will also have
authority to modify the governing ruling in any respect and to make new
rulings on group representation under section 6(c)(3)(C) of TSCA. A
verbatim transcript of the hearing will be made.
(e)(1) No later than the time set for requesting cross-examination,
a hearing participant may request that other alternative methods of
clarifying the record (such as informal conferences or the submittal of
additional information) be used. Such requests may be submitted either
in lieu of cross-examination requests, or in conjunction with them.
(2) The panel in passing on a cross-examination request may, as a
precondition to ruling on its merits, require that alternative means of
clarifying the record be used whether or not that has been requested
under paragraph (e)(1) of this section. In such a case, the results of
the use of such alternative means will be made available to the person
requesting cross-examination for a one-week comment period, and the
panel will make a final ruling on cross-examination within one week
thereafter.
(f) Waivers or extensions of any deadline in this section applicable
to persons other than EPA may be granted on the record of the hearing by
the person chairing it or in writing by the Hearing Chairman.
Sec. 750.41 Final rule.
(a) As soon as feasible after the deadline for submittal of reply
comments, EPA will issue a final rule. EPA will also publish at that
time:
(1) A list of all material added to the record (other than public
comments and material from the hearing record) which has not previously
been listed in a Federal Register document, and
(2) The effective date of the rule.
(b) EPA will grant or deny petitions under section 6(e)(3)(B) of
TSCA submitted pursuant to Sec. 750.31. EPA will act on such petitions
subsequent to opportunity for an informal hearing pursuant to this rule.
(c) In determining whether to grant an exemption to the PCB ban, EPA
will apply the two standards enunciated in section 6(e)(3)(B) of TSCA.
[44 FR 31560, Mar. 31, 1979, as amended at 72 FR 57238, Oct. 9, 2007]
[[Page 163]]
PART 761_POLYCHLORINATED BIPHENYLS (PCBs) MANUFACTURING, PROCESSING,
DISTRIBUTION IN COMMERCE, AND USE PROHIBITIONS--Table of Contents
Subpart A_General
Sec.
761.1 Applicability.
761.2 PCB concentration assumptions for use.
761.3 Definitions.
761.19 References.
Subpart B_Manufacturing, Processing, Distribution in Commerce, and Use
of PCBs and PCB Items
761.20 Prohibitions and exceptions.
761.30 Authorizations.
761.35 Storage for reuse.
Subpart C_Marking of PCBs and PCB Items
761.40 Marking requirements.
761.45 Marking formats.
Subpart D_Storage and Disposal
761.50 Applicability.
761.60 Disposal requirements.
761.61 PCB remediation waste.
761.62 Disposal of PCB bulk product waste.
761.63 PCB household waste storage and disposal.
761.64 Disposal of wastes generated as a result of research and
development activities authorized under Sec. 761.30(j) and
chemical analysis of PCBs.
761.65 Storage for disposal.
761.70 Incineration.
761.71 High efficiency boilers.
761.72 Scrap metal recovery ovens and smelters.
761.75 Chemical waste landfills.
761.77 Coordinated approval.
761.79 Decontamination standards and procedures.
Subpart E_Exemptions
761.80 Manufacturing, processing and distribution in commerce
exemptions.
Subpart F_Transboundary Shipments of PCBs for Disposal
761.91 Applicability.
761.93 Import for disposal.
761.97 Export for disposal.
761.99 Other transboundary shipments.
Subpart G_PCB Spill Cleanup Policy
761.120 Scope.
761.123 Definitions.
761.125 Requirements for PCB spill cleanup.
761.130 Sampling requirements.
761.135 Effect of compliance with this policy and enforcement.
Subparts H-I [Reserved]
Subpart J_General Records and Reports
761.180 Records and monitoring.
761.185 Certification program and retention of records by importers and
persons generating PCBs in excluded manufacturing processes.
761.187 Reporting importers and by persons generating PCBs in excluded
manufacturing processes.
761.193 Maintenance of monitoring records by persons who import,
manufacture, process, distribute in commerce, or use chemicals
containing inadvertently generated PCBs.
Subpart K_PCB Waste Disposal Records and Reports
761.202 EPA identification numbers.
761.205 Notification of PCB waste activity (EPA Form 7710-53).
761.207 The manifest--general requirements.
761.208 Obtaining manifests.
761.209 Number of copies of a manifest.
761.210 Use of the manifest--Generator requirements.
761.211 Manifest system--Transporter requirements.
761.212 Transporter compliance with the manifest.
761.213 Use of manifest--Commercial storage and disposal facility
requirements.
761.214 Retention of manifest records.
761.215 Manifest discrepancies.
761.216 Unmanifested waste report.
761.217 Exception reporting.
761.218 Certificate of disposal.
761.219 One-year exception reporting.
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.
[[Page 164]]
761.257 Determining the regulatory status of sampled pipe.
Subpart N_Cleanup Site Characterization Sampling for PCB Remediation
Waste in Accordance with 761.61(a)(2)
761.260 Applicability.
761.265 Sampling bulk PCB remediation waste and porous surfaces.
761.267 Sampling non-porous surfaces.
761.269 Sampling liquid PCB remediation waste.
761.272 Chemical extraction and analysis of samples.
761.274 Reporting PCB concentrations in samples.
Subpart O_Sampling To Verify Completion of Self-Implementing Cleanup and
On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces in
Accordance with 761.61(a)(6)
761.280 Application and scope.
761.283 Determination of the number of samples to collect and sample
collection locations.
761.286 Sample size and procedure for collecting a sample.
761.289 Compositing samples.
761.292 Chemical extraction and analysis of individual samples and
composite samples.
761.295 Reporting and recordkeeping of the PCB concentrations in
samples.
761.298 Decisions based on PCB concentration measurements resulting from
sampling.
Subpart P_Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse,
and On-Site or Off-Site Disposal Under 761.61(a)(6) and Determination
Under 761.79(b)(3)
761.300 Applicability.
761.302 Proportion of the total surface area to sample.
761.304 Determining sample location.
761.306 Sampling 1 meter square surfaces by random selection of halves.
761.308 Sample selection by random number generation on any two-
dimensional square grid.
761.310 Collecting the sample.
761.312 Compositing of samples.
761.314 Chemical analysis of standard wipe test samples.
761.316 Interpreting PCB concentration measurements resulting from this
sampling scheme.
Subpart Q_Self-Implementing Alternative Extraction and Chemical Analysis
Procedures for Non-liquid PCB Remediation Waste Samples
761.320 Applicability.
761.323 Sample preparation.
761.326 Conducting the comparison study.
Subpart R_Sampling Non-Liquid, Non-Metal PCB Bulk Product Waste for
Purposes of Characterization for PCB Disposal in Accordance With
761.62, and Sampling PCB Remediation Waste Destined for Off-Site
Disposal, in Accordance With 761.61
761.340 Applicability.
761.345 Form of the waste to be sampled.
761.346 Three levels of sampling.
761.347 First level sampling--waste from existing piles.
761.348 Contemporaneous sampling.
761.350 Subsampling from composite samples.
761.353 Second level of sample selection.
761.355 Third level of sample selection.
761.356 Conducting a leach test.
761.357 Reporting the results of the procedure used to simulate leachate
generation.
761.358 Determining the PCB concentration of samples of waste.
761.359 Reporting the PCB concentrations in samples.
Subpart S_Double Wash/Rinse Method for Decontaminating Non-Porous
Surfaces
761.360 Background.
761.363 Applicability.
761.366 Cleanup equipment.
761.369 Pre-cleaning the surface.
761.372 Specific requirements for relatively clean surfaces.
761.375 Specific requirements for surfaces coated or covered with dust,
dirt, grime, grease, or another absorbent material.
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.
[[Page 165]]
761.389 Testing parameter requirements.
761.392 Preparing validation study samples.
761.395 A validation study.
761.398 Reporting and recordkeeping.
Authority: 15 U.Sec. C. 2605, 2607, 2611, 2614, and 2616.
Subpart A_General
Sec. 761.1 Applicability.
(a) This part establishes prohibitions of, and requirements for, the
manufacture, processing, distribution in commerce, use, disposal,
storage, and marking of PCBs and PCB Items.
