[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2025 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 40
Protection of Environment
________________________
Parts 723 to 789
Revised as of July 1, 2025
Containing a codification of documents of general
applicability and future effect
As of July 1, 2025
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos
The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR) as
the official codification of Federal regulations established
under the Federal Register Act. Under the provisions of 44
U.S.C. 1507, the contents of the CFR, a special edition of the
Federal Register, shall be judicially noticed. The CFR is
prima facie evidence of the original documents published in
the Federal Register (44 U.S.C. 1510).
It is prohibited to use NARA's official seal and the stylized Code
of Federal Regulations logo on any republication of this
material without the express, written permission of the
Archivist of the United States or the Archivist's designee.
Any person using NARA's official seals and logos in a manner
inconsistent with the provisions of 36 CFR part 1200 is
subject to the penalties specified in 18 U.S.C. 506, 701, and
1017.
Use of ISBN Prefix
This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of
the 0-16 ISBN prefix is for U.S. Government Publishing Office
Official Editions only. The Superintendent of Documents of the
U.S. Government Publishing Office requests that any reprinted
edition clearly be labeled as a copy of the authentic work
with a new ISBN.
U . S . G O V E R N M E N T P U B L I S H I N G O F F I C E
------------------------------------------------------------------
U.S. Superintendent of Documents Washington, DC
20402-0001
http://bookstore.gpo.gov
Phone: toll-free (866) 512-1800; DC area (202) 512-1800
[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 517
Alphabetical List of Agencies Appearing in the CFR...... 537
List of CFR Sections Affected........................... 547
[[Page iv]]
----------------------------
Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 40 CFR 723.50 refers
to title 40, part 723,
section 50.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, July 1, 2025), consult the ``List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
amendments to existing regulations in the CFR. These OMB numbers are
placed as close as possible to the applicable recordkeeping or reporting
requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
the revision date stated on the cover of each volume are not carried.
Code users may find the text of provisions in effect on any given date
in the past by using the appropriate List of CFR Sections Affected
(LSA). For the convenience of the reader, a ``List of CFR Sections
Affected'' is published at the end of each CFR volume. For changes to
the Code prior to the LSA listings at the end of the volume, consult
previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
The term ``[Reserved]'' is used as a place holder within the Code of
Federal Regulations. An agency may add regulatory information at a
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used
editorially to indicate that a portion of the CFR was left vacant and
not dropped in error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is adequately summarized in the preamble
of the final rule and is available to the extent necessary to afford
fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed as
an approved incorporation by reference, please contact the agency that
issued the regulation containing that incorporation. If, after
contacting the agency, you find the material is not available, please
notify the Director of the Federal Register, National Archives and
Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001,
or email [email protected].
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Authorities
and Rules. A list of CFR titles, chapters, subchapters, and parts and an
alphabetical list of agencies publishing in the CFR are also included in
this volume.
[[Page vii]]
An index to the text of ``Title 3--The President'' is carried within
that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
volume, contact the issuing agency. The issuing agency's name appears at
the top of odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202-741-6000
or write to the Director, Office of the Federal Register, National
Archives and Records Administration, 8601 Adelphi Road, College Park, MD
20740-6001 or e-mail [email protected].
SALES
The Government Publishing Office (GPO) processes all sales and
distribution of the CFR. For payment by credit card, call toll-free,
866-512-1800, or DC area, 202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or
fax your order to 202-512-2104, 24 hours a day. For payment by check,
write to: U.S. Government Publishing Office Superintendent of Documents,
P.O. Box 37082, Washington, DC 20013-7082.
ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of
CFR Sections Affected), The United States Government Manual, the Federal
Register, Public Laws, Compilation of Presidential Documents and the
Privacy Act Compilation are available in electronic format via
www.govinfo.gov. For more information, contact the GPO Customer Contact
Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-
512-1800 (toll-free). E-mail, [email protected].
The Office of the Federal Register also offers a free service on the
National Archives and Records Administration's (NARA) website for public
law numbers, Federal Register finding aids, and related information.
Connect to NARA's website at www.archives.gov/federal-register.
The eCFR is a regularly updated, unofficial editorial compilation of
CFR material and Federal Register amendments, produced by the Office of
the Federal Register and the Government Publishing Office. It is
available at www.ecfr.gov.
Oliver A. Potts,
Director,
Office of the Federal Register
July 1, 2025
[[Page ix]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty-seven
volumes. The parts in these volumes are arranged in the following order:
Parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-
52.2019), part 52 (52.2020-end of part 52), parts 53-59, part 60 (60.1-
60.499), part 60 (60.500-end of part 60, sections), part 60
(Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63
(63.6580-63.8830), part 63 (63.8980-end of part 63), parts 64-71, parts
72-78, parts 79-80, part 81, parts 82-84, parts 85-96, parts 97-99,
parts 100-135, parts 136-149, parts 150-189, parts 190-259, parts 260-
265, parts 266-299, parts 300-399, parts 400-424, parts 425-699, parts
700-722, parts 723-789, parts 790-999, parts 1000-1059, and part 1060 to
end. The contents of these volumes represent all current regulations
codified under this title of the CFR as of July 1, 2025.
Chapter I--Environmental Protection Agency appears in all thirty-
seven volumes. OMB control numbers for title 40 appear in Sec. 9.1 of
this chapter.
Chapters IV-IX--Regulations issued by the Environmental Protection
Agency and Department of Justice, Council on Environmental Quality,
Chemical Safety and Hazard Investigation Board, Environmental Protection
Agency and Department of Defense; Uniform National Discharge Standards
for Vessels of the Armed Forces, Gulf Coast Ecosystem Restoration
Council, and the Federal Permitting Improvement Steering Council appear
in volume thirty-seven.
For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of
Federal Regulations publication program is under the direction of John
Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 723 to 789)
--------------------------------------------------------------------
Part
chapter i--Environmental Protection Agency (Continued)...... 723
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
--------------------------------------------------------------------
Editorial Note: Nomenclature changes to chapter I appear at 65 FR
47324, 47325, Aug. 2, 2000; 66 FR 34375, 34376, June 28, 2001.
SUBCHAPTER R--TOXIC SUBSTANCES CONTROL ACT
Part Page
723 Premanufacture notification exemptions...... 5
725 Reporting requirements and review processes
for microorganisms...................... 27
745 Lead-based paint poisoning prevention in
certain residential structures.......... 71
747 Metalworking fluids......................... 139
749 Water treatment chemicals................... 144
750 Procedures for rulemaking under section 6 of
the Toxic Substances Control Act........ 147
751 Regulation of certain chemical substances
and mixtures under section 6 of the
Toxic Substances Control Act............ 153
761 Polychlorinated biphenyls (PCBs)
manufacturing, processing, distribution
in commerce, and use prohibitions....... 234
763 Asbestos.................................... 374
766 Dibenzo-para-dioxins/dibenzofurans.......... 469
767-769
[Reserved]
770 Formaldehyde standards for composite wood
products................................ 479
771-789
[Reserved]
[[Page 5]]
SUBCHAPTER R_TOXIC SUBSTANCES CONTROL ACT
PART 723_PREMANUFACTURE NOTIFICATION EXEMPTIONS--Table of Contents
Subpart A [Reserved]
Subpart B_Specific Exemptions
Sec.
723.50 Chemical substances manufactured in quantities of 10,000
kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
723.175 Chemical substances used in or for the manufacture or processing
of instant photographic and peel-apart film articles.
723.250 Polymers.
Authority: 15 U.S.C. 2604.
Subpart A [Reserved]
Subpart B_Specific Exemptions
Sec. 723.50 Chemical substances manufactured in quantities of
10,000 kilograms or less per year, and chemical substances with low
environmental releases and human exposures.
(a) Purpose and scope. (1) This section grants an exemption from the
premanufacture notice requirements of section 5(a)(1)(A)(i) of the Toxic
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of:
(2) To manufacture a new chemical substance under the terms of this
exemption a manufacturer must:
(i) Submit a notice of intent to manufacture 30 days before
manufacture begins, as required under paragraph (e) of this section.
(ii) Comply with all other provisions of this section.
(3) This section does not apply to microorganisms subject to part
725 of this chapter.
(b) Definitions. The following definitions apply to this subpart.
(1) Act means the Toxic Substances Control Act (15 U.S.C. 2601 et
seq).
(2) Consumer means a private individual who uses a chemical
substance or any product containing the chemical substance in or around
a permanent or temporary household or residence, during recreation, or
for any personal use or enjoyment.
(3) Environment has the same meaning as in section 3 of the Act (15
U.S.C. 2602).
(4) Environmental transformation product means any chemical
substance resulting from the action of environmental processes on a
parent compound that changes the molecular identity of the parent
compound.
(5) Metabolite means a chemical entity produced by one or more
enzymatic or nonenzymatic reactions as a result of exposure of an
organism to a chemical substance.
(6) Serious acute effects means human disease processes or other
adverse effects that have short latency periods for development, result
from short-term exposure, or are a combination of these factors and that
are likely to result in death, severe or prolonged incapacitation,
disfigurement, or severe or prolonged loss of the ability to use a
normal bodily or intellectual function with a consequent impairment of
normal activities.
(7) Serious chronic effects means human disease processes or other
adverse effects that have long latency periods for development, result
from long-term exposure, are long-term illnesses, or are a combination
of these factors and that are likely to result in death, severe or
prolonged incapacitation, disfigurement, or severe or prolonged loss of
the ability to use a normal bodily or intellectual function with a
consequent impairment of normal activities.
(8) Significant environmental effects means:
(i) Any irreversible damage to biological, commercial, or
agricultural resources of importance to society;
(ii) Any reversible damage to biological, commercial, or
agricultural resources of importance to society if the 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
[[Page 6]]
identified as such by the Secretary of the Interior in accordance with
the Endangered Species Act, as amended (16 U.S.C. 1531).
(9) Site means a contiguous property unit. Property divided only by
a public right-of-way is one site. There may be more than one
manufacturing plant on a single site.
(10) The terms byproduct, EPA, importer, impurity, known to or
reasonably ascertainable, manufacture, manufacturer, new chemical
substance, person, possession or control, and test data have the same
meanings as in Sec. 720.3 of this chapter.
(11) PFAS or per- and poly-fluoroalkyl substance means a chemical
substance that contains at least one of these three structures:
(i) R-(CF2)-CF(R[min])R[sec], where both the CF2 and CF moieties are
saturated carbons;
(ii) R-CF2OCF2-R[min], where R and R[min] can either be F, O, or
saturated carbons; or
(iii) CF3C(CF3)R[min]R[sec], where R[min] and R[sec] can either be F
or saturated carbons.
(12) PBT chemical substance means a chemical substance possessing
characteristics of persistence (P) in the environment, accumulation in
biological organisms (bioaccumulation (B)), and toxicity (T) resulting
in potential risks to humans and ecosystems. For more information on
EPA's Policy on new chemical substances that are PBTs, see EPA's 1999
policy statement (64 FR 60194, November 4, 1999 (FRL-6097-7)).
(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
[[Page 7]]
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 paragraph
(c)(1) or (2) of this section, if EPA determines, in accordance with
paragraph (g) of this section, that the substance, any reasonably
anticipated metabolites, environmental transformation products, or
byproducts of the substance, or any reasonably anticipated impurities in
the substance, under anticipated conditions of manufacture, processing,
distribution in commerce, use, or disposal of the new chemical
substance:
(1) May cause:
(i) Serious acute (lethal or sublethal) effects;
(ii) Serious chronic (including carcinogenic and teratogenic)
effects; or
(ii) Significant environmental effects.
(2) Or is:
(i) A PFAS.
(ii) A PBT chemical substance with anticipated environmental
releases and potentially unreasonable exposures to humans or
environmental organisms.
(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
[[Page 8]]
known or not readily available to the manufacturer. To assist in
reporting this information, manufacturers may obtain a copy of EPA's
Guidance for Reporting Occupational Exposure and Environmental Release
Information under 40 CFR 723.50, available from the Environmental
Assistance Division at the address listed in paragraph (e)(1) of this
section. Where worker exposure and environmental release information is
not supplied by the manufacturer, EPA will generally apply ``bounding
estimates'' (i.e., exposure estimates higher than those incurred by
persons in the population with the highest exposure) to account for
uncertainties in actual exposure and release scenarios.
(ix) Type and category of notice. The manufacturer must clearly
indicate on the first page of the PMN form that the submission is a
``TSCA section 5(h)(4) exemption notice,'' and must indicate whether the
notice is being submitted under paragraph (c)(1) or (c)(2) of this
section. Manufacturers of chemical substances that qualify for an
exemption under both paragraph (c)(1) and (c)(2) of this section may
apply for either exemption, but not both.
(x) Test data (Sec. 720.50).
(xi) Certification. In addition to the certifications required in
EPA form 7710-25, the following certifications shall be included in
notices under this section. The manufacturer must certify that:
(A) The manufacturer intends to manufacture the new chemical
substance for commercial purposes, other than in small quantities solely
for research and development, under the terms of this section.
(B) The manufacturer is familiar with the terms of this section and
will comply with those terms.
(C) The new chemical substance for which the notice is submitted
meets all applicable exemption conditions.
(D) For substances manufactured under paragraph (c)(1) of this
section, the manufacturer intends to commence manufacture of the
exempted substance for commercial purposes within 1 year of the date of
the expiration of the 30-day review period.
(xii) Sanitized copy of notice. (A) The manufacturer must make all
claims of confidentiality in accordance with paragraph (l) of this
section. If any information is claimed confidential, the manufacturer
must submit a second copy of the notice, with all information claimed as
confidential deleted, in accordance with paragraph (l)(3) of this
section.
(B) If the manufacturer does not provide the second copy, the
submission will be considered incomplete.
(xiii) Safety Data Sheet (Sec. 720.45(i)).
(xiv) Physical and chemical properties and environmental fate
characteristics (Sec. 720.45(j)).
(3) Incomplete notices. EPA will conduct a pre-screen of the notice,
typically taking 2-3 days and according to the criteria under paragraph
(e)(2) of this section. If EPA concludes that the notice is incomplete,
EPA will notify the submitter and the review period will not begin. Once
the submitter corrects the errors or incomplete submission according to
the requirements provided by EPA and re-submits the notice to EPA, the
review period will begin. If EPA does not identify errors or determine
the notice to be incomplete during screening, the review period will
begin on the date EPA received the complete notice.
(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
[[Page 9]]
first exemption holder that it must, within 21 days of its receipt of
EPA's notice, either:
(A) Provide a new certification that it has commenced, or that it
will commence, manufacture of the new chemical substance under this
section within 1 year of the expiration of its exemption review period;
or
(B) Withdraw its exemption for the new chemical substance.
(ii) If the first exemption holder does not respond to the EPA's
notice under paragraph (f)(2)(i) of this section within the prescribed
time period, EPA shall issue a notice of ineligibility to the first
exemption holder under the provisions of paragraph (h)(2) of this
section.
(g) Review period. (1) EPA will review the notice submitted under
paragraph (e) of this section to determine whether manufacture of the
new chemical substance is eligible for the exemption. The review period
will run for 30 days from the date EPA receives a complete notice. 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) No person submitting a notice under paragraph (e) of this
section may manufacture the new chemical substance until EPA notifies
the submitter that the new chemical substance meets the terms of 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,
[[Page 10]]
and use in accordance with the terms of this section.
(v) If the Agency determines that manufacture of the new chemical
substance does not meet the terms of this section and that the
manufacturer did not act with due diligence and in good faith to meet
the terms of this section, the manufacturer must cease any continuing
manufacture, processing, distribution in commerce, and use of the new
chemical substance within 7 days of the written notification under
paragraph (h)(2)(iii) of this section. The manufacturer may not resume
manufacture, processing, distribution in commerce, and use of the new
chemical substance until it submits a notice under section 5(a)(1) of
the Act and part 720 of this chapter and EPA has made one of the five
determinations as set forth in section 5(a)(3) of the Act and taken the
action required in association with that determination.
(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 submit that information to EPA within ten days of
receiving the new information, but no later than five days before the
end of the applicable review period. The new information must be
submitted electronically to EPA via CDX and 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 or e-mail and submit the new
information electronically to EPA via CDX.
(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).
[[Page 11]]
(3) The annual production volume of chemical substances manufactured
under paragraph (c)(1) of this section for which the manufacturer
designated a binding annual production volume pursuant to paragraph
(e)(2)(vi) of this section must not exceed that designated volume.
(4) Any person who manufactures a new chemical substance under
paragraph (c)(1) or (c)(2) of this section must comply with the
provisions of this section, including submission of a new notice under
paragraph (e) of this section, before:
(i) Manufacturing the new chemical substance at a site that was not
approved in a previous exemption notice for the substance, except as
provided in paragraph (j)(6) of this section.
(ii) Manufacturing the new chemical substance for a use that was not
approved in a previous exemption notice for the substance.
(iii) Manufacturing the new chemical substance without employing the
human exposure and environmental release controls approved in a previous
exemption notice for the substance.
(iv) Manufacturing the new chemical substance in a physical form
different than that physical form approved in a previous exemption
notice for the substance and which form may increase the human exposure
to, or environmental release of, the new chemical substance over those
exposures or releases resulting from the physical form approved in the
previous notice.
(v) Manufacturing the chemical substance in annual production
volumes above any volume designated by the manufacturer as binding under
paragraph (e)(2)(vi) of this section in a previous exemption notice for
the substance.
(5) In an exemption notice informing EPA of a change in site, use,
or worker protection, or environmental release controls, the
manufacturer is not required to provide all of the same information
submitted to EPA in a previous exemption notice for that chemical
substance. The new exemption notice, however, must indicate the identity
of the new chemical substance; the manufacturer's name; the name and
telephone number of a technical contact; and location of the new site,
new worker protection or environmental release controls, and new use
information. The notice must also include the EPA-designated exemption
number assigned to 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
[[Page 12]]
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 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. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.
(m) Exemptions granted under superseded regulations. Manufacturers
holding exemptions granted under the superseded requirements of this
section (as in effect on May 26, 1995) shall either continue to comply
with those requirements (including the production volume limit) or apply
for a new exemption pursuant to this section. EPA will not accept
requests to amend exemptions granted under the superseded requirements;
manufacturers wishing to amend such exemptions must submit a new
exemption under paragraph (e) of this section. If a new exemption for a
new chemical substance is granted under this exemption to the
manufacturer holding an exemption under the superseded requirements, the
exemption under the superseded requirements for such substance shall be
void.
(n) Recordkeeping. (1) A manufacturer of a new chemical substance
under paragraph (c) of this section must maintain the records described
in this paragraph at the manufacturing site or site of importation for a
period of 5 years after their preparation.
[[Page 13]]
(2) The records must include the following to demonstrate compliance
with this section:
(i) Records of annual production volume and import volume.
(ii) Records documenting compliance with the applicable requirements
and restrictions of paragraphs (c), (e), (f), (h), (i), (j), and (k) of
this section.
(3) Any person who manufactures a new chemical substance under the
terms of this section must, upon request of a duly designated
representative of EPA, permit such person at all reasonable times to
have access to and to copy records kept under paragraph (n)(2) of this
section.
(4) The manufacturer must submit the records listed in paragraph
(n)(2) of this section to EPA upon request. Manufacturers must provide
these records within 15 working days of receipt of such request.
(o) Compliance. (1) Failure to comply with any provision of this
section is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Submitting materially misleading or false information in
connection with the requirements of any provision of this section is a
violation of this section and therefore a violation of section 15 of the
Act (15 U.S.C. 2614).
(3) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
(4) EPA may seek to enjoin the manufacture or processing of a
chemical substance in violation of this section, or act to seize any
chemical substance manufactured or processed in violation of this
section, or take other action under the authority of section 7 of the
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 1616).
(p) Subject to a significant new use rule or listed on TSCA
Inventory. If a significant new use rule is proposed or finalized in
part 721 of this chapter for a chemical substance described by a generic
chemical name or if the specific chemical identity of a chemical
substance is listed on the confidential portion of the TSCA Inventory,
EPA may make reasonable efforts to notify any persons who may also
manufacture the same chemical substance under the terms of this section.
A disclosure to a person with an approved exemption under this section
that the chemical substance is subject to a proposed or final rule in
part 721 of this chapter or is listed on the confidential portion of the
TSCA Inventory will not be considered public disclosure of confidential
business information under section 14 of the Act. The notification will
inform manufacturers subject to the terms of this section that the
chemical substance is subject to a proposed or final significant new use
rule under section 5(a)(2) of the Act or is listed on the TSCA
Inventory, and identify the proposed or final section in subpart E of
part 721 of this chapter that pertains to the chemical substance or the
generic name for that substance listed on the public portion of the TSCA
Inventory, as applicable.
[60 FR 16346, Mar. 29, 1995, as amended at 60 FR 34465, July 3, 1995; 62
FR 17932, Apr. 11, 1997; 64 FR 31989, June 15, 1999; 71 FR 33642, June
12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012; 78 FR
72828, Dec. 4, 2013; 80 FR 42746, July 20, 2015; 87 FR 39769, July 5,
2022; 88 FR 37173, June 7, 2023; 89 FR 102798, Dec. 18, 2024]
Editorial Note: At 89 FR 102798, Dec. 18, 2024, Sec. 723.50 was
amended in part by revising paragraph (a)(1). However, the set-out text
included revised text for the introductory paragraph of (a)(1), and not
the subparagraphs.
Sec. 723.175 Chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles.
(a) Purpose and scope. (1) This section grants an exemption from the
premanufacture notice requirements of section 5(a)(1)(A) of the Toxic
Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture and
processing of new chemical substances used in or for the manufacture or
processing of instant photographic and peel-apart film articles. This
section does not apply to microorganisms subject to part 725 of this
chapter.
(2) To manufacture a new chemical substance under the terms of this
exemption, a manufacturer of instant photographic or peel-apart film
articles must:
(i) Submit an exemption notice when manufacture begins under
paragraph (i) of this section.
[[Page 14]]
(ii) Comply with certain requirements to limit exposure to the new
chemical substance under paragraphs (e) through (h) of this section.
(iii) Comply with all recordkeeping requirements under paragraph (j)
of this section.
(iv) Remit the applicable fee specified in Sec. 700.45(c) of this
chapter.
(b) Definitions--(1) Act means the Toxic Substances Control Act (15
U.S.C. 2601 et seq.).
(2) An article is a manufactured item--
(i) Which is formed to a specific shape or design during
manufacture;
(ii) Which has end use function(s) dependent in whole or in part
upon its shape or design during end use; and
(iii) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article and that may occur as
described in Sec. 710.2 of this chapter except that fluids and
particles are not considered articles regardless of shape or design.
(3) The terms byproduct, EPA, impurities, person, and site have the
same meanings as in Sec. 710.3 of this chapter.
(4) The term category of chemical substances has the same meaning as
in section 26(c)(2) of the Act (15 U.S.C. 2625).
(5) The terms chemical substance, distribute in commerce,
distribution in commerce, environment, manufacture, new chemical
substance, and process have the same meanings as in section 3 of the Act
(15 U.S.C. 2602).
(6) Director of the Office of Pollution Prevention and Toxics means
the Director of the EPA Office of Pollution Prevention and Toxics or any
EPA employee designated by the Office Director to carry out the Office
Director's functions under this section.
(7) The term exemption category means a category of chemical
substances for which a person(s) has applied for or been granted an
exemption under section 5(h)(4) of the Act (15 U.S.C. 2604).
(8) The term instant photographic film article means a self-
developing photographic film article designed so that all the chemical
substances contained in the article, including the chemical substances
required to process the film, remain sealed during distribution and use.
(9) Intermediate means any chemical substance which is consumed in
whole or in part in a chemical reaction(s) used for the intentional
manufacture of another chemical substance.
(10) Known to or reasonably ascertainable means all information in a
person's possession or control, plus all information that a reasonable
person similarly situated might be expected to possess, control, or
know, or could obtain without unreasonable burden or cost.
(11) The term peel-apart film article means a self-developing
photographic film article consisting of a positive image receiving
sheet, a light sensitive negative sheet, and a sealed reagent pod
containing a developer reagent and designed so that all the chemical
substances required to develop or process the film will not remain
sealed within the article during and after the development of the film.
(12) Photographic article means any article which will become a
component of an instant photographic or peel-apart film article.
(13) Special production area means a demarcated area within which
all manufacturing, processing, and use of a new chemical substance takes
place, except as provided in paragraph (f) of this section, in
accordance with the requirements of paragraph (e) of this section.
(14) Test data means:
(i) Data from a formal or informal study, test, experiment, recorded
observation, monitoring, or measurement.
(ii) Information concerning the objectives, experimental methods and
materials, protocols, results, data analyses (including risk
assessments), and conclusions from a study, test, experiment, recorded
observation, monitoring, or measurement.
(15) Used in or for the manufacturing or processing of an instant
photographic or peel-apart film article, when used to describe
activities involving a new chemical substance, means the new chemical
substance--
(i) Is included in the article; or
(ii) Is an intermediate to a chemical substance included in the
article or is
[[Page 15]]
one of a series of intermediates used to manufacture a chemical
substance included in the article.
(16) Wet mixture means a water or organic solvent-based suspension,
solution, dispersion, or emulsion used in the manufacture of an instant
photographic or peel-apart film article.
(c) Exemption category. The exemption category includes new chemical
substances used in or for the manufacture or processing of instant
photographic or peel-apart film articles which are manufactured and
processed under the terms of this section.
(d) Applicability. This exemption applies only to manufacturers of
instant photographic or peel-apart film articles who:
(1) Manufacture the new chemical substances used in or for the
manufacture or processing of the instant photographic or peel-apart film
articles.
(2) Limit manufacture and processing of a new chemical substance to
the site(s) listed in the exemption notice for that new chemical
substance submitted under paragraph (i) of this section.
(3) Comply with the requirements of paragraphs (e), (f), (g), (h),
and (j) of this section.
(4) Do not distribute in commerce or use a peel-apart film article
containing a new chemical substance until submission of a premanufacture
notice under section 5(a)(1)(A) of the Act (15 U.S.C. 2604) and until
the review period for the notice has ended without EPA action to prevent
distribution or use.
(e) Conditions of manufacture and processing in the special
production area. All manufacturing, processing, and use operations
involving the new chemical substance must be performed in a special
production area under the conditions set forth in this paragraph until
the new chemical substance has been incorporated into a wet mixture,
photographic article, or instant photographic or peel-apart film
article.
(1) Exposure limits. In the special production area, the ambient air
concentration of the new chemical substance during manufacture,
processing, and use cannot exceed an 8-hour time weighted average (TWA)
of 10 ppm for gases and vapors and 50 [micro]g/m\3\ for particulates,
with an allowable TWA excursion of 50 percent above those concentrations
for a duration of 30 minutes or less.
(2) Respiratory protection--(i) Respirator requirement. Except as
specified in paragraph (e)(2)(ii) of this section, each person in the
special production area must wear an appropriate respiratory protection
device to protect against dusts, fumes, vapors, and other airborne
contaminants, as described in 29 CFR 1910.134. Selection of an
appropriate respirator must be made according to the guidance of
American National Standard Practices for Respiratory Protection Z88.2-
1969 and the NIOSH Certified Equipment List, U.S. Department of Health
and Human Services, NIOSH publication No. 80-144.
(ii) Waiver of respirator requirement. Employees are not required to
wear respirators if monitoring information collected and analyzed in
accordance with paragraph (e)(3) of this section demonstrates that the
ambient 8-hour TWA concentration of the new chemical substance in the
area is less than 1 ppm for gases and vapors and 5 [micro]g/m\3\ for
particulates with an allowable TWA excursion of 50 percent above these
concentrations for a duration of 30 minutes or less.
(iii) Quantitative fit test. Each respirator must be issued to a
specific individual for personal use. A quantitative fit test must be
performed for each respirator before its first use by that person in a
special production area.
(3) Monitoring--(i) When to monitor. (A) When suitable sampling and
analytic methods exist, periodic monitoring in accordance with this
paragraph must be done to ensure compliance with the exposure limits of
paragraphs (e)(1) and (e)(2)(ii) of this section.
(B) When suitable sampling and analytic methods do not exist,
compliance with the exposure limits of paragraph (e)(1) and the
requirements of paragraph (e)(10) of this section must be determined by
an evaluation of monitoring data developed for a surrogate chemical
substance possessing comparable physical-chemical properties under
similar manufacturing and processing conditions.
[[Page 16]]
(ii) Monitoring methods. A suitable air sampling method must permit
personal or fixed location sampling by conventional collection methods.
A suitable analytic method must have adequate sensitivity for the volume
of sample available and be specific for the new chemical substance being
monitored. If chemical-specific monitoring methods are not available,
nonspecific methods may be used if the concentration of the new chemical
substance is assumed to be the total concentration of chemical
substances monitored.
(iii) Monitoring frequency. (A) When suitable air sampling and
analytical procedures are available, monitoring must be done in each
special production area during the first three 8-hour work shifts
involving the manufacture or processing of each new chemical substance.
Thereafter, monitoring must be done in each special production area for
at least one 8-hour period per month, during a production run in which
the new chemical substance is manufactured or processed. Samples must be
of such frequency and pattern as to represent with reasonable accuracy
the mean level and maximum 30-minute level of employee exposure during
an 8-hour work shift. In monitoring for an 8-hour work shift or the
equivalent, samples must be collected periodically or continuously for
the duration of the 8-hour work shift. Samples must be taken during a
period which is likely to represent the maximum employee exposure.
(B) If the manufacturer demonstrates compliance with the exposure
limits for 3 consecutive months, further monitoring of the identical
process must be performed only every 6 months thereafter, unless there
is a significant change in the process, process design, or equipment. If
there is such a change, the manufacturer must begin monitoring again
according to the schedule in paragraph (e)(3)(iii)(A) of this section.
(iv) Location of monitoring. Air samples must be taken so as to
ensure that the samples adequately represent the ambient air
concentration of a new chemical substance present in each worker's
breathing zone.
(4) Engineering controls and exposure safeguards. Engineering
controls such as, but not limited to, isolation, enclosure, local
exhaust ventilation, and dust collection must be used to ensure
compliance with the exposure limits prescribed in paragraph (e)(1) or
(e)(2)(ii) of this section.
(5) Training, hygiene, and work practices--(i) Training. No employee
may enter a special production area before the completion of a training
program. The training program must be adapted to the individual
circumstances of the manufacturer and must address: The known physical-
chemical and toxicological properties of the chemical substances handled
in the area; procedures for using and maintaining respirators and other
personal safeguards; applicable principles of hygiene; special handling
procedures designed to limit personal exposure to, and inadvertent
release of, chemical substances; and procedures for responding to
emergencies or spills.
(ii) Hygiene. Appropriate standards of hygiene must be observed by
all employees handling a new chemical substance in manufacturing,
processing, or transfer operations. The manufacturer must provide
appropriate facilities for employee changing and wash-up. Food,
beverages, tobacco products, and cosmetics must not be allowed in
special production areas.
(iii) Work practices. Operating procedures such as those related to
chemical weighing and filtering, or the charging, discharging and clean-
up of process equipment, must be designed and conducted to ensure
compliance with the exposure limits prescribed in paragraph (e)(1) or
(e)(2)(ii) of this section. Written procedures and all materials
necessary for responding to emergency situations must be immediately
accessible to all employees in a special production area. Any spill or
unanticipated emission must be controlled by specially trained personnel
using the equipment and protective clothing described in paragraph
(e)(6) of this section.
(6) Personal protection devices. All workers engaged in the
manufacture and processing of a new chemical substance in the special
production area must wear suitable protective clothing
[[Page 17]]
or equipment, such as chemical-resistant coveralls, protective eyewear,
and gloves.
(7) Caution signs. Each special production area must be clearly
posted with signs identifying the area as a special production area
where new chemical substances are manufactured and processed under
controlled conditions. Each sign must clearly restrict entry into the
special production area to qualified personnel who are properly trained
and equipped with appropriate personal exposure safeguards.
(8) Removal for storage or transportation. A new chemical substance
that is not incorporated into a wet mixture, photographic article, or
instant photographic or peel-apart film article may be removed from the
special production area for purposes of storage between operational
steps or for purposes of transportation to another special production
area. Such storage or transportation must be conducted in a manner that
limits worker and environmental exposure through the use of engineering
controls, training, hygiene, work practices, and personal protective
devices appropriate to the chemical substance in question.
(9) Labeling. (i) Any new chemical substance removed from a special
production area or stored or transported between operational steps must
be clearly labeled. The label must show the identity of the new chemical
substance or an appropriate identification code, a statement of any
known hazards associated with it, a list of special handling
instructions, first aid information, spill control directions, and where
applicable, the appropriate U.S. Department of Transportation notations.
(ii) No label is required if the new chemical substance has been
incorporated into a photographic article, or if it is contained in a
sealed reaction vessel or pipeline, or if it has been incorporated into
an instant photographic or peel-apart film article.
(10) Areas immediately adjacent to the special production area. The
ambient air concentration of the new chemical substance in areas
immediately adjacent to the special production area must not exceed the
exposure limit established in paragraph (e)(2)(ii) of this section for
waiver of respirator protection within the special production area.
Periodic monitoring in accordance with paragraph (e)(3) of this section
must be performed in immediately adjacent areas where it is reasonable
to expect a risk of inhalation exposure.
(f) Conditions of processing outside the special production area. A
wet mixture may be incorporated into a photographic article or an
instant photographic or peel-apart film article outside the special
production area under the conditions listed in this paragraph:
(1) Engineering controls and exposure safeguards. Engineering
controls must limit the exposure to a new chemical substance contained
in a wet mixture.
(2) Training, hygiene and work practices--(i) Training. Training of
employees involved in the handling of wet mixtures containing a new
chemical substance must be adapted to the individual circumstances of
the employees' activities and must address: Procedures for using
personal exposure safeguards, applicable principles of hygiene, handling
procedures designed to limit personal exposure, and procedures for
responding to emergencies and spills.
(ii) Hygiene. Appropriate standards of hygiene that limit exposure
must be observed by all employees handling wet mixtures that contain new
chemical substances.
(iii) Work practices. Work practices and operating procedures must
be designed to limit exposure to any new chemical substance contained in
wet mixtures. Any spills or unanticipated releases of a wet mixture must
be controlled by trained personnel wearing appropriate protective
clothing or equipment such as gloves, eye protection, and, where
necessary, respirators or chemically impervious clothing.
(3) Personal protection devices. All workers engaged in the
processing of a wet mixture containing a new chemical substance must
wear suitable protective clothing or equipment such as coveralls,
protective eyewear, respirators, and gloves.
(g) Incorporation of photographic articles into instant photographic
and peel-apart film articles. A photographic article may be incorporated
into the instant photographic or peel-apart film
[[Page 18]]
article outside the special production area. The manufacturer must take
measures to limit worker and environmental exposure to new chemical
substances during these operations using engineering controls, training,
hygiene, work practices, and personal protective devices.
(h) Environmental release and waste treatment--(1) Release to land.
Process waste from manufacturing and processing operations in the
special production area that contain a new chemical substance are
considered to be hazardous waste and must be handled in accordance with
the requirements of parts 262 through 267 and parts 122 and 124 of this
chapter.
(2) Release to water. All wastewater or discharge which contain the
new chemical substance must be appropriately pretreated before release
to a Publicly Owned Treatment Works (POTW) or other receiving body of
water. In the case of release to a POTW, the pretreatment must prevent
structural damage to, obstruction of, or interference with the operation
of the POTW. The treatment of direct release to a receiving body of
water must be appropriate for the new chemical substance's physical-
chemical properties and potential toxicity.
(3) Release to air. All process emissions released to the air which
contain the new chemical substance must be vented through control
devices appropriate for the new chemical substance's physical-chemical
properties and potential toxicity.
(i) Exemption notice. An exemption notices must be submitted to EPA
when manufacture of the new chemical substance begins.
(1) Contents of exemption notice. The exemption notice must include
the following information:
(i) Manufacturer and sites. The notice must identify the
manufacturer and the sites and locations where the new chemical
substance and the instant photographic or peel-apart film articles will
be manufactured and processed.
(ii) Chemical identification. The notice must identify the new
chemical substance as follows:
(A) Class 1 substances. For chemical substances whose composition
can be represented by a definite structural diagram (Class 1
substances), the notice must provide the chemical name (preferably CAS
or IUPAC nomenclature), the molecular formula, CAS Registry Number (if
available), known synonyms (including trade names), and a structural
diagram.
(B) Class 2 substances. For chemical substances that cannot be fully
represented by a structural diagram, (Class 2 substances), the notice
must provide the chemical name, the molecular formula, the CAS Registry
Number (if available), and known synonyms (including trade names). The
notice must identify the immediate precursors and reactants by name and
CAS Registry Number (if available). The notice must include a partial or
incomplete structural diagram, if available.
(C) Polymers. For a polymer, the notice must identify monomers and
other reactants used in the manufacture of the polymer by chemical name
and CAS Registry Number. The notice must indicate the amount of each
monomer used (by weight percent of total monomer); the maximum residual
of each monomer present in the polymer; and a partial or incomplete
structural diagram, if available. The notice must indicate the number
average molecular weight of the polymer and characterize the anticipated
low molecular weight species. The notice must include this information
for each typical average molecular weight composition of the polymer to
be manufactured.
(iii) Impurities. The notice must identify the impurities that can
be reasonably anticipated to be present in the new chemical substance
when manufactured under the exemption by name and CAS Registry Number,
by class of substances, or by process or source. The notice also must
estimate the maximum percent (by weight) of each impurity in the new
chemical substance and the percent of unknown impurities present.
(iv) Physical-chemical properties. The notice must describe the
physical-chemical properties of the new chemical substance. Where
specific physical-chemical data are not available, reasonable estimates
and the techniques used to develop these estimates must be provided.
[[Page 19]]
(v) Byproducts. The notice must identify the name, CAS Registry
number (if available), and the volume of each byproduct that would be
manufactured during manufacture of the new chemical substance.
(vi) Production volume. The notice must include an estimate of the
anticipated maximum annual production volume.
(vii) Test data. The notice must include all information and test
data on the new chemical substance's health and environmental effects
that are known to or reasonably ascertainable by the manufacturer.
(viii) Identity of the article. The notice must identify and
describe the instant photographic film article(s) or peel-apart film
article(s) that will contain the new chemical substance.
(ix) Release to water. The notice must include a description of the
methods used to control and treat wastewater or discharge released to a
POTW or other receiving body of water. The notice must also identify the
POTW or receiving body of water.
(x) Certification. The manufacturer must certify in the notice that
it is familiar with the terms of the exemption and that the manufacture,
processing, distribution, use, and disposal of the new chemical
substance will comply with those terms.
(xi) Fee payment ID number. The manufacturer or processor must
include a payment identity number on the front page of the notice.
(2) Duplication of information in premanufacture notice. If a
manufacturer who submits an exemption notice under this paragraph has
already submitted, or simultaneously submits, a premanufacture notice
under section 5(a)(1)(A) of the Act for the new chemical substance, it
may, in lieu of submitting the information required by this paragraph,
reference the required information to the extent it is included in the
premanufacture notice. At a minimum, the exemption notice must identify
the manufacturer and the new chemical substance, and contain the
certification required by paragraph (i)(1)(x) of this section.
(3) Address. The exemption notice must be addressed to the Document
Control Office (DCO) (7407M), Office of Pollution Prevention and Toxics
(OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001.
(j) Recordkeeping. (1) Manufacturers of a new chemical substance
under this exemption must keep the following records for 30 years from
the final date of manufacture.
(i) Production records. Each manufacturer must maintain records of
the annual production volume of each new chemical substance manufactured
under the terms of the exemption. This record must indicate when
manufacture of the new chemical substance began.
(ii) Exposure monitoring records. Manufacturers must maintain an
accurate record of all monitoring required by this section. Monitoring
records may be adapted to the individual circumstances of the
manufacturer but, at a minimum, must contain the following information:
The chemical identity of the new chemical substance, date of the
monitoring, the actual monitoring data for each monitoring location and
sampling, and a reference to or description of the collection and
analytic techniques. If the manufacturer does not monitor, the
manufacturer must maintain a record of the reasons for not monitoring
and the methods used to determine compliance with the exposure limits of
paragraph (e)(1) of this section.
(iii) Training and exposure records. For each employee engaged in
the manufacture or processing of a new chemical substance, the company
must develop and maintain a record of the worker's participation in
required training. This record must also demonstrate the regular use of
personal exposure safeguards, including the results of any personal
exposure monitoring, the results of the quantitative fit test for the
worker's personal respirator, and any additional information related to
the worker's occupational exposure.
(iv) Treatment records. Manufacturers who release treated wastewater
or discharge containing a new chemical substance to a POTW or other
receiving body of water must maintain records of the method of
treatment.
(2) The manufacturer must make the records listed in paragraph
(j)(1) of this
[[Page 20]]
section available to EPA upon written request by the Director of the
Office of Pollution Prevention and Toxics. The manufacturer must provide
these records within 15 working days of receipt of this request.
(k) Confidentiality. If the manufacturer submits information under
paragraph (i) or (j) of this section which it claims to be confidential
business information, the manufacturer must clearly identify the
information at the time of submission to the Agency by bracketing,
circling, or underlining it and stamping it with ``CONFIDENTIAL'' or
some other appropriate designation. Any information so identified will
be treated in accordance with the procedures in part 2 of this chapter.
Any information not claimed confidential at the time of submission will
be made available to the public without further notice to the submitter.
(l) Amendment and repeal. (1) EPA may amend or repeal any term of
this exemption if it determines that the manufacture, processing,
distribution, use, and disposal of new chemical substances under the
terms of the exemption may present an unreasonable risk of injury to
health or the environment. EPA also may amend this exemption to enlarge
the exemption category or to reduce the restrictions or conditions of
the exemption.
(2) As required by section 5(h)(4) of the Act, EPA will amend or
repeal the substantive terms of an exemption granted under this part
only by the formal rulemaking procedures described in section 6(c)(2)
and (3) of the Act (15 U.S.C. 2605(c)).
(m) Prohibition of use of the exemption. The Director of the Office
of Pollution Prevention and Toxics may prohibit the manufacture,
processing, distribution, use, or disposal of any new chemical substance
under the terms of this exemption if he or she determines that the
manufacture, processing, distribution in commerce, use, or disposal of
the new chemical substance may present an unreasonable risk of injury to
health or the environment.
(n) Enforcement. (1) A failure to comply with any provision of this
part is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Submitting materially misleading or false information in
connection with the requirements of any provision of this part is a
violation of this regulation and therefore a violation of section 15 of
the Act (15 U.S.C. 2614).
(3) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
(4) EPA may seek to enjoin the manufacture of a new chemical
substance in violation of this exemption or act to seize any chemical
substances manufactured in violation of the exemption under the
authority of section 17 of the Act (15 U.S.C. 2616).
[83 FR 52719, Oct. 17, 2018]
Sec. 723.250 Polymers.
(a) Purpose and scope. (1) This section grants an exemption from
certain of the premanufacture notice requirements of section 5(a)(1)(A)
of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the
manufacture of certain polymers. This section does not apply to
microorganisms subject to part 725 of this chapter.
(2) To manufacture a new chemical substance under the terms of this
section, a manufacturer must:
(i) Determine that the substance meets the definition of polymer in
paragraph (b) of this section.
(ii) Determine that the substance is not specifically excluded by
paragraph (d) of this section.
(iii) Ensure that the substance meets the exemption criteria of
paragraph (e) of this section.
(iv) Submit a report as required under paragraph (f) of this
section.
(v) Comply with the recordkeeping requirements of paragraph (j) of
this section.
(b) Definitions. In addition to the definitions under section 3 of
the Act, 15 U.S.C. 2602, the following definitions apply to this part.
Act means the Toxic Substances Control Act (15 U.S.C. 2601 et seq.).
Biopolymer means a polymer directly produced by living or once-
living cells or cellular components.
Category of chemical substances has the same meaning as in section
26(c)(2) of the Act (15 U.S.C. 2625).
[[Page 21]]
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 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
[[Page 22]]
one another and form a continuous string within the molecule,
uninterrupted by units other than monomer units.
Polymer molecule means a molecule which contains a sequence of at
least 3 monomer units which are covalently bound to at least one other
monomer unit or other reactant.
Reactant means a chemical substance that is used intentionally in
the manufacture of a polymer to become chemically a part of the polymer
composition.
Reactive functional group means an atom or associated group of atoms
in a chemical substance that is intended or can reasonably be
anticipated to undergo further chemical reaction.
Reasonably anticipated means that a knowledgeable person would
expect a given physical or chemical composition or characteristic to
occur based on such factors as the nature of the precursors used to
manufacture the polymer, the type of reaction, the type of manufacturing
process, the products produced in polymerization, the intended uses of
the substance, or associated use conditions.
(c) Applicability. This section applies to manufacturers of new
chemical substances that otherwise must submit a premanufacture notice
to EPA under Sec. 720.22 of this chapter. New substances are eligible
for exemption under this section if they meet the definition of
``polymer'' in paragraph (b) of this section, and the criteria in
paragraph (e) of this section, and if they are not excluded from the
exemption under paragraph (d) of this section.
(d) Polymers that cannot be manufactured under this section--(1)
Cationic polymers. A polymer cannot be manufactured under this section
if the polymer is a cationic polymer as defined under paragraph (b) of
this section or if the polymer is reasonably anticipated to become a
cationic polymer in a natural aquatic environment (e.g., rivers, lakes)
unless:
(i) The polymer is a solid material that is not soluble or
dispersible in water and will be used only in the solid phase (e.g.,
polymers that will be used as ion exchange beads), or
(ii) The combined (total) functional group equivalent weight of
cationic groups in the polymer is equal to or greater than 5,000.
(2) Elemental limitations. (i) A polymer manufactured under this
section must contain as an integral part of its composition at least two
of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and
sulfur.
(ii) A polymer cannot be manufactured under this section if it
contains as an integral part of its composition, except as impurities,
any elements other than the following:
(A) The elements listed in paragraph (d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum, potassium, calcium, chlorine,
bromine, and iodine as the monatomic counterions Na = ,
Mg = 2, Al = 3, K = ,
Ca = 2, Cl-, Br-, or I-.
(C) Fluorine, chlorine, bromine, and iodine covalently bound to
carbon.
(D) Less than 0.20 weight percent of any combination of the atomic
elements lithium, boron, phosphorus, titanium, manganese, iron, nickel,
copper, zinc, tin, and zirconium.
(3) Polymers which degrade, decompose, or depolymerize. A polymer
cannot be manufactured under this section if the polymer is designed or
is reasonably anticipated to substantially degrade, decompose, or
depolymerize, including those polymers that could substantially
decompose after manufacture and use, even though they are not actually
intended to do so. For the purposes of this section, degradation,
decomposition, or depolymerization mean those types of chemical change
that convert a polymeric substance into simpler, smaller substances,
through processes including but not limited to oxidation, hydrolysis,
attack by solvents, heat, light, or microbial action.
(4) Polymers manufactured or imported from monomers and reactants
not on the TSCA Chemical Substance Inventory. A polymer cannot be
manufactured under this section if the polymer being manufactured or
imported is prepared from monomers and/or other reactants (that are
either charged to the reaction vessel or incorporated in the polymer at
levels of greater than 2 weight percent) that are not already included
on the TSCA Chemical Substance Inventory or manufactured under an
applicable TSCA section 5 exemption.
[[Page 23]]
(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.
(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:
[[Page 24]]
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...............
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
[[Page 25]]
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
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) through (3)
of this section a report of manufacture or import must be submitted by
January 31 of the year subsequent to initial manufacture, except that
for initial manufacture or import in 2023 the report must be submitted
by March 31, 2024. The report and accompanying claims must be submitted
via CDX (https://cdx.epa.gov/), using the TSCA Section 5 Notices and
Supports--ePMN application. See Sec. 720.40(a)(2)(ii) of this
subchapter for information on how to access e-PMN software. The notice
must include:
(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
[[Page 26]]
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 May 26, 1995) shall either continue to comply with
those requirements or follow all procedural and recordkeeping
requirements pursuant to this section. If an exemption holder continues
to follow the superseded regulations, the Notice of Commencement
requirements apply and the exempt polymer will continue to be listed on
the Inventory with exclusion criteria and exemption category
restrictions on residual monomer/reactant and low molecular weight
species content limitations.
(j) Recordkeeping. (1) A manufacturer of a new polymer under
paragraphs (e) of this section, must retain the records described in
this paragraph at the manufacturing site for a period of 5 years from
the date of commencement of manufacture.
(2) The records must include the following to demonstrate compliance
with the terms of this section:
(i) Chemical identity information as required in paragraph (g) of
this section.
(ii) Information to demonstrate that the new polymer is not
specifically excluded from the exemption.
(iii) Records of production volume for the first 3 years of
manufacture and the date of commencement of manufacture.
(iv) Information to demonstrate that the new polymer meets the
exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this
section.
(v) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the number-average MW
exemption criteria in paragraphs (e)(1) or (e)(2) of this section. The
analytical tests may include gel permeation chromatography (GPC).vapor
pressure osmometry (VPO), or other such tests which will demonstrate
that the polymer meets the number-average MW criterion.
(vi) Analytical data, or theoretical calculations (if it can be
documented that an analytical determination cannot be made or is not
necessary), to demonstrate that the polymer meets the criteria in
paragraphs (e)(1) or (e)(2) of this section, meets the low MW content
criteria in paragraphs (e)(1) or (e)(2) of this section.
(vii) If applicable, analytical data, or theoretical calculations
(if it can be documented that an analytical determination cannot be made
or is not necessary) required in paragraph (g) of this section for
determining monomers or reactants charged to the reaction vessel at
greater than 2 weight percent but incorporated at 2 weight percent or
less in the manufactured polymer.
(viii) The certification statements as required under paragraph (h)
of this section.
(3) The manufacturer must submit the records listed in paragraph
(j)(2) of this section to EPA upon written request by EPA. The
manufacturer must provide these records within 15 working days of
receipt of this request. In addition, any person who manufactures a new
chemical substance under the terms of this section, upon request of
[[Page 27]]
EPA, must permit such person at all reasonable times to have access to
and to copy these records.
(k) Submission of information. Information submitted to EPA under
this section must be sent in writing to: TSCA Document Control Officer,
(7407), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(l) Compliance. (1) A person who manufactures or imports a new
chemical substance and fails to comply with any provision of this
section is in violation of section 15 of the Act (15 U.S.C. 2614).
(2) Using for commercial purposes a chemical substance or mixture
which a person knew or had reason to know was manufactured, processed,
or distributed in commerce in violation of section 5 of the Act is a
violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by this section and
section 11 of the Act, is a violation of section 15 of the Act (15
U.S.C. 2614).
(4) Failure or refusal to permit entry or inspection as required by
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C.
2614).
(5) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who
submit materially misleading or false information in connection with the
requirements of any provision of this section may be subject to
penalties calculated as if they never filed their notices.
(6) EPA may seek to enjoin the manufacture or processing of a
chemical substance in violation of this section or act to seize any
chemical substance manufactured or processed in violation of this
section or take other actions under the authority of section 7 of the
Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
(m) Inspections. EPA will conduct inspections under section 11 of
the Act to assure compliance with section 5 and this section, to verify
that information submitted to EPA under this section is true and
correct, and to audit data submitted to EPA under this section.
(n) Confidentiality. Claims of confidentiality must be made in
accordance with the procedures described in 40 CFR part 703.
[60 FR 16332, Mar. 29, 1995, as amended at 62 FR 17932, Apr. 11, 1997;
75 FR 4305, Jan. 27, 2010; 87 FR 39769, July 5, 2022; 88 FR 37173, June
7, 2023; 89 FR 12250, Feb. 16, 2024]
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.
725.88 Uses of a microorganism.
725.95 Public file.
Subpart D_Microbial Commercial Activities Notification Requirements
725.100 Scope and purpose.
725.105 Persons who must report.
[[Page 28]]
725.110 Persons not subject to this subpart.
725.150 Procedural requirements for this subpart.
725.155 Information to be included in the MCAN.
725.160 Submission of health and environmental effects data.
725.170 EPA review of the MCAN.
725.190 Notice of commencement of manufacture or import.
Subpart E_Exemptions for Research and Development Activities
725.200 Scope and purpose.
725.205 Persons who may report under this subpart.
725.232 Activities subject to the jurisdiction of other Federal programs
or agencies.
725.234 Activities conducted inside a structure.
725.235 Conditions of exemption for activities conducted inside a
structure.
725.238 Activities conducted outside a structure.
725.239 Use of specific microorganisms in activities conducted outside a
structure.
725.250 Procedural requirements for the TERA.
725.255 Information to be included in the TERA.
725.260 Submission of health and environmental effects data.
725.270 EPA review of the TERA.
725.288 Revocation or modification of TERA approval.
Subpart F_Exemptions for Test Marketing
725.300 Scope and purpose.
725.305 Persons who may apply under this subpart.
725.350 Procedural requirements for this subpart.
725.355 Information to be included in the TME application.
725.370 EPA review of the TME application.
Subpart G_General Exemptions for New Microorganisms
725.400 Scope and purpose.
725.420 Recipient microorganisms.
725.421 Introduced genetic material.
725.422 Physical containment and control technologies.
725.424 Requirements for the Tier I exemption.
725.426 Applicability of the Tier I exemption.
725.428 Requirements for the Tier II exemption.
725.450 Procedural requirements for the Tier II exemption.
725.455 Information to be included in the Tier II exemption request.
725.470 EPA review of the Tier II exemption request.
Subparts H-K [Reserved]
Subpart L_Additional Procedures for Reporting on Significant New Uses of
Microorganisms
725.900 Scope and purpose.
725.910 Persons excluded from reporting significant new uses.
725.912 Exemptions.
725.920 Exports and imports.
725.950 Additional recordkeeping requirements.
725.975 EPA approval of alternative control measures.
725.980 Expedited procedures for issuing significant new use rules for
microorganisms subject to section 5(e) orders.
725.984 Modification or revocation of certain notification requirements.
Subpart M_Significant New Uses for Specific Microorganisms
725.1000 Scope.
725.1075 Burkholderia cepacia complex.
725.1079 Arsenic detecting strain of E. coli with extra-chromosomal
elements, including an intergeneric screening marker
(generic).
725.1080 Trichoderma reesei (generic).
725.1081 Trichoderma reesei modified (generic).
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.
Source: 62 FR 17932, Apr. 11, 1997, unless otherwise noted.
Subpart A_General Provisions and Applicability
Sec. 725.1 Scope and purpose.
(a) This part establishes all reporting requirements under section 5
of TSCA for manufacturers, importers, and processors of microorganisms
subject to TSCA jurisdiction for commercial purposes, including research
and development for commercial purposes. New microorganisms for which
manufacturers and importers are required to report under section
5(a)(1)(A) of TSCA are those that are intergeneric. In addition, under
section 5(a)(1)(B) of TSCA, manufacturers, importers, and processors may
be required to report for any microorganism that EPA determines by rule
is being manufactured, imported, or processed for a significant new use.
[[Page 29]]
(b) Any manufacturer, importer, or processor required to report
under section 5 of TSCA (see Sec. 725.100 for new microorganisms and
Sec. 725.900 for significant new uses) must file a Microbial Commercial
Activity Notice (MCAN) with EPA, unless the activity is eligible for a
specific exemption as described in this part. The general procedures for
filing MCANs are described in subpart D of this part. The exemptions
from the requirement to file a MCAN are for certain kinds of contained
activities (see Sec. Sec. 725.424 and 725.428), test marketing
activities (see Sec. 725.300), and research and development activities
described in paragraph (c) of this section.
(c) Any manufacturer, importer, or processor required to file a MCAN
for research and development (R&D) activities may instead file a TSCA
Experimental Release Application (TERA) for a specific test (see Sec.
725.250). A TERA is not required for certain R&D activities; however a
TERA exemption does not extend beyond the research and development
stage, to general commercial use of the microorganism, for which
compliance with MCAN requirements is required. The TERA exemptions are
for R&D activities subject to other Federal agencies or programs (see
Sec. 725.232), certain kinds of contained R&D activities (see Sec.
725.234), and R&D activities using certain listed microorganisms (see
Sec. 725.238).
(d) New microorganisms will be added to the Inventory established
under section 8 of TSCA once a MCAN has been received, the MCAN review
period has expired, and EPA receives a Notice of Commencement (NOC)
indicating that manufacture or importation has actually begun. New
microorganisms approved for use under a TERA will not be added to the
Inventory until a MCAN has been received, the MCAN review period has
expired, and EPA has received an NOC.
Sec. 725.3 Definitions.
Definitions in section 3 of the Act (15 U.S.C. 2602), as well as
definitions contained in Sec. Sec. 704.3, 720.3, and 721.3 of this
chapter, apply to this part unless otherwise specified in this section.
In addition, the following definitions apply to this part:
Consolidated microbial commercial activity notice or consolidated
MCAN means any MCAN submitted to EPA that covers more than one
microorganism (each being assigned a separate MCAN number by EPA) as a
result of a prenotice agreement with EPA.
Containment and/or inactivation controls means any combination of
engineering, mechanical, procedural, or biological controls designed and
operated to restrict environmental release of viable microorganisms from
a structure.
Director means the Director of the EPA Office of Pollution
Prevention and Toxics.
Exemption request means any application submitted to EPA under
subparts E, F, or G of this part.
General commercial use means use for commercial purposes other than
research and development.
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,
[[Page 30]]
fish, or other animals, and plants, including: Acute toxicity tests,
chronic toxicity tests, critical life stage tests, behavioral tests,
algal growth tests, seed germination tests, plant growth or damage
tests, microbial function tests, bioconcentration or bioaccumulation
tests, and model ecosystem (microcosm) studies.
(ii) Long- and short-term tests of mutagenicity, carcinogenicity, or
teratogenicity; dermatoxicity; cumulative, additive, and synergistic
effects; and acute, subchronic, and chronic effects.
(iii) Assessments of human and environmental exposure, including
workplace exposure, and impacts of a particular microorganism or
microbial mixture on the environment, including surveys, tests, and
studies of: Survival and transport in air, water, and soil; ability to
exchange genetic material with other microorganisms, ability to colonize
human or animal guts, and ability to colonize plants.
(iv) Monitoring data, when they have been aggregated and analyzed to
measure the exposure of humans or the environment to a microorganism.
(v) Any assessments of risk to health and the environment resulting
from the manufacture, processing, distribution in commerce, use, or
disposal of the microorganism.
Inactivation means that living microorganisms are rendered
nonviable.
Institutional Biosafety Committee means the committees described in
the NIH Guidelines in section IV.B.2.
Intergeneric microorganism means a microorganism that is formed by
the deliberate combination of genetic material originally isolated from
organisms of different taxonomic genera.
(1) The term ``intergeneric microorganism'' includes a microorganism
which contains a mobile genetic element which was first identified in a
microorganism in a genus different from the recipient microorganism.
(2) The term ``intergeneric microorganism'' does not include a
microorganism which contains introduced genetic material consisting of
only well-characterized, non-coding regulatory regions from another
genus.
Introduced genetic material means genetic material that is added to,
and remains as a component of, the genome of the recipient.
Manufacture, import, or process for commercial purposes means:
(1) To import, produce, manufacture, or process with the purpose of
obtaining an immediate or eventual commercial advantage for the
manufacturer, importer, or processor, and includes, among other things,
``manufacture'' or ``processing'' of any amount of a microorganism or
microbial mixture:
(i) For commercial distribution, including for test marketing.
(ii) For use by the manufacturer, including use for product research
and development or as an intermediate.
(2) The term also applies to substances that are produced
coincidentally during the manufacture, processing, use, or disposal of
another microorganism or microbial mixture, including byproducts that
are separated from that other microorganism 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.
[[Page 31]]
New microorganism means a microorganism not included on the
Inventory.
NIH Guidelines means the National Institutes of Health (NIH)
``Guidelines for Research Involving Recombinant DNA Molecules'' (July 5,
1994).
Non-coding regulatory region means a segment of introduced genetic
material for which:
(1) The regulatory region and any inserted flanking nucleotides do
not code for protein, peptide, or functional ribonucleic acid molecules.
(2) The regulatory region solely controls the activity of other
regions that code for protein or peptide molecules or act as recognition
sites for the initiation of nucleic acid or protein synthesis.
Small quantities solely for research and development (or ``small
quantities solely for purposes of scientific experimentation or analysis
or research on, or analysis of, such substance or another substance,
including such research or analysis for development of a product'')
means quantities of a microorganism manufactured, imported, or processed
or proposed to be manufactured, imported, or processed solely for
research and development that meet the requirements of Sec. 725.234.
Structure means a building or vessel which effectively surrounds and
encloses the microorganism and includes features designed to restrict
the microorganism from leaving.
Submerged standard industrial fermentation means a fermentation
system that meets all of the following conditions:
(1) Enzyme production is conducted under conditions of submerged
fermentation (i.e., growth of the microorganism occurs beneath the
surface of the liquid growth medium).
(2) Any fermentation of solid plant material or insoluble
substrates, to which T. reesei fermentation broth is added after the
submerged standard industrial fermentation operations used for enzyme
production is completed, may be initiated only after the inactivation of
the microorganism as delineated in 40 CFR 725.422(d).
Submission means any MCAN or exemption request submitted to EPA
under this part.
Technically qualified individual means a person or persons:
(1) Who, because of education, training, or experience, or a
combination of these factors, is capable of understanding the health and
environmental risks associated with the microorganism which is used
under his or her supervision,
(2) Who is responsible for enforcing appropriate methods of
conducting scientific experimentation, analysis, or microbiological
research to minimize such risks, and
(3) Who is responsible for the safety assessments and clearances
related to the procurement, storage, use, and disposal of the
microorganism as may be appropriate or required within the scope of
conducting a research and development activity.
TSCA Experimental Release Application or TERA means an exemption
request for a research and development activity, which is not eligible
for a full exemption from reporting under Sec. 725.232, Sec. 725.234,
or Sec. 725.238, submitted to EPA in accordance with subpart E of this
part.
Well-characterized for introduced genetic material means that the
following have been determined:
(1) The function of all of the products expressed from the
structural gene(s).
(2) The function of sequences that participate in the regulation of
expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and
their associated functions, where associated nucleotide sequences are
those sequences needed to move genetic material including linkers,
homopolymers, adaptors, transposons, insertion sequences, and
restriction enzyme sites.
[62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020]
Sec. 725.8 Coverage of this part.
(a) Microorganisms subject to this part. Only microorganisms which
are manufactured, imported, or processed for commercial purposes, as
defined in Sec. 725.3, are subject to the requirements of this part.
(b) Microorganisms automatically included on the Inventory.
Microorganisms that are not intergeneric are
[[Page 32]]
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 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.
[62 FR 17932, Apr. 11, 1997, as amended at 89 FR 102799, Dec. 18, 2024]
Sec. 725.12 Identification of microorganisms for Inventory and other
listing purposes.
To identify and list microorganisms on the Inventory, both taxonomic
designations and supplemental information will be used. The supplemental
information required in paragraph (b) of this section will be used to
specifically describe an individual microorganism on the Inventory.
Submitters must provide the supplemental information required by
paragraph (b) of this section to the extent necessary to enable a
microorganism to be accurately and unambiguously identified on the
Inventory.
(a) Taxonomic designation. The taxonomic designation of a
microorganism must be provided for the donor organism and the recipient
microorganism to the level of strain, as appropriate. These designations
must be substantiated by a letter from a culture collection, literature
references, or the results of tests conducted for the purpose of
taxonomic classification. Upon EPA's request to the submitter, data
supporting the taxonomic designation must be provided to EPA. The
genetic history of the recipient microorganism should be documented back
to the isolate from which it was derived.
(b) Supplemental information. The supplemental information described
in paragraphs (b)(1) and (b)(2) of this section is required to the
extent that it enables a microorganism to be accurately and
unambiguously identified.
(1) Phenotypic information. Phenotypic information means pertinent
traits that result from the interaction of a microorganism's genotype
and the environment in which it is intended to be used and may include
intentionally added biochemical and physiological traits.
(2) Genotypic information. Genotypic information means the pertinent
and distinguishing genotypic characteristics of a microorganism, such as
the identity of the introduced genetic material and the methods used to
construct the reported microorganism. This also may include information
on the vector construct, the cellular location, and the number of copies
of the introduced genetic material.
Sec. 725.15 Determining applicability when microorganism identity or
use is confidential or uncertain.
(a) Consulting EPA. Persons intending to conduct activities
involving microorganisms may determine their obligations under this part
by consulting the Inventory or the microorganisms and uses specified in
Sec. 725.239 or in subpart M of this part. This section establishes
procedures for EPA to assist persons in determining whether the
microorganism or the use is listed on the Inventory, in Sec. 725.239 or
in subpart M of this part.
(1) Confidential identity or use. In some cases it may not be
possible to directly determine if a specific microorganism is listed,
because portions of that entry may contain generic information to
protect confidential business information (CBI). If any portion of the
microorganism's identity or use has
[[Page 33]]
been claimed as CBI, that portion does not appear on the public version
of the Inventory, in Sec. 725.239 or in subpart M of this part.
Instead, it is contained in a confidential version held in EPA's
Confidential Business Information Center (CBIC). The public versions
contain generic information which masks the confidential business
information. A person who intends to conduct an activity involving a
microorganism or use whose entry is described with generic information
will need to inquire of EPA whether the unreported microorganism or use
is on the confidential version.
(2) Uncertain microorganism identity. The current state of
scientific knowledge leads to some imprecision in describing a
microorganism. As the state of knowledge increases, EPA will be
developing policies to determine whether one microorganism is equivalent
to another. Persons intending to conduct activities involving
microorganisms may inquire of EPA whether the microorganisms they intend
to manufacture (including import) or process are equivalent to specific
microorganisms described on the Inventory, in Sec. 725.239, or in
subpart M of this part.
(b) Requirement of bona fide intent. (1) EPA will answer the
inquiries described in paragraph (a) of this section only if the Agency
determines that the person has a bona fide intent to conduct the
activity for which reporting is required or for which any exemption may
apply.
(2) To establish a bona fide intent to manufacture (including
import) or process a microorganism, the person who proposes to
manufacture (including import) or process the microorganism must submit
the request to EPA via CDX. Prior to submission to EPA via CDX, such
bona fide intents to manufacture (including import) or process must be
generated and completed using e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how to access the e-PMN software. A
bona fide intent to manufacture (including import) or process must
contain the following information:
(i) Taxonomic designations and supplemental information required by
Sec. 725.12.
(ii) A signed statement certifying that the submitter intends to
manufacture (including import) or process the microorganism for
commercial purposes.
(iii) A description of research and development activities conducted
with the microorganism to date, demonstration of the submitter's ability
to produce or obtain the microorganism from a foreign manufacturer, and
the purpose for which the person will manufacture (including import) or
process the microorganism.
(iv) An indication of whether a related microorganism was previously
reviewed by EPA to the extent known by the submitter.
(v) A specific description of the major intended application or use
of the microorganism.
(c) If an importer or processor cannot provide all the information
required by paragraph (b) of this section, because it is claimed as
confidential business information by its foreign manufacturer or
supplier, the foreign manufacturer 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
[[Page 34]]
originally reported the microorganism that another person (whose
identity will remain confidential, if so requested) has demonstrated a
bona fide intent to manufacture (including import) or process the
microorganism and therefore was told that the microorganism is on the
Inventory, in Sec. 725.239, or in subpart M of this part.
(g) A disclosure to a person with a bona fide intent to manufacture
(including import) or process a particular microorganism that the
microorganism is on the Inventory, in Sec. 725.239, or in subpart M of
this part will not be considered a public disclosure of confidential
business information under section 14 of the Act.
(h) EPA will answer an inquiry on whether a particular microorganism
is subject to this part within 30 days after receipt of a complete
submission under paragraph (b) of this section.
