60-Day FR Notice

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Federal Register / Vol. 90, No. 217 / Thursday, November 13, 2025 / Proposed Rules
characteristics that would otherwise be a
prohibited basis only so long as that section’s
requirements, the requirements of
§ 1002.8(b)(3) and (4), and the other
requirements of this part are satisfied. Under
§ 1002.8(b)(2), once the characteristics of the
program’s class of participants are
established, the creditor is prohibited from
discriminating among potential participants
on a prohibited basis.
8(c) Special rule concerning requests and
use of information.
1. Request of prohibited basis information.
This section permits a creditor to request and
consider certain information that would
otherwise be prohibited by §§ 1002.5 and
1002.6 to determine an applicant’s eligibility
for a particular program.
2. Example. An example of a program
under which the creditor can ask for and
consider information about a prohibited basis
is an energy conservation program to assist
the elderly, for which the creditor must
consider the applicant’s age.

*

*

*

*

*

Russell Vought,
Acting Director, Consumer Financial
Protection Bureau.
[FR Doc. 2025–19864 Filed 11–12–25; 8:45 am]
BILLING CODE 4810–AM–P

ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 705
[EPA–HQ–OPPT–2020–0549; FRL–7902.3–
01–OCSPP]
RIN 2070–AL29

Perfluoroalkyl and Polyfluoroalkyl
Substances (PFAS) Data Reporting
and Recordkeeping Under the Toxic
Substances Control Act (TSCA);
Revision to Regulation
AGENCY: Environmental Protection

Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: The U.S. Environmental

Protection Agency (EPA or Agency) is
proposing amendments to the Toxic
Substances Control Act (TSCA)
regulation for reporting and
recordkeeping requirements for
perfluoroalkyl and polyfluoroalkyl
substances (PFAS). As promulgated in
October 2023, the regulation requires
manufacturers (including importers) of
PFAS in any year between 2011–2022 to
report certain data to EPA related to
exposure and environmental and health
effects. EPA is proposing to incorporate
certain exemptions and other
modifications to the scope of the
reporting regulation. These exemptions
would maintain important reporting on
PFAS, consistent with statutory
requirements, while exempting

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reporting on activities about which
manufacturers are least likely to know
or reasonably ascertain.
DATES: Comments must be received on
or before December 29, 2025. Comments
on the information collection provisions
of this proposed rule under the
Paperwork Reduction Act (PRA) must
be received by the Office of
Management and Budget’s Office of
Information and Regulatory Affairs
(OMB–OIRA) on or before December 15,
2025. Please refer to the PRA section
under ‘‘Statutory and Executive Order
Reviews’’ in this preamble for specific
instructions.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2020–0549,
through the Federal eRulemaking Portal
at https://www.regulations.gov. Follow
the online instructions for submitting
comments. Do not submit electronically
any information you consider to be
Confidential Business Information (CBI)
or other information for which
disclosure is restricted by statute.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
FOR FURTHER INFORMATION CONTACT:
For technical information contact:
Megan Nelson, Chemical Information,
Prioritization, and Toxics Release
Inventory Division (7406M), Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
498–1248; email address:
[email protected].
For general information contact: The
TSCA Assistance Information Service
Hotline, Goodwill Vision Enterprises,
422 South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
This action may apply to you if you
have manufactured (defined by statute
at 15 U.S.C. 2602(9) to include import)
PFAS for a commercial purpose at any
time from January 1, 2011, through
December 31, 2022. The following list of
North American Industry Classification
System (NAICS) codes is not intended
to be exhaustive but rather provides a
guide to help readers determine whether
this document applies to them.
Potentially affected entities may
include:

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• Utilities (NAICS code 22);
• Manufacturing (NAICS codes 31
through 33);
• Wholesale trade (NAICS code 42);
and
• Waste management and
remediation services (NAICS code 562).
This list details the types of entities
EPA is currently aware could
potentially be impacted by this action.
Other types of entities could also be
impacted. To determine whether your
entity is impacted by this action, please
examine the applicability criteria found
in 40 CFR 705.10 and 705.12. If you
have questions regarding the
applicability of this action to a
particular entity, consult the person
listed in the FOR FURTHER INFORMATION
CONTACT section.
Any use of the term ‘‘PFAS’’ or
‘‘perfluoroalkyl or polyfluoroalkyl
substance’’ refers to chemical
substances that meet the structural
definition of PFAS codified at 40 CFR
705.3. PFAS is defined as including at
least one of these three structures:
• R-(CF2)-CF(R′ )R″, where both the
CF2 and CF moieties are saturated
carbons;
• R-CF2OCF2-R′, where R and R′ can
either be F, O, or saturated carbons; and
• CF3C(CF3)R′-R″, where R′ and R″
can either be F or saturated carbons.
For a more thorough discussion of the
chemical substances included in this
rule, please see Unit III.A of the final
rule (88 FR 70516, October 11, 2023)
(FRL–7902–02–OCSPP).
This rule does not require reporting
on substances that are excluded from
the definition of ‘‘chemical substance’’
in TSCA section 3(2)(B). Those
exclusions include, but are not limited
to: any pesticide (as defined by the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA)) when
manufactured, processed, or distributed
in commerce for use as a pesticide; any
food, food additive, drug, cosmetic, or
device, as defined by the Federal Food,
Drug, and Cosmetic Act (FFDCA), when
manufactured, processed, or distributed
in commerce for use as a food, food
additive, drug, cosmetic or device;
tobacco or any tobacco product; any
source material, special nuclear
material, or byproduct material as such
terms are defined in the Atomic Energy
Act of 1954 (AEA); or, any article the
sale of which is subject to the tax
imposed by section 4181 of the Internal
Revenue Code of 1954. A PFAS may be
considered a ‘‘chemical substance’’ as
defined under TSCA for some, but not
all, uses of the PFAS. Some uses may be
excluded from the definition of
‘‘chemical substance,’’ as outlined
under TSCA section 3(2)(B). PFAS

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considered to be a ‘‘chemical substance’’
pursuant to the TSCA definition may
require reporting for such uses.

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B. What is the Agency’s authority for
taking this action?
As with the final rule published in the
Federal Register on October 11, 2023
(88 FR 70516) (FRL–7902–02–OCSPP),
and direct final amendment published
on September 5, 2024 (89 FR 72336)
(FRL–7902.1–02–OCSPP), EPA is
proposing this rule pursuant to its
authority in TSCA section 8(a)(7) (15
U.S.C. 2607(a)(7)). The National Defense
Authorization Act for Fiscal Year 2020
(NDAA) (Pub. L. 116–92, section 7351)
amended TSCA section 8(a) in
December 2019, adding TSCA section
8(a)(7), titled ‘‘PFAS Data.’’ TSCA
section 8(a)(7) requires EPA to
promulgate a rule ‘‘requiring each
person who has manufactured a
chemical substance that is a [PFAS] in
any year since January 1, 2011’’ to
report information described in TSCA
section 8(a)(2)(A) through (G). TSCA
section 8(a)(2)(A) through (G) includes a
broad range of information, such as
information related to chemical identity
and structure, production, use,
byproducts, exposure, disposal, and
health and environmental effects.
EPA has authority to reconsider and
revise previous decisions and to revise,
replace, or repeal a decision to the
extent permitted by law and supported
by reasoned explanation. See FCC v. Fox
Television Stations, Inc., 556 U.S. 502,
515 (2009); see also Motor Vehicle Mfrs.
Ass’n v. State Farm Mutual Auto. Ins.
Co., 463 U.S. 29, 42 (1983); see also FDA
v. Wages and White Lion Investments,
LLC, 145 S. Ct. 898 (2025). In other
words, unless provided otherwise by
statute, an agency may revise or rescind
prior actions so long as it acknowledges
the change in position, provides a
reasonable explanation for the new
position, and considers legitimate
reliance interests in the prior position.
C. What action is the Agency taking?
EPA is proposing to amend the onetime PFAS reporting and recordkeeping
regulation finalized on October 11, 2023
(88 FR 70516) (FRL–7902–02–OCSPP) to
incorporate the following exemptions to
the scope of reportable manufacturing
activities: a de minimis exemption of
0.1%; imported articles; byproducts;
impurities; research and development
(R&D); and non-isolated intermediates.
The Agency is further proposing
technical corrections to the reporting
requirements for the purpose of
clarifying what must be reported in
certain data fields and to adjust the data
submission period of the reporting