(b)(1) This part applies to all persons who manufacture, process,
distribute in commerce, use, or dispose of PCBs or PCB Items. Substances
that are regulated by this part include, but are not limited to:
dielectric fluids; solvents; oils; waste oils; heat transfer fluids;
hydraulic fluids; paints or coatings; sludges; slurries; sediments;
dredge spoils; soils; materials containing PCBs as a result of spills;
and other chemical substances or combinations of substances, including
impurities and byproducts and any byproduct, intermediate, or impurity
manufactured at any point in a process.
(2) Unless otherwise noted, PCB concentrations shall be determined
on a weight-per-weight basis (e.g., milligrams per kilogram), or for
liquids, on a weight-per-volume basis (e.g., milligrams per liter) if
the density of the liquid is also reported. Unless otherwise provided,
PCBs are quantified based on the formulation of PCBs present in the
material analyzed. For example, measure Aroclor \TM\ 1242 PCBs based on
a comparison with Aroclor \TM\ 1242 standards. Measure individual
congener PCBs based on a comparison with individual PCB congener
standards.
(3) Most provisions in this part apply only if PCBs are present in
concentrations above a specified level. Provisions that apply to PCBs at
concentrations of <50 ppm apply also to contaminated surfaces at PCB
concentrations of <=10 [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 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.
[[Page 166]]
(c) Definitions of the terms used in these regulations are in
subpart A. The basic requirements applicable to disposal and marking of
PCBs and PCB Items are set forth in subpart D--Disposal of PCBs and PCB
Items and in subpart C--Marking of PCBs and PCB Items. Prohibitions
applicable to PCB activities are set forth in subpart B--Manufacture,
Processing, Distribution in Commerce, and Use of PCBs and PCB Items.
Subpart B also includes authorizations from the prohibitions. Subparts C
and D set forth the specific requirements for disposal and marking of
PCBs and PCB Items.
(d) Section 15 of the Toxic Substances Control Act (TSCA) states
that failure to comply with these regulations is unlawful. Section 16
imposes liability for civil penalties upon any person who violates these
regulations, and the Administrator can establish appropriate remedies
for any violations subject to any limitations included in section 16 of
TSCA. Section 16 also subjects a person to criminal prosecution for a
violation which is knowing or willful. In addition, section 17
authorizes Federal district courts to enjoin activities prohibited by
these regulations, compel the taking of actions required by these
regulations, and issue orders to seize PCBs and PCB Items manufactured,
processed or distributed in violation of these regulations.
(e) These regulations do not preempt other more stringent Federal
statutes and regulations.
(f) Unless and until superseded by any new more stringent
regulations issued under EPA authorities, or any permits or any
pretreatment requirements issued by EPA, a state or local government
that affect release of PCBs to any particular medium:
(1) Persons who inadvertently manufacture or import PCBs generated
as unintentional impurities in excluded manufacturing processes, as
defined in Sec. 761.3, are exempt from the requirements of subpart B of
this part, provided that such persons comply with subpart J of this
part, as applicable.
(2) Persons who process, distribute in commerce, or use products
containing PCBs generated in excluded manufacturing processes defined in
Sec. 761.3 are exempt from the requirements of subpart B provided that
such persons comply with subpart J of this part, as applicable.
(3) Persons who process, distribute in commerce, or use products
containing recycled PCBs defined in Sec. 761.3, are exempt from the
requirements of subpart B of this part, provided that such persons
comply with subpart J of this part, as applicable.
(4) Except as provided in Sec. 761.20 (d) and (e), persons who
process, distribute in commerce, or use products containing excluded PCB
products as defined in Sec. 761.3, are exempt from the requirements of
subpart B of this part.
(Sec. 6, Pub. L. 94-469, 90 Stat. 2020 (15 U.Sec. 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.
[[Page 167]]
(4) Any person must assume that a capacitor manufactured prior to
July 2, 1979, whose PCB concentration is not established contains
=500 ppm PCBs. Any person may assume that a capacitor
manufactured after July 2, 1979, is non-PCB (i.e., <50 ppm PCBs). If the
date of manufacture is unknown, any person must assume the capacitor
contains =500 ppm PCBs. Any person may assume that a
capacitor marked at the time of manufacture with the statement ``No
PCBs'' in accordance with Sec. 761.40(g) is non-PCB.
(b) PCB concentration may be established by:
(1) Testing the equipment; or
(2)(i) A permanent label, mark, or other documentation from the
manufacturer of the equipment indicating its PCB concentration at the
time of manufacture; and
(ii) Service records or other documentation indicating the PCB
concentration of all fluids used in servicing the equipment since it was
first manufactured.
[63 FR 35436, June 29, 1998, as amended at 64 FR 33759, June 24, 1999]
Sec. 761.3 Definitions.
For the purpose of this part:
Administrator means the Administrator of the Environmental
Protection Agency, or any employee of the Agency to whom the
Administrator may either herein or by order delegate his authority to
carry out his functions, or any person who shall by operation of law be
authorized to carry out such functions.
Agency means the United States Environmental Protection Agency.
Air compressor system means air compressors, piping, receiver tanks,
volume tanks and bottles, dryers, airlines, and related appurtenances.
Annual document log means the detailed information maintained at the
facility on the PCB waste handling at the facility.
Annual report means the written document submitted each year by each
disposer and commercial storer of PCB waste to the appropriate EPA
Regional Administrator. The annual report is a brief summary of the
information included in the annual document log.
ASTM means American Society for Testing and Materials, 100 Barr
Harbor Drive, West Conshohocken, PA 19428-2959.
Byproduct means a chemical substance produced without separate
commercial intent during the manufacturing or processing of another
chemical substance(s) or mixture(s).
Capacitor means a device for accumulating and holding a charge of
electricity and consisting of conducting surfaces separated by a
dielectric. Types of capacitors are as follows:
(1) Small capacitor means a capacitor which contains less than 1.36
kg (3 lbs.) of dielectric fluid. The following assumptions may be used
if the actual weight of the dielectric fluid is unknown. A capacitor
whose total volume is less than 1,639 cubic centimeters (100 cubic
inches) may be considered to contain less than 1.36 kgs (3 lbs.) of
dielectric fluid and a capacitor whose total volume is more than 3,278
cubic centimeters (200 cubic inches) must be considered to contain more
than 1.36 kg (3 lbs.) of dielectric fluid. A capacitor whose volume is
between 1,639 and 3,278 cubic centimeters may be considered to contain
less then 1.36 kg (3 lbs.) of dielectric fluid if the total weight of
the capacitor is less than 4.08 kg (9 lbs.).
(2) Large high voltage capacitor means a capacitor which contains
1.36 kg (3 lbs.) or more of dielectric fluid and which operates at 2,000
volts (a.c. or d.c.) or above.
(3) Large low voltage capacitor means a capacitor which contains
1.36 kg (3 lbs.) or more of dielectric fluid and which operates below
2,000 volts (a.c. or d.c.).
CERCLA means the Comprehensive Environmental Response, Compensation,
and Liability Act (42 U.Sec. 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.Sec. C. 1001 and 15 U.Sec. 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
[[Page 168]]
that this information is true, accurate, and complete.
Chemical substance, (1) except as provided in paragraph (2) of this
definition, means any organic or inorganic substance of a particular
molecular identity, including: Any combination of such substances
occurring in whole or part as a result of a chemical reaction or
occurring in nature, and any element or uncombined radical.
(2) Such term does not include: Any mixture; any pesticide (as
defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when
manufactured, processed, or distributed in commerce for use as a
pesticide; tobacco or any tobacco product; any source material, special
nuclear material, or byproduct material (as such terms are defined in
the Atomic Energy Act of 1954 and regulations issued under such Act);
any article the sale of which is subject to the tax imposed by section
4181 of the Internal Revenue Code of 1954 (determined without regard to
any exemptions from such tax provided by section 4182 or section 4221 or
any provisions of such Code); and any food, food additive, drug,
cosmetic, or device (as such terms are defined in section 201 of the
Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic, or device.