[62 FR 17932, Apr. 11, 1997, as amended at 80 FR 42747, July 20, 2015]
Sec. 725.17 Consultation with EPA.
Persons may consult with EPA, either in writing or by telephone,
about their obligations under this part. Written consultation is
preferred. Written inquiries should be sent to the following address:
Environmental Assistance Division (7408), Office of Pollution Prevention
and Toxics, U.S. Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, ATTN: Biotechnology Notice
Consultation. Persons wishing to consult with EPA by telephone should
call (202) 554-1404; hearing impaired TDD (202) 554-0551 or e-mail:
[email protected].
Subpart B_Administrative Procedures
Sec. 725.20 Scope and purpose.
This subpart describes general administrative procedures applicable
to all persons who submit MCANs and exemption requests to EPA under
section 5 of the Act for microorganisms.
Sec. 725.25 General administrative requirements.
(a) General. (1) Each person who is subject to the notification
provisions of this part must complete, sign, and submit a MCAN or
exemption request containing the information as required for the
appropriate submission under this part. Except as otherwise provided,
each submission must include all referenced attachments. All information
in the submission (unless certain attachments appear in the open
scientific literature) must be in English. All information submitted
must be true and correct.
(2) In addition to specific information required, the submitter
should submit all information known to or reasonably ascertainable by
the submitter that would permit EPA to make a reasoned evaluation of the
human health and environmental effects of the microorganism and any
microbial mixture or article that may contain the microorganism.
(b) Certification. Persons submitting MCANs and exemption requests
to EPA under this part, and material related to their reporting
obligations under this 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
[[Page 35]]
in Sec. 725.155, Sec. 725.255, Sec. 725.355, or Sec. 725.455, as
appropriate, to the extent such information is known to or reasonably
ascertainable by the submitter.
(2) In accordance with Sec. 725.160 or Sec. 725.260, as
appropriate, the submission must also include any test data in the
submitter's possession or control and descriptions of other data which
are known to or reasonably ascertainable by the submitter and which
concern the health and environmental effects of the microorganism.
(e) Agency or joint submissions. (1) A manufacturer or importer may
designate an agent to assist in submitting the MCAN. If so, only the
manufacturer or importer, and not the agent, signs the certification on
the form.
(2) A manufacturer or importer may authorize another person, (e.g.,
a supplier or a toll manufacturer) to report some of the information
required in the MCAN to EPA on its behalf. The manufacturer or importer
should indicate in a cover letter accompanying the MCAN which
information will be supplied by another person and identify that other
person as a joint submitter where indicated in their MCAN. The other
person supplying information (i.e., the joint submitter) may submit the
information to EPA either in the MCAN or a Letter of Support, except
that if the joint submitter is not incorporated, licensed, or doing
business in the United States, the joint submitter must submit the
information to EPA in a Letter of Support only, rather than the MCAN.
The joint submitter must indicate in the MCAN or Letter of Support the
identity of the manufacturer or importer. Any person who submits the
MCAN or Letter of Support for a joint submission must sign and certify
the MCAN or Letter of Support.
(3) If EPA receives a submission which does not include the
information required, which the submitter indicates that it has
authorized another person to provide, the review period will not begin
until EPA receives all of the required information.
(f) Microorganisms subject to a section 4 test rule. (1) Except as
provided in paragraph (f)(3) of this section, if a person intends to
manufacture or import a new microorganism which is subject to the
notification requirements of this part, and the microorganism is subject
to a test rule promulgated under section 4 of the Act before the notice
is submitted, section 5(b)(1) of the Act requires the person to submit
the test data required by the testing rule with the notice. The person
must submit the data in the form and manner specified in the test rule
and in accordance with Sec. 725.160. If the person does not submit the
test data, the submission is incomplete and EPA will follow the
procedures in Sec. 725.33.
(2) If EPA has granted the submitter an exemption under section 4(c)
of the Act from the requirement to conduct tests and submit data, the
person may not file a MCAN or TERA until EPA receives the test data.
(3) If EPA has granted the submitter an exemption under section 4(c)
of the Act and if another person previously has submitted the test data
to EPA, 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.
[[Page 36]]
(h) Data that need not be submitted. Specific data requirements are
listed in subparts D, E, F, G, and L of this part. The following is a
list of data that need not be submitted under this part:
(1) Data previously submitted to EPA. (i) A person need not submit
any data previously submitted to EPA with no claims of confidentiality
if the new submission includes: the office or person to whom the data
were submitted; the date of submission; and, if appropriate, a standard
literature citation as specified in Sec. 725.160(a)(3)(ii).
(ii) For data previously submitted to EPA with a claim of
confidentiality, the person must resubmit the data with the new
submission and any claim of confidentiality, under Sec. 725.80.
(2) Efficacy data. This part does not require submission of any data
related solely to product efficacy. However, including efficacy data
will improve EPA's ability to assess the benefits of the use of the
microorganism. This does not exempt a person from submitting any of the
data specified in Sec. 725.160 or Sec. 725.260.
(3) Non-U.S. exposure data. This part does not require submission of
any data which relates only to exposure of humans or the environment
outside the United States. This does not exclude nonexposure data such
as data on health effects (including epidemiological studies),
ecological effects, physical and chemical properties, or environmental
fate characteristics.
(i) Fees. Persons submitting MCANs and exemption requests to EPA
under this part are subject to the applicable fees and conditions
specified in Sec. Sec. 700.40, 700.45(c), and 700.49 of this chapter.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013; 83 FR 52723, Oct. 17, 2018]
Sec. 725.27 Submissions.
Each person who is required to submit information under this part
must submit the information in the form and manner set forth in the
appropriate subpart.
(a) Requirements specific to MCANs are described in Sec. Sec.
725.150 through 725.160.
(b) Requirements specific to TERAs are described in Sec. Sec.
725.250 through 725.260.
(c) Requirements specific to test marketing exemptions (TMEs) are
described in Sec. Sec. 725.350 and 725.355.
(d) Requirements specific to Tier I and Tier II exemptions for
certain general commercial uses are described in Sec. Sec. 725.424
through 725.470.
(e) Additional requirements specific to significant new uses for
microorganisms are described at Sec. 725.950.
Sec. 725.28 Notice that submission is not required.
When EPA receives a MCAN or exemption request, EPA will review it to
determine whether the microorganism is subject to the requirements of
this part. If EPA determines that the microorganism is not subject to
these requirements, EPA will notify the submitter that section 5 of the
Act does not prevent the manufacture, import, or processing of the
microorganism and that the submission is not needed.
Sec. 725.29 EPA acknowledgement of receipt of submission.
(a) EPA will acknowledge receipt of each submission by sending a
letter via CDX or U.S. mail to the submitter that identifies the number
assigned to each MCAN or exemption request and the date on which the
review period begins. The review period will begin on the date the MCAN
or exemption request is received by the Office of Pollution Prevention
and Toxics Document Control Officer.
(b) The acknowledgement does not constitute a finding by EPA that
the submission is in compliance with this part.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010]
Sec. 725.32 Errors in the submission.
(a) Within 30 days of receipt of the submission, EPA may request
that the submitter remedy errors in the submission. The following are
examples of such errors:
(1) Failure to date the submission.
(2) Typographical errors that cause data to be misleading or answers
to any questions to be unclear.
(3) Contradictory information.
(4) Ambiguous statements or information.
[[Page 37]]
(b) In the request to correct the submission, EPA will explain the
action which the submitter must take to correct the submission.
(c) If the submitter fails to correct the submission within 15 days
of receipt of the request, EPA may extend the review period.
Sec. 725.33 Incomplete submissions.
(a) A submission under this part is not complete, and the review
period does not begin, if:
(1) The wrong person files the submission.
(2) The submitter does not attach and sign the certification
statement as required by Sec. 725.25(b).
(3) Some or all of the information in the submission or any
attachments are not in English, except for published scientific
literature.
(4) The submitter does not provide information that is required by
sections 5(d)(1)(B) and (C) of the Act and Sec. 725.160 or 725.260, as
appropriate.
(5) The submitter does not provide information required by Sec.
725.25, Sec. 725.155, Sec. 725.255, Sec. 725.355, or Sec. 725.455,
as appropriate, or indicate that it is not known to or reasonably
ascertainable by the submitter.
(6) The submitter has asserted confidentiality claims and has failed
to:
(i) Submit a second copy of the submission with all confidential
information deleted for the public file, as required by Sec.
725.80(b)(2).
(ii) Comply with the substantiation requirements as described in
Sec. 725.94.
(7) The submitter does not include any information required by
section 5(b)(1) of the Act and pursuant to a rule promulgated under
section 4 of the Act, as required by Sec. 725.25(f).
(8) The submitter does not submit data which the submitter believes
show that the microorganism will not present an unreasonable risk of
injury to health or the environment, if EPA has listed the microorganism
under section 5(b)(4) of the Act, as required in Sec. 725.25(g).
(9) The submitter does not remit the fees required by Sec.
700.45(c) of this chapter.
(10) The submitter does not include an identifying number and a
payment identity number.
(11) The submitter does not submit the notice in the manner set
forth in Sec. 725.25(c).
(b)(1) If EPA receives an incomplete submission under this part, the
Director, or a designee, will notify the submitter within 30 days of
receipt that the submission is incomplete and that the review period
will not begin until EPA receives a complete submission.
(2) If EPA obtains additional information during the review period
for any submission that indicates the original submission was
incomplete, the Director, or a designee, may declare the submission
incomplete within 30 days after EPA obtains the additional information
and so notify the submitter.
(c) The notification that a submission is incomplete under paragraph
(b) of this section will include:
(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
[[Page 38]]
originally requested. If EPA can complete its review within the review
period beginning on the date of the submission, the Director, or a
designee, may inform the submitter that the running of the review period
will resume on the date EPA originally declared it incomplete.
(3) If the Director, or a designee, modifies the requirements for
completing the submission or concurs with EPA's original determination,
the review period will begin when EPA receives a complete submission.
(f) If EPA discovers at any time that a person submitted materially
false or misleading statements in information submitted under this part,
EPA may find that the submission was incomplete from the date it was
submitted, and take any other appropriate action.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 788, Jan. 6, 2010; 83
FR 52723, Oct. 17, 2018]
Sec. 725.36 New information.
(a) During the review period, if a submitter possesses, controls, or
knows of new information that materially adds to, changes, or otherwise
makes significantly more complete the information included in the MCAN
or exemption request, the submitter must send that information within 10
days of receiving the new information, but no later than 5 days before
the end of the review period. The new information must be sent in the
same manner the original notice or exemption was sent, as described in
Sec. 725.25(c)(1), (c)(2), and (c)(3).
(b) The new submission must clearly identify the submitter, the MCAN
or exemption request to which the new information is related, and the
number assigned to that submission by EPA, if known to the submitter.
(c) If the new information becomes available during the last 5 days
of the review period, the submitter must immediately inform the EPA
contact for that submission by telephone of the new information.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010]
Sec. 725.40 Notice in the Federal Register.
(a) Filing of Federal Register notice. After EPA receives a MCAN or
an exemption request under this part, EPA will issue a notice in the
Federal Register including the information specified in paragraph (b) of
this section.
(b) Contents of notice. (1) In the public interest, the specific
microorganism identity listed in the submission will be published in the
Federal Register unless the submitter has claimed the microorganism
identity confidential. If the submitter claims confidentiality, a
generic name will be published in accordance with Sec. 725.85.
(2) The categories of use of the microorganism will be published as
reported in the submission unless this information is claimed
confidential. If confidentiality is claimed, the generic information
which is submitted under Sec. 725.88 will be published.
(3) A list of information submitted in accordance with Sec.
725.160(a), Sec. 725.255, 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.
[[Page 39]]
(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, or in
writing, including by e-mail, 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 or written request for suspension may be granted by EPA
for a maximum of 30 days only. Requests for longer suspension must only
be submitted in the manner set forth in paragraph (b)(2) of this
section.
(d) If the submitter has not made a previous oral or written
request, the running of the applicable 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; 89 FR 102799, Dec. 18, 2024]
Sec. 725.56 Extension of the review period.
(a) At any time during the review period, EPA may unilaterally
determine that good cause exists to extend the review period specified
for MCANs, or the exemption requests.
(b) If EPA makes such a determination, EPA:
(1) Will notify the submitter that EPA is extending the review
period for a specified length of time and state the reasons for the
extension.
(2) For MCANs, EPA may issue a notice for publication in the Federal
Register which states that EPA is extending the review period and gives
the reasons for the extension.
(c) The total period of the extension may be for a period of up to
the same length of time as specified for each type of submission in
Sec. 725.50. If the initial extension is for less than the total time
allowed, EPA may make additional extensions. However, the sum of the
extensions may not exceed the total allowed.
(d) The following are examples of situations in which EPA may find
that good cause exists for extending the review period:
(1) EPA has reviewed the submission and is seeking additional
information.
(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 applicable 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
[[Page 40]]
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; 89 FR 102799, Dec. 18, 2024]
Sec. 725.65 Recordkeeping.
(a) General provisions. (1) Any person who submits a notice under
this part must retain documentation of information in the submission,
including:
(i) Any data in the submitter's possession or control; and
(ii) Records of production volume for the first 3 years of
manufacture, import, or processing.
(2) Any person who submits a notice under this part must retain
documentation of the date of commencement of testing, manufacture,
import, or processing.
(3) Any person who is exempt from some or all of the reporting
requirements of this part must retain documentation that supports the
exemption.
(4) All information required by this section must be retained for 3
years from the date of commencement of each activity for which records
are required under this part.
(b) Specific requirements. In addition to the requirements of
paragraph (a) of this section, specific recordkeeping requirements
included in certain subparts must also be followed.
(1) Additional recordkeeping requirements for activities conducted
inside a structure are set forth in Sec. 725.235(h).
(2) Additional recordkeeping requirements for TERAs are set forth in
Sec. 725.250(f).
(3) Additional recordkeeping requirements for TMEs are set forth in
Sec. 725.350(c).
(4) Additional recordkeeping requirements for Tier I exemptions
under subpart G of this part are set forth in Sec. 725.424(a)(5).
(5) Additional recordkeeping requirements for Tier II exemptions
under subpart G of this part are set forth in Sec. 725.450(d).
(6) Additional recordkeeping requirements for significant new uses
of microorganisms reported under subpart L of this part are set forth in
Sec. 725.850. Recordkeeping requirements may also be included when a
microorganism and significant new use are added to subpart M of this
part.
Sec. 725.67 Applications to exempt new microorganisms from this part.
(a) Submission. (1) Any manufacturer or importer of a new
microorganism may request, under TSCA section 5(h)(4), an exemption, in
whole or in part, from this part by sending a Letter of Application in
the manner set forth in Sec. 725.25(c).
(2) General provisions. The Letter of Application should provide
information to show that any activities affected by the requested
exemption will not present an unreasonable risk of injury to health or
the environment. This information should include data described in the
following paragraphs.
(i) The effects of the new microorganism on health and the
environment.
(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;
[[Page 41]]
(B) Information to evaluate the relationship of the microorganism to
any other closely related microorganisms which have a potential for
adverse effects on health or the environment;
(C) A history of safe commercial use for the microorganism;
(D) Commercial uses indicating that the microorganism products might
be subject to TSCA;
(E) Studies which indicate the potential for the microorganism to
cause adverse effects to health or the environment; and
(F) Studies which indicate the survival characteristics of the
microorganism in the environment.
(b) Processing of the Letter of Application by EPA--(1) Grant of the
Application. If, after consideration of the Letter of Application and
any other relevant information available to EPA, the Assistant
Administrator for Chemical Safety and Pollution Prevention makes a
preliminary determination that the new microorganism will not present an
unreasonable risk of injury to health or the environment, the Assistant
Administrator will propose a rule to grant the exemption using the
applicable procedures in part 750 of this chapter.
(2) Denial of the application. If the Assistant Administrator
decides that the preliminary determination described in paragraph (b)(1)
of this section cannot be made, the application will be denied by
sending the applicant a written statement with the Assistant
Administrator's reasons for denial.
(c) Processing of the exemption--(1) Unreasonable risk standard.
Granting a section 5(h)(4) exemption requires a determination that the
activities will not present an unreasonable risk of injury to health or
the environment.
(i) An unreasonable risk determination under the Act is an
administrative judgment that requires balancing of the harm to health or
the environment that a chemical substance may cause and the magnitude
and severity of that harm, against the social and economic effects on
society of EPA action to reduce that harm.
(ii) A determination of unreasonable risk under section 5(h)(4) of
the Act will examine the reasonably ascertainable economic and social
consequences of granting or denying the exemption after consideration of
the effect on the national economy, small business, technological
innovation, the environment, and public health.
(2) Grant of the exemption. The exemption will be granted if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the new microorganism will not present an
unreasonable risk of injury to health or the environment.
(3) Denial of the exemption. The exemption will be denied if the
Assistant Administrator determines, after consideration of all relevant
evidence presented in the rulemaking proceeding described in paragraph
(b)(1) of this section, that the determination described in paragraph
(c)(2) of this section cannot be made. A final decision terminating the
rulemaking proceeding will be published in the Federal Register.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 77
FR 46292, Aug. 3, 2012]
Sec. 725.70 Compliance.
(a) Failure to comply with any provision of this part is a violation
of section 15 of the Act (15 U.S.C. 2614).
(b) A person who manufactures or imports a microorganism before a
MCAN is submitted and the MCAN review period expires is in violation of
section 15 of the Act even if that person was not required to submit the
MCAN under Sec. 725.105.
(c) Using a microorganism which a person knew or had reason to know
was manufactured, processed, or distributed in commerce in violation of
section 5 of the Act or this part is a violation of section 15 of the
Act (15 U.S.C. 2614).
(d) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
(e) Failure or refusal to permit entry or inspection as required by
section 11 of the Act is a violation of section 15 of the Act (15 U.S.C.
2614).
(f) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each
[[Page 42]]
violation. Persons who submit materially misleading or false information
in connection with the requirements of any provision of this part may be
subject to penalties calculated as if they never filed their
submissions.
(g) EPA may seek to enjoin the manufacture or processing of a
microorganism in violation of this part or act to seize any
microorganism manufactured or processed in violation of this part or
take other actions under the authority of section 7 of the Act (15
U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
Sec. 725.75 Inspections.
EPA will conduct inspections under section 11 of the Act to assure
compliance with section 5 of the Act and this part, to verify that
information required by EPA under this part is true and correct, and to
audit data submitted to EPA under this part.
Subpart C_Confidentiality and Public Access to Information
Sec. 725.80 General provisions for confidentiality claims.
Claims of confidentiality must be made in accordance with the
procedures described in 40 CFR part 703, except as modified in this
paragraph. In general, references to ``chemical'' or ``chemical
identity'' in part 703 are equivalent to ``microorganism'' or
``microorganism identity'' for the purposes of this part.
(a) In place of Sec. 703.5(b)(3)(v) of this subchapter, the
following question must be answered: Has EPA, another Federal agency, or
court made any confidentiality determination regarding information
associated with this microorganism? If yes, please provide the
circumstances associated with the prior determination, whether the
information was found to be entitled to confidential treatment, the
entity that made the decision, and the date of the determination.
(b) In place of Sec. 703.5(b)(4) of this subchapter, the following
questions apply:
(1) Has the identity of the microorganism been kept confidential to
the extent that competitors do not know it is being manufactured or
imported into US commerce? If not, explain why the microorganism
identity should still be afforded confidential status (e.g., the
microorganism is publicly known only as being distributed in commerce
for research and development purposes, but no other information about
the current commercial distribution of the microorganism in the United
States is publicly available).
(2) Does the microorganism leave the site of production or testing
in a form which is accessible to the public or to competitors? If yes,
please explain what measures have been taken to guard against the
discovery of its identity. Further, what is the cost to a competitor, in
time and money, to develop appropriate use conditions? What factors
facilitate or impede product analysis?
[88 FR 37173, June 7, 2023]
Sec. 725.88 Uses of a microorganism.
(a) Assertion of claim. A person who submits information to EPA
under this part on the categories or proposed categories of use of a
microorganism may assert a claim of confidentiality for this
information.
(b) Requirements for claim. A submitter that asserts such a claim
must:
(1) Report the categories or proposed categories of use of the
microorganism.
(2) Provide, in nonconfidential form, a description of the uses that
is only as generic as necessary to protect the confidential business
information. The generic use description will be included in the Federal
Register notice described in Sec. 725.40.
(c) Generic use description. The person must submit the information
required by paragraph (b) of this section by describing the uses as
precisely as possible, without revealing the information which is
claimed confidential, to disclose as much as possible how the use may
result in human exposure to the microorganism or its release to the
environment.
Sec. 725.95 Public file.
All information submitted, including any health and safety study of
a microorganism and other supporting documentation, will become part of
the public file for that submission, unless such materials are claimed
as confidential in accordance with this section. In addition, EPA may
add materials to
[[Page 43]]
the public file, subject to subpart C of this part. Publicly available
materials are available at the docket addresses in Sec. 700.17(b)(1)
and (2) of this subchapter and on EPA's website.
[88 FR 37174, June 7, 2023]
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 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
[[Page 44]]
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 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.
[[Page 45]]
(ii) Information on the morphological and physiological features of
the new microorganism.
(iii) Other specific data by which the new microorganism may be
uniquely identified for Inventory purposes.
(2) Genetic construction of the new microorganism. (i) Data
substantiating the taxonomy of the donor organism(s). In lieu of data,
EPA will accept a letter from a culture collection substantiating
taxonomy, provided EPA, upon request to the submitter, may have access
to the data supporting the taxonomic designation.
(ii) Description of the traits for which the new microorganism has
been selected or developed and other traits known to have been added or
modified.
(iii) A detailed description of the genetic construction of the new
microorganism, including the technique used to modify the microorganism
(e.g., fusion of cells, injection of DNA, electroporation or chemical
poration, or methods used for induced mutation and selection). The
description should include, for example, a description of the introduced
genetic material, including any regulatory sequences and structural
genes and the products of those genes; how the introduced genetic
material is expected to affect behavior of the recipient; expression,
alteration, and stability of the introduced genetic material; methods
for vector construction and introduction; and a description of the
regulatory and structural genes that are components of the introduced
genetic material, including genetic maps of the introduced sequences.
(3) Phenotypic and ecological characteristics. (i) Habitat,
geographical distribution, and source of the recipient microorganism.
(ii) Survival and dissemination under relevant environmental
conditions including a description of methods for detecting the new or
recipient microorganism(s) in the environment and the sensitivity limit
of detection for these techniques.
(iii) A description of anticipated biological interactions with and
effects on target organisms and other organisms such as competitors,
prey, hosts, symbionts, parasites, and pathogens; a description of host
range; a description of pathogenicity, infectivity, toxicity, virulence,
or action as a vector of pathogens; and capacity for genetic transfer
under laboratory and relevant environmental conditions.
(iv) A description of anticipated involvement in biogeochemical or
biological cycling processes, involvement in rate limiting steps in
mineral or nutrient cycling, or involvement in inorganic compounds
cycling (such as possible sequestration or transformation of heavy
metals).
(e) Byproducts. A description of the byproducts resulting from the
manufacture, processing, use, and disposal of the new microorganism.
(f) Total production volume. The estimated maximum amount of the new
microorganism intended to be manufactured or imported during the first
year of production and the estimated maximum amount to be manufactured
or imported during any consecutive 12-month period during the first 3
years of production. This estimate may be by weight or volume and should
include an estimation of viability (i.e., viable cells per unit volume
or colony forming units per unit dry weight).
(g) Use information. A description of intended categories of use by
function and application, the estimated percent of production volume
devoted to each category of use, and the percent of the new
microorganism in the formulation for each commercial or consumer use.
(h) Worker exposure and environmental release. (1) For sites
controlled by the submitter:
(i) The identity of sites where the new microorganism will be
manufactured, processed, or used. For purposes of this section, the site
for a person who imports a new microorganism is the site of the
operating unit within the person's organization which is directly
responsible for importing the new microorganism and which controls the
import transaction. The import 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
[[Page 46]]
points of release of the new microorganism from the process, including a
description of all controls, including engineering controls, used to
prevent such releases.
(iii) Worker exposure information, including worker activities,
physical form of process streams which contain the new microorganism to
which workers may be exposed, the number of workers, and the duration of
activities.
(iv) Information on release of the new microorganism to the
environment, including the quantity and media of release and type of
control technology used.
(v) A narrative description of the intended transport of the new
microorganism, including the means of transport, containment methods to
be used during transport, and emergency containment procedures to be
followed in case of accidental release.
(vi) Procedures for disposal of any articles, waste, clothing, or
other equipment involved in the activity, including procedures for
inactivation of the new microorganism, containment, disinfection, and
disposal of contaminated items.
(2) For sites not controlled by the submitter, a description of each
type of processing and use operation involving the new microorganism,
including identification of the estimated number of processing or use
sites, situations in which worker exposure to and/or environmental
release of the new microorganism will occur, the number of workers
exposed and the duration of exposure; procedures for transport of the
new microorganism and for disposal, including procedures for
inactivation of the new microorganism; and control measures which limit
worker exposure and environmental release.
Sec. 725.160 Submission of health and environmental effects data.
(a) Test data on the new microorganism in the possession or control
of the submitter. (1) Except as provided in Sec. 725.25(h), and in
addition to the information required by Sec. 725.155(d)(3), each MCAN
must contain all test data in the submitter's possession or control
which are related to the effects on health or the environment of any
manufacture, processing, distribution in commerce, use, or disposal of
the new microorganism or any microbial mixture or article containing the
new microorganism, or any combination of such activities. This includes
test data concerning the new microorganism in a pure culture or
formulated form as used or as intended to be used in one of the
activities listed above.
(2) A full report or standard literature citation must be submitted
for the following types of test data:
(i) Health effects data.
(ii) Ecological effects data.
(iii) Physical and chemical properties data.
(iv) Environmental fate characteristics.
(v) Monitoring data and other test data related to human exposure to
or environmental release of the new microorganism.
(3)(i) If the data do not appear in the open scientific literature,
the submitter must provide a full report. A full report includes the
experimental methods and materials, results, discussion and data
analysis, conclusions, references, and the name and address of the
laboratory that developed the data.
(ii) If the data appear in the open scientific literature, the
submitter need only provide a standard literature citation. A standard
literature citation includes author, title, periodical name, date of
publication, volume, and page numbers.
(4)(i) If a study, report, or test is incomplete when a person
submits a MCAN, the submitter must identify the nature and purpose of
the study; name and address of the laboratory developing the data;
progress to date; types of data collected, significant preliminary
results; and anticipated completion date.
(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.
[[Page 47]]
(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 EPA 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) Determinations. (1) Within the applicable review period, EPA
will make one of the following five determinations on the microorganism,
as set forth in section 5(a)(3) of the Act:
(i) The microorganism presents an unreasonable risk of injury to
health or the environment, as set forth in section 5(a)(3)(A) of the
Act.
(ii) Information available to EPA is insufficient to permit a
reasoned evaluation of the health and the environmental effects of the
microorganism, as set forth in section 5(a)(3)(B)(i) of the Act.
(iii) In the absence of sufficient information to permit EPA to make
such an evaluation, the microorganism may present an unreasonable risk
of injury to health or the environment, as set forth in section
5(a)(3)(B)(ii)(I) of the Act.
(iv) The microorganism is or will be produced in substantial
quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there
is or may be significant or
[[Page 48]]
substantial human exposure to the substance, as set forth in section
5(a)(3)(B)(ii)(II) of the Act.
(v) The microorganism is not likely to present an unreasonable risk
of injury to health or the environment, as set forth in section
5(a)(3)(C) of the Act.
(2) EPA will take the following actions required in association with
the determination.
(i) For determinations described in paragraph (b)(1)(i) of this
section, EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the microorganism, or any combination of such activities, to the extent
necessary to protect against an unreasonable risk of injury to health or
the environment, as set forth in section 5(f) of the Act, or will issue
a proposed rule under section 6(a) of the Act, as set forth in section
5(f) of the Act.
(ii) For determinations described in paragraphs (b)(1)(ii), (iii),
or (iv), EPA will issue the submitter an order to prohibit or limit the
manufacture, processing, distribution in commerce, use, or disposal of
the microorganism, or any combination of such activities, to the extent
necessary to protect against an unreasonable risk of injury to health or
the environment, as set forth in section 5(e) of the Act. EPA may issue
an order under section 5(e) of the Act that requires certain testing to
be conducted and presented to EPA after the applicable review period has
concluded.
(iii) Following determinations described in paragraph (b)(1)(v) of
this section, EPA will issue the submitter a document containing EPA's
final determination and will submit for publication in the Federal
Register a statement of the finding, as set forth in section 5(g) of the
Act. Upon EPA's issuance of the determination document, the submitter
may commence the manufacture of the microorganism without waiting for
the end of the applicable review period.
(3) EPA may modify or revoke the prohibitions and limitations in an
order issued under paragraph (b)(2)(i) or (ii) of this section after the
applicable review period has ended if EPA receives additional
information, testing, studies, or reports that EPA determines, upon
review, demonstrate that such prohibitions or limitations are no longer
necessary to protect against an unreasonable risk of injury to health or
the environment. Where such information demonstrates that the
prohibitions or limitations of the order are not sufficient to protect
against an unreasonable risk of injury to health or the environment, EPA
may modify the order or take other action, as appropriate, to the extent
necessary to protect against such risk.
(4) No person submitting an MCAN in response to the requirements of
this subpart may manufacture a microorganism subject to this subpart
until EPA has issued a determination in accordance with paragraph (b)(1)
of this section and taken the associated action required under paragraph
(b)(2) of this section.
[62 FR 17932, Apr. 11, 1997, as amended by 89 FR 102799, Dec. 18, 2024]
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 claims any
information on
[[Page 49]]
the form as confidential, the claim must be asserted and substantiated
in accordance with the requirements described in part 703 of this
subchapter and Sec. 725.80, as indicated in EPA Form 7710-56. If the
submitter wants the microorganism identity to be listed on the
confidential portion of the TSCA Inventory, the microorganism identity
must be claimed as confidential and also follow the certification,
substantiation, and generic name requirements described in part 703 of
this subchapter and paragraphs (e) and (f) of this section.
(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.
(e) Requirements for assertion. Any person who asserts a
confidentiality claim for microorganism identity must:
(1) Comply with the requirements of paragraph (f) of this section
regarding submission of a generic name.
(2) Agree that EPA may disclose to a person with a bona fide intent
to manufacture or import the microorganism the fact that the particular
microorganism is included on the confidential TSCA Inventory for
purposes of notification under section 5(a)(1)(A) of the Act.
(3) Have available and agree to furnish to EPA upon request the
taxonomic designations and supplemental information required by Sec.
725.12.
(4) Make claims of confidentiality in accordance with the procedures
described in 40 CFR part 703.
(f) Generic name. If a submitter asserts a claim of confidentiality
for microorganism identity in a notice of commencement, they must
provide a generic name.
(1) Generic names must:
(i) Be structurally descriptive (e.g., not a trade name); and
(ii) Be consistent with guidance on the determination of
structurally descriptive generic names, developed in accordance with
section 14(c)(4)(A) of the Act (e.g., Guidance for Creating Generic
Names for Confidential Chemical Substance Identity Reporting under
TSCA). Generic names for microorganisms may only mask the portion of
microorganism identity that the submitter believes is proprietary
(considering that the identity of a microorganism to be listed on the
TSCA Inventory must include taxonomic designations (genus, species, and
strain), key phenotypic traits, key genotypic traits and modifications,
genetic material that has been introduced or modified, any vector
constructs used, cellular location of introduced or modified genes,
number and type of genes introduced or modified, and method of
construction or modification). Taxonomic designation (in most cases down
to strain) must be included in the generic name except where the
submitter claims the taxonomic designation confidential, in which case
the person making such claim must provide an explanation of why such
masking is necessary to protect proprietary information. Additionally,
the generic microorganism identity must include a statement regarding
the function and stability of the genetic construct. This includes an
indication of whether the introduced or modified genes are present on
the chromosome or extrachromosomal.
(2) Generic names will be reviewed by EPA at the time of submission.
(i) If EPA concludes that a proposed generic name meets the criteria
in paragraph (f)(1) of this section, EPA will include that generic name
in the public TSCA Inventory listing for that substance.
(ii) If the proposed generic name does not meet the criteria in
paragraph (f)(1) of this section, EPA will notify the submitter
concerning the deficiency via CDX, as described in Sec. 703.5(h) of
this subchapter. EPA will provide ten business days to correct the
deficiency and provide an alternative generic name that would be
acceptable to EPA. If the alternative generic name proposed by EPA is
acceptable to the submitter (or if the submitter does not respond within
the ten-day period), EPA will place that alternative generic name on the
public TSCA Inventory. If the alternative generic name proposed by EPA
is not acceptable to the submitter, the submitter must submit a revised
generic
[[Page 50]]
name that meets the criteria in paragraph (f)(1) of this section and an
explanation of how EPA's proposed generic name reveals confidential
information. If EPA concludes that the revised generic name also does
not meet the criteria in paragraph (f)(1) of this section, EPA will hold
the notice of commencement for a period of up to 10 business days.
Reporting requirements will not be considered to have been met and the
microorganism will not be added to the TSCA Inventory during this
period. If the submission remains deficient after this 10-day period,
EPA will proceed with CBI review of the microorganism identity claim and
will likely deny the claim.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 789, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013; 88 FR 37174, June 7, 2023]
Subpart E_Exemptions for Research and Development Activities
Sec. 725.200 Scope and purpose.
(a) This subpart describes exemptions from the reporting
requirements under subpart D of this part for research and development
activities involving microorganisms.
(b) In lieu of complying with subpart D of this part, persons
described in Sec. 725.205 may submit a TSCA Experimental Release
Application (TERA) for research and development activities involving
microorganisms or otherwise comply with this subpart.
(c) Exemptions from part 725 are provided at Sec. Sec. 725.232,
725.234, and 725.238.
(d) Submission requirements specific for TERAs are described at
Sec. 725.250.
(e) Data requirements for TERAs are set forth in Sec. Sec. 725.255
and 725.260.
(f) EPA review procedures specific for TERAs are set forth in
Sec. Sec. 725.270 and 725.288.
(g) Subparts A through C of this part apply to any submission under
this subpart.
Sec. 725.205 Persons who may report under this subpart.
(a) Commercial research and development activities involving new
microorganisms or significant new uses of microorganisms are subject to
reporting under this part unless they qualify for an exemption under
this part.
(b) Commercial purposes for research and development means that the
activities are conducted with the purpose of obtaining an immediate or
eventual commercial advantage for the researcher and would include:
(1) All research and development activities which are funded
directly, in whole or in part, by a commercial entity regardless of who
is actually conducting the research. Indications that the research and
development activities are funded directly, in whole or in part, may
include, but are not limited to:
(i) Situations in which a commercial entity contracts directly with
a university or researcher; or
(ii) Situations in which a commercial entity gives a conditional
grant where the commercial entity holds patent rights, or establishes a
joint venture where the commercial entity holds patent or licensing
rights; or
(iii) Any other situation in which the commercial entity intends to
obtain an immediate or eventual commercial advantage for the commercial
entity and/or the researcher.
(2) Research and development activities that are not funded directly
by a commercial entity, if the researcher intends to obtain an immediate
or eventual commercial advantage. Indications that the researcher
intends to obtain an immediate or eventual commercial advantage may
include, but are not limited to:
(i) The research is directed toward developing a commercially viable
improvement of a product already on the market; or
(ii) The researcher has sought or is seeking commercial funding for
the purpose of developing a commercial application; or
(iii) The researcher or university has sought or is seeking a patent
to protect a commercial application which the research is developing; or
(iv) Other evidence that the researcher is aware of a commercial
application for the research and has directed the research toward
developing that application.
(c) Certain research and development activities involving
microorganisms
[[Page 51]]
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. 725.232, Sec.
725.234, or Sec. 725.238 is exempt from TERA reporting under this
subpart.
(d) A microorganism is not exempt from reporting under subpart D of
this part if any amount of the microorganism, including as part of a
mixture, is processed, distributed in commerce, or used, for any
commercial purpose other than research and development.
(e) Quantities of the inactivated microorganism, or mixtures or
articles containing the inactivated microorganism, remaining after
completion of research and development activities may be disposed of as
a waste in accordance with applicable Federal, State, and local
regulations.
(f) A person who manufactures, imports, or processes a microorganism
solely for research and development is not required to comply with the
requirements of this section if:
(1) The person is manufacturing a microbial pesticide identified in
Sec. 172.45(c), or
(2) The person is manufacturing a microbial pesticide for which an
Experimental Use Permit is required, pursuant to Sec. 172.3; or
(3) The person is manufacturing a microbial pesticide for which a
notification or an Experimental Use Permit is not required to be
submitted.
Sec. 725.232 Activities subject to the jurisdiction of other Federal
programs or agencies.
This part does not apply to any research and development activity
that meets all of the following conditions.
(a) The microorganism is manufactured, imported, or processed solely
for research and development activities.
(b) There is no intentional testing of a microorganism outside of a
structure, as structure is defined in Sec. 725.3.
(c)(1) The person receives research funds from another Federal
agency, and the funds are awarded on the condition that the research
will be conducted in accordance with the relevant portions of the NIH
Guidelines, or
(2) A Federal agency or program otherwise imposes the legally
binding requirement that the research is to be conducted in accordance
with relevant portions of the NIH Guidelines.
Sec. 725.234 Activities conducted inside a structure.
A person who manufactures, imports, or processes a microorganism is
not subject to the reporting requirements under subpart D of this part
if all of the following conditions are met:
(a) The microorganism is manufactured, imported, or processed solely
for research and development activities.
(b) The microorganism is used by, or directly under the supervision
of, a technically qualified individual, as defined in Sec. 725.3. The
technically qualified individual must maintain documentation of the
procedures selected to comply with paragraph (d) of this section and
must ensure that the procedures are used.
(c) There is no intentional testing of a microorganism outside of a
structure, as structure is defined in Sec. 725.3.
(d) Containment and/or inactivation controls. (1) Selection and use
of containment and/or inactivation controls inside a structure for a
particular microorganism shall take into account the following:
(i) Factors relevant to the organism's ability to survive in the
environment.
(ii) Potential routes of release in air, solids and liquids; in or
on waste materials and equipment; in or on people, including maintenance
and custodial personnel; and in or on other organisms, such as insects
and rodents.
(iii) Procedures for transfer of materials between facilities.
(2) The technically qualified individual's selection of containment
and/or inactivation controls shall be approved and certified by an
authorized official (other than the TQI) of the institution that is
conducting the test prior to the commencement of the test.
(3) Records shall be developed and maintained describing the
selection and use of containment and/or inactivation controls, as
specified in Sec. 725.235(c). These records, which must be maintained
at the location where the research and development activity is being
conducted, shall be submitted
[[Page 52]]
to EPA upon written request and within the time frame specified in EPA's
request.
(4) Subsequent to EPA review of records in accordance with paragraph
(d)(3) of this section, changes to the containment/inactivation controls
selected under paragraph (d)(1) of this section must be made upon EPA
order. Failure to comply with EPA's order shall result in automatic loss
of eligibility for an exemption under this section.
(e) The manufacturer, importer, or processor notifies all persons in
its employ or to whom it directly distributes the microorganism, who are
engaged in experimentation, research, or analysis on the microorganism,
including the manufacture, processing, use, transport, storage, and
disposal of the microorganism associated with research and development
activities, of any risk to health, identified under Sec. 725.235(a),
which may be associated with the microorganism. The notification must be
made in accordance with Sec. 725.235(b).
Sec. 725.235 Conditions of exemption for activities conducted inside
a structure.
(a) Determination of risks. To determine whether notification under
Sec. 725.234(e) is required, the manufacturer, importer, or processor
must do one of the following:
(1) For research conducted in accordance with the NIH Guidelines,
the manufacturer, importer, or processor must meet the conditions laid
out at IV-B-4-d of the NIH Guidelines; or
(2) For all other research conducted in accordance with Sec.
725.234, the manufacturer, importer, or processor must review and
evaluate the following information to determine whether there is reason
to believe there is any risk to health which may be associated with the
microorganism:
(i) Information in its possession or control concerning any
significant adverse reaction of persons exposed to the microorganism
which may reasonably be associated with such exposure.
(ii) Information provided to the manufacturer, importer, or
processor by a supplier or any other person concerning a health risk
believed to be associated with the microorganism.
(iii) Health and environmental effects data in its possession or
control concerning the microorganism.
(iv) Information on health effects which accompanies any EPA rule or
order issued under TSCA section 4, 5, or 6 of the Act that applies to
the microorganism and of which the manufacturer, importer, or processor
has knowledge.
(b) Notification to employees and others. (1) The manufacturer,
importer, or processor must notify the persons identified in Sec.
725.234(e) by means of a container labeling system, conspicuous
placement of notices in areas where exposure may occur, written
notification to each person potentially exposed, or any other method of
notification which adequately informs persons of health 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,
[[Page 53]]
or notification simultaneous with initiation of the experiment, the
information submitted for review or notification, along with standard
laboratory records, shall satisfy the recordkeeping requirements
specified in Sec. 725.234(d)(3).
(B) For experiments exempt from Institutional Biosafety Committee
review or notification simultaneous with initiation of the experiment,
documentation of the exemption, along with standard laboratory records,
shall satisfy the recordkeeping requirement specified in Sec.
725.234(d)(3).
(ii) Documentation of how the following requirements are satisfied
under the NIH Guidelines:
(A) Copies or citations to information reviewed and evaluated to
determine the need to make any notification of risk.
(B) Documentation of the nature and method of notification of risk,
including copies of any labels or written notices used.
(C) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of the microorganism, the amount distributed,
and copies of the notifications required.
(2) For all other research conducted in accordance with Sec.
725.234, a person who manufacturers, imports, or processes a
microorganism under this section, must maintain the following records:
(i) Records describing selection and use of containment and/or
inactivation controls required by Sec. 725.234(d)(3) and certification
by an authorized official required by Sec. 725.234(d)(2) for each
microorganism.
(ii) Copies or citations to information reviewed and evaluated under
paragraph (a) of this section to determine the need to make any
notification of risk.
(iii) Documentation of the nature and method of notification under
paragraph (b)(1) of this section, including copies of any labels or
written notices used.
(iv) The names and addresses of any persons other than the
manufacturer, importer, or processor to whom the substance is
distributed, the identity of the microorganism, the amount distributed,
and copies of the notifications required under paragraph (b)(2) of this
section.
Sec. 725.238 Activities conducted outside a structure.
(a) Exemption. (1) Research and development activities involving
intentional testing in the environment of certain microorganisms listed
in Sec. 725.239 may be conducted without prior review by EPA if all of
the conditions of this section and Sec. 725.239 are met.
(2) The research and development activity involving a microorganism
listed in Sec. 725.239 must be conducted by, or directly under the
supervision of, a technically qualified individual, as defined in Sec.
725.3.
(b) Certification. To be eligible for the exemption under this
section, a manufacturer or importer must submit to EPA prior to
initiation of the activity a document signed by an authorized official
containing the following information:
(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.
[[Page 54]]
(2) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in Sec. 725.421(c).
(ii) The introduced genetic material must consist only of the
following components:
(A) The structural gene(s) of interest, which have the following
limitations:
(1) For structural genes encoding marker sequences, the gene is
limited to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.
(2) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.
(B) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.
(ii) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Bradyrhizobium japonicum.
(b) Rhizobium meliloti. To qualify for an exemption under this
section, all of the following conditions must be met for a test
involving Rhizobium meliloti:
(1) Characteristics of recipient microorganism. The recipient
microorganism is limited to strains of Rhizobium meliloti.
(2) Modification of traits. (i) The introduced genetic material must
meet the criteria for poorly mobilizable listed in Sec. 725.421(c) of
this part.
(ii) The introduced genetic material must consist only of the
following components:
(A) The structural gene(s) of interest, which have the following
limitations:
(1) For structural genes encoding marker sequences, the gene is
limited to the aadH gene, which confers resistance to the antibiotics
streptomycin and spectinomycin.
(2) For traits other than antibiotic resistance, the structural gene
must be limited to the genera Bradyrhizobium and Rhizobium.
(B) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(C) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(D) The vector nucleotide sequences needed for vector transfer.
(E) The vector nucleotide sequences needed for vector maintenance.
(3) Limitations on exposure. (i) The test site area must be no more
than 10 terrestrial acres.
(ii) The technically qualified individual must select appropriate
methods to limit the dissemination of modified Rhizobium meliloti.
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
[[Page 55]]
the approval, as well as conditions described in the TERA, and remains
liable for compliance with all terms and conditions, regardless of who
conducts the research and development activity. Any person conducting
the research and development activity approved under the TERA must
comply with all terms of the TERA approval, as well as the conditions
described in the TERA.
(f) Recordkeeping. Persons submitting a TERA must comply with the
recordkeeping requirements of Sec. 725.65. In addition, the following
requirements apply to TERAs:
(1) Each person submitting a TERA under this part must retain
documentation of information contained in the TERA for a period of 3
years from the date that the results of the study are submitted to the
Agency.
(2) Summaries of all data, conclusions, and reports resulting from
the conduct of the research and development activity under the TERA must
be submitted to the EPA address identified in Sec. 725.25(c) within 1
year of the termination of the activity.
Sec. 725.255 Information to be included in the TERA.
(a) To review a TERA, EPA must have sufficient information to permit
a reasoned evaluation of the health and environmental effects of the
planned test in the environment. The person seeking EPA approval must
submit all information known to or reasonably ascertainable by the
submitter on the microorganism(s) and the research and development
activity, including information not listed in paragraphs (c), (d), and
(e) of this section that the person believes will be useful for EPA's
risk assessment. The TERA must be in writing and must include at least
the information described in the following paragraphs.
(b) When specific information is not submitted, an explanation of
why such information is not available or not applicable must be
included.
(c) Persons applying for a TERA, must include the submitter
identification and microorganism identity information required for MCANs
in Sec. 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TERA must submit phenotypic and
ecological characteristics information required in Sec. 725.155(d)(3)
as it relates directly to the conditions of the proposed research and
development activity.
(e) Persons applying for a TERA must also submit the following
information about the proposed research and development activity:
(1) A detailed description of the proposed research and development
activity. (i) The objectives and significance of the activity and a
rationale for testing the microorganisms in the environment.
(ii) Number of microorganisms released (including viability per
volume if applicable) and the method(s) of application or release.
(iii) Characteristics of the test site(s), including location,
geographical, physical, chemical, and biological features, proximity to
human habitation or activity, and description 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),
[[Page 56]]
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 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
[[Page 57]]
may prescribe additional conditions which must be followed by the
submitter.
(ii) If EPA determines that it can no longer conclude that the
activity will not present an unreasonable risk of injury to health or
the environment, it will notify the submitter in writing that EPA is
revoking its approval and state its reasons. In that event, the
submitter must terminate the research and development activity within 48
hours of receipt of the notice in accordance with directions provided by
EPA in the notice.
(b) Evidence of unreasonable risk. (1) If, after approval of a TERA
under this subpart, EPA determines that the proposed research and
development activity will present an unreasonable risk of injury to
health or the environment, EPA will notify the submitter in writing and
state its reasons.
(2) In the notice, EPA may prescribe additional safeguards to
address or reduce the risk, or may instruct the submitter to suspend the
research and development activities.
(3) Within 48 hours, the submitter must implement the instructions
contained in the notice. The submitter may then submit additional
information or arguments concerning the matters raised by EPA and
whether EPA should modify or revoke the approval of the TERA in
accordance with paragraph (a)(2) of this section.
(4) EPA will consider the information and arguments in accordance
with paragraph (a)(3) of this section.
(5) Following consideration of the information and arguments under
paragraph (a)(3) of this section, if EPA notifies the submitter that the
R&D activity must be suspended or terminted, the submitter may resume
the activity only upon written notice from EPA that EPA has approved
resumption of the activity. In approving resumption of an activity, EPA
may prescribe additional conditions which must be followed by the
submitter.
(c) Modifications. If, after approval of a TERA under this subpart,
the submitter concludes that it is necessary to alter the conduct of the
research and development activity in a manner which would result in the
activity being different from that described in the TERA agreement and
any conditions EPA prescribed in its approval, the submitter must inform
the EPA contact for the TERA and may not modify the activity without the
approval of EPA.
Subpart F_Exemptions for Test Marketing
Sec. 725.300 Scope and purpose.
(a) This subpart describes exemptions from the reporting
requirements under subpart D of this part for test marketing activities
involving microorganisms.
(b) In lieu of complying with subpart D of this part, persons
described in Sec. 725.305 may submit an application for a test
marketing exemption (TME).
(c) Submission requirements specific for TME applications are
described at Sec. 725.350.
(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
[[Page 58]]
apply to applications submitted under this subpart:
(a) Prenotice consultation. EPA strongly suggests that for a TME,
the applicant contact EPA for a prenotice consultation regarding
eligibility for a TME.
(b) When to submit a TME application. Each person who is eligible to
apply for a TME under this subpart must submit the application at least
45 calendar days before the person intends to commence the test
marketing activity.
(c) Recordkeeping. Each person who is granted a TME must comply with
the recordkeeping requirements of Sec. 725.65. In addition, any person
who obtains a TME must retain documentation of compliance with any
restrictions imposed by EPA when it grants the TME. This information
must be retained for 3 years from the final date of manufacture or
import under the exemption.
Sec. 725.355 Information to be included in the TME application.
(a) To review a TME application, EPA must have sufficient
information to permit a reasoned evaluation of the health and
environmental effects of the planned test marketing activity. The person
seeking EPA approval must submit all information known to or reasonably
ascertainable by the person on the microorganism and the test marketing
activity, including information not listed in paragraphs (c), (d), and
(e) of this section that the person believes will demonstrate that the
microorganism will not present an unreasonable risk of injury to health
or the environment as a result of the test marketing. The TME
application must be in writing and must include at least the information
described in paragraphs (b), (c), (d), and (e) of this section.
(b) When specific information is not submitted, an explanation of
why such information is not available or not applicable must be
included.
(c) Persons applying for a TME must submit the submitter
identification and microorganism identity information required for MCANs
in Sec. 725.155(c), (d)(1), and (d)(2).
(d) Persons applying for a TME must submit phenotypic and ecological
characteristics information required in Sec. 725.155(d)(3) as it
relates directly to the conditions of the proposed test marketing
activity.
(e) Persons applying for a TME must also submit the following
information about the proposed test marketing activity:
(1) Proposed test marketing activity. (i) The maximum quantity of
the microorganism which the applicant will manufacture or import for
test marketing.
(ii) The maximum number of persons who may be provided the
microorganism during test marketing.
(iii) The maximum number of persons who may be exposed to the
microorganism as a result of test marketing, including information
regarding duration and route of such exposures.
(iv) A description of the test marketing activity, including its
duration and how it can be distinguished from full-scale commercial
production and research and development activities.
(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
[[Page 59]]
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.
(k) Trichoderma reesei strain QM6a and its derivatives used only in
submerged standard industrial fermentation operations as defined at 40
CFR 725.3.
(l) Bacillus amyloliquefaciens subsp. amyloliquefaciens.
[62 FR 17932, Apr. 11, 1997, as amended at 85 FR 13772, Mar. 10, 2020]
Sec. 725.421 Introduced genetic material.
For a new microorganism to qualify for either exemption under this
subpart, introduced genetic material must meet all of the criteria
listed in this section.
(a) Limited in size. The introduced genetic material must consist
only of the following:
(1) The structural gene(s) of interest.
(2) The regulatory sequences permitting the expression of solely the
gene(s) of interest.
(3) Associated nucleotide sequences needed to move genetic material,
including linkers, homopolymers, adaptors, transposons, insertion
sequences, and restriction enzyme sites.
(4) The nucleotide sequences needed for vector transfer.
(5) The nucleotide sequences needed for vector maintenance.
(b) Well-characterized. For introduced genetic material, well-
characterized means that the following have been determined:
(1) The function of all of the products expressed from the
structural gene(s).
(2) The function of sequences that participate in the regulation of
expression of the structural gene(s).
(3) The presence or absence of associated nucleotide sequences and
their associated functions, where associated nucleotide sequences are
those sequences needed to move genetic material including linkers,
homopolymers, adaptors, transposons, insertion sequences, and
restriction enzyme sites.
(c) Poorly mobilizable. The ability of the introduced genetic
material to be transferred and mobilized is inactivated, with a
resulting frequency of transfer of less than 10-8 transfer
events per recipient.
(d) Free of certain sequences. (1) The introduced genetic material
must not contain a functional portion of any of the toxin-encoding
sequences described in this paragraph (d).
(i) For the purposes of this section, a functional portion of a
toxin-encoding sequence means any sequence which codes for a polypeptide
that has one of the following effects:
(A) It directly or indirectly contributes to toxic effects in
humans. Directly contributes to toxic effects in humans means those
sequences encoding polypeptides that have direct toxicity to target
cells. An example of a sequence which directly contributes to toxic
effects in humans is one which encodes the portion of diphtheria toxin,
listed in paragraph (d)(2) of this
[[Page 60]]
section, capable of interacting with elongation factor 2, leading to
inhibition of protein synthesis in target respiratory, heart, kidney,
and nerve tissues. Indirectly contributes to toxic effects in humans
means a sequence whose encoded polypeptide is not directly toxic to
target cells, yet still adversely affects humans. An example of a
sequence which indirectly contributes to toxic effects is the sequence
which encodes the portion of the botulinum toxin, listed in paragraph
(d)(3) of this section, capable of blocking the release of acetylcholine
from gangliosides. Botulinum toxin affects neuromuscular junctions by
its blockage of acetylcholine release, leading to irreversible
relaxation of muscles and respiratory arrest.
(B) It binds a toxin or toxin precursor to target human cells.
(C) It facilitates intracellular transport of a toxin in target
human cells.
(ii) While these toxins are listed (with synonyms in parentheses) in
paragraphs (d)(2) through (d)(7) of this section according to the source
organism, it is use of the nucleotide sequences that encode the toxins
that is being restricted and not the use of the source organisms. The
source organisms are listed to provide specificity in identification of
sequences whose use is restricted. Although similar or identical
sequences may be isolated from organisms other than those listed below
in paragraphs (d)(2) through (d)(7) of this section, these comparable
toxin sequences, regardless of the organism from which they are derived,
must not be included in the introduced genetic material.
(2) Sequences for protein synthesis inhibitor.
Sequence Source Toxin Name
Corynebacterium diphtheriae & C. ulcerans Diphtheria toxin
Pseudomonas aeruginosa Exotoxin A
Shigella dysenteriae Shigella toxin (Shiga toxin,
Shigella dysenteriae type I
toxin, Vero cell toxin)
Abrus precatorius, seeds Abrin
Ricinus communis, seeds Ricin
(3) Sequences for neurotoxins.
Sequence Source Toxin Name
Clostridium botulinum Neurotoxins A, B, C1, D, E,
F, G (Botulinum toxins,
botulinal toxins)
Clostridium tetani Tetanus toxin
(tetanospasmin)
Proteus mirabilis Neurotoxin
Staphylococcus aureus Alpha toxin (alpha lysin)
Yersinia pestis Murine toxin
Snake toxins ............................
Bungarus caeruleus Caeruleotoxin
Bungarus multicinctus Beta-bungarotoxin
(phospholipase)
Crotalus spp. Crotoxin (phospholipase)
Dendroaspis viridis Neurotoxin
Naja naja varieties Neurotoxin
Notechia scutatus Notexin (phospholipase)
Oxyuranus scutellatus Taipoxin
Invertebrate toxins
Chironex fleckeri Neurotoxin
Androctnus australis Neurotoxin
Centruroides sculpturatus Neurotoxin
(4) Sequences for oxygen labile cytolysins.
Sequence Source Toxin Name
Bacillus alve Alveolysin
Bacillus cereus Cereolysin
Bacillus laterosporus Laterosporolysin
Bacillus thuringiensis Thuringiolysin
Clostridium bifermentans Lysin
Clostridium botulinum Lysin
Clostridium caproicum Lysin
Clostridium chauvoei Delta-toxin
Clostridium histolyticum Epsilon-toxin
Clostridium novyi Gamma-toxin
Clostridium oedematiens Delta-toxin
Clostridium perfringens Theta-toxin (Perfringolysin)
Clostridium septicum Delta-toxin
Clostridium sordellii Lysin
Clostridium tetani Tetanolysin
Listeria monocytogenes Listeriolysin (A B)
Streptococcus pneumoniae Pneumolysin
Streptococcus pyogene Streptolysin O (SLO)
(5) Sequences for toxins affecting membrane function.
Sequence Source Toxin Name
Bacillus anthracis Edema factor (Factors I II);
Lethal factor (Factors II
III)
Bacillus cereus Enterotoxin (diarrheagenic
toxin, mouse lethal factor)
Bordetella pertussis Adenylate cyclase (Heat-
labile factor); Pertussigen
(pertussis toxin, islet
activating factor,
histamine sensitizing
factor, lymphocytosis
promoting factor)
Clostridium botulinum C2 toxin
Clostridium difficile Enterotoxin (toxin A)
Clostridium perfringens Beta-toxin; Delta-toxin
Escherichia coli & other Heat-labile enterotoxins
Enterobacteriaceae spp. (LT); Heat-stable
enterotoxins (STa, ST1
subtypes ST1a ST1b; also
STb, STII)
Legionella pneumophila Cytolysin
Vibrio cholerae & Vibrio mimicus Cholera toxin (choleragen)
(6) Sequences that affect membrane integrity.
[[Page 61]]
Sequence Source Toxin Name
Clostridium bifermentans & other Lecithinase
Clostridium spp
Clostridium perfringens Alpha-toxin (phospholipase
C, lecithinase);
Enterotoxin
Corynebacterium pyogenes & other Cytolysin (phospholipase C),
Corynebacterium spp. Ovis toxin
(sphingomyelinase D)
Staphylococcus aureus Beta-lysin (beta toxin)
(7) Sequences that are general cytotoxins.
Sequence Source Toxin Name
Adenia digitata Modeccin
Aeromonas hydrophila Aerolysin (beta-lysin,
cytotoxic lysin)
Clostridium difficile Cytotoxin (toxin B)
Clostridium perfringens Beta-toxin; Epsilon-toxin;
Kappa-toxin
Escherichia coli & other Cytotoxin (Shiga-like toxin,
Enterobacteriaceae spp. Vero cell toxin)
Pseudomonas aeruginosa Proteases
Staphylococcus aureus Gamma lysin (Gamma toxin);
Enterotoxins (SEA, SEB,
SEC, SED SEE); Pyrogenic
exotoxins A B; Toxic shock
syndrome toxins (TSST-1)
Staphylococcus aureus & Pseudomonas Leucocidin (leukocidin,
aeruginosa cytotoxin)
Streptococcus pyogenes Streptolysin S (SLS);
Erythrogenic toxins
(scarlet fever toxins,
pyrogenic exotoxins)
Yersinia enterocolitica Heat-stable enterotoxins
(ST)
Sec. 725.422 Physical containment and control technologies.
The manufacturer must meet all of the following criteria for
physical containment and control technologies for any facility in which
the new microorganism will be used for a Tier I exemption; these
criteria also serve as guidance for a Tier II exemption.
(a) Use a structure that is designed and operated to contain the new
microorganism.
(b) Control access to the structure.
(c) Provide written, published, and implemented procedures for the
safety of personnel and control of hygiene.
(d) Use inactivation procedures demonstrated and documented to be
effective against the new microorganism contained in liquid and solid
wastes prior to disposal of the wastes. The inactivation procedures must
reduce viable microbial populations by at least 6 logs in liquid and
solid wastes.
(e) Use features known to be effective in minimizing viable
microbial populations in aerosols and exhaust gases released from the
structure, and document use of such features.
(f) Use systems for controlling dissemination of the new
microorganism through other routes, and document use of such features.
(g) Have in place emergency clean-up procedures.
Sec. 725.424 Requirements for the Tier I exemption.
(a) Conditions of exemption. The manufacture or import of a new
microorganism for commercial purposes is not subject to review under
this part if all of the following conditions are met for all activities
involving the new microorganism:
(1) The recipient microorganism is listed in and meets any
requirements specified in Sec. 725.420.
(2) The introduced genetic material meets the criteria under Sec.
725.421.
(3) The physical containment and control technologies of any
facility in which the microorganism will be manufactured, processed, or
used meet the criteria under Sec. 725.422.
(4) The manufacturer or importer submits a certification described
in paragraph (b) of this section to EPA at least 10 days before
commencing initial manufacture or import of a new microorganism derived
from a recipient microorganism listed in Sec. 725.420.
(5) The manufacturer or importer complies with the recordkeeping
requirements of Sec. 725.65 and maintains records for the initial and
subsequent uses of the new microorganism that verify compliance with the
following:
(i) The certifications made in paragraph (b) of this section.
(ii) All the eligibility criteria for the Tier I exemption including
the criteria for the recipient microorganism, the introduced genetic
material, the physical containment and control technologies.
(b) Certification. To be eligible for the Tier I exemption under
this subpart, the manufacturer or importer must submit to EPA a document
signed by a responsible company official containing the information
listed in this paragraph.
(1) Name and address of manufacturer or importer.
(2) Date when manufacture or import is expected to begin.
[[Page 62]]
(3) The identification (genus, species) of the recipient
microorganism listed in Sec. 725.420 which is being used to create the
new microorganism which will be used under the conditions of the Tier I
exemption.
(4) Certification of the following:
(i) Compliance with the introduced genetic material criteria
described in Sec. 725.421.
(ii) Compliance with the containment requirements described in Sec.
725.422, including the provision in paragraph (a)(3) of this section.
(5) The site of waste disposal and the type of permits for disposal,
the permit numbers and the institutions issuing the permits.
(6) The certification statement required in Sec. 725.25(b).
Certification of submission of test data is not required for the Tier I
exemption.
Sec. 725.426 Applicability of the Tier I exemption.
The Tier I exemption under Sec. 725.424 applies only to a
manufacturer or importer of a new microorganism that certifies that the
microorganism will be used in all cases in compliance with Sec. Sec.
725.420, 725.421, and 725.422.
Sec. 725.428 Requirements for the Tier II exemption.
The manufacturer or importer of a new microorganism for commercial
purposes may submit to EPA a Tier II exemption request in lieu of a MCAN
under subpart D of this part if all of the following conditions are met:
(a) The recipient microorganism is listed in and meets any
requirements specified in Sec. 725.420.
(b) The introduced genetic material meets the criteria under Sec.
725.421.
(c) Adequate physical containment and control technologies are used.
The criteria listed under Sec. 725.422 for physical containment and
control technologies of facilities should be used as guidance to satisfy
the Tier II exemption request data requirements listed at Sec.
725.455(d). EPA will review proposed process and containment procedures
as part of the submission for a Tier II exemption under this section.
Sec. 725.450 Procedural requirements for the Tier II exemption.
General requirements for all submissions under this part are
contained in Sec. 725.25. In addition, the following requirements apply
to requests submitted under this subpart:
(a) Prenotice consultation. EPA strongly suggests that for a Tier II
exemption, the submitter contact the Agency for a prenotice consultation
regarding eligibility for the exemption.
(b) When to submit the Tier II exemption request. Each person who is
eligible to submit a Tier II exemption request under this subpart must
submit the request at least 45 calendar days before the person intends
to commence manufacture or import.
(c) Contents of the Tier II exemption request. Each person who
submits a request under this subpart must provide the information
described in Sec. Sec. 725.428 and 725.455, as well as information
known to or reasonably ascertainable by the person that would permit EPA
to determine that use of the microorganism, under the conditions
specified in the request, will not present an unreasonable risk of
injury to health or the environment.
(d) Recordkeeping. Each person who submits a request under this
subpart must comply with the recordkeeping requirements of Sec. 725.65.
In addition, the submitter should maintain records which contain
information that verifies compliance with the following:
(1) The certifications made in the request.
(2) All the eligibility criteria for the Tier II exemption request
including the criteria for the recipient microorganism, the introduced
genetic material, the physical containment and control technologies.
Sec. 725.455 Information to be included in the Tier II exemption request.
The submitter must indicate clearly that the submission is a Tier II
exemption request for a microorganism instead of the MCAN under subpart
D of this part and must submit the following information:
(a) Submitter identification. (1) The name and headquarters address
of the submitter.
[[Page 63]]
(2) The name, address, and office telephone number (including area
code) of the principal technical contact representing the submitter.
(b) Microorganism identity information. (1) Identification (genus,
species, and strain) of the recipient microorganism. Genus, species
designation should be substantiated by a letter from a culture
collection or a brief summary of the results of tests conducted for
taxonomic identification.
(2) Type of genetic modification and the function of the introduced
genetic material.
(3) Site of insertion.
(4) Certification of compliance with the introduced genetic material
criteria described in Sec. 725.421.
(c) Production volume. Production volume, including total liters per
year, and the maximum cell concentration achieved during the production
process.
(d) Process and containment information. (1) A description of the
process including the following:
(i) Identity and location of the manufacturing site(s).
(ii) Process flow diagram illustrating the production process,
including downstream separations, and indicating the containment
envelope around the appropriate equipment.
(iii) Identities and quantities of feedstocks.
(iv) Sources and quantities of potential releases to both the
workplace and environment, and a description of engineering controls,
inactivation procedures, and other measures which will reduce worker
exposure and environmental releases.
(v) A description of procedures which will be undertaken to prevent
fugitive emissions, i.e. leak detection and repair program.
(vi) A description of procedures/safeguards to prevent and mitigate
accidental releases to the workplace and the environment.
(2) Certification of those elements of the containment criteria
described in Sec. 725.422 with which the manufacturer is in compliance,
including stating by number the elements with which the manufacturer is
in full compliance.
(e) The site of waste disposal and the type of permits for disposal,
the permit numbers and the institutions issuing the permits.
(f) The certification statement required in Sec. 725.25(b).
Certification of submission of test data is not required for the Tier II
exemption.
Sec. 725.470 EPA review of the Tier II exemption request.
General procedures for review of all submissions under this part are
contained in Sec. Sec. 725.28 through 725.60. In addition, the
following procedures apply to EPA review of Tier II exemption requests
submitted under this subpart:
(a) Length of the review period. The review period for the request
will be 45 days from the date the Document Control Officer for the
Office of Pollution Prevention and Toxics receives a complete request,
or the date EPA determines the request is complete under Sec. 725.33,
unless the Agency extends the review period for good cause under Sec.
725.56.
(b) Criteria for review. EPA will review the request to determine
that the new microorganism complies with Sec. 725.428 and that its
manufacture, processing, use, and disposal as described in the request
will not present an unreasonable risk of injury to health or the
environment.
(c) EPA decision regarding the Tier II exemption request. A decision
concerning a request under this subpart will be made by the
Administrator, or a designee.
(d) Determination that the microorganism is ineligible for a Tier II
review. (1) EPA may determine that the manufacturer or importer is not
eligible for Tier II review, because the microorganism does not meet the
criteria under Sec. 725.428 or the Administrator, or a designee,
decides that there is insufficient information to determine that the
conditions of manufacture, processing, use, or disposal of the
microorganism as described in the request will not present an
unreasonable risk to health or the environment.
(2) If the Agency makes this determination, the Administrator, or a
designee will notify the manufacturer or importer by telephone, followed
by a letter, that the request has been denied. The letter will explain
reasons for the denial.
[[Page 64]]
(3) If the request is denied, the manufacturer or importer may
submit the information necessary to constitute a MCAN under subpart D of
this part.
(e) Approval or denial of the Tier II exemption request. (1) No
later than 45 days after EPA receives a request, the Agency will either
approve or deny the request.
(2) In approving a request, EPA may impose any restrictions
necessary to ensure that the microorganism will not present an
unreasonable risk of injury to health and the environment as a result of
general commercial use.