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regulation. While EPA is proposing no
other amendments to the scope of the
regulation, including to the period for
which reporting is required, the Agency
is also seeking comment on certain
other aspects of the regulation.
D. Why is the Agency taking this action?
In a series of Executive Orders,
President Trump has directed agency
heads to review regulations under their
jurisdiction for consistency with law
and Administration policy and to
identify inconsistent regulations for
potential recission or modification. For
example, Executive Order 14219,
‘‘Ensuring Lawful Governance and
Implementing the President’s
‘Department of Government Efficiency’
Deregulatory Initiative,’’ directs
agencies to initiate a process to review
existing rules for consistency with the
best reading of the governing statute,
Administration policy, cost-benefit
balancing principles, and to rescind or
revise regulations as appropriate (90 FR
10583, February 19, 2025). Among the
categories of regulations to be identified
are those that significantly and
unjustifiably impede technological
innovation, infrastructure development,
disaster response, inflation reduction,
R&D, economic development, energy
production, land use, and foreign policy
objectives and those that impose undue
burdens on small business and impede
private enterprise and entrepreneurship.
Consistent with Executive Order
14219 and the Administration’s
priorities, EPA identified the TSCA
section 8(a)(7) PFAS reporting
regulation for reconsideration. The
Agency is reconsidering exempting
certain reportable activities. The Agency
has identified several aspects of the
TSCA section 8(a)(7) PFAS reporting
regulation for potential revision in light
of TSCA section 8(a)(5):
• TSCA section 8(a)(5)(A) directs the
Agency, to the extent feasible, to not
require unnecessary or duplicative
reporting. After reconsidering its earlier
position in the 2023 final rule, EPA
believes reporting on certain activities
may be unnecessary for the reasons
articulated in this preamble. In addition,
EPA believes some byproduct reporting
may be duplicative. See the relevant
discussions in Unit III for more detail.
• TSCA section 8(a)(5)(B) directs the
Agency, to the extent feasible, to
minimize cost of compliance on small
manufacturers. Under TSCA section
8(a), a ‘‘small manufacturer’’ is a
manufacturer that either has revenues
less than $120 million and
manufactures less than 100,000 pounds
in production volume for a chemical
substance or has revenues less than $12

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million regardless of production volume
annually.
• TSCA section 8(a)(5)(C) directs the
Agency, to the extent feasible, to apply
reporting obligations to only those
persons likely to have information
relevant to the effective implementation
of TSCA.
EPA has also reconsidered the scope
of the reporting requirements in light of
TSCA section 2(c), which directs the
Agency to carry out TSCA ‘‘in a
reasonable and prudent manner’’ and to
‘‘consider the environmental, economic,
and social impact of any action.’’ See
Chem. Mfrs. Ass’n v. EPA, 899 F.2d 344,
347–48 (5th Cir. 1990) (‘‘Congress [ ]
plainly intended the EPA to consider
the economic impact of any actions
taken by it under the TSCA’’) (citing 15
U.S.C. 2601(c); emphasis in original);
see also Nat’l Ass’n of Home Builders v.
EPA, 682 F.3d 1032, 1039 (D.C. Cir.
2012); Ausimont U.S.A. Inc. v. EPA, 838
F.2d 93, 95 (3d Cir. 1988). Unlike
certain other TSCA provisions, section
8(a)(7) does not direct EPA how to use
the information collected under the
PFAS reporting rule. In contrast, for
example, TSCA section 8(b)(10) directs
EPA to promulgate a rule ‘‘to assist in
the preparation of’’ an inventory of
mercury supply, use, and trade in the
United States.’’ The stated purpose of
TSCA section 8(b)(10) data collection is
to create a mercury inventory and to
recommend actions to achieve mercury
use reduction. See NRDC, Inc. v. EPA,
961 F.3d 160, 175 (2d Cir. 2020)
(‘‘Congress’s instruction to EPA to create
and publish ‘an inventory of mercury
supply, use, and trade, in the United
States,’ evinces its affirmative interest in
cataloguing both the nature and extent
of mercury use in the United States
economy. Congress made clear that it
intends EPA to collect and publish
information on mercury use.’’). TSCA
section 8(a)(7) does not specify any such
use for the data collection. EPA also
notes that commenters on the TSCA
section 8(a)(7) proposed rule stated that
its associated burden was
disproportionate to the benefits that
would be derived from the data
collected under the rule. EPA has
reconsidered its position and, consistent
with TSCA sections 2(c) and 8(a)(5),
proposes to exempt certain activities
from the rule given the lack of express
statutory directive to create a full
inventory of all PFAS manufacturing
activities.
Although EPA now believes
information on certain reportable
activities is not necessary at this time,
the Agency may in the future determine
that such information is necessary to
support particular regulatory actions.

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Courts have supported such a
sequenced process to addressing an
Agency’s statutory obligations. See S.
Coast Air Qual. Mgmt. Dist. v. EPA, 554
F.3d 1076, 1080 (D.C. Cir. 2009);
Bluewater Network v. EPA, 372 F.3d
404, 411 (D.C. Cir. 2004). Here, it is
reasonable to defer the collection of
certain information until there is a clear
role that such information could play to
support a program mission of the
Agency. TSCA grants EPA adequate
authority to secure such information as
needed, including under TSCA section
8, should the information collected
sunder TSCA section 8(a)(7) prove
insufficient or outdated for a particular
action.
E. What are the estimated incremental
impacts of this action?
EPA has prepared an Economic
Analysis of the potential impacts
associated with this proposed rule (Ref.
1). The primary purpose of this
proposed rule is to incorporate certain
exemptions to the scope of reportable
manufacturing activities for PFAS
manufactured from 2011 to 2022, as
required under TSCA section 8(a)(7).
This proposed action would reduce
the burden on entities least likely to
know and report relevant information
without sacrificing the known and
reasonably ascertainable data related to
historically manufactured PFAS.
Through the proposed exemptions and
other clarifications to the regulation,
this action is expected to provide both
regulatory relief and greater regulatory
certainty to regulated parties, resulting
in a net reduction in cost while
retaining the majority of PFAS
manufacture reporting requirements.
The reporting community is expected
to receive burden reductions from the
proposed amendments to the PFAS
reporting rule associated with rule
familiarization, compliance
determination, form completion, and
recordkeeping activities. EPA is also
accounting for the sunk costs of
companies that have undertaken some
level of rule familiarization and
compliance determination when
estimating the expected reduction in
costs. EPA estimates that approximately
6–12 percent of the expected costs of the
October 11, 2023, TSCA section 8(a)(7)
final rule (88 FR 70516) (FRL–7902–02–
OCSPP) have already accrued. This
estimate is based on best professional
judgment; see Unit IV.B for additional
discussion and requests for public
comments on this estimate. Under the
proposed rule, EPA estimates a total
industry burden reduction of 10–11.
million fewer total hours, or a cost
savings of $786–$843 million compared

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to the October 11, 2023, TSCA section
8(a)(7) final rule (88 FR 70516) (FRL–
7902–02–OCSPP) requirements.
Affected small businesses are expected
to be relieved of 9.3–9.9 million total
hours, or $703–$761 million in costs.
The Agency is not expected to incur
incremental costs. The total incremental
social cost savings of the proposed rule
compared to the October 11, 2023,
TSCA section 8(a)(7) final rule (88 FR
70516) (FRL–7902–02–OCSPP) is
therefore estimated to be approximately
$786–$843 million.
F. Severability
EPA intends that the provisions of
this proposed rulemaking would, if
finalized, be severable from one another.
In the event that any individual
provision or part of this rulemaking is
invalidated, EPA intends that this
would not render the entire rulemaking
invalid, and that any individual
provisions that are finalized would
continue to be followed.
II. Background
A. TSCA Section 8(a)(7)
President Trump signed into law the
National Defense Authorization Act for
Fiscal Year 2020 (NDAA) on December
20, 2019 (Pub. L. 116–92). Among other
provisions, section 7321 of the NDAA
created TSCA section 8(a)(7). TSCA
section 8(a)(7) states that the
Administrator ‘‘shall promulgate a rule
in accordance with this subsection
requiring each person who has
manufactured a chemical substance that
is a [PFAS] in any year since January 1,
2011, to submit to the Administrator a
report that includes, for each year since
January 1, 2011, the information
described in subparagraphs (A) through
(G) of paragraph (2).’’ The categories of
information described in sections
8(a)(2)(A) through (G) are:
• The common or trade name,
chemical identity and molecular
structure of each chemical substance or
mixture for which a report is required;
• Categories or proposed categories of
use for each substance or mixture;
• Total amount of each substance or
mixture manufactured or processed, the
amounts manufactured or processed for
each category of use, and reasonable
estimates of the respective proposed
amounts;
• Descriptions of byproducts
resulting from the manufacture,
processing, use, or disposal of each
substance or mixture;
• All existing information concerning
the environmental and health effects of
each substance or mixture;
• The number of individuals exposed,
and reasonable estimates on the number

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of individuals who will be exposed, to
each substance or mixture in their
places of work and the duration of their
exposure; and
• The manner or method of disposal
of each substance or mixture, and any
change in such manner or method.
B. The PFAS Data Reporting Rule Under
TSCA Section 8(a)(7)
On June 28, 2021, EPA proposed the
TSCA section 8(a)(7) PFAS reporting
rule (86 FR 33926) (FRL–10017–78).
This rule proposed to require any
person who had manufactured
(including imported) a PFAS (including
as a mixture or an article containing a
PFAS) as defined by a structural
definition to report the required
information for each year from 2011 to
2022 (86 FR 33926, June 28, 2021)
(FRL–10017–78), to the extent such
information is known to or reasonably
ascertainable by the manufacturer. EPA
did not propose any reporting
exemptions or thresholds that other
TSCA reporting rules have used, such as
for chemical substances in imported
articles, R&D chemicals, impurities, and
certain byproducts. Additionally, EPA
proposed no flexibilities for small
manufacturers.
After a 90-day public comment period
and additional information gathering on
the proposed rule’s burden and cost
estimates, EPA could not support a
certification under the Regulatory
Flexibility Act (RFA) that the rule
would impose no significant economic
impact on a substantial number of small
entities. EPA thus convened a Small
Business Advocacy Review (SBAR)
Panel in April 2022. The Panel used
feedback from small entity
representatives to develop a Panel
Report (Ref. 2) and Initial Regulatory
Flexibility Analysis (IRFA) (Ref. 3). EPA
opened a second public comment
period (87 FR 72439) (FRL–7902–04–
OCSPP) on November 25, 2022, to
solicit comment on the proposed rule’s
IRFA, SBAR Panel Report, and other
aspects of the proposed rule that may
have been impacted by EPA actions or
proposed actions after the proposed
rule’s publication in June 2021.
EPA considered comments and other
stakeholder input, including from the
SBAR Panel, in developing the final
rule, which was published on October
11, 2023 (88 FR 70516) (FRL–7902–02–
OCSPP). Public input informed changes
from the 2021 proposed rule, including
the scope of the PFAS structural
definition, the duration of the data
submission period, and the inclusion of
shorter reporting forms for certain PFAS
manufacturing scenarios. However, EPA
did not add any exemptions as