Chemical waste landfill means a landfill at which protection against
risk of injury to health or the environment from migration of PCBs to
land, water, or the atmosphere is provided from PCBs and PCB Items
deposited therein by locating, engineering, and operating the landfill
as specified in Sec. 761.75.
Cleanup site means the areal extent of contamination and all
suitable areas in very close proximity to the contamination necessary
for implementation of a cleanup of PCB remediation waste, regardless of
whether the site was intended for management of waste.
Commerce means trade, traffic, transportation, or other commerce:
(1) Between a place in a State and any place outside of such State,
or
(2) Which affects trade, traffic, transportation, or commerce
described in paragraph (1) of this definition.
Commercial storer of PCB waste means the owner or operator of each
facility that is subject to the PCB storage unit standards of Sec.
761.65(b)(1) or (c)(7) or meets the alternate storage criteria of Sec.
761.65(b)(2), and who engages in storage activities involving either PCB
waste generated by others or that was removed while servicing the
equipment owned by others and brokered for disposal. The receipt of a
fee or any other form of compensation for storage services is not
necessary to qualify as a commercial storer of PCB waste. A generator
who only stores its own waste is subject to the storage requirements of
Sec. 761.65, but is not required to obtain approval as a commercial
storer. If a facility's storage of PCB waste generated by others at no
time exceeds a total of 500 gallons of liquid and/or non-liquid material
containing PCBs at regulated levels, the owner or operator is a
commercial storer but is not required to seek EPA approval as a
commercial storer of PCB waste. Storage of one company's PCB waste by a
related company is not considered commercial storage. A ``related
company'' includes, but is not limited to: a parent company and its
subsidiaries; sibling companies owned by the same parent company;
companies owned by a common holding company; members of electric
cooperatives; entities within the same Executive agency as defined at 5
U.Sec. 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
[[Page 169]]
useful life of PCBs and PCB Items. Disposal includes spills, leaks, and
other uncontrolled discharges of PCBs as well as actions related to
containing, transporting, destroying, degrading, decontaminating, or
confining PCBs and PCB Items.
Disposer of PCB waste, as the term is used in subparts J and K of
this part, means any person who owns or operates a facility approved by
EPA for the disposal of PCB waste which is regulated for disposal under
the requirements of subpart D of this part.
Distribute in commerce and Distribution in Commerce when used to
describe an action taken with respect to a chemical substance, mixture,
or article containing a substance or mixture means to sell, or the sale
of, the substance, mixture, or article in commerce; to introduce or
deliver for introduction into commerce, or the introduction or delivery
for introduction into commerce of the substance, mixture, or article; or
to hold or the holding of, the substance, mixture, or article after its
introduction into commerce.
DOT means the United States Department of Transportation.
Dry weight means the weight of the sample, excluding the weight of
the water in the sample. Prior to chemical analysis the water may be
removed by any reproducible method that is applicable to measuring PCBs
in the sample matrix at the concentration of concern, such as air drying
at ambient temperature, filtration, decantation, heating at low
temperature followed by cooling in the presence of a desiccant, or other
processes or combinations of processes which would remove water but not
remove PCBs from the sample. Analytical procedures which calculate the
dry weight concentration by adjusting for moisture content may also be
used.
EPA identification number means the 12-digit number assigned to a
facility by EPA upon notification of PCB waste activity under Sec.
761.205.
Excluded manufacturing process means a manufacturing process in
which quantities of PCBs, as determined in accordance with the
definition of inadvertently generated PCBs, calculated as defined, and
from which releases to products, air, and water meet the requirements of
paragraphs (1) through (5) of this definition, or the importation of
products containing PCBs as unintentional impurities, which products
meet the requirements of paragraphs (1) and (2) of this definition.
(1) The concentration of inadvertently generated PCBs in products
leaving any manufacturing site or imported into the United States must
have an annual average of less than 25 ppm, with a 50 ppm maximum.
(2) The concentration of inadvertently generated PCBs in the
components of detergent bars leaving the manufacturing site or imported
into the United States must be less than 5 ppm.
(3) The release of inadvertently generated PCBs at the point at
which emissions are vented to ambient air must be less than 10 ppm.
(4) The amount of inadvertently generated PCBs added to water
discharged from a manufacturing site must be less than 100 micrograms
per resolvable gas chromatographic peak per liter of water discharged.
(5) Disposal of any other process wastes above concentrations of 50
ppm PCB must be in accordance with subpart D of this part.
Excluded PCB products means PCB materials which appear at
concentrations less than 50 ppm, including but not limited to:
(1) Non-Aroclor inadvertently generated PCBs as a byproduct or
impurity resulting from a chemical manufacturing process.
(2) Products contaminated with Aroclor or other PCB materials from
historic PCB uses (investment casting waxes are one example).
(3) Recycled fluids and/or equipment contaminated during use
involving the 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.
[[Page 170]]
(ii) The products or source of the products containing <50 ppm
concentrations PCBs were legally manufactured, processed, distributed in
commerce, or used, i.e., pursuant to authority granted by EPA
regulation, by exemption petition, by settlement agreement, or pursuant
to other Agency-approved programs;
(iii) The resulting PCB concentration (i.e. below 50 ppm) is not a
result of dilution, or leaks and spills of PCBs in concentrations over
50 ppm.
Facility means all contiguous land, and structures, other
appurtenances, and improvements on the land, used for the treatment,
storage, or disposal of PCB waste. A facility may consist of one or more
treatment, storage, or disposal units.
Fluorescent light ballast means a device that electrically controls
fluorescent light fixtures and that includes a capacitor containing 0.1
kg or less of dielectric.
Generator of PCB waste means any person whose act or process
produces PCBs that are regulated for disposal under subpart D of this
part, or whose act first causes PCBs or PCB Items to become subject to
the disposal requirements of subpart D of this part, or who has physical
control over the PCBs when a decision is made that the use of the PCBs
has been terminated and therefore is subject to the disposal
requirements of subpart D of this part. Unless another provision of this
part specifically requires a site-specific meaning, ``generator of PCB
waste'' includes all of the sites of PCB waste generation owned or
operated by the person who generates PCB waste.
High occupancy area means any area where PCB remediation waste has
been disposed of on-site and where occupancy for any individual not
wearing dermal and respiratory protection for a calendar year is: 840
hours or more (an average of 16.8 hours or more per week) for non-porous
surfaces and 335 hours or more (an average of 6.7 hours or more per
week) for bulk PCB remediation waste. Examples could include a
residence, school, day care center, sleeping quarters, a single or
multiple occupancy 40 hours per week work station, a school class room,
a cafeteria in an industrial facility, a control room, and a work
station at an assembly line.
Importer means any person defined as an ``importer'' at Sec.
720.3(l) of this chapter who imports PCBs or PCB Items and is under the
jurisdiction of the United States.
Impurity means a chemical substance which is unintentionally present
with another chemical substance.
In or Near Commercial Buildings means within the interior of, on the
roof of, attached to the exterior wall of, in the parking area serving,
or within 30 meters of a non-industrial non-substation building.
Commercial buildings are typically accessible to both members of the
general public and employees, and include: (1) Public assembly
properties, (2) educational properties, (3) institutional properties,
(4) residential properties, (5) stores, (6) office buildings, and (7)
transportation centers (e.g., airport terminal buildings, subway
stations, bus stations, or train stations).
Incinerator means an engineered device using controlled flame
combustion to thermally degrade PCBs and PCB Items. Examples of devices
used for incineration include rotary kilns, liquid injection
incinerators, cement kilns, and high temperature boilers.
Industrial building means a building directly used in manufacturing
or technically productive enterprises. Industrial buildings are not
generally or typically accessible to other than workers. Industrial
buildings include buildings used directly in the production of power,
the manufacture of products, the mining of raw materials, and the
storage of textiles, petroleum products, wood and paper products,
chemicals, plastics, and metals.
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.
[[Page 171]]
Low occupancy area means any area where PCB remediation waste has
been disposed of on-site and where occupancy for any individual not
wearing dermal and respiratory protection for a calendar year is: less
than 840 hours (an average of 16.8 hours per week) for non-porous
surfaces and less than 335 hours (an average of 6.7 hours per week) for
bulk PCB remediation waste. Examples could include an electrical
substation or a location in an industrial facility where a worker spends
small amounts of time per week (such as an unoccupied area outside a
building, an electrical equipment vault, or in the non-office space in a
warehouse where occupancy is transitory).