(f) EPA may seek to enjoin the manufacture or import of a
microorganism in violation of this subpart, or act to seize any
microorganism manufactured or imported in violation of this section or
take other actions under the authority of sections 7 or 17 of the Act.
(g) A manufacturer or importer may only proceed after receipt of EPA
approval.
Subparts H-K [Reserved]
Subpart L_Additional Procedures for Reporting on Significant New Uses of
Microorganisms
Sec. 725.900 Scope and purpose.
(a) This subpart describes additional provisions governing
submission of MCANs for microorganisms subject to significant new use
rules identified in subpart M of this part.
(b) Manufacturers, importers, and processors described in Sec.
725.105(c) must submit a MCAN under subpart D of this part for
significant new uses of microorganisms described in subpart M of this
part, unless they are excluded under Sec. 725.910 or Sec. 725.912.
(c) Section 725.920 discusses exports and imports.
(d) Additional recordkeeping requirements specific to significant
new uses of microorganisms are described in Sec. 725.950.
(e) Section 725.975 describes how EPA will approve alternative means
of complying with significant new use requirements designated in subpart
M of this part.
(f) Expedited procedures for promulgating significant new use
requirements under subpart M of this part for microorganisms subject to
section 5(e) orders are discussed in Sec. Sec. 725.980 and 725.984.
(g) This subpart L contains provisions governing submission and
review of notices for the microorganisms and significant new uses
identified in subpart M of this part. The provisions of this subpart L
apply to the microorganisms and significant new uses identified in
subpart M of this part, except to the extent that they are specifically
modified or supplanted by specific requirements in subpart M of this
part. In the event of a conflict between the provisions of this subpart
L and the provisions of subpart M of this part, the provisions of
subpart M of this part shall govern.
(h) The provisions of subparts A through F of this part also apply
to subparts L and M of this part. For purposes of subparts L and M of
this part, wherever the words ``microorganism'' or ``new microorganism''
appear in subparts A through F of this part, it shall mean the
microorganism subject to subparts L and M of this part. In the event of
a conflict between the provisions of subparts A through F and the
provisions of subparts L and M of this part, the provisions of subparts
L and M of this part shall govern.
Sec. 725.910 Persons excluded from reporting significant new uses.
(a) A person who intends to manufacture, import, or process a
microorganism identified in subpart M of this part and who intends to
distribute it in commerce is not required to submit a MCAN under subpart
D of this part, if that person can document one or more of the following
as to each recipient of the microorganism from that person:
(1) That the person has notified the recipient, in writing, of the
specific section in subpart M of this part which identifies the
microorganism and its designated significant new uses, or
(2) That the recipient has knowledge of the specific section in
subpart M of this part which identifies the microorganism and its
designated significant new uses, or
(3) That the recipient cannot undertake any significant new use
described
[[Page 65]]
in the specific section in subpart M of this part.
(b) The manufacturer, importer, or processor described in paragraph
(a) of this section must submit a MCAN under subpart D of this part, if
such person has knowledge at the time of commercial distribution of the
microorganism identified in the specific section in subpart M of this
part that a recipient intends to engage in a designated significant new
use of that microorganism without submitting a MCAN under this part.
(c) A person who processes a microorganism identified in a specific
section in subpart M of this part for a significant new use of that
microorganism is not required to submit a MCAN if that person can
document each of the following:
(1) That the person does not know the specific microorganism
identity of the microorganism being processed, and
(2) That the person is processing the microorganism without
knowledge that the microorganism is identified in subpart M of this
part.
(d)(1) If at any time after commencing distribution in commerce of a
microorganism identified in a specific section in subpart M of this
part, a person who manufactures, imports, or processes a microorganism
described in subpart M of this part and distributes it in commerce has
knowledge that a recipient of the microorganism is engaging in a
significant new use of that microorganism designated in that section
without submitting a MCAN under this part, the person is required to
cease supplying the microorganism to that recipient and to submit a MCAN
for that microorganism and significant new use, unless the person is
able to document each of the following:
(i) That the person has notified the recipient and EPA enforcement
authorities (at the address in paragraph (d)(1)(iii) of this section),
in writing within 15 working days of the time the person develops
knowledge that the recipient is engaging in a significant new use, that
the recipient is engaging in a significant new use without submitting a
MCAN.
(ii) That, within 15 working days of notifying the recipient as
described in paragraph (d)(1)(i) of this section, the person received
from the recipient, in writing, a statement of assurance that the
recipient is aware of the terms of the applicable section in subpart M
of this part and will not engage in the significant new use.
(iii) That the person has promptly provided EPA enforcement
authorities with a copy of the recipient's statement of assurance
described in paragraph (d)(1)(ii) of this section. The copy must be sent
to the Director, Office of Compliance (2221A), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(2) If EPA notifies the manufacturer, importer, or processor that
the recipient is engaging in a significant new use after providing the
statement of assurance described in paragraph (d)(1)(ii) of this section
and without submitting a MCAN under this part, the manufacturer,
importer, or processor shall immediately cease distribution to that
recipient until the manufacturer, importer, or processor or the
recipient has submitted a MCAN under this part and the MCAN review
period has ended.
(3) If, after receiving a statement of assurance from a recipient
under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or
processor has knowledge that the recipient is engaging in a significant
new use without submitting a MCAN under this part, the manufacturer,
importer, or processor must immediately cease distributing the
microorganism to that recipient and notify EPA enforcement authorities
at the address identified in paragraph (d)(1)(iii) of this section. The
manufacturer, importer, or processor may not resume distribution to that
recipient until any one of the following has occurred:
(i) The manufacturer, importer, or processor has submitted a MCAN
under this part and the MCAN review period has ended.
(ii) The recipient has submitted a MCAN under this part and the MCAN
review period has ended.
(iii) The manufacturer, importer, or processor has received notice
from EPA enforcement authorities that it may resume distribution to that
recipient.
[[Page 66]]
Sec. 725.912 Exemptions.
Persons identified in Sec. 725.105(c) are not required to submit a
MCAN under subpart D of this part for a microorganism identified in
subpart M of this part, unless otherwise specified in a specific section
in subpart M, if:
(a) The person submits a MCAN for the microorganism prior to the
promulgation date of the section in subpart M of this part which
identifies the microorganism, and the person receives written
notification of compliance from EPA prior to the effective date of such
section. The MCAN submitter must comply with any applicable requirement
of section 5(b) of the Act. The MCAN must include the information and
test data specified in section 5(d)(1) of the Act. For purposes of this
exemption, the specific section in subpart M of this part which
identifies the microorganism and Sec. Sec. 725.3, 725.15, 725.65,
725.70, 725.75, 725.100, and 725.900 apply; after the effective date of
the section in subpart M of this part which identifies the
microorganism, Sec. Sec. 725.105 and 725.910 apply and Sec. 725.920
continues to apply. EPA will provide the MCAN submitter with written
notification of compliance only if one of the following occurs:
(1) EPA is unable to make the finding that the activities described
in the MCAN will or may present an unreasonable risk of injury to health
or the environment under reasonably foreseeable circumstances, or
(2) EPA and the person negotiate a consent order under section 5(e)
of the Act, such order to take effect on the effective date of the
section in subpart M of this part which identifies the microorganism.
(b) The person is operating under the terms of a consent order
issued under section 5(e) of the Act applicable to that person. If a
provision of such section 5(e) order is inconsistent with a specific
significant new use identified in subpart M of this part, abiding by the
provision of the section 5(e) order exempts the person from submitting a
MCAN for that specific significant new use.
Sec. 725.920 Exports and imports.
(a) Exports. Persons who intend to export a microorganism identified
in subpart M of this part, or in any proposed rule which would amend
subpart M of this part, are subject to the export notification
provisions of section 12(b) of the Act. The regulations that interpret
section 12(b) appear at part 707 of this chapter.
(b) Imports. Persons who import a substance identified in a specific
section in subpart M of this part are subject to the import
certification requirements under section 13 of the Act, which are
codified at 19 CFR Sec. Sec. 12.118 through 12.127 and 127.28(i). The
EPA policy in support of the import certification requirements appears
at part 707 of this chapter.
Sec. 725.950 Additional recordkeeping requirements.
Persons submitting a MCAN for a significant new use of a
microorganism must comply with the recordkeeping requirements of Sec.
725.65. In addition, the following requirements apply:
(a) At the time EPA adds a microorganism to subpart M of this part,
EPA may specify appropriate recordkeeping requirements. Each
manufacturer, importer, and processor of the microorganism shall
maintain the records for 3 years from the date of their creation.
(b) The records required to be maintained under this section may
include the following:
(1) Records documenting the information contained in the MCAN
submitted to EPA.
(2) Records documenting the manufacture and importation volume of
the microorganism and the corresponding dates of manufacture and import.
(3) Records documenting volumes of the microorganism purchased
domestically by processors of the microorganism, names and addresses of
suppliers and corresponding dates of purchase.
(4) Records documenting the names and addresses (including shipment
destination address, if different) of all persons outside the site of
manufacture or import to whom the manufacturer, importer, or processor
directly sells or transfers the microorganism, the date of each sale or
transfer, and the quantity of the microorganism sold or transferred on
such date.
[[Page 67]]
Sec. 725.975 EPA approval of alternative control measures.
(a) In certain sections of subpart M of this part, significant new
uses for the identified microorganisms are described as the failure to
establish and implement programs providing for the use of either:
specific measures to control worker exposure to or release of
microorganisms which are identified in such sections, or alternative
measures to control worker exposure or environmental release which EPA
has determined provide substantially the same degree of protection as
the specified control measures. Persons who manufacture, import, or
process a microorganism identified in such sections and who intend to
employ alternative measures to control worker exposure or environmental
release must submit a request to EPA for a determination of equivalency
before commencing manufacture, import, or processing involving the
alternative control measures.
(b) Persons submitting a request for a determination of equivalency
to EPA under this part must submit the request to EPA (via CDX) using e-
PMN software. See 40 CFR 720.40(a)(2)(ii) for information on how to
obtain e-PMN software. Support documents related to these requests must
also be submitted to EPA via CDX using e-PMN software. A request for a
determination of equivalency must contain:
(1) The name of the submitter.
(2) The specific identity of the microorganism.
(3) The citation for the specific section in subpart M of this part
which pertains to the microorganism for which the request is being
submitted.
(4) A detailed description of the activities involved.
(5) The specifications of the alternative worker exposure control
measures or environmental release control measures.
(6) A detailed analysis explaining why such alternative control
measures provide substantially the same degree of protection as the
specific control measures identified in the specific section in subpart
M of this part which pertains to the microorganism for which the request
is being submitted.
(7) The data and information described in Sec. Sec. 725.155 and
725.160. If such data and information have already been submitted to
EPA's Office of Pollution Prevention and Toxics, the submitter need only
document that it was previously submitted, to whom, and the date it was
submitted.
(c) Requests for determinations of equivalency will be reviewed by
EPA within 45 days. Determinations under this paragraph will be made by
the Director, or a designee. Notice of the results of such
determinations will be mailed to the submitter.
(d) If EPA notifies the submitter under paragraph (c) of this
section that EPA has determined that the alternative control measures
provide substantially the same degree of protection as the specified
control measures identified in the specific section of subpart M of this
part which pertains to the microorganism for which the request is being
submitted, the submitter may commence manufacture, import, or processing
in accordance with the specifications for alternative worker exposure
control measures or environmental release control measures identified in
the submitter's request, and may alter any corresponding notification to
workers to reflect such alternative controls. Deviations from the
activities described in the EPA notification constitute a significant
new use and are subject to the requirements of this part.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Sec. 725.980 Expedited procedures for issuing significant new use
rules for microorganisms subject to section 5(e) orders.
(a) Selection of microorganisms. (1) In accordance with the
expedited process specified in this section, EPA will issue significant
new use notification requirements for each new microorganism that, after
MCAN review under subpart D of this part, becomes subject to a final
order issued under section 5(e) of the Act, except for an order that
prohibits manufacture and import of the microorganism, unless EPA
determines that significant new use notification requirements are not
needed for the microorganism.
[[Page 68]]
(2) If EPA determines that significant new use notifications
requirements are not needed for a microorganism that is subject to a
final order issued under section 5(e) of the Act, EPA will issue a
notice in the Federal Register explaining why the significant new use
requirements are not needed.
(b) Designation of requirements. (1) The significant new use
notification and other specific requirements will be based on and be
consistent with the provisions included in the final order issued for
the microorganism under section 5(e) of the Act. EPA may also designate
additional activities as significant new uses which will be subject to
notification.
(2) Significant new use requirements and other specific requirements
designated under this section will be listed in subpart M of this part.
For each microorganism, subpart M of this part will identify:
(i) The microorganism name.
(ii) The activities designated as significant new uses.
(iii) Other specific requirements applicable to the microorganism,
including recordkeeping requirements or any other requirements included
in the final section 5(e) order.
(c) Procedures for issuing significant new use rules--(1) Possible
processes. EPA will issue significant new use rules (SNURs) under this
section by one of the following three processes: direct final
rulemaking, interim final rulemaking, or notice and comment rulemaking.
EPA will use the direct final rulemaking process to issue significant
new use rules unless it determines that, in a particular case, one of
the other processes is more appropriate.
(2) Notice in the Federal Register. Federal Register documents
issued to propose or establish significant new uses under this section
will contain the following:
(i) The microorganism identity or, if its specific identity is
claimed confidential, an appropriate generic microorganism name and an
accession number assigned by EPA.
(ii) The MCAN number.
(iii) A summary of EPA's findings under section 5(e)(1)(A) of the
Act for the final order issued under section 5(e).
(iv) Designation of the significant new uses subject to, or proposed
to be subject to, notification and any other applicable requirements.
(v) Any modification of subpart L of this part applicable to the
specific microorganism and significant new uses.
(vi) If the Federal Register document establishes a final rule, or
notifies the public that a final rule will not be issued after public
comment has been received, the document will describe comments received
and EPA's response.
(3) Direct final rulemaking. (i) EPA will use direct final
rulemaking to issue a significant new use rule, when specific
requirements will be based on and be consistent with the provisions
included in the final order issued for the microorganism under section
5(e) of the Act. EPA will issue a final rule in the Federal Register
following its decision to develop a significant new use rule under this
section for a specific new microorganism.
(ii) The Federal Register document will state that, unless written
notice is received by EPA within 30 days of publication that someone
wishes to submit adverse or critical comments, the rule will be
effective 60 days from the date of publication. The written notice of
intent to submit adverse or critical comments should state which SNUR(s)
will be the subject of the adverse or critical comments, if several
SNURs are established through the direct final rule. If notice is
received within 30 days that someone wishes to submit adverse or
critical comments, the section(s) of the direct final rule containing
the SNUR(s) for which a notice of intent to comment was received will be
withdrawn by EPA issuing a document in the final rule section of the
Federal Register, and a proposal will be published in the proposed rule
section of the Federal Register. The proposal will establish a 30-day
comment period.
(iii) If EPA, having considered any timely comments submitted in
response to the proposal, decides to establish notification requirements
under this section, EPA will issue a
[[Page 69]]
final rule adding the microorganism to subpart M of this part and
designating the significant new uses subject to notification.
(4) Interim final rulemaking. (i) EPA will use the interim final
rulemaking procedure to issue a significant new use rule, when specific
requirements will be based on and be consistent with the provisions
included in the final order issued for the microorganism under section
5(e) of the Act. The Agency will issue an interim final rule in the
Federal Register following its decision to develop a significant new use
rule for a specific new microorganism. The document will state EPA's
reasons for using the interim final rulemaking procedure.
(A) The significant new use rule will take effect on the date of
publication.
(B) Persons will be given 30 days from the date of publication to
submit comments.
(ii) Interim final rules issued under this section shall cease to be
in effect 180 days after publication unless, within the 180-day period,
EPA issues a final rule in the Federal Register responding to any
written comments received during the 30-day comment period specified in
paragraph (c)(4)(i)(B) of this section and promulgating final
significant new use notification requirements and other requirements for
the microorganism.
(5) Notice and comment rulemaking. (i) EPA will use a notice and
comment procedure to issue a significant new use rule, when EPA is
designating additional activities which are not provisions included in
the final order issued for the microorganism under section 5(e) of the
Act as significant new uses which will be subject to notification. EPA
will issue a proposal in the Federal Register following its decision to
develop a significant new use rule under this section for a specific new
microorganism. Persons will be given 30 days to comment on whether EPA
should establish notification requirements for the microorganism under
this part.
(ii) If EPA, having considered any timely comments, decides to
establish notification requirements under this section, EPA will issue a
final rule adding the microorganism to subpart M of this part and
designating the significant new uses subject to notification.
(d) Schedule for issuing significant new use rules. (1) Unless EPA
determines that a significant new use rule should not be issued under
this section, EPA will issue a proposed rule, a direct final rule, or an
interim final rule within 180 days of receipt of a valid notice of
commencement under Sec. 725.190.
(2) If EPA receives adverse or critical significant comments
following publication of a proposed or interim final rule, EPA will
either withdraw the rule or issue a final rule addressing the comments
received.
Sec. 725.984 Modification or revocation of certain notification
requirements.
(a) Criteria for modification or revocation. EPA may at any time
modify or revoke significant new use notification requirements for a
microorganism which has been added to subpart M of this part using the
procedures of Sec. 725.980. Such action may be taken under this section
if EPA makes one of the following determinations, unless other
information shows that the requirements should be retained:
(1) Test data or other information obtained by EPA provide a
reasonable basis for concluding that activities designated as
significant new uses of the microorganism will not present an
unreasonable risk of injury to health or the environment.
(2) EPA has promulgated a rule under section 4 or 6 of the Act, or
EPA or another agency has taken action under another law, for the
microorganism that eliminates the need for significant new use
notification under section 5(a)(2) of the Act.
(3) EPA has received MCANs for some or all of the activities
designated as significant new uses of the microorganism and, after
reviewing such MCANs, concluded that there is no need to require
additional notice from persons who propose to engage in identical or
similar activities.
(4) EPA has examined new information, or has reexamined the test
data or other information supporting its finding under section
5(e)(1)(A)(ii)(I) of the Act and has concluded that a rational basis no
longer exists for the findings that activities involving the
[[Page 70]]
microorganism may present an unreasonable risk of injury to health or
the environment required under section 5(e)(1)(A) of the Act.
(5) Certain activities involving the microorganism have been
designated as significant new uses pending the completion of testing,
and adequate test data developed in accordance with applicable
procedures and criteria have been submitted to EPA.
(b) Procedures for limitation or revocation. Modification or
revocation of significant new use notification requirements for a
microorganism that has been added to subpart M of this part using the
procedures described in Sec. 725.980 may occur either at EPA's
initiative or in response to a written request.
(1) Any affected person may request modification or revocation of
significant new use notification requirements for a microorganism that
has been added to subpart M of this part using the procedures described
in Sec. 725.980. The request must be accompanied by information
sufficient to support the request. Persons submitting a request to EPA
under this part must submit the request to EPA (via CDX) using e-PMN
software. See 40 CFR 720.40(a)(2)(ii) for information on how to obtain
e-PMN software. Support documents related to these requests must also be
submitted to EPA via CDX using e-PMN software.
(2) The Director, or a designee, will consider the request, make a
determination whether to initiate rulemaking to modify the requirements,
and notify the requester of that determination by certified letter. If
the request is denied, the letter will explain why EPA has concluded
that the significant new use notification requirements for that
microorganism should remain in effect.
(3) If EPA concludes that significant new use notification
requirements for a microorganism should be limited or revoked, EPA will
propose the changes in a notice in the Federal Register, briefly
describe the grounds for the action, and provide interested parties an
opportunity to comment.
[62 FR 17932, Apr. 11, 1997, as amended at 75 FR 790, Jan. 6, 2010; 78
FR 72828, Dec. 4, 2013]
Subpart M_Significant New Uses for Specific Microorganisms
Sec. 725.1000 Scope.
This subpart identifies uses of microorganisms which EPA has
determined to be significant new uses under the authority of section
5(a)(2) of the Toxic Substances Control Act.
Sec. 725.1075 Burkholderia cepacia complex.
(a) Microorganism and significant new uses subject to reporting. (1)
The microorganisms identified as the Burkholderia cepacia complex
defined as containing the following nine species, Burkholderia cepacia,
Burkholderia multivorans, Burkholderia stabilis, Burkholderia
vietnamiensis, Burkholderia ambifaria, Burkholderia pyrrocinia,
Burkholderia cepacia genomovar VIII (Burkholderia anthina), and
Burkholderia cepacia genomovars III and VI are subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new use is any use other than research and
development in the degradation of chemicals via injection into
subsurface groundwater.
(b) [Reserved]
[68 FR 35320, June 13, 2003]
Sec. 725.1079 Arsenic detecting strain of E. coli with
extra-chromosomal elements, including an intergeneric screening marker
(generic).
(a) Microorganism and significant new uses subject to reporting. (1)
The genetically-modified microorganism identified generically as arsenic
detecting strain of E. coli with extra-chromosomal elements, including
an intergeneric screening marker (MCAN J-18-41) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) It is a significant new use to manufacture (excluding import)
the microorganism in the United States for any use.
(ii) It is a significant new use to use the microorganism other than
to detect arsenic in small water samples.
[[Page 71]]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and processors
of this microorganism.
(2) Modification or revocation of certain notification requirements.
The provisions of Sec. 725.984 apply to this section.
[86 FR 24336, May 6, 2021]
Sec. 725.1080 Trichoderma reesei (generic).
(a) Microorganism and significant new uses subject to reporting. (1)
The genetically modified microorganism identified as Trichoderma reesei
strain 3CH-3 (MCAN J-19-1) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2)(i) The significant new use is any manufacturing, processing, or
use of the microorganism other than in a fermentation system that meets
all of the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any further fermentation, such as saccharification (i.e.,
addition of Trichoderma reesei fermentation broth to solid plant
material or insoluble substrate after the standard industrial
fermentation is completed), is initiated only after the inactivation of
the microorganism as delineated in Sec. 725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (c) and (i) of this chapter, are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 of this chapter apply to this section.
[86 FR 22875, Apr. 30, 2021]
Sec. 725.1081 Trichoderma reesei modified (generic).
(a) Microorganism and significant new uses subject to reporting. (1)
The genetically modified microorganism generically identified as
Trichoderma reesei modified (MCAN J-16-26) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2)(i) It is a significant new use to manufacture, process, or use
the microorganism other than in a fermentation system that meets all of
the following conditions:
(A) Enzyme production occurs by submerged fermentation (i.e., for
enzyme production, growth of the microorganism occurs beneath the
surface of the liquid growth medium); and
(B) Any fermentation of solid plant material or insoluble substrate
to which Trichoderma reesei fermentation broth is added after the
standard industrial fermentation is completed is initiated only after
the inactivation of the microorganism as delineated in Sec. 725.422(d).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart L of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
725.950(b)(2) through (4) are applicable to manufacturers and processors
of this microorganism.
(2) Modification or revocation of certain notification requirements.
The provisions of Sec. 725.984 apply to this section.
[87 FR 73955, Dec. 2, 2022]
PART 745_LEAD-BASED PAINT POISONING PREVENTION IN CERTAIN RESIDENTIAL
STRUCTURES--Table of Contents
Subparts A-C [Reserved]
Subpart D_Lead-Based Paint Hazards
Sec.
745.61 Scope and applicability.
745.63 Definitions.
745.65 Lead-based paint hazards.
745.67 Incorporation by reference.
Subpart E_Residential Property Renovation
745.80 Purpose.
[[Page 72]]
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.
745.237 Inspections.
745.238 Fees for accreditation and certification of lead-based paint
activities.
745.239 Effective dates.
Subparts M-P [Reserved]
Subpart Q_State and Indian Tribal Programs
745.320 Scope and purpose.
745.323 Definitions.
745.324 Authorization of State or Tribal programs.
745.325 Lead-based paint activities: State and Tribal program
requirements.
745.326 Renovation: State and Tribal program requirements.
745.327 State or Indian Tribal lead-based paint compliance and
enforcement programs.
745.339 Effective date.
Authority: 15 U.S.C. 2605, 2607, 2681-2692 and 42 U.S.C. 4852d.
Source: 61 FR 9085, Mar. 6, 1996, unless otherwise noted.
Subparts A-C [Reserved]
Subpart D_Lead-Based Paint Hazards
Source: 66 FR 1237, Jan. 5, 2001, unless otherwise noted.
Sec. 745.61 Scope and applicability.
(a) This subpart identifies lead-based paint hazards.
(b) The standards for lead-based paint hazards apply to target
housing and child-occupied facilities.
(c) Nothing in this subpart requires the owner of property(ies)
subject to these standards to evaluate the property(ies) for the
presence of lead-based paint hazards or take any action to control these
conditions if one or more of them is identified.
(d) Before January 13, 2025, the levels identified in 40 CFR
745.227(e)(8)(viii) were referred to as clearance levels. On or after
January 13, 2025, the levels identified in Sec. 745.227(e)(8)(viii) are
referred to as action levels.
[66 FR 1237, Jan. 5, 2001, as amended at 89 FR 89456, Nov. 12, 2024]
[[Page 73]]
Sec. 745.63 Definitions.
The following definitions apply to part 745.
Arithmetic mean means the algebraic sum of data values divided by
the number of data values (e.g., the sum of the concentration of lead in
several soil samples divided by the number of samples).
Chewable surface means an interior or exterior surface painted with
lead-based paint that a young child can mouth or chew. A chewable
surface is the same as an ``accessible surface'' as defined in 42 U.S.C.
4851b(2)). Hard metal substrates and other materials that cannot be
dented by the bite of a young child are not considered chewable.
Common area group means a group of common areas that are similar in
design, construction, and function. Common area groups include, but are
not limited to hallways, stairwells, and laundry rooms.
Concentration means the relative content of a specific substance
contained within a larger mass, such as the amount of lead (in
micrograms per gram or parts per million by weight) in a sample of dust
or soil.
Deteriorated paint means any interior or exterior paint or other
coating that is peeling, chipping, chalking or cracking, or any paint or
coating located on an interior or exterior surface or fixture that is
otherwise damaged or separated from the substrate.
Dripline means the area within 3 feet surrounding the perimeter of a
building.
Friction surface means an interior or exterior surface that is
subject to abrasion or friction, including, but not limited to, certain
window, floor, and stair surfaces.
Impact surface means an interior or exterior surface that is subject
to damage by repeated sudden force such as certain parts of door frames.
Interior window sill means the portion of the horizontal window
ledge that protrudes into the interior of the room.
Lead-based paint hazard means hazardous lead-based paint, dust-lead
hazard or soil-lead hazard as identified in Sec. 745.65.
Loading means the quantity of a specific substance present per unit
of surface area, such as the amount of lead in micrograms contained in
the dust collected from a certain surface area divided by the surface
area in square feet or square meters.
Mid-yard means an area of a residential yard approximately midway
between the dripline of a residential building and the nearest property
boundary or between the driplines of a residential building and another
building on the same property.
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.
Reportable level means the lowest analyte concentration (or amount)
that does not contain a ``less than'' qualifier and that is reported
with confidence for a specific method by a laboratory recognized by EPA
under TSCA section 405(b).
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
[[Page 74]]
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.''
Wipe sample means a sample collected by wiping a representative
surface of known area, as determined by ASTM E1728/E1728M-20
(incorporated by reference, see Sec. 745.67), or equivalent method,
with an acceptable wipe material as defined in ASTM E1792-20
(incorporated by reference, see Sec. 745.67).
[66 FR 1237, Jan. 5, 2001, as amended at 89 FR 89456, Nov. 12, 2024]
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. Before January 12, 2026, a dust-lead hazard is
surface dust in a residential dwelling or child-occupied facility that
contains a mass-per-area concentration of lead equal to or exceeding 10
[micro]g/ft\2\ for floors or 100 [micro]g/ft\2\ for interior window
sills based on wipe samples. On or after January 12, 2026, a dust-lead
hazard is surface dust in a residential dwelling or child-occupied
facility that contains a mass-per-area concentration of any reportable
level of lead for floors or for interior window sills based on wipe
samples analyzed by an NLLAP-recognized laboratory.
(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:
[[Page 75]]
(1) Two square feet of deteriorated lead-based paint per room or
equivalent,
(2) Twenty square feet of deteriorated paint on the exterior
building, or
(3) Ten percent of the total surface area of deteriorated paint on
an interior or exterior type of component with a small surface area.
[66 FR 1237, Jan. 5, 2001, as amended at 84 FR 32648, July 9, 2019; 89
FR 89456, Nov. 12, 2024]
Sec. 745.67 Incorporation by reference.
Certain material is incorporated by reference into this subpart with
the approval of the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by
reference (IBR) material is available for inspection at the
Environmental Protection Agency (EPA) and at the National Archives and
Records Administration (NARA). Contact EPA at: OPPT Docket in the
Environmental Protection Agency Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW,
Washington, DC. The EPA/DC Public Reading Room hours of operation are
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The telephone number of the EPA/DC Public Reading room is (202) 566-
1744, and the telephone number for the OPPT Docket is (202) 566-0280.
For information on the availability of this material at NARA, visit
www.archives.gov/federal-register/ cfr/ibr-locations or email
[email protected]. The material may be obtained from the following
sources:
(a) ASTM. ASTM International, 100 Barr Harbor Dr., P.O. Box C700,
West Conshohocken, PA 19428-2959; (877) 909-ASTM; www.astm.org.
(1) ASTM E1728/E1728M-20, Standard Practice for Collection of
Settled Dust Samples Using Wipe Sampling Methods for Subsequent Lead
Determination, Approved January 1, 2020; IBR approved for Sec. 745.63.
(2) ASTM E1792-20, Standard Specification for Wipe Sampling
Materials for Lead in Surface Dust, Approved September 1, 2020; IBR
approved for Sec. 745.63.
(b) [Reserved]
[89 FR 89456, Nov. 12, 2024]
Subpart E_Residential Property Renovation
Source: 63 FR 29919, June 1, 1998, unless otherwise noted.
Sec. 745.80 Purpose.
This subpart contains regulations developed under sections 402 and
406 of the Toxic Substances Control Act (15 U.S.C. 2682 and 2686) and
applies to all renovations performed for compensation in target housing
and child-occupied facilities. The purpose of this subpart is to ensure
the following:
(a) Owners and occupants of target housing and child-occupied
facilities receive information on lead-based paint hazards before these
renovations begin; and
(b) Individuals performing renovations regulated in accordance with
Sec. 745.82 are properly trained; renovators and firms performing these
renovations are certified; and the work practices in Sec. 745.85 are
followed during these renovations.
[73 FR 21758, Apr. 22, 2008]
Sec. 745.81 Effective dates.
(a) Training, certification and accreditation requirements and work
practice standards. The training, certification and accreditation
requirements and work practice standards in this subpart are applicable
in any State or Indian Tribal area that does not have a renovation
program that is authorized under subpart Q of this part. The training,
certification and accreditation requirements and work practice standards
in this subpart will become effective as follows:
(1) Training programs. Effective June 23, 2008, no training program
may provide, offer, or claim to provide training or refresher training
for EPA certification as a renovator or a dust sampling technician
without accreditation from EPA under Sec. 745.225. Training programs
may apply for accreditation under Sec. 745.225 beginning April 22,
2009.
(2) Firms. (i) Firms may apply for certification under Sec. 745.89
beginning October 22, 2009.
[[Page 76]]
(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. 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. On or after December 22, 2008,
renovators or firms performing renovations in States and Indian Tribal
areas without an authorized program must provide owners and occupants
the following EPA pamphlet: Renovate Right: Important Lead Hazard
Information for Families, Child Care Providers and Schools.
(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; 89
FR 89457, Nov. 12, 2024]
Sec. 745.82 Applicability.
(a) This subpart applies to all renovations performed for
compensation in target housing and child-occupied facilities, except for
the following:
(1) Renovations in target housing or child-occupied facilities in
which a written determination has been made by an inspector or risk
assessor (certified pursuant to either Federal regulations at Sec.
745.226 or a State or Tribal certification program authorized pursuant
to Sec. 745.324) that the components affected by the renovation are
free of paint or other surface coatings that contain lead equal to or in
excess of 1.0 milligrams/per square centimeter (mg/cm\2\) or 0.5% by
weight, where the firm performing the renovation has obtained a copy of
the determination.
(2) Renovations in target housing or child-occupied facilities in
which a certified renovator, using an EPA recognized test kit as defined
in Sec. 745.83 and following the kit manufacturer's instructions, has
tested each component affected by the renovation and determined that the
components are free of paint or other surface coatings that contain lead
equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the
components make up an integrated whole, such as the individual stair
treads and risers of a single staircase, the renovator is required to
test only one of the individual components, unless the individual
components appear to have been repainted or refinished separately.
(3) Renovations in target housing or child-occupied facilities in
which a certified renovator has collected a paint chip sample from each
painted component affected by the renovation and a laboratory recognized
by EPA pursuant to section 405(b) of TSCA as being capable of performing
analyses for lead compounds in paint chip samples has determined that
the samples are free of paint or other surface coatings that contain
lead equal to or in excess of 1.0 mg/cm\2\ or 0.5% by weight. If the
components make up an integrated whole, such as the individual stair
treads and risers of a single staircase, the renovator is required to
test only one of the individual components, unless the individual
components appear to have been repainted or refinished separately.
(b) The information distribution requirements in Sec. 745.84 do not
apply to emergency renovations, which are renovation activities that
were not planned but result from a sudden, unexpected event (such as
non-routine
[[Page 77]]
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 cloth designed to be used
for cleaning hard surfaces such as uncarpeted floors or counter tops.
Electronic means the submission of an application, payment, or
notification using the Agency's Central Data Exchange (CDX), or
successor platform.
[[Page 78]]
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
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
[[Page 79]]
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; 89 FR 89457, Nov. 12, 2024]
Sec. 745.84 Information distribution requirements.
(a) Renovations in dwelling units. No more than 60 days before
beginning renovation activities in any residential dwelling unit of
target housing, the firm performing the renovation must:
(1) Provide the owner of the unit with the pamphlet, and comply with
one of the following:
(i) Obtain, from the owner, a written acknowledgment that the owner
has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(2) In addition to the requirements in paragraph (a)(1) of this
section, if the owner does not occupy the dwelling unit, provide an
adult occupant of the unit with the pamphlet, and comply with one of the
following:
(i) Obtain, from the adult occupant, a written acknowledgment that
the occupant has received the pamphlet; or certify in writing that a
pamphlet has been delivered to the dwelling and that the firm performing
the renovation has been unsuccessful in obtaining a written
acknowledgment from an adult occupant. Such certification must include
the address of the unit undergoing renovation, the date and method of
delivery of the pamphlet, names of the persons delivering the pamphlet,
reason for lack of acknowledgment (e.g., occupant refuses to sign, no
adult occupant available), the signature of a representative of the firm
performing the renovation, and the date of signature.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(b) Renovations in common areas. No more than 60 days before
beginning renovation activities in common areas of multi-unit target
housing, the firm performing the renovation must:
(1) Provide the owner with the pamphlet, and comply with one of the
following:
(i) Obtain, from the owner, a written acknowledgment that the owner
has received the pamphlet.
(ii) Obtain a certificate of mailing at least 7 days prior to the
renovation.
(2) Comply with one of the following. (i) Notify in writing, or
ensure written notification of, each affected unit and make the pamphlet
available upon request prior to the start of renovation. Such
notification shall be accomplished by distributing written notice to
each affected unit. The notice shall describe the general nature and
locations of the planned renovation activities; the expected starting
and ending
[[Page 80]]
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 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
[[Page 81]]
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
that extend from the floor to the ceiling and are tightly sealed at
joints with the floor, ceiling and walls.
[[Page 82]]
(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.
(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
[[Page 83]]
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.
(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
[[Page 84]]
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 sample results are below the dust-lead action levels 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; 89
FR 89457, Nov. 12, 2024]
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-
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
[[Page 85]]
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).
(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:
[[Page 86]]
(1) The owner of the building; and, if different,
(2) An adult occupant of the residential dwelling, if the renovation
took place within a residential dwelling, or an adult representative of
the child-occupied facility, if the renovation took place within a
child-occupied facility.
(3) When performing renovations in common areas of multi-unit target
housing, renovation firms must post these dust sampling reports or
information on how interested occupants of the housing being renovated
can obtain a copy of the report. This information must be posted in
areas where they are likely to be seen by the occupants of all of the
affected units.
[73 FR 21761, Apr. 22, 2008, as amended at 75 FR 24819, May 6, 2010; 76
FR 47939, Aug. 5, 2011]
Sec. 745.87 Enforcement and inspections.
(a) Failure or refusal to comply with any provision of this subpart
is a violation of TSCA section 409 (15 U.S.C. 2689).
(b) Failure or refusal to establish and maintain records or to make
available or permit access to or copying of records, as required by this
subpart, is a violation of TSCA sections 15 and 409 (15 U.S.C. 2614 and
2689).
(c) Failure or refusal to permit entry or inspection as required by
40 CFR 745.87 and TSCA section 11 (15 U.S.C. 2610) is a violation of
sections 15 and 409 (15 U.S.C. 2614 and 2689).
(d) Violators may be subject to civil and criminal sanctions
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation.
(e) Lead-based paint is assumed to be present at renovations covered
by this subpart. EPA may conduct inspections and issue subpoenas
pursuant to the provisions of TSCA section 11 (15 U.S.C. 2610) to ensure
compliance with this subpart.
[63 FR 29919, June 1, 1998, as amended at 73 FR 21763, Apr. 22, 2008]
Sec. 745.88 Recognized test kits.
(a) Effective June 23, 2008, EPA recognizes the test kits that have
been determined by National Institute of Standards and Technology
research to meet the negative response criteria described in paragraph
(c)(1) of this section. This recognition will last until EPA publicizes
its recognition of the first test kit that meets both the negative
response and positive response criteria in paragraph (c) of this
section.
(b) No other test kits will be recognized until they are tested
through EPA's Environmental Technology Verification Program or other
equivalent EPA approved testing program.
(1) Effective September 1, 2008, to initiate the testing process, a
test kit manufacturer must submit a sufficient number of kits, along
with the instructions for using the kits, to EPA. The test kit
manufacturer should first visit the following website for information on
where to apply: http://www.epa.gov/etv /howtoapply.html.
(2) After the kit has been tested through the Environmental
Technology Verification Program or other equivalent approved EPA testing
program, EPA will review the report to determine whether the required
criteria have been met.
(3) Before September 1, 2010, test kits must meet only the negative
response criteria in paragraph (c)(1) of this section. The recognition
of kits that meet only this criteria will last until EPA publicizes its
recognition of the first test kits that meets both of the criteria in
paragraph (c) of this section.
(4) After September 1, 2010, test kits must meet both of the
criteria in paragraph (c) of this section.
(5) If the report demonstrates that the kit meets the required
criteria, EPA will issue a notice of recognition to the kit
manufacturer, provide them with the report, and post the information on
EPA's website.
(6) If the report demonstrates that the kit does not meet the
required criteria, EPA will notify the kit manufacturer and provide them
with the report.
(c) Response criteria--(1) Negative response criteria. For paint
containing lead at or above the regulated level, 1.0 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
[[Page 87]]
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 electronically 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 electronically 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 electronic 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
electronically submitted 90 days or more before the date the firm's
current certification expires. If the firm's application is complete and
timely, the firm's current certification will remain in effect until its
expiration date or until EPA has made a final decision to approve or
disapprove the re-certification application, whichever is later.
(ii) If the firm submits a complete re-certification application
less than 90 days before its current certification expires, and EPA does
not approve the application before the expiration date, the firm's
current certification will expire and the firm will not be able to
conduct renovations until EPA approves its re-certification application.
(iii) If the firm fails to obtain recertification before the firm's
current certification expires, the firm must not perform renovations or
dust sampling until it is certified anew pursuant to paragraph (a) of
this section.
(2) EPA action on an application. After EPA receives a firm's
application for re-certification, EPA will review the
[[Page 88]]
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 certification, a firm must electronically 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, as amended at 89 FR 89457, Nov. 12, 2024]
Sec. 745.90 Renovator certification and dust sampling technician
certification.
(a) Renovator certification and dust sampling technician
certification. (1) To become a certified renovator or certified dust
sampling technician, an individual must successfully complete the
appropriate course accredited by EPA under Sec. 745.225 or by a State
or Tribal program that is authorized under subpart Q of this part. The
course completion certificate serves as proof of certification. EPA
renovator certification allows the certified individual to perform
renovations covered by this section in any State or Indian Tribal area
that does not have a renovation program that is authorized under subpart
Q of this part. EPA dust sampling technician certification allows the
certified individual to perform dust clearance sampling under Sec.
745.85(c) in any State or Indian Tribal
[[Page 89]]
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 before 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 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 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 action levels in accordance with Sec. 745.227(e)(8).
[[Page 90]]
(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; 89 FR 89457, Nov. 12, 2024]
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.
(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
[[Page 91]]
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
------------------------------------------------------------------------
(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 electronically in
accordance with the instructions provided with the application package.
[[Page 92]]
(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; 89
FR 89457, Nov. 12, 2024]
Subpart F_Disclosure of Known Lead-Based Paint and/or Lead-Based Paint
Hazards Upon Sale or Lease of Residential Property
Sec. 745.100 Purpose.
This subpart implements the provisions of 42 U.S.C. 4852d, which
impose certain requirements on the sale or lease of target housing.
Under this subpart, a seller or lessor of target housing shall disclose
to the purchaser or lessee the presence of any known lead-based paint
and/or lead-based paint hazards; provide available records and reports;
provide the purchaser or lessee with a lead hazard information pamphlet;
give purchasers a 10-day opportunity to conduct a risk assessment or
inspection; and attach specific disclosure and warning language to the
sales or leasing contract before the purchaser or lessee is obligated
under a contract to purchase or lease target housing.
Sec. 745.101 Scope and applicability.
This subpart applies to all transactions to sell or lease target
housing, including subleases, with the exception of the following:
(a) Sales of target housing at foreclosure.
(b) Leases of target housing that have been found to be lead-based
paint free by an inspector certified under the Federal certification
program or under a federally accredited State or tribal certification
program. Until a Federal certification program or federally accredited
State certification program is in place within the State, inspectors
shall be considered qualified to conduct an inspection for this purpose
if they have received certification under any existing State or tribal
inspector certification program. The lessor has the option of using the
results of additional test(s) by a certified inspector to confirm or
refute a prior finding.
(c) Short-term leases of 100 days or less, where no lease renewal or
extension can occur.
(d) Renewals of existing leases in target housing in which the
lessor has previously disclosed all information required under Sec.
745.107 and where no new information described in Sec. 745.107 has come
into the possession of the lessor. For the purposes of this paragraph,
renewal shall include both renegotiation of existing lease terms and/or
ratification of a new lease.
Sec. 745.102 Effective dates.
The requirements in this subpart take effect in the following
manner:
(a) For owners of more than four residential dwellings, the
requirements shall take effect on September 6, 1996.
(b) For owners of one to four residential dwellings, the
requirements shall take effect on December 6, 1996.
Sec. 745.103 Definitions.
The following definitions apply to this subpart.
The Act means the Residential Lead-Based Paint Hazard Reduction Act
of 1992, 42 U.S.C. 4852d.
Agent means any party who enters into a contract with a seller or
lessor, including any party who enters into a contract with a
representative of the seller or lessor, for the purpose of selling or
leasing target housing. This term does not apply to purchasers or any
purchaser's representative who receives all compensation from the
purchaser.
Available means in the possession of or reasonably obtainable by the
seller or lessor at the time of the disclosure.
Common area means a portion of a building generally accessible to
all
[[Page 93]]
residents/users including, but not limited to, hallways, stairways,
laundry and recreational rooms, playgrounds, community centers, and
boundary fences.
Contract for the purchase and sale of residential real property
means any contract or agreement in which one party agrees to purchase an
interest in real property on which there is situated one or more
residential dwellings used or occupied, or intended to be used or
occupied, in whole or in part, as the home or residence of one or more
persons.
EPA means the Environmental Protection Agency.
Evaluation means a risk assessment and/or inspection.
Foreclosure means any of the various methods, statutory or
otherwise, known in different jurisdictions, of enforcing payment of a
debt, by the taking and selling of real property.
Housing for the elderly means retirement communities or similar
types of housing reserved for households composed of one or more persons
62 years of age or more at the time of initial occupancy.
HUD means the U.S. Department of Housing and Urban Development.
Inspection means:
(1) A surface-by-surface investigation to determine the presence of
lead-based paint as provided in section 302(c) of the Lead-Based Paint
Poisoning and Prevention Act [42 U.S.C. 4822], and
(2) The provision of a report explaining the results of the
investigation.
Lead-based paint means paint or other surface coatings that contain
lead equal to or in excess of 1.0 milligram per square centimeter or 0.5
percent by weight.
Lead-based paint free housing means target housing that has been
found to be free of paint or other surface coatings that contain lead
equal to or in excess of 1.0 milligram per square centimeter or 0.5
percent by weight.
Lead-based paint hazard means any condition that causes exposure to
lead from lead-contaminated dust, lead-contaminated soil, or lead-
contaminated paint that is deteriorated or present in accessible
surfaces, friction surfaces, or impact surfaces that would result in
adverse human health effects as established by the appropriate Federal
agency.
Lessee means any entity that enters into an agreement to lease,
rent, or sublease target housing, including but not limited to
individuals, partnerships, corporations, trusts, government agencies,
housing agencies, Indian tribes, and nonprofit organizations.
Lessor means any entity that offers target housing for lease, rent,
or sublease, including but not limited to individuals, partnerships,
corporations, trusts, government agencies, housing agencies, Indian
tribes, and nonprofit organizations.
Owner means any entity that has legal title to target housing,
including but not limited to individuals, partnerships, corporations,
trusts, government agencies, housing agencies, Indian tribes, and
nonprofit organizations, except where a mortgagee holds legal title to
property serving as collateral for a mortgage loan, in which case the
owner would be the mortgagor.
Purchaser means an entity that enters into an agreement to purchase
an interest in target housing, including but not limited to individuals,
partnerships, corporations, trusts, government agencies, housing
agencies, Indian tribes, and nonprofit organizations.
Reduction means measures designed to reduce or eliminate human
exposure to lead-based paint hazards through methods including interim
controls and abatement.
Residential dwelling means:
(1) A single-family dwelling, including attached structures such as
porches and stoops; or
(2) A single-family dwelling unit in a structure that contains more
than one separate residential dwelling unit, and 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;
[[Page 94]]
(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 or any 0-bedroom
dwelling (unless any child who is less than 6 years of age resides or is
expected to reside in such housing).
TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601.
0-bedroom dwelling means any residential dwelling in which the
living area is not separated from the sleeping area. The term includes
efficiencies, studio apartments, dormitory housing, military barracks,
and rentals of individual rooms in residential dwellings.
[61 FR 9085, Mar. 6, 1996, as amended at 89 FR 89458, Nov. 12, 2024]
Sec. 745.107 Disclosure requirements for sellers and lessors.
(a) The following activities shall be completed before the purchaser
or lessee is obligated under any contract to purchase or lease target
housing that is not otherwise an exempt transaction pursuant to Sec.
745.101. Nothing in this section implies a positive obligation on the
seller or lessor to conduct any evaluation or reduction activities.
(1) The seller or lessor shall provide the purchaser or lessee with
an EPA-approved lead hazard information pamphlet. Such pamphlets include
the EPA document entitled Protect Your Family From Lead in Your Home
(EPA 747-K-94-001) or an equivalent pamphlet that has been approved for
use in that State by EPA.
(2) The seller or lessor shall disclose to the purchaser or lessee
the presence of any known lead-based paint and/or lead-based paint
hazards in the target housing being sold or leased. The seller or lessor
shall also disclose any additional information available concerning the
known lead-based paint and/or lead-based paint hazards, such as the
basis for the determination that lead-based paint and/or lead-based
paint hazards exist, the location of the lead-based paint and/or lead-
based paint hazards, and the condition of the painted surfaces.
(3) The seller or lessor shall disclose to each agent the presence
of any known lead-based paint and/or lead-based paint hazards in the
target housing being sold or leased and the existence of any available
records or reports pertaining to lead-based paint and/or lead-based
paint hazards. The seller or lessor shall also disclose any additional
information available concerning the known lead-based paint and/or lead-
based paint hazards, such as the basis for the determination that lead-
based paint and/or lead-based paint hazards exist, the location of the
lead-based paint and/or lead-based paint hazards, and the condition of
the painted surfaces.
(4) The seller or lessor shall provide the purchaser or lessee with
any records or reports available to the seller or lessor pertaining to
lead-based paint and/or lead-based paint hazards in the target housing
being sold or leased. This requirement includes records or reports
regarding common areas. This requirement also includes records or
reports regarding other residential dwellings in multifamily target
housing, provided that such information is part of an evaluation or
reduction of lead-based paint and/or lead-based paint hazards in the
target housing as a whole.
(b) If any of the disclosure activities identified in paragraph (a)
of this section occurs after the purchaser or lessee has provided an
offer to purchase or
[[Page 95]]
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 (3) of this section and the
lead hazard information pamphlet required under 15 U.S.C. 2686.
(5) A statement by the purchaser that he/she has either:
(i) Received the opportunity to conduct the risk assessment or
inspection required by Sec. 745.110(a); or
(ii) Waived the opportunity.
(6) When one or more agents are involved in the transaction to sell
target housing on behalf of the seller, a statement that:
(i) The agent has informed the seller of the seller's obligations
under 42 U.S.C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with
the requirements of this subpart.
(7) The signatures of the sellers, agents, and purchasers certifying
to the accuracy of their statements to the best of their knowledge,
along with the dates of signature.
(b) Lessor requirements. Each contract to lease target housing shall
include, as an attachment or within the contract, the following
elements, in the language of the contract (e.g., English, Spanish):
(1) A Lead Warning Statement with the following language:
Housing built before 1978 may contain lead-based paint. Lead from
paint, paint chips, and dust can pose health hazards if not managed
properly. Lead exposure is especially harmful to young children and
pregnant women. Before renting pre-1978 housing, lessors must disclose
the presence of known
[[Page 96]]
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 (3) of this section and the lead hazard
information pamphlet required under 15 U.S.C. 2686.
(5) When one or more agents are involved in the transaction to lease
target housing on behalf of the lessor, a statement that:
(i) The agent has informed the lessor of the lessor as obligations
under 42 U.S.C. 4852d; and
(ii) The agent is aware of his/her duty to ensure compliance with
the requirements of this subpart.
(6) The signatures of the lessors, agents, and lessees, certifying
to the accuracy of their statements, to the best of their knowledge,
along with the dates of signature.
(c) Retention of Certification and Acknowledgment Information. (1)
The seller, and any agent, shall retain a copy of the completed
attachment required under paragraph (a) of this section for no less than
3 years from the completion date of the sale. The lessor, and any agent,
shall retain a copy of the completed attachment or lease contract
containing the information required under paragraph (b) of this section
for no less than 3 years from the commencement of the leasing period.
(2) This recordkeeping requirement is not intended to place any
limitations on civil suits under the Act, or to otherwise affect a
lessee's or purchaser's rights under the civil penalty provisions of 42
U.S.C. 4852d(b)(3).
(d) The seller, lessor, or agent shall not be responsible for the
failure of a purchaser's or lessee's legal representative (where such
representative receives all compensation from the purchaser or lessee)
to transmit disclosure materials to the purchaser or lessee, provided
that all required parties have completed and signed the necessary
certification and acknowledgment language required under paragraphs (a)
and (b) of this section.
[61 FR 9085, Mar. 6, 1996, as amended at 89 FR 89458, Nov. 12, 2024]
Sec. 745.115 Agent responsibilities.
(a) Each agent shall ensure compliance with all requirements of this
subpart. To ensure compliance, the agent shall:
(1) Inform the seller or lessor of his/her obligations under
Sec. Sec. 745.107, 745.110, and 745.113.
(2) Ensure that the seller or lessor has performed all activities
required under Sec. Sec. 745.107, 745.110, and 745.113, or personally
ensure compliance with the requirements of Sec. Sec. 745.107, 745.110,
and 745.113.
(b) If the agent has complied with paragraph (a)(1) of this section,
the agent shall not be liable for the failure to disclose to a purchaser
or lessee the presence of lead-based paint and/or lead-based paint
hazards known by a seller or lessor but not disclosed to the agent.
Sec. 745.118 Enforcement.
(a) Any person who knowingly fails to comply with any provision of
this subpart shall be subject to civil monetary penalties in accordance
with the provisions of 42 U.S.C. 3545 and 24 CFR part 30.
(b) The Secretary is authorized to take such action as may be
necessary to enjoin any violation of this subpart in the appropriate
Federal district court.
[[Page 97]]
(c) Any person who knowingly violates the provisions of this subpart
shall be jointly and severally liable to the purchaser or lessee in an
amount equal to 3 times the amount of damages incurred by such
individual.
(d) In any civil action brought for damages pursuant to 42 U.S.C.
4852d(b)(3), the appropriate court may award court costs to the party
commencing such action, together with reasonable attorney fees and any
expert witness fees, if that party prevails.
(e) Failure or refusal to comply with Sec. 745.107 (disclosure
requirements for sellers and lessors), Sec. 745.110 (opportunity to
conduct an evaluation), Sec. 745.113 (certification and acknowledgment
of disclosure), or Sec. 745.115 (agent responsibilities) is a violation
of 42 U.S.C. 4852d(b)(5) and of TSCA section 409 (15 U.S.C. 2689).
(f) Violators may be subject to civil and criminal sanctions
pursuant to TSCA section 16 (15 U.S.C. 2615) for each violation. For
purposes of enforcing this subpart, the penalty for each violation
applicable under 15 U.S.C. 2615 shall not be more than $11,000 for all
violations occuring after July 28, 1997; all violations occuring on or
prior to that date are subject to a penalty not more than $10,000. The
civil monetary penalty amounts listed in this section may not reflect
recent inflation adjustments EPA is required to make. The current
maximum and minimum statutory civil penalty amounts are located in Sec.
19.4.
[61 FR 9085, Mar. 6, 1996, as amended at 62 FR 35041, June 27, 1997; 89
FR 88656, Nov. 8, 2024]
Sec. 745.119 Impact on State and local requirements.
Nothing in this subpart shall relieve a seller, lessor, or agent
from any responsibility for compliance with State or local laws,
ordinances, codes, or regulations governing notice or disclosure of
known lead-based paint or lead-based paint hazards. Neither HUD nor EPA
assumes any responsibility for ensuring compliance with such State or
local requirements.
Subparts G-K [Reserved]
Subpart L_Lead-Based Paint Activities
Source: 61 FR 45813, Aug. 29, 1996, unless otherwise noted.
Sec. 745.220 Scope and applicability.
(a) This subpart contains procedures and requirements for the
accreditation of training programs for lead-based paint activities and
renovations, procedures and requirements for the certification of
individuals and firms engaged in lead-based paint activities, and work
practice standards for performing such activities. This subpart also
requires that, except as discussed below, all lead-based paint
activities, as defined in this subpart, be performed by certified
individuals and firms.
(b) This subpart applies to all individuals and firms who are
engaged in lead-based paint activities as defined in Sec. 745.223,
except persons who perform these activities within residential dwellings
that they own, unless the residential dwelling is occupied by a person
or persons other than the owner or the owner's immediate family while
these activities are being performed, or a child residing in the
building has been identified as having an elevated blood lead level.
This subpart applies only in those States or Indian Country that do not
have an authorized State or Tribal program pursuant to Sec. 745.324 of
subpart Q.
(c) Each department, agency, and instrumentality of the executive,
legislative, and judicial branches of the Federal Government having
jurisdiction over any property or facility, or engaged in any activity
resulting, or which may result, in a lead-based paint hazard, and each
officer, agent, or employee thereof shall be subject to, and comply
with, all Federal, State, interstate, and local requirements, both
substantive and procedural, including the requirements of this subpart
regarding lead-based paint, lead-based paint activities, and lead-based
paint hazards.
(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
[[Page 98]]
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, in the case of dust-lead
hazards to below the action levels. Abatement includes, but is not
limited to:
(1) The removal of paint and dust (in the case of dust-lead hazards
to below the action levels), 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 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, in the case of dust-lead hazards to below the action levels; or
(B) Are designed to permanently eliminate lead-based paint hazards,
in the case of dust-lead hazards to below the action levels, and are
described in paragraphs (1) and (2) of this definition.
(ii) Projects resulting in the permanent elimination of lead-based
paint hazards, in the case of dust-lead hazards to below the action
levels, 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, in the case of dust-lead hazards to below the action
levels, 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, in the case of dust-lead hazards to below the action
levels, 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, in the case of dust-lead
hazards to below the action levels, 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, in the case of dust-lead hazards to
below the action levels.
Action levels are the values that indicate the amount of lead in
dust on a surface following completion of an abatement activity. To
complete abatement when dust sampling is required, values below these
levels must be achieved. EPA previously used the term ``clearance
levels'' to refer to these levels.
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.
[[Page 99]]
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-related testing.
Certified abatement worker means an individual who has been trained
by an accredited training program, as defined by this section, and
certified by EPA pursuant to Sec. 745.226 to perform abatements.
Certified project designer means an individual who has been trained
by an accredited training program, as defined by this section, and
certified by EPA pursuant to Sec. 745.226 to prepare abatement project
designs, occupant protection plans, and abatement reports.
Certified risk assessor means an individual who has been trained by
an accredited training program, as defined by this section, and
certified by EPA pursuant to Sec. 745.226 to conduct risk assessments.
A risk assessor also samples for the presence of lead in dust and soil
for the purposes of abatement-related 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, 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 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.
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
[[Page 100]]
otherwise separating from the substrate of a building component.
Discipline means one of the specific types or categories of lead-
based paint activities identified in this subpart for which individuals
may receive training from accredited programs and become certified by
EPA. For example, ``abatement worker'' is a discipline.
Distinct painting history means the application history, as
indicated by its visual appearance or a record of application, over
time, of paint or other surface coatings to a component or room.
Documented methodologies are methods or protocols used to sample for
the presence of lead in paint, dust, and soil.
Electronic means the submission of an application, payment, or
notification using the Agency's Central Data Exchange (CDX), or
successor platform.
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.
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.
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.
[[Page 101]]
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 under age 6 including, but not limited to, living rooms,
kitchen areas, dens, play rooms, and children's bedrooms.
Local government means a county, city, town, borough, parish,
district, association, or other public body (including an agency
comprised of two or more of the foregoing entities) created under State
law.
Multi-family dwelling means a structure that contains more than one
separate residential dwelling unit, which is used or occupied, or
intended to be used or occupied, in whole or in part, as the home or
residence of one or more persons.
Nonprofit means an entity which has demonstrated to any branch of
the Federal Government or to a State, municipal, tribal or territorial
government, that no part of its net earnings inure to the benefit of any
private shareholder or individual.
Paint in poor condition means more than 10 square feet of
deteriorated paint on exterior components with large surface areas; or
more than 2 square feet of deteriorated paint on interior components
with large surface areas (e.g., walls, ceilings, floors, doors); or more
than 10 percent of the total surface area of the component is
deteriorated on interior or exterior components with small surface areas
(window sills, baseboards, soffits, trim).
Permanently covered soil means soil which has been separated from
human contact by the placement of a barrier consisting of solid,
relatively impermeable materials, such as pavement or concrete. Grass,
mulch, and other landscaping materials are not considered permanent
covering.
Person means any natural or judicial person including any
individual, corporation, partnership, or association; any Indian Tribe,
State, or political subdivision thereof; any interstate body; and any
department, agency, or instrumentality of the Federal government.
Principal instructor means the individual who has the primary
responsibility for organizing and teaching a particular course.
Recognized laboratory means an environmental laboratory recognized
by EPA pursuant to TSCA section 405(b) as being capable of performing an
analysis for lead compounds in paint, soil, and dust.
Reduction means measures designed to reduce or eliminate human
exposure to lead-based paint hazards through methods including interim
controls and abatement.
Residential dwelling means (1) a detached single family dwelling
unit, including attached structures such as porches and stoops; or (2) a
single family dwelling unit in a structure that contains more than one
separate residential dwelling unit, which is used or occupied, or
intended to be used or occupied, in whole or in part, as the home or
residence of one or more persons.
Risk assessment means (1) an on-site investigation to determine the
existence, nature, severity, and location of lead-based paint hazards,
and (2) the provision of a report by the individual 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 or any 0-bedroom
dwelling (unless any child who is less than 6 years of age resides or is
expected to reside in such housing).
[[Page 102]]
Training curriculum means an established set of course topics for
instruction in an accredited training program for a particular
discipline designed to provide specialized knowledge and skills.
Training hour means at least 50 minutes of actual learning,
including, but not limited to, time devoted to lecture, learning
activities, small group activities, demonstrations, evaluations, and/or
hands-on experience.
Training manager means the individual responsible for administering
a training program and monitoring the performance of principal
instructors and guest instructors.
Training provider means any organization or entity accredited under
Sec. 745.225 to offer lead-based paint activities courses.
Visual inspection for abatement-related testing means the visual
examination of a residential dwelling or a child-occupied facility
following an abatement to determine whether or not the abatement has
been successfully completed.
Visual inspection for risk assessment means the visual examination
of a residential dwelling or a child-occupied facility to determine the
existence of deteriorated lead-based paint or other potential sources of
lead-based paint hazards.
[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 31097, June 9, 1999; 66
FR 1239, Jan. 5, 2001; 69 FR 18495, Apr. 8, 2004; 86 FR 994, Jan. 7,
2021; 89 FR 89458, Nov. 12, 2024]
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 an
electronic 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
[[Page 103]]
Tribe that has been authorized by EPA under subpart Q of this part, the
training program manager shall include a statement certifying that, as
well.
(vi) If a training program does not use EPA-recommended model
training materials, its application for accreditation shall also
include:
(A) A copy of the student and instructor manuals, or other materials
to be used for each course.
(B) A copy of the course agenda for each course.
(C) When applying for accreditation of a course in a language other
than English, a signed statement from a qualified, independent
translator that they had compared the course to the English language
version and found the translation to be accurate.
(vii) All training programs shall include in their application for
accreditation the following:
(A) A description of the facilities and equipment to be used for
lecture and hands-on training.
(B) A copy of the course test blueprint for each course.
(C) A description of the activities and procedures that will be used
for conducting the assessment of hands-on skills for each course.
(D) A copy of the quality control plan as described in paragraph
(c)(9) of this section.
(2) If a training program meets the requirements in paragraph (c) of
this section, then EPA shall approve the application for accreditation
no more than 180 days after receiving a complete application from the
training program. In the case of approval, a certificate of
accreditation shall be sent to the applicant. In the case of
disapproval, a letter describing the reasons for disapproval shall be
sent to the applicant. Prior to disapproval, EPA may, at its discretion,
work with the applicant to address inadequacies in the application for
accreditation. EPA may also request additional materials retained by the
training program under paragraph (i) of this section. If a training
program's application is disapproved, the program may reapply for
accreditation at any time.
(3) A training program may apply for accreditation to offer courses
or refresher courses in as many disciplines as it chooses. A training
program may seek accreditation for additional courses at any time as
long as the program can demonstrate that it meets the requirements of
this section.
(4) A training program applying for accreditation must submit the
appropriate fees in accordance with Sec. 745.238.
(c) Requirements for the accreditation of training programs. A
training program accredited by EPA to offer lead-based paint activities
courses, renovator courses, or dust sampling technician courses must
meet the following requirements:
(1) The training program shall employ a training manager who has:
(i) At least 2 years of experience, education, or training in
teaching workers or adults; or
(ii) A bachelor's or graduate degree in building construction
technology, engineering, industrial hygiene, safety, public health,
education, business administration or program management or a related
field; or
(iii) Two years of experience in managing a training program
specializing in environmental hazards; and
(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
[[Page 104]]
of the teaching of all course material. The training manager may
designate guest instructors as needed for a portion of the course to
provide instruction specific to the lecture, hands-on activities, or
work practice components of a course. However, the principal instructor
is primarily responsible for teaching the course materials and must be
present to provide instruction (or oversight of portions of the course
taught by guest instructors) for the course for which he has been
designated the principal instructor.
(4) The following documents shall be recognized by EPA as evidence
that training managers and principal instructors have the education,
work experience, training requirements or demonstrated experience,
specifically listed in paragraphs (c)(1) and (c)(2) of this section.
This documentation must be submitted with the accreditation application
and retained by the training program as required by the recordkeeping
requirements contained in paragraph (i) of this section. Those documents
include the following:
(i) Official academic transcripts or diploma as evidence of meeting
the education requirements.
(ii) Resumes, letters of reference, or documentation of work
experience, as evidence of meeting the work experience requirements.
(iii) Certificates from train-the-trainer courses and lead-specific
training courses, as evidence of meeting the training requirements.
(5) The training program shall ensure the availability of, and
provide adequate facilities for, the delivery of the lecture, course
test, hands-on training, and assessment activities. This includes
providing training equipment that reflects current work practices and
maintaining or updating the equipment and facilities as needed.
(6) To become accredited in the following disciplines, the training
program shall provide training courses that meet the following training
requirements:
(i) The inspector course shall last a minimum of 24 training hours,
with a minimum of 8 hours devoted to hands-on training activities. The
minimum curriculum requirements for the inspector course are contained
in paragraph (d)(1) of this section.
(ii) The risk assessor course shall last a minimum of 16 training
hours, with a minimum of 4 hours devoted to hands-on training
activities. The minimum curriculum requirements for the risk assessor
course are contained in paragraph (d)(2) of this section.
(iii) The supervisor course shall last a minimum of 32 training
hours, with a minimum of 8 hours devoted to hands-on activities. The
minimum curriculum requirements for the supervisor course are contained
in paragraph (d)(3) of this section.
(iv) The project designer course shall last a minimum of 8 training
hours. The minimum curriculum requirements for the project designer
course are contained in paragraph (d)(4) of this section.
(v) The abatement worker course shall last a minimum of 16 training
hours, with a minimum of 8 hours devoted to hands-on training
activities. The minimum curriculum requirements for the abatement worker
course 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.
[[Page 105]]
(B) The training provider must track each student's course log-ins,
launches, progress, and completion, and maintain these records in
accordance with paragraph (i) of this section.
(C) The course must include periodic knowledge checks equivalent to
the number and content of the knowledge checks contained in EPA's model
course, but at least 16 over the entire course. The knowledge checks
must be successfully completed before the student can go on to the next
module.
(D) There must be a test of at least 20 questions at the end of the
electronic learning portion of the course, of which 80% must be answered
correctly by the student for successful completion of the electronic
learning portion of the course. The test must be designed so that
students to do not receive feedback on their test answers until after
they have completed and submitted the test.
(E) Each student must be able to save or print a copy of an
electronic learning course completion certificate. The electronic
certificate must not be susceptible to easy editing.
(7) For each course offered, the training program shall conduct
either a course test at the completion of the course, and if applicable,
a hands-on skills assessment, or in the alternative, a proficiency test
for that discipline. Each student must successfully complete the hands-
on skills assessment and receive a passing score on the course test to
pass any course, or successfully complete a proficiency test.
(i) The training manager is responsible for maintaining the validity
and integrity of the hands-on skills assessment or proficiency test to
ensure that it accurately evaluates the trainees' performance of the
work practices and procedures associated with the course topics
contained in paragraph (d) of this section.
(ii) The training manager is responsible for maintaining the
validity and integrity of the course test to ensure that it accurately
evaluates the trainees' knowledge and retention of the course topics.
(iii) The course test shall be developed in accordance with the test
blueprint submitted with the training accreditation application.
(8) The training program shall issue unique course completion
certificates to each individual who passes the training course. The
course completion certificate shall include:
(i) The name, a unique identification number, and address of the
individual.
(ii) The name of the particular course that the individual
completed.
(iii) Dates of course completion/test passage.