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requested by commenters and as
recommended by the SBAR Panel.
The final rule established a 12-month
data collection period for manufacturers
following the effective date of the rule,
followed by a six-month data
submission period, with information
from most PFAS manufacturers due to
EPA by May 8, 2025. Small
manufacturers reporting exclusively as
article importers had a 12-month
submission period, with a reporting
deadline of November 10, 2025.
C. Implementation Status of the PFAS
Data Reporting Rule
Data have not yet been submitted
under the PFAS reporting rule. Since
promulgating the final rule on October
11, 2023, the Agency has moved the
reporting deadline twice. EPA needed to
move the submission period due to the
delay in the development of the
reporting application on EPA’s Central
Data Exchange (CDX, the Agency’s
electronic reporting site), related
information technology (IT)
infrastructure challenges, and the ability
to conduct user testing data needed for
IT reporting application development.
On September 5, 2024, EPA
promulgated a direct final rule (89 FR
72336) (FRL–7902.1–02–OCSPP) to
move the start of the data submission
period from November 12, 2024, to July
11, 2025. EPA subsequently published
an interim final rule on May 13, 2025
(90 FR 20236) (FRL–7902.2–01–OCSPP)
to move the start of the data submission
period from July 11, 2025, to April 13,
2026. EPA noted the need for such
amendments due to further delays in
developing the CDX infrastructure and
conducting industry beta testing to
ensure the reporting application collects
and stores data as intended.
III. Proposed Amendments

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A. Proposed Exemptions
EPA is proposing to add certain
exemptions to the scope of reportable
PFAS manufacturing activities under 40
CFR 705. EPA intends these exemptions
to be similar to the TSCA Chemical Data
Reporting (CDR) rule (40 CFR 711) and,
in addition, proposes to include the de
minimis exemption described in Unit
III.A.1. In some scenarios, more than
one of these proposed exemptions may
provide the same regulatory relief from
reporting. For example, an importer of
articles which contain low levels of
PFAS may be exempt from reporting by
virtue of both the imported articles and
de minimis exemptions. EPA is
interested in public comments on
potential means to consolidate the
proposed exemptions, while providing

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the same regulatory relief and in public
comments on the potential benefits and
drawbacks of finalizing all proposed
exemptions or a subset of proposed
exemptions when viewed in
combination.
The purpose of this rule is to better
understand the PFAS manufactured
(including imported) in the United
States for commercial purposes, to the
extent the information is known to or
reasonably ascertainable by regulated
entities. EPA recognizes that the number
of entities that will need to search their
records to identify the information is
greater than the number of entities that
will ultimately report. In EPA’s 2023
Economic Analysis (Ref. 4) and FRFA
(Ref. 5), the Agency assumed that, of all
small article importers conducting due
diligence to identify any reportable
PFAS, only 10% would ultimately
determine that they had known or
reasonably ascertainable information to
report on PFAS imported in articles.
That is, 90% of the small article
importers would be burdened by
compliance determination activities
only to then determine that they do not
need to report because the information
is not known or reasonably
ascertainable.
After further consideration of the
Agency’s obligations under TSCA
sections 8(a)(7), 8(a)(5), and 2(c), EPA is
reassessing whether the volume of
potential data collected justifies the
total burden of implementing that
collection and what result Congress
intended when it added TSCA section
8(a)(7) within the broader structure of
section 8. Therefore, EPA is proposing
these exemptions to maintain
meaningful reporting on PFAS while
exempting regulated entities that are
least likely to have relevant information,
alleviating some compliance burden
(e.g., rule familiarization,
recordkeeping), and eliminating some
reporting where EPA has now
determined that the reportable
information is unnecessary to fulfill
statutory obligations. These proposed
exemptions also aim to minimize, to the
extent feasible, the burden of regulatory
compliance on small manufacturers,
pursuant to TSCA section 8(a)(5)(B).
These proposed exemptions are
responsive to the agency’s obligations
under the Regulatory Flexibility Act and
are consistent with several of the
recommendations that were made in the
2022 SBAR Panel Report (Ref. 2). EPA
estimates that with these proposed
exemptions, small businesses subject to
the October 11, 2023, final rule (88 FR
70516) (FRL–7902–02–OCSPP) would
be relieved of over $703–$761 million in
net regulatory compliance burden.

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1. De Minimis
EPA is proposing a de minimis
concentration exemption for reportable
PFAS in mixtures or articles under
which PFAS concentrations below 0.1%
would be exempt from reporting. This
low-concentration exemption would
apply regardless of total production
volume of the mixture or article.
Implicit in most statutes is the authority
for an implementing agency to exempt
de minimis concentrations from the
scope of general rules. ‘‘[T]he venerable
maxim de minimis non curat lex (‘‘the
law cares not for trifles’’) as part of the
established background of legal
principles against which all enactments
are adopted, and which all enactments
(absent contrary indication) are deemed
to accept.’’ Wis. Dep’t of Revenue v.
William Wrigley, Jr., Co., 505 U.S. 214,
231 (1992); Citadel Sec. v. SEC, 45 F.4th
27, 36 (D.C. Cir. 2022) (explaining that
an agency decision was reasonable and
supported by the maxim); Shays v.
Federal Election Commission, 414 F.3d
76, 113–14 (D.C. Cir. 2005) (‘‘Predicated
on the notion that the Congress is
always presumed to intend that
pointless expenditures of effort be
avoided, such authority is inherent in
most statutory schemes, by
implication.’’) (internal quotation marks
omitted); Ober v. Whitman, 243 F.3d
1190, 1194 (9th Cir. 2001); EDF, Inc. v.
EPA, 82 F.3d 451, 466–467 (D.C. Cir.
1996). This principle only covers
situations where ‘‘the burdens of
regulation yield a gain of trivial or no
value.’’ EDF, 82 F.3d at 466.
EPA proposes to apply the de minimis
principle here because nothing in TSCA
section 8 suggests an intent to depart
from this background rule of
construction. Nor is the statutory
language in TSCA section 8(a)(7) so
uncompromisingly rigid as to preclude
a de minimis exemption. Under TSCA
section 8(a)(7), EPA must gather
information from manufacturers of
PFAS, but TSCA section 8(a)(5) grants
EPA broad authority to reduce the
burdens of such reporting to the extent
feasible by placing the ‘‘PFAS Data’’
paragraph within TSCA section 8,
Congress intended this authority to
apply. Also, as noted above in Unit I.D.,
Congress indicated a practical intent for
implementation of TSCA—the statute
shall be carried out ‘‘in a reasonable and
prudent manner.’’ 15 U.S.C. 2601(c). A
de minimis exemption is a reasonable
and familiar means to achieve such
ends.
The proposed de minimis level of
0.1% is appropriate because of the
retrospective nature of the reporting and
contemporary recordkeeping practices.