Manifest means the shipping document EPA form 8700-22 and any
continuation sheet attached to EPA form 8700-22, originated and signed
by the generator of PCB waste in accordance with the instructions
included with the form and subpart K of this part.
Manned Control Center means an electrical power distribution control
room where the operating conditions of a PCB Transformer are
continuously monitored during the normal hours of operation (of the
facility), and, where the duty engineers, electricians, or other trained
personnel have the capability to deenergize a PCB Transformer completely
within 1 minute of the receipt of a signal indicating abnormal operating
conditions such as an overtemperature condition or overpressure
condition in a PCB Transformer.
Manufacture means to produce, manufacture, or import into the
customs territory of the United States.
Manufacturing process means all of a series of unit operations
operating at a site, resulting in the production of a product.
Mark means the descriptive name, instructions, cautions, or other
information applied to PCBs and PCB Items, or other objects subject to
these regulations.
Marked means the marking of PCB Items and PCB storage areas and
transport vehicles by means of applying a legible mark by painting,
fixation of an adhesive label, or by any other method that meets the
requirements of these regulations.
Market/Marketers means the processing or distributing in commerce,
or the person who processes or distributes in commerce, used oil fuels
to burners or other marketers, and may include the generator of the fuel
if it markets the fuel directly to the burner.
Mineral Oil PCB Transformer means any transformer originally
designed to contain mineral oil as the dielectric fluid and which has
been tested and found to contain 500 ppm or greater PCBs.
Mixture means any combination of two or more chemical substances if
the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except that such term does
include any combination which occurs, in whole or in part, as a result
of a chemical reaction if none of the chemical substances comprising the
combination is a new chemical substance and if the combination could
have been manufactured for commercial purposes without a chemical
reaction at the time the chemical substances comprising the combination
were combined.
Municipal solid wastes means garbage, refuse, sludges, wastes, and
other discarded materials resulting from residential and non-industrial
operations and activities, such as household activities, office
functions, and commercial housekeeping wastes.
Natural gas pipeline system means natural gas gathering facilities,
natural gas pipe, natural gas compressors, natural gas storage
facilities, and natural gas pipeline appurtenances (including
instrumentation and vessels directly in contact with transported natural
gas such as valves, regulators, drips, filter separators, etc., but not
including air compressors).
Non-liquid PCBs means materials containing PCBs that by visual
inspection do not flow at room temperature (25 C or 77 F) or from
which no liquid passes when a 100 g or 100 ml representative sample is
placed in a mesh number 60 5 percent paint filter
and allowed to drain at room temperature for 5 minutes.
Non-PCB Transformer means any transformer that contains less than 50
ppm PCB; except that any transformer that has been converted from a PCB
[[Page 172]]
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.Sec.
Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161.
On site means within the boundaries of a contiguous property unit.
Open burning means the combustion of any PCB regulated for disposal,
in a manner not approved or otherwise allowed under subpart D of this
part, and without any of the following:
(1) Control of combustion air to maintain adequate temperature for
efficient combustion.
(2) Containment of the combustion reaction in an enclosed device to
provide sufficient residence time and mixing for complete combustion.
(3) Control of emission of the gaseous combustion products.
PCB and PCBs means any chemical substance that is limited to the
biphenyl molecule that has been chlorinated to varying degrees or any
combination of substances which contains such substance. Refer to Sec.
761.1(b) for applicable concentrations of PCBs. PCB and PCBs as
contained in PCB items are defined in Sec. 761.3. For any purposes
under this part, inadvertently generated non-Aroclor PCBs are defined as
the total PCBs calculated following division of the quantity of
monochlorinated biphenyls by 50 and dichlorinated biphenyls by 5.
PCB Article means any manufactured article, other than a PCB
Container, that contains PCBs and whose surface(s) has been in direct
contact with PCBs. ``PCB Article'' includes capacitors, transformers,
electric motors, pumps, pipes and any other manufactured item (1) which
is formed to a specific shape or design during manufacture, (2) which
has end use function(s) dependent in whole or in part upon its shape or
design during end use, and (3) which has either no change of chemical
composition during its end use or only those changes of composition
which have no commercial purpose separate from that of the PCB Article.
PCB Article Container means any package, can, bottle, bag, barrel,
drum, tank, or other device used to contain PCB Articles or PCB
Equipment, and whose surface(s) has not been in direct contact with
PCBs.
PCB bulk product waste means waste derived from manufactured
products containing PCBs in a non-liquid state, at any concentration
where the concentration at the time of designation for disposal was
=50 ppm PCBs. PCB bulk product waste does not include PCBs or
PCB Items regulated for disposal under Sec. 761.60(a) through (c),
Sec. 761.61, Sec. 761.63, or Sec. 761.64. PCB bulk product waste
includes, but is not limited to:
(1) Non-liquid bulk wastes or debris from the demolition of
buildings and other man-made structures manufactured, coated, or
serviced with PCBs. PCB bulk product waste does not include debris from
the demolition of buildings or other man-made structures that is
contaminated by spills from regulated PCBs which have not been disposed
of, decontaminated, or otherwise cleaned up in accordance with subpart D
of this part.
(2) PCB-containing wastes from the shredding of automobiles,
household appliances, or industrial appliances.
(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.
[[Page 173]]
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.
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
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use under this part. PCB remediation waste means soil, rags, and other
debris generated as a result of any PCB spill cleanup, including, but
not limited to:
(1) Environmental media containing PCBs, such as soil and gravel;
dredged materials, such as sediments, settled sediment fines, and
aqueous decantate from sediment.
(2) Sewage sludge containing <50 ppm PCBs and not in use according
to Sec. 761.20(a)(4); PCB sewage sludge; commercial or industrial
sludge contaminated as the result of a spill of PCBs including sludges
located in or removed from any pollution control device; aqueous
decantate from an industrial sludge.
(3) Buildings and other man-made structures (such as concrete
floors, wood floors, or walls contaminated from a leaking PCB or PCB-
Contaminated Transformer), porous surfaces, and non-porous surfaces.
PCB sewage sludge means sewage sludge as defined in 40 CFR 503.9(w)
which contains =50 ppm PCBs, as measured on a dry weight
basis.
PCB Transformer means any transformer that contains =500
ppm PCBs. For PCB concentration assumptions applicable to transformers
containing 1.36 kilograms (3 lbs.) or more of fluid other than mineral
oil, see Sec. 761.2. For provisions permitting reclassification of
electrical equipment, including PCB Transformers, containing
=500 ppm PCBs to PCB-Contaminated Electrical Equipment, see
Sec. 761.30(a) and (h).
PCB waste(s) means those PCBs and PCB Items that are subject to the
disposal requirements of subpart D of this part.
Performance-based organic decontamination fluid (PODF) means
kerosene, diesel fuel, terpene hydrocarbons, and terpene hydrocarbon/
alcohol mixtures.
Person means any natural or judicial person including any
individual, corporation, partnership, or association; any State or
political subdivision thereof; any interstate body; and any department,
agency, or instrumentality of the Federal Government.
Porous surface means any surface that allows PCBs to penetrate or
pass into itself including, but not limited to, paint or coating on
metal; corroded metal; fibrous glass or glass wool; unglazed ceramics;
ceramics with a porous glaze; porous building stone such as sandstone,
travertine, limestone, or coral rock; low-density plastics such as
styrofoam and low-density polyethylene; coated (varnished or painted) or
uncoated wood; concrete or cement; plaster; plasterboard; wallboard;
rubber; fiberboard; chipboard; asphalt; or tar paper. For purposes of
cleaning and disposing of PCB remediation waste, porous surfaces have
different requirements than non-porous surfaces.
Posing an exposure risk to food or feed means being in any location
where human food or animal feed products could be exposed to PCBs
released from a PCB Item. A PCB Item poses an exposure risk to food or
feed if PCBs released in any way from the PCB Item have a potential
pathway to human food or animal feed. EPA considers human food or animal
feed to include items regulated by the U.Sec. 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).