(iv) For initial inspector, risk assessor, project designer,
supervisor, or abatement worker course completion certificates, the
expiration date of interim certification, which is 6 months from the
date of course completion.
(v) The name, address, and telephone number of the training program.
(vi) The language in which the course was taught.
(vii) For renovator and dust sampling technician course completion
certificates, a photograph of the individual. The photograph must be an
accurate 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
[[Page 106]]
verify the contents of the application for accreditation as described in
paragraph (b) of this section.
(13) The training manager must provide notification of renovator,
dust sampling technician, or lead-based paint activities courses
offered.
(i) The training manager must provide EPA with notification of all
renovator, dust sampling technician, or lead-based paint activities
courses offered except for any renovator course without hands-on
training delivered via electronic learning. The original notification
must be received by EPA at least 7 business days prior to the start date
of any renovator, dust sampling technician, or lead-based paint
activities course.
(ii) The training manager must provide EPA updated notification when
renovator, dust sampling technician, or lead-based paint activities
courses will begin on a date other than the start date specified in the
original notification, as follows:
(A) For renovator, dust sampling technician, or lead-based paint
activities courses beginning prior to the start date provided to EPA, an
updated notification must be received by EPA at least 7 business days
before the new start date.
(B) For renovator, dust sampling technician, or lead-based paint
activities courses beginning after the start date provided to EPA, an
updated notification must be received by EPA at least 2 business days
before the start date provided to EPA.
(iii) The training manager must update EPA of any change in location
of renovator, dust sampling technician, or lead-based paint activities
courses at least 7 business days prior to the start date provided to
EPA.
(iv) The training manager must update EPA regarding any course
cancellations, or any other change to the original notification. Updated
notifications must be received by EPA at least 2 business days prior to
the start date provided to EPA.
(v) Each notification, including updates, must include the
following:
(A) Notification type (original, update, cancellation).
(B) Training program name, EPA accreditation number, address, and
telephone number.
(C) Course discipline, type (initial/refresher), and the language in
which instruction will be given.
(D) Date(s) and time(s) of training.
(E) Training location(s) telephone number, and address.
(F) Principal instructor's name.
(G) Training manager's name and signature.
(vi) Notification must be accomplished electronically. Instructions
can be obtained online at https://www.epa.gov/lead or from the NLIC at
1-800-424-LEAD (5323). Hearing- or speech-impaired persons may reach
this telephone number through TTY by calling the toll-free Federal
Communications Commission's Telecommunications Relay Service at 711.
(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:
[[Page 107]]
(A) Training program name, EPA accreditation number, address, and
telephone number.
(B) Course discipline and type (initial/refresher).
(C) Date(s) of training.
(D) The following information for each student who took the course:
(1) Name.
(2) Address.
(3) Date of birth.
(4) Course completion certificate number.
(5) Course test score.
(6) For renovator or dust sampling technician courses, a digital
photograph of the student.
(7) For renovator refresher courses, the expiration date of
certification.
(E) Training manager's name and signature.
(iii) Notification must be accomplished electronically. Instructions
can be obtained online at https://www.epa.gov/lead or from the NLIC at
1-800-424-LEAD (5323).
(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) Action levels and testing, including random sampling.
(vii) Preparation of the final inspection report.
(viii) Recordkeeping.
(2) Risk assessor. Instruction in the topics described in paragraphs
(d)(2)(iv), (vi), and (vii) of this section must be included in the
hands-on portion of the course.
(i) Role and responsibilities of a risk assessor.
(ii) Collection of background information to perform a risk
assessment.
(iii) Sources of environmental lead contamination such as paint,
surface dust and soil, water, air, packaging, and food.
(iv) Visual inspection for the purposes of identifying potential
sources of lead-based paint hazards.
(v) Lead hazard screen protocol.
(vi) Sampling for other sources of lead exposure.
(vii) Interpretation of lead-based paint and other lead sampling
results, including all applicable Federal or State guidance or
regulations pertaining to lead-based paint hazards.
(viii) Development of hazard control options, the role of interim
controls, and operations and maintenance activities to reduce lead-based
paint hazards.
(ix) Preparation of a final risk assessment report.
(3) Supervisor. Instruction in the topics described in paragraphs
(d)(3)(v), (vii), (viii), (ix), and (x) of this section must be included
in the hands-on portion of the course.
(i) Role and responsibilities of a supervisor.
(ii) Background information on lead and its adverse health effects.
(iii) Background information on Federal, State, and local
regulations and guidance that pertain to lead-based paint abatement.
(iv) Liability and insurance issues relating to lead-based paint
abatement.
(v) Risk assessment and inspection report interpretation.
(vi) Development and implementation of an occupant protection plan
and abatement report.
(vii) Lead-based paint hazard recognition and control.
(viii) Lead-based paint abatement and lead-based paint hazard
reduction methods, including restricted practices.
(ix) Interior dust abatement/cleanup or lead-based paint hazard
control and reduction methods.
[[Page 108]]
(x) Soil and exterior dust abatement or lead-based paint hazard
control and reduction methods.
(xi) Action levels 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) Action levels 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) Action levels and testing.
(vi) Report preparation.
(e) Requirements for the accreditation of refresher training
programs. A training program may seek accreditation to offer refresher
training courses in any of the following disciplines: Inspector, risk
assessor, supervisor, project designer, abatement worker, renovator, and
dust sampling technician. A training program accredited by EPA to offer
refresher training must meet the following minimum requirements:
(1) Each refresher course shall review the curriculum topics of the
full-length courses listed under paragraph (d) of this section, as
appropriate. In addition, to become accredited to offer refresher
training courses, training programs shall ensure that their courses
[[Page 109]]
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 an electronic application to EPA
containing the following information:
(i) The refresher training program's name, address, and telephone
number.
(ii) A list of courses for which it is applying for accreditation.
(iii) The name and documentation of the qualifications of the
training program manager.
(iv) The name(s) and documentation of the qualifications of the
principal instructor(s).
(v) A statement signed by the training program manager certifying
that the refresher training program meets the minimum requirements
established in paragraph (c) of this section, except for the
requirements in paragraph (c)(6) of this section. If a training program
uses EPA-developed model training materials, or training materials
approved by a State or Indian Tribe that has been authorized by EPA
under Sec. 745.324 to develop its refresher training course materials,
the training manager shall include a statement certifying that, as well.
(vi) If the refresher training course materials are not based on
EPA-developed model training materials, the training program's
application for accreditation shall include:
(A) A copy of the student and instructor manuals to be used for each
course.
(B) A copy of the course agenda for each course.
(vii) All refresher training programs shall include in their
application for accreditation the following:
(A) A description of the facilities and equipment to be used for
lecture and hands-on training.
(B) A copy of the course test blueprint for each course.
(C) A description of the activities and procedures that will be used
for conducting the assessment of hands-on skills for each course (if
applicable).
(D) A copy of the quality control plan as described in paragraph
(c)(9) of this section.
(viii) The requirements in paragraphs (c)(1) through (5),
(c)(6)(viii) and (c)(7) through (14) of this section apply to refresher
training providers.
(ix) If a refresher training program meets the requirements listed
in this paragraph, then EPA shall approve the application for
accreditation no more than 180 days after receiving a complete
application from the refresher
[[Page 110]]
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
electronic application to EPA no later than 180 days before its
accreditation expires. If a training program does not submit its
application for re-accreditation by that date, EPA cannot guarantee that
the program will be re-accredited before the end of the accreditation
period.
(3) The training program's application for re-accreditation shall
contain:
(i) The training program's name, address, and telephone number.
(ii) A list of courses for which it is applying for re-
accreditation.
(iii) The name and qualifications of the training program manager.
(iv) The name(s) and qualifications of the principal instructor(s).
(v) A description of any changes to the training facility, equipment
or course materials since its last application was approved that
adversely affects the students' ability to learn.
(vi) A statement signed by the program manager stating:
(A) That the training program complies at all times with all
requirements in paragraphs (c) and (e) of this section, as applicable;
and
(B) The recordkeeping and reporting requirements of paragraph (i) of
this section shall be followed.
(vii) A payment of appropriate fees in accordance with Sec.
745.238.
(4) Upon request, the training program shall allow EPA to audit the
training program to verify the contents of the application for re-
accreditation as described in paragraph (f)(3) of this section.
(g) Suspension, revocation, and modification of accredited training
programs. (1) EPA may, after notice and an opportunity for hearing,
suspend, revoke, or modify training program accreditation, including
refresher training accreditation, if a training program, training
manager, or other person with supervisory authority over the training
program has:
(i) Misrepresented the contents of a training course to EPA and/or
the student population.
(ii) Failed to submit required information or notifications in a
timely manner.
(iii) Failed to maintain required records.
(iv) Falsified accreditation records, instructor qualifications, or
other accreditation-related information or documentation.
(v) Failed to comply with the training standards and requirements in
this section.
(vi) Failed to comply with Federal, State, or local lead-based paint
statutes or regulations.
(vii) Made false or misleading statements to EPA in its application
for accreditation or re-accreditation which EPA relied upon in approving
the application.
(2) In addition to an administrative or judicial finding of
violation, execution of a consent agreement in settlement of an
enforcement action constitutes, for purposes of this section, evidence
of a failure to comply with relevant statutes or regulations.
(h) Procedures for suspension, revocation or modification of
training program accreditation. (1) Prior to taking action 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.
[[Page 111]]
(iii) Actions, if any, which the affected entity may take to avoid
suspension, revocation, or modification, or to receive accreditation in
the future.
(iv) The opportunity and method for requesting a hearing prior to
final EPA action to suspend, revoke or modify accreditation.
(v) Any additional information, as appropriate, which EPA may
provide.
(2) If a hearing is requested by the accredited training program,
EPA shall:
(i) Provide the affected entity an opportunity to offer written
statements in response to EPA's assertions of the legal and factual
basis for its proposed action, and any other explanations, comments, and
arguments it deems relevant to the proposed action.
(ii) Provide the affected entity such other procedural opportunities
as EPA may deem appropriate to ensure a fair and impartial hearing.
(iii) Appoint an official of EPA as Presiding Officer to conduct the
hearing. No person shall serve as Presiding Officer if he or she has had
any prior connection with the specific matter.
(3) The Presiding Officer appointed pursuant to paragraph (h)(2) of
this section shall:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of
the request for a hearing.
(ii) Consider all relevant evidence, explanation, comment, and
argument submitted.
(iii) Notify the affected entity in writing within 90 days of
completion of the hearing of his or her decision and order. Such an
order is a final agency action which may be subject to judicial review.
(4) If EPA determines that the public health, interest, or welfare
warrants immediate action to suspend the accreditation of any training
program prior to the opportunity for a hearing, it shall:
(i) Notify the affected entity of its intent to immediately suspend
training program accreditation for the reasons listed in paragraph
(g)(1) of this section. If a suspension, revocation, or modification
notice has not previously been issued pursuant to paragraph (g)(1) of
this section, it shall be issued at the same time the emergency
suspension notice is issued.
(ii) Notify the affected entity in writing of the grounds for the
immediate suspension and why it is necessary to suspend the entity's
accreditation before an opportunity for a suspension, revocation or
modification hearing.
(iii) Notify the affected entity of the anticipated commencement
date and duration of the immediate suspension.
(iv) Notify the affected entity of its right to request a hearing on
the immediate suspension within 15 days of the suspension taking place
and the procedures for the conduct of such a hearing.
(5) Any notice, decision, or order issued by EPA under this section,
any transcripts or other verbatim record of oral testimony, and any
documents filed by an accredited training program in a hearing under
this section shall be available to the public, except as otherwise
provided by section 14 of TSCA or by 40 CFR part 2. Any such hearing at
which oral testimony is presented shall be open to the public, except
that the Presiding Officer may exclude the public to the extent
necessary to allow presentation of information which may be entitled to
confidential treatment under section 14 of TSCA or 40 CFR part 2.
(6) The public shall be notified of the suspension, revocation,
modification or reinstatement of a training program's accreditation
through appropriate mechanisms.
(7) EPA shall maintain a list of parties whose accreditation has
been suspended, revoked, modified or reinstated.
(i) Training program recordkeeping requirements. (1) Accredited
training programs shall maintain, and make available to EPA, upon
request, the following records:
(i) All documents specified in paragraph (c)(4) of this section that
demonstrate the qualifications listed in 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:
[[Page 112]]
(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) [Reserved]
(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
electronically submit a completed ``Accreditation Application for
Training Providers,'' signed by an authorized agent of the training
provider, noting on the form that it is submitted as an amendment and
indicating the information that has changed.
(3) Training managers, principal instructors, permanent training
locations. If the amendment includes a new training program manager, any
new or additional principal instructor(s), or any new permanent training
location(s), the training provider is not permitted to provide training
under the new training manager or offer courses taught by any new
principal instructor(s) or at the new training location(s) until EPA
either approves the amendment or 30 days have elapsed, whichever occurs
earlier. Except:
(i) If the amendment includes a new training program manager or new
or additional principal instructor that was identified in a training
provider accreditation application that EPA has already approved under
this section, the training provider may begin to provide training under
the new training manager or offer courses taught by the new principal
instructor on an interim basis as soon as the provider submits the
amendment to EPA. The training provider may continue to provide training
under the new training manager or offer courses taught by the new
principal instructor if EPA approves the amendment or if EPA does not
disapprove the amendment within 30 days.
(ii) If the amendment includes a new permanent training location,
the training provider may begin to provide training at the new permanent
training location on an interim basis as soon as the provider submits
the amendment to EPA. The training provider may continue to provide
training at the new permanent training location if EPA approves the
amendment or if EPA does
[[Page 113]]
not disapprove the amendment within 30 days.
[76 FR 47939, Aug. 5, 2011, as amended at 81 FR 7995, Feb. 17, 2016; 89
FR 89459, Nov. 12, 2024; 89 FR 101490, Dec. 16, 2024]
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 electronic 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 electronic application attaching 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) [Reserved]
(3) Following the submission of an electronic application
demonstrating that all the requirements of this section have been meet,
EPA shall certify an applicant as an inspector, risk assessor,
supervisor, project designer, or abatement worker, as appropriate.
(4) Upon receiving EPA certification, individuals conducting lead-
based paint activities shall comply with the work practice standards for
performing the appropriate lead-based paint activities as established in
Sec. 745.227.
(5) It shall be a violation of TSCA for an individual to conduct any
of the lead-based paint activities described in Sec. 745.227 after
March 1, 2000, if that individual has not been certified by EPA pursuant
to this section to do so.
(6) Individuals applying for certification must submit the
appropriate fees in accordance with Sec. 745.238.
(b) Inspector, risk assessor or supervisor. (1) To become certified
by EPA as an inspector, risk assessor, or supervisor, pursuant to
paragraph (a)(1)(i) of this section, an individual must:
(i) Successfully complete an accredited course in the appropriate
discipline and receive a course completion certificate from an
accredited training program.
(ii) Pass the certification exam in the appropriate discipline
offered by EPA; and,
(iii) Meet or exceed the following experience and/or education
requirements:
(A) Inspectors. (1) No additional experience and/or education
requirements.
(2) [Reserved]
(B) Risk assessors. (1) Successful completion of an accredited
training course for inspectors; and
(2) Bachelor's degree and 1 year of experience in a related field
(e.g., lead, asbestos, environmental remediation work, or construction),
or an Associates degree and 2 years experience in a related field (e.g.,
lead, asbestos, environmental remediation work, or construction); or
(3) Certification as an industrial hygienist, professional engineer,
registered architect and/or certification in a related engineering/
health/environmental field (e.g., safety professional, environmental
scientist); or
(4) A high school diploma (or equivalent), and at least 3 years of
experience in a related field (e.g., lead, asbestos, environmental
remediation work or construction).
(C) Supervisor: (1) One year of experience as a certified lead-based
paint abatement worker; or
(2) At least 2 years of experience in a related field (e.g., lead,
asbestos, or environmental remediation work) or in the building trades.
(2) The following documents shall be recognized by EPA as evidence
of meeting the requirements listed in (b)(2)(iii) of this paragraph:
(i) Official academic transcripts or diploma, as evidence of meeting
the education requirements.
(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:
[[Page 114]]
(i) Successfully complete an accredited course in the appropriate
discipline and receive a course completion certificate from an
accredited training program.
(ii) Meet or exceed the education and/or experience requirements in
paragraph (b)(1)(iii) of this section.
(4) The course completion certificate shall serve as interim
certification for an individual until the next available opportunity to
take the certification exam. Such interim certification shall expire 6
months after issuance.
(5) After passing the appropriate certification exam and submitting
an application demonstrating that he/she meets the appropriate training,
education, and/or experience prerequisites described in paragraph (b)(1)
of this section, an individual shall be issued a certificate by EPA. To
maintain certification, an individual must be re-certified as described
in paragraph (e) of this section.
(6) An individual may take the certification exam no more than three
times within 6 months of receiving a course completion certificate.
(7) If an individual does not pass the certification exam and
receive a certificate within 6 months of receiving his/her course
completion certificate, the individual must retake the appropriate
course from an accredited training program before reapplying for
certification from EPA.
(c) Abatement worker and project designer. (1) To become certified
by EPA as an abatement worker or project designer, pursuant to paragraph
(a)(1)(i) of this section, an individual must:
(i) Successfully complete an accredited course in the appropriate
discipline and receive a course completion certificate from an
accredited training program.
(ii) Meet or exceed the following additional experience and/or
education requirements:
(A) Abatement workers. (1) No additional experience and/or education
requirements.
(2) [Reserved]
(B) Project designers. (1) Successful completion of an accredited
training course for supervisors.
(2) Bachelor's degree in engineering, architecture, or a related
profession, and 1 year of experience in building construction and design
or a related field; or
(3) Four years of experience in building construction and design or
a related field.
(2) The following documents shall be recognized by EPA as evidence
of meeting the requirements listed in this paragraph:
(i) Official academic transcripts or diploma, as evidence of meeting
the education requirements.
(ii) Resumes, letters of reference, or documentation of work
experience, as evidence of meeting the work experience requirements.
(iii) Course completion certificates from lead-specific or other
related training courses, issued by accredited training programs, as
evidence of meeting the training requirements.
(3) The course completion certificate shall serve as an interim
certification until certification from EPA is received, but shall be
valid for no more than 6 months from the date of completion.
(4) After successfully completing the appropriate training courses
and meeting any other qualifications described in paragraph (c)(1) of
this section, an individual shall be issued a certificate from EPA. To
maintain certification, an individual must be re-certified as described
in paragraph (e) of this section.
(d) Certification based on prior training. (1) Any individual who
received training in a lead-based paint activity between October 1,
1990, and March 1, 1999 shall be eligible for certification by EPA under
the alternative procedures contained in this paragraph. Individuals who
have received lead-based paint activities training at an EPA-authorized
State or Tribal accredited 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
[[Page 115]]
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 electronically 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 electronically 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 electronically submit to EPA
an application 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 electronic application
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) [Reserved]
(6) Firms applying for certification must submit the appropriate
fees in accordance with Sec. 745.238.
(7) To maintain certification a firm shall submit appropriate fees
in accordance with Sec. 745.238 every 3 years.
(g) Suspension, revocation, and modification of certifications of
individuals engaged in lead-based paint activities. (1) EPA may, after
notice and opportunity for hearing, suspend, revoke, or modify an
individual's certification if an individual has:
(i) Obtained training documentation through fraudulent means.
(ii) Gained admission to and completed an accredited training
program through misrepresentation of admission requirements.
(iii) Obtained certification through misrepresentation of
certification requirements or related documents dealing with education,
training, professional registration, or experience.
(iv) Performed work requiring certification at a job site without
having proof of certification.
(v) Permitted the duplication or use of the individual's own
certificate by another.
(vi) Performed work for which certification is required, but for
which appropriate certification has not been received.
(vii) Failed to comply with the appropriate work practice standards
for lead-based paint activities at Sec. 745.227.
[[Page 116]]
(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 application for certification to
EPA.
(iv) Failed to maintain required records.
(v) Failed to comply with Federal, State, or local lead-based paint
statutes or regulations.
(2) In addition to an administrative or judicial finding of
violation, for purposes of this section only, execution of a consent
agreement in settlement of an enforcement action constitutes evidence of
a failure to comply with relevant statutes or regulations.
(i) Procedures for suspension, revocation, or modification of the
certification of individuals or firms. (1) If EPA decides to suspend,
revoke, or modify the certification of any individual or firm, it shall
notify the affected entity in writing of the following:
(i) The legal and factual basis for the suspension, revocation, or
modification.
(ii) The commencement date and duration of the suspension,
revocation, or modification.
(iii) Actions, if any, which the affected entity may take to avoid
suspension, revocation, or modification or to receive certification in
the future.
(iv) The opportunity and method for requesting a hearing prior to
final EPA action to suspend, revoke, or modify certification.
(v) Any additional information, as appropriate, which EPA may
provide.
(2) If a hearing is requested by the certified individual or firm,
EPA shall:
(i) Provide the affected entity an opportunity to offer written
statements in response to EPA's assertion of the legal and factual basis
and any other explanations, comments, and arguments it deems relevant to
the proposed action.
(ii) Provide the affected entity such other procedural opportunities
as EPA may deem appropriate to ensure a fair and impartial hearing.
(iii) Appoint an official of EPA as Presiding Officer to conduct the
hearing. No person shall serve as Presiding Officer if he or she has had
any prior connection with the specific matter.
(3) The Presiding Officer shall:
(i) Conduct a fair, orderly, and impartial hearing within 90 days of
the request for a hearing;
(ii) Consider all relevant evidence, explanation, comment, and
argument submitted; and
(iii) Notify the affected entity in writing within 90 days of
completion of the hearing of his or her decision and order. Such an
order is a final EPA action subject to judicial review.
(4) If EPA determines that the public health, interest, or welfare
warrants immediate action to suspend the certification of any individual
or firm prior to the opportunity for a hearing, it shall:
(i) Notify the affected entity of its intent to immediately suspend
certification for the reasons listed in paragraph (h)(1) of this
section. If a suspension, revocation, or modification notice has not
previously been issued, it 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
[[Page 117]]
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; 89 FR 89459, Nov. 12, 2024]
Sec. 745.227 Work practice standards for conducting lead-based paint
activities: target housing and child-occupied facilities.
(a) Effective date, applicability, and terms. (1) Beginning on March
1, 2000, all lead-based paint activities shall be performed pursuant to
the work practice standards contained in this section.
(2) When performing any lead-based paint activity described by the
certified individual as an inspection, lead-hazard screen, risk
assessment or abatement, a certified individual must perform that
activity in compliance with the appropriate requirements below.
(3) Documented methodologies that are appropriate for this section
are found in the following: The U.S. Department of Housing and Urban
Development (HUD) Guidelines for the Evaluation and Control of Lead-
Based Paint Hazards in Housing; the EPA Guidance on Residential Lead-
Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil; the EPA
Residential Sampling for Lead: Protocols for Dust and Soil Sampling (EPA
report number 7474-R-95-001); Regulations, guidance, methods or
protocols issued by States and Indian Tribes that have been authorized
by EPA; and other equivalent methods and quidelines.
(b) Inspection. (1) An inspection shall be conducted only by a
person certified by EPA as an inspector or risk assessor and, if
conducted, must be conducted according to the procedures in this
paragraph.
(2) When conducting an inspection, the following locations shall be
selected according to documented methodologies and tested for the
presence of lead-based paint:
(i) In a residential dwelling and child-occupied facility, each
component with a distinct painting history and each exterior component
with a distinct painting history shall be tested for lead-based paint,
except those components that the inspector or risk assessor determines
to have been replaced after 1978, or to not contain lead-based paint;
and
(ii) In a multi-family dwelling or child-occupied facility, each
component with a distinct painting history in every common area, except
those components that the inspector or risk assessor determines to have
been replaced after 1978, or to not contain lead-based paint.
(3) Paint shall be sampled in the following manner:
(i) The analysis of paint to determine the presence of lead shall be
conducted using documented methodologies which incorporate adequate
quality control procedures; and/or
(ii) All collected paint chip samples shall be analyzed according to
paragraph (f) of this section to determine if they contain detectable
levels of lead that can be quantified numerically.
(4) The certified inspector or risk assessor shall prepare an
inspection report which shall include the following information:
(i) Date of each inspection.
(ii) Address of building.
(iii) Date of construction.
(iv) Apartment numbers (if applicable).
(v) Name, address, and telephone number of the owner or owners of
each residential dwelling or child-occupied facility.
(vi) Name, signature, and certification number of each certified
inspector and/or risk assessor conducting testing.
[[Page 118]]
(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 under age 6 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, under age 6, 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)(2)(iv) of this section, the risk assessor shall also collect
composite dust samples from common areas where one or more children,
under age 6, are most likely to come into contact with dust.
(3) Dust samples shall be collected and analyzed in the following
manner:
(i) All dust samples shall be taken using documented methodologies
that incorporate adequate quality control procedures.
(ii) All collected dust samples shall be analyzed according to
paragraph (f) of this section to determine if they contain detectable
levels of lead that can be quantified numerically.
(4) Paint shall be sampled in the following manner:
(i) The analysis of paint to determine the presence of lead shall be
conducted using documented methodologies which incorporate adequate
quality control procedures; and/or
(ii) All collected paint chip samples shall be analyzed according to
paragraph (f) of this section to determine if they contain detectable
levels of lead that can be quantified numerically.
(5) The risk assessor shall prepare a lead hazard screen report,
which shall include the following information:
(i) The information required in a risk assessment report as
specified in paragraph (d) of this section, including paragraphs
(d)(11)(i) through (d)(11)(xiv), and excluding paragraphs (d)(11)(xv)
through (d)(11)(xviii) of this section. Additionally, any background
information collected pursuant to paragraph (c)(2)(i) of this section
shall be included in the risk assessment report; and
(ii) Recommendations, if warranted, for a follow-up risk assessment,
and as appropriate, any further actions.
(d) Risk assessment. (1) A risk assessment shall be conducted only
by a person certified by EPA as a risk assessor and, if conducted, must
be conducted according to the procedures in this paragraph.
(2) A visual inspection for risk assessment of the residential
dwelling or child-occupied facility shall be undertaken to locate the
existence of deteriorated paint, assess the extent and causes of the
deterioration, and other potential lead-based paint hazards.
(3) Background information regarding the physical characteristics of
the residential dwelling or child-occupied facility and occupant use
patterns that may cause lead-based paint exposure to
[[Page 119]]
one or more children under age 6 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, under age 6, 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, under age 6, 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, under age 6, and in other
common areas in the child-occupied facility where one or more children,
under age 6, are likely to come into contact with dust.
(8) Soil samples shall be collected and analyzed for lead
concentrations in the following locations:
(i) Exterior play areas where bare soil is present; and
(ii) The rest of the yard (i.e., non-play areas) where bare soil is
present.
(iii) Dripline/foundation areas where bare soil is present.
(9) Any paint, dust, or soil sampling or testing shall be conducted
using documented methodologies that incorporate adequate quality control
procedures.
(10) Any collected paint chip, dust, or soil samples shall be
analyzed according to paragraph (f) of this section to determine if they
contain detectable levels of lead that can be quantified numerically.
(11) The certified risk assessor shall prepare a risk assessment
report which shall include the following information:
(i) Date of assessment.
(ii) Address of each building.
(iii) Date of construction of buildings.
(iv) Apartment number (if applicable).
(v) Name, address, and telephone number of each owner of each
building.
(vi) Name, signature, and certification of the certified risk
assessor conducting the assessment.
(vii) Name, address, and telephone number of the certified firm
employing each certified risk assessor if applicable.
(viii) Name, address, and telephone number of each recognized
laboratory conducting analysis of collected samples.
(ix) Results of the visual inspection.
(x) Testing method and sampling procedure for paint analysis
employed.
(xi) Specific locations of each painted component tested for the
presence of lead.
(xii) All data collected from on-site testing, including quality
control data and, if used, the serial number of any XRF device.
(xiii) All results of laboratory analysis on collected paint, soil,
and dust samples.
(xiv) Any other sampling results.
(xv) Any background information collected pursuant to paragraph
(d)(3) of this section.
(xvi) To the extent that they are used as part of the lead-based
paint hazard determination, the results of any previous inspections or
analyses for the presence of lead-based paint, or other assessments of
lead-based paint-related hazards.
(xvii) A description of the location, type, and severity of
identified lead-
[[Page 120]]
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 notification to take advantage of this
abbreviated notification period.
(iii) Except as provided in paragraph (e)(4)(ii) of this section,
updated notification must be provided to EPA for lead-based paint
abatement activities that will begin on a date other than the start date
specified in the original notification, as follows:
(A) For lead-based paint abatement activities beginning prior to the
start date provided to EPA an updated notification must be received by
EPA at least 5 business days before the new start date included in the
notification.
(B) For lead-based paint abatement activities beginning after the
start date provided to EPA an updated notification must be received by
EPA on or before the start date provided to EPA.
(iv) Except as provided in paragraph (e)(4)(ii) of this section,
updated notification must be provided to EPA for any change in location
of lead-based paint abatement activities at least 5 business days prior
to the start date provided to EPA.
(v) Updated notification must be provided to EPA when lead-based
paint abatement activities are canceled, or when there are other
significant changes including, but not limited to, when the square
footage or acreage to be abated changes by more than 20%. This updated
notification must be received by EPA on or before the start date
provided to EPA, or if work has already begun, within 24 hours of the
change.
(vi) The following must be included in each notification:
(A) Notification type (original, updated, cancellation).
(B) Date when lead-based paint abatement activities will start.
(C) Date when lead-based paint abatement activities will end
(approximation using best professional judgement).
(D) Firm's name, EPA certification number, address, telephone
number.
(E) Type of building (e.g., single family dwelling, multi-family
dwelling,
[[Page 121]]
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 electronically. Instructions
can be obtained online at https://www.epa.gov/lead, or from the NLIC at
1-800-424-LEAD (5323).
(viii) Lead-based paint abatement activities shall not begin on a
date, or at a location other than that specified in either an original
or updated notification, in the event of changes to the original
notification.
(ix) No firm or individual shall engage in lead-based paint
abatement activities, as defined in Sec. 745.223, prior to notifying
EPA of such activities according to the requirements of this paragraph.
(5) A written occupant protection plan shall be developed for all
abatement projects and shall be prepared according to the following
procedures:
(i) The occupant protection plan shall be unique to each residential
dwelling or child-occupied facility and be developed prior to the
abatement. The occupant protection plan shall describe the measures and
management procedures that will be taken during the abatement to protect
the building occupants from exposure to any lead-based paint hazards.
(ii) A certified supervisor or project designer shall prepare the
occupant protection plan.
(6) The work practices listed below shall be restricted during an
abatement as follows:
(i) Open-flame burning or torching of lead-based paint is
prohibited;
(ii) Machine sanding or grinding or abrasive blasting or
sandblasting of lead-based paint is prohibited unless used with High
Efficiency Particulate Air (HEPA) exhaust control which removes
particles of 0.3 microns or larger from the air at 99.97 percent or
greater efficiency;
(iii) Dry scraping of lead-based paint is permitted only in
conjunction with heat guns or around electrical outlets or when treating
defective paint spots totaling no more than 2 square feet in any one
room, hallway or stairwell or totaling no more than 20 square feet on
exterior surfaces; and
(iv) Operating a heat gun on lead-based paint is permitted only at
temperatures below 1100 degrees Fahrenheit.
(7) If conducted, soil abatement shall be conducted in one of the
following ways:
(i) If the soil is removed:
(A) The soil shall be replaced by soil with a lead concentration as
close to local background as practicable, but no greater than 400 ppm.
(B) The soil that is removed shall not be used as top soil at
another residential property or child-occupied facility.
(ii) If soil is not removed, the soil shall be permanently covered,
as defined in Sec. 745.223.
(8) The following post-abatement 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
post-abatement testing procedures.
(ii) Following the visual inspection and any post-abatement cleanup
required by paragraph (e)(8)(i) of this section, post-abatement sampling
for lead in dust shall be conducted. Post-abatement sampling may be
conducted by employing single-surface sampling or composite sampling
techniques.
(iii) Dust samples for post-abatement testing purposes shall be
taken using
[[Page 122]]
documented methodologies that incorporate adequate quality control
procedures.
(iv) Dust samples for post-abatement testing purposes shall be taken
a minimum of 1 hour after completion of final post-abatement cleanup
activities.
(v) The following post-abatement testing 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:
(vi) The rooms, hallways or stairwells selected for sampling shall
be selected according to documented methodologies.
(vii) The certified inspector or risk assessor shall compare the
residual lead level (as determined by the laboratory analysis) from each
single surface dust sample with action 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
action 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 action level or if the residual lead
level in a composite dust sample equals or exceeds the applicable action
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) Before January 12, 2026, the action levels for lead in dust
are 10 [micro]g/ft\2\ for floors, 100 [micro]g/ft\2\ for interior window
sills, and 400 [micro]g/ft\2\ for window troughs. On or after January
12, 2026, the action levels for lead in dust are 5 [micro]g/ft\2\ for
floors, 40 [micro]g/ft\2\ for interior window sills, and 100 [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
post-abatement testing 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 action levels.
(iii) The randomly selected residential dwellings shall be sampled
and evaluated according to the post-abatement testing 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 post-abatement sampling and the date of
sampling.
(v) The results of post-abatement dust-lead 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.
(vii) On or after January 12, 2026, when post-abatement dust-lead
testing results are below the dust-lead action levels and at or above
the dust-lead reportable levels, a dust-lead hazard statement with the
following language must be included:
Although the completed abatement project achieved dust-lead below
action levels, some dust-lead hazards remain because any reportable
level of dust-lead is considered a dust-lead hazard by the U.S.
Environmental Protection Agency in a residential dwelling or child-
occupied facility. In order for abatement work to be considered complete
under EPA regulations, dust-lead levels must be
[[Page 123]]
below the action levels, which are established based on reliability,
effectiveness and safety. To continue to reduce lead exposure from dust,
the EPA pamphlet entitled Protect Your Family From Lead in Your Home
includes recommendations such as: using a vacuum with a high-efficiency
particulate air (HEPA) filter on furniture and other items returned to
the work area, and regularly cleaning hard surfaces with a damp cloth or
sponge and a general all-purpose cleaner. For more information on how to
continue to reduce lead exposure, see Protect Your Family From Lead in
Your Home.
(f) Collection and laboratory analysis of samples. Any paint chip,
dust, or soil samples collected pursuant to the work practice standards
contained in this section shall be:
(1) Collected by persons certified by EPA as an inspector or risk
assessor; and
(2) Analyzed by a laboratory recognized by EPA pursuant to section
405(b) of TSCA as being capable of performing analyses for lead
compounds in paint chip, dust, and soil samples.
(g) Composite dust sampling. Composite dust sampling may only be
conducted in the situations specified in paragraphs (c) through (e) of
this section. If such sampling is conducted, the following conditions
shall apply:
(1) Composite dust samples shall consist of at least two subsamples;
(2) Every component that is being tested shall be included in the
sampling; and
(3) Composite dust samples shall not consist of subsamples from more
than one type of component.
(h) Determinations. (1) Lead-based paint is present:
(i) On any surface that is tested and found to contain lead equal to
or in excess of 1.0 milligrams per square centimeter or equal to or in
excess of 0.5% by weight; and
(ii) On any surface like a surface tested in the same room
equivalent that has a similar painting history and that is found to be
lead-based paint.
(2) A paint-lead hazard is present:
(i) On any friction surface that is subject to abrasion and where
the lead dust levels on the nearest horizontal surface underneath the
friction surface (e.g., the window sill or floor) are equal to or
greater than the dust hazard levels identified in Sec. 745.65(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) Dust-lead hazards and dust-lead action levels are identified for
residential dwellings and child-occupied facilities as follows:
(i) Before January 12, 2026, a dust lead-hazard is present in a
residential dwelling or child-occupied facility on floors and interior
window sills when the weighted arithmetic mean lead loading for all
single surface or composite samples of floors and interior window sills
are equal to or greater than 10 [micro]g/ft\2\ for floors and 100
[micro]g/ft\2\ for interior window sills, respectively; for projects
where post-abatement dust-lead testing is required or otherwise
performed, levels of lead in dust must be below 10 [micro]g/ft\2\ for
floors, 100 [micro]g/ft\2\ for interior window sills, and 400 [micro]g/
ft\2\ for window troughs for purposes of the action levels; on or after
January 12, 2026, a dust lead-hazard is present in a residential
dwelling or child-occupied facility on floors and interior window sills
when the lead loading for any single surface or composite sample of
floors and interior window sills is equal to or greater than any
reportable level of dust-lead for floors and for interior window sills;
for projects where post-abatement dust-lead testing is required or
otherwise performed, levels of lead in dust must be below 5 [micro]g/
ft\2\ for floors, 40 [micro]g/ft\2\ for interior window sills, and 100
[micro]g/ft\2\ for window troughs for purposes of clearing the action
level;
(ii) A dust lead-hazard is present 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
[[Page 124]]
property (and, for projects where post-abatement dust-lead testing is
required or otherwise performed, levels of lead in dust must be below
the applicable value from paragraph (i) of this paragraph for purposes
of the action levels); and
(iii) A dust lead-hazard is present 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 (and, for projects where post-abatement dust-lead testing is
required or otherwise performed, levels of lead in dust must be below
the applicable value from paragraph (i) of this paragraph for purposes
of the action levels).
(4) A soil-lead hazard is present:
(i) In a play area when the soil-lead concentration from a composite
play area sample of bare soil is equal to or greater than 400 parts per
million; or
(ii) In the rest of the yard when the arithmetic mean lead
concentration from a composite sample (or arithmetic mean of composite
samples) of bare soil from the rest of the yard (i.e., non-play areas)
for each residential building on a property is equal to or greater than
1,200 parts per million.
(i) Recordkeeping. All reports or plans required in this section
shall be maintained by the certified firm or individual who prepared the
report for no fewer than 3 years. The certified firm or individual also
shall provide copies of these reports to the building owner who
contracted for its services.
[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 42852, Aug. 6, 1999; 66
FR 1239, Jan. 5, 2001; 69 FR 18496, Apr. 8, 2004; 84 FR 32648, July 9,
2019; 86 FR 994, Jan. 7, 2021; 89 FR 89459, Nov. 12, 2024; 89 FR 101490,
Dec. 16, 2024]
Editorial Note: At 89 FR 89459, Nov. 12, 2024, and corrected at 89
FR 101490, Dec. 16, 2024, Sec. 745.227 was amended in part by revising
paragraph (e)(8)(v). However, the set-out text included revised text for
the introductory paragraph of (e)(8)(v), and not the subparagraphs.
Sec. 745.228 Accreditation of training programs: public and commercial
buildings, bridges and superstructures. [Reserved]
Sec. 745.229 Certification of individuals and firms engaged in
lead-based paint activities: public and commercial buildings, bridges
and superstructures. [Reserved]
Sec. 745.230 Work practice standards for conducting lead-based paint
activities: public and commercial buildings, bridges and superstructures.
[Reserved]
Sec. 745.233 Lead-based paint activities requirements.
Lead-based paint activities, as defined in this part, shall only be
conducted according to the procedures and work practice standards
contained in Sec. 745.227 of this subpart. No individual or firm may
offer to perform or perform any lead-based paint activity as defined in
this part, unless certified to perform that activity according to the
procedures in Sec. 745.226.
Sec. 745.235 Enforcement.
(a) Failure or refusal to comply with any requirement of Sec.
745.225, Sec. 745.226, Sec. 745.227, or Sec. 745.233 is a prohibited
act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
(b) Failure or refusal to establish, maintain, provide, copy, or
permit access to records or reports as required by Sec. 745.225, Sec.
745.226, or Sec. 745.227 is a prohibited act under sections 15 and 409
of TSCA (15 U.S.C. 2614, 2689).
(c) Failure or refusal to permit entry or inspection as required by
Sec. 745.237 and section 11 of TSCA (15 U.S.C. 2610) is a prohibited
act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689).
(d) In addition to the above, any individual or firm that performs
any of the following acts shall be deemed to have committed a prohibited
act under sections 15 and 409 of TSCA (15 U.S.C. 2614, 2689). These
include the following:
(i) Obtaining certification through fraudulent representation;
(ii) Failing to obtain certification from EPA and performing work
requiring certification at a job site; or
(iii) Fraudulently obtaining certification and engaging in any lead-
based paint activities requiring certification.
[[Page 125]]
(e) Violators are subject to civil and criminal sanctions pursuant
to section 16 of TSCA (15 U.S.C. 2615) for each violation.
Sec. 745.237 Inspections.
EPA may conduct reasonable inspections pursuant to the provisions of
section 11 of TSCA (15 U.S.C. 2610) to ensure compliance with this
subpart.
Sec. 745.238 Fees for accreditation and certification of lead-based
paint activities.
(a) Purpose. To establish and impose fees for certified individuals
and firms engaged in lead-based paint activities and persons operating
accredited training programs under section 402(a) of the Toxic
Substances Control Act (TSCA).
(b) Persons who must pay fees. Fees in accordance with paragraph (c)
of this section must be paid by:
(1) Training programs. (i) All non-exempt training programs applying
to EPA for the accreditation and re-accreditation of training programs
in one or more of the following disciplines: inspector, risk assessor,
supervisor, project designer, abatement worker.
(ii) Exemptions. No fee shall be imposed on any training program
operated by a State, federally recognized Indian Tribe, local
government, or nonprofit organization. This exemption does not apply to
the certification of firms or individuals.
(2) Firms and individuals. All firms and individuals seeking
certification and re-certification from EPA to engage in lead-based
paint activities in one or more of the following disciplines: inspector,
risk assessor, supervisor, project designer, abatement worker.
(c) Fee amounts--(1) Certification and accreditation fees. Initial
and renewal certification and accreditation fees are specified in the
following table:
------------------------------------------------------------------------
Re-accreditation
(every 4 years,
Training Program Accreditation see 40 CFR
745.225(f)(1) for
details)
------------------------------------------------------------------------
Initial Course ..................
Inspector....................... $870.............. $620
Risk assessor................... $870.............. $620
Supervisor...................... $870.............. $620
Worker.......................... $870.............. $620
Project Designer................ $870.............. $620
------------------------------------------------------------------------
Refresher Course ..................
Inspector....................... $690.............. $580
Risk assessor................... $690.............. $580
Supervisor...................... $690.............. $580
Worker.......................... $690.............. $580
Project Designer................ $690.............. $580
------------------------------------------------------------------------
Lead-based Paint Activities-- Certification Re-certification
Individual (every 3 years,
see 40 CFR
745.226(e)(1) for
details)
------------------------------------------------------------------------
Inspector $410 $410
Risk assessor................... $410.............. $410
Supervisor...................... $410.............. $410
Worker.......................... $310.............. $310
Project designer................ $410.............. $410
Tribal certification (each $10............... $10
discipline).
------------------------------------------------------------------------
Lead-based Paint Activities-- Certification Re-certification
Firm (every 3 years,
see 40 CFR
745.226(f)(7) for
details)
------------------------------------------------------------------------
Firm $550 $550
Combined Renovation and Lead- $550 $550
based Paint Activities Firm
Application
Combined Renovation and Lead- $20 $20
based Paint Activities Tribal
Firm Application
Tribal Firm $20 $20
------------------------------------------------------------------------
[[Page 126]]
(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
electronically (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 electronically (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 electronically (titled ``Accreditation Application for
Training Programs''), the materials described at Sec. 745.225, and the
application fee described in paragraph (c) of this section.
(e) Identification card replacement and certificate replacement. (1)
Parties seeking identification card or certificate replacement shall
electronically 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 electronically in the amount
specified in paragraph (c)(3) of this section in accordance with the
instructions.
(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; 89 FR 89461, Nov. 12,
2024]
Sec. 745.239 Effective dates.
This subpart L shall apply in any State or Indian Country that does
not have an authorized program under subpart Q, effective August 31,
1998. In such States or Indian Country:
(a) Training programs shall not provide, offer or claim to provide
training or refresher training for certification without accreditation
from EPA pursuant to Sec. 745.225 on or after March 1, 1999.
(b) No individual or firm shall perform, offer, or claim to perform
lead-based paint activities, as defined in this subpart, without
certification from EPA to conduct such activities pursuant to Sec.
745.226 on or after March 1, 2000.
(c) All lead-based paint activities shall be performed pursuant to
the work practice standards contained in Sec. 745.227 on or after March
1, 2000.
[61 FR 45813, Aug. 29, 1996, as amended at 64 FR 42852, Aug. 6, 1999]
[[Page 127]]
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.S. government,
notwithstanding the issuance of any patent, and including rights-of-way
running throughout the reservation; (2) all dependent Indian communities
within the borders of the United States whether within the original or
subsequently acquired territory thereof, and whether within or outside
the limits of a State; and (3) all Indian allotments, the Indian titles
which have not been extinguished, including rights-of-way running
through the same.
Indian Tribe means any Indian Tribe, band, nation, or community
recognized by the Secretary of the Interior and exercising substantial
governmental duties and powers.
Sec. 745.324 Authorization of State or Tribal programs.
(a) Application content and procedures. (1) Any State or Indian
Tribe that seeks authorization from EPA to administer and enforce the
provisions of subpart E or subpart L of this part must submit an
application to the Administrator in accordance with this paragraph.
(2) Before developing an application for authorization, a State or
Indian Tribe shall disseminate a public notice of intent to seek such
authorization and provide an opportunity for a public hearing.
(3) A State or Tribal application shall include:
(i) A transmittal letter from the State Governor or Tribal
Chairperson (or equivalent official) requesting program approval.
[[Page 128]]
(ii) A summary of the State or Tribal program. This summary will be
used to provide notice to residents of the State or Tribe.
(iii) A description of the State or Tribal program in accordance
with paragraph (b) of this section.
(iv) An Attorney General's or Tribal Counsel's (or equivalent)
statement in accordance with paragraph (c) of this section.
(v) Copies of all applicable State or Tribal statutes, regulations,
standards, and other materials that provide the State or Indian Tribe
with the authority to administer and enforce a lead-based paint program.
(4) After submitting an application, the Agency will publish a
Federal Register notice that contains an announcement of the receipt of
the State or Tribal application, the summary of the program as provided
by the State or Tribe, and a request for public comments to be mailed to
the appropriate EPA Regional Office. This comment period shall last for
no less than 45 days. EPA will consider these comments during its review
of the State or Tribal application.
(5) Within 60 days of submission of a State or Tribal application,
EPA will, if requested, conduct a public hearing in each State or Indian
Country seeking program authorization and will consider all comments
submitted at that hearing during the review of the State or Tribal
application.
(b) Program description. A State or Indian Tribe seeking to
administer and enforce a program under this subpart must submit a
description of the program. The description of the State or Tribal
program must include:
(1)(i) The name of the State or Tribal agency that is or will be
responsible for administering and enforcing the program, the name of the
official in that agency designated as the point of contact with EPA, and
addresses and phone numbers where this official can be contacted.
(ii) Where more than one agency is or will be responsible for
administering and enforcing the program, the State or Indian Tribe must
designate a primary agency to oversee and coordinate administration and
enforcement of the program and serve as the primary contact with EPA.
(iii) In the event that more than one agency is or will be
responsible for administering and enforcing the program, the application
must also include a description of the functions to be performed by each
agency. The desciption shall explain and how the program will be
coordinated by the primary agency to ensure consistency and effective
administration of the within the State or Indian Tribe.
(2) To demonstrate that the State or Tribal program is at least as
protective as the Federal program, fulfilling the criteria in paragraph
(e)(2)(i) of this section, the State or Tribal application must include:
(i) A description of the program that demonstrates that the program
contains all of the elements specified in Sec. 745.325, Sec. 745.326,
or both; and
(ii) An analysis of the State or Tribal program that compares the
program to the Federal program in subpart E or subpart L of this part,
or both. This analysis must demonstrate how the program is, in the
State's or Indian Tribe's assessment, at least as protective as the
elements in the Federal program at subpart E or subpart L of this part,
or both. EPA will use this analysis to evaluate the protectiveness of
the State or Tribal program in making its determination pursuant to
paragraph (e)(2)(i) of this section.
(3) To demonstrate that the State or Tribal program provides
adequate enforcement, fulfilling the criteria in paragraph (e)(2)(ii) of
this section, the State or Tribal application must include a description
of the State or Tribal lead-based paint compliance and enforcement
program that demonstrates that the program contains all of the elements
specified at Sec. 745.327. This description shall include copies of all
policies, certifications, plans, reports, and other materials that
demonstrate that the State or Tribal program contains all of the
elements specified at Sec. 745.327.
(4)(i) The program description for an Indian Tribe shall also
include a map, legal description, or other information sufficient to
identify the geographical extent of the territory over which the Indian
Tribe exercises jurisdiction.
[[Page 129]]
(ii) The program description for an Indian Tribe shall also include
a demonstration that the Indian Tribe:
(A) Is recognized by the Secretary of the Interior.
(B) has an existing government exercising substantial governmental
duties and powers.
(C) has adequate civil regulatory jurisdiction (as shown in the
Tribal legal certification in paragraph (c)(2) of this section) over the
subject matter and entities regulated.
(D) is reasonably expected to be capable of administering the
Federal program for which it is seeking authorization.
(iii) If the Administrator has previously determined that an Indian
Tribe has met the prerequisites in paragraphs (b)(4)(ii)(A) and (B) of
this section for another EPA program, the Indian Tribe need provide only
that information unique to the lead-based paint program required by
paragraphs (b)(4)(ii)(C) and (D) of this section.
(c) Attorney General's statement. (1) A State or Indian Tribe must
submit a written statement signed by the Attorney General or Tribal
Counsel (or equivalent) certifying that the laws and regulations of the
State or Indian Tribe provide adequate legal authority to administer and
enforce the State or Tribal program. This statement shall include
citations to the specific statutes and regulations providing that legal
authority.
(2) The Tribal legal certification (the equivalent to the Attorney
General's statement) may also be submitted and signed by an independent
attorney retained by the Indian Tribe for representation in matters
before EPA or the courts pertaining to the Indian Tribe's program. The
certification shall include an assertion that the attorney has the
authority to represent the Indian Tribe with respect to the Indian
Tribe's authorization application.
(3) If a State application seeks approval of its program to operate
in Indian Country, the required legal certification shall include an
analysis of the applicant's authority to implement its provisions in
Indian Country. The applicant shall include a map delineating the area
over which it seeks to operate the program.
(d) Program certification. (1) At the time of submitting an
application, a State may also certify to the Administrator that the
State program meets the requirements contained in paragraphs (e)(2)(i)
and (e)(2)(ii) of this section.
(2) If this certification is contained in a State's application, the
program shall be deemed to be authorized by EPA until such time as the
Administrator disapproves the program application or withdraws the
program authorization. A program shall not be deemed authorized pursuant
to this subpart to the extent that jurisdiction is asserted over Indian
Country, including non-member fee lands within an Indian reservation.
(3) If the application does not contain such certification, the
State program will be authorized only after the Administrator authorizes
the program in accordance with paragraph (e) of this section.
(4) This certification shall take the form of a letter from the
Governor or the Attorney General to the Administrator. The certification
shall reference the program analysis in paragraph (b)(3) of this section
as the basis for concluding that the State program is at least as
protective as the Federal program, and provides adequate enforcement.
(e) EPA approval. (1) EPA will fully review and consider all
portions of a State or Tribal application.
(2) Within 180 days of receipt of a complete State or Tribal
application, the Administrator shall either authorize the program or
disapprove the application. The Administrator shall authorize the
program, after notice and the opportunity for public comment and a
public hearing, only if the Administrator finds that:
(i) The State or Tribal program is at least as protective of human
health and the environment as the corresponding Federal program under
subpart E or subpart L of this part, or both; and
(ii) The State or Tribal program provides adequate enforcement.
(3) EPA shall notify in writing the State or Indian Tribe of the
Administrator's decision to authorize the State
[[Page 130]]
or Tribal program or disapprove the State's or Indian Tribe's
application.
(4) If the State or Indian Tribe applies for authorization of State
or Tribal programs under both subpart E and subpart L, EPA may, as
appropriate, authorize one program and disapprove the other.
(f) EPA administration and enforcement. (1) If a State or Indian
Tribe does not have an authorized program to administer and enforce
subpart L of this part in effect by August 31, 1998, the Administrator
shall, by such date, establish and enforce the provisions of subpart L
of this part as the Federal program for that State or Indian Country.
(2) If a State or Indian Tribe does not have an authorized program
to administer and enforce the pre-renovation education requirements of
subpart E of this part by August 31, 1998, the Administrator will, by
such date, enforce those provisions of subpart E of this part as the
Federal program for that State or Indian Country. If a State or Indian
Tribe does not have an authorized program to administer and enforce the
training, certification and accreditation requirements and work practice
standards of subpart E of this part by April 22, 2009, the Administrator
will, by such date, enforce those provisions of subpart E of this part
as the Federal program for that State or Indian Country.
(3) Upon authorization of a State or Tribal program, pursuant to
paragraph (d) or (e) of this section, it shall be an unlawful act under
sections 15 and 409 of TSCA for any person to fail or refuse to comply
with any requirements of such program.
(g) Oversight. EPA shall periodically evaluate the adequacy of a
State's or Indian Tribe's implementation and enforcement of its
authorized programs.
(h) Reports. Beginning 12 months after the date of program
authorization, the primary agency for each State or Indian Tribe that
has an authorized program shall submit a written report to the EPA
Regional Administrator for the Region in which the State or Indian Tribe
is located. This report shall be submitted at least once every 12 months
for the first 3 years after program authorization. If these reports
demonstrate successful program implementation, the Agency will
automatically extend the reporting interval to every 2 years. If the
subsequent reports demonstrate problems with implementation, EPA will
require a return to annual reporting until the reports demonstrate
successful program implementation, at which time the Agency will extend
the reporting interval to every 2 years. The report shall include the
following information:
(1) Any significant changes in the content or administration of the
State or Tribal program implemented since the previous reporting period;
and
(2) All information regarding the lead-based paint enforcement and
compliance activities listed at Sec. 745.327(d) ``Summary on Progress
and Performance.''
(i) Withdrawal of authorization. (1) If EPA concludes that a State
or Indian Tribe is not administering and enforcing an authorized program
in compliance with the standards, regulations, and other requirements of
sections 401 through 412 of TSCA and this subpart, the Administrator
shall notify the primary agency for the State or Indian Tribe in writing
and indicate EPA's intent to withdraw authorization of the program.
(2) The Notice of Intent to Withdraw shall:
(i) Identify the program aspects that EPA believes are inadequate
and provide a factual basis for such findings.
(ii) Include copies of relevant documents.
(iii) Provide an opportunity for the State or Indian Tribe to
respond either in writing or at a meeting with appropriate EPA
officials.
(3) EPA may request that an informal conference be held between
representatives of the State or Indian Tribe and EPA officials.
(4) Prior to issuance of a withdrawal, a State or Indian Tribe may
request that EPA hold a public hearing. At this hearing, EPA, the State
or Indian Tribe, and the public may present facts bearing on whether the
State's or Indian Tribe's authorization should be withdrawn.
(5) If EPA finds that deficiencies warranting withdrawal did not
exist or
[[Page 131]]
were corrected by the State or Indian Tribe, EPA may rescind its Notice
of Intent to Withdraw authorization.
(6) Where EPA finds that deficiencies in the State or Tribal program
exist that warrant withdrawal, an agreement to correct the deficiencies
shall be jointly prepared by the State or Indian Tribe and EPA. The
agreement shall describe the deficiencies found in the program, specify
the steps the State or Indian Tribe has taken or will take to remedy the
deficiencies, and establish a schedule, no longer than 180 days, for
each remedial action to be initiated.
(7) If the State or Indian Tribe does not respond within 60 days of
issuance of the Notice of Intent to Withdraw or an agreement is not
reached within 180 days after EPA determines that a State or Indian
Tribe is not in compliance with the Federal program, the Agency shall
issue an order withdrawing the State's or Indian Tribe's authorization.
(8) By the date of such order, the Administrator will establish and
enforce the provisions of subpart E or subpart L of this part, or both,
as the Federal program for that State or Indian Country.
[61 FR 45825, Aug. 29, 1996, as amended at 73 FR 21767, Apr. 22, 2008]
Sec. 745.325 Lead-based paint activities: State and Tribal program
requirements.
(a) Program elements. To receive authorization from EPA, a State or
Tribal program must contain at least the following program elements for
lead-based paint activities:
(1) Procedures and requirements for the accreditation of lead-based
paint activities training programs.
(2) Procedures and requirements for the certification of individuals
engaged in lead-based paint activities.
(3) Work practice standards for the conduct of lead-based paint
activities.
(4) Requirements that all lead-based paint activities be conducted
by appropriately certified contractors.
(5) Development of the appropriate infrastructure or government
capacity to effectively carry out a State or Tribal program.
(b) Accreditation of training programs. The State or Indian Tribe
must have either:
(1) Procedures and requirements for the accreditation of training
programs that establish:
(i) Requirements for the accreditation of training programs,
including but not limited to:
(A) Training curriculum requirements.
(B) Training hour requirements.
(C) Hands-on training requirements.
(D) Trainee competency and proficiency requirements.
(E) Requirements for training program quality control.
(ii) Procedures for the re-accreditation of training programs.
(iii) Procedures for the oversight of training programs.
(iv) Procedures for the suspension, revocation, or modification of
training program accreditations; or
(2) Procedures or regulations, for the purposes of certification,
for the acceptance of training offered by an accredited training
provider in a State or Tribe authorized by EPA.
(c) Certification of individuals. The State or Indian Tribe must
have requirements for the certification of individuals that:
(1) Ensure that certified individuals:
(i) Are trained by an accredited training program; and
(ii) Possess appropriate education or experience qualifications for
certification.
(2) Establish procedures for re-certification.
(3) Require the conduct of lead-based paint activities in accordance
with work practice standards established by the State or Indian Tribe.
(4) Establish procedures for the suspension, revocation, or
modification of certifications.
(5) Establish requirements and procedures for the administration of
a third-party certification exam.
(d) Work practice standards for the conduct of lead-based paint
activities. The State or Indian Tribe must have requirements or
standards that ensure that lead-based paint activities are conducted
reliably, effectively, and safely. At a minimum the State's or Indian
Tribe's work practice standards
[[Page 132]]
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, in
the case of dust-lead hazards to below the action levels, 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 sampling and
conformance with the action levels established or adopted by the State
or Indian Tribe.
(iv) The abatement contractor develops a report that describes areas
of the residential dwelling or child-occupied facility abated and the
techniques employed.
(v) The certified abatement contractor or the firm retains
appropriate records.
(e) Revisions to lead-based paint activities program requirements.
When EPA publishes in the Federal Register revisions to the lead-based
paint activities program requirements contained in subpart L of this
part:
(1) A State or Tribe with a lead-based paint activities program
approved before the effective date of the revisions to the lead-based
paint activities program requirements in subpart L of this part must
demonstrate that it meets the requirements of this section in a report
that it submits pursuant to Sec. 745.324(h) but no later than two years
after the effective date of the revisions.
(2) A State or Tribe with an application for approval of a lead-
based paint activities program submitted but not approved before the
effective date of
[[Page 133]]
the revisions to the lead-based paint activities program requirements in
subpart L of this part must demonstrate that it meets the requirements
of this section either by amending its application or in a report that
it submits pursuant to Sec. 745.324(h) but no later than two years
after the effective date of the revisions.
(3) A State or Tribe submitting its application for approval of a
lead-based paint activities program on or after the effective date of
the revisions must demonstrate in its application that it meets the
requirements of the new lead-based paint activities program requirements
in subpart L of this part.
[61 FR 45825, Aug. 29, 1996, as amended at 66 FR 1240, Jan. 5, 2001; 84
FR 32648, July 9, 2019; 89 FR 89461, Nov. 12, 2024]
Sec. 745.326 Renovation: State and Tribal program requirements.
(a) Program elements. To receive authorization from EPA, a State or
Tribal program must contain the following program elements:
(1) For pre-renovation education programs, procedures and
requirements for the distribution of lead hazard information to owners
and occupants of target housing and child-occupied facilities before
renovations for compensation.
(2) For renovation training, certification, accreditation, and work
practice standards programs:
(i) Procedures and requirements for the accreditation of renovation
and dust sampling technician training programs. A State and Tribal
program is not required to include procedures and requirements for the
dust sampling technician training discipline if the State or Tribal
program requires dust sampling to be performed by a certified lead-based
paint inspector or risk assessor.
(ii) Procedures and requirements for accredited initial and
refresher training for renovators and dust sampling technicians and on-
the-job training for other individuals who perform renovations.
(iii) Procedures and requirements for the certification of
individuals and/or firms.
(iv) Requirements that all renovations be conducted by appropriately
certified individuals and/or firms.
(v) Work practice standards for the conduct of renovations.
(3) For all renovation programs, development of the appropriate
infrastructure or government capacity to effectively carry out a State
or Tribal program.
(b) Pre-renovation education. To be considered at least as
protective as the Federal program, the State or Tribal program must:
(1) Establish clear standards for identifying renovation activities
that trigger the information distribution requirements.
(2) Establish procedures for distributing the lead hazard
information to owners and occupants of housing and child-occupied
facilities prior to renovation activities.
(3) Require that the information to be distributed include either
the pamphlet titled Renovate Right: Important Lead Hazard Information
for Families, Child Care Providers and Schools, developed by EPA under
section 406(a) of TSCA, or an alternate pamphlet or package of lead
hazard information that has been submitted by the State or Tribe,
reviewed by EPA, and approved by EPA for that State or Tribe. Such
information must contain renovation-specific information similar to that
in Renovate Right: Important Lead Hazard Information for Families, Child
Care Providers and Schools, must meet the content requirements
prescribed by section 406(a) of TSCA, and must be in a format that is
readable to the diverse audience of housing and child-occupied facility
owners and occupants in that State or Tribe.
(i) A State or Tribe with a pre-renovation education program
approved before June 23, 2008, must demonstrate that it meets the
requirements of this section no later than the first report that it
submits pursuant to Sec. 745.324(h) on or after April 22, 2009.
(ii) A State or Tribe with an application for approval of a pre-
renovation education program submitted but not approved before June 23,
2008, must demonstrate that it meets the requirements of this section
either by amending its application or in the first report
[[Page 134]]
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) but no later than 2 years after the
effective date of the revisions.
[[Page 135]]
(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 process described at Sec.
745.324(a), or, for
[[Page 136]]
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 137]]
(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 138]]
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 139]]
are satisfied in their lead-based paint program.
[61 FR 45825, Aug. 29, 1996, as amended at 70 FR 59889, Oct. 13, 2005;
73 FR 21769, Apr. 22, 2008; 76 FR 47946, Aug. 5, 2011]
Sec. 745.339 Effective date.
States and Indian Tribes may seek authorization to administer and
enforce subpart L of this part pursuant to this subpart at any time.
States and Indian Tribes may seek authorization to administer and
enforce the pre-renovation education provisions of subpart E of this
part pursuant to this subpart at any time. States and Indian Tribes may
seek authorization to administer and enforce all of subpart E of this
part pursuant to this subpart effective June 23, 2008.
[73 FR 21769, Apr. 22, 2008]
PART 747_METALWORKING FLUIDS--Table of Contents
Subpart A [Reserved]
Subpart B_Specific Use Requirements for Certain Chemical Substances
Sec.
747.115 Mixed mono and diamides of an organic acid.
747.195 Triethanolamine salt of a substituted organic acid.
747.200 Triethanolamine salt of tricarboxylic acid.
Authority: 15 U.S.C. 2604 and 2605.
Subpart A [Reserved]
Subpart B_Specific Use Requirements for Certain Chemical Substances
Sec. 747.115 Mixed mono and diamides of an organic acid.
This section identifies activities with respect to a chemical
substance which are prohibited and requires that warnings and
instructions accompany the substance when distributed in commerce.
(a) Chemical substance subject to this section. The following
chemical substance, referred to by its premanufacture notice number and
generic chemical name, is subject to this section: P-84-529, mixed mono
and diamides of an organic acid.
(b) Definitions. Definitions in section 3 of the Act, 15 U.S.C.
2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(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 140]]
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.S.C. 2614].
(2) Failure or refusal to permit access to or copying of records, as
required under section 11 of the Act, is a violation of section 15 of
the Act [15 U.S.C. 2614].
(3) Failure or refusal to permit entry or inspection, as required
under section 11 of the Act, is a violation of section 15 of the Act [15
U.S.C. 2614].
(4) Violators may be subject to the civil and criminal penalties in
section
[[Page 141]]
16 of the Act [15 U.S.C. 2615] for each violation.
(5) EPA may seek to enjoin the processing, distribution in commerce,
or use of a chemical substance in violation of this section; act to
seize any chemical substance processed, distributed in commerce, or used
in violation of this section; or take other actions under the authority
of sections 7 and 17 of the Act [15 U.S.C. 2605 and 2616].
[49 FR 36855, Sept. 20, 1984]
Sec. 747.195 Triethanolamine salt of a substituted organic acid.
This section identifies activities with respect to a chemical
substance which are prohibited and requires that warnings and
instructions accompany the substance when distributed in commerce.
(a) Chemical substance subject to this section. The following
chemical substance, referred to by its premanufacture notice number and
generic chemical name, is subject to this section: P-84-310,
triethanolamine salt of a substituted organic acid.
(b) Definitions. Definitions in section 3 of the Act, 15 U.S.C.
2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(1) The terms Act, article, chemical substance, commerce, importer,
impurity, Inventory, manufacturer, person, process, processor, and small
quantities solely for research and development, have the same meaning as
in Sec. 720.3 of this chapter.
(2) Metalworking fluid means a liquid of any viscosity or color
containing intentionally added water used in metal machining operations
for the purpose of cooling, lubricating, or rust inhibition.
(3) Nitrosating agent means any substance that has the potential to
transfer a nitrosyl group (--NO) to a primary, secondary, or tertiary
amine to form the corresponding nitrosamine.
(4) Process or distribute in commerce solely for export means to
process or distribute in commerce solely for export from the United
States under the following restrictions on domestic activity:
(i) Processing must be performed at sites under the control of the
processor.
(ii) Distribution in commerce is limited to purposes of export.
(iii) The processor or distributor may not use the substance except
in small quantities solely for research and development.
(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 142]]
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.S.C. 2614).
(2) Failure or refusal to permit access to or copying of records, as
required under section 11 of the Act, is a violation of section 15 of
the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection, as required
under section 11 of the Act, is a violation of section 15 of the Act (15
U.S.C. 2614).
[49 FR 24668, June 14, 1984]
Sec. 747.200 Triethanolamine salt of tricarboxylic acid.
This section identifies activities with respect to two chemical
substances which are prohibited and requires that warnings and
instructions accompany the substances when distributed in commerce.
(a) Chemical substances subject to this section. The following
chemical substances, referred to by their premanufacture notice numbers
and generic chemical names, are subject to this section:
P-83-1005, triethanolamine salt of tricarboxylic acid; and
P-83-1062, tricarboxylic acid.
(b) Definitions. Definitions in section 3 of the Act, 15 U.S.C.
2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(1) The terms Act, article, byproducts, chemical substance,
commerce, imported,
[[Page 143]]
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 144]]
(2) Except for manufacturers and importers of P-83-1005 and P-83-
1062, no processor, distributor, or user of P-83-1005 or P-83-1062 will
be in violation of this section unless that person has received a letter
specified in paragraph (d)(1) or (3) of this section or a container with
the label specified in paragraph (d)(2) of this section.
(f) Exemptions and exclusions. The chemical substances identified in
paragraph (a) of this section are not subject to the requirements of
paragraphs (c) and (d) of this section, if:
(1) The substance is manufactured, imported, processed, distributed
in commerce, and used only in small quantities solely for research and
development, and if the substance is manufactured, imported, processed,
distributed in commerce, and used in accordance with section 5(h)(3) of
the Act.