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During the lookback period for
reporting, reporters are unlikely to have
records of PFAS amounts below 0.1%
due to U.S. and international
requirements at the time, e.g., for
labeling and recordkeeping. During the
development of the 2023 final rule,
several commenters and small entity
representatives described the challenges
of determining the presence of a PFAS
in past imports when the concentration
would have been below the Safety Data
Sheet (SDS) or the European Union’s
Registration, Evaluation, Authorization
and Restriction of Chemicals (REACH)
notification levels (see docket comments
EPA–HQ–OPPT–2020–0549–0054,
0105, 0107, 0139, 0163, and 0165).
Suppliers covered under SDS and
REACH notification requirements need
not provide notification of PFAS levels
below 0.1% under the most stringent
chemical hazard classifications. Without
REACH notifications having required
notice for PFAS below 0.1% of a
mixture or an article during the
retroactive reporting time frame,
companies would not have known that
they have manufactured (including
imported) PFAS below that de minimis
concentration. See 15 U.S.C.
2607(a)(5)(C). Additionally, the
Occupational Safety and Health
Administration’s (OSHA) Hazard
Communication Standard (29 CFR
1910.1200) sets cut-offs for the
minimum concentration of a chemical
that triggers requirements for an SDS.
The cut-off level of 0.1% is generally
applied to chemicals classified as
‘‘health hazards’’ and a chemical is
classified as a health hazard if it poses
certain hazardous effects. Health
hazards include, among others,
chemicals that are carcinogens,
reproductive toxins, irritants, and
sensitizers (29 CFR 1910.1200(c) and
Appendix A). Some evidence suggests
that exposure to certain PFAS may lead
to adverse health effects, including an
increased risk of some cancers, as
identified in the EPA’s National PFAS
Testing Strategy (Ref. 6). Identifying
whether a mixture or article contains
PFAS below 0.1% would be time
consuming and complicated because
PFAS were not required to be reported
on an SDS during the relevant lookback
period.
EPA also considered potential
impacts of other statutory or regulatory
requirements pertaining to de minimis
levels of PFAS that were in effect during
the 2011–2022 reporting period, to the
extent those requirements may impact
manufacturers’ knowledge of and ability
to report on manufacturing of de
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articles. During most of the lookback
period, there were few international
labeling or notification requirements for
small concentrations of PFAS. As public
commenters previously noted, the
REACH regulation in the European
Union only placed certain groups of
PFAS on their Substances of Very High
Concern (SVHC) Candidate List
beginning in 2019, with HFPO–DA and
its salts (Ref. 7). These listings triggered
additional legal obligations, including
safety communication to customers,
when articles contain an SVHC at
concentrations above 0.1% (Ref. 8).
Thus, it is unlikely that manufacturers
would have been able to identify such
small concentrations of PFAS in
mixtures and articles during this rule’s
reporting period. As suppliers were not
obligated to disclose de minimis levels
of PFAS, those manufacturers likely
would not know of the existence of such
PFAS and render those mixtures and
articles not known or reasonably
ascertainable under TSCA Section
8(a)(5).
Moreover, a uniform 0.1% de minimis
threshold would relieve manufacturers
of burden related to investigating the
relevant exemption level and applying
different concentrations to different
PFAS. The OSHA Hazard
Communication Standard for chemicals
not classified as a ‘‘health hazard’’ uses
a cut-off concentration of 1.0% by
weight, and the extent to which many
PFAS present health concerns similar to
those relatively few PFAS known to be
‘‘health hazards’’ is unclear. Although
most PFAS are not classified as health
hazards under 29 CFR 1910.1200, EPA
is proposing a universal de minimis
concentration exemption of 0.1% for all
PFAS to reduce the burden of
determining which concentration is
applicable to each reportable PFAS.
Further, PFAS are typically present at
low concentrations in mixtures, so a 1%
de minimis threshold may remove
otherwise reportable information from
the scope of the rule. In part, this
rulemaking is designed to identify and
address available information gaps
involving PFAS, so EPA believes that
applying a lower, uniform 0.1% de
minimis concentration threshold for all
reportable PFAS helps address
information gaps where information
exists and still alleviates burden by
providing a de minimis threshold.
EPA also considered establishing de
minimis levels based on detection limits
in validated analytical methods
developed by EPA. As of August 2025,
EPA has developed analytical methods
for the detection of dozens of PFAS in
various environmental media (see
https://www.epa.gov/water-research/

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pfas-analytical-methods-developmentand-sampling-research). However, EPA
identified several limitations to this
potential approach to such an
exemption. First, the number of PFAS
that have at least one analytical method
is a small portion of the broader
universe of known PFAS. The detection
limits associated with those PFAS with
analytical methods are also at different
levels, varying by orders of magnitude.
Further, some of the lowest detection
limits (in parts per trillion) would
render any exemption based on
concentrations below such limits
ineffectual. EPA ultimately determined
that basing a proposed de minimis
exemption level on these analytical
methods would be inappropriate. As
noted in Unit IV, EPA seeks comment
on the proposed 0.1% de minimis level,
including information on what
concentration level other than 0.1%
might be appropriate for an exemption.
EPA also proposes to exempt these de
minimis concentrations of PFAS in
mixtures and articles (see Unit III.A.2.)
from the scope of the rule based on the
Agency’s information needs under
TSCA section 8(a)(5)(A). The Agency
has determined that information about
such PFAS in mixtures is unnecessary,
in part because EPA does not anticipate
publishing an ‘‘inventory’’ of all PFAS
manufactured since 2011 such that EPA
would need a complete reporting of all
PFAS in U.S. markets. Compare 15
U.S.C. 2607(a)(7) with 15 U.S.C.
2607(b)(10). Additionally, EPA does not
anticipate evaluating PFAS that may
only be manufactured in de minimis
levels in the near future under TSCA
(see 2024 TSCA section 8(d) rule ((89 FR
100756, 100758, December 13, 2024)
(FRL–11164–02–OCSPP). Manufacturers
that report pursuant to this rule are
required to provide downstream
processing and use information about
the use of PFAS in consumer and
commercial products, including articles.
Thus, despite the provision of de
minimis and imported article
exemptions (discussed below), EPA
anticipates it will receive information
on low concentrations and articles from
original manufacturers of PFAS who are
most likely to have such information
and who are likely to report pursuant to
this rule should the proposed
exemptions be finalized. Such
information from these manufacturers
will help the Agency identify situations
in which more information about PFAS
in articles may be necessary, and EPA
will address such needs when they are
identified.

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2. Imported Articles
EPA is proposing to exempt PFAS
imported as part of an article from the
scope of reportable activities (see
proposed 40 CFR 705.5, 705.12, 705.18,
and 705.30). An ‘‘article’’ is defined in
40 CFR 704.3 as ‘‘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.’’
EPA recognizes that importing PFAS
in articles between 2011–2022 is an
activity about which manufacturers are
unlikely to have known or reasonably
ascertainable information. As discussed
above, SDS and REACH notification
requirements are not likely to have
revealed the content of PFAS in
imported articles during the time span
covered by this retroactive reporting
rule, which is a perspective shared
widely by commenters and the small
entity representatives to the SBAR Panel
(87 FR 72439, November 25, 2022)
(FRL–7902–04–OCSPP). Thus,
importers of articles across many
industries have the burden of reviewing
any past SDSs or other records, such as
REACH notifications, for confirmation
that PFAS has been imported in those
articles. EPA has now reconsidered the
weight of that input and now proposes
to exempt importing articles in an effort
to apply reporting obligations, to the
extent feasible, to those persons likely to
have information (TSCA section
8(a)(5)(C)).
Should EPA finalize this proposal by
exempting the reporting on PFAS in
imported articles, the Agency will
nevertheless receive information on the
incorporation of PFAS in articles. The
rule requires manufacturers to report on
processing and use (both industrial and
consumer/commercial) for their
manufactured PFAS, such as any
incorporation in articles (40 CFR
705.15(c)). The processing and use
reporting requirements will inform the
Agency’s understanding of which PFAS
are used in various types of industrial
processes or consumer and commercial
products, which will be instructive to
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EPA is also proposing this imported
articles exemption under TSCA section
8(a)(5)(A), as the Agency finds that
requiring retroactive reporting on
importing articles with PFAS is
unnecessary (in addition to EPA finding
that requiring reporting from importers
of articles containing PFAS exceeds
EPA’s authority under TSCA Section
8(a)(7), see the below paragraph). On
balance, EPA finds it unnecessary to
require reporting for this activity and
impose related non-reporting burden
activities such as rule compliance
determination and due diligence record
searches when such importers are
unlikely to have relevant information.
In addition, EPA proposes that
requiring reporting from importers of
articles containing PFAS exceeded
EPA’s authority under TSCA section
8(a)(7). In the NDAA, Congress directed
the EPA to require reporting from ‘‘each
person who has manufactured a
chemical substance that is a [PFAS].’’ 15
U.S.C. 2607(a)(7) (emphasis added). As
a general matter, TSCA section 3(2)(A)
defines ‘‘chemical substance’’ as ‘‘any
organic or inorganic substance of a
particular molecular identity,’’
including natural combinations,
elements, and uncombined radicals.
TSCA section 3(9) defines
‘‘manufacture’’ to include production,
manufacture, and imports. By specifying
‘‘a chemical substance that is a [PFAS],’’
in TSCA section 8(a)(7), however,
Congress provided that the reporting
requirement would apply to a narrower
universe than TSCA would generally
cover.
Specifically, EPA proposes to
conclude that the NDAA is best read as
excluding articles and targeting the
reporting requirement to manufacturers
of the PFAS themselves. Had Congress
intended the legislation to include
articles that contain a PFAS substance,
it could have said so. Here, Congress
chose to target manufacturers (including
importers) of the PFAS themselves, as
indicated by the specific phrase ‘‘that is
a’’ (instead of a more inclusive term
such as ‘‘contains’’). Where Congress
omits expansive modifiers, they should
not be inferred. EPA is soliciting
feedback on this argument, which was
raised by commenters on the June 2021
proposed rule (86 FR 33926) (FRL–
10017–78). Since EPA is proposing to
exempt article importers under TSCA
section 8(a)(5) as discussed above, this
rationale would lead to the same
outcome in terms of regulatory
requirements.