[[Page 175]]
(3) An incinerator approved under section 3005(c) of the Resource
Conservation and Recovery Act (42 U.Sec. 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.Sec. 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 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
[[Page 176]]
Evaluating Solid Waste,'' which is available from either the National
Technical Information Service (NTIS, U.Sec. Department of Commerce, 5285
Port Royal Rd., Springfield, VA 22161, telephone: (703) 487-4650 or the
U.Sec. Government Printing Office (U.Sec. GPO, 710 North Capitol St., NW.,
Washington, DC 20401, telephone: (202) 783-3238.
Totally enclosed manner means any manner that will ensure no
exposure of human beings or the environment to any concentration of
PCBs.
Transfer facility means any transportation-related facility
including loading docks, parking areas, and other similar areas where
shipments of PCB waste are held during the normal course of
transportation. Transport vehicles are not transfer facilities under
this definition, unless they are used for the storage of PCB waste,
rather than for actual transport activities. Storage areas for PCB waste
at transfer facilities are subject to the storage facility standards of
Sec. 761.65, but such storage areas are exempt from the approval
requirements of Sec. 761.65(d) and the recordkeeping requirements of
Sec. 761.180, unless the same PCB waste is stored there for a period of
more than 10 consecutive days between destinations.
Transporter of PCB waste means, for the purposes of subpart K of
this part, any person engaged in the transportation of regulated PCB
waste by air, rail, highway, or water for purposes other than
consolidation by a generator.
Transport vehicle means a motor vehicle or rail car used for the
transportation of cargo by any mode. Each cargo-carrying body (e.g.,
trailer, railroad freight car) is a separate transport vehicle.
Treatability Study means a study in which PCB waste is subjected to
a treatment process to determine:
(1) Whether the waste is amenable to the treatment process;
(2) What pretreatment (if any) is required;
(3) The optimal process conditions needed to achieve the desired
treatment;
(4) The efficiency of a treatment process for the specific type of
waste (i.e., soil, sludge, liquid, etc.); or,
(5) The characteristics and volumes of residuals from a particular
treatment process. A ``treatability study'' is not a mechanism to
commercially treat or dispose of PCB waste. Treatment is a form of
disposal under this part.
TSCA means the Toxic Substances Control Act (15 U.Sec. 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.Sec. GPO means the U.Sec. 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.Sec. 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.Sec. C. 552(a) and 1 CFR part 51. To enforce
[[Page 177]]
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.
(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
[[Page 178]]
and PCB Items for disposal are established pursuant to section 6(e)(1)
of TSCA. Subject to any exemptions granted pursuant to section
6(e)(3)(B) of TSCA, the activities listed in paragraphs (b) and (c) of
this section are prohibited pursuant to section (6)(e)(3)(A) of TSCA. In
addition, the Administrator hereby finds, under the authority of section
12(a)(2) of TSCA, that the manufacture, processing, and distribution in
commerce of PCBs at concentrations of 50 ppm or greater and PCB Items
with PCB concentrations of 50 ppm or greater present an unreasonable
risk of injury to health within the United States. This finding is based
upon the well-documented human health and environmental hazard of PCB
exposure, the high probability of human and environmental exposure to
PCBs and PCB Items from manufacturing, processing, or distribution
activities; the potential hazard of PCB exposure posed by the
transportation of PCBs or PCB Items within the United States; and the
evidence that contamination of the environment by PCBs is spread far
beyond the areas where they are used. In addition, the Administrator
hereby finds, for purposes of section 6(e)(2)(C) of TSCA, that any
exposure of human beings or the environment to PCBs, as measured or
detected by any scientifically acceptable analytical method, may be
significant, depending on such factors as the quantity of PCBs involved
in the exposure, the likelihood of exposure to humans and the
environment, and the effect of exposure. For purposes of determining
which PCB Items are totally enclosed, pursuant to section 6(e)(2)(C) of
TSCA, since exposure to such Items may be significant, the Administrator
further finds that a totally enclosed manner is a manner which results
in no exposure to humans or the environment to PCBs. The following
activities are considered totally enclosed: distribution in commerce of
intact, nonleaking electrical equipment such as transformers (including
transformers used in railway locomotives and self-propelled cars),
capacitors, electromagnets, voltage regulators, switches (including
sectionalizers and motor starters), circuit breakers, reclosers, and
cable that contain PCBs at any concentration and processing and
distribution in commerce of PCB Equipment containing an intact,
nonleaking PCB Capacitor. See paragraph (c)(1) of this section for
provisions allowing the distribution in commerce of PCBs and PCB Items.
(a) No persons may use any PCB, or any PCB Item regardless of
concentration, in any manner other than in a totally enclosed manner
within the United States unless authorized under Sec. 761.30, except
that:
(1) An authorization is not required to use those PCBs or PCB Items
which consist of excluded PCB products as defined in Sec. 761.3.
(2) An authorization is not required to use those PCBs or PCB Items
resulting from an excluded manufacturing process or recycled PCBs as
defined in Sec. 761.3, provided all applicable conditions of Sec.
761.1(f) are met.
(3) An authorization is not required to use those PCB Items which
contain or whose surfaces have been in contact with excluded PCB
products as defined in Sec. 761.3.
(4) An authorization is not required to use sewage sludge where the
uses are regulated at parts 257, 258, and 503 of this chapter. No person
may blend or otherwise dilute PCBs regulated for disposal, including PCB
sewage sludge and sewage sludge not used pursuant to parts 257, 258, and
503 of this chapter, for purposes of use or to avoid disposal
requirements under this part. Except as explicitly provided in subpart D
of this part, no person may dispose of regulated PCB wastes including,
but not limited to, PCB remediation waste, PCB bulk product waste, PCBs,
and PCB industrial sludges, into treatment 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
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export from the United States without an exemption, except that an
exemption is not required to process or distribute in commerce PCBs or
PCB Items resulting from an excluded manufacturing process as defined in
Sec. 761.3, or to process or distribute in commerce recycled PCBs as
defined in Sec. 761.3, or to process or distribute in commerce excluded
PCB products as defined in Sec. 761.3, provided that all applicable
conditions of Sec. 761.1(f) are met. In addition, the activities
described in paragraphs (c) (1) through (5) of this section may also be
conducted without an exemption, under the conditions specified therein.
(1) PCBs at concentrations of 50 ppm or greater, or PCB Items with
PCB concentrations of 50 ppm or greater, sold before July 1, 1979 for
purposes other than resale may be distributed in commerce only in a
totally enclosed manner after that date.
(2) Any person may process and distribute in commerce for disposal
PCBs at concentrations of =50 ppm, or PCB Items with PCB
concentrations of =50 ppm, if they comply with the applicable
provisions of this part.
(i) Processing activities which are primarily associated with and
facilitate storage or transportation for disposal do not require a TSCA
PCB storage or disposal approval.
(ii) Processing activities which are primarily associated with and
facilitate treatment, as defined in Sec. 260.10 of this chapter, or
disposal require a TSCA PCB disposal approval unless they are part of an
existing approval, are part of a self-implementing activity under Sec.
761.61(a) or Sec. 761.79 (b) or (c), or are otherwise specifically
allowed under subpart D of this part.
(iii) With the exception of provisions in Sec. 761.60 (a)(2) and
(a)(3), in order to meet the intent of Sec. 761.1(b), processing,
diluting, or otherwise blending of waste prior to being introduced into
a disposal unit for purposes of meeting a PCB concentration limit shall
be done in accordance with a TSCA PCB disposal approval or comply with
the requirements of Sec. 761.79.
(iv) Where the rate of delivering liquids or non-liquids into a PCB
disposal unit is an operating parameter, this rate shall be a condition
of the TSCA PCB disposal approval for the unit when an approval is
required.
(3) PCBs and PCB Items may be exported for disposal in accordance
with the requirements of subpart F of this part.
(4) PCBs, at concentrations of less than 50 ppm, or PCB Items, with
concentrations of less than 50 ppm, may be processed and distributed in
commerce for purposes of disposal.