(2) The substance is manufactured, imported, processed, distributed
in commerce, or used only as an impurity.
(3) The substance is imported, processed, distributed in commerce,
or used only as part of an article.
(4) The substance is manufactured solely for export.
(g) Enforcement. (1) Failure to comply with any provision of this
section is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to permit access to or copying of records, as
required under section 11 of the Act, is a violation of a section 15 of
the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection, as required
under section 11 of the Act, is a violation of section 15 of the Act (15
U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C 2615) for each violation.
(5) EPA may seek to enjoin the processing, distribution in commerce,
or use of a chemical substance in violation of this section, act to
seize any chemical substance, processed, distributed in commerce, or
used in violation of this section or take other actions under the
authority of section 7 or 17 of the Act (15 U.S.C. 2605 or 2616).
[49 FR 2772, Jan. 23, 1984]
PART 749_WATER TREATMENT CHEMICALS--Table of Contents
Subparts A-C [Reserved]
Subpart D_Air Conditioning and Cooling Systems
Sec.
749.68 Hexavalent chromium-based water treatment chemicals in cooling
systems.
Authority: 15 U.S.C. 2605 and 2607.
Subparts A-C [Reserved]
Subpart D_Air Conditioning and Cooling Systems
Sec. 749.68 Hexavalent chromium-based water treatment chemicals in
cooling systems.
(a) Chemicals subject to this section. Hexavalent chromium-based
water treatment chemicals that contain hexavalent chromium, usually in
the form of sodium dichromate (CAS No. 10588-01-9), are subject to this
section. Other examples of hexavalent chromium compounds that can be
used to treat water are: Chromic acid (CAS No. 7738-94-5), chromium
trioxide (CAS No. 1333-83-0), dichromic acid (CAS No.13530-68-2),
potassium chromate (CAS No. 7789-00-6), potassium dichromate (CAS No.
7778-50-9), sodium chromate (CAS No. 7775-11-3), zinc chromate (CAS No.
13530-65-9), zinc chromate hydroxide (CAS No. 153936-94-6), zinc
dichromate (CAS No. 14018-95-2), and zinc potassium chromate (CAS No.
11103-86-9).
(b) Purpose. The purpose of this section is to impose certain
requirements on activities involving hexavalent chromium-based water
treatment chemicals to prevent unreasonable risks associated with human
exposure to air emissions of hexavalent chromium from comfort cooling
towers.
(c) Applicability. This section is applicable to use of hexavalent
chromium-based water treatment chemicals in comfort cooling towers and
to distribution in commerce of hexavalent chromium-based water treatment
chemicals for use in cooling systems.
(d) Definitions. Definitions in section 3 of the Toxic Substances
Control Act,
[[Page 145]]
15 U.S.C. 2602, apply to this section unless otherwise specified in this
paragraph. In addition, the following definitions apply:
(1) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.
(2) Chilled water loop means any closed cooling water system that
transfers heat from air handling units or refrigeration equipment to a
refrigeration machine, or chiller.
(3) Closed cooling water system means any configuration of equipment
in which heat is transferred by circulating water that is contained
within the equipment and not discharged to the air; chilled water loops
are included.
(4) Comfort cooling towers means cooling towers that are dedicated
exlusively to and are an integral part of heating, ventilation, and air
conditioning or refrigeration systems.
(5) Container means any bag, barrel, bottle, box, can, cylinder,
drum, or the like that holds hexavalent chromium-based water treatment
chemicals for use in cooling systems.
(6) Cooling tower means an open water recirculating device that uses
fans or natural draft to draw or force ambient air through the device to
cool warm water by direct contact.
(7) Cooling system means any cooling tower or closed cooling water
system.
(8) Distributor means any person who distributes in commerce water
treatment chemicals for use in cooling systems.
(9) EPA means the Environmental Protection Agency.
(10) Hexavalent chromium means the oxidation state of chromium with
an oxidation number of + 6; a coordination number of 4 and tetrahedral
geometry.
(11) Hexavalent chromium-based water treatment chemicals means any
chemical containing hexavalent chromium which can be used to treat
water, either alone or in combination with other chemicals, where the
mixture can be used to treat water.
(12) Industrial cooling tower means any cooling tower used to remove
heat from industrial processes, chemical reactions, or plants producing
electrical power.
(13) Label means any written, printed, or graphic material displayed
on or affixed to containers of hexavalent chromium-based water treatment
chemicals that are to be used in cooling systems.
(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 146]]
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.S.C. 2614).
(2) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of
the Act (15 U.S.C. 2614).
[[Page 147]]
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
(k) Inspections. EPA will conduct inspections under section 11 of
the Act (15 U.S.C. 2610) to ensure compliance with this section.
[55 FR 240, Jan. 3, 1990, as amended at 59 FR 42773, Aug. 19, 1994]
PART 750_PROCEDURES FOR RULEMAKING UNDER SECTION 6 OF THE TOXIC
SUBSTANCES CONTROL ACT--Table of Contents
Subpart A [Reserved]
Subpart B_Interim Procedural Rules for Manufacturing Exemptions
Sec.
750.10 Applicability.
750.11 Filing of petitions for exemption.
750.12 Consolidation of rulemakings.
750.13 Notice of proposed rulemaking.
750.14 Confidentiality.
750.15 Final rule.
Subpart C_Interim Procedural Rules for Processing and Distribution in
Commerce Exemptions
750.30 Applicability.
750.31 Filing of petitions for exemption.
750.32 Consolidation of rulemaking.
750.33 Notice of proposed rulemaking.
750.34 Confidentiality.
750.35 Final rule.
Authority: 15 U.S.C. 2605.
Subpart A [Reserved]
Subpart B_Interim Procedural Rules for Manufacturing Exemptions
Source: 43 FR 50905, Nov. 1, 1978, unless otherwise noted.
Sec. 750.10 Applicability.
Sections 750.10-750.15 apply to all rulemakings under authority of
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15 U.S.C.
2605(e)(3)(B) with respect to petitions filed pursuant to Sec.
750.11(a).
[81 FR 93636, Dec. 21, 2016]
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.
[[Page 148]]
(7) The basis for the petitioner's contention that he meets the
criterion of section 6(e)(3)(B)(ii) of TSCA concerning substitutes for
PCB's.
(8) Quantification of the reasonably ascertainable economic
consequences of denial of the petition for exemption from the 1979
manufacturing ban and an explanation of the manner of computation.
(d) Request for further information. The Agency reserves the right
to request further information as to each petition prior to or after
publication of the notice of proposed rulemaking required by Sec.
750.13.
(e) Renewal requests. (1) Any petitioner who has been granted an
exemption under section 6(e)(3)(B) of TSCA, on or after May 25, 1994,
and who seeks to renew that exemption without changing its terms, must
submit a letter by certified mail to EPA requesting that the exemption
be granted for the following year.
(i) This letter must contain a certification by the petitioner that
the type of activities, the procedures for handling the PCBs, the amount
of PCBs handled, and any other aspect of the exemption have not changed
from the original exemption petition request.
(ii) This letter must be received by EPA at least 6 months prior to
the expiration of the existing exemption.
(iii) If a petitioner fails to make a submission or the submission
is not timely under this section, the exemption will expire 1 year from
the effective date of granting that exemption.
(iv) EPA will address a timely submission of a renewal request by
rulemaking and either grant or deny the request.
(2) Any petitioner who has been granted an exemption on or after May
25, 1994, and who seeks to increase the amount of PCBs handled or to
change the type of activities, the procedures for handling the PCBs, and
any other aspect of their existing exemption must submit a new exemption
petition to EPA. The existing exemption activity may continue until the
new submission is addressed by rulemaking, provided the activity
conforms to the terms of the current exemption approved by EPA, and the
petitioner complies with the conditions of paragraph (e)(1) of this
section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B)
exemption in a rule prior to May 25, 1994, and who seeks to increase the
amount of PCBs handled or to change the type of activities, the
procedures for handling the PCBs, and any other aspect of their existing
exemption must submit a new exemption petition to EPA. The existing
exemption activity may continue until the new submission is addressed by
rulemaking, provided the activity conforms to the terms of the original
exemption approved by EPA.
[43 FR 50905, Nov. 1, 1978, as amended at 53 FR 12524, Apr. 15, 1988; 59
FR 16998, Apr. 11, 1994; 72 FR 57238, Oct. 9, 2007; 74 FR 30232, June
25, 2009]
Sec. 750.12 Consolidation of rulemakings.
All petitions received pursuant to Sec. 750.11(a) will be
consolidated into one rulemaking with one informal hearing held on all
petitions.
Sec. 750.13 Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed pursuant to Sec. 750.11(a)
shall begin with the publication of a notice of proposed rulemaking in
the Federal Register. The notice shall state in summary form the
required information described in Sec. 750.11(c). Due to time
constraints, the notice need not indicate what action EPA proposes to
take on the exemption petitions.
[81 FR 93636, Dec. 21, 2016]
Sec. 750.14 Confidentiality.
The Agency encourages the submission of nonconfidential information
by petitioners and commenters. The Agency does not wish to have
unnecessary restrictions on access to the rulemaking record. However, if
a petitioner or commenter believes that he can only state his position
through the use of information claimed to be confidential, he may submit
it. Such information must be separately submitted for the rulemaking
record and marked ``confidential'' by the submitter. For the information
claimed to be confidential, the Agency will list only the date and the
name and address of the petitioner
[[Page 149]]
or commenter in the public file, noting that the petitioner or commenter
has requested confidential treatment. The information claimed to be
confidential will be placed in a confidential file. A petitioner must
also file a nonconfidential petition with a nonconfidential summary of
the confidential information to be placed in the public file. Similarly,
a commenter must supply a nonconfidential summary of the information
claimed to be confidential to be placed in the public file. Any
information not marked as confidential will be placed in the public
file. Information marked confidential will be treated in accordance with
the procedures in part 2, subpart B of this title.
[43 FR 50905, Nov. 1, 1978. Redesignated at 81 FR 93636, Dec. 21, 2016]
Sec. 750.15 Final rule.
(a) [Reserved]
(b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B)
submitted pursuant to Sec. 750.11.
(c) In determining whether to grant an exemption to the PCB ban, the
Agency shall apply the two standards enunciated in TSCA section
6(e)(3)(B).
[81 FR 93636, Dec. 21, 2016]
Subpart C_Interim Procedural Rules for Processing and Distribution in
Commerce Exemptions
Source: 44 FR 31560, Mar. 31, 1979, unless otherwise noted.
Sec. 750.30 Applicability.
Sections 750.30 through 750.35 apply to all rulemakings under
authority of section 6(e)(3)(B) of the Toxic Substances Control Act
(TSCA), 15 U.S.C. 2605(e)(3)(B) with respect to petitions for PCB
processing and distribution in commerce exemptions filed pursuant to
Sec. 750.31(a).
[81 FR 93636, Dec. 21, 2016]
Sec. 750.31 Filing of petitions for exemption.
(a) Who may file. Any person seeking an exemption from the PCB
processing and distribution in commerce prohibitions imposed by section
6(e)(3)(A)(ii) 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.
[[Page 150]]
(5) Small quantities for research and development. Persons who
process or distribute in commerce small quantities of PCBs for research
and development may submit a single consolidated petition. The name and
address of each petitioner must be stated in the petition.
(6) Microscopy. Persons who process or distribute in commerce PCBs
for use as a mounting medium in microscopy may submit a single
consolidated petition on behalf of any number of petitioners. The name
and address of each petitioner must be stated in the petition.
(7) Processing of PCB Articles into PCB Equipment. A person who
processes (incorporates) PCB Articles (such as small PCB Capacitors)
into PCB Equipment may submit a petition on behalf of himself and all
persons who further process or distribute in commerce PCB Equipment
built by the petitioner. For example, a builder of motors who places
small PCB Capacitors in the motors may submit a petition on behalf of
all persons who process or incorporate motors built by the petitioner
into other pieces of PCB Equipment and all those who sell the equipment.
Such a petition is not required to identify the persons who distribute
in commerce or further process the PCB Equipment. A separate petition
must be filed, however, by each processor of PCB Articles into PCB
Equipment.
(8) Processing of PCB Equipment into other PCB Equipment. A person
who processes (incorporates) PCB Equipment into other PCB Equipment may
submit a petition on behalf of himself and all persons who further
process or distribute in commerce PCB Equipment built by the petitioner.
Such a petition is not required to identify the persons who distribute
in commerce or further process the PCB Equipment. If a petition has been
filed under paragraph (a)(7) of this section by the builder of the
original PCB Equipment, no other petition is required.
(9) Distribution of PCB Equipment. Distributors in commerce of PCB
Equipment may submit a consolidated petition on behalf of persons who
distribute in commerce PCB Equipment of one type (such as air
conditioners). The petition is not required to name the persons who
distribute in commerce the affected PCB Equipment.
(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
[[Page 151]]
not result'' from the granting of the petition for exemption.
(7) The basis for the petitioner's contention that under section
6(e)(3)(B)(ii) ``good faith efforts have been made to develop a chemical
substance which does not present an unreasonable risk of injury to
health or the environment and which may be substituted for'' the PCB.
(8) Quantification of the reasonably ascertainable economic
consequences of denying the petition for exemption and an explanation of
the manner of computation.
(9) In addition to the information in paragraphs (c)(1) through
(c)(8) of this section, certain petitions must contain additional
information as follows:
(i) Persons who process or distribute in commerce dielectric fluids
containing 50 ppm or greater PCB for use in PCB Transformers, railroad
transformers, or PCB electromagnets must also state the expected number
of PCB Transformers, railroad transformers, or PCB electromagnets to be
serviced under the exemption. In addition, a person must identify all
the facilities which he owns or operates where he services PCB
transformers, railroad transformers, or PCB electromagnets.
(ii) Persons filing petitions under paragraph (a)(1) of this section
(Processing and Distribution in Commerce of PCB-Contaminated Transformer
Dielectric Fluid) must also provide the expected number of PCB-
Contaminated Transformers to be serviced under the requested exemption
and the expected method of disposal of waste dielectric fluid. In
addition, a person must identify all the facilities which he owns or
operates where he services PCB-Contaminated Transformers. This
information, as well as the information required by paragraphs (c)(1),
(c)(3), and (c)(5) of this section, must be provided for each person
represented by the petition. All other information may be provided on a
group basis.
(iii) Persons filing petitions under paragraphs (a)(2) (Contaminated
Substances and Mixtures-Processing) and (a)(3) (Contaminated Substances
and Mixtures-Distribution in Commerce) must also provide a justification
for the class grouping selected and a description of the uses and the
human and environmental exposure associated with each use of the PCB-
contaminated 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.
[[Page 152]]
(vii) Persons filing petitions under paragraphs (a) (5) and (6) of
this section must provide the information required by paragraphs (c) (1)
through (8) of this section for each petitioner named in the petition.
(d) EPA reserves the right to request further information as to each
petition where necessary to determine whether the petition meets the
statutory tests of section 6(e)(3)(B) of TSCA prior to or after
publication of the notice of proposed rulemaking required by Sec.
750.33 of these rules.
(e) Renewal requests. (1) Any petitioner who has been granted an
exemption under 40 CFR 761.80, except paragraph (g) of 40 CFR 761.80, on
or after May 25, 1994, and who seeks to renew that exemption without
changing its terms, must submit a letter by certified mail to EPA
requesting that the exemption be granted for the following year.
(i) This letter must contain a certification by the petitioner that
the type of activities, the procedures for handling the PCBs, the amount
of PCBs handled, and any other aspect of the exemption have not changed
from the original exemption petition request.
(ii) This letter must be received by EPA at least 6 months prior to
the expiration of the existing exemption.
(iii) If a petitioner fails to make a submission or the submission
is not timely under this section, the exemption will expire 1 year from
the effective date of granting that exemption.
(iv) EPA will address a timely submission of a renewal request by
rulemaking and either grant or deny the request.
(2) Any petitioner who has been granted an exemption on or after May
25, 1994, and who seeks to increase the amount of PCBs handled or to
change the type of activities, the procedures for handling the PCBs, and
any other aspect of their existing exemption must submit a new exemption
petition to EPA. The existing exemption activity may continue until the
new submission is addressed by rulemaking, provided the activity
conforms to the terms of the current exemption approved by EPA, and the
petitioner complies with the conditions of paragraph (e)(1) of this
section.
(3) Any petitioner who has been granted a TSCA section 6(e)(3)(B)
exemption in a rule prior to May 25, 1994, and who seeks to increase the
amount of PCBs handled or to change the type of activities, the
procedures for handling the PCBs, and any other aspect of their existing
exemption must submit a new exemption petition to EPA. The existing
exemption activity may continue until the new submission is addressed by
rulemaking, provided the activity conforms to the terms of the original
exemption approved by EPA.
[44 FR 31560, Mar. 31, 1979, as amended at 53 FR 12524, Apr. 15, 1988;
59 FR 16998, Apr. 11, 1994; 63 FR 35436, June 29, 1998; 72 FR 57238,
Oct. 9, 2007; 74 FR 30232, June 25, 2009]
Sec. 750.32 Consolidation of rulemaking.
All petitions received pursuant to Sec. 750.31(a) will be
consolidated into one rulemaking with one informal hearing held on all
petitions.
Sec. 750.33 Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed pursuant to Sec. 750.31(a)
shall begin with the publication of a notice of proposed rulemaking in
the Federal Register. The notice shall state in summary form the
required information described in Sec. 750.31(c).
[81 FR 93636, Dec. 21, 2016]
Sec. 750.34 Confidentiality.
EPA encourages the submission of non-confidential information by
petitioners and commentors. EPA does not wish to have unnecessary
restrictions on access to the rulemaking record. However, if a
petitioner or commentor believes that he can only state his position
through the use of information claimed to be confidential, he may submit
it. Such information must be separately submitted for the rulemaking
record and marked ``confidential'' by the submitter. For the information
claimed to be confidential, EPA will list only the date and the name and
address of the petitioner or commentor in the public file, noting that
the petitioner or commentor has requested confidential treatment. The
information claimed to be confidential will be
[[Page 153]]
placed in a confidential file. A petitioner must also file a non-
confidential petition with a non-confidential summary of the
confidential information to be placed in the public file. Similarly, a
commentor must supply a non-confidential summary of the information
claimed to be confidential to be placed in the public file. Any
information not marked as confidential will be placed in the public
file. Information marked confidential will be treated in accordance with
the procedures in part 2, subpart B of this title.
[44 FR 31560, Mar. 31, 1979. Redesignated at 81 FR 93636, Dec. 21, 2016]
Sec. 750.35 Final rule.
(a) [Reserved]
(b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B)
submitted pursuant to Sec. 750.31.
(c) In determining whether to grant an exemption to the PCB ban, EPA
will apply the two standards enunciated in TSCA section 6(e)(3)(B).
[81 FR 93636, Dec. 21, 2016]
PART 751_REGULATION OF CERTAIN CHEMICAL SUBSTANCES AND MIXTURES UNDER
SECTION 6 OF THE TOXIC SUBSTANCES CONTROL ACT--Table of Contents
Subpart A_General Provisions
Sec.
751.1 Purpose.
751.5 Definitions.
751.7 Exports and imports.
751.9 Enforcement and inspections.
Subpart B_Methylene Chloride
751.101 General.
751.103 Definitions.
751.105 Prohibition of manufacturing (including import), processing, and
distribution in commerce related to consumer paint and coating
removal.
751.107 Other prohibitions of manufacturing (including import),
processing, distribution in commerce, and use.
751.109 Workplace Chemical Protection Program.
751.111 Downstream notification.
751.113 Recordkeeping requirements.
751.115 Exemptions.
751.117 Interim requirements for paint and coating removal for the
refinishing of wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural, or historic
value.
Subpart C [Reserved]
Subpart D_Trichloroethylene (TCE)
751.301 General.
751.303 Definitions.
751.305 Prohibitions of manufacturing, processing, distribution in
commerce, use and disposal.
751.307 Phase-out of processing trichloroethylene to manufacture of HFC-
134a.
751.309 Phase-out of trichloroethylene use in vapor degreasing for
booster rocket nozzles.
751.311 Phase-out of TCE use in the industrial and commercial use of TCE
in laboratory use in asphalt testing and recovery.
751.313 Phase-out of disposal of TCE to industrial pre-treatment,
treatment, or publicly owned treatment works.
751.315 Workplace chemical protection program.
751.317 Workplace requirements for energized electrical cleaner.
751.319 Workplace requirements for wastewater.
751.321 Downstream notification.
751.323 Recordkeeping requirements.
751.325 Exemptions.
Subpart E_Persistent, Bioaccumulative, and Toxic Chemicals
751.401 General.
751.403 Definitions.
751.405 DecaBDE.
751.407 PIP (3:1).
751.409 2,4,6-TTBP.
751.411 PCTP.
751.413 HCBD.
Subpart F_Chrysotile Asbestos
751.501 General.
751.503 Definitions.
751.505 Manufacturing, processing and commercial use of chrysotile
asbestos diaphragms in the chlor-alkali industry.
751.507 Certification of compliance for the chlor-alkali industry.
751.509 Other prohibitions and restrictions of the manufacturing,
processing and commercial use of chrysotile asbestos.
751.511 Interim workplace controls of asbestos exposures.
751.513 Disposal.
751.515 Recordkeeping.
Subpart G_Perchloroethylene (PCE)
751.601 General.
751.603 Definitions.
[[Page 154]]
751.605 Prohibitions of manufacturing, processing, distribution in
commerce, and use.
751.607 Workplace Chemical Protection Program (WCPP).
751.609 Workplace requirements for laboratory use.
751.611 Workplace requirements for energized electrical cleaner.
751.613 Downstream notification.
751.615 Recordkeeping requirements.
751.617 Exemptions.
Subpart H_Carbon Tetrachloride
751.701 General.
751.703 Definitions.
751.705 Prohibition of Certain Industrial and Commercial Uses and
Manufacturing, Processing, and Distribution in Commerce of
Carbon Tetrachloride for those Uses.
751.707 Workplace Chemical Protection Program (WCPP).
751.709 Workplace Restrictions for the Industrial and Commercial Use as
a Laboratory Chemical, Including the Use of Carbon
Tetrachloride as a Laboratory Chemical by the U.S. Department
of Defense.
751.711 Downstream Notification.
751.713 Recordkeeping Requirements.
Authority: 15 U.S.C. 2605, 15 U.S.C. 2625(l)(4).
Source: 84 FR 11435, Mar. 27, 2019, unless otherwise noted.
Subpart A_General Provisions
Sec. 751.1 Purpose.
This part sets forth requirements under section 6(a) of the Toxic
Substances Control Act, 15 U.S.C. 2605(a), regulating the manufacture
(including import), processing, distribution in commerce, use, or
disposal of certain chemical substances and mixtures in order to address
unreasonable risks to the extent necessary so that the chemical
substance or mixture no longer presents such risk.
Sec. 751.5 Definitions.
The definitions in section 3 of the Toxic Substances Control Act, 15
U.S.C. 2602, apply to this part except as otherwise established in any
subpart under this part.
Act or TSCA means the Toxic Substances Control Act, 15 U.S.C. 2601
et seq.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture;
(2) Which has end use function(s) dependent in whole or in part upon
its shape or design during end use; and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
CASRN means Chemical Abstracts Service Registry Number.
Designated representative means any individual or organization to
whom a potentially exposed person gives written authorization to
exercise a right of access. A recognized or certified collective
bargaining agent must be treated automatically as a designated
representative without regard to written authorization.
Direct dermal contact means direct handling of a chemical substance
or mixture or skin contact with surfaces that may be contaminated with a
chemical substance or mixture.
ECEL is an Existing Chemical Exposure Limit, and means an airborne
concentration calculated as an eight (8)-hour time-weighted average
(TWA).
EPA means the U.S. Environmental Protection Agency.
Exposure group means a group of potentially exposed persons with a
similar exposure profile to a chemical substance or mixture based on the
substantial similarity of tasks performed, the manner in which the tasks
are performed, and the materials and processes with which they work.
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this part.
Person means any natural person, firm, company, corporation, joint
venture, partnership, sole proprietorship,
[[Page 155]]
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.
Potentially exposed person means any person who may be exposed to a
chemical substance or mixture in a workplace as a result of a condition
of use of that chemical substance or mixture.
Product means the chemical substance, a mixture containing the
chemical substance, or any object that contains the chemical substance
or mixture containing the chemical substance that is not an article.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance exceed, or there is a reasonable possibility they may exceed,
the applicable Existing Chemical Exposure Limit (ECEL) or the EPA Short
Term Exposure Limit (EPA STEL).
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Any distributor
with at least one consumer end user customer is considered a retailer. A
person who distributes in commerce or makes available a chemical
substance or mixture solely to commercial or industrial end users or
solely to commercial or industrial businesses is not considered a
retailer.
[84 FR 11435, Mar. 27, 2019, as amended at 89 FR 39296, May 8, 2024; 89
FR 103607, Dec. 18, 2024]
Sec. 751.7 Exports and imports.
(a) Exports. Persons who intend to export a chemical substance
identified in any subpart under this part are subject to the export
notification provisions of section 12(b) of the Act. The regulations
that interpret section 12(b) appear at 40 CFR part 707, subpart D.
(b) Imports. Persons who import a substance identified in any
subpart under this part are subject to the import certification
requirements under section 13 of the Act, which are codified at 19 CFR
12.118 through 12.127. See also 19 CFR 127.28.
Sec. 751.9 Enforcement and inspections.
(a) Enforcement. (1) Failure to comply with any provision of this
part is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Failure or refusal to establish and maintain records or to
permit access to or copying of records, as required by the Act, is a
violation of section 15 of the Act (15 U.S.C. 2614).
(3) Failure or refusal to permit entry or inspection as required by
section 11 of the Act (15 U.S.C. 2610) is a violation of section 15 of
the Act (15 U.S.C. 2614).
(4) Violators may be subject to the civil and criminal penalties in
section 16 of the Act (15 U.S.C. 2615) for each violation.
(b) Inspections. EPA may conduct inspections under section 11 of the
Act (15 U.S.C. 2610) to ensure compliance with this part.
Subpart B_Methylene Chloride
Sec. 751.101 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of methylene chloride (CASRN 75-09-2) to prevent
unreasonable risks of injury to health.
(b) De minimis threshold. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to products containing methylene chloride at thresholds less than 0.1
percent by weight. This provision does not apply to Sec. 751.105.
[89 FR 39296, May 8, 2024]
Sec. 751.103 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Consumer paint and coating removal means paint and coating removal
performed by any natural person who uses a paint and coating removal
product for any personal use without receiving remuneration or other
form of payment.
[[Page 156]]
Distribution in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec. 751.111 and 751.113.
ECEL is an Existing Chemical Exposure Limit, and means an airborne
concentration calculated as an eight (8)-hour time-weighted average
(TWA).
ECEL action level means a concentration of airborne methylene
chloride of 1 part per million (1 ppm) calculated as an 8-hour time
weighted average (TWA).
EPA STEL is a Short Term Exposure Limit, which is an EPA regulatory
limit on workplace exposure to an airborne concentration of a chemical
substance, based on an exposure of less than eight hours.
Paint and coating removal means application of a chemical or use of
another method to remove, loosen, or deteriorate any paint, varnish,
lacquer, graffiti, surface protectants, or other coating from a
substrate, including objects, vehicles, architectural features, or
structures.
Retailer means a person who distributes in commerce or makes
available a chemical substance or mixture to consumer end users,
including e-commerce internet sales or distribution. Any distributor
with at least one consumer end user customer is considered a retailer. A
person who distributes in commerce or makes available a chemical
substance or mixture solely to commercial or industrial end users or
solely to commercial or industrial businesses is not considered a
retailer.
[84 FR 11435, Mar. 27, 2019, as amended at 89 FR 39296, May 8, 2024]
Sec. 751.105 Prohibition of manufacturing (including import),
processing, and distribution in commerce related to consumer paint
and coating removal.
(a) After November 22, 2019, all persons are prohibited from
manufacturing, processing and distributing in commerce methylene
chloride for consumer paint and coating removal.
(b) After November 22, 2019, all persons are prohibited from
distributing in commerce methylene chloride, including any methylene
chloride containing products, for paint and coating removal to
retailers.
(c) After November 22, 2019, all retailers are prohibited from
distributing in commerce methylene chloride, including any methylene
chloride containing products, for paint and coating removal.
[84 FR 11435, Mar. 27, 2019, as amended at 89 FR 39296, May 8, 2024]
Sec. 751.107 Other prohibitions of manufacturing (including import),
processing, distribution in commerce, and use.
(a) Applicability. (1) This section applies to all manufacturing
(including import), processing, and distribution in commerce of
methylene chloride for consumer use other than for the paint and coating
removal use addressed under Sec. 751.105.
(2) This section applies to:
(i) All manufacturing (including import), processing, and
distribution in commerce of methylene chloride for industrial or
commercial use, other than for the conditions of use addressed under
Sec. 751.109(a); and
(ii) All commercial or industrial use of methylene chloride, other
than the conditions of use addressed under Sec. 751.109(a).
(3) This section does not apply to manufacturing, processing, or
distribution in commerce of methylene chloride solely for export that
meets the conditions described in TSCA section 12(a)(1)(A) and (B).
(b) Prohibitions. (1) After February 3, 2025, all persons are
prohibited from distributing in commerce (including making available)
methylene chloride, including any methylene chloride-containing
products, to retailers for any use.
(2) After May 5, 2025, all retailers are prohibited from
distributing in commerce (including making available) methylene
chloride, including any methylene chloride-containing products, for any
use.
(3) After May 5, 2025, all persons are prohibited from manufacturing
(including import) methylene chloride, for the uses listed in paragraphs
(a)(1) and (2) of this section except for those uses specified in
paragraphs (b)(7) through (9) of this section.
[[Page 157]]
(4) After August 1, 2025, all persons are prohibited from processing
methylene chloride, including any methylene chloride-containing
products, for the uses listed in paragraphs (a)(1) and (2) of this
section except for those uses specified in paragraphs (b)(7) through (9)
of this section.
(5) After January 28, 2026, all persons are prohibited from
distributing in commerce (including making available) methylene
chloride, including any methylene chloride-containing products, for any
use described in paragraphs (a)(1) and (2) of this section except for
those uses specified in paragraphs (b)(7) through (9) of this section.
(6) After April 28, 2026, all persons are prohibited from industrial
or commercial use of methylene chloride, including any methylene
chloride containing products, for the uses listed in paragraph (a)(2) of
this section except for those uses specified in paragraphs (b)(7)
through (9) of this section.
(7) After May 8, 2034, all persons are prohibited from manufacturing
(including import), processing, distribution in commerce, or use of
methylene chloride, including any methylene chloride containing
products, for industrial or commercial use in an emergency by the
National Aeronautics and Space Administration or its contractors as
described in Sec. 751.115(b).
(8) After May 8, 2029, all persons are prohibited from manufacturing
(including import), processing, distribution in commerce, or use of
methylene chloride, including any methylene chloride containing
products, for industrial or commercial use for paint and coating removal
for refinishing of wooden furniture, decorative pieces and architectural
fixtures of artistic, cultural, or historic significance, with interim
requirements as described in Sec. 751.117.
(9) After May 8, 2029, all persons are prohibited from manufacturing
(including import), processing, distribution in commerce, or use of
methylene chloride, including any methylene chloride-containing
products, for industrial or commercial use for adhesives and sealants in
aircraft, space vehicle, and turbine applications for structural and
safety critical non-structural applications.
[89 FR 39296, May 8, 2024]
Sec. 751.109 Workplace Chemical Protection Program.
(a) Applicability. The provisions of this section apply to the
following conditions of use of methylene chloride, including
manufacturing and processing for export, except to the extent the
conditions of use are prohibited by Sec. Sec. 751.105 and 751.107:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing: as a reactant;
(4) Processing: incorporation into a formulation, mixture, or
reaction product;
(5) Processing: repackaging;
(6) Processing: recycling;
(7) Industrial and commercial use as a laboratory chemical;
(8) Industrial or commercial use for paint and coating removal from
safety-critical, corrosion-sensitive components of aircraft and
spacecraft;
(9) Industrial or commercial use as a bonding agent for solvent
welding;
(10) Industrial and commercial use as a processing aid;
(11) Industrial and commercial use for plastic and rubber products
manufacturing;
(12) Industrial and commercial use as a solvent that becomes part of
a formulation or mixture, where that formulation or mixture will be used
inside a manufacturing process, and the solvent (methylene chloride)
will be reclaimed; and
(13) Disposal.
(b) Relationship to other regulations. For purposes of this section:
(1) Any provisions applying to ``employee'' in 29 CFR 1910.132,
1910.134, and 1910.1052 also apply equally to potentially exposed
persons; and
(2) Any provisions applying to ``employer'' in 29 CFR 1910.132,
1910.134, and 1910.1052 also apply equally to any owner or operator for
the regulated area.
(c) Exposure limits--(1) ECEL. The owner or operator must ensure
that no person is exposed to an airborne concentration of methylene
chloride in excess of 2 parts of methylene chloride per million parts of
air (2 ppm) as an 8-hour TWA after February 8, 2027 for
[[Page 158]]
Federal agencies and Federal contractors acting for or on behalf of the
Federal Government, August 1, 2025 for other owners and operators, or
beginning 4 months after introduction of methylene chloride into the
workplace if methylene chloride use commences after May 5, 2025,
consistent with paragraphs (d) through (f) of this section.
(2) EPA STEL. The owner or operator must ensure that no person is
exposed to an airborne concentration of methylene chloride in excess of
16 parts of methylene chloride per million parts of air (16 ppm) as
determined over a sampling period of 15 minutes after February 8, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal Government, August 1, 2025 for other owners and operators,
or beginning 4 months after introduction of methylene chloride into the
workplace if methylene chloride use commences after May 5, 2025,
consistent with paragraphs (d) through (f) of this section.
(3) Regulated areas. The owner or operator must:
(i) Establish and maintain regulated areas in accordance with 29 CFR
1910.1052(e)(2) and (4) through (7) by February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, August 1, 2025 for other owners and operators, or within 3
months after receipt of the results of any monitoring data consistent
with paragraph (d) of this section.
(ii) Establish a regulated area wherever a potentially exposed
person's exposure to airborne concentrations of methylene chloride
exceeds or can reasonably be expected to exceed either the ECEL or EPA
STEL.
(iii) Demarcate regulated areas from the rest of the workplace in
any manner that adequately establishes and alerts potentially exposed
persons to the boundaries of the area and minimizes the number of
authorized persons exposed to methylene chloride within the regulated
area.
(iv) Restrict access to the regulated area by any potentially
exposed person who lacks proper training, personal protective equipment,
or is otherwise unauthorized to enter.
(d) Exposure monitoring--(1) In general--(i) Characterization of
exposures. Owners or operators must determine each potentially exposed
person's exposure, without regard to respiratory protection, by either:
(A) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(B) Taking personal breathing zone air samples that are
representative of each potentially exposed person's exposure.
(ii) Representative samples. Owners or operators are permitted to
consider personal breathing zone air samples to be representative of
each potentially exposed person's exposure, without regard to
respiratory protection, when they are taken as follows:
(A) ECEL. The owner or operator has taken one or more personal
breathing zone air samples for at least one potentially exposed person
in each job classification in a work area during every work shift, and
the person sampled is expected to have the highest methylene chloride
exposure.
(B) EPA STEL. The owner or operator has taken one or more personal
breathing zone air samples which indicate the highest likely 15-minute
exposures during such operations for at least one potentially exposed
person in each job classification in the work area during every work
shift, and the person sampled is expected to have the highest methylene
chloride exposure.
(C) Exception. Personal breathing zone air samples taken during one
work shift may be used to represent potentially exposed person exposures
on other work shifts where the owner or operator can document that the
tasks performed and conditions in the workplace are similar across
shifts.
(iii) Accuracy of monitoring. Owners or operators must ensure that
the methods used to perform exposure monitoring produce results that are
accurate to a confidence level of 95%, and are:
(A) Within plus or minus 25% for airborne concentrations of
methylene chloride above the ECEL or the EPA STEL; or
(B) Within plus or minus 35% for airborne concentrations of
methylene
[[Page 159]]
chloride at or above the ECEL action level but at or below the ECEL.
(iv) Currency of monitoring data. Owners or operators are not
permitted to rely on monitoring data that is more than 5 years old to
demonstrate compliance with initial or periodic monitoring requirements
for either the ECEL or the EPA STEL.
(2) Initial monitoring. By November 9, 2026 for Federal agencies and
Federal contractors acting for or on behalf of the Federal Government,
by May 5, 2025 for other owners and operators, or within 30 days of
introduction of methylene chloride into the workplace, whichever is
later, each owner or operator covered by this section must perform an
initial exposure monitoring to determine each potentially exposed
person's exposure, unless:
(i) An owner or operator has objective data generated within the
last 5 years prior to May 8, 2024 that demonstrates to EPA that
methylene chloride cannot be released in the workplace in airborne
concentrations at or above the ECEL action level (1-ppm 8-hour TWA) or
above the EPA STEL (16 ppm 15-minute TWA) and that the data represents
the highest methylene chloride exposures likely to occur under
conditions of use described in paragraph (a) of this section; or
(ii) Where potentially exposed persons are exposed to methylene
chloride for fewer than 30 days per year, and the owner or operator has
measurements by direct-metering devices which give immediate results and
which provide sufficient information regarding exposures to determine
and implement the control measures that are necessary to reduce
exposures to below the ECEL action level and EPA STEL.
(3) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
methylene chloride in accordance with table 1.
Table 1 to Paragraph (d)(3)--Periodic Monitoring Requirements Based on
Initial Exposure Monitoring Results
------------------------------------------------------------------------
Air concentration condition observed
during initial exposure monitoring Periodic monitoring requirement
------------------------------------------------------------------------
If the initial exposure monitoring ECEL and EPA STEL periodic
concentration is below the ECEL action monitoring at least once in
level and at or below the EPA STEL. every 5 years.
If the initial exposure monitoring ECEL periodic required at least
concentration is below the ECEL action once every 5 years, and EPA
level and above the EPA STEL. STEL periodic monitoring
required every 3 months.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months.
action level and at or below the ECEL;
and at or below the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is at or above the ECEL 6 months and EPA STEL periodic
action level and at or below the ECEL; monitoring every 3 months.
and above the EPA STEL.
If the initial exposure monitoring ECEL periodic monitoring every
concentration is above the ECEL and 3 months and EPA STEL periodic
below, at, or above the EPA STEL. monitoring every 3 months.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency from
indicate that potential exposure has every 3 months to every 6
decreased from above the ECEL to at or months.
below the ECEL, but at or above the
ECEL action level.
If 2 consecutive monitoring events have Transition from ECEL periodic
taken place at least 7 days apart that monitoring frequency from
indicate that potential exposure has every 6 months to once every 5
decreased to below the ECEL action years. The second consecutive
level and at or below the EPA STEL. monitoring event will
delineate the new date from
which the next 5-year periodic
exposure monitoring must
occur.
If the owner or operator engages in any The owner or operator may forgo
conditions of use described in the upcoming periodic
paragraph (a) of this section and is monitoring event. However,
required to monitor either the ECEL or documentation of cessation of
EPA STEL in a 3-month interval, but use of methylene chloride must
does not engage in any of those uses be maintained, and initial
for the entirety of the 3-month monitoring is required when
interval. the owner or operator resumes
or starts any of the
conditions of use described in
paragraph (a) of this section.
Owner or operator engages in any The owner or operator may forgo
conditions of use described in the upcoming periodic
paragraph (a) of this section and is monitoring event. However,
required to monitor the ECEL in a 6- documentation of cessation of
month interval, but does not engage in the condition(s) of use must
any of those uses for the entirety of be maintained until periodic
the 6-month interval. monitoring resumes, and
initial monitoring is required
when the owner or operator
resumes or starts any of the
conditions of use described in
paragraph (a) of this section.
------------------------------------------------------------------------
[[Page 160]]
(4) Additional monitoring. The owner or operator must conduct the
exposure monitoring required by paragraph (d)(2) of this section within
30 days after any change that may reasonably be expected to introduce
additional sources of exposure to methylene chloride, or otherwise
result in increased exposure to methylene chloride compared to the most
recent monitoring event. Examples of situations that may require
additional monitoring include changes in production, process, control
equipment, or work practices, or a leak, rupture, or other breakdown.
(5) Notification of monitoring results. (i) The owner or operator
must inform potentially exposed persons of monitoring results within 15
working days.
(ii) This notification must include the following:
(A) Exposure monitoring results;
(B) Identification and explanation of the ECEL, ECEL Action Level,
and EPA STEL;
(C) Whether the airborne concentration of methylene chloride exceeds
the ECEL action level, ECEL or the EPA STEL;
(D) If the ECEL or EPA STEL is exceeded, descriptions of actions
taken by the owner or operator to reduce exposure in accordance with
paragraph (e)(1)((i) of this section;
(E) Explanation of any required respiratory protection provided in
accordance with as paragraphs (e)(1)(ii) and (f) of this section;
(F) Quantity of methylene chloride in use at the time of monitoring;
(G) Location of methylene chloride use at the time of monitoring;
(H) Manner of methylene chloride use at the time of monitoring; and
(I) Identified releases of methylene chloride.
(iii) Notice must be provided in plain language writing, in a
language that the person understands, to each potentially exposed person
or posted in an appropriate and accessible location outside the
regulated area with an English-language version and a non-English
language version representing the language of the largest group of
workers who do not read English.
(6) Observation of monitoring. (i) The owner or operator must
provide affected potentially exposed persons an opportunity to observe
exposure monitoring conducted in accordance with this paragraph (d) that
is representative of the potentially exposed person's exposure.
(ii) The owner or operator must ensure that potentially exposed
persons are provided with personal protective equipment appropriate for
the observation of monitoring.
(e) ECEL control procedures and plan--(1) Methods of compliance. (i)
By May 10, 2027 for Federal agencies and Federal contractors acting for
or on behalf of the Federal Government, or by October 30, 2025 for other
owners and operators, the owner or operator must institute one or a
combination of elimination, substitution, engineering controls, work
practices, or administrative controls to reduce exposure to or below the
ECEL and EPA STEL except to the extent that the owner or operator can
demonstrate that such controls are not feasible.
(ii) If the feasible controls, required by paragraph (e)(1)(i) of
this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL or EPA STEL, then the
owner or operator must use such controls to reduce exposure to the
lowest levels achievable by these controls and must supplement those
controls with the use of respiratory protection that complies with the
requirements of paragraph (f) of this section to reduce exposures to or
below the ECEL or EPA STEL.
(iii) Where an owner or operator cannot demonstrate exposure below
the ECEL, including through the use of all feasible engineering
controls, work practices, or administrative controls as described in
paragraph (e)(1)(i) of this section, and, has not demonstrated that it
has appropriately supplemented with respiratory protection that complies
with the requirements of paragraphs (e)(1)(ii) and (f) of this section,
this will constitute a failure to comply with the ECEL.
(iv) For the Department of Defense and Federal contractors acting
for or on behalf of the Department of Defense, in the event that ongoing
or planned construction is necessary to
[[Page 161]]
implement the feasible controls required by paragraph (e)(1)(i) of this
section such that no one is exposed above the ECEL or EPA STEL, the
deadlines in paragraph (e)(1)(i) of this section are extended to May 7,
2029. Ongoing or planned construction efforts to address exposures above
the ECEL and EPA STEL must be documented in the exposure control plan
required by paragraph (e)(2) of this section.
(2) Exposure control plan. By May 10, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal Government,
or by October 30, 2025 for other owners and operators, the owner or
operator must develop and implement an exposure control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraph (e)(1)(i) of this section, in the following sequence--
elimination, substitution, engineering controls, and work practices and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement the exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) A description of activities conducted by the owner or operator
to review and update the exposure control plan to ensure effectiveness
of the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls; and
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to methylene chloride, or otherwise result in increased
exposure to methylene chloride, including procedures for implementing
corrective actions to mitigate exposure to methylene chloride.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls, instituted under paragraph (e) of this section.
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (c) through (e) of this section.
(iii) Availability of exposure control plan. (A) Owners or operators
must make the exposure control plan and associated records, including
exposure monitoring, respiratory protection program implementation, and
dermal protection program implementation records, available to
potentially exposed persons.
(B) Owners or operators must notify potentially exposed persons of
the availability of the plan and associated records within 30 days of
the date that the exposure control plan is completed and at least
annually thereafter. The notification must be provided in accordance
with the requirements of paragraph (d)(5)(iii) of this section.
(C) Upon request by the potentially exposed person, the owner or
operator must provide the specified records at a reasonable time, place,
and manner. If the owner or operator is unable to provide the requested
records within 15 days, the owner or operator must, within those 15
days, inform the potentially exposed person requesting the record(s) of
the reason for the delay and the earliest date when the record can be
made available.
(3) Respirator requirements. The owner or operator must supply a
respirator, selected in accordance with paragraph (f) of this section,
to each potentially exposed person who enters a regulated area and must
ensure each potentially exposed person uses that respirator
[[Page 162]]
whenever methylene chloride exposures may exceed the ECEL or EPA STEL.
(f) Respiratory protection--(1) Respirator conditions. After
February 8, 2027 for Federal agencies and Federal contractors acting for
or on behalf of the Federal Government, after August 1, 2025 for other
owners and operators, or within 3 months after receipt of the results of
any exposure monitoring as described in paragraph (d) of this section,
owners or operators must provide respiratory protection to all
potentially exposed persons in the regulated area as outlined in
paragraph (c)(3) of this section, and according to the provisions
outlined in 29 CFR 1910.134(a) through (l) (except 29 CFR
1910.134(d)(1)(iii)) and as specified in this paragraph (f) for
potentially exposed persons exposed to methylene chloride in
concentrations above the ECEL or the EPA STEL. For the purpose of this
paragraph (f), the maximum use concentration (MUC) as used in 29 CFR
1910.134 must be calculated by multiplying the assigned protection
factor (APF) specified for a respirator by the ECEL or EPA STEL.
(2) Respirator selection criteria. The type of respiratory
protection that regulated entities must select and provide to
potentially exposed persons in accordance with 29 CFR
1910.1052(g)(3)(i), is directly related to the monitoring results, as
follows:
(i) If the measured exposure concentration is at or below the ECEL
or EPA STEL: no respiratory protection is required.
(ii) If the measured exposure concentration is above 2 ppm and less
than or equal to 50 ppm: the respirator protection required is any NIOSH
Approved[supreg] supplied-air respirator (SAR) or airline respirator in
a continuous-flow mode equipped with a loose-fitting facepiece or
helmet/hood (APF 25).
(iii) If the measured exposure concentration is above 50 ppm and
less than or equal to 100 ppm the respirator protection required is:
(A) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a demand mode equipped with a full facepiece (APF
50); or
(B) Any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in demand-mode equipped with a full facepiece or helmet/hood (APF
50).
(iv) If the measured exposure concentration is unknown or at any
value above 100 ppm and up to 2,000 ppm the respirator protection
required is:
(A) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a continuous-flow mode equipped with a full
facepiece or certified helmet/hood that has been tested to demonstrate
performance at a level of a protection of APF 1,000 or greater. (APF
1,000); or
(B) Any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in pressure-demand or other positive-pressure mode
equipped with a full facepiece and an auxiliary self-contained air
supply (APF 1,000); or
(C) Any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in a pressure-demand or other positive-pressure mode equipped
with a full facepiece or certified helmet/hood (APF 10,000).
(3) Minimal respiratory protection. Requirements outlined in
paragraph (e)(2) of this section represent the minimum respiratory
protection requirements, such that any respirator affording a higher
degree of protection than the required respirator may be used.
(g) Dermal protection. (1) After February 8, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
Government, or after August 1, 2025 for other owners and operators,
owners or operators must require the donning of gloves that are
chemically resistant to methylene chloride with activity-specific
training where dermal contact with methylene chloride is possible, after
application of the requirements in paragraph (e) of this section, in
accordance with the NIOSH hierarchy of controls.
(2) Owners or operators must minimize and protect potentially
exposed persons from dermal exposure in accordance with 29 CFR
1910.1052(h) and (i).
(h) Training. Owners or operators must provide training in
accordance with 29 CFR 1910.1052(l)(1) through (6) to potentially
exposed persons prior to or at the time of initial assignment to a job
involving potential exposure to
[[Page 163]]
methylene chloride. In addition, if respiratory protection or PPE must
be worn within a regulated area, owners or operators must provide
training in accordance with 29 CFR 1910.132(f) to potentially exposed
persons within that regulated area.
[89 FR 39297, May 8, 2024]
Sec. 751.111 Downstream notification.
(a) After August 26, 2019, and before October 7, 2024, each person
who manufactures (including imports), and before December 4, 2024
processes or distributes in commerce methylene chloride for any use
must, prior to or concurrent with the shipment, notify companies to whom
methylene chloride is shipped, in writing, of the restrictions described
in Sec. 751.105. Notification must occur by inserting the following
text in section 1(c) and section 15 of the SDS provided with the
methylene chloride or with any methylene chloride-containing product:
This chemical/product is not and cannot be distributed in commerce
(as defined in TSCA section 3(5)) or processed (as defined in TSCA
section 3(13)) for consumer paint or coating removal.
(b) Beginning on October 7, 2024, each person who manufactures
(including import) methylene chloride for any use must, prior to or
concurrent with the shipment, notify companies to whom methylene
chloride is shipped, in writing, of the restrictions described in this
subpart in accordance with paragraph (d) of this section.
(c) Beginning on December 4, 2024, each person who processes or
distributes in commerce methylene chloride or methylene chloride-
containing products for any use must, prior to or concurrent with the
shipment, notify companies to whom methylene chloride is shipped, in
writing, of the restrictions described in this subpart in accordance
with paragraph (d) of this section.
(d) The notification required under paragraphs (b) and (c) of this
section must occur by inserting the following text in section 1(c) and
section 15 of the SDS provided with the methylene chloride or with any
methylene chloride-containing product:
After February 3, 2025, this chemical substance (as defined in TSCA
section 3(2))/product cannot be distributed in commerce to retailers.
After January 28, 2026, this chemical substance (as defined in TSCA
section 3(2))/product is and can only be distributed in commerce or
processed with a concentration of methylene chloride equal to or greater
than 0.1% by weight for the following purposes: (1) Processing as a
reactant; (2) Processing for incorporation into a formulation, mixture,
or reaction product; (3) Processing for repackaging; (4) Processing for
recycling; (5) Industrial or commercial use as a laboratory chemical;
(6) Industrial or commercial use as a bonding agent for solvent welding;
(7) Industrial and commercial use as a paint and coating remover from
safety critical, corrosion-sensitive components of aircraft and
spacecraft; (8) Industrial and commercial use as a processing aid; (9)
Industrial and commercial use for plastic and rubber products
manufacturing; (10) Industrial and commercial use as a solvent that
becomes part of a formulation or mixture, where that formulation or
mixture will be used inside a manufacturing process, and the solvent
(methylene chloride) will be reclaimed; (11) Industrial and commercial
use in the refinishing for wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural or historic value until May
8, 2029; (12) Industrial and commercial use in adhesives and sealants in
aircraft, space vehicle, and turbine applications for structural and
safety critical non-structural applications until May 8, 2029; (13)
Disposal; and (14) Export.
[89 FR 39300, May 8, 2024]
Sec. 751.113 Recordkeeping requirements.
(a) General records. Each person who manufactures (including
imports), processes, or distributes in commerce any methylene chloride
after August 26, 2019, must retain in one location at the headquarters
of the company, or at the facility for which the records were generated
beginning July 8, 2024, documentation showing:
(1) The name, address, contact, and telephone number of companies to
whom methylene chloride was shipped;
(2) A copy of the notification provided under Sec. 751.111; and
(3) The amount of methylene chloride shipped.
(b) Exposure control records. Owners or operators must retain
records of:
(1) The exposure control plan as described in Sec. 751.109(e)(2);
(2) Implementation of the exposure control plan described in Sec.
751.109(e)(2), including:
[[Page 164]]
(i) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness; and
(ii) Confirmation that all persons are properly implementing the
exposure controls.
(3) Personal protective equipment (PPE) and respiratory protection
used by potentially exposed persons and program implementation,
including fit-testing, pursuant to Sec. 751.109(f) and (g);
(4) Information and training provided pursuant to Sec. 751.109(h);
and
(5) Occurrence and duration of any start-up, shutdown, or
malfunction of exposure controls or of facility equipment that causes
air concentrations to be above the ECEL or EPA STEL and subsequent
corrective actions taken during start-up, shutdown, or malfunctions to
mitigate exposures to methylene chloride.
(c) Objective data. Objective data generated during the previous 5
years, when used to forgo the initial exposure monitoring, must include:
(1) The use of methylene chloride being evaluated;
(2) The source of objective data;
(3) The measurement methods, measurement results, and measurement
analysis of the use of methylene chloride; and
(4) Any other relevant data to the operations, processes, or
person's exposure.
(d) Exposure monitoring records. (1) Owners or operators are
required to retain monitoring records that include, at minimum, the
information described at 29 CFR 1910.1052(m)(2)(ii)(A) through (F). For
the purposes of this paragraph (d)(1), cross-referenced provisions in 29
CFR 1910.1052(m)(2)(ii) applying to an ``employee'' apply equally to
potentially exposed persons and cross-referenced provisions applying to
an ``employer'' also apply equally to owners or operators.
(2) For each monitoring event of methylene chloride required under
this subpart, owners or operators must also document the following:
(i) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(ii) The identity of all other potentially exposed persons whose
exposure was not measured and whose exposure is intended to be
represented by the area or representative sampling monitoring;
(iii) Use of established analytical methods;
(iv) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792 or use of a laboratory accredited by the
AIHA or another industry-recognized program; and
(v) Information regarding air monitoring equipment including: Type,
maintenance, calibrations, performance tests, limits of detection, and
any malfunctions.
(3) Owners or operators must maintain copies of exposure monitoring
notifications provided pursuant to Sec. 751.109(d)(5).
(e) Availability of exposure control plans. Owners or operators must
document the notice to and ability of any potentially exposed persons to
access the exposure control plan and other associated records in
accordance with Sec. 751.109(e)(2)(iii).
(f) Records related to exemptions. To maintain eligibility for an
exemption described in Sec. 751.115, the records maintained by the
owners or operators must demonstrate compliance with the specific
conditions of the exemption.
(g) Records related to the refinishing of wooden furniture,
decorative pieces, and architectural fixtures. (1) Owners and operators
of workplaces engaged in the industrial or commercial use of methylene
chloride for the refinishing of wooden furniture, decorative pieces, and
architectural fixtures of artistic, cultural, or historic value must
document each instance of refinishing such pieces.
(2) The documentation required by paragraph (g)(1) of this section
must include:
(i) The date of the refinishing activity;
(ii) A description of the wooden piece that was refinished and an
explanation of its artistic, cultural, or historic value;
(iii) The name of the owner of the refinished wooden piece;
(iv) The name of the individual(s) that refinished the wooden piece;
(v) A description of the methylene chloride product used and the
quantity
[[Page 165]]
of the product used to perform the refinishing; and
(vi) Records demonstrating compliance with the requirements of Sec.
751.117.
(h) Minimum record retention period. The records required under this
section must be retained for at least 5 years from the date that such
records were generated.
[89 FR 39301, May 8, 2024]
Sec. 751.115 Exemptions.
(a) In general. (1) Time-limited exemptions described in this
section are established in accordance with 15 U.S.C. 2605(g)(1).
(2) To be eligible for the exemptions established in this section,
regulated parties must comply with all conditions promulgated in this
section for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Exemption for emergency use by the National Aeronautics and
Space Administration. Under 15 U.S.C. 2605(g)(1)(A), the use of
methylene chloride or methylene chloride-containing products in an
emergency by the National Aeronautics and Space Administration and its
contractors operating within the scope of their contracted work for the
conditions of use identified in paragraph (b)(1) of this section is
exempt from the requirements of Sec. 751.107(b)(3) through (6) until
May 8, 2034.
(1) Applicability. This exemption shall apply to the following
specific conditions of use:
(i) Industrial and commercial use as solvent for cold cleaning;
(ii) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner;
(iii) Industrial and commercial use in adhesives, sealants, and
caulks;
(iv) Industrial and commercial use in adhesive and caulk removers;
(v) Industrial and commercial use in metal non-aerosol degreasers;
(vi) Industrial and commercial use in non-aerosol degreasers and
cleaners; and
(vii) Industrial and commercial use as solvent that becomes part of
a formulation or mixture.
(2) Emergency use. (i) In general. An emergency is a serious and
sudden situation requiring immediate action, within 15 days or less,
necessary to protect:
(A) Safety of the National Aeronautics and Space Administration's or
their contractors' personnel;
(B) The National Aeronautics and Space Administration's missions;
(C) Human health, safety, or property, including that of adjacent
communities; or
(D) The environment.
(ii) Duration. Each emergency is a separate situation; if use of
methylene chloride exceeds 15 days, then justification must be
documented.
(3) Eligibility. To be eligible for the exemption, the National
Aeronautics and Space Administration and its contractors must:
(i) Select methylene chloride because there are no technically and
economically feasible safer alternatives available during the emergency.
(ii) Perform the emergency use of methylene chloride at locations
controlled by the National Aeronautics and Space Administration or its
contractors.
(iii) Comply with the following conditions:
(A) Notification. Within 15 working days of the emergency use by the
National Aeronautics and Space Administration or its contractors, the
National Aeronautics and Space Administration and its contractors must
provide notice to the EPA Assistant Administrators of both the Office of
Enforcement and Compliance Assurance and the Office of Chemical Safety
and Pollution Prevention that includes the following:
(1) Identification of the condition of use detailed in paragraph
(b)(1) of this section to which the emergency use applies;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(2)(i) of this section; and
(3) An explanation of why methylene chloride was selected, including
why there were no technically and economically feasible safer
alternatives available in the particular emergency.
(B) Exposure. The owner or operator must comply with and document
such compliance efforts under the Workplace Chemical Protection Program
provisions in Sec. 751.109, to the extent
[[Page 166]]
technically feasible in light of the particular emergency.
(C) Recordkeeping. The owner or operator of the location where the
use takes place must comply with the recordkeeping requirements in Sec.
751.113.
[89 FR 39301, May 8, 2024]
Sec. 751.117 Interim requirements for paint and coating removal for
the refinishing of wooden furniture, decorative pieces, and architectural
fixtures of artistic, cultural, or historic value.
Beginning July 8, 2024, and notwithstanding the timeframes
identified in Sec. 751.109, all persons using methylene chloride,
including any methylene chloride containing products, for industrial and
commercial use for the refinishing of wooden furniture, decorative
pieces and architectural fixtures of artistic, cultural, or historic
value must:
(a) Establish a regulated area in accordance with Sec.
751.109(c)(3);
(b) Use local exhaust ventilation, both bringing air in from outside
and pulling methylene chloride vapors away from the potentially exposed
person; and
(c) Provide minimum respiratory protection:
(1) Use any NIOSH Approved[supreg] Supplied-Air Respirator (SAR) or
airline respirator in a demand mode equipped with a full facepiece (APF
50) or any NIOSH Approved[supreg] Self-Contained Breathing Apparatus
(SCBA) in demand-mode equipped with a full facepiece or helmet/hood (APF
50); or
(2) Use the appropriate respirator based on initial monitoring as
identified in Sec. 751.109(f)(2).
(d) Comply with the recordkeeping requirements in Sec. 751.113(g).
[89 FR 39302, May 8, 2024]
Subpart C [Reserved]
Subpart D_Trichloroethylene (TCE)
Source: 89 FR 102623, Dec. 17, 2024, unless otherwise noted.
Sec. 751.301 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, and disposal of trichloroethylene (TCE) (CASRN 79-01-6) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Regulatory threshold. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to products containing TCE at thresholds less than 0.1 percent by
weight. This threshold does not apply to wastewater.
(c) Byproducts within site-limited, physically enclosed systems.
Unless otherwise specified in this subpart, the prohibitions and
restrictions of this subpart do not apply to TCE processed as a
byproduct when that byproduct TCE is processed within a site-limited,
physically enclosed system that is part of the same overall
manufacturing process from which the byproduct TCE was generated. This
exclusion does not permit TCE to be present in any product that results
from such site-limited, physically enclosed systems, except as permitted
by paragraph (b) of this section.
(d) Owner and operator requirements. Any requirement for an owner or
operator or an owner and operator is a requirement for any individual
that is either an owner or an operator.
Sec. 751.303 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. 751.321 and Sec. 751.323.
Interim ECEL means a concentration of airborne TCE of 0.2 parts per
million (ppm) calculated as an eight (8)-hour time weighted average
(TWA) that will be in place only for the timeframes indicated for
specified conditions of use, after which prohibitions would take effect.
Interim ECEL action level means a concentration of airborne TCE of
0.1 parts per million (ppm) calculated as an eight (8)-hour time-
weighted average (TWA).
[[Page 167]]
Site-limited has the same meaning as in 40 CFR 711.3.
Sec. 751.305 Prohibitions of manufacturing, processing, distribution
in commerce, use and disposal.
(a) Applicability. The provisions of this section apply to the
following:
(1) Manufacturing (including importing and manufacturing for
export);
(2) Processing (including processing for export);
(3) All industrial and commercial uses;
(4) All consumer uses;
(5) Distribution in commerce; and
(6) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works.
(b) Prohibitions. (1) After March 17, 2025, all persons are
prohibited from manufacturing (including importing and manufacturing for
export) TCE, except as specified for manufacturing in paragraphs (b)(5)
through (25) of this section.
(2) After June 16, 2025, all persons are prohibited from processing
(including processing for export) and distributing in commerce
(including making available) TCE, including any TCE-containing products,
except as specified for processing or distributing in commerce in
paragraphs (b)(5) through (25) of this section, and all retailers are
prohibited from distributing in commerce (including making available)
TCE for any use.
(3) After September 15, 2025, all persons are prohibited from
industrial and commercial use of TCE, including any TCE-containing
products, except as specified for industrial or commercial use in
paragraphs (b)(5) through (25) of this section.
(4) After September 15, 2025, all persons manufacturing (including
importing), processing, and using TCE are prohibited from disposal of
TCE to industrial pre-treatment, industrial treatment, or publicly owned
treatment works except as specified in paragraphs (b)(14), (23) (24),
and (26) of this section.
(5) After June 16, 2025, all persons are prohibited from
manufacturing (including importing) TCE for industrial and commercial
use for batch vapor degreasing in open-top and closed-loop degreasing
equipment, except for the use specified in paragraphs (b)(11), (15),
(16), (17), (20), and (21) of this section.
(6) After September 15, 2025, all persons are prohibited from
processing TCE for industrial and commercial use for batch vapor
degreasing in open-top and closed-loop degreasing equipment, except for
the use specified in paragraphs (b)(11), (15), (16), (17), (20), and
(21) of this section.
(7) After December 18, 2025, all persons are prohibited from the
industrial and commercial use of TCE for batch vapor degreasing in open-
top and closed-loop degreasing equipment, except for the use specified
in paragraphs (b)(11), (15), (16), (17), (20), and (21) of this section.
(8) After June 10, 2026, all persons are prohibited from
manufacturing (including importing) TCE for: (i) Processing of TCE as a
reactant/intermediate, except for the use as specified in paragraph
(b)(18) of this section; and (ii) Processing TCE for the industrial and
commercial use of TCE as a processing aid for: process solvent used in
battery manufacture; process solvent used in polymer fiber spinning,
fluoroelastomer manufacture and Alcantara manufacture; extraction
solvent used in caprolactam manufacture; precipitant used in beta-
cyclodextrin manufacture, except for those uses specified in paragraphs
(b)(14), (23) and (24) of this section.
(9) After December 18, 2026, all persons are prohibited from: (i)
Processing TCE as a reactant/intermediate, except for the use as
specified in paragraph (b)(18) of this section; and (ii) Processing for
and industrial and commercial use of TCE as a processing aid in: process
solvent used in battery manufacture; process solvent used in polymer
fiber spinning, fluoroelastomer manufacture and Alcantara manufacture;
extraction solvent used in caprolactam manufacture; precipitant used in
beta-cyclodextrin manufacture, except for those uses specified in
paragraphs (b)(14), (23) and (24) of this section.
(10) After December 18, 2027, all persons are prohibited from
industrial and commercial use of TCE in energized
[[Page 168]]
electrical cleaners and from the manufacturing (including importing),
processing, and distribution in commerce of TCE for such a use.
(11) After December 18, 2029, all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop batch
vapor degreasing for rayon fabric scouring for end use in producing
rocket booster nozzles for Federal agencies and their contractors, and
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use. If such persons obtain and maintain the
records required by Sec. Sec. 751.309 and 751.323 demonstrating that a
final pre-launch test was completed using an alternative to TCE in the
production of the rocket booster nozzles, the industrial and commercial
use of TCE as a solvent in closed-loop batch vapor degreasing for rayon
fabric scouring for end use in producing rocket booster nozzles for
Federal agencies and their contractors, and manufacturing (including
importing), processing, and distribution in commerce of TCE for such use
may continue beyond December 18, 2029.
(12) After December 18, 2029, all persons are prohibited from
industrial and commercial use of TCE in adhesives and sealants for
essential aerospace applications, and from the manufacturing (including
importing), processing, and distribution in commerce of TCE for such
uses.
(13) After December 18, 2029, all persons are prohibited from the
industrial and commercial use of TCE as a laboratory chemical for
asphalt testing and recovery using manual centrifuge processes, and
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use, as further detailed in Sec. 751.311.
(14) After December 18, 2029, all persons are prohibited from the
industrial and commercial use of TCE as a processing aid for lithium
battery separator manufacturing, and the manufacturing (including
importing), processing, and distribution in commerce of TCE for such use
as well as the disposal of TCE from such industrial or commercial use to
industrial pre-treatment, industrial treatment, or publicly owned
treatment works.
(15) After December 18, 2029, all persons are prohibited from the
industrial and commercial use of TCE for batch vapor degreasing for
land-based DoD defense systems by Federal agencies and their
contractors, and from the manufacturing (including importing),
processing, and distribution in commerce of TCE for such use.
(16) After December 18, 2031, all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop batch
vapor degreasing necessary for rocket engine cleaning by Federal
Agencies and their contractors as described in Sec. 751.325(b)(1) and
the manufacturing (including importing), processing, and distribution in
commerce of TCE for such use.
(17) After December 18, 2031, all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop and
open-top batch vapor degreasing for essential aerospace parts and
components and narrow tubing for medical devices, and manufacturing
(including importing), processing, and distribution in commerce of TCE
for such use as described in Sec. 751.325(b)(2).
(18) After June 18, 2033, all persons are prohibited from the
industrial and commercial use of TCE as an intermediate for
manufacturing hydrofluorocarbon 134-a, also known as 1,1,1,2-
tetrafluroethane (HFC-134a: CASRN 811-97-2), and manufacturing
(including importing), processing, and distribution in commerce for such
use as described in Sec. 751.307.
(19) After December 18, 2034, all persons are prohibited from the
industrial and commercial use of TCE in laboratory use for asphalt
testing and recovery, and manufacturing (including importing),
processing, and distribution in commerce of TCE for such use, as
described in Sec. 751.311.
(20) After December 18, 2034, all persons are prohibited from the
industrial and commercial use of TCE as a solvent in closed-loop batch
vapor degreasing for rayon fabric scouring for end use in producing
rocket booster nozzles for Federal agencies and their
[[Page 169]]
contractors, and manufacturing (including importing), processing, and
distribution in commerce of TCE for such use.