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3. Byproducts, Impurities, and NonIsolated Intermediates
EPA is proposing to exempt the
manufacture of PFAS as byproducts,
impurities, non-isolated intermediates,
or upon incidental exposure, or end use
of another substance or mixture from
the scope of reportable activities when
such substances are manufactured
under conditions described in 40 CFR
720.30(h). These proposed exemptions
align with existing exemptions under
TSCA for substances not manufactured
and used for a separate commercial
purpose and is consistent with the
approach taken in EPA’s CDR rule (see
40 CFR 711.10(c)).
EPA describes the byproduct,
impurity, and non-isolated intermediate
activity exemptions below. Overall, the
exemptions reflect a practical
application of TSCA section 8(a)(5)(C),
under which EPA shall, to the extent
feasible, apply reporting obligations
only to those persons likely to have
relevant information. EPA has
historically exempted such
manufacturing activities (i.e.,
impurities, non-isolated intermediates,
and certain byproducts; manufacturing
low quantities solely for R&D purposes)
from the scope of reporting obligations
under TSCA sections 5 and 8. EPA is
not proposing to exempt other types of
manufacturing activities, including for
byproducts subsequently used for a
commercial purpose listed in 40 CFR
720.30(g), as the Agency believes PFAS
manufacturers are more likely to have
relevant information on those
manufacturing activities. As proposed,
these exemptions would ensure that
manufacturers remain focused on
reporting PFAS with greater commercial
relevance and potential exposure
pathways while relieving industry of
disproportionately burdensome
reporting. By eliminating the need to
search for and report on data related to
these manufacturing activities that have
been traditionally exempt from other
TSCA reporting requirements,
manufacturers would avoid resourceintensive record reviews and
unnecessary administrative burden for
reporting activities unlikely to provide
relevant information.
Byproducts. The regulation currently
requires a manufacturer of PFAS to
report in separate chemical reports each
PFAS that is manufactured, without
exception. EPA is proposing to exempt
from the requirement to report PFAS
that are solely manufactured as a
byproduct in a manner described in 40
CFR 720.30(h) (see proposed 40 CFR
705.12). Specifically, EPA is proposing
to exempt any byproduct not used for

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commercial purposes. ‘‘Byproduct’’ is
defined in 40 CFR 704.3 to mean ‘‘a
chemical substance produced without a
separate commercial intent during the
manufacture, processing, use, or
disposal of another chemical
substance(s) or mixture(s).’’
EPA is proposing this exemption
because it now believes this information
is unnecessary to implement its
statutory obligations and potentially
duplicative. Consistent with TSCA
section 8(a)(5)(A), EPA believes it is
appropriate to exempt manufacturers of
PFAS as a byproduct when they are not
used for a commercial purpose. EPA
does not find that the reportable
information on PFAS manufactured as
byproducts and without subsequent
commercial use is necessary,
considering the Agency’s ongoing
obligations under TSCA are limited to
specific PFAS, not the entire class, and
because of the expected low exposure
potential to such non-commercial PFAS.
However, EPA is interested in learning
about the intended commercial uses of
PFAS, including PFAS when
manufactured as a byproduct, and thus
is not proposing to exempt manufacture
of PFAS as a byproduct if it is used for
a commercial purpose. Further, this
proposed byproduct exemption would
apply only to the byproduct. The
exemption does not apply to component
substances extracted from a byproduct,
when the extracted substances are
reportable PFAS.
For certain reporting requirements
(e.g., CDR), EPA has exempted
manufacture of byproducts for specific
types of commercial purposes (see
proposed 40 CFR 720.30(g)). For this
rule, EPA is not proposing to exempt
PFAS manufactured as byproducts that
are used for a commercial purpose as
listed at 40 CFR 720.30(g). These types
of commercial purposes may provide
relevant information on exposure
pathways of interest to EPA, such as
applying PFAS-containing wastes to
land for soil enrichment or when
burned as a fuel (Ref. 9).
This proposed exemption does not
impact the need to report information
about any byproducts resulting from the
manufacture, processing, use, or
disposal of each reportable PFAS under
40 CFR 705.15(e), consistent with the
requirement under TSCA section
8(a)(2)(D). If you are reporting the
manufacture of a PFAS with byproducts
produced during the manufacture,
processing, use, or disposal of that
PFAS, you must report basic
information (e.g., chemical identity,
related PFAS activity, volume, and
environmental releases) about the
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non-byproduct PFAS will provide
information on all byproducts produced
while manufacturing, processing, using,
or disposing of the given PFAS (e.g.,
polytetrafluoroethylene (PTFE) is a
reportable PFAS and reporting on PTFE
where ‘‘GenX chemicals’’ were created
as a byproduct in the production of
PTFE would result in reporting on PTFE
including information on the
manufacture of GenX chemicals as
PTFE’s byproduct (see Ref. 10 for more
information on GenX chemicals)).
EPA notes that pursuant to this
proposed exemption, the Agency will
not receive reporting on PFAS
manufactured as byproducts of a nonPFAS. In addition, under the 2023 final
rule, a processor would need to report
as a manufacturer for any PFAScontaining byproducts; with this
proposed exemption, such reporting
would not occur unless the byproducts
have a separate commercial use.
EPA further believes reporting on
PFAS manufactured as byproducts in
the manner described at 40 CFR
720.30(h) may be duplicative of the
requirements to report on any byproduct
produced during the manufacture,
processing, use, or disposal of a
reportable PFAS. As described above, if
a PFAS is manufactured as a byproduct
during the manufacture, processing, use,
or disposal of a reportable PFAS, EPA
would receive information that is
known or reasonably ascertainable on
that byproduct, including the chemical
identity and the amounts released to
different environmental media. Given
the scope of the definition of PFAS
under 40 CFR 705.3, many fluorinated
substances (including their potential
byproducts) are captured such that
reporting on those fluorinated
byproducts would be identified and
reported on in the precursor PFAS’s
report.
EPA has determined that information
related to PFAS manufactured as
byproducts without separate
commercial uses, under the same
conditions that are exempt from CDR, is
unnecessary and potentially
duplicative. Accordingly, EPA is
proposing this activity exemption under
section 8(a)(5)(A).
Impurities. EPA is proposing to
exempt the manufacture of PFAS as
impurities from the scope of reportable
activities, as described in 40 CFR
720.30(h)(1) (see proposed 40 CFR
705.12). This exemption is also
incorporated in the CDR regulation (see
40 CFR 711.10(c)). As defined at 40 CFR
704.3, an impurity is a chemical
substance unintentionally present with
another chemical substance. Impurities
are not manufactured for distribution in

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commerce as chemical substances per
se, and they have no distinct
commercial purpose apart from the
substance, mixture, or article in which
they are contained.
EPA proposes that, consistent with
TSCA section 8(a)(5)(A), requiring this
information is unnecessary. As
explained in CDR guidance (see Ref. 11),
in evaluating whether a PFAS is an
impurity, EPA considers the source of
the substance in the manufacturing
process. A substance that arises
unintentionally in a final product
because it was introduced
unintentionally as a component of a raw
material, it may be considered an
impurity. This is distinguishable from a
byproduct, which is a substance formed
as part of the intended chemical
reaction or byproduct stream and
intentionally retained would not meet
the definition of an impurity and may
be subject to reporting. EPA
understands there are likely no PFAS
manufactured as impurities
domestically, as PFAS are not likely to
be unintentionally present in raw
materials introduced into a process.
Thus, the manufacturing of PFAS as
impurities would only derive from the
import of materials with PFAS as
impurities. Such importers are not
likely to know about the presence of
PFAS, let alone any reportable
information under section 8(a)(7).
Therefore, exempting manufacturers
(including importers) of impurities
would not meaningfully impact the
scope of the universe of manufacturers
of PFAS impurities who would have
relevant information to report under this
rule. Such an exemption would
therefore be consistent with TSCA
section 8(a)(5)(C), which requires EPA
to, to the extent feasible, extend
reporting obligations to those likely to
have relevant information. Without
relevant information to report under this
rule, EPA has determined that
exempting the manufacture of PFAS as
impurities is appropriate. EPA is
seeking public comment on this
proposed exemption to ensure that the
definitions and exemption conditions of
byproducts and impurities are
consistently and appropriately applied
to PFAS manufacturing activities.
Non-isolated intermediates.
Consistent with the proposed
exemptions to align with 40 CFR
720.30(h), EPA is proposing to exempt
otherwise-reportable PFAS that are nonisolated intermediates (see proposed 40
CFR 705.12). Non-isolated
intermediates, as defined at 40 CFR
704.3, are substances manufactured and
consumed within a closed system
during the production of another

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chemical substance. These
intermediates are not intentionally
removed from process equipment, such
as reaction vessels or continuous flow
systems, and are not stored, packaged,
or transported. Because these substances
remain confined within closed systems
and are not expected to be released in
the environment or handled by workers,
EPA has determined that reporting on
non-isolated intermediates is
unnecessary because these
intermediates do not result in
meaningful human or environmental
exposure. EPA is proposing this
exemption consistent with TSCA
section 8(a)(5)(A). Additionally, as
described earlier in Unit III.A.3.,
manufacturers have generally not been
required to submit reports related to the
manufacture of non-isolated
intermediates under TSCA. The Agency
has exempted non-isolated
intermediates in the past, in part,
because such substances often are
extremely difficult to identify. See 15
U.S.C. 2607(a)(5)(C).
4. Research and Development (R&D)
Chemicals
EPA is proposing to exempt PFAS
manufactured (including imported) in
small quantities for R&D purposes (see
proposed 40 CFR 705.12). The proposed
exemption, while limited to PFAS
manufactured solely for R&D purposes,
has no threshold limit. EPA notes that
such quantities manufactured solely for
R&D purposes are quantities no greater
than reasonably necessary for those R&D
activities (see 40 CFR 704.3, which
defines small quantities for research and
development as ‘‘quantities of a
chemical substance manufactured,
imported, or processed or proposed to
be manufactured, imported, or
processed solely for research and
development that are not greater than
reasonably necessary for such
purposes’’).
Based on stakeholder input, EPA
understands that information on PFAS
manufactured solely for R&D purposes
would be limited and would provide
minimal information regarding PFAS
exposures and quantities in commerce,
which were the focuses of TSCA section
8(a)(7). EPA does not see such
information as improving the Agency’s
understanding of the exposures and
potential risks of such PFAS under
TSCA. Pursuant to TSCA section
8(a)(5)(A), EPA has determined
information about such chemicals is
unnecessary. EPA may consider future
data calls for R&D chemicals if the
Agency determines a need to do so.
Further, other TSCA reporting
requirements have incorporated