(5) Decontaminated materials. Any person may distribute in commerce
equipment, structures, or other liquid or non-liquid materials that were
contaminated with PCBs =50 ppm, including those not otherwise
authorized for distribution in commerce under this part, provided that
one of the following applies:
(i) The materials were decontaminated in accordance with a TSCA PCB
disposal approval issued under subpart D of this part, with Sec.
761.79, or with applicable EPA PCB spill cleanup policies in effect at
the time of the decontamination.
(ii) If not previously decontaminated, the materials now meet an
applicable decontamination standard in Sec. 761.79(b).
(d) The use of waste oil that contains any detectable concentration
of PCB as a sealant, coating, or dust control agent is prohibited.
Prohibited uses include, but are not limited to, road oiling, general
dust control, use as a pesticide or herbicide carrier, and use as a rust
preventative on pipes.
(e) In addition to any applicable requirements under 40 CFR part
279, subparts G and H, marketers and burners 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
[[Page 180]]
market off-specification used oil who are subject to the requirements at
40 CFR part 279 and the notification requirements of 40 CFR 279.73.
(iii) Burners identified in 40 CFR 279.61(a)(1) and (2). Only
burners in the automotive industry may burn used oil generated from
automotive sources in used oil-fired space heaters provided the
provisions of 40 CFR 279.23 are met. The Regional Administrator may
grant a variance for a boiler that does not meet the 40 CFR 279.61(a)(1)
and (2) criteria after considering the criteria listed in 40 CFR 260.32
(a) through (f). The applicant must address the relevant criteria
contained in 40 CFR 260.32 (a) through (f) in an application to the
Regional Administrator.
(2) Testing of used oil fuel. Used oil to be burned for energy
recovery is presumed to contain quantifiable levels (2 ppm) of PCB
unless the marketer obtains analyses (testing) or other information that
the used oil fuel does not contain quantifiable levels of PCBs.
(i) The person who first claims that a used oil fuel does not
contain quantifiable level (2 ppm) PCB must obtain analyses or other
information to support that claim.
(ii) Testing to determine the PCB concentration in used oil may be
conducted on individual samples, or in accordance with the testing
procedures described in Sec. 761.60(g)(2). However, for purposes of
this part, if any PCBs at a concentration of 50 ppm or greater have been
added to the container or equipment, then the total container contents
must be considered as having a PCB concentration of 50 ppm or greater
for purposes of complying with the disposal requirements of this part.
(iii) Other information documenting that the used oil fuel does not
contain quantifiable levels (2 ppm) of PCBs may consist of either
personal, special knowledge of the source and composition of the used
oil, or a certification from the person generating the used oil claiming
that the oil contains no detectable PCBs.
(3) Restrictions on burning. (i) Used oil containing any
quantifiable levels of PCB may be burned for energy recovery only in the
combustion facilities identified in paragraph (e)(1) of this section
when such facilities are operating at normal operating temperatures
(this prohibits feeding these fuels during either startup or shutdown
operations). Owners and operators of such facilities are ``burners'' of
used oil fuels.
(ii) Before a burner accepts from a marketer the first shipment of
used oil fuel containing detectable PCBs (2 ppm), the burner must
provide the marketer a one-time written and signed notice certifying
that:
(A) The burner has complied with any notification requirements
applicable to ``qualified incinerators'' (Sec. 761.3) or to ``burners''
regulated under 40 CFR part 279, subpart G.
(B) The burner will burn the used oil only in a combustion facility
identified in paragraph (e)(1) of this section and identify the class of
burner he qualifies.
(4) Recordkeeping requirements. The following recordkeeping
requirements are in addition to the recordkeeping requirements for
marketers found in 40 CFR 279.72(b), 279.74(a), (b) and (c), and 279.75,
and for burners found in 40 CFR 279.65 and 279.66.
(i) Marketers. Marketers who first claim that the used oil fuel
contains no detectable PCBs must include among the records required by
40 CFR 279.72(b) and 279.74(b) and (c), copies of the analysis or other
information documenting his claim, and he must include among the records
required by 40 CFR 279.74(a) and (c) and 279.75, a copy of each
certification notice received or prepared relating to transactions
involving PCB-containing used oil.
(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.Sec. 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]
[[Page 181]]
Sec. 761.30 Authorizations.
The following non-totally enclosed PCB activities are authorized
pursuant to section 6(e)(2)(B) of TSCA:
(a) Use in and servicing of transformers (other than railroad
transformers). PCBs at any concentration may be used in transformers
(other than in railroad locomotives and self-propelled railroad cars)
and may be used for purposes of servicing including rebuilding these
transformers for the remainder of their useful lives, subject to the
following conditions:
(1) Use conditions. (i) As of October 1, 1985, the use and storage
for reuse of PCB Transformers that pose an exposure risk to food or feed
is prohibited.
(ii) As of October 1, 1990, the use of network PCB Transformers with
higher secondary voltages (secondary voltages equal to or greater than
480 volts, including 480/277 volt systems) in or near commercial
buildings is prohibited. Network PCB Transformers with higher secondary
voltages which are removed from service in accordance with this
requirement must either be reclassified to PCB Contaminated or non PCB
status, placed into storage for disposal, or disposed.
(iii) Except as otherwise provided, as of October 1, 1985, the
installation of PCB Transformers, which have been placed into storage
for reuse or which have been removed from another location, in or near
commercial buildings is prohibited.
(A) Retrofilled mineral oil PCB Transformers may be installed for
reclassification purposes indefinitely after October 1, 1990.
(B) Once a retrofilled transformer has been installed for
reclassification purposes, it must be tested 3 months after installation
to ascertain the concentration of PCBs. If the PCB concentration is
below 50 ppm, the transformer can be reclassified as a non-PCB
Transformer. If the PCB concentration is between 50 and 500 ppm, the
transformer can be reclassified as a PCB-Contaminated transformer. If
the PCB concentration remains at 500 ppm or greater, the entire process
must either be repeated until the transformer has been reclassified to a
non-PCB or PCB-Contaminated transformer in accordance with paragraph
(a)(2)(v) of this section or the transformer must be removed from
service.
(iv) As of October 1, 1990, all higher secondary voltage radial PCB
Transformers, in use in or near commercial buildings, and lower
secondary voltage network PCB Transformers not located in sidewalk
vaults in or near commercial buildings (network transformers with
secondary voltages below 480 volts) that have not been removed from
service as provided in paragraph (a)(1)(iv)(B) of this section, must be
equipped with electrical protection to avoid transformer ruptures caused
by high current faults. As of February 25, 1991, all lower secondary
voltage radial PCB Transformers, in use in or near commercial buildings,
must be equipped with electrical protection to avoid transformer
ruptures caused by high current faults.
(A) Current-limiting fuses or other equivalent technology must be
used to detect sustained high current faults and provide for the
complete deenergization of the transformer (within several hundredths of
a second in the case of higher secondary voltage radial PCB Transformers
and within tenths of a second in the case of lower secondary voltage
network PCB Transformers), before transformer rupture occurs. Lower
secondary voltage radial PCB Transformers must be equipped with
electrical protection as provided in paragraph (a)(1)(iv)(E) of this
section. The installation, setting, and maintenance of current-limiting
fuses or other equivalent technology to 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
[[Page 182]]
(a)(1)(iv)(A) of this section and which are not located in sidewalk
vaults, must register in writing those transformers with the EPA
Regional Administrator in the appropriate region. The information
required to be provided in writing to the Regional Administrator
includes:
(1) The specific location of the PCB Transformer(s).
(2) The address(es) of the building(s) and the physical location of
the PCB Transformer(s) on the building site(s).
(3) The identification number(s) of the PCB Transformer(s).
(D) As of October 1, 1993, all lower secondary voltage network PCB
Transformers located in sidewalk vaults (network transformers with
secondary voltages below 480 volts) in use near commercial buildings
must be removed from service.
(E) As of February 25, 1991, all lower secondary voltage radial PCB
Transformers must be equipped with electrical protection, such as
current-limiting fuses or other equivalent technology, to detect
sustained high current faults and provide for the complete
deenergization of the transformer or complete deenergization of the
faulted phase of the transformer within several hundredths of a second.