(21) After December 18, 2034, for vessels of the Armed Forces and
their systems, and in the maintenance, fabrication, and sustainment for
and of such vessels and systems, prohibit the industrial and commercial
use of TCE as (and manufacturing (including importing), processing, and
distribution in commerce of TCE for): potting compounds for naval
electronic systems and equipment; sealing compounds for high and ultra-
high vacuum systems; bonding compounds for materials testing and
maintenance of underwater systems and bonding of nonmetallic materials;
and cleaning agents to satisfy cleaning requirements (which includes
degreasing using wipes, sprays, solvents and vapor degreasing) for:
materials and components required for military ordnance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes.
(22) After December 18, 2034, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of TCE, including any TCE containing products, for industrial or
commercial use in an emergency by NASA or its contractors as described
in Sec. 751.325(b)(4), and manufacturing (including importing),
processing, and distribution in commerce of TCE for such use.
(23) After December 18, 2044, all persons are prohibited from the
industrial and commercial use of TCE as a processing aid for lead-acid
battery separator manufacturing, and the manufacturing (including
importing), processing, and distribution in commerce of TCE for such
use, as well as the disposal of TCE from such industrial or commercial
use to industrial pre-treatment, industrial treatment, or publicly owned
treatment works.
(24) After December 18, 2039, all persons are prohibited from the
industrial and commercial use of TCE as a processing aid for specialty
polymeric microporous sheet materials manufacturing, and the
manufacturing (including importing), processing, and distribution in
commerce of TCE for such use, as well as the disposal of TCE from such
industrial or commercial use to industrial pre-treatment, industrial
treatment, or publicly owned treatment works.
(25) After December 18, 2074, all persons are prohibited from
industrial and commercial uses of TCE for the laboratory uses described
in Sec. 751.325(b)(7), and from the manufacturing (including
importing), processing, and distribution in commerce of TCE for such
uses.
(26) After December 18, 2074, all persons are prohibited from
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works for the purposes of cleanup projects of
TCE-contaminated water and groundwater as described in Sec.
751.325(b)(8).
Sec. 751.307 Phase-out of processing trichloroethylene to manufacture
of HFC-134a.
(a) Baseline. Before June 16, 2025, each manufacturer of HFC-134a
who processes TCE as an intermediate must establish a baseline annual
volume of TCE processed as an intermediate.
(1) The manufacturer must use the average annual volume of any 12
consecutive months in the 3 years preceding December 17, 2024 to
calculate the baseline.
(2) The manufacturer must retain records that demonstrate how the
baseline annual volume was calculated, in accordance with Sec.
751.323(d)(1).
(b) Phase-out. (1) Beginning June 7, 2027, each manufacturer of HFC-
134a who processes TCE as an intermediate is not permitted to process
TCE as an intermediate at an annual volume greater than 75 percent of
the baseline.
(2) Beginning June 18, 2029, each manufacturer of HFC-134a who
processes
[[Page 170]]
TCE as an intermediate is not permitted to process TCE as an
intermediate at an annual volume greater than 50 percent of the
baseline.
(3) Beginning June 18, 2031, each manufacturer of HFC-134a who
processes TCE as an intermediate is not permitted to process TCE as an
intermediate at an annual volume greater than 25 percent of the baseline
so established.
(4) Beginning June 18, 2033, each manufacturer of HFC-134a who
processes TCE as an intermediate is prohibited from processing TCE as an
intermediate.
(c) Workplace chemical protection program. The owner or operator of
the location where TCE is processed as an intermediate in accordance
with this section, and manufacturers (including importers) and
processors of TCE for such use, must comply with Sec. 751.315.
(d) Recordkeeping. The owner or operator of the location where TCE
is processed as an intermediate in accordance with this section must
comply with the recordkeeping requirements in Sec. 751.323.
Sec. 751.309 Phase-out of trichloroethylene use in vapor degreasing
for rocket booster nozzles.
(a) In accordance with Sec. 751.305(b)(11), until December 18,
2029, TCE may be used as a solvent in closed-loop batch vapor degreasing
for rayon fabric scouring for end use in producing rocket booster
nozzles for Federal agencies and their contractors, and manufactured
(including imported), processed, and distributed in commerce for such
use.
(b) From December 18, 2029, until December 18, 2034, TCE may only be
used as a solvent in closed-loop batch vapor degreasing for rayon fabric
scouring for end use in producing rocket booster nozzles, and
manufactured (including imported), processed, and distributed in
commerce for such use, by Federal agencies and their contractors who
maintain records demonstrating that a final pre-launch test of rocket
booster nozzles without using TCE was completed.
(c) If a suitable alternative to TCE is identified and validated
before the end of this phase-out period, Federal agencies and their
contractors must transition to that alternative.
(d) The owner or operator of the location where TCE is used as a
solvent in closed-loop batch vapor degreasing for rayon fabric scouring
for end use in producing rocket booster nozzles in accordance with this
section, and manufacturers (including importers) and processors of TCE
for such use, must comply with Sec. 751.315.
(e) The owner or operator of the location where TCE is used as a
solvent in closed-loop batch vapor degreasing for rayon fabric scouring
for end use in producing rocket booster nozzles in accordance with this
section must comply with the recordkeeping requirements in Sec.
751.323.
Sec. 751.311 Phase-out of TCE use in the industrial and commercial
use of TCE in laboratory use in asphalt testing and recovery.
(a) In accordance with Sec. 751.305(b)(18), until December 18,
2034, TCE may be manufactured (including imported), processed,
distributed in commerce, and used in industrial and commercial use of
TCE in laboratory use for asphalt testing and recovery.
(b) From December 18, 2029, until December 18, 2034, TCE is only
permitted to be manufactured (including imported), processed,
distributed in commerce, and used in industrial and commercial use of
TCE in laboratory use for asphalt testing and recovery for methods that
do not include manual centrifuge processes.
(c) The use of TCE as a laboratory chemical must be performed on the
premises of a laboratory.
(d) The owner or operator of the location where such use of TCE as a
laboratory chemical occurs, and manufacturers (including importers) and
processors of TCE for such use, must comply with the Workplace Chemical
Protection Program provisions in Sec. 751.315.
(e) The owner or operator of the location where such use of TCE as a
laboratory chemical occurs must comply with the recordkeeping
requirements in Sec. 751.323.
[[Page 171]]
Sec. 751.313 Phase-out of disposal of TCE to industrial pre-treatment,
treatment, or publicly owned treatment works.
(a) After September 15, 2025, all persons manufacturing (including
importing), processing, and using TCE are prohibited from disposal of
TCE to industrial pre-treatment, industrial treatment, or publicly owned
treatment works except as specified in the other subsections of this
unit.
(b) After December 18, 2029, all industrial and commercial users of
TCE for lithium battery separator manufacturing are prohibited from
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works.
(c) After December 18, 2039, all industrial and commercial users of
TCE for specialty polymeric microporous sheet materials manufacturing
are prohibited from disposal of TCE to industrial pre-treatment,
industrial treatment, or publicly owned treatment works.
(d) After December 18, 2044, all industrial and commercial users of
TCE for lead-acid battery separator manufacturing are prohibited from
disposal of TCE to industrial pre-treatment, industrial treatment, or
publicly owned treatment works.
(e) The owner or operator of the location where disposal of TCE to
industrial pre-treatment, treatment, or to a publicly owned treatment
works occurs must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(f) The owner or operator of the publicly owned treatment works
where disposal of TCE occurs must comply with the wastewater workplace
protections in Sec. 751.319.
(g) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
Sec. 751.315 Workplace chemical protection program.
(a) Applicability. The provisions of this section apply to the
following conditions of use of TCE when permitted to continue beyond
December 18, 2025, pursuant to accordance with Sec. Sec. 751.305(b)(8)
through (25), 751.307, 751.309, and 751.311:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing as a reactant/intermediate;
(4) Processing into formulation, mixture, or reaction product;
(5) Processing (repackaging);
(6) Processing (recycling);
(7) Industrial and commercial use of TCE as a processing aid in:
process solvent used in battery manufacture; process solvent used in
polymer fiber spinning, fluoroelastomer manufacture and Alcantara
manufacture; extraction solvent used in caprolactam manufacture;
precipitant used in beta-cyclodextrin manufacture;
(8) Industrial and commercial use of TCE as an adhesive and sealant
for essential aerospace applications;
(9) Industrial and commercial use of TCE in other miscellaneous
industrial and commercial uses (laboratory use);
(10) Industrial and commercial use of TCE as a solvent in closed-
loop batch vapor degreasing for rayon fabric scouring for end use in
rocket booster nozzle production by Federal agencies and their
contractors;
(11) Industrial and commercial use of TCE in closed-loop or open-top
batch vapor degreasing for essential aerospace parts and components and
narrow tubing used for medical devices;
(12) Industrial and commercial use of TCE for vessels of the Armed
Forces and their systems, and in the maintenance, fabrication, and
sustainment for and of such vessels and systems; as potting compounds
for naval electronic systems and equipment; sealing compounds for high
and ultra-high vacuum systems; bonding compounds for materials testing
and maintenance of underwater systems and bonding of nonmetallic
materials; and cleaning agents to satisfy cleaning requirements (which
includes degreasing using wipes, sprays, solvents and vapor degreasing)
for: materials and components required for military ordnance testing;
temporary resin repairs in vessel spaces where welding is not
authorized; ensuring polyurethane adhesion for electronic systems and
equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication
[[Page 172]]
and prototyping processes to remove coolant and other residue from
machine parts; machined part fabrications for naval systems;
installation of topside rubber tile material aboard vessels; and vapor
degreasing required for substrate surface preparation prior to
electroplating processes;
(13) Industrial and commercial use of TCE as a solvent in closed-
loop batch vapor degreasing necessary for rocket engine cleaning by
Federal agencies and their contractors;
(14) Industrial and commercial use of TCE in batch vapor degreasing
for land-based DoD defense systems by Federal agencies and their
contractors; and
(15) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works, except to the extent that
the activity is covered by the workplace protections in Sec. 751.319.
(b) Interim existing chemical exposure limit (interim ECEL)--(1)
Applicability. The provisions of this paragraph (b) apply to any
workplace engaged in the conditions of use listed in paragraphs (a)(1)
through (15) of this section.
(2) Interim ECEL. Beginning September 20, 2027 for Federal agencies
and Federal contractors acting for or on behalf of the Federal
government, or by September 15, 2025 for non-Federal owners and
operators, or beginning 120 days after introduction of TCE into the
workplace if TCE use commences after June 16, 2025, the owner or
operator must ensure that no person is exposed to an airborne
concentration of TCE in excess of the interim ECEL, consistent with the
requirements of paragraph (c) of this section and, if necessary,
paragraph (e)(1) of this section.
(3) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure, without regard to
respiratory protection, by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each exposure group.
(B) Personal breathing zone air samples are representative of the 8-
hour TWA of all potentially exposed persons in an exposure group if the
samples are of at least one person's work-shift exposure who represents
the highest potential TCE exposures in that exposure group. Personal
breathing zone air samples taken during one work shift may be used to
represent potentially exposed person exposures on other work shifts
where the owner or operator can document that the tasks performed and
conditions in the workplace are similar across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good Laboratory
Practice Standards in 40 CFR part 792 or a laboratory accredited by the
American Industrial Hygiene Association (AIHA) or another industry-
recognized program.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of TCE.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect unless an Environmental Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist reviews the monitoring results and
determines re-monitoring is not necessary.
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 16, 2025 for non-Federal owners and operators or within 30
days of introduction of TCE into the workplace, whichever is later, each
owner or operator covered by this section must perform initial
monitoring of potentially exposed persons. Where the owner or operator
has monitoring results from monitoring conducted within five years prior
to February 18, 2025 and the monitoring satisfies all other requirements
of this section, the owner or operator may rely on such earlier
monitoring results to satisfy the requirements of this paragraph.
(iii) Periodic monitoring. The owner or operator must establish an
exposure
[[Page 173]]
monitoring program for periodic monitoring of exposure to TCE in
accordance with Table 1.
Table 1 to Sec. 751.311(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
the interim ECEL action level (<0.1 required at least once every
ppm 8-hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within 180 days of
or above the interim ECEL action level the most recent exposure
but at or below the interim ECEL (=0.1 ppm 8-hour TWA, <=0.2 ppm
8-hour TWA).
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within 90 days of the
above the interim ECEL (<0.2 ppm 8- most recent exposure
hour TWA). monitoring.
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a six-month period, indicate that monitoring.
airborne exposure is below the interim
ECEL action level (<0.1 ppm 8-hour
TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which compliance the next periodic monitoring
with the WCPP is required but does not event. However, documentation
manufacture, process, use, or dispose of cessation of use of TCE is
of TCE in that condition of use over required; and periodic
the entirety of time since the last monitoring is required when
required monitoring event. the owner or operator resumes
the condition of use.
------------------------------------------------------------------------
(iv) Additional monitoring. (A) The owner or operator must conduct
the exposure monitoring required by paragraph (b)(3)(ii) of this section
within 30 days after there has been a change in the production, process,
control equipment, personnel or work practices that may reasonably be
expected to result in new or additional exposures above the interim ECEL
action level or when the owner or operator has any reason to believe
that new or additional exposures above the interim ECEL action level
have occurred. Prior monitoring data cannot be used to meet this
requirement.
(B) Whenever start-ups or shutdown, or spills, leaks, ruptures, or
other breakdowns or unexpected releases occur that may lead to exposure
to potentially exposed persons, the owner or operator must conduct the
exposure monitoring required by paragraph (b)(3)(ii) of this section
within 30 days after the conclusion of the start-up or shut down and/or
the cleanup of the spill or repair of the leak, rupture, or other
breakdown. Prior monitoring data cannot be used to meet this
requirement.
(v) Observation of monitoring. (A) Owners and operators must provide
potentially exposed persons or their designated representatives an
opportunity to observe any monitoring of occupational exposure to TCE
that is conducted under this section and designed to characterize their
exposure.
(B) When monitoring observation requires entry into a regulated
area, the owner or operator must provide the observers with the required
PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group, and their designated representative, of any
monitoring results within 15 working days of receipt of those monitoring
results.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the interim ECEL and interim
ECEL action level;
(3) Statement of whether the monitored airborne concentration of TCE
exceeds the interim ECEL action level or interim ECEL;
(4) If the interim ECEL is exceeded, descriptions of any exposure
controls implemented by the owner or operator to reduce exposure to or
below the interim ECEL;
(5) Explanation of any respiratory protection provided in accordance
with paragraphs (b)(4) and I of this section;
[[Page 174]]
(6) Quantity of TCE in use at the time of monitoring;
(7) Location(s) of TCE use at the time of monitoring;
(8) Manner of TCE use at the time of monitoring; and
(9) Identified releases of TCE.
(C) Notice must be written, in plain language, and either provided
to each potentially exposed person individually in a language that the
person understands, or posted in an appropriate and accessible location
outside the regulated area with an English-language version and a non-
English language version representing the language of the largest group
of workers who do not read English.
(4) Regulated areas--(i) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or by September 15, 2025 for non-Federal owners and
operators, or within 90 days after receipt of any exposure monitoring
that indicates exposures exceeding the interim ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of TCE exceed or can reasonably be expected to exceed the
interim ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that adequately
establishes and alerts persons to the boundaries of the area and
minimizes the number of authorized persons exposed to TCE within the
regulated area.
(iv) Provision of respirators. (A) The owner or operator must ensure
that each person who enters a regulated area is supplied with a
respirator selected in accordance with paragraph I(e) of this section
and must ensure that all persons within the regulated area are using the
provided respirators whenever TCE exposures may exceed the interim ECEL,
except as provided in paragraph (B) of this section.
(B) An owner or operator who has implemented all feasible controls
as required in paragraph (c)(1)(i) of this section, and who has
established a regulated area as required by paragraphs (b)(4)(i) of this
section where TCE exposure can be reliably predicted to exceed the
interim ECEL only on certain days (for example, because of work or
process schedule) must have persons use respirators in that regulated
area on those days.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase TCE exposure.
(B) The owner or operator must ensure that while persons are wearing
respirators in the regulated area, they do not engage in activities
which interfere with respirator performance.
(c) Interim ECEL control procedures and plan--(1) Methods of
compliance. (i) By December 17, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
December 18, 2025, for non-Federal owners and operators, the owner or
operator must institute one or a combination of elimination,
substitution, engineering controls or administrative controls to reduce
exposure to or below the interim ECEL except to the extent that the
owner or operator can demonstrate that such controls are not feasible as
an interim measure, in accordance with the hierarchy of controls.
(ii) If the feasible controls required under paragraph (c)(1)(i) of
this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the interim ECEL, then the owner
or operator must use such controls to reduce exposure to the lowest
levels achievable by these controls and must supplement those controls
by the use of respiratory protection that complies with the requirements
of paragraph (e) of this section.
(iii) Where an owner or operator cannot demonstrate exposure to TCE
has been reduced to or below the interim ECEL through the use of
controls required under paragraphs (c)(1)(i) and (ii) of this section,
and has not demonstrated that it has appropriately supplemented feasible
exposure controls with respiratory protection that complies with the
requirements of paragraph (e) of this section, this will constitute a
failure to comply with the interim ECEL.
[[Page 175]]
(2) Exposure control plan. By December 17, 2027 for Federal agencies
and Federal contractors acting for or on behalf of the Federal
government, or by December 18, 2025, for non-Federal owners and
operators, each owner and operator must establish and implement an
exposure control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraph (c)(1)(i) of this section, in the following sequence:
elimination, substitution, engineering controls and administrative
controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement exposure controls selected, including proper installation,
regular inspections, maintenance, training, or other actions;
(D) A description of each regulated area, how they are demarcated,
and persons authorized to enter the regulated areas;
(E) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls;
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to TCE, or otherwise result in increased exposure to TCE,
including procedures for implementing corrective actions to mitigate
exposure to TCE.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the interim ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls instituted under this paragraph (c).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) and (c) of this section.
(iii) Availability of exposure control plan. (A) Owners or operators
must make the exposure control plan and associated records, including
interim ECEL exposure monitoring records, interim ECEL compliance
records, and workplace participation records available to potentially
exposed persons and their designated representative.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated records must be provided in plain language writing to each
potentially exposed person in a language that the person understands or
posted in an appropriate and accessible location outside the regulated
area with an English-language version and a non-English language version
representing the language of the largest group of workers who do not
read English.
(D) Upon request by the potentially exposed person or their
designated representative(s), the owner or operator must provide the
specified records at a reasonable time, place, and manner. If the owner
or operator is unable to provide the requested records within 15 working
days, the owner or operator must, within those 15 working days, inform
the potentially exposed person or designated representative(s)
requesting the record(s) of the reason for the delay and the earliest
date when the record will be made available.
(d) Workplace information and training. (1) By September 20, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or by September 15, 2025 for non-Federal owners
and operators, the owner or operator must institute a
[[Page 176]]
training program and ensure that persons potentially exposed to TCE
participate in the program according to the requirements of this
paragraph (d).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of initial assignment to a job
involving potential exposure to TCE.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(4) The following information and training must be provided to all
persons potentially exposed to TCE:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
TCE and the specific operations in the workplace that could result in
exposure to TCE, particularly noting where each regulated area is
located;
(iii) Methods and observations that may be used to detect the
presence or release of TCE in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance, or odor of TCE when being released);
(iv) The acute and chronic health hazards of TCE as detailed on
relevant Safety Data Sheets; and
(v) The principles of safe use and handling of TCE and measures
potentially exposed persons can take to protect themselves from TCE,
including specific procedures the owner or operator has implemented to
protect potentially exposed persons from exposure to TCE, such as
appropriate work practices, emergency procedures, and personal
protective equipment to be used.
(5) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of TCE in the
workplace.
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where those exposures exceed or can reasonably be
expected to exceed the interim ECEL action level, the owner or operator
must update the training and ensure that each potentially exposed person
is re-trained.
(e) Personal protective equipment (PPE)--(1) Respiratory protection.
(i) By September 20, 2027 for Federal agencies and Federal contractors
acting for or on behalf of the Federal government, or by September 15,
2025 for non-Federal owners and operators, or within 90 days after
receipt of any exposure monitoring that indicates exposures exceeding
the interim ECEL, or, if an owner or operator is required to provide
respiratory protection pursuant to paragraphs (b)(4)(iv) and (c)(1)(ii)
of this section, the owner or operator must ensure that each potentially
exposed person is provided with a respirator according to the
requirements of this section.
(ii) For purposes of this paragraph (e)(1) of this section, cross-
referenced provisions in 29 CFR 1910.134 applying to an ``employee''
apply equally to potentially exposed persons and cross-referenced
provisions applying to an ``employer'' also apply equally to owners or
operators. Other terms in cross-referenced provisions in 29 CFR 1910.134
that are defined in 29 CFR 1910.134(b) have the meaning assigned to them
in that paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
September 15, 2025 for non-Federal owners and operators, or within 90
days after receipt of any exposure monitoring that indicates exposures
exceeding the interim ECEL, if an owner or operator is required to
provide respiratory protection pursuant to paragraph (b)(4)(iv) or
(c)(1)(ii), the owner or operator must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection based
on a medical evaluation consistent with the requirements of 29 CFR
1910.134(e). If a potentially exposed person cannot use a negative-
pressure respirator that would otherwise be required, then the owner or
operator must provide that person with an alternative respirator.
[[Page 177]]
The alternative respirator must have less breathing resistance than the
negative-pressure respirator and provide equivalent or greater
protection. If the person is unable to use an alternative respirator,
then the person must not be permitted to enter the regulated area.
(v) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator selections
to each affected person consistent with the requirements of 29 CFR
1910.134(f).
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to TCE, owners and operators must provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k).
(viii) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below 0.2 ppm
(200 ppb): no respiratory protection is required.
(B) If the measured exposure concentration is above 0.2 ppm (200
ppb) and less than or equal to 2 ppm (2,000 ppb) (10 times interim
ECEL): Any National Institute for Occupational Safety and Health (NIOSH)
Approved air-purifying half mask respirator equipped with organic vapor
cartridges or canisters; or any NIOSH Approved Supplied-Air Respirator
(SAR) or Airline Respirator operated in demand mode equipped with a half
mask; or any NIOSH Approved Self-Contained Breathing Apparatus (SCBA) in
a demand mode equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 2 ppm and less
than or equal to 5 ppm (25 times interim ECEL): Any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; or any NIOSH Approved SAR or Airline Respirator in a
continuous-flow mode equipped with a loose-fitting facepiece or helmet/
hood [APF 25].
(D) If the measured exposure concentration is above 5 ppm and less
than or equal to 10 ppm (50 times interim ECEL): Any NIOSH Approved air-
purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a half
mask; any NIOSH Approved SAR or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or any
NIOSH Approved SCBA in demand-mode equipped with a full facepiece or
helmet/hood [APF 50].
(E) If the measured exposure concentration is above 10 ppm and less
than or equal to 200 ppm (1,000 times interim ECEL): Any NIOSH Approved
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved SAR or Airline Respirator in
a continuous-flow mode equipped with full facepiece; any NIOSH Approved
SAR or Airline Respirator in pressure-demand or other positive-pressure
mode equipped with a full facepiece and an auxiliary self-contained air
supply; or any NIOSH Approved SAR or Airline Respirator in a continuous-
flow mode equipped with a helmet or hood and that has been tested to
demonstrated performance at a level of a protection of APF 1,000 or
greater [APF 1000].
(F) If the measured exposure concentration is greater than 200 ppm
(1,000+ times interim ECEL): Any NIOSH Approved SCBA equipped with a
full facepiece or hood/helmet and operated in a pressure demand or other
[[Page 178]]
positive pressure mode; air supply [APF 10,000+].
(G) If the exposure concentration is unknown: Any NIOSH Approved
combination SAR equipped with a full facepiece and operated in pressure
demand or other positive pressure mode with an auxiliary self-contained
air supply; or any NIOSH Approved SCBA operated in pressure demand or
other positive pressure mode and equipped with a full facepiece or hood/
helmet [APF 1000+].
(x) Owners and operators must select and provide respirators
consistent with the requirements of 29 CFR 1910.134(d)(1)(iv), and with
consideration of workplace and user factors that affect respirator
performance and reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select NIOSH Approved respirators that have an end-of-service-
life indicator (ESLI) appropriate for TCE; or
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The written
respiratory protection program required by paragraph (e)(1)(iii) of this
section must include a description of the information and data relied
upon, the basis for reliance on the information and data, and the basis
for the canister and cartridge change schedule.
(xii) Owners and operators must, consistent with 29 CFR 1910.134(j),
ensure that all respirator filters, cartridges, and canisters used in
the workplace are labeled and color coded per NIOSH requirements and
that the label is not removed and remains legible.
(xiii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH approval.
(xiv) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29 CFR
1910.134(l), to ensure that the provisions of the written respiratory
protection program required under paragraph (e)(1)(iii) of this section
are being effectively implemented.
(xv) The respiratory protection requirements in this paragraph
represent the minimum respiratory protection requirements, such that any
respirator affording a higher degree of protection than the required
respirator may be used.
(2) Dermal protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by September 15, 2025 for non-Federal owners and
operators, owners and operators must supply and require the donning of
gloves by potentially exposed persons that are chemically resistant to
TCE where dermal exposure to TCE can be expected to occur, after
application of the requirements in paragraph (c) of this section, in
accordance with the hierarchy of controls.
(ii) Owners and operators must provide gloves that are of safe
design and construction for the work to be performed and that properly
fit each person who is required to use gloves.
(iii) Owners and operators must communicate glove selections to each
affected person and ensure that each person who is required to wear
gloves uses and maintains them in a sanitary, reliable, and undamaged
condition.
(iv) Owners and operators must provide activity-specific dermal PPE
training in accordance with 29 CFR 1910.132(f) to all persons required
to use gloves prior to or at the time of initial assignment to a job
involving potential dermal exposure to TCE. For the purposes of this
paragraph (e)(4)(iv), provisions in 29 CFR 1910.132(f) applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(v) Owners and operators must retrain each person required to use
gloves annually or whenever the owner or operator has reason to believe
that a previously trained person does not have the required
understanding and skill to properly use the gloves, or when changes in
the workplace or in PPE to be used render the previous training
obsolete.
[[Page 179]]
Sec. 751.317 Workplace requirements for energized electrical cleaner.
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of TCE in energized electrical cleaner.
(b) Energized electrical cleaner requirements--(1) Personal
Protective Equipment (PPE). (i) The provisions of this paragraph (b)
apply after September 15, 2025.
(ii) Owners or operators must ensure that all potentially exposed
persons using TCE, including any TCE-containing products, are provided
with dermal PPE and training on proper use of PPE as outlined in Sec.
751.315(e)(2).
(iii) Owners or operators must ensure that all persons using TCE,
including any TCE containing products, are provided with respiratory PPE
and training on proper use of PPE in accordance with Sec.
751.315(e)(1), except that instead of selecting appropriate respirators
based on monitoring results pursuant to paragraph (e)(1)(ix), owners or
operators must select from and provide the following types of
respirators: any NIOSH Approved air-purifying full facepiece respirator
equipped with organic vapor cartridges or canisters; any NIOSH Approved
Powered Air-Purifying Respirator (PAPR) with a half mask equipped with
organic vapor cartridges or canisters; any NIOSH Approved Supplied-Air
Respirator (SAR) or Airline Respirator in a continuous flow mode
equipped with a half mask; any NIOSH Approved Supplied-Air Respirator
(SAR) or Airline Respirator operated in a pressure-demand or other
positive-pressure mode with a half mask; any NIOSH Approved SCBA in
demand-mode equipped with a full facepiece or helmet/hood [APF 50]; or
any respirator affording a higher degree of protection.
(2) Alternative to PPE Requirements. (i) As an alternative to the
requirements in paragraph (b)(1) of this section, the owner or operator
may choose to follow the Workplace Chemical Protection Program (WCPP)
provisions in Sec. 751.315.
(ii) Owners or operators who choose to follow the WCPP as an
alternative to the requirements in paragraph (b)(1) of this section
must:
(A) Document and maintain a statement that they are electing to
comply with the WCPP.
(B) Comply with the WCPP provisions in Sec. 751.315 and document
compliance in accordance with Sec. 751.323(b).
Sec. 751.319 Workplace requirements for wastewater.
(a) Applicability. The provisions of this section apply to the
following disposal sub-conditions of use for their respective phaseouts,
in accordance with Sec. 751.305 (b) (14), (23), (24), and (26):
(1) Cleanup of sites with TCE water contamination; and,
(2) Publicly owned treatment works.
(b) Cleanup sites. Beginning September 15, 2025 the owner or
operator of the location where potentially exposed persons are involved
in the disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purposes of
facilitating cleanup projects of TCE-contaminated water and groundwater
must ensure that potentially exposed persons involved with the activity
of removing the TCE-contaminated water and groundwater from the location
where it was located and treating the removed TCE-contaminated water and
groundwater on site are protected to the interim ECEL level of 0.2 ppm
and protected from dermal contact with TCE-containing wastewater in
accordance with the following requirements. For the purposes of this
paragraph (b) of this section, cross-referenced provisions in 29 CFR
1910.120 applying to an ``employee'' apply equally to potentially
exposed persons and cross-referenced provisions applying to an
``employer'' also apply equally to owners or operators.
(1) Written site-specific safety and health plan. Owners and
operators must have a site-specific safety and health plan that
addresses the health hazards presented by TCE to potentially exposed
persons involved in the disposal of TCE-containing wastewater and that
contains elements consistent with 29 CFR 1910.120(b)(4)(ii)(A), (B),
(C), (E) and (F).
(2) Training. Owners and operators must provide training consistent
with Sec. 751.315(d) to potentially exposed persons prior to or at the
time of initial
[[Page 180]]
assignment to a cleanup site job that involves the disposal of TCE-
containing wastewater.
(3) Engineering controls, work practices and PPE. Engineering
controls, work practices, and, if necessary, PPE must be implemented and
provided in compliance with 40 CFR 751.315(c)(1) and (e).
(4) Exposure monitoring. (i) By September 15, 2025 or upon initial
entry to a cleanup site, whichever is later, owners and operators must
perform representative air monitoring consistent with 29 CFR
1910.120(h)(2) to identify any exposures to airborne TCE above the
interim ECEL.
(ii) Owners and operators must perform periodic air monitoring
consistent with 29 CFR 1910.120(h)(3) when there is any indication that
exposures may have exceeded the interim ECEL since prior monitoring.
(iii) Owners and operators must monitor the exposures of those
persons likely to have the highest exposures to airborne TCE above the
interim ECEL by using personal air sampling frequently enough to
characterize their exposures consistent with 29 CFR 1910.120(h)(4).
(iv) Owners and operators must perform exposure monitoring at least
once every five years.
(c) Publicly owned treatment works. By September 15, 2025 owners or
operators of publicly owned treatment works, where there is a reasonable
possibility of the presence of TCE, must comply with one of the
following:
(1) Water screening level. (i) Screen industrial wastewater
discharge received at publicly owned treatment works by sampling and
analyzing for a water concentration of TCE.
(ii) If the TCE concentration in wastewater exceeds 0.00284 mg/L of
TCE, owners or operators must comply with the Workplace Chemical
Protection Program provisions in Sec. 751.315, except for the initial
monitoring requirements in paragraph Sec. 751.315(b)(3)(ii).
(2) Alternative to water screening level. (i) As an alternative to
the requirements in paragraph (1) of this section, the owner or operator
may choose to follow the Workplace Chemical Protection Program (WCPP)
provisions in Sec. 751.315.
(ii) Owners or operators who choose to follow the WCPP as an
alternative to the requirements in paragraph (1) of this section must
comply with the WCPP provisions in Sec. 751.315 and document compliance
in accordance with Sec. 751.323(b).
Sec. 751.321 Downstream notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) TCE for any use must, prior to or concurrent with
the shipment, notify companies to whom TCE is shipped, in writing, of
the restrictions described in this subpart in accordance with paragraph
(c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce TCE or any TCE-containing products for any use
must, prior to or concurrent with the shipment, notify companies to whom
TCE is shipped, in writing, of the restrictions described in this
subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in section 1(c) and
15 of the Safety Data Sheet (SDS) provided with the TCE or with any TCE-
containing product:
After June 16, 2025, this chemical/product is and can only be
domestically manufactured, imported, processed, or distributed in
commerce for the following purposes until the following prohibitions
take effect: (1) Processing as an intermediate a) for the manufacture of
HFC-134a until June 18, 2033, and b) for all other processing as a
reactant/intermediate until December 18, 2026; (2) Industrial and
commercial use as a solvent for open-top batch vapor degreasing until
December 18, 2025; (3) Industrial and commercial use as a solvent for
closed-loop batch vapor degreasing until December 18, 2025, except for
industrial and commercial use in batch vapor degreasing for land-based
DoD defense systems by Federal agencies and their contractors until
December 18, 2029, and except for industrial and commercial use as a
solvent for closed-loop batch vapor degreasing necessary for rocket
engine cleaning by Federal agencies and their contractors until December
18, 2031, and except for industrial and commercial use of TCE in closed-
loop and open-top batch vapor degreasing for essential aerospace parts
and
[[Page 181]]
components and narrow tubing used in medical devices until December 18,
2031, and except for industrial and commercial use as a solvent for
closed-loop batch vapor degreasing for rayon fabric scouring for end use
in rocket booster nozzle production by Federal agencies and their
contractors until December 18, 2034; (4) Industrial and commercial use
in processing aid (a) for lithium battery separator manufacturing until
December 18, 2029, and (b) for lead-acid battery separator manufacturing
until December 18, 2044, and (c) for specialty polymeric microporous
sheet material manufacturing until December 18, 2039, and (d) in process
solvent used in battery manufacture; in process solvent used in polymer
fiber spinning, fluoroelastomer manufacture and Alcantara manufacture;
in extraction solvent used in caprolactam manufacture; and in
precipitant used in beta-cyclodextrin manufacture until December 18,
2026; (5) Industrial and commercial uses for vessels of the Armed Forces
and their systems, and in the maintenance, fabrication, and sustainment
for and of such vessels and systems until December 18, 2034; and (6)
Industrial and commercial use for laboratory use (a) for essential
laboratory activities until December 18, 2074 and (b) for asphalt
testing and recovery using manual centrifuge processes until December
18, 2029 and for asphalt testing and recovery until December 18, 2034.
Sec. 751.323 Recordkeeping requirements.
(a) General records. After February 18, 2025, all persons who
manufacture, process, distribute in commerce, or engage in industrial or
commercial use of TCE or TCE-containing products must maintain ordinary
business records, such as invoices and bills-of-lading related to
compliance with the prohibitions, restrictions, and other provisions of
this subpart.
(b) Workplace chemical protection program compliance. (1) Interim
ECEL exposure monitoring. For each monitoring event, owners or operators
subject to the interim ECEL described in Sec. 751.315(b) must document
the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s), and manner of TCE in use at the time
of each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.315(b)(3)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.315(b)(3)(i)(D);
(vii) Compliance with the Good Laboratory Practice Standards in
accordance with 40 CFR part 792, or use of a laboratory accredited by
the AIHA or another industry-recognized program as required by Sec.
751.315(b)(3)(i)(C);
(viii) Information regarding air monitoring equipment, including:
type, maintenance, calibrations, performance tests, limits of detection,
and any malfunctions;
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.315(b)(3)(vi).
(2) Interim ECEL compliance. Owners or operators subject to the
interim ECEL described in Sec. 751.315(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.315(c)(2).
(ii) Implementation of the exposure control plan described in Sec.
751.315(c)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes an exceedance of the interim
ECEL and any subsequent corrective actions taken by the owner or
operator during the start-up, shutdown, or malfunctions to mitigate
exposures to TCE.
(iii) Respiratory protection used by each potentially exposed person
and PPE program implementation as described in Sec. 751.315(e),
including:
(A) The name, workplace address, work shift, job classification, and
work
[[Page 182]]
area of each potentially exposed person, and the type of respiratory
protection provided to each potentially exposed person;
(B) The basis for the specific PPE selection in accordance with
Sec. 751.315(e); and
(C) Fit testing and training in accordance with Sec. 751.315(e).
(iv) Information and training provided as required in Sec.
751.315(d).
(3) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person who may
reasonably be affected by TCE inhalation exposure and their designated
representative to readily access the exposure control plans, facility
exposure monitoring records, PPE program implementation records, or any
other information relevant to TCE exposure in the workplace.
(c) Records related to exemptions. To maintain eligibility for an
exemption described in Sec. 751.325, owners or operators must maintain
records related to, and demonstrating compliance with, the specific
conditions of the exemption.
(d) Records related to phase-outs. (1) Beginning February 18, 2025,
each manufacturer of HFC-134a who uses TCE as an intermediate under
Sec. 751.307 must maintain records of the annual quantity of TCE
purchased and processed until the termination of all processing of TCE
as an intermediate and, beginning June 16, 2025, must maintain records
that demonstrate how the baseline annual volume was calculated, in
accordance with Sec. 751.307(a)(1).
(2) Beginning September 15, 2025, each person using TCE under Sec.
751.309 for industrial and commercial use as a solvent for closed-loop
batch vapor degreasing for rayon fabric scouring for end use in rocket
booster nozzle production by Federal agencies and their contractors must
maintain records demonstrating that the end use is in rocket booster
nozzle production for Federal agencies and their contractors.
(3) Beginning September 15, 2025, each person using TCE under Sec.
751.311 for industrial and commercial use in laboratory use for asphalt
testing and recovery must maintain records demonstrating compliance with
the use of TCE as specified in Sec. 751.311.
(4) After December 18, 2029, each person using TCE under Sec.
751.311 for industrial and commercial use in laboratory use for asphalt
testing and recovery must maintain records demonstrating compliance with
the provision in Sec. 751.311 that the use of TCE in laboratory use for
asphalt testing and recovery be in methods that do not include manual
centrifuge processes.
(5) After December 18, 2029, each person using TCE under Sec.
751.309 for industrial and commercial use as a solvent for closed-loop
batch vapor degreasing, specifically for rayon fabric scouring, must
maintain records that demonstrate that a final pre-launch test of rocket
booster nozzles without using TCE was completed.
(e) Records related to workplace requirements for energized
electrical cleaner. (1) Owners and operators subject to the energized
electrical cleaner requirements described in Sec. 751.317 must retain
records of:
(i) Statement regarding whether the owner or operator is complying
with the prescriptive PPE requirements described in Sec. 751.317(b)(1)
or with the WCPP described in Sec. 751.317(b)(2).
(ii) Dermal and respiratory protection used by each potentially
exposed person and program implementation as described in Sec.
751.317(b)(1) or WCPP records described in Sec. 751.323(b).
(2) Distributors of TCE, including TCE containing products, for use
in energized electrical cleaning must retain sale records, including:
(i) Name of purchaser;
(ii) Date of sale; and
(iii) Quantity of TCE or TCE containing products sold.
(f) Records related to wastewater workplace protection requirements.
(1) Owners and operators subject to the wastewater workplace protection
requirements for cleanup sites described in Sec. 751.319 must retain
records related to and demonstrating compliance with the provisions of
Sec. 751.319 and 29 CFR 1910.120 that are applicable to the particular
site and records related to and demonstrating compliance with the
interim ECEL.
(2) Publicly owned treatment works must retain records related to
and demonstrating compliance with the
[[Page 183]]
wastewater screening and other requirements described in Sec. 751.319,
and if applicable must retain records for the WCPP as described in Sec.
751.323(b).
(g) Minimum record retention periods. The records required under
this section must be retained for at least 5 years from the date that
such records were generated, except for the records required under
paragraph (d)(1), which must be retained for at least 5 years after the
use of TCE covered by the records has ceased.
Sec. 751.325 Exemptions.
(a) In general. (1) The time-limited exemptions described in this
section are established in accordance with 15 U.S.C. 2605(g).
(2) In order to be eligible for the exemptions described in this
section, regulated parties must comply with all conditions established
for such exemptions in this section.
(b) Exemptions--(1) Closed-loop batch vapor degreasing necessary for
rocket engine cleaning by Federal agencies and their contractors until
December 18, 2031. The following are specific conditions of the
exemption for industrial and commercial use of TCE as a solvent for
closed-loop vapor degreasing necessary for rocket engine cleaning by
Federal agencies and their contractors described in Sec.
751.305(b)(15):
(i) The use of TCE in industrial and commercial as a solvent for
closed-loop vapor degreasing is limited to the closed-loop batch vapor
degreasing necessary for rocket engine cleaning by Federal agencies and
their contractors.
(ii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(iii) The owner or operator of the location where such use of TCE
occurs, and manufacturers (including importers) and processors of TCE
for such use, must comply with the recordkeeping requirements in Sec.
751.323.
(2) Closed-loop and Open-top batch vapor degreasing for essential
aerospace parts and components and narrow tubing for medical devices
until December 18, 2031. The following are specific conditions of the
exemption for vapor degreasing described in Sec. 751.305(b)(16):
(i) The use of TCE for closed-loop and open-top batch vapor
degreasing is limited to the cleaning of:
(A) Essential aerospace parts and components where cleaning
alternatives present technical feasibility or performance challenges to
meet specifications from Federal agencies or other long-standing design
specifications included in existing contracts; and
(B) Narrow tubing for medical devices.
(ii) The owner or operator of the location where such use of TCE
occurs, and manufacturers (including importers) and processors of TCE
for such use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(iii) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
(3) Certain industrial and commercial uses of TCE for vessels of the
Armed Forces and their systems, and in the maintenance, fabrication, and
sustainment for and of such vessels and systems until December 18, 2034.
The following are specific conditions of the exemption for industrial
and commercial uses of TCE for vessels of the Armed Forces and their
systems, and in the maintenance, fabrication, and sustainment for and of
such vessels and systems described in Sec. 751.305(b)(20):
(i) The industrial and commercial use of TCE must be limited for
vessels of the Armed Forces and their systems, and in the maintenance,
fabrication, and sustainment for and of such vessels and systems: as
potting compounds for naval electronic systems and equipment; sealing
compounds for high and ultra-high vacuum systems; bonding compounds for
materials testing and maintenance of underwater systems and bonding of
nonmetallic materials; and cleaning agents to satisfy cleaning
requirements (which includes degreasing using wipes, sprays, solvents
and vapor degreasing) for: materials and components required for
military ordnance testing; temporary resin repairs in vessel spaces
where welding
[[Page 184]]
is not authorized; ensuring polyurethane adhesion for electronic systems
and equipment repair and installation of elastomeric materials; various
naval combat systems, radars, sensors, equipment; fabrication and
prototyping processes to remove coolant and other residue from machine
parts; machined part fabrications for naval systems; installation of
topside rubber tile material aboard vessels; and vapor degreasing
required for substrate surface preparation prior to electroplating
processes.
(ii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(iii) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
(4) Use of TCE or TCE-containing products in an emergency by the
National Aeronautics and Space Administration and its contractors
operating within the scope of their contracted work until December 18,
2034--(i) Applicability. This exemption shall apply to the following
specific conditions of use:
(A) Industrial and commercial use as solvent for open-top or closed-
loop batch vapor degreasing.
(B) Industrial and commercial use as solvent for cold cleaning.
(C) Industrial and commercial use as a solvent for aerosol spray
degreaser/cleaner and mold release.
(D) Industrial and commercial use as a lubricant and grease in tap
and die fluid.
(E) Industrial and commercial use as a lubricant and grease in
penetrating lubricant.
(F) Industrial and commercial use as an adhesive and sealant in
solvent-based adhesives. and sealants.
(G) Industrial and commercial as a functional fluid in heat exchange
fluid.
(H) Industrial and commercial use in corrosion inhibitors and anti-
scaling agents.
(I) Industrial and commercial use of TCE as a processing aid.
(J) Manufacturing (including importing) and processing of TCE for
the industrial and commercial uses listed in paragraphs (b)(4)(i)(A)
through (I) of this section.
(ii) Emergency use--(A) In general. An emergency is a serious and
sudden situation requiring immediate action, within 15 days or less,
necessary to protect:
(1) Safety of NASA's or their contractors' personnel;
(2) NASA's missions;
(3) Human health, safety, or property, including that of adjacent
communities; or
(4) The environment.
(B) Duration. Each emergency is a separate situation; if use of TCE
exceeds 15 days, then justification must be documented.
(iii) Eligibility. To be eligible for the exemption, the NASA and
its contractors must:
(A) Select TCE because there are no technically and economically
feasible safer alternatives available during the emergency.
(B) Perform the emergency use of TCE at locations controlled by NASA
or its contractors.
(C) Comply with the following conditions:
(1) Notification. Within 15 working days of the emergency use by
NASA and its contractors, NASA must provide notice to the EPA Assistant
Administrators of both the Office of Enforcement and Compliance
Assurance and the Office of Chemical Safety and Pollution Prevention
that includes the following:
(i) Identification of the conditions of use detailed in paragraph
(b)(4)(i) of this section that the emergency use fell under;
(ii) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(4)(i)(B) of this section; and
(iii) An explanation of why TCE was selected, including why there
were no technically and economically feasible safer alternatives
available in the particular emergency.
(2) Exposure control. The owner or operator must comply with the
Workplace Chemical Protection Program provisions in Sec. 751.315, to
the extent technically feasible in light of the particular emergency.
[[Page 185]]
(3) Recordkeeping. The owner or operator of the location where the
use takes place must comply with the recordkeeping requirements in Sec.
751.323.
(5) Lead-acid battery separator manufacturing until December 18,
2044. The following are specific conditions of the exemption for use as
a processing aid in the manufacturing of lead-acid battery separators
described in Sec. 751.305(b)(22):
(i) The use of TCE as a processing aid for battery separator
manufacturing must be limited to lead acid battery separator
manufacturing.
(ii) This specific industrial and commercial use of TCE as a
processing aid can only be used at industrial facilities in which TCE is
in use for the manufacture of lead acid battery separators prior to
February 18, 2025.
(iii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(iv) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
(6) Industrial and commercial use of TCE as a processing aid for
specialty polymeric microporous sheet materials manufacturing until
December 18, 2039. The following are specific conditions of the
exemption for industrial and commercial use as a processing aid at Sec.
751.305(b)(23):
(i) The use of TCE as a processing aid must be limited to specialty
polymeric microporous sheet materials manufacturing.
(ii) This specific industrial and commercial use of TCE as a
processing aid can only be used at industrial facilities in which TCE is
in use for the manufacture of specialty polymeric microporous sheet
materials prior to February 18, 2025.
(iii) The owner or operator of the location where such use occurs,
and manufacturers (including importers) and processors of TCE for such
use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(iv) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
(7) Laboratory use for essential laboratory activities until
December 18, 2074. The following are specific conditions of the
exemption for laboratory use at Sec. 751.305(b)(24):
(i) The industrial and commercial use of TCE as a laboratory
chemical must only be for essential laboratory activities. Essential
laboratory activities are:
(A) Laboratory activities associated with cleanup and exposure
monitoring activities, including chemical analysis, chemical synthesis,
extracting or purifying other chemicals, dissolving other substances,
research and development for the advancement of cleanup activities, and
as an analytical standard for monitoring related to TCE contamination or
exposure monitoring.
(B) Laboratory activities conducted by Federal agencies and their
contractors, other than those described in paragraph (b)(7)(i)(A) of
this section, and similar laboratory activities, provided the use is
essential to the agency's mission.
(ii) The use of TCE as a laboratory chemical for testing asphalt is
regulated under Sec. 751.311, and is not considered an essential
laboratory activity.
(iii) The use of TCE as a laboratory chemical must be performed on
the premises of a laboratory.
(iv) The owner or operator of the location where such use of TCE
occurs, and manufacturers (including importers) and processors of TCE
for such use, must comply with the Workplace Chemical Protection Program
provisions in Sec. 751.315.
(v) The owner or operator of the location where such use of TCE
occurs must comply with the recordkeeping requirements in Sec. 751.323.
(8) Disposal of TCE to industrial pre-treatment, industrial
treatment, or publicly owned treatment works for the purposes of cleanup
projects of TCE-contaminated water and groundwater until December 18,
2074. The following are specific conditions of the exemption for
disposal at Sec. 751.305(b)(25):
(i) The disposal of TCE to industrial pre-treatment, industrial
treatment, or
[[Page 186]]
publicly owned treatment works must only be for the purposes of cleanup
projects of TCE-contaminated water and groundwater, and is limited to
sites undergoing cleanup under CERCLA, RCRA, or other Federal, state,
and local government laws, regulations, or requirements.
(ii) The owner or operator of the cleanup site location where TCE
industrial treatment or pretreatment occurs must comply with the
wastewater worker protection requirements in Sec. 751.319.
(iii) The owner or operator of publicly owned treatment works that
receive TCE wastewater must comply with the worker protection
requirements in Sec. 751.319.
(iv) The owner or operator of the location where such disposal of
TCE occurs must comply with the recordkeeping requirements in Sec.
751.323.
Subpart E_Persistent, Bioaccumulative, and Toxic Chemicals
Source: 86 FR 879, Jan. 6, 2021, unless otherwise noted.
Sec. 751.401 General.
(a) This subpart establishes prohibitions and restrictions on the
manufacturing, processing, and distribution in commerce of persistent,
bioaccumulative, and toxic chemicals in accordance with TSCA section
6(h), 15 U.S.C 2605(h).
(b) Unless otherwise specified in this subpart, prohibitions and
restrictions of this subpart do not apply to the following activities:
(1) Distribution in commerce of any chemical substance, or any
product or article that contains the chemical substance, that has
previously been sold or supplied to an end user, i.e., any person that
purchased or acquired the finished good for purposes other than resale.
An example of an end user is a consumer who resells a product they no
longer intend to use or who donates an article to charity.
(2) Disposal of any chemical substance, or any product or article
that contains the chemical substance, as well as importation, processing
and distribution in commerce of any chemical substance or any product or
article that contains the chemical substance for purposes of disposal.
(3) Manufacturing, processing, distribution in commerce, and use of
any chemical substance, or any product or article that contains the
chemical substance, for research and development, as defined in Sec.
751.403.
(c) Owner and operator requirements. Any requirement for an owner or
operator or an owner and operator is a requirement for any individual
that is either an owner or an operator.
[86 FR 879, Jan. 6, 2021, as amended at 89 FR 91514, Nov. 19, 2024]
Sec. 751.403 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section.
2,4,6-TTBP means the chemical substance 2,4,6-tris(tert-butyl)phenol
(CASRN 732-26-3).
2,4,6-TTBP oil and lubricant additives means any 2,4,6-TTBP-
containing additive to a product of any viscosity intended to reduce
friction between moving parts, whether mineral oil or synthetic base,
including engine crankcase and gear oils and bearing greases. 2,4,6-TTBP
oil and lubricant additive does not include hydraulic fluid and other
oils whose primary purpose is not friction reduction.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture,
(2) Which has end use function(s) dependent in whole or in part upon
its shape or design during end use, and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.
DecaBDE means the chemical substance decabromodiphenyl ether (CASRN
1163-19-5).
HCBD means the chemical substance hexachlorobutadiene (CASRN 87-68-
3).
Lubricants and grease mean any product used to reduce friction,
heat, or wear between moving or adjacent solid
[[Page 187]]
surfaces, or that enhance the lubricity of other substances.
PCTP means the chemical substance pentachlorothiophenol (CASRN 133-
49-3).
PIP (3:1) means the chemical substance phenol, isopropylated
phosphate (3:1) (CASRN 68937-41-7).
Potentially exposed person means any person who may be exposed to a
chemical substance or mixture regulated under this subpart as a result
of the use of that chemical or mixture.
Product means the chemical substance, a mixture containing the
chemical substance, or any object that contains the chemical substance
or mixture containing the chemical substance that is not an article.
Regulated area means an area established by the regulated entity to
demarcate areas where airborne concentrations of a specific chemical
substance can reasonably be expected.
Research and Development means laboratory and research use only for
purposes of scientific experimentation or analysis, or chemical research
on, or analysis of, the chemical substance, including methods for
disposal, but not for research or analysis for the development of a new
product, or refinement of an existing product that contains the chemical
substance.
[86 FR 879, Jan. 6, 2021, as amended at 86 FR 894, 909, 922, 932, Jan.
6, 2021; 89 FR 91514, Nov. 19, 2024]
Sec. 751.405 DecaBDE.
(a) Prohibition--(1) General. (i) Except as provided in paragraphs
(a)(2) and (b) of this section, all persons are prohibited from all
manufacturing and processing of decaBDE or decaBDE-containing products
or articles after March 8, 2021, and all persons are prohibited from all
distribution in commerce of decaBDE or decaBDE-containing products or
articles after January 6, 2022.
(ii) Unless otherwise specified in this subpart, the prohibitions
and restrictions of this subpart do not apply to products or articles
containing decaBDE at concentrations less than 0.1% by weight, if the
decaBDE was not intentionally added to the product or article.
(2) Phase-in of Prohibitions for Specific Uses of decaBDE and
decaBDE-containing Products or Articles. (i) After July 6, 2022, all
persons are prohibited from all manufacturing, processing, and
distribution in commerce decaBDE for use in curtains in the hospitality
industry, and the curtains to which decaBDE has been added.
(ii) After January 6, 2023, all persons are prohibited from all
processing and distribution in commerce of decaBDE for use in wire and
cable insulation in nuclear power generation facilities (including test
and research reactors).
(iii) After January 8, 2024, all persons are prohibited from all
manufacturing, processing, and distribution in commerce of decaBDE for
use in parts installed in and distributed as part of new aerospace
vehicles, and the parts to which decaBDE has been added for such
vehicles. After the end of the aerospace vehicles service lives, all
persons are prohibited from all importing, processing, and distribution
in commerce of aerospace vehicles manufactured before January 8, 2024
that contain decaBDE in any part. After the end of the aerospace
vehicles service lives, all persons are prohibited from all manufacture,
processing and distribution in commerce of decaBDE for use in
replacement parts for aerospace vehicles, and the replacement parts to
which decaBDE has been added for such vehicles.
(iv) After the end of the vehicles service lives or 2036, whichever
is earlier, all persons are prohibited from all manufacture, processing
and distribution in commerce of decaBDE for use in replacement parts for
motor vehicles, and the replacement parts to which decaBDE has been
added for such vehicles.
(v) After the end of the pallets' service life, all persons are
prohibited from all distribution in commerce of plastic shipping pallets
that contain decaBDE and were manufactured prior March 8, 2021.
(vi) After the end of the wire and cables' service life, all persons
are prohibited from all processing and distribution in commerce of
decaBDE-containing wire and cable insulation for nuclear power
generation facilities (including test and research reactors).
[[Page 188]]
(b) Exclusions to the Prohibition. Distribution in commerce and
recycling of decaBDE-containing plastic from products or articles, and
processing and distribution in commerce of decaBDE-containing products
or articles made from such recycled plastic, where no new decaBDE is
added during the recycling or production processes is not subject to the
prohibition in paragraph (a) of this section.
(c) Recordkeeping. (1) After March 8, 2021, all persons who
manufacture, process, or distribute in commerce decaBDE or decaBDE-
containing products or articles must maintain ordinary business records,
such as invoices and bills-of-lading related to compliance with the
prohibitions, restrictions, and other provisions of this section.
(i) These records must be maintained for a period of five years from
the date the record is generated.
(ii) These records must include a statement that the decaBDE or the
decaBDE-containing products or articles are in compliance with 40 CFR
751.405(a).
(iii) These records must be made available to EPA upon request.
(2) The recordkeeping requirements in paragraph (c)(1) do not apply
to the activities described in paragraphs (a)(2)(v) and (b) of this
section.
(d) Signage in regulated areas. (1) After January 21, 2025, all
persons who process, including recycle, plastic shipping pallets that
contain decaBDE must place signs at every entry point into the regulated
area.
(2) Each sign must show clearly, prominently, in multiple languages
as appropriate, and in an easily readable font size the following text:
Decabromodiphenyl ether (decaBDE) (CASRN 1163-19-5), a chemical that
has been identified as a persistent, bioaccumulative, and toxic (PBT)
chemical by the U.S. Environmental Protection Agency, may be present in
this regulated area. All persons in this regulated area who recycle
existing plastic shipping pallets that contain decaBDE are required to
wear personal protective equipment, including respiratory protection
that is at least as protective as a NIOSH-approved N95 respirator with
an assigned protection factor (APF) of 10 and dermal protection of
gloves that are chemically resistant to decaBDE, per regulations at 40
CFR 751.405(e).
(e) Workplace protection--(1) Applicability. After January 21, 2025,
the provisions of this paragraph (e) apply to any workplaces engaged in
manufacturing and processing of decaBDE and decaBDE-containing products
and articles, except for those identified in paragraph (e)(6) of this
section.
(2) Regulated areas. Owners or operators must establish and maintain
regulated areas as defined in 40 CFR 751.403.
(i) The owner or operator must limit access to regulated areas to
authorized persons.
(ii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and alerts
persons to the boundaries of the regulated area and minimizes the number
of authorized persons exposed to decaBDE within the regulated area.
(iii) The owner or operator must ensure that each potentially
exposed person is provided with a respirator according to the
requirements of paragraph (e) of this section and must ensure that all
potentially exposed persons within the regulated area are using the
provided respirators whenever exposures to airborne concentrations of
decaBDE can reasonably be expected.
(iv) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated area,
persons do not engage in non-work activities that may increase exposure
to decaBDE.
(3) Respiratory protection. The owner or operator must provide
respiratory protection to all potentially exposed persons in the
regulated area as demarcated in accordance with paragraph (e)(2) of this
section, and according to the provisions outlined in 29 CFR 1910.134(b),
(c)(1), (3) and (4), (d)(1)(iv), (f), and (g) through (l) and, as
specified in this paragraph (e)(3) for potentially exposed persons to
decaBDE during expected time of use.
[[Page 189]]
(i) For purposes of this paragraph (e)(3), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are defined
in 29 CFR 1910.134(b) have the meaning assigned to them in 29 CFR
1910.134(b).
(ii) Owners and operators must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator selections
to each affected person consistent with the requirements of 29 CFR
1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(v) Prior to or at the time of initial assignment to a job involving
potential exposure to decaBDE, owners and operators must provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(vii) The type of respiratory protection that the owners or operator
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved N95 respirator (APF 10).
(viii) Owners and operators must select and provide respirators as
required in paragraph (e)(3) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(ix) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(x) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29 CFR
1910.134(l), to ensure that the provisions of the written respiratory
protection program required under paragraph (e)(3) of this section are
being effectively implemented.
(xi) The respiratory protection requirements in this paragraph
(e)(3) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(4) Dermal protection. (i) Owners or operators must require the
donning of gloves that are chemically resistant to decaBDE with
activity-specific training where dermal contact with decaBDE is
reasonably expected. Owners or operators must minimize and protect
potentially exposed persons from dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with decaBDE in the specific work area where it is
selected for use, selected in accordance with this paragraph (e)(4) and
provided in accordance with 29 CFR 1910.132(h), to each person who is
reasonably likely to be dermally exposed in the work area through direct
dermal contact with decaBDE. For the purposes of this paragraph (e)(4),
provisions in 29 CFR 1910.132(h) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the
work to be performed must be provided, used, and maintained in a
sanitary, reliable, and undamaged condition. Owners and
[[Page 190]]
operators must select PPE that properly fits each affected person and
communicate PPE selections to each affected person.
(iv) Owners or operators must provide training in accordance with 29
CFR 1910.132(f) to all persons required to use dermal protection prior
to or at the time of initial assignment to a job involving exposure to
decaBDE. For the purposes of this paragraph (e)(4), provisions in 29 CFR
1910.132(f) applying to an ``employee'' also apply equally to
potentially exposed persons, and provisions applying to an ``employer''
also apply equally to owners or operators.
(v) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have the
required understanding and skill to properly use dermal protection, or
when changes in the workplace or in dermal protection to be used render
the previous training obsolete.
(5) Workplace protection records. (i) The owner or operator of
workplaces engaged in the manufacturing and processing of decaBDE and
decaBDE-containing products and articles, except for those identified in
paragraph (e)(6) of this section, must retain records of:
(A) The name, workplace address, work shift, job classification, and
work area of each person reasonably likely to directly handle decaBDE or
handle equipment or materials on which decaBDE may be present;
(B) The basis for the regulated area as defined in Sec. 751.403,
including monitoring data and documentation of any controls or
combination of controls that have reduced exposure to where airborne
concentrations of decaBDE can no longer reasonably be expected resulting
in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by
each of these persons, the respiratory protection used by each
potentially exposed person, and PPE program implementation, including
fit-testing and training;
(D) The basis for the PPE selection (e.g., demonstration based on
permeation testing or manufacturer specifications that each item of PPE
selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area); and
(E) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE.
(ii) These records must be maintained for a period of five years
from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons
and their designate representative an opportunity to observe records
related to the basis of the PPE or another control measure selection,
including potential monitoring results that are representative of the
potentially exposed person's exposure.
(6) Exclusions. The following are not subject to the workplace
protection requirements of paragraph (e) of this section:
(i) Import of decaBDE and decaBDE-containing products and articles.
(ii) Recycling of decaBDE-containing plastic from products or
articles and decaBDE-containing products or articles made from such
recycled plastic, where no new decaBDE is added during the recycling or
production processes, except for those articles identified in paragraph
(a)(2)(v) of this section.
(iii) Processing addressed in paragraph (a)(2)(vi) of this section
of decaBDE-containing wire and cable insulation for use in nuclear power
generation facilities.
(iv) Processing of new and replacement parts to which decaBDE has
been added for motor and aerospace vehicles, and the motor and aerospace
vehicles that contain new and replacement parts to which decaBDE has
been added.
(f) Export notification for decaBDE-containing products and
articles. All persons intending to export decaBDE-containing wire and
cable for nuclear power generation facilities (including test and
research reactors) are required to notify EPA under TSCA section
[[Page 191]]
12(b) and the provisions of subpart D of 40 CFR part 707. The exemption
at 40 CFR 707.60(b) does not apply to decaBDE-containing wire and cable
for nuclear power generation facilities.
(g) Prohibition on releases to water. After January 21, 2025, all
persons are prohibited from releasing decaBDE to water during
manufacturing, processing, and distribution in commerce of decaBDE and
decaBDE-containing products, and such persons are required to follow any
applicable regulations for preventing the release of decaBDE.
[86 FR 894, Jan. 6, 2021, as amended at 89 FR 91514, Nov. 19, 2024]
Sec. 751.407 PIP (3:1).
(a) Prohibitions--(1) General prohibition on processing and
distribution in commerce. Except as provided in paragraphs (a)(2) and
(b) of this section, all persons are prohibited from all processing and
distributing in commerce of PIP (3:1), including in PIP (3:1)-containing
products or articles after March 8, 2021. Except as provided in
paragraphs (a)(2) and (b) of this section, the prohibitions and
restrictions of this subpart do not apply to products or articles
containing PIP (3:1) at concentrations less than 0.1 percent by weight,
if the PIP (3:1) was not intentionally added to the product or article.
(2) Phase-in prohibitions for specific uses of PIP (3:1) and PIP
(3:1)-containing products and articles. Except for the activities
described in paragraph (b) of this section or where another phase-in
prohibition with longer-term deadlines exists as described in this
section:
(i) After January 6, 2025, all persons are prohibited from all
processing and distributing in commerce of PIP (3:1) for use in
adhesives and sealants, PIP (3:1)-containing products for use in
adhesives and sealants, and PIP (3:1)-containing adhesives and sealants.
(ii) After January 1, 2022, all persons are prohibited from all
processing and distributing in commerce of PIP (3:1) for use in
photographic printing articles and PIP (3:1)-containing photographic
printing articles.
(iii) After October 31, 2024, all persons are prohibited from all
processing and distribution of PIP (3:1) for use in articles and all
processing of PIP (3:1)-containing articles. After October 31, 2026, all
persons are prohibited from distribution in commerce of PIP (3:1)-
containing articles.
(iv) After November 21, 2039, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in lubricants and greases and PIP (3:1)-containing
lubricants and grease.
(v) After November 21, 2039, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) for use in parts
for new motor vehicles, including heavy motorized machinery, and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products for use in parts for new motor vehicles, including
heavy motorized machinery, and manufacturing and processing of PIP
(3:1)-containing parts for such new vehicles.
(vi) After November 19, 2054, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in replacement parts for motor vehicles, including
heavy motorized machinery, and manufacturing and processing of PIP
(3:1)-containing replacement parts for such vehicles.
(vii) After November 19, 2054, all persons are prohibited from all
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in parts for new aerospace vehicles, and manufacturing
and processing of PIP (3:1)-containing parts for such vehicles.
(viii) After the end of the aerospace vehicles service lives, all
persons are prohibited from all processing and distribution in commerce
of PIP (3:1) and manufacturing, processing, and distribution in commerce
of PIP (3:1)-containing products for use in replacement parts for
aerospace vehicles and manufacturing and processing of PIP (3:1)-
containing replacement parts for such vehicles.
(ix) After November 19, 2029, all persons are prohibited from
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing,
[[Page 192]]
and distribution in commerce of PIP (3:1)-containing products for use in
marine antifouling coating products that are registered under the
Federal, Insecticide, Fungicide, Rodenticide Act and that meet U.S.
Department of Defense specification requirements.
(x) After November 20, 2034, all persons are prohibited from
processing, and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in parts for new manufacturing equipment, including in
the semiconductor industry, for new heating, ventilation, air-
conditioning, refrigeration, and water-heating equipment, new power
generating equipment, new laboratory equipment, new commercial
electronic equipment, and the manufacturing and processing of PIP (3:1)-
containing parts for those equipment.
(xi) After the end of the manufacturing and laboratory equipment
service lives, all persons are prohibited from processing and
distribution in commerce of PIP (3:1) and manufacturing, processing, and
distribution in commerce of PIP (3:1)-containing products for use in
replacement parts and manufacturing and processing of PIP (3:1)-
containing replacement parts for manufacturing equipment and laboratory
equipment, respectively. After November 19, 2049 all persons are
prohibited from processing and distribution in commerce of PIP (3:1) and
manufacturing, processing, and distribution in commerce of PIP (3:1)-
containing products for use in replacement parts and manufacturing and
processing of PIP (3:1)-containing replacement parts for heating,
ventilation, air-conditioning, refrigeration, and water-heating
equipment, for power generating equipment, and for commercial electronic
equipment. After November 19, 2031 all persons are prohibited from
processing and distribution in commerce of PIP (3:1) and manufacturing,
processing, and distribution in commerce of PIP (3:1)-containing
products for use in replacement parts and manufacturing and processing
of PIP (3:1)-containing replacement parts for consumer electronic
equipment.
(b) Exclusions. The following activities are not subject to the
prohibitions in paragraph (a) of this section.
(1) Processing and distribution in commerce of:
(i) PIP (3:1) for use in hydraulic fluids either for the aviation
industry or to meet military specifications for safety and performance
where no alternative chemical is available that meets U.S. Department of
Defense specification requirements, PIP (3:1)-containing products for
use in such hydraulic fluids, and PIP (3:1)-containing hydraulic fluids
either for the aviation industry or to meet military specifications for
safety and performance where no alternative chemical is available that
meets U.S. Department of Defense specification requirements.
(ii) PIP (3:1) for use in lubricants and greases for aerospace use
and turbine engines, PIP (3:1)-containing products for use in lubricants
and greases for aerospace use and turbine engines, and PIP (3:1)-
containing lubricants and greases for aerospace use and turbine engines;
(iii) PIP (3:1) and PIP (3:1)-containing products for use in circuit
boards and wire harnesses, including but not limited to terminal and
fuse covers, cable sleeves, casings, connectors, and tapes, and PIP
(3:1)-containing circuit boards and wire harnesses including but not
limited to terminal and fuse covers, cable sleeves, casings, connectors,
and tapes.