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exemptions of small quantities of R&D
chemicals consistent with the definition
at 40 CFR 704.3 (for example, TSCA
section 5 new chemicals reporting (see
40 CFR 720.30(c)), inventory reporting
(see TSCA section 8(b)(1)), and CDR
reporting (see 40 CFR 711.10(a)).
Without a historical need to provide
reporting on PFAS manufactured in
small quantities solely for R&D purposes
under both TSCA section 5 and other
section 8 actions, EPA believes
manufacturers of such R&D PFAS will
be unlikely to have information
responsive to the data request under
TSCA section 8(a)(7). Therefore,
exempting such manufacturers is
consistent with EPA’s obligations under
TSCA section 8(a)(5)(C) to apply
reporting requirements to only those
persons likely to have such relevant
information.
Exempting PFAS manufactured solely
for R&D purposes is also consistent with
EPA’s obligations under TSCA section
8(a)(5)(B), to minimize, to the extent
feasible, the cost of compliance with
TSCA section 8 rules on small
manufacturers. In the SBAR Panel
conducted for this rule in 2022 (see Unit
II.B.), EPA learned from a small entity
representative that their small business
manufactured PFAS for laboratory and
analytical purposes and is not generally
subject to TSCA reporting requirements.
Under this proposed exemption, EPA
will minimize compliance costs on such
small manufacturers pursuant to TSCA
section 8(a)(5)(B).
This exemption is also being
proposed pursuant to the
Administration’s priorities as outlined
in Executive Order 14219, which seeks
to reduce regulations that impose costs
that ‘‘impede’’ R&D and economic
development activities. Based on input
from manufacturers (for example,
comments EPA–HQ–OPPT–2020–0549–
0069, 0084, and 0143), the requirement
to report on typically exempt R&D
substances, even in a streamlined
reporting form with fewer required data
fields, would impose significant burden
on manufacturers who may have up to
thousands of small quantity R&D
substances, whose R&D staff would
need to assist with the efforts to respond
to this rule, including by searching
through ‘‘potentially hundreds of lab
notebooks’’ (comment EPA–HQ–OPPT–
2020–0549–0143). Exempting PFAS
manufactured in small quantities solely
for R&D activities alleviates the
compliance burden on those
stakeholders conducting commercial
R&D and other economic development
activities and provides more resources
to carry out such activities.

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B. Submission Period
EPA is proposing to amend the data
submission period to accommodate the
changes to the reporting scope in this
proposal. EPA believes a shift to the
data submission period is appropriate
when the reporting regulation has
changed. This allows reporters to
familiarize themselves with the
amended rule and ensure their data are
responsive to the amended rule and
EPA to modify the reporting application
as needed, such as removing the option
of streamlined reporting forms for
article importers and R&D
manufacturers.
EPA proposes to alter the submission
period as follows: the submission period
will begin 60 days after the effective
date of the final rule and will last for
three months (see proposed 40 CFR
705.20). The time EPA took to develop
the 2023 final rule and engage with
stakeholders on the content of the rule,
as well as the time that has passed since
promulgation of the 2023 final rule,
suggests to the Agency that reporters
have had adequate time to consider how
they intend to comply with the rule.
Because no reporting will be required
from article importers due to the
proposed exemption (see Unit III.A.2.),
EPA proposes to remove the reporting
deadline for small manufacturers who
would report under this rule exclusively
as article importers.
C. Clarifications and Technical
Corrections
1. Scope of Environmental and Health
Effects Information
The current rule requires the
submission of exposure-related
information and ‘‘all existing
information concerning the
environmental and health effects’’ of the
chemical substances covered by this
rule. ‘‘All existing information
concerning environmental and health
effects’’ is defined as ‘‘any information
of any effect of a chemical substance or
mixture on health or the environment or
both’’ (40 CFR 705.3) and is intended to
be interpreted broadly. In addition,
certain information is required to be
reported using the OECD-harmonized
template (OHT) format. EPA proposes to
clarify the requirements related to
reporting using the OHT format,
including to propose a regulatory
change to confirm that OHTs are
required for unpublished study reports
on the environmental and health effects
of the reportable PFAS, except for
exposure information provided in the
fielded data elements throughout the
reporting application.

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In Unit III.E of the 2023 final rule,
EPA described the need to submit all
existing information concerning health
and environmental effects in the OHT
format, where such templates exist for
the type of data reported (40 CFR
705.15(f)). To avoid duplicative
reporting, EPA proposes to clarify that
the use of OHTs is not required for
exposure-related information otherwise
reported in the fielded data elements (40
CFR 705.15(b)–(e) and (g)–(h)). See
proposed amendments to 40 CFR
705.15(f)(1). EPA did not quantify the
burden associated with this proposed
regulatory text change. EPA is seeking
public comment on the OHT
requirement for environmental and
health effect information and associated
burden.

2. Consumer and Commercial Product
Categories
EPA is proposing to update the names
used for specific consumer and
commercial product categories as
required under 40 CFR 705.15(c)(4).
Like the clarification above, this
proposed change would not alter any
reporting requirements or introduce
new burden but rather aims to clarify
existing requirements. EPA has received
requests for clarification from data
submitters under the CDR regulation,
which uses the same product category
names, so EPA proposes to clarify the
names and descriptions for the same
consumer and commercial articlerelated codes in the PFAS Data
Reporting Rule (see Table 5 at 40 CFR
705.15(c)(4)). For example, under

50931

CC303, EPA proposes to add ‘‘Articles
without routine direct contact, such as’’
to the associated name to better define
the difference between CC303 and
CC304, which has been confusing for
some CDR data submitters. In addition,
EPA is proposing to revise the product
category code names associated with
CC217 through CC221 and CC305 to
more clearly identify the types of
articles and materials covered within
those categories. See Table 1 below for
a comparison between the proposed and
existing impacted product category
codes and names. Table 1. also includes
descriptions for each code, which EPA
provides in reporting guidance. The
proposed changes eliminate the overlap
between the categories and reduce
reporter uncertainty regarding the
correct category to report.

TABLE 1—UPDATED PRODUCT CATEGORY NAMES
Column A: current product codes

Column B: proposed product codes

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Code
Name

Description

CC217 ............

Construction and building materials
covering large surface areas, including wood articles.

Floor decking, claddings, toys outdoor equipment, walls, flooring.

CC218 ............

Construction and building materials
covering large surface areas, including paper articles; metal articles; stone, plaster, cement,
glass and ceramic articles.

Construction and building materials; e.g., insulation panels, wall
papers, roof sheets, drinking
water pipes, sewer pipes, cement flooring, mirrors.

CC219 ............

Machinery, mechanical appliances,
electrical/electronic articles.

Refrigerators, washing machines,
vacuum cleaners, computers,
telephones, drills, saws, smoke
detectors, thermostats, radiators.

CC220 ............

Other machinery, mechanical appliances, electronic/electronic articles.

Large-scale stationary industrial
tools.

CC221 ............

Construction and building materials
covering large surface areas, including metal articles.

Roof sheets, drinking water pipes,
sewer pipes.

CC303 ............

Packaging (excluding food packaging), including rubber articles;
plastic articles (hard); plastic articles (soft).

Phone covers, personal tablet covers, styrofoam packaging, bubble wrap.

CC304 ............

Other articles with routine direct
contact during normal use including rubber articles; plastic
articles (hard).

Gloves, boots, clothing, rubber
handles, gear lever, steering
wheels, handles, pencils,
handheld device casing.

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Name

Description

Wood and engineered wood artiFloor decking, flooring, lumber,
cles: Construction and building
plywood, walls, claddings, outmaterials covering large surface
door playground equipment, inareas.
door toy structures/play-gyms.
Non-metal and non-wood articles
Insulation panels, wall papers, roof
not covered elsewhere: Conshingles/tiles, siding, synthetic
struction and building materials
flooring/composite floor decking
covering large surface areas, in(non-wood), climbing walls,
cluding but not limited to paper
drinking water pipes (non-metal),
articles; plastic, rubber, fibersewer pipes (non-metal), cement
glass, and other composite artiflooring, windows, mirrors, boat
cles; stone, asphalt, plaster, cehulls (non-metal, such as fiberment, glass, and ceramic articles.
glass), automobile panels (nonmetal).
Small-scale complex (i.e., mixed
Refrigerators, washing machines,
material) machinery, mechanical
vacuum cleaners, computers,
appliances, and electrical/electelephones, drills, saws, smoke
tronic articles.
detectors, thermostats, radiators,
motorcycles, motor scooters, ebikes/electric bicycles, remotecontrol cars/drones, portable
solar panels.
Large-scale complex (i.e., mixed
Large-scale stationary industrial
material) machinery, motor vehitools, heavy machinery/vehicles,
cles, mechanical appliances,
trucks, tractors, ships, planes,
and electrical/electronic articles.
solar panels/arrays, wind turbines, electrical infrastructure,
large computer servers/network
systems, heating/cooling/AC
systems.
Metal products, including construc- Shipping containers, steel framing,
tion/building materials, parts, or
rebar, roof sheets, heating/coolother metal articles not covered
ing/air-exchange ductwork,
elsewhere.
drinking water pipes (metal),
sewer pipes (metal), wheels, aircraft wings, boat hulls, automobile frames/panels.
Articles without routine direct conPhone covers, personal tablet covtact, such as packaging (excluders, styrofoam packaging, bubing food packaging), including
ble wrap.
rubber articles; plastic articles
(hard); plastic articles (soft).
Other articles with routine direct
Gloves, boots, clothing, rubber
contact during normal use, inhandles, gear lever, steering
cluding rubber articles; plastic
wheels, handles, pencils,
articles (hard).
handheld device casing.