The installation, setting, and maintenance of current-limiting fuses or
other equivalent technology to avoid PCB Transformer ruptures from
sustained high current faults must be completed in accordance with good
engineering practices.
(v) As of October 1, 1990, all radial PCB Transformers with higher
secondary voltages (480 volts and above, including 480/277 volt systems)
in use in or near commercial buildings must, in addition to the
requirements of paragraph (a)(1)(iv)(A) of this section, be equipped
with protection to avoid transformer ruptures caused by sustained low
current faults.
(A) Pressure and temperature sensors (or other equivalent technology
which has been demonstrated to be effective in early detection of
sustained low current faults) must be used in these transformers to
detect sustained low current faults.
(B) Disconnect equipment must be provided to insure complete
deenergization of the transformer in the event of a sensed abnormal
condition (e.g., an overpressure or overtemperature condition in the
transformer), caused by a sustained low current fault. The disconnect
equipment must be configured to operate automatically within 30 seconds
to 1 minute of the receipt of a signal indicating an abnormal condition
from a sustained low current fault, or can be configured to allow for
manual deenergization from a manned on-site control center upon the
receipt of an audio or visual signal indicating an abnormal condition
caused by a sustained low current fault. Manual deenergization from a
manned on-site control center must occur within 1 minute of the receipt
of the audio or visual signal indicating an abnormal condition caused by
a sustained low current fault. If automatic operation is selected and a
circuit breaker is utilized for disconnection, it must also have the
capability to be manually opened if necessary.
(C) The enhanced electrical protective system required for the
detection of sustained low current faults and the complete and rapid
deenergization of transformers must be properly installed, maintained,
and set sensitive enough (in accordance with good engineering practices)
to detect sustained low current faults and allow for rapid and total
deenergization prior to PCB Transformer rupture (either violent or non
violent rupture) and release of PCBs.
(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
[[Page 183]]
no later than 30 days after it is identified as such. This requirement
does not apply to transformer owners who have previously registered with
the EPA PCB Transformers located at the same address as the transformer
that they assumed to be PCB-Contaminated and later determined to be a
PCB Transformer.
(2) A person who takes possession of a PCB Transformer after
December 28, 1998 is not required to register or re-register the
transformer with the EPA.
(B) Any person submitting a registration under this section must
include:
(1) Company name and address.
(2) Contact name and telephone number.
(3) Address where these transformers are located. For mobile sources
such as ships, provide the name of the ship.
(4) Number of PCB Transformers and the total weight in kilograms of
PCBs contained in the transformers.
(5) Whether any transformers at this location contain flammable
dielectric fluid (optional).
(6) Signature of the owner, operator, or other authorized
representative certifying the accuracy of the information submitted.
(C) A transformer owner must retain a record of each PCB
Transformer's registration (e.g., a copy of the registration and the
return receipt signed by EPA) with the inspection and maintenance
records required for each PCB Transformer under paragraph (a)(1)(xii)(I)
of this section.
(D) A transformer owner must comply with all requirements of
paragraph (a)(1)(vi)(A) of this section to continue the PCB-
Transformer's authorization for use, or storage for reuse, pursuant to
this section and TSCA section 6(e)(2)(B).
(vii) As of December 1, 1985, PCB Transformers in use in or near
commercial buildings must be registered with building owners. For PCB
Transformers located in commercial buildings, PCB Transformer owners
must register the transformers with the building owner of record. For
PCB Transformers located near commercial buildings, PCB Transformer
owners must register the transformers with all owners of buildings
located within 30 meters of the PCB Transformer(s). Information required
to be provided to building owners by PCB Transformer owners includes but
is not limited to:
(A) The specific location of the PCB Transformer(s).
(B) The principal constituent of the dielectric fluid in the
transformer(s) (e.g., PCBs, mineral oil, or silicone oil).
(C) The type of transformer installation (e.g., 208/120 volt
network, 208/120 volt radial, 208 volt radial, 480 volt network, 480/277
volt network, 480 volt radial, 480/277 volt radial).
(viii) As of December 1, 1985, combustible materials, including, but
not limited to paints, solvents, plastics, paper, and sawn wood must not
be stored within a PCB Transformer enclosure (i.e., in a transformer
vault or in a partitioned area housing a transformer); within 5 meters
of a transformer enclosure, or, if unenclosed (unpartitioned), within 5
meters of a PCB Transformer.
(ix) A visual inspection of each PCB Transformer (as defined in the
definition of ``PCB Transformer'' under Sec. 761.3) in use or stored
for reuse shall be performed at least once every 3 months. These
inspections may take place any time during the 3-month periods: January-
March, April-June, July-September, and October-December as long as there
is a minimum of 30 days between inspections. The visual inspection must
include investigation for any leak of dielectric fluid on or around the
transformer. The extent of the visual inspections will depend on 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
[[Page 184]]
and inspected daily to verify containment of the leak. Trenches, dikes,
buckets, and pans are examples of proper containment measures.
(xi) If a PCB Transformer is involved in a fire-related incident,
the owner of the transformer must immediately report the incident to the
National Response Center (toll-free 1-800-424-8802; in Washington, DC
202-426-2675). A fire-related incident is defined as any incident
involving a PCB Transformer which involves the generation of sufficient
heat and/or pressure (by any source) to result in the violent or non-
violent rupture of a PCB Transformer and the release of PCBs.
Information must be provided regarding the type of PCB Transformer
installation involved in the fire-related incident (e.g., high or low
secondary voltage network transformer, high or low secondary voltage
simple radial system, expanded radial system, primary selective system,
primary loop system, or secondary selective system or other systems) and
the readily ascertainable cause of the fire-related incident (e.g., high
current fault in the primary or secondary or low current fault in
secondary). The owner of the PCB Transformer must also take measures as
soon as practically and safely possible to contain and control any
potential releases of PCBs and incomplete combustion products into
water. These measures include, but are not limited to:
(A) The blocking of all floor drains in the vicinity of the
transformer.
(B) The containment of water runoff.
(C) The control and treatment (prior to release) of any water used
in subsequent cleanup operations.
(xii) Records of inspection and maintenance history shall be
maintained at least 3 years after disposing of the transformer and shall
be made available for inspection, upon request by EPA. Such records
shall contain the following information for each PCB Transformer:
(A) Its location.
(B) The date of each visual inspection and the date that leak was
discovered, if different from the inspection date.
(C) The person performing the inspection.
(D) The location of any leak(s).
(E) An estimate of the amount of dielectric fluid released from any
leak.
(F) The date of any cleanup, containment, repair, or replacement.
(G) A description of any cleanup, containment, or repair performed.
(H) The results of any containment and daily inspection required for
uncorrected active leaks.
(I) Record of the registration of PCB Transformer(s).
(J) Records of transfer of ownership in compliance with Sec.
761.180(a)(2)(ix).
(xiii) A reduced visual inspection frequency of at least once every
12 months applies to PCB Transformers that utilize either of the
following risk reduction measures. These inspections may take place any
time during the calendar year as long as there is a minimum of 180 days
between inspections.
(A) A PCB Transformer which has impervious, undrained, secondary
containment capacity of at least 100 percent of the total dielectric
fluid volume of all transformers so contained or
(B) A PCB Transformer which has been tested and found to contain
less than 60,000 ppm PCBs (after 3 months of in service use if the
transformer has been serviced for purposes of reducing the PCB
concentration).
(xiv) An increased visual inspection frequency of at least once
every week applies to any PCB Transformer in use or stored for reuse
which poses an exposure risk to food or feed. The user of a PCB
Transformer posing an exposure 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:
[[Page 185]]
(A) Report fire-related incidents, effective immediately after
discovery.
(B) Mark the PCB transformer within 7 days after discovery.
(C) Mark the vault door, machinery room door, fence, hallway or
other means of access to the PCB Transformer within 7 days after
discovery.
(D) Register the PCB Transformer in writing with the building owner
within 30 days of discovery.
(E) Install electrical protective equipment on a radial PCB
Transformer and a non-sidewalk vault, lower secondary voltage network
PCB Transformer in or near a commercial building within 18 months of
discovery or by October 1, 1990, whichever is later.