(iv) PIP (3:1) and PIP (3:1)-containing products for use as an
intermediate in a closed system to produce cyanoacrylate adhesives;
(v) PIP (3:1) for use in specialized engine air filters for
locomotive and marine applications, PIP (3:1) containing products for
use in specialized engine air filters for locomotive and marine
applications, and PIP (3:1)-containing specialized engine air filters
for locomotive and marine applications;
(vi) Plastic for recycling from products or articles containing PIP
(3:1), where no new PIP (3:1) is added during the recycling process; and
(vii) Finished products or articles made of plastic recycled or
reused from products or articles containing PIP (3:1), where no new PIP
(3:1) was added
[[Page 193]]
during the production of the products or articles made of recycled
plastic.
(viii) Articles that contain PIP (3:1), and where PIP (3:1) has not
been newly added, for the purpose of repair or maintenance.
(2) Distribution in commerce of:
(i) PIP (3:1)-containing parts for vehicles meeting the requirements
in paragraphs (a)(2)(v) through (viii) of this section, for equipment
meeting requirements in paragraphs (a)(2)(x) through (xi) of this
section, and the vehicles and equipment that contain such parts.
(ii) [Reserved]
(c) Prohibition on releases to water. After March 8, 2021, all
persons are prohibited from releasing PIP (3:1) to water during
manufacturing, processing and distribution in commerce of PIP (3:1) and
PIP (3:1) containing products, and all persons are required to follow
all applicable regulations and best management practices for preventing
the release of PIP (3:1) and PIP (3:1)-containing products to water
during commercial use.
(d) Recordkeeping. (1) After March 8, 2021, persons who manufacture,
process, or distribute in commerce PIP (3:1) or PIP (3:1)-containing
products or articles must maintain ordinary business records, such as
invoices and bills-of-lading, related to compliance with the
prohibitions, restrictions, and other provisions of this section. These
records must be maintained for a period of five years from the date the
record is generated.
(2) These records must include a statement that the PIP (3:1), or
the PIP (3:1)-containing products or articles, are in compliance with 40
CFR 751.407(a).
(3) These records must be made available to EPA upon request.
(4) The recordkeeping requirements in paragraph (d) of this section
do not apply to the activities described in paragraphs (b)(1)(vi) and
(vii) of this section. The recordkeeping requirements in paragraph (d)
of this section also do not apply to PIP (3:1)-containing articles until
October 31, 2024.
(e) Downstream notification. (1) Each person who manufactures PIP
(3:1) for any use after March 8, 2021 must, prior to or concurrent with
the shipment, notify persons to whom PIP (3:1) is shipped, in writing,
of the restrictions described in this subpart.
(2) Each person who processes or distributes in commerce PIP (3:1)
or PIP (3:1)-containing products for any use after July 6, 2021 must,
prior to or concurrent with the shipment, notify persons to whom PIP
(3:1) is shipped, in writing, of the restrictions described in this
subpart.
(3) Downstream notification must occur by inserting the text in
paragraphs (e)(3)(i) and (ii) of this section in the Safety Data Sheet
(SDS) by February 19, 2025, or by including on the label of any PIP
(3:1) or PIP (3:1)-containing product by May 19, 2026, the label
language in paragraph (e)(3)(iii) of this section:
(i) SDS Section 1(c).
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet military
specifications for safety and performance where no alternative chemical
is available that meets U.S. Department of Defense specification
requirements, (2) In lubricants and greases for aerospace and turbine
uses and, for all other lubricant and grease uses before November 21,
2039, (3) circuit boards and wire harnesses, including but not limited
to terminal and fuse covers, cable sleeves, casings, connectors and
tapes, (4) As an intermediate in the manufacture of cyanoacrylate glue,
(5) In specialized engine air filters for locomotive and marine
applications, (6) In adhesives and sealants before January 6, 2025,
after which use in adhesives and sealants is prohibited, (7) In new
parts for motor vehicles before November 21, 2039 and replacement parts
for motor vehicles before November 19, 2054, (8) In new parts for
aerospace vehicles before November 19, 2054 and replacement parts for
aerospace vehicles after the end of the aerospace vehicles service
lives, (9) In marine antifouling coating products that are registered
under the Federal Insecticide, Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense specification requirements before
November 19, 2029, (10) In new manufacturing equipment, new products or
articles in the semiconductor industry, for new heating, ventilation,
air-conditioning, refrigeration, and water-heating equipment, new power
generating equipment, new laboratory equipment, new commercial
electronic equipment, and new consumer electronic equipment before
November 20, 2034, (11) replacement parts for manufacturing and
laboratory equipment after the
[[Page 194]]
end of the equipment's service life, (12) replacement parts for heating,
ventilation, air-conditioning, refrigeration, and water-heating
equipment, for power generating equipment, and for commercial electronic
equipment before November 19, 2049, (13) replacement parts for consumer
electronic equipment before November 19, 2031, (14) in other articles
before October 31, 2024, after which use in articles other than those
with later phase-in prohibition dates or exclusions is prohibited. In
addition, all persons are prohibited from releasing PIP (3:1) to water
during manufacturing, processing, and distribution in commerce, and must
follow all existing regulations and best practices to prevent the
release of PIP (3:1) to water during the commercial use of PIP (3:1).
(ii) SDS Section 15.
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet military
specifications for safety and performance where no alternative chemical
is available that meets U.S. Department of Defense specification
requirements, (2) In lubricants and greases for aerospace and turbine
uses and lubricants and, for all other lubricant and grease uses before
November 21, 2039, (3) circuit boards and wire harnesses, including but
not limited to terminal and fuse covers, cable sleeves, casings,
connectors and tapes, (4) As an intermediate in the manufacture of
cyanoacrylate glue, (5) In specialized engine air filters for locomotive
and marine applications, (6) In adhesives and sealants before January 6,
2025, after which use in adhesives and sealants is prohibited, (7) In
new parts for motor vehicles before November 21, 2039 and replacement
parts for motor vehicles before November 19, 2054, (8) In new parts for
aerospace vehicles before November 19, 2054 and replacement parts for
aerospace vehicles after the end of the aerospace vehicles service
lives, (9) In marine antifouling coating products that are registered
under the Federal Insecticide, Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense specification requirements before
November 19, 2029, (10) In new manufacturing equipment, new products or
articles in the semiconductor industry, for new heating, ventilation,
air-conditioning, refrigeration, and water-heating equipment, new power
generating equipment, new laboratory equipment, new commercial
electronic equipment, and new consumer electronic equipment before
November 20, 2034, (11) replacement parts for manufacturing and
laboratory equipment after the end of the equipment's service life, (12)
replacement parts for heating, ventilation, air-conditioning,
refrigeration, and water-heating equipment, for power generating
equipment, and for commercial electronic equipment before November 19,
2049, (13) replacement parts for consumer electronic equipment before
November 19, 2031, (14) in other articles before October 31, 2024, after
which use in articles other than those with later phase-in prohibition
dates or exclusions is prohibited. In addition, all persons are
prohibited from releasing PIP (3:1) to water during manufacturing,
processing, and distribution in commerce, and must follow all existing
regulations and best practices to prevent the release of PIP (3:1) to
water during the commercial use of PIP (3:1).
(iii) Labeling.
The Environmental Protection Agency prohibits processing and
distribution of this chemical/product for any use other than: (1) In
hydraulic fluids either for the aviation industry or to meet military
specifications for safety and performance where no alternative chemical
is available that meets U.S. Department of Defense specification
requirements, (2) In lubricants and greases for aerospace and turbine
uses and, for all other lubricant and grease uses before November 21,
2039, (3) circuit boards and wire harnesses, including but not limited
to terminal and fuse covers, cable sleeves, casings, connectors and
tapes, (4) As an intermediate in the manufacture of cyanoacrylate glue,
(5) In specialized engine air filters for locomotive and marine
applications, (6) In adhesives and sealants before January 6, 2025,
after which use in adhesives and sealants is prohibited, (7) In new
parts for motor vehicles before November 21, 2039 and replacement parts
for motor vehicles before November 19, 2054, (8) In new parts for
aerospace vehicles before November 19, 2054 and replacement parts for
aerospace vehicles after the end of the aerospace vehicles service
lives, (9) In marine antifouling coating products that are registered
under the Federal Insecticide, Fungicide, and Rodenticide Act and that
meet U.S. Department of Defense specification requirements before
November 19, 2029, (10) In new manufacturing equipment, new products or
articles in the semiconductor industry, for new heating, ventilation,
air-conditioning, refrigeration, and water-heating equipment, new power
generating equipment, new laboratory equipment, new commercial
electronic equipment, and new consumer electronic equipment before
November 20, 2034, (11) replacement parts for manufacturing and
laboratory equipment after the end of the equipment's service life, (12)
replacement parts for heating, ventilation, air-conditioning,
refrigeration, and water-heating equipment, for power generating
equipment, and for commercial electronic equipment before November 19,
2049, (13) replacement parts for consumer electronic equipment before
November 19, 2031, (14) in other
[[Page 195]]
articles before October 31, 2024, after which use in articles other than
those with later phase-in prohibition dates or exclusions is prohibited.
In addition, all persons are prohibited from releasing PIP (3:1) to
water during manufacturing, processing, and distribution in commerce,
and must follow all existing regulations and best practices to prevent
the release of PIP (3:1) to water during the commercial use of PIP
(3:1).
(4) Any downstream notification that occurs under paragraph (e) of
this section between February 19, 2025 and May 19, 2026, must include a
safety data sheet with the language in paragraphs (e)(3)(i) and (ii) of
this section unless distributing products with labels reflecting the
language in paragraph (e)(3)(iii) of this section.
(5) The downstream notification requirements in paragraph (e) of
this section do not apply to the activities described in paragraphs
(b)(1)(vi) and (vii) of this section.
(f) Workplace protection--(1) Applicability. After January 21, 2025,
the provisions of this paragraph (f) apply to workplaces engaged in the
manufacturing and processing of PIP (3:1) and PIP (3:1)-containing
products and articles, except for those identified in paragraph (f)(7)
of this section.
(2) Regulated areas. Owners or operators must establish and maintain
regulated areas as defined in Sec. 751.403.
(i) The owner or operator must limit access to regulated areas to
authorized persons.
(ii) The owner or operator must demarcate regulated areas from the
rest of the workplace in a manner that adequately establishes and alerts
persons to the boundaries of the regulated area and minimizes the number
of authorized persons exposed to PIP (3:1) within the regulated area.
(iii) The owner or operator must ensure each potentially exposed
person is provided with a respirator according to the requirements of
paragraph (f) of this section and must ensure that all potentially
exposed persons within the regulated area are using the provided
respirators whenever exposures to airborne concentrations of PIP (3:1)
can reasonably be expected.
(iv) The owner or operator must ensure that while persons are
wearing respirators in the regulated area, they do not engage in
activities that interfere with respirator seal or performance.
(v) The owner or operator must ensure that, within a regulated area,
persons do not engage in non-work activities that may increase exposure
to PIP (3:1).
(3) Respiratory protection. The owner or operator must provide
respiratory protection to all potentially exposed persons in the
regulated area as demarcated in accordance with paragraph (f)(2) of this
section, and according to the provisions outlined in 29 CFR 1910.134(b),
(c)(1), (3) and (4), (d)(1)(iv), (f), and (g) through (l) and as
specified in this paragraph (f)(3) for potentially exposed persons to
PIP (3:1) during expected time of use.
(i) For purposes of this paragraph (f)(3), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are defined
in 29 CFR 1910.134(b) have the meaning assigned to them in 29 CFR
190.134(b).
(ii) Owners and operators must develop and administer a written
respiratory protection program consistent with the requirements of 29
CFR 1910.134(c)(1), (3) and (4).
(iii) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator selections
to each affected person consistent with the requirements of 29 CFR
1910.134(f).
(iv) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(v) Prior to or at the time of initial assignment to a job involving
potential exposure to PIP (3:1) owners and operators must provide
training to all persons required to use respiratory protection
consistent with 29 CFR 1910.134(k).
(vi) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the
[[Page 196]]
owner or operator has reason to believe that a previously trained person
does not have the required understanding and skill to properly use PPE,
or when changes in the workplace or in PPE to be used render the
previous training obsolete.
(vii) The type of respiratory protection that the owner or operator
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved APF 10 air-purifying half mask
respirator except for those uses identified in paragraphs (f)(3)(viii)
and (ix) of this section.
(viii) The type of respiratory protection that owners or operators
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved N95 respirator (APF 10) for the
manufacturing and processing of PIP (3:1), and PIP (3:1)-containing
products for use in new and replacement parts for motor vehicles,
including heavy machinery, and aerospace vehicles.
(ix) The type of respiratory protection that owners or operators
must select and provide to potentially exposed persons must be at least
as protective as a NIOSH-approved APF 50 purifying respirator for use as
an intermediate to produce cyanoacrylate adhesives when PIP (3:1) and
PIP (3:1)-containing products are not contained in a closed system
(i.e., except as described in paragraph (f)(7)(iii) of this section).
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(3) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29 CFR
1910.134(l), to ensure that the provisions of the written respiratory
protection program required under paragraph (f)(3) of this section are
being effectively implemented.
(xiii) The respiratory protection requirements in this paragraph
(f)(3) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(4) Dermal protection. (i) Owners or operators must require the
donning of gloves that are chemically resistant to PIP (3:1) with
activity-specific training where dermal contact with PIP (3:1) is
reasonably expected. Owners or operators must minimize and protect
potentially exposed persons from dermal exposure in accordance with 29
CFR 1910.132.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with PIP (3:1) in the specific work area where it is
selected for use, selected in accordance with this paragraph (f)(4) and
provided in accordance with 29 CFR 1910.132(h), to each person who is
reasonably likely to be dermally exposed in the work area through direct
dermal contact with PIP (3:1) For the purposes of this paragraph (f)(4),
provisions in 29 CFR 1910.132(h) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(iii) Dermal PPE that is of safe design and construction for the
work to be performed must be provided, used, and maintained in a
sanitary, reliable, and undamaged condition. Owners and operators must
select PPE that properly fits each affected person and communicate PPE
selections to each affected person.
(iv) Owners or operators must provide training in accordance with 29
CFR 1910.132(f) to all persons required to use dermal protection prior
to or at the time of initial assignment to a job involving exposure to
PIP (3:1). For the purposes of this paragraph (f)(4), provisions in 29
CFR 1910.132(f) applying to an ``employee'' also apply equally to
potentially exposed persons, and provisions applying to an ``employer''
also apply equally to owners or operators.
[[Page 197]]
(v) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have the
required understanding and skill to properly use dermal protection, or
when changes in the workplace or in dermal protection to be used render
the previous training obsolete.
(5) Engineering controls. Owners or operators manufacturing
cyanoacrylate adhesives using PIP (3:1) as an intermediate processing
aid must use the following engineering controls:
(i) Must take place in a closed loop system, and
(ii) General and local exhaust ventilation must be provided.
(6) Workplace protection records. (i) Owners or operators subject to
requirements described in this section must retain records of:
(A) The name, workplace address, work shift, job classification, and
work area of each person reasonably likely to directly handle PIP (3:1)
or handle equipment or materials on which PIP (3:1) may be present, and
the type of PPE selected to be worn by each of these persons;
(B) The basis for the regulated area as defined in Sec. 751.403,
including monitoring data and documentation of any controls or
combination of controls that have reduced exposure to where airborne
concentrations of PIP (3:1) can no longer reasonably be expected
resulting in a smaller or no regulated area being established;
(C) The type of PPE selected by the owner or operator for use by
each of these persons, the respiratory protection used by each
potentially exposed person and PPE program implementation, including
fit-testing and training;
(D) The basis for PPE selection (e.g., demonstration based on
permeation testing or manufacturer specifications that each item of PPE
selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(E) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE; and
(F) For owners and operators using PIP (3:1) as an intermediate
processing aid in the manufacturing of cyanoacrylate adhesives,
compliance with paragraph (f)(5) of this section.
(ii) These records must be maintained for a period of five years
from the date the record is generated.
(iii) These records must be made available to EPA upon request.
(iv) The owner or operator must provide potentially exposed persons
and their designated representative an opportunity to observe records
related to the basis of the PPE or another control measure selection,
including potential monitoring results that is representative of the
potentially exposed person's exposure.
(7) Exclusions. The following are not subject to the workplace
protection requirements of paragraph (f) of this section:
(i) Import of PIP (3:1) and PIP (3:1)-containing products and
articles.
(ii) Processing of PIP (3:1)-containing adhesives and sealants,
specialized engine filters for locomotive and marine applications, and
the products or articles described in paragraphs (b)(1)(vi) and (vii) of
this section.
(iii) Processing of PIP (3:1)-containing new and replacement parts
to which PIP (3:1) has been added for motor and aerospace vehicles and
for manufacturing, HVAC, refrigeration and water heating equipment,
electric and electronic equipment, and power generating equipment and
the motor and aerospace vehicles, manufacturing, HVAC, refrigeration and
water heating equipment, electric and electronic equipment, and power
generating equipment that contain new and replacement parts to which PIP
(3:1) has been added.
(iv) Processing of PIP (3:1) and PIP (3:1)-containing products for
use as an intermediate to produce cyanoacrylate adhesives when PIP (3:1)
and PIP (3:1)-containing products are contained in a
[[Page 198]]
closed system as described in paragraph (f)(6) of this section are not
subject to the provisions of paragraphs (f)(3) and (4) of this section.
[86 FR 909, Jan. 6, 2021, as amended at 86 FR 51832, Sept. 17, 2021; 87
FR 12886, Mar. 8, 2022; 89 FR 91516, Nov. 19, 2024]
Sec. 751.409 2,4,6-TTBP.
(a) Prohibitions. (1) After January 6, 2026, all persons are
prohibited from all distribution in commerce of 2,4,6-TTBP, at any
concentration above 0.3 percent by weight, in containers with a volume
less than 35 gallons.
(2) After January 6, 2026, all persons are prohibited from all
processing and distribution in commerce of 2,4,6-TTBP oil and lubricant
additives at any concentration above 0.3 percent by weight.
(b) Recordkeeping. After January 6, 2026, distributors of 2,4,6-TTBP
must maintain ordinary business records, such as invoices and bills-of-
lading, related to compliance with the prohibitions, restrictions, and
other provisions of this section. These records must be maintained for a
period of three years from the date the record is generated.
Sec. 751.411 PCTP.
(a) Prohibition. After March 8, 2021, all persons are prohibited
from all manufacturing and processing of PCTP or PCTP-containing
products or articles, unless PCTP concentrations are at or below 1% by
weight. After January 6, 2022, all persons are prohibited from all
distribution in commerce of PCTP or PCTP-containing products or
articles, unless PCTP concentrations are at or below 1% by weight.
(b) Recordkeeping. After March 8, 2021, manufacturers, processors
and distributors of PCTP or PCTP-containing products or articles must
maintain ordinary business records related to compliance with the
prohibitions, restrictions and other provisions of this section, such as
invoices and bills-of-lading. These records must be maintained for a
period of three years from the date the record is generated.
[86 FR 922, Jan. 6, 2021]
Sec. 751.413 HCBD.
(a) Prohibition. After March 8, 2021, all persons are prohibited
from all manufacturing, processing and distribution in commerce of HCBD
and HCBD-containing products or articles, except for the following:
(1) Unintentional production of HCBD as a byproduct in the
production of chlorinated solvents; and
(2) Processing and distribution in commerce of HCBD for burning as a
waste fuel.
(b) Recordkeeping. After March 8, 2021, manufacturers, processors
and distributors of HCBD or HCBD-containing products or articles must
maintain ordinary business records related to compliance with the
prohibitions, restrictions and other provisions of this section, such as
invoices and bills-of-lading. These records must be maintained for a
period of three years from the date the record is generated.
[86 FR 932, Jan. 6, 2021]
Subpart F_Chrysotile Asbestos
Source: 89 FR 22005, Mar. 28, 2024, unless otherwise noted.
Sec. 751.501 General.
This subpart sets certain restrictions on the manufacture (including
import), processing, distribution in commerce, and commercial use and
disposal of chrysotile asbestos (CASRN 132207-32-0) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a), 15 U.S.C. 2605(a).
Sec. 751.503 Definitions.
The definitions in subpart A of this part apply to this subpart
unless otherwise specified in this section. In addition, the following
definitions apply to this subpart:
Aftermarket automotive brakes and linings means any automotive
friction brake articles sold in the secondary market as replacement
parts (e.g., brake pads, linings and shoes) used in disc and drum brake
systems on automobiles and trucks.
Article means a manufactured item:
(1) Which is formed to a specific shape or design during
manufacture;
[[Page 199]]
(2) Which has end use function(s) dependent in whole or in part upon
its shape or design during end use; and
(3) Which has either no change of chemical composition during its
end use or only those changes of composition which have no commercial
purpose separate from that of the article, and that result from a
chemical reaction that occurs upon end use of other chemical substances,
mixtures, or articles; except that fluids and particles are not
considered articles regardless of shape or design.
Authorized person means any person specifically authorized by the
owner or operator to enter, and whose duties require the person to
enter, a regulated area.
Chrysotile asbestos is the asbestiform variety of a hydrated
magnesium silicate mineral, with relatively long and flexible
crystalline fibers that are capable of being woven.
Disposal means to discard, throw away, or otherwise complete or
terminate the useful life of chrysotile asbestos, including any
chrysotile asbestos-containing products or articles.
Distribution in commerce has the same meaning as in section 3 of the
Act, but the term does not include distribution of chrysotile asbestos
waste solely for purposes of disposal in accordance with this Subpart.
Diaphragms means semipermeable diaphragms, which separate the anode
from the cathode chemicals in the production of chlorine and sodium
hydroxide (caustic soda).
Gasket means an article used to form a leakproof seal between fixed
components.
Membrane technology means a chlor-alkali production technology that
uses chlorine production cells in which the anode and the cathode are
separated by an ion-exchange membrane that is designed to allow only
sodium ions and some water to pass through it.
Nuclear material means any source material, special nuclear
material, or byproduct material (as such terms are defined in the Atomic
Energy Act of 1954, as amended, and regulations issued under such Act).
Oilfield brake blocks means the friction brake blocks component in
drawworks used in the hoisting mechanism for oil well drilling rigs.
Other gaskets means gaskets other than sheet gaskets in chemical
production, to include gaskets used in the exhaust systems of utility
vehicles.
Other vehicle friction products means friction articles such as
brakes and clutches, other than aftermarket automotive brakes and
linings, installed on any vehicle, including on off-road vehicles,
trains, planes, etc. Other vehicle friction products does not include
articles used in the NASA Super Guppy Turbine aircraft, a specialty
cargo plane used for the transportation of oversized equipment that is
owned and operated by the National Aeronautics and Space Administration
(NASA).
Owner or operator means any person who owns, leases, operates,
controls, or supervises a workplace covered by this subpart.
Potentially exposed person means any person who may be
occupationally exposed to a chemical substance or mixture in a workplace
as a result of a condition of use of that chemical substance or mixture.
Processing has the same meaning as in section 3 of the Act, but the
term does not include processing of chrysotile asbestos waste solely for
purposes of disposal in accordance with this subpart.
Regulated area means an area established by the regulated entity to
demarcate where airborne concentrations of a specific chemical substance
exceed, or there is a reasonable possibility they may exceed, the ECEL.
Savannah River Site means the Department of Energy's nuclear waste
management and related national defense operations at its Savannah River
Site in Aiken, Barnwell and Allendale counties in South Carolina,
including operations at H-Canyon, F and H Tank Farms, Defense Waste
Processing Facility, Savannah River National Laboratory and any on-site
facility managed by Savannah River Nuclear Solutions.
Sheet gaskets in chemical production means gaskets cut from
sheeting, including asbestos-containing rubberized sheeting, that are
used in facilities for extreme condition applications such as
[[Page 200]]
titanium dioxide manufacturing, or processing nuclear material.
Sec. 751.505 Manufacturing, processing, distribution in commerce and
commercial use of chrysotile asbestos diaphragms in the chlor-alkali
industry.
(a) After May 28, 2024, all persons are prohibited from manufacture
(including import) of chrysotile asbestos, including any chrysotile
asbestos-containing products or articles, for diaphragms in the chlor-
alkali industry.
(b) After May 28, 2029, all persons are prohibited from processing,
distribution in commerce and commercial use of chrysotile asbestos,
including any chrysotile asbestos-containing products or articles, for
diaphragms in the chlor-alkali industry, except as provided in
paragraphs (c) through (d) of this section.
(c) Any person who meets all of the criteria of this paragraph (c)
may process, distribute in commerce and commercially use chrysotile
asbestos, including any chrysotile asbestos-containing products or
articles, for diaphragms in the chlor-alkali industry at no more than
two facilities until May 25, 2032:
(1) On May 28, 2024, the person owns or operates more than one
facility that uses chrysotile asbestos in chlor-alkali production;
(2) The person is converting more than one facility that the person
owns or operates that as of May 28, 2024 uses chrysotile asbestos in
chlor-alkali production from the use of chrysotile asbestos diaphragms
to non-chrysotile asbestos membrane technology, and by May 28, 2029, the
person has ceased all processing, distribution in commerce and
commercial use of chrysotile asbestos at one (or more) facility
undergoing or that has undergone conversion to non-chrysotile asbestos
membrane technology; and
(3) The person certifies to EPA compliance with the provisions of
this paragraph, in accordance with Sec. 751.507.
(d) Any person who meets all of the criteria of this paragraph (d)
may process, distribute in commerce and commercially use chrysotile
asbestos, including any chrysotile asbestos-containing products or
articles, for diaphragms in the chlor-alkali industry at not more than
one facility until May 26, 2036:
(1) On May 28, 2024, the person owns or operates more than two
facilities that use chrysotile asbestos in chlor-alkali production; and
(2) The person is converting more than two facilities that the
person owns or operates that as of May 28, 2024 use chrysotile asbestos
in chlor-alkali production from the use of chrysotile asbestos
diaphragms to non-chrysotile asbestos membrane technology:
(i) By May 28, 2029, the person has ceased all processing,
distribution in commerce and commercial use of chrysotile asbestos at
one (or more) facility undergoing or that has undergone such conversion;
and
(ii) By May 25, 2032 the person has ceased all processing,
distribution in commerce and commercial use of chrysotile asbestos at
two (or more) facilities undergoing or that have undergone conversion to
non-chrysotile asbestos membrane technology; and
(3) The person certifies to EPA compliance with the provisions of
this paragraph, in accordance with Sec. 751.507.
Sec. 751.507 Certification of compliance for the chlor-alkali industry.
(a) In addition to meeting the requirements of Sec. Sec.
751.505(c), any person who processes, distributes in commerce or
commercially uses chrysotile asbestos for diaphragms in the chlor-alkali
industry between May 28, 2029 and May 25, 2032 must:
(1) Certify to EPA their compliance with all requirements of Sec.
751.505(c); and
(2) Provide the following information to EPA to support their
compliance with the requirements of Sec. 751.505(c):
(i) Identification of the facility for which, by May 28, 2029, the
person has ceased all processing, distribution in commerce and
commercial use of chrysotile asbestos, pursuant to Sec. 751.505(c)(2),
including:
(A) facility name, location, and mailing address;
(B) name of facility manager or other contact, title, phone number
and email address; and
(C) date the person ceased all processing, distribution in commerce
and
[[Page 201]]
commercial use of chrysotile asbestos at the facility.
(ii) Identification of the facility or facilities (no more than two
facilities) for which the person will after May 28, 2029, continue to
process, distribute in commerce and commercially use chrysotile asbestos
diaphragms while the facility or facilities are being converted to non-
chrysotile asbestos membrane technology, pursuant to Sec. 751.505(c),
including for each facility:
(A) facility name, location, and mailing address; and
(B) name of facility manager or other contact, title, phone number
and email address.
(b) In addition to meeting the requirements of paragraph (a) of this
section and Sec. Sec. 751.505(d), any person who processes, distributes
in commerce or commercially uses chrysotile asbestos for diaphragms in
the chlor-alkali industry between May 25, 2032 and May 26, 2036 must:
(1) Certify to EPA their compliance with all requirements of Sec.
751.505(d); and
(2) Provide the following information to EPA to support their
compliance with the requirements of Sec. 751.505(d):
(i) Identification of the facility identified in Sec.
751.505(d)(2)(ii) at which as of May 25, 2032, the person has ceased all
processing, distribution in commerce and commercial use of chrysotile
asbestos, including:
(A) facility name, location, and mailing address;
(B) name of facility manager or other contact, title, phone number
and email address; and
(C) date the person has ceased all processing, distribution in
commerce and commercial use of chrysotile asbestos at the facility.
(ii) Identification of the facility at which the person will between
May 25, 2032 and no later than May 26, 2036, continue to process,
distribute in commerce and commercially use chrysotile asbestos
diaphragms while the facility is being converted to non-chrysotile
asbestos membrane technology pursuant to Sec. 751.505(d), including:
(A) facility name, location, and mailing address; and
(B) name of facility manager or other contact, title, phone number
and email address.
(c) The certification required by paragraphs (a) and (b) of this
section must be signed and dated by a responsible corporate officer. For
the purpose of this section, a responsible corporate officer means: a
president, secretary, treasurer, or vice-president of the corporation in
charge of chlor-alkali operations, or any other person who performs
similar policy or decision-making functions for the corporation.
(d) Any person signing a document under paragraph (c) of this
section shall also make the following certification:
``I certify under penalty of law that this document was prepared
under my direction or supervision, and the information is, to the best
of my knowledge and belief, true, accurate, and complete. I am aware it
is unlawful to knowingly submit incomplete, false and/or misleading
information and there are criminal penalties for such conduct.''
(e) This certification must be submitted to the Director, Office of
Pollution Prevention and Toxics (OPPT), using the address specified at
40 CFR 700.17(a).
(1) The certification under paragraph (a) of this section must be
submitted no later than 10 business days after May 28, 2029; and
(2) The certification under paragraph (b) of this section must be
submitted no later than 10 business days after May 25, 2032.
Sec. 751.509 Other prohibitions and restrictions on the manufacturing,
processing, distribution in commerce and commercial use of chrysotile
asbestos.
(a) After May 27, 2026, all persons are prohibited from
manufacturing (including importing), processing, distributing in
commerce, and commercial use of chrysotile asbestos, including any
chrysotile asbestos-containing products or articles, for use in sheet
gaskets for chemical production, except as provided in paragraphs (b)
and (c) of this section. Any sheet gaskets for chemical production which
are already installed for use on May 27, 2026 are not
[[Page 202]]
subject to the distribution in commerce and commercial use prohibitions.
(b) Any person may commercially use chrysotile asbestos sheet
gaskets for titanium dioxide production until May 28, 2029.
(c)(1)(i) Any person may commercially use chrysotile asbestos sheet
gaskets for processing nuclear material until May 28, 2029.
(ii) Any person may commercially use chrysotile asbestos sheet
gaskets for processing nuclear material at the Savannah River Site until
December 31, 2037.
(2) After November 25, 2024, any person commercially using
chrysotile asbestos sheet gaskets for processing nuclear material
pursuant to (c)(1)(i) and (ii) must have in place exposure controls
expected to reduce exposure of potentially exposed persons to asbestos,
and provide potentially exposed persons in the regulated area where
chrysotile asbestos sheet gasket replacement is being performed a full-
face air purifying respirator with a P-100 (HEPA) cartridge (providing
an assigned protection factor of 50), or other respirator that provides
a similar or higher level of protection to the wearer.
(3)(i) Any sheet gaskets for processing nuclear material which are
already installed for use on May 28, 2029 are not subject to the
distribution in commerce and commercial use prohibitions in paragraphs
(a) of this section.
(ii) Any sheet gaskets for processing nuclear material at the
Savannah River Site which are already installed for use on December 31,
2037, are not subject to the distribution in commerce and commercial use
prohibitions in paragraphs (a) of this section.
(d) After November 25, 2024, all persons are prohibited from
manufacturing (including importing), processing, distribution in
commerce and commercial use of chrysotile asbestos, including any
chrysotile asbestos-containing products or articles, for commercial use
of:
(1) Oilfield brake blocks;
(2) Aftermarket automotive brakes and linings;
(3) Other vehicle friction products; and
(4) Other gaskets.
(e) After November 25, 2024, all persons are prohibited from the
manufacturing (including importing), processing, and distribution in
commerce of chrysotile asbestos, including any chrysotile asbestos-
containing products or articles, for consumer use of:
(1) Aftermarket automotive brakes and linings; and
(2) Other gaskets.
(f) On November 25, 2024:
(1) Any aftermarket automotive brakes and linings, other vehicle
friction products, and other gaskets which are already installed for
commercial use are not subject to the prohibitions on distribution in
commerce and commercial use under paragraph (d) of this section.
(2) Any aftermarket automotive brakes and linings, and other gaskets
which are already installed for consumer use are not subject to the
distribution in commerce prohibition under paragraph (e) of this
section.
Sec. 751.511 Interim workplace controls of chrysotile asbestos exposures.
(a) Applicability. This section applies to processing and commercial
use of chrysotile asbestos, including any chrysotile asbestos-containing
products or articles, for chrysotile asbestos diaphragms in the chlor-
alkali industry; and to the commercial use of chrysotile asbestos sheet
gaskets for titanium dioxide production.
(b) Interim Existing Chemical Exposure Limit (ECEL). Beginning
November 25, 2024, the owner or operator must ensure that no person is
exposed to an airborne concentration of chrysotile asbestos in excess of
the interim ECEL for chrysotile asbestos of 0.005 fibers (f)/cubic
centimeter (cc) as an eight (8)-hour time-weighted average (TWA). Where
an owner or operator cannot demonstrate exposure at or below the ECEL,
including through the use of all technically feasible engineering
controls or work practices as described in paragraph (e)(1) of this
section, and has not demonstrated that it has appropriately supplemented
with respiratory protection that complies with the requirements of
paragraph (f) of this section, this will constitute a failure to comply
with the ECEL.
[[Page 203]]
(c) Exposure monitoring--(1) In general. (i) Owners or operators
must determine each potentially exposed person's exposure from personal
breathing zone air samples that are representative of the 8-hour TWA
exposure of each potentially exposed person.
(ii) Representative 8-hour TWA of a potentially exposed person's
exposure must be determined on the basis of one or more samples
representing full-shift exposures for each shift for each potentially
exposed person in each job classification in each work area.
(2) Initial exposure monitoring. No later than November 25, 2024
each owner or operator covered by paragraph (a) of this section as of
May 28, 2024, must perform initial exposure monitoring of all
potentially exposed persons.
(3) Periodic exposure monitoring. The owner or operator must
establish an exposure monitoring program for periodic monitoring of
exposure to chrysotile asbestos. If one or more samples representing
full-shift exposures from the most recent exposure monitoring exceeds
the ECEL (0.005 f/cc 8-hour TWA), periodic exposure
monitoring is required within three months of the most recent exposure
monitoring. Otherwise, periodic exposure monitoring is required within
six months of the most recent exposure monitoring.
(4) Additional exposure monitoring. The owner or operator must
conduct additional exposure monitoring within a reasonable timeframe
after there has been a change in the production, process, control
equipment, personnel or work practices that may result in new or
additional exposures above the ECEL or the owner or operator has any
reason to suspect that a change may result in new or additional
exposures above the ECEL.
(5) Method of monitoring. (i) Exposure monitoring samples must be
personal breathing zone samples collected and analyzed using methods and
quality control procedures described in Appendix A to 29 CFR 1910.1001,
or as referenced in Appendix A to 29 CFR 1910.1001 (Appendix B to 29 CFR
1910.1001, OSHA method ID-160, or the NIOSH 7400 method).
(ii) Owners or operators must use exposure monitoring methods that
conform with the OSHA Reference Method specified in Appendix A of 29 CFR
1910.1001 or an equivalent method. If an equivalent method is used, the
owner or operator must ensure that the method meets the following
criteria:
(A) Replicate exposure data used to establish equivalency are
collected in side-by-side field and laboratory comparisons; and
(B) The comparison indicates that 90% of the samples collected in
the range 0.5 to 2.0 times the ECEL or the lowest concentration possible
have an accuracy range of plus or minus 25 percent of the OSHA Reference
Method specified in Appendix A of 29 CFR 1910.1001 at a 95 percent
confidence level as demonstrated by a statistically valid protocol. The
NIOSH 7402 analytical method may be applied to adjust the analytical
result to include only chrysotile asbestos.
(6) Notification of exposure monitoring results. (i) The owner or
operator must, within 15 business days of receipt of monitoring results,
notify each potentially exposed person of these results either
individually in writing or by posting the results in an appropriate
location that is accessible to all potentially exposed persons. The
notice must be in plain language and understandable to all potentially
exposed persons.
(ii) The written notification required by paragraph (c)(6)(i) of
this section must include the corrective action being taken by the owner
or operator to reduce exposure to or below the ECEL, wherever monitoring
results indicated that the ECEL had been exceeded.
(d) Regulated areas--(1) Establishment. Beginning November 25, 2024
the owner or operator must establish regulated areas wherever airborne
concentrations of chrysotile asbestos exceed, or there is a reasonable
possibility that they may exceed, the ECEL.
(2) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that minimizes the
number of persons who will be exposed to chrysotile asbestos.
(3) Access. The owner or operator must limit access to regulated
areas to
[[Page 204]]
authorized persons or other persons required by work duties to be
present in regulated areas.
(4) Provision of respirators. The owner or operator must supply a
respirator selected in accordance with paragraph (f) of this section to
each person entering a regulated area and must require the use of such
respirator.
(5) Prohibited activities. The owner or operator must ensure that
persons do not eat, drink, smoke, chew tobacco or gum, or apply
cosmetics in the regulated area.
(e) Exposure Control Procedures and Plan--(1) Exposure Controls. (A)
The owner or operator must institute engineering controls and work
practices to reduce and maintain airborne chrysotile asbestos
concentrations to or below the ECEL, except to the extent that the owner
or operator can demonstrate that such controls are not feasible.
(B) Wherever the feasible engineering controls and work practices
that can be instituted are not sufficient to reduce airborne chrysotile
asbestos concentrations to or below the ECEL, the owner or operator must
use them to reduce exposures to the lowest levels achievable by these
controls. If the feasible engineering controls and work practices cannot
reduce exposures to or below the ECEL, the owner or operator must
supplement the controls by providing and requiring the use of
respiratory protection that complies with the requirements of paragraph
(f) of this section.
(2) Exposure Control Plan Requirements. (i) Beginning March 28,
2025, when the airborne chrysotile asbestos concentrations exceed the
ECEL, or are reasonably expected to exceed the ECEL, owners and
operators must establish and implement an exposure control plan to
reduce exposures to all potentially exposed persons to or below the ECEL
by means of engineering controls and work practices, and by the use of
respiratory protection where required under paragraph (e)(1)(B) of this
section. The exposure control plan must be available to persons exposed
to chrysotile asbestos.
(ii) The exposure control plan must be reviewed and updated as
necessary, but at least annually, to reflect any significant changes in
the status of the owner or operator's compliance with the requirements
of this section.
(iii) The owner or operator must not implement a schedule of
personnel rotation as a means of compliance with the ECEL.
(iv) The exposure control plan must include:
(A) An explanation of the exposure controls considered, a rationale
for why exposure controls were selected or not selected, based on
feasibility, effectiveness, and other relevant considerations;
(B) Descriptions of actions the owner or operator must take to
implement the exposure controls selected, including proper installation,
maintenance, training, or other actions, and the estimated timeline for
implementing such controls;
(C) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls; and
(D) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to chrysotile asbestos, or otherwise result in increased
exposure to chrysotile asbestos, including procedures for implementing
corrective actions to mitigate exposure to chrysotile asbestos.
(f) Respiratory protection--(1) Method of Compliance. Beginning
November 25, 2024, if an owner or operator is required to provide
respiratory protection pursuant to paragraphs (d)(4) or (e)(1)(B) of
this section, the owner or operator must provide each potentially
exposed person with a respirator according to the requirements of this
section.
(2) Respirator program. For purposes of this paragraph (f)(2), the
cross-referenced provisions in 29 CFR 1910.134 applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(i) Owners and operators must select respiratory protection that
properly
[[Page 205]]
fits each affected person and communicate respirator selections to each
affected person consistent with the requirements of 29 CFR 1910.134(f)
and 1910.134 App. A.
(ii) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j) and 1910.134 App. B-1 to B-2.
(iii) Prior to or at the time of initial assignment to a job
involving potential exposure to chrysotile asbestos, owners and
operators must provide training and retraining to all persons required
to use respiratory protection consistent with 29 CFR 1910.134(k).
(3) Respirator selection. Owners or operators must select and
provide appropriate respirators based on the most recent exposure
monitoring. The minimum respiratory protection that must be provided is
as follows:
(i) If the most recent exposure monitoring indicates that the
exposure concentration is at or below the 0.005 f/cc (ECEL): no
respiratory protection is required.
(ii) If the most recent exposure monitoring indicates that the
exposure concentration is above 0.005 f/cc (ECEL) and less than or equal
to 0.05 f/cc (10 times the ECEL):
(A) A half-mask supplied-air respirator (SAR) or airline respirator
operated in demand mode; or
(B) A half-mask self-contained breathing apparatus (SCBA) respirator
operated in demand mode (Assigned Protection Factor 10).
(iii) If the most recent exposure monitoring indicates that the
exposure concentration is above 0.05 f/cc (10 times the ECEL) and less
than or equal to 0.125 f/cc (25 times the ECEL): A loose fitting
facepiece supplied-air respirator (SAR) or airline respirator operated
in continuous flow mode (Assigned Protection Factor 25).
(iv) If the most recent exposure monitoring indicates that the
exposure concentration is above 0.125 f/cc (25 times the ECEL) and less
than or equal to 0.25 f/cc (50 times the ECEL):
(A) A full facepiece supplied-air respirator (SAR) or airline
respirator operated in demand mode; or
(B) A half-mask supplied-air respirator (SAR) or airline respirator
operated in continuous flow mode; or
(C) A half-mask supplied-air respirator (SAR) or airline respirator
operated in pressure-demand or other positive-pressure mode; or
(D) A full facepiece self-contained breathing apparatus (SCBA)
respirator operated in demand mode; or
(E) A helmet/hood self-contained breathing apparatus (SCBA)
respirator operated in demand mode (Assigned Protection Factor 50).
(v) If the most recent exposure monitoring indicates that the
exposure concentration is above 0.25 f/cc (50 times the ECEL) and less
than or equal to 5 f/cc (1,000 times the ECEL): A full-facepiece
supplied-air respirator (SAR) or airline respirator operated in
pressure-demand or other positive-pressure mode (Assigned Protection
Factor 1,000).
(vi) If the most recent exposure monitoring indicates that the
exposure concentration is above 5 f/cc (1,000 times the ECEL) and less
than or equal to 50 f/cc (10,000 times the ECEL):
(A) A full-facepiece self-contained breathing apparatus (SCBA)
respirator operated in pressure-demand or other positive-pressure mode;
or
(B) A helmet/hood self-contained breathing apparatus (SCBA)
respirator operated in pressure-demand or other positive-pressure mode
(Assigned Protection Factor 10,000).
(vii) The respiratory protection requirements in paragraph (f)(3) of
this section represent the minimum respiratory protection requirements,
such that any respirator affording a higher degree of protection than
the required respirator may be used.
(g) Workplace information and training. (1) By November 25, 2024,
the owner or operator must institute a training program and ensure that
persons potentially exposed to chrysotile asbestos participate in the
program according to the requirements of this paragraph (g).
(2) The owner or operator must train each potentially exposed person
prior or at the time of a potential exposure
[[Page 206]]
to chrysotile asbestos and at least annually thereafter.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(4) The following information and training must be provided to all
persons potentially exposed to chrysotile asbestos:
(i) The health effects associated with exposure to chrysotile
asbestos, based on the most recent publication by EPA, OSHA, NIOSH, and/
or CDC;
(ii) The quantity, location, manner of use, release, and storage of
chrysotile asbestos and the specific operations in the workplace that
could result in exposure to chrysotile asbestos, noting where each
regulated area is located;
(iii) The specific procedures implemented to control exposures and
manage occupational risks to persons potentially exposed to chrysotile
asbestos, such as engineering controls, work practices and personal
protective equipment to be used; and
(iv) The requirements of this section, as well as how to access or
obtain a copy of these regulations.
(5) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, or
when the airborne concentration of chrysotile asbestos increases, or
when the exposure control plan is updated according to paragraph
(e)(2)(ii) of this section, the owner or operator must update the
training and re-train each potentially exposed person.
Sec. 751.513 Disposal.
(a) After November 25, 2024, all persons disposing of chrysotile
asbestos and any chrysotile asbestos-containing products or articles
subject to Sec. 751.505, must dispose of chrysotile asbestos and any
chrysotile asbestos-containing products or articles, as applicable:
(1) In accordance with the Asbestos General Industry Standard--(29
CFR 1910.1001(k)).
(2) In conformance with the asbestos waste disposal requirements at
40 CFR 61.150.
(b) After November 25, 2024, all persons disposing of chrysotile
asbestos and any chrysotile asbestos-containing products or articles
subject to paragraphs (a) through (c) of Sec. 751.509 must dispose of
chrysotile asbestos and any chrysotile asbestos-containing products or
articles, as applicable:
(1) In accordance with the Asbestos Safety and Health Regulations
for Construction--(29 CFR 1926.1101)
(2) [Reserved]
(c) After November 25, 2024, all persons disposing of chrysotile
asbestos and any chrysotile asbestos-containing products or articles
subject to Sec. 751.509(d) must dispose of chrysotile asbestos and any
chrysotile asbestos-containing products or articles, as applicable:
(1) In accordance with the Asbestos General Industry Standard--(29
CFR 1910.1001).
(2) In conformance with the asbestos waste disposal requirements at
40 CFR 61.150.
(d) After November 25, 2024, each manufacturer (including importer),
processor, and distributor of chrysotile asbestos, including any
chrysotile asbestos-containing products or articles, for consumer use,
disposing of chrysotile asbestos and any chrysotile asbestos-containing
products or articles subject to Sec. 751.509(e), must dispose of
chrysotile asbestos and any chrysotile asbestos-containing products or
articles, as applicable:
(1) In accordance with the Asbestos General Industry Standard at 29
CFR 1910.1001(k).
(2) In conformance with the asbestos waste disposal requirements at
40 CFR 61.150.
Sec. 751.515 Recordkeeping.
(a) General records. After November 25, 2024, all persons who
manufacture (including import), process, or distribute in commerce or
engage in commercial use of chrysotile asbestos must maintain ordinary
business records, such as invoices and bills-of-lading related to
compliance with the prohibitions, restrictions, and other provisions of
this subpart.
(b) Certification of compliance for chlor-alkali industry records.
Persons required pursuant to Sec. 751.507 to certify compliance with
Sec. 751.505 must:
[[Page 207]]
(1) Retain records of certifications prepared to comply with Sec.
751.507 and records to substantiate such certifications; and
(2) Make the records retained pursuant to paragraph (b)(1) of this
section available to EPA for inspection.
(c) Interim workplace controls of chrysotile asbestos exposures
records--(1) Exposure monitoring. For each monitoring event, owners or
operators subject to the exposure monitoring required by Sec.
751.511(c) must document, retain records of the following and make them
available to EPA for inspection:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of chrysotile asbestos use
at the time of each monitoring event;
(iii) All measurements that may be necessary to determine sampling
conditions that may have affected the monitoring results;
(iv) Name, address, work shift, job classification, work area, and
type of respiratory protection (if any) of each monitored person;
(v) Sampling and analytical methods used and documentation of
compliance with the quality control procedures described in Sec.
751.511(c)(5)(i) and (ii); and
(vi) Notification of exposure monitoring results in accordance with
Sec. 751.511(c)(6).
(2) Other requirements. Owners or operators subject to the interim
workplace controls described in Sec. 751.511 must retain records and
make them available to EPA for inspection of:
(i) The exposure control plan and its implementation as required by
Sec. 751.511(e).
(ii) Respiratory protection used and program implementation as
described in Sec. 751.511(f); and
(iii) Information and training provided by the owner or operator as
required by Sec. 751.511(g).
(d) Disposal records. Each person, except a consumer, who disposes
of any chrysotile asbestos and any chrysotile asbestos-containing
products or articles subject to Sec. 751.513, after November 25, 2024
must retain in one location at the headquarters of the company, or at
the facility for which the records were generated, documentation showing
any records related to any disposal of chrysotile asbestos and any
chrysotile asbestos-containing products or articles generated pursuant
to, or otherwise documenting compliance with, regulations specified in
Sec. 751.513.
(e) Retention. The documentation in this section must be retained
for 5 years from the date of generation.
[89 FR 22005, Mar. 28, 2024; 89 FR 31655, Apr. 25, 2024]
Subpart G_Perchloroethylene (PCE)
Source: 89 FR 103607, Dec. 18, 2024, unless otherwise noted.
Sec. 751.601 General.
(a) Applicability. This Subpart establishes prohibitions and
restrictions on the manufacture (including import), processing,
distribution in commerce, use, and disposal of perchloroethylene (CASRN
127-18-4) (PCE), also known as tetrachloroethylene, to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Regulatory threshold. Unless otherwise specified in this
Subpart, the prohibitions and restrictions of this Subpart do not apply
to products containing PCE at thresholds less than 0.1 percent by
weight.
(c) Owner and operator requirements. Any requirement for an owner or
operator, or an owner and operator, is a requirement for any individual
that is either an owner or an operator.
Sec. 751.603 Definitions.
The definitions in Subpart A of part 751 apply to this Subpart
unless otherwise specified in this section. In addition, the following
definitions apply to this Subpart:
3rd generation machine means a dry-to-dry machine with a
refrigerated condenser, as those terms are defined in 40 CFR part 63,
subpart M.
4th or 5th generation machine means a dry-to-dry machine with a
carbon adsorber and refrigerated condenser, as those terms are defined
in 40 CFR part 63, subpart M.
[[Page 208]]
Distribute in commerce has the same meaning as in section 3 of the
Act, except that the term does not include retailers for purposes of
Sec. Sec. 751.613 and 751.615.
ECEL has the same meaning as in Sec. 751.5 and, for PCE, is an
airborne concentration of PCE of 0.14 part per million (ppm).
ECEL action level means a concentration of airborne PCE of 0.10 part
per million (ppm) calculated as an eight (8)-hour time-weighted average
(TWA).
Energized electrical cleaner means a product that meets both of the
following criteria: (1) the product is labeled to clean and/or degrease
electrical equipment, where cleaning and/or degreasing is accomplished
when electrical current exists, or when there is a residual electrical
potential from a component, such as a capacitor; and (2) the product
label clearly displays the statements: ``Energized Equipment use only.
Not to be used for motorized vehicle maintenance, or their parts.''
Sec. 751.605 Prohibitions of manufacturing, processing, distribution
in commerce, and use.
(a) Applicability. (1) The provisions of this section apply as
indicated in paragraph (b) of this section to all manufacturing
(including import), processing, and distribution in commerce of PCE for
consumer use.
(2) The provisions of this section apply as indicated in paragraph
(b) of this section to:
(i) All manufacturing (including import), processing, and
distribution in commerce of PCE for industrial and commercial use, other
than for the industrial and commercial uses addressed under Sec. Sec.
751.607(a), 751.609(a), and 751.611(a), or covered by paragraph (a)(3)
of this section; and
(ii) All industrial and commercial use of PCE, other than the
industrial and commercial uses addressed under Sec. Sec. 751.607(a),
751.609(a), and 751.611(a), or covered by paragraph (a)(3) of this
section.
(3) The provisions of this section apply as indicated in paragraph
(b) of this section to all manufacturing (including import), processing,
distribution in commerce, and industrial and commercial use of PCE in
dry cleaning and related spot cleaning, including:
(i) Industrial and commercial use in dry cleaning and related spot
cleaning in 3rd generation machines; and
(ii) Industrial and commercial use in dry cleaning and related spot
cleaning in 4th and 5th generation machines.
(4) This section does not apply to the distribution in commerce or
use of clothing and articles that have been commercially dry cleaned
with PCE.
(5) This section does not apply to manufacturing, processing, or
distribution in commerce of PCE solely for export that meets the
conditions described in TSCA section 12(a)(1)(A) and (B).
(b) Prohibitions. (1) After June 11, 2026, all persons are
prohibited from manufacturing (including importing) PCE for the uses
listed in paragraphs (a)(1) and (a)(2)(ii) of this section.
(2) After September 9, 2026, all persons are prohibited from
processing PCE, including any PCE-containing products, for the uses
listed in paragraphs (a)(1) and (a)(2)(ii) of this section.
(3) After December 8, 2026, all persons are prohibited from
distributing in commerce (including making available) PCE, including any
PCE-containing products, to retailers for any use other than commercial
dry cleaning.
(4) After March 8, 2027, all retailers are prohibited from
distributing in commerce (including making available) PCE, including any
PCE-containing products.
(5) After March 8, 2027, all persons are prohibited from
distributing in commerce (including making available) PCE, including any
PCE-containing products, for the uses described in paragraphs (a)(1) and
(a)(2)(ii) of this section.
(6) After June 7, 2027, all persons are prohibited from industrial
or commercial use of PCE, including any PCE-containing products, for the
uses listed in paragraph (a)(2)(ii) of this section.
(7) All persons are prohibited from industrial or commercial use of
PCE in dry cleaning machines acquired after June 16, 2025.
(8) After December 20, 2027, all persons are prohibited from
industrial or
[[Page 209]]
commercial use of PCE for the use listed in paragraph (a)(3)(i) of this
section.
(9) After December 19, 2034, all persons are prohibited from the
manufacturing (including importing), processing, distribution in
commerce, or industrial or commercial use of PCE for dry cleaning and
spot cleaning, including for the use listed in paragraph (a)(3)(ii) of
this section.
(10) After December 19, 2034, all persons are prohibited from
manufacturing (including import), processing, distribution in commerce,
or use of PCE, including any PCE containing products, for industrial or
commercial use in an emergency by the National Aeronautics and Space
Administration or its contractors as described in Sec. 751.117(b).
Sec. 751.607 Workplace Chemical Protection Program (WCPP).
(a) Applicability. The provisions of this section apply to the
following conditions of use of PCE, including manufacturing and
processing for export, unless otherwise indicated in this section,
except to the extent the conditions of use are prohibited by Sec.
751.605:
(1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing as a reactant/intermediate;
(4) Processing into formulation, mixture or reaction product;
(5) Repackaging;
(6) Industrial and commercial use as solvent for open-top batch
vapor degreasing;
(7) Industrial and commercial use as solvent for closed-loop batch
vapor degreasing
(8) Industrial and commercial use in maskant for chemical milling;
(9) Industrial and commercial use in solvent-based adhesives and
sealants;
(10) Industrial and commercial use as a processing aid in catalyst
regeneration in petrochemical manufacturing;
(11) Industrial and commercial use as a processing aid in sectors
other than petrochemical manufacturing;
(12) Industrial and commercial use for cold cleaning of tanker
vessels;
(13) Recycling; and
(14) Disposal.
(b) Existing chemical exposure limit (ECEL)--(1) Applicability. The
provisions of this paragraph (b) apply to any workplace engaged in a
condition of use that is listed in paragraph (a)(1) through (12) of this
section and not prohibited by Sec. 751.605.
(2) Eight-hour time-weighted average (TWA) ECEL. Beginning September
20, 2027 for Federal agencies and Federal contractors acting for or on
behalf of the Federal government, March 13, 2026 for non-Federal owners
and operators, or beginning four months after introduction of PCE into
the workplace if PCE use commences after December 15, 2025, the owner or
operator must ensure that no person is exposed to an airborne
concentration of PCE in excess of the ECEL, consistent with the
requirements of paragraph (d)(1)(i) of this section and, if necessary,
paragraph (f) of this section.
(3) Exposure monitoring--(i) General.
(A) Owners or operators must determine each potentially exposed
person's exposure, without regard to respiratory protection, by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each exposure group.
(B) Personal breathing zone air samples are representative of the 8-
hour TWA of all potentially exposed persons in an exposure group if the
samples are of at least one person's full-shift exposure who represents
the highest potential PCE exposures in that exposure group. Personal
breathing zone air samples taken during one work shift may be used to
represent potentially exposed person exposures on other work shifts
where the owner or operator can document that the tasks performed and
conditions in the workplace are similar across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good Laboratory
Practice (GLP) Standards in 40 CFR part 792 or a laboratory accredited
by the American Industrial Hygiene Association (AIHA) or another
industry-recognized program.
[[Page 210]]
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of PCE.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect, unless an Environmental Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist reviews the monitoring results and
determines re-monitoring is not necessary.
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
by December 15, 2025 for non-Federal owners and operators, or within 30
days of introduction of PCE into the workplace, whichever is later, each
owner or operator covered by this section must perform initial
monitoring of potentially exposed persons. Where the owner or operator
has monitoring results from monitoring conducted within five years prior
to February 18, 2025 and the monitoring satisfies all other requirements
of this section, the owner or operator may rely on such earlier
monitoring results to satisfy the requirements of this paragraph.
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to PCE
in accordance with table 1.
Table 1 to Sec. 751.607(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Air concentration condition Periodic monitoring requirement
------------------------------------------------------------------------
If initial exposure monitoring is below Periodic exposure monitoring is
ECEL action level (<0.10 ppm 8-hour required at least once every
TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL (0.14 ppm 8- of the most recent exposure
hour TWA). monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (=0.10 monitoring.
ppm 8-hour TWA, <=0.14 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6 month period, indicate exposure is monitoring.
below the ECEL action level (<0.10 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic monitoring
is required but does not manufacture, event. However, documentation
process, use, or dispose of PCE in of cessation of use of PCE is
that condition of use over the required; and periodic
entirety of time since the last monitoring is required when
required monitoring event. the owner or operator resumes
the condition of use.
------------------------------------------------------------------------
(iv) Additional monitoring. (A) The owner or operator must conduct
the exposure monitoring required by paragraph (b)(3)(ii) of this section
within 30 days after there has been a change in the production, process,
control equipment, personnel or work practices that may reasonably be
expected to result in new or additional exposures above the ECEL action
level or when the owner or operator has any reason to believe that new
or additional exposures above the ECEL action level have occurred. Prior
monitoring data cannot be used to meet this requirement.
(B) Whenever start-ups or shutdowns, or spills, leaks, ruptures or
other breakdowns or unexpected releases occur that may lead to exposure
to potentially exposed persons, the owner or operator must conduct the
exposure monitoring required by paragraph (b)(3)(ii) of this section
within 30 days after the conclusion of the start-up or shutdown and/or
the cleanup of the spill or repair of the leak, rupture or other
breakdown. Prior monitoring data cannot be used to meet this
requirement.
(v) Observation of monitoring. (A) Owners and operators must provide
potentially exposed persons or their designated representatives an
opportunity to observe any monitoring of occupational exposure to PCE
that is conducted under this section and designed to characterize their
exposure.
(B) When monitoring observation requires entry into a regulated
area, the
[[Page 211]]
owner or operator must provide the observers with the required PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group and their designated representatives of any
monitoring results within 15 working days of receipt of those monitoring
results.
(B) This notification must include the following:
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level;
(3) Statement of whether the monitored airborne concentration of PCE
exceeds the ECEL action level or ECEL;
(4) If the ECEL is exceeded, descriptions of any exposure controls
implemented by the owner or operator to reduce exposures to or below the
ECEL, as required by paragraph (d)(1) of this section;
(5) Explanation of any respiratory protection provided in accordance
with paragraphs (b)(4)(iv), (d)(1)(i), and (f) of this section;
(6) Quantity of PCE in use at the time of monitoring;
(7) Location of PCE use at the time of monitoring;
(8) Manner of PCE use at the time of monitoring; and
(9) Identified releases of PCE.
(C) Notice must be written in plain language and either provided to
each potentially exposed person and their designated representatives
individually in a language that the person understands, or posted in an
appropriate and accessible location outside the regulated area with an
English-language version and a non-English language version representing
the language of the largest group of workers who do not read English.
(4) Regulated areas--(i) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government and by March 13, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of PCE exceed or can reasonably be expected to exceed,
the ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that adequately
establishes and alerts persons to the boundaries of the area and
minimizes the number of authorized persons exposed to PCE within the
regulated area.
(iv) Provisions of respirators. (A) The owner or operator must
ensure that each person who enters a regulated area is supplied with a
respirator selected in accordance with paragraph (f) of this section and
must ensure that all persons within the regulated area are using the
provided respirators whenever PCE exposures may exceed the ECEL.
(B) An owner or operator who has implemented all feasible controls
as required in paragraph (d)(1)(i) of this section, and who has
established a regulated area as required by paragraph (b)(4)(i) of this
section where PCE exposure can be reliably predicted to exceed the ECEL
only on certain days (for example, because of work or process schedule)
must have persons use respirators in that regulated area on those days.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase PCE exposure.
(B) The owner or operator must ensure that while persons are wearing
respirators in the regulated area, they do not engage in activities
which interfere with respirator performance.
(c) DDCC. Beginning September 20, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government
and beginning March 13, 2026 for non-Federal owners and operators,
owners or operators must ensure that all persons are separated,
distanced, physically removed,
[[Page 212]]
or isolated from direct dermal contact with PCE consistent with the
requirements of paragraph (d)(1)(ii) of this section and, if necessary,
paragraph (f) of this section.
(d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) By December 20, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 7, 2027 for non-Federal owners and operators, the owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to reduce
exposure to or below the ECEL except to the extent that the owner or
operator can demonstrate that such controls are not feasible, in
accordance with the hierarchy of controls.
(B) If the feasible controls required under paragraph (d)(1)(i)(A)
of this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL, then the owner or
operator must use such controls to reduce exposure to the lowest levels
achievable by these controls and must supplement those controls with the
use of respiratory protection that complies with the requirements of
paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate exposure to PCE
has been reduced to or below the ECEL through the use of controls
required under paragraphs (d)(1)(i)(A) and (B) of this section, and has
not demonstrated that it has appropriately supplemented with respiratory
protection that complies with the requirements of paragraph (f) of this
section, this will constitute a failure to comply with the ECEL.
(ii) DDCC requirements. (A) By December 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 7, 2027 for non-Federal owners and operators, the
owner or operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with PCE except to the
extent that the owner or operator can demonstrate that such controls are
not feasible.
(B) If the feasible controls required under paragraph (d)(1)(ii)(A)
of this section that can be instituted do not prevent direct dermal
contact, then the owner or operator must use such controls to reduce
direct dermal contact to the extent achievable by these controls and
must supplement those controls with the use of dermal protection that
complies with the requirements of paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate direct dermal
contact to PCE is prevented through the use of controls required under
paragraphs (d)(1)(ii)(A) and (B) of this section, and has not
demonstrated that it has appropriately supplemented with dermal
protection that complies with the requirements of paragraph (f) of this
section, this will constitute a failure to comply with the direct dermal
contact control requirements.
(2) Exposure control plan. By December 20, 2027 for Federal agencies
and Federal contractors acting for or on behalf of the Federal
government, or by June 7, 2027 for non-Federal owners and operators,
each owner and operator must establish and implement an exposure control
plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraphs (d)(1)(i)(A) and (d)(1)(ii)(A) of this section, in the
following sequence: elimination, substitution, engineering controls and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement exposure controls selected, including proper installation,
regular inspections, maintenance, training or other actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
[[Page 213]]
(E) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and confirm that all persons are properly implementing the
exposure controls; and
(F) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to PCE, or otherwise result in increased exposure to PCE,
including procedures for implementing corrective actions to mitigate
exposure to PCE.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls instituted under this paragraph (d).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every 5 years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) through (d) of this section.
(iii) Availability of exposure control plan. (A) Owners or operators
must make the exposure control plan and associated records, including
ECEL exposure monitoring records, ECEL compliance records, DDCC
compliance records, and workplace participation records described in
Sec. 751.615(b), available to potentially exposed persons and their
designated representatives.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated records must be provided in plain language writing to each
potentially exposed person in a language that the person understands or
posted in an appropriate and accessible location outside the regulated
area with an English-language version and a non-English language version
representing the language of the largest group of workers who do not
read English.
(D) Upon request by the potentially exposed person or their
designated representative(s), the owner or operator must provide the
specified records at a reasonable time, place, and manner. If the owner
or operator is unable to provide the requested records within 15 working
days, the owner or operator must, within those 15 working days, inform
the potentially exposed person or designated representative(s)
requesting the record(s) of the reason for the delay and the earliest
date when the record will be made available.
(e) Workplace information and training. (1) By March 13, 2026, the
owner or operator must institute a training program and ensure that
persons potentially exposed to PCE participate in the program according
to the requirements of this paragraph (e).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of a potential exposure to
PCE.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained.
(4) The following information and training must be provided to all
persons potentially exposed to PCE:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
PCE and the specific operations in the workplace that could result in
exposure to PCE, particularly noting where each regulated area is
located;
(iii) Methods and observations that may be used to detect the
presence or release of PCE in the workplace (such as monitoring
conducted by the owner or operator, continuous monitoring devices,
visual appearance or odor of PCE when being released);
(iv) The acute and chronic health hazards of PCE as detailed on
relevant Safety Data Sheets; and
(v) The principles of safe use and handling of PCE and measures
potentially
[[Page 214]]
exposed persons can take to protect themselves from PCE, including
specific procedures the owner or operator has implemented to protect
potentially exposed persons from exposure to PCE, such as appropriate
work practices, emergency procedures, and personal protective equipment
to be used.
(5) The owner or operator must re-train each potentially exposed
person annually to ensure that each such person maintains the requisite
understanding of the principles of safe use and handling of PCE in the
workplace.
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where such exposure exceeds or can reasonably be
expected to exceed the ECEL action level or increase potential for
direct dermal contact, the owner or operator must update the training
and ensure that each potentially exposed person is re-trained.
(f) Personal protective equipment (PPE)--(1) Protection. The
provisions of paragraph (f) apply to any owner or operator that is
required to provide respiratory protection pursuant to paragraphs
(b)(4)(iv) or (d)(1)(i)(B) of this section or Sec. 751.611(b), or
dermal protection pursuant to paragraphs (c) or (d)(1)(ii)(B) of this
section, Sec. 751.609(b)(2), or Sec. 751.611(b).
(2) Respiratory protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, by March 13, 2026 for non-Federal owners and operators, or
within three months after receipt of any exposure monitoring that
indicates exposures exceeding the ECEL, if an owner or operator is
required to provide respiratory protection pursuant to paragraph (f)(1)
of this section, the owner or operator must ensure that each potentially
exposed person is provided with a respirator according to the
requirements of this section.
(ii) For purposes of this paragraph (f)(2), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are defined
in 29 CFR 1910.134(b) have the meaning assigned to them in that
paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
March 13, 2026 for non-Federal owners and operators, or within three
months after receipt of any exposure monitoring that indicates exposures
exceeding the ECEL, if an owner or operator is required to provide
respiratory protection pursuant to paragraph (f)(1) of this section, the
owner or operator must develop and administer a written respiratory
protection program consistent with the requirements of 29 CFR
1910.134(c)(1), (c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection
required by paragraph (f)(2)(i) of this section based on a medical
evaluation consistent with the requirements of 29 CFR 1910.134(e). If a
potentially exposed person cannot use a negative-pressure respirator
that would otherwise be required by paragraph (f)(1) of this section,
then the owner or operator must provide that person with an alternative
respirator. The alternative respirator must have less breathing
resistance than the negative-pressure respirator and provide equivalent
or greater protection. If the person is unable to use an alternative
respirator, then the person must not be permitted to enter the regulated
area.
(v) Owners and operators must select respiratory protection that
properly fits each affected person and communicate respirator selections
to each affected person consistent with the requirements of 29 CFR
1910.134(f),1910.134 App A.
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j),1910.134 App. B-1 to B-2.
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to PCE, owners and operators
[[Page 215]]
must provide training to all persons required to use respiratory
protection consistent with 29 CFR 1910.134(k), 1910.134 App. D.
(viii) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below 0.14 ppm:
no respiratory protection is required.