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Federal Register / Vol. 90, No. 217 / Thursday, November 13, 2025 / Proposed Rules
TABLE 1—UPDATED PRODUCT CATEGORY NAMES—Continued
Column A: current product codes

Column B: proposed product codes

Code

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CC305 ............

Name

Description

Name

Description

Toys intended for children’s use
(and child dedicated articles), including fabrics, textiles, and apparel; or plastic articles (hard).

Stuffed toys, blankets, comfort objects, dolls, car, animals, teething rings.

Toys intended for children’s use
(and child-dedicated articles), including but not limited to fabrics,
textiles, and apparel; metal articles; wood articles; paper articles; plaster, glass, and ceramic
articles; and/or plastic, rubber, fiberglass, and other composite
articles (hard).

Outdoor playground equipment/
parts, swing sets, slides, play
forts/tree houses, indoor toy
structures/play gyms, skates,
baseball gloves, stuffed toys/animals, blankets, comfort objects,
dolls, action figures, balls, toy
cars/trucks, wagons, teething
rings.

IV. Requests for Comment
EPA requests comment on the content
of this proposed rule and the Economic
Analysis prepared in support of this
proposed rule (Ref. 1). In addition, EPA
is providing a list of issues on which the
Agency is specifically requesting public
comment. EPA encourages all interested
persons to submit comments on the
topics raised in this proposal. This
input will assist the Agency in
developing a final rule that successfully
addresses information needs while
minimizing potential reporting burdens
associated with the regulation. EPA
requests that commenters include
materials supporting their rationale to
the extent possible.
1. As described in Unit III.A.1., EPA
is soliciting comment on the proposed
0.1% de minimis exemption for PFAS in
mixtures and articles. EPA is also
interested in comments on a 1.0% de
minimis exemption for PFAS in
mixtures and articles instead of the
proposed 0.1% de minimis exemption,
or another appropriate de minimis level.
2. As described in Unit III.A.2, EPA is
soliciting comment on an imported
articles exemption. EPA is also
interested in comments on the Agency’s
reconsidered interpretation of the
statutory language of the NDAA and
whether the NDAA is best read as
excluding articles from the scope of
reporting.
3. As described in Unit III.A.3, EPA is
soliciting comment on exempting
certain byproducts, impurities, and nonisolated intermediates by incorporating
the exemptions at 40 CFR 720.30(h).
This exemption would extend to PFAS
that are manufactured upon incidental
exposure or end use of another
substance or mixture based on
conditions described in 40 CFR
720.30(h)(3)–(7).
4. As described in Unit III.A.4, EPA is
soliciting comment on an exemption for
manufacturing PFAS in small quantities
for R&D activities.
5. As described in Unit III.B, EPA is
soliciting comment on whether the
Agency’s proposed amendment to the

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data submission period is appropriate to
accommodate the proposed changes to
the PFAS Data Reporting Rule.
6. As described in Unit III.C.1, EPA is
soliciting comment on the requirements
related to reporting using the OHT
format, including to propose a
regulatory change to confirm that OHTs
are required for unpublished study
reports on the environmental and health
effects of the reportable PFAS, except
for exposure information provided in
the fielded data elements throughout the
reporting application. EPA has not
quantified and is also soliciting
comment on the potential burden with
the OHT requirement for unpublished
study reports under 40 CFR 705.15(f).
Additionally, in response to stakeholder
requests that EPA has received, EPA is
soliciting comment on whether to
maintain the requirement for full study
reports under 40 CFR 705.15(f) or to
provide an option for a submitter to
provide a robust study summary in lieu
of the full study report, with the
submitter to provide the full study
report upon reasonable EPA request,
such as when technical concerns about
the data or methodology as described in
the summary are identified or the
Agency deems that the summary is not
robust. EPA continues to maintain its
position that full study reports are
necessary; however, the Agency is
amenable to receiving further
perspectives on this topic to further
inform its understanding of stakeholder
concerns.
7. EPA is soliciting comment on the
nature and extent of any reliance
interests that may have arisen from the
October 11, 2023, TSCA section 8(a)(7)
final rule.
In addition to the topics listed above
and proposed in this action, EPA is also
soliciting comment on specific
questions discussed below in this Unit.
A. Should EPA amend the scope of
reportable chemicals?
EPA is not proposing changes to the
scope of reportable chemical substances
but is soliciting comment on this topic.

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EPA is receptive to feedback on a
possible means to lower burden by
modifying the scope of reportable
substances, such as by limiting
reporting to those PFAS with a
Chemical Abstracts Service Registry
Number (CASRN), or, in the case of a
PFAS listed as confidential on the TSCA
Inventory, a TSCA Accession Number or
Low-Volume Exemption Number. EPA
received comments on the 2021
proposed rule and input during the
SBAR Panel related to the scope of
reportable PFAS, including some
requests to codify a discrete list of
covered PFAS rather than a structural
definition; see, for example, docket
comments EPA–HQ–OPPT–2020–0549–
0063, 0122, 0165, and 0168, and SBAR
Panel Report (Ref. 2). In the final rule
published on October 11, 2023 (88 FR
70516) (FRL–7902–02–OCSPP), EPA
determined that a structural definition
of PFAS was appropriate for this rule.
Further, EPA was unable to publicly
identify all PFAS on the TSCA
Inventory, as some identities have
confidentiality claims and currently
lack a generic name to indicate that
chemical substance is a PFAS. The
inclusion of those chemicals on a
discrete list for reporting under this rule
would not be permitted because that
would divulge CBI. Additionally, as
chemical innovation has led to new
PFAS compounds, limiting the scope of
the regulation to certain existing
compounds on the TSCA Inventory
would create aa gap in the regulation
regarding any chemical substances not
already on the Inventory. In light of the
proposed exemptions outlined in Unit
III.A, however, EPA is interested in
comments on the scope of reportable
substances in this regulation.
Further, EPA has received stakeholder
comment recommending a productionvolume threshold below which
reporting on a given PFAS would not be
required. EPA has received feedback
from certain stakeholders that a 2,500
lbs. threshold would be appropriate for
this rule, as the Chemical Data
Reporting Rule provides a 2,500 lbs.

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threshold for chemical substances
subject to specific TSCA activities (see
40 CFR 711.8). However, EPA is not
proposing to provide a productionvolume threshold. Because this rule
aims to provide an understanding of
which PFAS have been commercially
manufactured in the United States since
2011, and for which uses, EPA does not
believe that incorporating a minimum
threshold would enable the Agency to
meet its information needs. EPA
understands that some PFAS that were
manufactured in lower quantities may
still persist in the environment, and the
Agency is interested in understanding
the extent of environmental exposure.
EPA also notes that there is precedent
for promulgating a TSCA rule without a
minimum threshold where the regulated
chemical(s) are of significant interest to
EPA, including due to potential health
or environmental concerns.
EPA is amenable to comments
regarding the benefits and/or drawbacks
of providing such a threshold and what
would be an appropriate threshold. EPA
would also be interested in comments
on whether such a threshold would
either make other proposed exemptions
unnecessary or impact their scope, e.g.,
the de minimis threshold.
B. Should EPA modify any assumptions
or cost savings calculations in its
Economic Analysis?
EPA is specifically seeking comments
and data to consider in developing an
Economic Analysis for a final rule. In
this proposed rule’s Economic Analysis
(Ref. 1), EPA assumes that 255
manufacturing firms have undergone all
compliance determination and rule
familiarization activities, and 20,985
article importers have undergone some
level of compliance determination and
rule familiarization since the
promulgation of the final rule on
October 11, 2023 (88 FR 70516) (FRL–
7902–02–OCSPP). Therefore, EPA
estimates that approximately 5% of the
estimated total industry cost for the
2023 final rule has already occurred.
These assumptions of sunk costs for
article importers are based on inquiries
EPA has received specifically related to
this rule’s imported article scope, EPA’s
expectation that small article importers
would be less likely to have completed
rule familiarization and compliance
determination activities due to their
delayed reporting deadline under the
2023 final rule, and EPA’s best
professional judgement.
In considering the burden reduction
this proposed rule would provide, EPA
is seeking comment on its assumptions,
including on the sunk costs estimates
described above and on the assumption