(F) Remove a non-sidewalk vault, lower secondary voltage network PCB
Transformer in or near a commercial building, if electrical protective
equipment is not installed, within 18 months of discovery or by October
1, 1993, whichever is later.
(G) Remove a lower secondary voltage network PCB Transformer located
in a sidewalk vault in or near a commercial building, within 18 months
of discovery or by October 1, 1993, whichever is later.
(H) Retrofill and reclassify a radial PCB Transformer or a lower or
higher secondary voltage network PCB Transformer, located in other than
a sidewalk vault in or near a commercial building, within 18 months or
by October 1, 1990, whichever is later. This is an option in lieu of
installing electrical protective equipment on a radial or lower
secondary voltage network PCB Transformer located in other than a
sidewalk vault or of removing a higher secondary voltage network PCB
Transformer or a lower secondary voltage network PCB Transformer,
located in a sidewalk vault, from service.
(I) Retrofill and reclassify a lower secondary voltage network PCB
Transformer, located in a sidewalk vault, in or near a commercial
building within 18 months or by October 1, 1993, whichever is later.
This is an option in lieu of installing electrical protective equipment
or removing the transformer from service.
(J) Retrofill and reclassify a higher secondary voltage network PCB
Transformer, located in a sidewalk vault, in or near a commercial
building within 18 months or by October 1, 1990, whichever is later.
This is an option in lieu of other requirements.
(2) Servicing conditions. (i) Transformers classified as PCB-
Contaminated Electrical Equipment (as defined in the definition of
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be
serviced (including rebuilding) only with dielectric fluid containing
less than 500 ppm PCB.
(ii) Any servicing (including rebuilding) of PCB Transformers (as
defined in the definition of ``PCB Transformer'' under Sec. 761.3) that
requires the removal of the transformer coil from the transformer casing
is prohibited. PCB Transformers may be serviced (including topping off)
with dielectric fluid at any PCB concentration.
(iii) PCBs removed during any servicing activity must be captured
and either reused as dielectric fluid or disposed of in accordance with
the requirements of Sec. 761.60. PCBs from PCB Transformers must not be
mixed with or added to dielectric fluid from PCB-Contaminated Electrical
Equipment.
(iv) Regardless of its PCB concentration, dielectric fluids
containing less than 500 ppm PCB that are mixed with fluids that contain
500 ppm or greater PCB must not be used as dielectric fluid in any
electrical equipment. The entire mixture of dielectric fluid must be
considered to be greater than 500 ppm PCB and must be disposed of in an
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.
[[Page 186]]
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
----------------------------------------------------------------------------------------------------------------
(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
[[Page 187]]
and distributed in commerce for purposes of servicing these transformers
in a manner other than a totally enclosed manner subject to the
following conditions:
(1) Use restrictions. After July 1, 1986, use of railroad
transformers that contain dielectric fluids with a PCB concentration
1,000 ppm is prohibited.
(2) Servicing restrictions. (i) If the coil is removed from the
casing of a railroad transformer (e.g., the transformer is rebuilt),
after January 1, 1982, the railroad transformer may not be refilled with
dielectric fluid containing a PCB concentration greater than 50 ppm;
(ii) After January 1, 1984, railroad transformers may only be
serviced with dielectric fluid containing less than 1000 ppm PCB, except
as provided in paragraph (b)(2)(i) of this section;
(iii) Dielectric fluid may be filtered through activated carbon or
otherwise industrially processed for the purpose of reducing the PCB
concentration in the fluid;
(iv) Any PCB dielectric fluid that is used to service PCB railroad
transformers must be stored in accordance with the storage for disposal
requirements of Sec. 761.65;
(v) After July 1, 1979, processing and distribution in commerce of
PCBs for purposes of servicing railroad transformers is permitted only
for persons who are granted an exemption under TSCA section 6(e)(3)(B).
(vi) A PCB Transformer may be converted to a PCB-Contaminated
Transformer or to a non-PCB Transformer by draining, refilling, and/or
otherwise servicing the railroad transformer. In order to reclassify,
the railroad transformer's dielectric fluid must contain less than 500
ppm (for conversion to PCB-Contaminated Transformer) or less than 50 ppm
PCB (for conversion to a non-PCB Transformer) after a minimum of three
months of inservice use subsequent to the last servicing conducted for
the purpose of reducing the PCB concentration in the transformer.
(c) Use in mining equipment. After January 1, 1982, PCBs may be used
in mining equipment only at a concentration level of <50 ppm.
(d) Use in heat transfer systems. After July 1, 1984, PCBs may be
used in heat transfer systems only at a concentration level of <50 ppm.
Heat transfer systems that were in operation after July 1, 1984, with a
concentration level of <50 ppm PCBs may be serviced to maintain a
concentration level of <50 ppm PCBs. Heat transfer systems may only be
serviced with fluids containing <50 ppm PCBs.
(e) Use in hydraulic systems. After July 1, 1984, PCBs may be used
in hydraulic systems only at a concentration level of <50 ppm. Hydraulic
systems that were in operation after July 1, 1984, with a concentration
level of <50 ppm PCBs may be serviced to maintain a concentration level
of <50 ppm PCBs. Hydraulic systems may only be serviced with fluids
containing <50 ppm PCBs.
(f) Use in carbonless copy paper. Carbonless copy paper containing
PCBs may be used in a manner other than a totally enclosed manner
indefinitely.
(g) [Reserved]
(h) Use in and servicing of electromagnets, switches and voltage
regulators. PCBs at any concentration may be used in electromagnets,
switches (including sectionalizers and motor starters), and voltage
regulators and may be used for purposes of servicing this equipment
(including rebuilding) for the remainder of their useful lives, subject
to the following conditions:
(1) Use conditions. (i) After October 1, 1985, the use and storage
for reuse of 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
[[Page 188]]
the voltage regulator and the release of PCBs.
(C) The owner of the voltage regulator must inspect it in accordance
with the requirements of paragraphs (a)(1)(ix), (a)(1)(xiii), and
(a)(1)(xiv) of this section that apply to PCB Transformers.
(D) The owner of the voltage regulator must comply with the
recordkeeping and reporting requirements at Sec. 761.180.
(iii) The owner of a voltage regulator that assumes it contains <500
ppm PCBs as provided in Sec. 761.2, and discovers by testing that it is
contaminated at =500 ppm PCBs, must comply with paragraph
(h)(1)(ii)(A) of this section 7 days after the discovery, and paragraphs
(h)(1)(ii)(B), (h)(1)(ii)(C), and (h)(1)(ii)(D) of this section
immediately upon discovery.
(2) Servicing conditions. (i) Servicing (including rebuilding) any
electromagnet, switch, or voltage regulator with a PCB concentration of
500 ppm or greater which requires the removal and rework of the internal
components is prohibited.
(ii) Electromagnets, switches, and voltage regulators classified as
PCB-Contaminated Electrical Equipment (as defined in the definition of
``PCB-Contaminated Electrical Equipment'' under Sec. 761.3) may be
serviced (including rebuilding) only with dielectric fluid containing
less than 500 ppm PCB.
(iii) PCBs removed during any servicing activity must be captured
and either reused as dielectric fluid or disposed of in accordance with
the requirements of Sec. 761.60. PCBs from electromagnets switches, and
voltage regulators with a PCB concentration of at least 500 ppm must not
be mixed with or added to dielectric fluid from PCB-Contaminated
Electrical Equipment.
(iv) Regardless of its PCB concentration, dielectric fluids
containing less than 500 ppm PCB that are mixed with fluids that contain
500 ppm or greater PCB must not be used as dielectric fluid in any
electrical equipment. The entire mixture of dielectric fluid must be
considered to be greater than 500 ppm PCB and must be disposed of in an
incinerator that meets the requirements of Sec. 761.70.
(v) You may reclassify an electromagnet, switch, or voltage
regulator that has been tested and determined to have a concentration of
=500 ppm PCBs to PCB-Contaminated status (=50 but
<500 ppm) or to non-PCB status (<50 ppm), and you may reclassify a PCB-
Contaminated electromagnet, switch, or voltage regulator that has been
tested and determined to have a concentration of