(B) If the measured exposure concentration is above 0.14 ppm and
less than or equal to 1.4 ppm (10 times ECEL): Any National Institute
for Occupational Safety and Health (NIOSH) Approved[supreg] air-
purifying half mask respirator equipped with organic vapor cartridges or
canisters; or any NIOSH Approved[supreg] Supplied-Air Respirator (SAR)
or Airline Respirator operated in demand mode equipped with a half mask;
or any NIOSH Approved[supreg] Self-Contained Breathing Apparatus (SCBA)
in a demand mode equipped with a half mask [APF 10].
(C) If the measured exposure concentration is above 1.4 ppm and less
than or equal to 3.5 ppm (25 times ECEL): Any NIOSH Approved[supreg]
Powered Air-Purifying Respirator (PAPR) equipped with a loose-fitting
facepiece or hood/helmet equipped with organic vapor cartridges or
canisters; or any NIOSH Approved[supreg] SAR or Airline Respirator in a
continuous-flow mode equipped with a loose-fitting facepiece or helmet/
hood [APF 25].
(D) If the measured exposure concentration is above 3.5 ppm and less
than or equal to 7.0 ppm (50 times ECEL): Any NIOSH Approved[supreg]
air-purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] PAPR with a half
mask equipped with organic vapor cartridges or canisters; any NIOSH
Approved[supreg] SAR or Airline Respirator in a continuous flow mode
equipped with a half mask; any NIOSH Approved[supreg] SAR or Airline
Respirator operated in a pressure-demand or other positive-pressure mode
with a half mask; or any NIOSH Approved[supreg] SCBA in demand-mode
equipped with a full facepiece or helmet/hood [APF 50].
(E) If the measured exposure concentration is above 7.0 ppm and less
than or equal to 140 ppm (1,000 times ECEL): Any NIOSH Approved[supreg]
PAPR equipped with a full facepiece equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] SAR or Airline
Respirator in a continuous-flow mode equipped with full facepiece; any
NIOSH Approved[supreg] SAR or Airline Respirator in pressure-demand or
other positive-pressure mode equipped with a full facepiece and an
auxiliary self-contained air supply; or any NIOSH Approved[supreg] SAR
or Airline Respirator in a continuous-flow mode equipped with a helmet
or hood and that has been tested to demonstrated performance at a level
of a protection of APF 1,000 or greater [APF 1000].
(F) If the measured exposure concentration is greater than 140 ppm
(1,000+ times ECEL): Any NIOSH Approved[supreg] Self-Contained Breathing
Apparatus (SCBA) in a pressure-demand or other positive-pressure mode
equipped with a full facepiece or helmet/hood [APF 10,000].
(G) If the exposure concentration is unknown: Any NIOSH
Approved[supreg] combination supplied air respirator equipped with a
full facepiece and operated in pressure demand or other positive
pressure mode with an auxiliary self-contained air supply; or any NIOSH
Approved[supreg] SCBA operated in pressure demand or other positive
pressure mode and equipped with a full facepiece or hood/helmet [APF
1000+].
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(2) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select respirators that have an end-of-service-life indicator
(ESLI) that is NIOSH Approved[supreg] for PCE; or
[[Page 216]]
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The written
respiratory protection program required by paragraph (f)(2)(iii) of this
section must include a description of the information and data relied
upon, the basis for reliance on the information and data, and the basis
for the canister and cartridge change schedule.
(xii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29 CFR
1910.134(l), to ensure that the provisions of the written respiratory
protection program required under paragraph (f)(2)(iii) of this section
are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph
(f)(2) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(3) Dermal protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by March 13, 2026 for non-Federal owners and operators,
if an owner or operator is required to provide dermal protection
pursuant to paragraph (f)(1) of this section, the owner or operators
must ensure that each potentially exposed person is provided with dermal
PPE according to the requirements of this section.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with PCE in the specific work area where it is selected
for use, selected in accordance with this paragraph (f)(3) and provided
in accordance with 29 CFR 1910.132(h), to each person who is reasonably
likely to be dermally exposed in the work area through direct dermal
contact with PCE. For the purposes of this paragraph (f)(3)(ii),
provisions in 29 CFR 1910.132(h) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(iii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in this
paragraph (f)(3) to each person who is reasonably likely to be dermally
exposed in the work area through direct dermal contact with PCE. For the
purposes of this paragraph (f)(3)(iii), provisions in 29 CFR 1910.133(b)
applying to an ``employer'' also apply equally to owners or operators.
(iv) Owners or operators must select and provide to persons
appropriate dermal PPE based on an evaluation of the performance
characteristics of the PPE relative to the task(s) to be performed,
conditions present, and the duration of use. Replacement PPE must be
provided immediately if any person is dermally exposed to PCE longer
than the breakthrough time period for which testing has demonstrated
that the PPE will be impermeable or if there is a chemical permeation or
breakage of the PPE. Dermal PPE must include, but is not limited to, the
following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier or by individually prepared third-party
testing.
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(v) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with PCE during normal and expected duration and
conditions of exposure within the work area by evaluating the
specifications from the manufacturer or supplier or individually
prepared third-party testing of the dermal PPE or of the material used
in construction of the dermal PPE, to establish that the dermal PPE will
be impervious to PCE alone and in likely combination with other chemical
substances in the work area.
[[Page 217]]
(vi) Dermal PPE that is of safe design and construction for the work
to be performed must be provided, used, and maintained in a sanitary,
reliable, and undamaged condition. Owners and operators must select PPE
that properly fits each affected person and communicate PPE selections
to each affected person.
(vii) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to PCE. For the purposes of this paragraph (f)(3)(vii),
provisions in 29 CFR 1910.132(f) applying to an ``employee'' also apply
equally to potentially exposed persons, and provisions applying to an
``employer'' also apply equally to owners or operators.
(viii) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have the
required understanding and skill to properly use dermal protection, or
when changes in the workplace or in dermal protection to be used render
the previous training obsolete.
Sec. 751.609 Workplace requirements for laboratory use.
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of PCE as a laboratory chemical.
(b) Laboratory use requirements. (1) After December 15, 2025, owners
or operators must ensure laboratory ventilation devices such as fume
hoods or glove boxes are in use and functioning properly and that
specific measures are taken to ensure proper and adequate performance of
such equipment to minimize exposures to potentially exposed persons in
the area when PCE is used in a laboratory setting.
(2) After December 15, 2025, owners or operators must ensure that
all persons reasonably likely to be exposed from direct dermal contact
to PCE in a laboratory setting are provided with dermal personal
protective equipment and training on proper use of PPE in a manner
consistent with Sec. 751.607(f)(3), except that the date listed in
paragraph (f)(3)(i) does not apply.
Sec. 751.611 Workplace requirements for energized electrical cleaner.
(a) Applicability. The provisions of this section apply as indicated
in paragraphs (b) through (d) of this section to:
(1) All manufacturing (including importing), processing, and
distribution in commerce of PCE for industrial and commercial use as
energized electrical cleaner, and
(2) Industrial and commercial use of PCE as energized electrical
cleaner.
(b) Energized electrical cleaner requirements. The provisions of
this paragraph (b) apply to any workplace engaged in the condition of
use listed in paragraph (a)(2).
(1) PPE. (i) The provisions of this paragraph (b)(1) apply after
March 13, 2026.
(ii) Owners or operators must ensure that all potentially exposed
persons using PCE, including any PCE containing products, are provided
with dermal PPE and training on proper use of PPE in accordance with
Sec. 751.607(f)(3).
(iii) If any of the criteria in paragraphs (b)(1)(iii)(A) or (B) are
met, then owners or operators must ensure that all persons using PCE,
including any PCE containing products, are provided with respiratory PPE
and training on proper use of PPE in accordance with Sec.
751.607(f)(2), except that instead of selecting appropriate respirators
based on monitoring results pursuant to paragraph (f)(2)(ix), owners or
operators must select from and provide the following types of
respirators: any NIOSH Approved[supreg] air-purifying full facepiece
respirator equipped with organic vapor cartridges or canisters; any
NIOSH Approved[supreg] PAPR with a half mask equipped with organic vapor
cartridges or canisters; any NIOSH Approved[supreg] SAR or Airline
Respirator in a continuous flow mode equipped with a half mask; any
NIOSH Approved[supreg] SAR or Airline Respirator operated in a pressure-
demand or other positive-pressure mode with a half mask; any NIOSH
Approved[supreg] SCBA in demand-mode equipped with a full facepiece or
[[Page 218]]
helmet/hood [APF 50]; or any respirator affording a higher degree of
protection.
(A) The potentially exposed person is in a confined space, as
defined in 29 CFR 1910.146(b), or in an enclosed space, as described in
29 CFR 1910.269(e); or
(B) The potentially exposed person approaches the exposed energized
equipment closer than the employer's established minimum approach
distance required under 29 CFR 1910.269(l)(3) or when there is no
established minimum approach distance.
(2) Alternative to PPE requirements. (i) As an alternative to the
requirements in paragraph (b)(1) of this section, the owner or operator
may choose to follow the WCPP provisions in Sec. 751.607.
(ii) Owners or operators who choose to follow the WCPP as an
alternative to the requirements in paragraph (b)(1) of this section
must:
(A) Document and maintain a statement that they are electing to
comply with the WCPP.
(B) Comply with the WCPP provisions in Sec. 751.607 and document
compliance in accordance with Sec. 751.615(b).
(c) Label. After March 13, 2026, all manufacturers (including
importers), processors and distributors in commerce of PCE or PCE-
containing products for industrial and commercial use as energized
electrical cleaner must provide a label securely attached to each
product. Label information must be prominently displayed and in an
easily readable font size, with the sentences:
``This product contains perchloroethylene (PCE) (CASRN 127-18-4), a
chemical determined by the Environmental Protection Agency to present
unreasonable risk of injury to health under the Toxic Substances Control
Act (TSCA), based on neurotoxicity and other adverse health effects. The
use of PCE is restricted under 40 CFR part 751, subpart G. This product
is for Energized Equipment use only. Not to be used for motorized
vehicle maintenance, or their parts.''
(d) Self-certification. After March 13, 2026, the owner or operator
of the business entity purchasing and using PCE, including any PCE
containing products, for the industrial and commercial use as energized
electrical cleaner must self-certify that use is in compliance with
requirements of paragraph (b) of this section with the following written
statement.
(1) The self-certification must include the following written
statement:
I certify each of the following statements under penalty of law.
This document was prepared under my direction and supervision. This
energized electrical cleaner will be used for energized equipment use
only. This business entity has implemented and complies with the EPA
requirements for the use of energized electrical cleaner that contains
perchloroethylene under 40 CFR 751.611 and only trained and qualified
persons will handle the energized electrical cleaner. Based on my
inquiry of the person or persons who manages this business entity and/or
those persons directly responsible for implementing the EPA requirements
for energized electrical cleaner that contains perchloroethylene, and to
the best of my knowledge and belief, this business entity is in
compliance with the EPA requirements for energized electrical cleaner. I
am aware that there are significant penalties, including the possibility
of civil penalties for failing to comply with these requirements and
criminal fines and imprisonment, for knowingly failing to comply with
these requirements. I understand that this certification shall serve as
a certification that this business entity will properly implement and
comply with the EPA requirements for energized electrical cleaner
consistent with the applicable regulatory timelines.
(2) The self-certification must also include the following:
(i) Printed name and signature, job classification, title, email
address, and phone number of the owner or operator who is self-
certifying.
(ii) Date of self-certification.
(iii) Name and address of the business entity.
(iv) Indication of whether this is the business entity's first
purchase of PCE, including PCE containing products, after publication of
the final rule.
(3) Owners or operators or persons specifically authorized by the
owner or operator to purchase energized electrical cleaner must provide
a copy of the self-certification statement for each business entity to
the distributor from whom PCE, including PCE containing products, is
being purchased, for every purchase.
(4) Distributors of PCE, including PCE containing products, must
review the self-certification statement to ensure it is appropriately
completed to
[[Page 219]]
include the owner or operator's and the business entity's information
required by this section.
(5) Distributors of PCE, including PCE containing products, must
have a complete and valid self-certification statement in accordance
with this section for each sale of PCE, including PCE containing
products, for use in energized electrical cleaning.
Sec. 751.613 Downstream notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) PCE for any use must, prior to or concurrent with
the shipment, notify companies to whom PCE is shipped, in writing, of
the restrictions described in this Subpart in accordance with paragraph
(c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce PCE or any PCE-containing products for any use
must, prior to or concurrent with the shipment, notify companies to whom
PCE is shipped, in writing, of the restrictions described in this
Subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in Section 1(c) and
15 of the Safety Data Sheet (SDS) provided with the PCE or with any PCE-
containing product:
After December 8, 2026 this chemical substance (as defined in TSCA
section 3(2))/product cannot be distributed in commerce to retailers for
any use. After March 8, 2027, this chemical substance (as defined in
TSCA section 3(2))/product is and can only be distributed in commerce or
processed with a concentration of PCE equal to or greater than 0.1% by
weight for the following purposes: (1) Processing as a reactant/
intermediate; (2) Processing into formulation, mixture or reaction
product; (3) Processing by repackaging; (4) Recycling; (5) Industrial
and commercial use as solvent in open-top batch vapor degreasing; (6)
Industrial and commercial use as solvent in closed-loop batch vapor
degreasing; (7) Industrial and commercial use in maskant for chemical
milling; (8) Industrial and commercial use as a processing aid in
catalyst regeneration in petrochemical manufacturing; (9) Industrial and
commercial use as a processing aid in sectors other than petrochemical
manufacturing; (10) Industrial and commercial use as solvent for cold
cleaning of tanker vessels; (11) Industrial and commercial use as
energized electrical cleaner; (12) Industrial and commercial use in
laboratory chemicals; (13) Industrial and commercial use in solvent-
based adhesives and sealants; (14) Industrial and commercial use in dry
cleaning in 3rd generation machines until December 20, 2027; (15)
Industrial and commercial use in all dry cleaning and related spot
cleaning until December 19, 2034; (16) Export; and (17) Disposal.
Sec. 751.615 Recordkeeping requirements.
(a) General records. After February 18, 2025, all persons who
manufacture (including import), process, distribute in commerce, or
engage in industrial or commercial use of PCE or PCE-containing products
must maintain ordinary business records, such as downstream
notifications, invoices and bills-of-lading related to compliance with
the prohibitions, restrictions, and other provisions of this subpart G.
(b) WCPP compliance--(1) ECEL exposure monitoring. For each
monitoring event, owners or operators subject to the ECEL described in
Sec. 751.607(b) must document and retain records of the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of PCE use at the time of
each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.607(b)(3)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.607(b)(3)(i)(D);
(vii) Compliance with the GLP Standards in 40 CFR part 792, or use
of a laboratory accredited by the AIHA or another industry-recognized
program, as required by Sec. 751.607(b)(3)(i)(C); and
(viii) Information regarding air monitoring equipment, including:
Type, maintenance, calibrations, performance tests, limits of detection,
and any malfunctions;
[[Page 220]]
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.607(b)(3)(v).
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.607(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.607(d)(2);
(ii) Implementation of the exposure control plan as described in
Sec. 751.607(d)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown, or
malfunction of the facility that causes an exceedance of the ECEL and
any subsequent corrective actions taken by the owner or operator during
the start-up, shutdown, or malfunctions to mitigate exposures to PCE.
(iii) Respiratory protection used by each potentially exposed person
and PPE program implementation as described in Sec. 751.607(f)(2)
including:
(A) The name, workplace address, work shift, job classification,
work area of each potentially exposed person, and the type of
respiratory protection provided to each potentially exposed person;
(B) The basis for the specific respiratory protection selection in
accordance with Sec. 751.607(f)(2); and
(C) Fit testing and training in accordance with Sec. 751.607(f)(2).
(iv) Information and training provided as required in Sec.
751.607(e).
(3) DDCC compliance. Owners or operators subject to DDCC
requirements described in Sec. 751.607(c) must retain records of:
(i) Exposure control plan as described in Sec. 751.607(d)(2);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.607(f)(3),
including:
(A) The name, workplace address, work shift, job classification, and
work area of each person reasonably likely to directly handle PCE or
handle equipment or materials on which PCE may be present and the type
of PPE selected to be worn by each of these persons;
(B) The basis for specific PPE selection (e.g., demonstration based
on permeation testing or manufacturer specifications that each item of
PPE selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE;
(D) Occurrence and duration of any direct dermal contact with PCE
that occurs during any activity or malfunction at the workplace that
causes direct dermal exposures to occur and/or glove breakthrough, and
corrective actions to be taken during and immediately following that
activity or malfunction to prevent direct dermal contact to PCE; and
(E) Training in accordance with Sec. 751.607(f)(3).
(iii) Information and training provided as required in Sec.
751.607(e).
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person that may
reasonably be affected by PCE inhalation exposure or direct dermal
contact and their designated representatives to readily access the
exposure control plans, facility exposure monitoring records, PPE
program implementation records, or any other information relevant to PCE
exposure in the workplace.
(c) Workplace requirements for laboratory use compliance. Owners and
operators subject to the laboratory chemical requirements described in
Sec. 751.609 must retain records of:
(1) Dermal protection used by each potentially exposed person and
PPE program implementation, as described in Sec. 751.615(b)(3)(ii);
(2) Documentation identifying: Criteria that the owner or operator
will
[[Page 221]]
use to determine and implement control measures to reduce potentially
exposed persons' exposure to PCE including laboratory ventilation
devices;
(3) Documentation identifying: Implementation of properly
functioning laboratory ventilation devices using manufacturer's
instructions for installation, use, and maintenance of the devices
including inspections, tests, development of maintenance procedures, the
establishment of criteria for acceptable test results, and documentation
of test and inspection results; and
(d) Workplace requirements for energized electrical cleaner. (1)
Owners and operators subject to the energized electrical cleaner
requirements described in Sec. 751.611 must retain records of:
(i) Statement regarding whether the owner or operator is complying
with the prescriptive PPE requirements described in Sec. 751.611(b)(1)
or with the WCPP described in Sec. 751.611(b)(2).
(ii) Dermal and respiratory protection used by each potentially
exposed person and program implementation as described in Sec.
751.611(b)(1) or WCPP records described in Sec. 751.615(b).
(iii) Labels used as described in Sec. 751.611(c).
(iv) Self-certification statements provided as described in Sec.
751.611(d)(1)-(3).
(2) Distributors of PCE, including PCE containing products, for use
in energized electrical cleaning must retain sale records, including:
(i) Name of purchaser;
(ii) Date of sale;
(iii) Quantity of PCE or PCE containing products sold;
(iv) Self-certification statement for each purchase of PCE; and
(v) Copies of labels required in Sec. 751.611(c).
(e) Records related to exemptions. To maintain eligibility for an
exemption described in Sec. 751.617, the records maintained by the
owners or operators must demonstrate compliance with the specific
conditions of the exemption.
(f) Retention. Owners or operators must retain the records required
under this section for a period of 5 years from the date that such
records were generated.
Sec. 751.617 Exemptions.
(a) General applicability. (1) Time-limited exemptions described in
this section are established in accordance with 15 U.S.C. 2605(g)(1).
(2) To be eligible for the exemptions established in this section,
regulated parties must comply with all conditions promulgated in this
section for such exemptions in accordance with 15 U.S.C. 2605(g)(4).
(b) Time-limited exemption for emergency use by the National
Aeronautics and Space Administration. Under 15 U.S.C. 2605(g)(1)(A), use
of PCE or PCE containing products for the conditions of use identified
in paragraph (b)(1) of this section in an emergency by the National
Aeronautics and Space Administration (NASA) and its contractors
operating within the scope of their contracted work is exempt from the
requirements of Sec. 751.605 until December 19, 2034.
(1) Applicability. This exemption shall apply to the following
specific conditions of use:
(i) Industrial and commercial use as solvent for cold cleaning; and
(ii) Industrial and commercial use in wipe cleaning.
(2) Emergency use. (i) An emergency is a serious and sudden
situation requiring immediate action, within 15 days or less, necessary
to protect:
(A) Safety of NASA's or their contractors' personnel;
(B) NASA's missions;
(C) Human health, safety, or property, including that of adjacent
communities; or
(D) The environment.
(ii) Each emergency is a separate situation; if use of PCE exceeds
15 days, then justification must be documented.
(3) Eligibility. To be eligible for the exemption, NASA and its
contractors must:
(i) Select PCE because there are no technically and economically
feasible safer alternatives available during the emergency.
(ii) Perform the emergency use of PCE at locations controlled by
NASA or its contractors.
(iii) Comply with the following conditions:
[[Page 222]]
(A) Within 15 working days of the emergency use by NASA or its
contractors, NASA and its contractors must provide notice to the EPA
Assistant Administrators of both the Office of Enforcement and
Compliance Assurance and the Office of Chemical Safety and Pollution
Prevention that includes the following:
(1) Identification of the conditions of use detailed in paragraph
(b)(1) of this section that the emergency use fell under;
(2) An explanation for why the emergency use met the definition of
emergency in paragraph (b)(2)(i) of this section; and
(3) An explanation of why PCE was selected, including why there were
no technically and economically feasible safer alternatives available in
the particular emergency.
(iv) The owner or operator must comply with and document such
compliance efforts under the WCPP provisions in Sec. 751.607, to the
extent technically feasible in light of the particular emergency.
(v) The owner or operator of the location where the use takes place
must comply with the recordkeeping requirements in Sec. 751.615.
Subpart H_Carbon Tetrachloride
Source: 89 FR 103551, Dec. 18, 2024, unless otherwise noted.
Sec. 751.701 General.
(a) Applicability. This subpart sets certain restrictions on the
manufacture (including import), processing, distribution in commerce,
use, or disposal of carbon tetrachloride (CASRN 56-23-5) to prevent
unreasonable risk of injury to health in accordance with TSCA section
6(a).
(b) Trace quantities exclusion. Unless otherwise specified in this
subpart, the prohibitions and restrictions of this subpart do not apply
to carbon tetrachloride that is solely present unintentionally in trace
quantities with another chemical substance or mixture.
(c) Owner and operator requirements. Any requirement for an owner or
operator, or an owner and operator, is a requirement for any individual
that is either an owner or an operator.
Sec. 751.703 Definitions.
The definitions in subpart A of this part apply to this Subpart
unless otherwise specified in this section. In addition, the following
definitions apply:
ECEL has the same meaning as in Sec. 751.5 and for CTC, is an
airborne concentration of carbon tetrachloride of 0.03 parts per million
(ppm) calculated as an eight (8)-hour time-weighted average (TWA).
ECEL action level means a concentration of airborne carbon
tetrachloride of 0.02 parts per million (ppm) calculated as an eight
(8)-hour time-weighted average (TWA).
Sec. 751.705 Prohibition of Certain Industrial and Commercial Uses
and Manufacturing, Processing, and Distribution in Commerce of Carbon
Tetrachloride for those Uses.
(a) Prohibitions. (1) After June 16, 2025, all persons are
prohibited from manufacturing, processing, distributing in commerce
(including making available) and using carbon tetrachloride for the
following conditions of use:
(i) Processing condition of use: Incorporation into formulation,
mixture or reaction products in petrochemical-derived manufacturing
except in the manufacture of vinyl chloride.
(ii) Industrial and commercial conditions of use:
(A) Industrial and commercial use as an industrial processing aid in
the manufacture of petrochemicals-derived products except in the
manufacture of vinyl chloride.
(B) Industrial and commercial use in the manufacture of other basic
chemicals (including manufacturing of chlorinated compounds used in
solvents, adhesives, asphalt, and paints and coatings), except for use
in the elimination of nitrogen trichloride in the production of chlorine
and caustic soda and the recovery of chlorine in tail gas from the
production of chlorine.
(C) Industrial and commercial use in metal recovery.
(D) Industrial and commercial use as an additive.
[[Page 223]]
(2) After December 18, 2025, all persons are prohibited from
manufacturing, processing, distributing in commerce (including making
available) and using carbon tetrachloride for industrial and commercial
specialty uses by the U.S. Department of Defense except as provided in
Sec. 751.709.
(b) [Reserved]
Sec. 751.707 Workplace Chemical Protection Program (WCPP).
(a) Applicability. The provisions of this section apply to the
following conditions of use of carbon tetrachloride, including
manufacturing and processing for export, except to the extent the
conditions of use are prohibited by Sec. 751.705:
(1) Domestic manufacture, except where carbon tetrachloride is
manufactured solely as a byproduct.
(2) Import.
(3) Processing as a reactant in the production of
hydrochlorofluorocarbons, hydrofluorocarbons, hydrofluoroolefins and
perchloroethylene.
(4) Processing: Incorporation into formulation, mixture, or reaction
products for agricultural products manufacturing, vinyl chloride
manufacturing, and other basic organic and inorganic chemical
manufacturing.
(5) Processing: Repackaging for use as a laboratory chemical.
(6) Processing: Recycling.
(7) Industrial and commercial use as an industrial processing aid in
the manufacture of agricultural products and vinyl chloride.
(8) Industrial and commercial use in the elimination of nitrogen
trichloride in the production of chlorine and caustic soda and the
recovery of chlorine in tail gas from the production of chlorine.
(9) Disposal.
(b) Existing chemical exposure limit (ECEL)--(1) Eight-hour time-
weighted average (TWA) ECEL. Beginning September 20, 2027 for Federal
agencies or Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or beginning four months after introduction of carbon
tetrachloride into the workplace if carbon tetrachloride commences after
June 11, 2026, the owner or operator must ensure that no person is
exposed to an airborne concentration of carbon tetrachloride in excess
of the ECEL, consistent with the requirements of paragraph (d)(1)(i) of
this section and, if necessary, paragraph (f) of this section.
(2) Exposure monitoring--(i) General. (A) Owners or operators must
determine each potentially exposed person's exposure, without regard to
respiratory protection, by either:
(1) Taking a personal breathing zone air sample of each potentially
exposed person's exposure; or
(2) Taking personal breathing zone air samples that are
representative of the 8-hour TWA of each exposure group.
(B) Personal breathing zone air samples are representative of the 8-
hour TWA of all potentially exposed persons in an exposure group if the
samples are of at least one person's full-shift exposure who represents
the highest potential carbon tetrachloride exposures in that exposure
group. Personal breathing zone air samples taken during one work shift
may be used to represent potentially exposed person exposures on other
work shifts where the owner or operator can document that the tasks
performed and conditions in the workplace are similar across shifts.
(C) Exposure samples must be analyzed using an appropriate
analytical method by a laboratory that complies with the Good Laboratory
Practice Standards in 40 CFR part 792 or a laboratory accredited by the
American Industrial Hygiene Association (AIHA) or another industry-
recognized program.
(D) Owners or operators must ensure that methods used to perform
exposure monitoring produce results that are accurate, to a confidence
level of 95 percent, to within plus or minus 25 percent for airborne
concentrations of carbon tetrachloride.
(E) Owners and operators must re-monitor within 15 working days
after receipt of any exposure monitoring when results indicate non-
detect, unless an Environmental Professional as defined at 40 CFR 312.10
or a Certified Industrial Hygienist reviews the exposure monitoring
results and determines re-monitoring is not necessary.
[[Page 224]]
(ii) Initial monitoring. By June 21, 2027 for Federal agencies and
Federal contractors acting for or on behalf of the Federal government,
or by June 11, 2026 for non-Federal owners and operators, or within 30
days of introduction of carbon tetrachloride into the workplace,
whichever is later, each owner or operator covered by this section must
perform initial monitoring of potentially exposed persons. Where the
owner or operator has monitoring results from monitoring conducted
within five years prior to February 18, 2025 and the monitoring
satisfies all other requirements of this section, the owner or operator
may rely on such earlier monitoring results to satisfy the requirements
of this paragraph (b)(2)(ii).
(iii) Periodic monitoring. The owner or operator must establish an
exposure monitoring program for periodic monitoring of exposure to
carbon tetrachloride in accordance with Table 1.
Table 1 to Sec. 751.707(b)(3)(iii)--Periodic Monitoring Requirements
------------------------------------------------------------------------
Periodic exposure monitoring
Air concentration condition requirement
------------------------------------------------------------------------
If all initial exposure monitoring is Periodic exposure monitoring is
below the ECEL action level (<0.02 ppm required at least once every
8-hour TWA). five years.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is required within three months
above the ECEL ( 0.03 ppm 8- of the most recent exposure
hour TWA). monitoring.
If the most recent exposure monitoring Periodic exposure monitoring is
indicates that airborne exposure is at required within six months of
or above the ECEL action level but at the most recent exposure
or below the ECEL (=0.02 monitoring.
ppm 8-hour TWA, <=0.03 ppm 8-hour TWA).
If the two most recent (non-initial) Periodic exposure monitoring is
exposure monitoring measurements, required within five years of
taken at least seven days apart within the most recent exposure
a 6-month period, indicate exposure is monitoring.
below the ECEL action level (<0.02 ppm
8-hour TWA).
If the owner or operator engages in a The owner or operator may forgo
condition of use for which WCPP ECEL the next periodic exposure
would be required but does not monitoring event. However,
manufacture, process, use, or dispose documentation of cessation of
of carbon tetrachloride in that use of carbon tetrachloride is
condition of use over the entirety of required; and periodic
time since the last required monitoring would be required
monitoring event. when the owner or operator
resumes the condition of use.
------------------------------------------------------------------------
(iv) Additional exposure monitoring. (A) The owner or operator must
conduct additional exposure monitoring within a reasonable timeframe
whenever there has been a change in the production, process, control
equipment, personnel or work practices that may reasonably be expected
to result in new or additional exposures above the ECEL or when the
owner or operator has any reason to believe that new or additional
exposures above the ECEL action level have occurred.
(B) Whenever start-ups or shutdowns, or ruptures, malfunctions or
other breakdowns or unexpected releases occur that may lead to exposure
to potentially exposed persons, the owner or operator must conduct the
additional exposure monitoring within a reasonable timeframe after the
conclusion of the start-up or shutdown and/or the cleanup, repair or
remedial action of the malfunction or other breakdown or unexpected
release. Prior monitoring data cannot be used to meet this requirement.
(v) Observation of monitoring. (A) Owners and operators must provide
potentially exposed persons or their designated representatives an
opportunity to observe any monitoring of occupational exposure to CTC
that is conducted under this section and designed to characterize their
exposure.
(B) When monitoring observation requires entry into a regulated
area, the owner or operator must provide the observers with the required
PPE.
(C) Only persons who are authorized to have access to facilities
classified in the interest of national security must be permitted to
observe exposure monitoring conducted in such facilities.
(vi) Notification of monitoring results. (A) The owner or operator
must inform each person whose exposures are monitored or who is part of
a monitored exposure group and their designated representatives of any
monitoring results within 15 working days of receipt of those monitoring
results.
(B) This notification must include the following:
[[Page 225]]
(1) Exposure monitoring results;
(2) Identification and explanation of the ECEL and ECEL action
level;
(3) Statement of whether the monitored airborne concentration of
carbon tetrachloride exceeds the ECEL action level or ECEL;
(4) If the ECEL is exceeded, descriptions of any exposure controls
implemented by the owner or operator to reduce exposures to or below the
ECEL, as required by paragraph (d)(1) of this section;
(5) Explanation of any required respiratory protection provided in
accordance with paragraphs (b)(3)(iv), (d)(1)(i), and (f) of this
section;
(6) Quantity of carbon tetrachloride in use at the time of
monitoring;
(7) Location of carbon tetrachloride use at the time of monitoring;
(8) Manner of carbon tetrachloride use at the time of monitoring;
and
(9) Identified releases of carbon tetrachloride;
(C) Notice must be written in plain language and either provided to
each potentially exposed person and their designated representatives
individually in a language that the person understands, or posted in an
appropriate and accessible location outside the regulated area with an
English-language version and a non-English language version representing
the language of the largest group of workers who do not read English.
(3) Regulated areas--(i) Establishment. By September 20, 2027 for
Federal agencies and Federal contractors acting for or on behalf of the
Federal government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, the owner or
operator must establish and maintain a regulated area wherever airborne
concentrations of carbon tetrachloride exceeds or can reasonably be
expected to exceed the ECEL.
(ii) Access. The owner or operator must limit access to regulated
areas to authorized persons.
(iii) Demarcation. The owner or operator must demarcate regulated
areas from the rest of the workplace in a manner that adequately
establishes and alerts persons to the boundaries of the area and
minimizes the number of authorized persons exposed to carbon
tetrachloride within the regulated area.
(iv) Provisions of respirators. (A) The owner or operator must
ensure that each person who enters a regulated area is supplied with a
respirator selected in accordance with paragraph (f) of this section and
must ensure that all persons within the regulated area are using the
provided respirators whenever carbon tetrachloride exposures may exceed
the ECEL.
(B) An owner or operator who has implemented all feasible controls
as required in paragraph (d)(1)(i) of this section, and who has
established a regulated area as required by paragraph (b)(3)(i) of this
section where carbon tetrachloride exposure can be reliably predicted to
exceed the ECEL only on certain days (for example, because of work or
process schedule) must have persons use respirators in that regulated
area on those days.
(v) Prohibited activities. (A) The owner or operator must ensure
that, within a regulated area, persons do not engage in non-work
activities which may increase CTC exposure.
(B) The owner or operator must ensure that while persons are wearing
respirators in the regulated area, they do not engage in activities
which interfere with respirator performance.
(c) Direct dermal contact controls (DDCC). Beginning September 20,
2027 for Federal agencies or Federal contractors acting for or on behalf
of the Federal government, or by June 16, 2025 for non-Federal owners
and operators, or within 30 days of introduction of carbon tetrachloride
into the workplace, whichever is later, owners or operators must ensure
that all persons are separated, distanced, physically removed, or
isolated to prevent direct dermal contact with carbon tetrachloride or
from contact with equipment or materials on which carbon tetrachloride
may exist consistent with the requirements of paragraph (d)(1)(ii) of
this section and, if necessary, paragraph (f) of this section.
(d) Exposure control procedures and plan--(1) Methods of
compliance--(i) ECEL. (A) By December 3, 2027, the owner or operator
must institute one
[[Page 226]]
or a combination of elimination, substitution, engineering controls, or
administrative controls to reduce exposure to or below the ECEL except
to the extent that the owner or operator can demonstrate that such
controls are not feasible, in accordance with the hierarchy of controls.
(B) If the feasible controls required under paragraph (d)(1)(i)(A)
of this section that can be instituted do not reduce exposures for
potentially exposed persons to or below the ECEL, then the owner or
operator must use such controls to reduce exposure to the lowest levels
achievable by these controls and must supplement those controls with the
use of respiratory protection that complies with the requirements of
paragraph (f) of this section.
(C) Where an owner or operator cannot demonstrate exposure to carbon
tetrachloride has been reduced to or below the ECEL through the use of
controls required under paragraphs (d)(1)(i)(A) and (B) of this section,
and has not demonstrated that it has appropriately supplemented with
respiratory protection that complies with the requirements of paragraph
(f) of this section, this will constitute a failure to comply with the
ECEL.
(D) The owner or operator must ensure that any engineering controls
instituted under paragraph (d)(1)(i)(A) of this section do not increase
emissions of carbon tetrachloride to ambient air outside the workplace.
(ii) Direct dermal contact controls (DDCC). (A) The owner or
operator must institute one or a combination of elimination,
substitution, engineering controls, or administrative controls to
prevent all persons from direct dermal contact with carbon tetrachloride
except to the extent that the owner or operator can demonstrate that
such controls are not feasible.
(B) If the feasible controls required under paragraph (d)(1)(ii)(A)
of this section that can be instituted do not prevent direct dermal
contact with carbon tetrachloride, then the owner or operator must use
such controls to reduce direct dermal contact to the extent achievable
by these controls and must supplement those controls by the use of
dermal protection that complies with the requirements of paragraph (f)
of this section.
(C) Where an owner or operator cannot demonstrate that direct dermal
contact to carbon tetrachloride is prevented through the use of controls
required under paragraphs (d)(1)(ii)(A) and (B) of this section, and has
not demonstrated that it has appropriately supplemented with dermal
protection that complies with the requirements of paragraph (f) of this
section, this will constitute a failure to comply with the DDCC
requirements.
(2) Exposure control plan. By December 3, 2027, each owner and
operator must establish and implement an exposure control plan.
(i) Exposure control plan contents. The exposure control plan must
include documentation of the following:
(A) Identification of exposure controls that were considered,
including those that were used or not used to meet the requirements of
paragraphs (d)(1)(i)(A) and (d)(1)(ii)(A) of this section, in the
following sequence: elimination, substitution, engineering controls and
administrative controls;
(B) For each exposure control considered, a rationale for why the
exposure control was selected or not selected based on feasibility,
effectiveness, and other relevant considerations;
(C) A description of actions the owner or operator must take to
implement exposure controls selected, including proper installation,
regular inspections, maintenance, training or other actions;
(D) A description of regulated areas, how they are demarcated, and
persons authorized to enter the regulated areas;
(E) Attestation that exposure controls selected do not increase
emissions of carbon tetrachloride to ambient air outside of the
workplace and whether additional equipment was installed to capture or
otherwise prevent increased emissions of carbon tetrachloride to ambient
air;
(F) Description of activities conducted by the owner or operator to
review and update the exposure control plan to ensure effectiveness of
the exposure controls, identify any necessary updates to the exposure
controls, and
[[Page 227]]
confirm that all persons are properly implementing the exposure
controls;
(G) An explanation of the procedures for responding to any change
that may reasonably be expected to introduce additional sources of
exposure to carbon tetrachloride, or otherwise result in increased
exposure to carbon tetrachloride, including procedures for implementing
corrective actions to mitigate exposure to carbon tetrachloride.
(ii) Exposure control plan requirements. (A) The owner or operator
must not implement a schedule of personnel rotation as a means of
compliance with the ECEL.
(B) The owner or operator must maintain the effectiveness of any
controls instituted under this paragraph (d).
(C) The exposure control plan must be reviewed and updated as
necessary, but at least every five years, to reflect any significant
changes in the status of the owner or operator's approach to compliance
with paragraphs (b) through (d) of this section.
(iii) Availability of exposure control plan. (A) Owners or operators
must make the exposure control plan and associated records, including
ECEL exposure monitoring records, ECEL compliance records, DDCC
compliance records, and workplace participation records described in
Sec. 751.713(b), available to potentially exposed persons and their
designated representatives.
(B) Owners or operators must notify potentially exposed persons and
their designated representatives of the availability of the exposure
control plan and associated records within 30 days of the date that the
exposure control plan is completed and at least annually thereafter.
(C) Notice of the availability of the exposure control plan and
associated records must be provided in plain language writing to each
potentially exposed person in a language that the person understands or
posted in an appropriate and accessible location outside the regulated
area with an English-language version and a non-English language version
representing the language of the largest group of workers who do not
read English.
(D) Upon request by the potentially exposed person or their
designated representative(s), the owner or operator must provide the
specified records at a reasonable time, place, and manner. If the owner
or operator is unable to provide the requested records within 15 days,
the owner or operator must, within those 15 days, inform the potentially
exposed person or designated representative(s) requesting the record(s)
of the reason for the delay and the earliest date when the record will
be made available.
(e) Workplace information and training. (1) By September 20, 2027
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or by September 9, 2026 for non-Federal owners
and operators, the owner or operator must institute a training program
and ensure that persons potentially exposed to carbon tetrachloride
participate in the program according to the requirements of this
paragraph (e).
(2) The owner or operator must ensure that each potentially exposed
person is trained prior to or at the time of a potential exposure to
carbon tetrachloride.
(3) The owner or operator must ensure that information and training
is presented in a manner that is understandable to each person required
to be trained and in multiple languages as appropriate, such as, based
on languages spoken by potentially exposed persons in the workplace.
(4) The following information and training must be provided to all
persons potentially exposed to carbon tetrachloride:
(i) The requirements of this section, as well as how to access or
obtain a copy of these requirements in the workplace;
(ii) The quantity, location, manner of use, release, and storage of
carbon tetrachloride and the specific operations in the workplace that
could result in exposure to carbon tetrachloride, particularly noting
where each regulated area is located;
(iii) Methods and observations that may be used to detect the
presence or release of carbon tetrachloride in the
[[Page 228]]
workplace (such as monitoring conducted by the owner or operator,
continuous monitoring devices, visual appearance or odor of carbon
tetrachloride when being released);
(iv) The acute and chronic health hazards of carbon tetrachloride as
detailed on relevant Safety Data Sheets; and
(v) The principles of safe use and handling of carbon tetrachloride
and measures potentially exposed persons can take to protect themselves
from carbon tetrachloride, including specific procedures the owner or
operator has implemented to protect potentially exposed persons from
exposure to carbon tetrachloride, such as appropriate work practices,
emergency procedures, and personal protective equipment to be used.
(5) The owner or operator must re-train each potentially exposed
person as necessary, but at minimum annually, to ensure that each such
person maintains the requisite understanding of the principles of safe
use and handling of carbon tetrachloride in the workplace.
(6) Whenever there are workplace changes, such as modifications of
tasks or procedures or the institution of new tasks or procedures, that
increase exposure, and where such exposure exceeds or can reasonably be
expected to exceed the ECEL action level or increase potential for
direct dermal contact with carbon tetrachloride, the owner or operator
must update the training as necessary to ensure that each potentially
exposed person is re-trained.
(f) Personal protective equipment (PPE). (1) General. The provisions
of this paragraph (f) apply to any owner or operator that is required to
provide respiratory protection pursuant to paragraphs (b)(3)(iv) or
(d)(1)(i)(B) of this section or dermal protection pursuant to paragraphs
(c) or (d)(1)(ii)(B) of this section or Sec. 751.709(b)(3) or (4).
(2) Respiratory protection. (i) By September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by September 9, 2026 for non-Federal owners and
operators, or within three months after receipt of any exposure
monitoring that indicates exposures exceeding the ECEL, if an owner or
operator is required to provide respiratory protection pursuant to
paragraph (f)(1) of this section, the owner or operator must ensure that
each potentially exposed person is provided with a respirator according
to the requirements of this section.
(ii) For purposes of this paragraph (f)(2), cross-referenced
provisions in 29 CFR 1910.134 applying to an ``employee'' apply equally
to potentially exposed persons and cross-referenced provisions applying
to an ``employer'' also apply equally to owners or operators. Other
terms in cross-referenced provisions in 29 CFR 1910.134 that are defined
in 29 CFR 1910.134(b) have the meaning assigned to them in that
paragraph.
(iii) By September 20, 2027 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or by
September 9, 2026 for non-Federal owners and operators, or within three
months after receipt of any exposure monitoring that indicates exposures
exceeding the ECEL, if an owner or operator is required to provide
respiratory protection pursuant to (f)(1) of this section, the owner or
operator must develop and administer a written respiratory protection
program consistent with the requirements of 29 CFR 1910.134(c)(1),
(c)(3) and (c)(4).
(iv) Owners and operators must select respiratory protection
required by paragraph (f)(2)(i) of this section based on a medical
evaluation consistent with the requirements of 29 CFR 1910.134(e). If a
potentially exposed person cannot use a negative-pressure respirator
that would otherwise be required by paragraph (f)(1) of this section,
then the owner or operator must provide that person with an alternative
respirator. The alternative respirator must have less breathing
resistance than the negative-pressure respirator and provide equivalent
or greater protection. If the person is unable to use an alternative
respirator, then the person must not be permitted to enter the regulated
area.
(v) Owners and operators must select respiratory protection that
properly
[[Page 229]]
fits each affected person and communicate respirator selections to each
affected person consistent with the requirements of 29 CFR 1910.134(f).
(vi) Owners and operators must provide, ensure use of, and maintain
(in a sanitary, reliable, and undamaged condition) respiratory
protection that is of safe design and construction for the applicable
condition of use consistent with the requirements of 29 CFR 1910.134(g)
through (j).
(vii) Prior to or at the time of initial assignment to a job
involving potential exposure to carbon tetrachloride, owners and
operators must provide training to all persons required to use
respiratory protection consistent with 29 CFR 1910.134(k).
(viii) Owners and operators must retrain all persons required to use
PPE at least annually, or whenever the owner or operator has reason to
believe that a previously trained person does not have the required
understanding and skill to properly use PPE, or when changes in the
workplace or in PPE to be used render the previous training obsolete.
(ix) Owners or operators must select and provide to persons
appropriate respirators as indicated by the most recent monitoring
results as follows:
(A) If the measured exposure concentration is at or below the 0.03
ppm: no respiratory protection is required.
(B) If the measured exposure concentration is above 0.03 ppm and
less than or equal to 0.3 ppm (10 times ECEL): Any National Institute
for Occupational Safety and Health(NIOSH)-Approved air-purifying half
mask respirator equipped with organic vapor cartridges or canisters; or
any NIOSH Approved Supplied-Air Respirator (SAR) or Airline Respirator
operated in demand mode equipped with a half mask; or any NIOSH Approved
Self-Contained Breathing Apparatus (SCBA) in demand mode equipped with a
half mask [APF 10].
(C) If the measured exposure concentration is above 0.3 ppm and less
than or equal to 0.75 ppm (25 times ECEL): Any NIOSH Approved Powered
Air-Purifying Respirator (PAPR) equipped with a loose-fitting facepiece
or hood/helmet equipped with organic vapor cartridges or canisters; any
NIOSH Approved continuous flow supplied air respirator equipped with a
loose-fitting facepiece; or any NIOSH Approved Supplied-Air Respirator
(SAR) or Airline Respirator in a continuous-flow mode equipped with a
loose-fitting facepiece or helmet/hood [APF 25].
(D) If the measured exposure concentration is above 0.75 ppm and
less than or equal to 1.5 ppm (50 times ECEL): Any NIOSH Approved air-
purifying full facepiece respirator equipped with organic vapor
cartridges or canisters; any NIOSH Approved PAPR with a half mask
equipped with organic vapor cartridges or canisters; any NIOSH Approved
SAR or Airline Respirator in a continuous flow mode equipped with a half
mask; any NIOSH Approved SAR or Airline Respirator operated in a
pressure-demand or other positive-pressure mode with a half mask; or any
NIOSH Approved SCBA in demand-mode equipped with a full facepiece or
helmet/hood [APF 50].
(E) If the measured exposure concentration is above 1.5 ppm and less
than or equal to 30 ppm (1,000 times ECEL): Any NIOSH Approved PAPR
equipped with a full facepiece equipped with organic vapor cartridges or
canisters; any NIOSH Approved SAR or Airline Respirator in a continuous-
flow mode equipped with full facepiece; any NIOSH Approved SAR or
Airline Respirator in pressure-demand or other positive-pressure mode
equipped with a full facepiece and an auxiliary self-contained air
supply; or any NIOSH Approved SAR or Airline Respirator in a continuous-
flow mode equipped with a helmet or hood and that has been tested to
demonstrated performance at a level of a protection of APF 1,000 or
greater [APF 1000].
(F) If the measured exposure concentration is greater than 30 ppm
(1,000 times ECEL): Any NIOSH Approved SCBA in a pressure-demand or
other positive-pressure mode equipped with a full facepiece helmet/hood
[APF 10,000].
(G) If the exposure concentration is unknown: Any NIOSH Approved
combination supplied air respirator equipped with a full facepiece and
operated in pressure demand or other positive pressure mode with an
auxiliary self-contained air supply; or any
[[Page 230]]
NIOSH Approved SCBA operated in pressure demand or other positive
pressure mode and equipped with a full facepiece or helmet/hood [APF
1000+].
(x) Owners and operators must select and provide respirators as
required in paragraph (f)(2) of this section consistent with the
requirements of 29 CFR 1910.134(d)(1)(iv), and with consideration of
workplace and user factors that affect respirator performance and
reliability.
(xi) Owners and operators who select air-purifying respirators must
either:
(A) Select respirators that have an end-of-service-life indicator
(ESLI) that is NIOSH Approved[supreg] for carbon tetrachloride; or
(B) Implement a change schedule for canisters and cartridges based
on objective information or data that ensures that canisters and
cartridges are changed before the end of their service life. The written
respiratory protection program required by paragraph (f)(2)(iii) of this
section must include a description of the information and data relied
upon, the basis for reliance on the information and data, and the basis
for the canister and cartridge change schedule.
(xii) Owners and operators must ensure that respirators are used in
compliance with the terms of the respirator's NIOSH certification.
(xiii) Owners and operators must conduct regular evaluations of the
workplace, including consultations with potentially exposed persons
using respiratory protection, consistent with the requirements of 29 CFR
1910.134(l), to ensure that the provisions of the written respiratory
protection program required under paragraph (f)(2)(iii) of this section
are being effectively implemented.
(xiv) The respiratory protection requirements in this paragraph
(f)(2) represent the minimum respiratory protection requirements, such
that any respirator affording a higher degree of protection than the
required respirator may be used.
(3) Dermal protection. (i) Beginning September 20, 2027 for Federal
agencies and Federal contractors acting for or on behalf of the Federal
government, or by June 16, 2025 for non-Federal owners and operators, if
an owner or operator is required to provide dermal protection pursuant
to paragraph (f)(1), the owner or operator must ensure that each
potentially exposed person is provided with dermal PPE according to the
requirements of this section.
(ii) Owners or operators must supply and require the donning of
dermal PPE that separates and provides a barrier to prevent direct
dermal contact with carbon tetrachloride in the specific work area where
it is selected for use, selected in accordance with this paragraph and
provided in accordance with 29 CFR 1910.132(h), to each person who is
reasonably likely to be dermally exposed in the work area through direct
dermal contact with carbon tetrachloride. For the purposes of this
subsection, provisions in 29 CFR 1910.132(h) applying to an ``employee''
also apply equally to potentially exposed persons, and provisions
applying to an ``employer'' also apply equally to owners or operators.
(iii) Owners or operators must select and provide dermal PPE in
accordance with 29 CFR 1910.133(b) and additionally as specified in this
paragraph (f)(3) to each person who is reasonably likely to be dermally
exposed in the work area through direct dermal contact with carbon
tetrachloride. For the purposes of this paragraph (f)(3)(iii),
provisions in 29 CFR 1910.133(b) applying to an ``employer'' also apply
equally to owners or operators.
(iv) Owners or operators must select and provide to persons
appropriate dermal PPE based on an evaluation of the performance
characteristics of the PPE relative to the task(s) to be performed,
conditions present, and the duration of use. Replacement PPE must be
provided immediately if any person is dermally exposed to CTC longer
than the breakthrough time period for which testing has demonstrated
that the PPE will be impermeable or if there is a chemical permeation or
breakage of the PPE. Dermal PPE must include, but is not limited to, the
following items:
(A) Impervious gloves selected based on specifications from the
manufacturer or supplier or by individually prepared third-party
testing.
[[Page 231]]
(B) Impervious clothing covering the exposed areas of the body
(e.g., long pants, long sleeved shirt).
(v) Owners or operators must demonstrate that each item of gloves
and other clothing selected provides an impervious barrier to prevent
direct dermal contact with carbon tetrachloride during normal and
expected duration and conditions of exposure within the work area by
evaluating the specifications from the manufacturer or supplier or
individually prepared third-party testing of the dermal PPE, or of the
material used in construction of the dermal PPE, to establish that the
dermal PPE will be impervious to carbon tetrachloride alone and in
likely combination with other chemical substances in the work area.
(vi) Dermal PPE that is of safe design and construction for the work
to be performed must be provided, used, and maintained in a sanitary,
reliable, and undamaged condition. Owners and operators must select PPE
that properly fits each affected person and communicate PPE selections
to each affected person.
(vii) Owners or operators must provide training in accordance with
29 CFR 1910.132(f) to all persons required to use dermal protection
prior to or at the time of initial assignment to a job involving
exposure to carbon tetrachloride. For the purposes of this paragraph
(f)(3)(vii), provisions in 29 CFR 1910.132(f) applying to an
``employee'' also apply equally to potentially exposed persons, and
provisions applying to an ``employer'' also apply equally to owners or
operators.
(viii) Owners and operators must retrain each person required to use
dermal protection at least annually or whenever the owner or operator
has reason to believe that a previously trained person does not have the
required understanding and skill to properly use dermal protection, or
when changes in the workplace or in dermal protection to be used render
the previous training obsolete.
Sec. 751.709 Workplace Restrictions for the Industrial and Commercial
Use as a Laboratory Chemical, Including the Use of Carbon Tetrachloride
as a Laboratory Chemical by the U.S. Department of Defense.
(a) Applicability. The provisions of this section apply to the
industrial and commercial use of carbon tetrachloride as a laboratory
chemical, including the U.S. Department of Defense's industrial and
commercial use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(b) Laboratory chemical requirements. (1) After December 18, 2025
for Federal agencies and Federal contractors acting for or on behalf of
the Federal government, or after June 16, 2025 for non-Federal owners
and operators, owners or operators must ensure laboratory ventilation
devices such as fume hoods or glove boxes are in use and functioning
properly and that specific measures are taken to ensure proper and
adequate performance of such equipment to minimize exposures to
potentially exposed persons in the area when carbon tetrachloride is
used as a laboratory chemical, except for the U.S. Department of
Defense's use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction.
(2) After December 18, 2025, the U.S. Department of Defense must
ensure that advanced engineering controls are in use and functioning
properly and that specific measures are taken to ensure proper and
adequate performance of such equipment to minimize exposures to
potentially exposed persons in the area during the industrial/commercial
use of carbon tetrachloride as a laboratory chemical in chemical weapons
destruction.
(3) After December 18, 2025 for Federal agencies and Federal
contractors acting for or on behalf of the Federal government, or after
June 16, 2025 for non-Federal owners and operators, owners or operators
must ensure that all persons reasonably likely to be exposed from direct
dermal contact to carbon tetrachloride when carbon tetrachloride is used
as a laboratory chemical, except for the U.S. Department of Defense's
industrial and commercial use of carbon tetrachloride as
[[Page 232]]
a laboratory chemical in chemical weapons destruction, are provided with
dermal PPE and training on proper use of PPE in a manner consistent with
Sec. 751.707(f)(3).
(4) After December 18, 2025, U.S. Department of Defense must ensure
that all persons reasonably likely to be exposed from direct dermal
contact to carbon tetrachloride through the industrial and commercial
use of carbon tetrachloride as a laboratory chemical in chemical weapons
destruction are provided with dermal PPE and training on proper use of
PPE in a manner consistent with Sec. 751.707(f)(3), except that the
date listed in paragraph (f)(3)(i) does not apply.
Sec. 751.711 Downstream Notification.
(a) Beginning on February 18, 2025, each person who manufactures
(including imports) carbon tetrachloride for any use must, prior to or
concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(b) Beginning on June 16, 2025, each person who processes or
distributes in commerce carbon tetrachloride for any use must, prior to
or concurrent with the shipment, notify companies to whom carbon
tetrachloride is shipped, in writing, of the restrictions described in
this Subpart in accordance with paragraph (c) of this section.
(c) The notification required under paragraphs (a) and (b) of this
section must occur by inserting the following text in Sections 1(c) and
15 of the Safety Data Sheet (SDS) provided with the carbon
tetrachloride:
After June 16, 2025, this chemical substance (as defined in TSCA
section 3(2)) may not be distributed in commerce or processed in greater
than trace quantities for the following purposes: Incorporation into
formulation, mixture or reaction products in petrochemical-derived
manufacturing except in the manufacture of vinyl chloride; Industrial
and commercial use as an industrial processing aid in the manufacture of
petrochemicals-derived products except in the manufacture of vinyl
chloride; Industrial and commercial use in the manufacture of other
basic chemicals (including manufacturing of chlorinated compounds used
in solvents, adhesives, asphalt, and paints and coatings), except for
use in the elimination of nitrogen trichloride in the production of
chlorine and caustic soda and the recovery of chlorine in tail gas from
the production of chlorine; Industrial and commercial use in metal
recovery; Industrial and commercial use as an additive; and beginning
December 18, 2025, industrial and commercial specialty uses by the U.S.
Department of Defense.
Sec. 751.713 Recordkeeping Requirements.
(a) General records. After February 18, 2025, all persons who
manufacture (including import), process, distribute in commerce, or
engage in industrial or commercial use of carbon tetrachloride must
maintain ordinary business records, such as downstream notifications,
invoices and bills-of-lading related to compliance with the
prohibitions, restrictions, and other provisions of this subpart.
(b) Workplace Chemical Protection Program compliance--(1) ECEL
exposure monitoring. For each monitoring event, owners or operators
subject to the ECEL described in Sec. 751.707(b) must document and
retain records of the following:
(i) Dates, duration, and results of each sample taken;
(ii) The quantity, location(s) and manner of use of carbon
tetrachloride in use at the time of each monitoring event;
(iii) All measurements that may be necessary to determine the
conditions that may affect the monitoring results;
(iv) Name, workplace address, work shift, job classification, work
area, and type of respiratory protection (if any) by each monitored
person;
(v) Identification of all potentially exposed persons that a
monitored person is intended to represent if using a representative
sample, consistent with Sec. 751.707(b)(2)(i)(A) and (B);
(vi) Sampling and analytical methods used as described in Sec.
751.707(b)(2)(i)(D);
(vii) Compliance with the Good Laboratory Practice Standards in 40
CFR part 792, or use of laboratory accredited by the AIHA or another
industry-recognized program, as required by Sec. 751.707(b)(2)(i)(C);
and
(viii) Information regarding air monitoring equipment, including:
type,
[[Page 233]]
maintenance, calibrations, performance tests, limits of detection, and
any malfunctions;
(ix) Re-monitoring determinations conducted by an Environmental
Professional as defined at 40 CFR 312.10 or a Certified Industrial
Hygienist, if results indicated non-detect; and
(x) Notification of exposure monitoring results in accordance with
Sec. 751.707(b)(2)(v).
(2) ECEL compliance. Owners or operators subject to the ECEL
described in Sec. 751.707(b) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Implementation of the exposure control plan as described in
Sec. 751.707(d)(2), including:
(A) Any regular inspections, evaluations, and updating of the
exposure controls to maintain effectiveness;
(B) Confirmation that all persons are implementing the exposure
controls; and
(C) Each occurrence and duration of any start-up, shutdown,
ruptures, or malfunction of the facility that causes an exceedance of
the ECEL, any subsequent corrective actions taken by the owner or
operator during the start-up, shutdown, ruptures, or malfunctions to
mitigate exposures to CTC, and documentation indicating that additional
monitoring was completed within a reasonable timeframe.
(iii) Respiratory protection used by each potentially exposed person
and PPE program implementation as described in Sec. 751.707(f)(2)
including:
(A) The name, workplace address, work shift, job classification,
work area of each potentially exposed person, and the type of
respiratory protection provided to each potentially exposed person;
(B) The basis for the specific respiratory protection selection in
accordance with Sec. 751.707(f)(2); and
(C) Fit testing and training in accordance with Sec. 751.707(f)(2).
(iv) Information and training as required in Sec. 751.707(e).
(3) DDCC compliance. Owners or operators subject to DDCC
requirements described in Sec. 751.707(c) must retain records of:
(i) Exposure control plan as described in Sec. 751.707(d)(2);
(ii) Dermal protection used by each potentially exposed person and
PPE program implementation as described in Sec. 751.707(f)(3),
including:
(A) The name, workplace address, work shift, job classification, and
work area of each person reasonably likely to directly handle carbon
tetrachloride or handle equipment or materials on which carbon
tetrachloride may be present and the type of PPE selected to be worn by
each of these persons;
(B) The basis for specific PPE selection (e.g., demonstration based
on permeation testing or manufacturer specifications that each item of
PPE selected provides an impervious barrier to prevent exposure during
expected duration and conditions of exposure, including the likely
combinations of chemical substances to which the PPE may be exposed in
the work area);
(C) Appropriately sized PPE and training on proper application,
wear, and removal of PPE, and proper care/disposal of PPE;
(D) Occurrence and duration of any direct dermal contact with carbon
tetrachloride that occurs during any activity or malfunction at the
workplace that causes direct dermal exposures to occur and/or glove
breakthrough, and corrective actions to be taken during and immediately
following that activity or malfunction to prevent direct dermal contact
to carbon tetrachloride; and
(E) Training in accordance with Sec. 751.707(f)(3).
(iii) Information and training provided as required in Sec.
751.707(e).
(4) Workplace participation. Owners or operators must document the
notice to and ability of any potentially exposed person that may
reasonably be affected by carbon tetrachloride inhalation exposure or
direct dermal contact and their designated representatives to readily
access the exposure control plans, facility exposure monitoring records,
PPE program implementation records, or any other information relevant to
carbon tetrachloride exposure in the workplace.
(c) Workplace requirements for laboratory use compliance. Owners and
operators subject to the laboratory chemical requirements described in
Sec. 751.709 must retain records of:
[[Page 234]]
(1) Dermal protection used by each potentially exposed person and
PPE program implementation, as described in Sec. 751.713(b)(3)(ii); and
(2) Documentation identifying criteria that the owner or operator
will use to determine and implement control measures to reduce
potentially exposed persons' exposure to carbon tetrachloride including
laboratory ventilation devices;
(3) Documentation identifying: implementation of a properly
functioning laboratory ventilation devices using manufacturer's
instructions for installation, use, and maintenance of the devices
including inspections, tests, development of maintenance procedures, the
establishment of criteria for acceptable test results, and documentation
of test and inspection results, except for the U.S. Department of
Defense's use of carbon tetrachloride as a laboratory chemical in
chemical weapons destruction; and
(4) For the U.S. Department of Defense's use of carbon tetrachloride
as a laboratory chemical in chemical weapons destruction, documentation
identifying implementation of advanced engineering controls that are in
use and functioning properly and specific measures taken to ensure
proper and adequate performance.
(d) Retention. Owners or operators must retain the records required
under this section for a period of five years from the date that such
records were generated.
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 Incorporation by reference.
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.
761.66 Emergency situations.
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,
[[Page 235]]
process, distribute in commerce, or use chemicals containing
inadvertently generated PCBs.
Subpart K_PCB Waste Disposal Records and Reports
761.202 EPA identification numbers.
761.205 Notification of PCB waste activity (EPA Form 7710-53).
761.207 The manifest--general requirements.
761.208 Obtaining manifests.
761.209 Number of copies of a manifest.
761.210 Use of the manifest--Generator requirements.
761.211 Manifest system--Transporter requirements.
761.212 Transporter compliance with the manifest.
761.213 Use of manifest--Commercial storage and disposal facility
requirements.
761.214 Retention of manifest records.
761.215 Manifest discrepancies.
761.216 Unmanifested waste report.
761.217 Exception reporting.
761.218 Certificate of disposal.
761.219 One-year exception reporting.
Subpart L [Reserved]
Subpart M_Determining a PCB Concentration for Purposes of Abandonment or
Disposal of Natural Gas Pipeline: Selecting Sample Sites, Collecting
Surface Samples, and Analyzing Standard PCB Wipe Samples
761.240 Scope and definitions.
761.243 Standard wipe sample method and size.
761.247 Sample site selection for pipe segment removal.
761.250 Sample site selection for pipeline section abandonment.
761.253 Chemical analysis.
761.257 Determining the regulatory status of sampled pipe.
Subpart N_Cleanup Site Characterization Sampling for PCB Remediation
Waste in Accordance with 761.61(a)(2)
761.260 Applicability.
761.265 Sampling bulk PCB remediation waste and porous surfaces.
761.267 Sampling non-porous surfaces.
761.269 Sampling liquid PCB remediation waste.
761.272 Chemical extraction and analysis of samples.
761.274 Reporting PCB concentrations in samples.
Subpart O_Sampling To Verify Completion of Self-Implementing Cleanup and
On-Site Disposal of Bulk PCB Remediation Waste and Porous Surfaces in
Accordance with 761.61(a)(6)
761.280 Application and scope.
761.283 Determination of the number of samples to collect and sample
collection locations.
761.286 Sample size and procedure for collecting a sample.
761.289 Compositing samples.
761.292 Chemical extraction and analysis of individual samples and
composite samples.
761.295 Reporting and recordkeeping of the PCB concentrations in
samples.
761.298 Decisions based on PCB concentration measurements resulting from
sampling.
Subpart P_Sampling Non-Porous Surfaces for Measurement-Based Use, Reuse,
and On-Site or Off-Site Disposal Under 761.61(a)(6) and Determination
Under 761.79(b)(3)
761.300 Applicability.
761.302 Proportion of the total surface area to sample.
761.304 Determining sample location.
761.306 Sampling 1 meter square surfaces by random selection of halves.
761.308 Sample selection by random number generation on any two-
dimensional square grid.
761.310 Collecting the sample.
761.312 Compositing of samples.
761.314 Chemical analysis of standard wipe test samples.
761.316 Interpreting PCB concentration measurements resulting from this
sampling scheme.
Subpart Q_Self-Implementing Alternative Extraction and Chemical Analysis
Procedures for Non-liquid PCB Remediation Waste Samples
761.320 Applicability.
761.323 Sample preparation.
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.
[[Page 236]]
761.345 Form of the waste to be sampled.
761.346 Three levels of sampling.
761.347 First level sampling--waste from existing piles.
761.348 Contemporaneous sampling.
761.350 Subsampling from composite samples.
761.353 Second level of sample selection.
761.355 Third level of sample selection.
761.356 Conducting a leach test.
761.357 Reporting the results of the procedure used to simulate leachate
generation.
761.358 Determining the PCB concentration of samples of waste.
761.359 Reporting the PCB concentrations in samples.
Subpart S_Double Wash/Rinse Method for Decontaminating Non-Porous
Surfaces
761.360 Background.
761.363 Applicability.
761.366 Cleanup equipment.
761.369 Pre-cleaning the surface.
761.372 Specific requirements for relatively clean surfaces.
761.375 Specific requirements for surfaces coated or covered with dust,
dirt, grime, grease, or another absorbent material.
761.378 Decontamination, reuse, and disposal of solvents, cleaners, and
equipment.
Subpart T_Comparison Study for Validating a New Performance-Based
Decontamination Solvent Under 761.79(d)(4)
761.380 Background.
761.383 Applicability.
761.386 Required experimental conditions for the validation study and
subsequent use during decontamination.
761.389 Testing parameter requirements.
761.392 Preparing validation study samples.
761.395 A validation study.
761.398 Reporting and recordkeeping.
Authority: 15 U.S.C. 2605, 2607, 2611, 2614, and 2616 and 42 U.S.C.
6939g.
Source: 43 FR 7156, Feb. 17, 1978, unless otherwise noted.
Subpart A_General
Sec. 761.1 Applicability.
(a) This part establishes prohibitions of, and requirements for, the
manufacture, processing, distribution in commerce, use, disposal,
storage, and marking of PCBs and PCB Items.
(b)(1) This part applies to all persons who manufacture, process,
distribute in commerce, use, or dispose of PCBs or PCB Items. Substances
that are regulated by this part include, but are not limited to:
dielectric fluids; solvents; oils; waste oils; heat transfer fluids;
hydraulic fluids; paints or coatings; sludges; slurries; sediments;
dredge spoils; soils; materials containing PCBs as a result of spills;
and other chemical substances or combinations of substances, including
impurities and byproducts and any byproduct, intermediate, or impurity
manufactured at any point in a process.
(2) Unless otherwise noted, PCB concentrations shall be determined
on a weight-per-weight basis (e.g., milligrams per kilogram), or for
liquids, on a weight-per-volume basis (e.g., milligrams per liter) if
the density of the liquid is also reported. Unless otherwise provided,
PCBs are quantified based on the formulation of PCBs present in the
material analyzed. For example, measure Aroclor \TM\ 1242 PCBs based on
a comparison with Aroclor \TM\ 1242 standards. Measure individual
congener PCBs based on a comparison with individual PCB congener
standards.
(3) Most provisions in this part apply only if PCBs are present in
concentrations above a specified level. Provisions that apply to PCBs at
concentrations of <50 ppm apply also to contaminated surfaces at PCB
concentrations of <=10 [micro]g/100 cm\2\. Provisions that apply to PCBs
at concentrations of =50 to <500 ppm apply also to
contaminated surfaces at PCB concentrations of