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that the exemption for article importers
and the 26 percent reduction in
reporting from manufacturers would not
result in a large reduction in benefits.
EPA requests any information that can
be provided to refine its estimates
related to cost savings of this proposed
action.
V. References
The following is a listing of the
documents specifically referenced in
this document. The docket includes
these documents and other information
EPA considered, including documents
that are referenced within the
documents that are included in the
docket, even if the referenced document
is not physically located in the docket.
For assistance in locating these other
documents, please consult the technical
person listed under FOR FURTHER
INFORMATION CONTACT.
1. EPA. Economic Analysis for the Proposed
Rule entitled: ‘‘Perfluoroalkyl and
Polyfluoroalkyl Substances (PFAS) Data
Reporting and Recordkeeping under the
Toxics Substances Control Act (TSCA);
Revision to Regulation.’’ May 2025.
2. EPA. Final Report of the Small Business
Advocacy Review Panel on EPA’s
Proposed Rule: Toxic Substances Control
Act Reporting and Recordkeeping
Requirements for Perfluoroalkyl and
Polyfluoroalkyl Substances. August 2,
2022. https://www.regulations.gov/
document/EPA-HQ-OPPT-2020-05490123.
3. EPA. Initial Regulatory Flexibility Analysis
(IRFA) and Updated Economic Analysis
for TSCA Section 8(a)(7) Reporting and
Recordkeeping Requirements for
Perfluoroalkyl and Polyfluoroalkyl
Substances. November 2022.
4. EPA. Economic Analysis for the Final
TSCA Section 8(a)(7) Reporting and
Recordkeeping Requirements for
Perfluoroalkyl and Polyfluoroalkyl
Substances. September 2023.
5. EPA. Final Regulatory Flexibility Analysis
and Updated Economic Analysis for
TSCA Section 8(a)(7) Reporting and
Recordkeeping Requirements for
Perfluoroalkyl and Polyfluoroalkyl
Substances. September 2023.
6. EPA. ‘‘National PFAS Testing Strategy:
Identification of Candidate Per- and
Poly-fluoroalkyl Substances (PFAS) for
Testing.’’ October 2021. Available at
https://www.epa.gov/system/files/
documents/2021-10/pfas-natl-teststrategy.pdf.
7. European Chemicals Agency (ECHA). ‘‘Perand polyfluoroalkyl substances (PFAS).’’
August 2025. Available at https://
echa.europa.eu/hot-topics/
perfluoroalkyl-chemicals-pfas.
8. Lexxion. ‘‘Global Regulations Around
PFAS: The Past, the present and the
Future.’’ January 2025. Available at
https://icrl.lexxion.eu/article/icrl/2023/
1/4/display/html.
9. EPA. ‘‘Fact Sheet: Draft Sewage Sludge
Risk Assessment for PFOA and PFOS.’’

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January 2025. Available at https://
www.epa.gov/system/files/documents/
2025-01/fact-sheet-draft-sewage-sludgerisk-assessment-pfoa-pfos.pdf.
10. EPA. ‘‘Human Health Toxicity Values for
Hexafluoropropylene Oxide (HFPO)
Dimer Acid and Its Ammonium Salt
(CASRN 13252–13–6 and CASRN
62037–80–3).’’ Available at https://
www.epa.gov/system/files/documents/
2021-10/genx-chemicals-toxicityassessment_tech-edited_oct-21-508.pdf.
11. EPA. ‘‘Chemical Data Reporting
Byproducts, Impurities, and Recycling
Scenarios.’’ December 2022. Available at
https://tscaguideme.epa.gov/ords/tscagme/r/tsca/cdr-guideme/
gd?gd=byproductrecycling.
12. EPA. ‘‘Supporting Statement for an
Information Collection Request (ICR)
Under the Paperwork Reduction Act
(PRA).’’ May 2025.

VI. Statutory and Executive Orders
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is a significant regulatory
action as defined under section 3(f)(1) of
Executive Order 12866. Accordingly, it
was submitted to the Office of
Management and Budget (OMB) for
review under Executive Order 12866 (58
FR 51735, October 4, 1993). Any
changes made in response to Executive
Order 12866 review have been
documented in the docket. The EPA
prepared an analysis of the potential
costs and benefits associated with this
action. This analysis (Ref. 1) is available
in the docket and is briefly summarize
in Unit I.E.
B. Executive Order 14192: Unleashing
Prosperity Through Deregulation
This action is expected to be an
Executive Order 14192 deregulatory
action. Details on the estimated cost
savings of this proposed rule can be
found in EPA’s analysis of the potential
costs and benefits associated with this
action (Ref. 1).
C. Paperwork Reduction Act (PRA)
The information collection activities
in this proposed rule have been
submitted for approval to the Office of
Management and Budget (OMB) under
the PRA. The Information Collection
Request (ICR) document that the EPA
prepared has been assigned EPA ICR
number 2682.03, to replace an existing
approved ICR. You can find a copy of
the ICR in the docket for this rule (Ref.
12), and it is briefly summarized here.

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The reporting requirements identified
in the proposed rule would enable EPA
to meet the statutory obligations
required by TSCA section 8(a)(7) and
collect data related to the identities,
manufacture, use, exposure, and
disposal of PFAS manufactured in the
United States since 2011. These
proposed reporting requirements would
also help the Agency to collect existing
information on the health and
environmental effects of PFAS. EPA
intends to use information collected
under the rule to assist in chemical
assessments under TSCA, and to inform
any additional work necessary under
environmental protection mandates
beyond TSCA. Respondents may claim
some of the information reported to EPA
under the proposed rule as CBI under
TSCA section 14. TSCA section 14(c)
requires a supporting statement and
certification for confidentiality claims
asserted after June 22, 2016.
Respondents/affected entities: Nonexempt manufacturers (including
importers) of PFAS in any year between
January 1, 2011, and December 31, 2022.
Respondent’s obligation to respond:
Mandatory (15 U.S.C. 2607(a)(7)).
Estimated number of respondents:
255.
Frequency of response: Once.
Total estimated burden: 134,004
hours (per year). Burden is defined at 5
CFR 1320.3(b).
Total estimated cost: $11.4 million
(per year), includes no annualized
capital or operation & maintenance
costs.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for the EPA’s regulations in 40
CFR are listed in 40 CFR part 9.
Submit your comments on the
Agency’s need for this information, the
accuracy of the provided burden
estimates and any suggested methods
for minimizing respondent burden to
the EPA using the docket identified at
the beginning of this rule. The EPA will
respond to any ICR-related comments in
the final rule. You may also send your
ICR-related comments to OMB’s Office
of Information and Regulatory Affairs
using the interface at www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under Review—
Open for Public Comments’’ or by using
the search function. OMB must receive
comments no later than [INSERT DATE

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30 DAYS AFTER PUBLICATION IN
THE FEDERAL REGISTER].
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. In making this
determination, the EPA concludes that
the impact of concern for this rule is any
significant adverse economic impact on
small entities and that the agency is
certifying that this rule will not have a
significant economic impact on a
substantial number of small entities
because the rule relieves regulatory
burden on the small entities subject to
the rule. This proposed action would
alleviate reporting requirements on
small entities subject to an existing rule
by exempting certain activities from the
scope of reporting. As a result of the
proposed exemptions, an estimated
127,469 small article importers would
no longer be subject to the regulation.
Additionally, as a result of the proposed
revisions, an estimated 241 small
manufacturing firms would see lower
reporting costs. Affected small
businesses are expected to be relieved of
$703–$761 million in costs. This
proposed action would not impose
incremental costs on any small entities.
We have therefore concluded that this
action will relieve regulatory burden for
all directly regulated small entities.
E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million (in
1995 dollars and adjusted annually for
inflation) or more as described in
UMRA, 2. U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. The action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
F. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999), because it will not have
substantial direct effects on the states,
on the relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive

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Order 13175 (65 FR 67249, November 9,
2000), because it will not have
substantial direct effects on tribal
governments, on the relationship
between the Federal government and
the Indian tribes, or on the distribution
of power and responsibilities between
the Federal government and Indian
tribes. This action does not impose
substantial direct compliance costs on
federally recognized Indian tribal
governments. Thus, Executive Order
13175 does not apply to this action.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997) as
applying only to those regulatory
actions that concern environmental
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. Therefore, this action
is not subject to Executive Order 13045
because it does not concern an
environmental human health risk or
safety risk. Since this action does not
concern human health, EPA’s Policy on
Children’s Health also does not apply.
Although this action would not
establish an environmental standard
intended to mitigate health or safety
risks, the information that would be
submitted to EPA in accordance with
this proposed rule would be used to
inform the Agency’s decision-making
process regarding chemical substances
to which children may be
disproportionately exposed. This
information may also assist the Agency
and others in determining whether the
chemical substances covered in this
proposed rule present potential risks,
which would allow the Agency and
others to take appropriate action to
investigate and mitigate those risks.
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a ‘‘significant
energy action’’ because it is not likely to
have any adverse effect on the supply,
distribution or use of energy.
J. National Technology Transfer and
Advancement Act (NTTAA)
This action does not involve technical
standards under the NTTAA section
12(d), 15 U.S.C. 272.

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Federal Register / Vol. 90, No. 217 / Thursday, November 13, 2025 / Proposed Rules
List of Subjects in 40 CFR Part 705
Environmental protection, Chemicals,
Recordkeeping and reporting
requirements.
Lee Zeldin,
Administrator.

Therefore, for the reasons set forth in
the preamble, EPA proposes to amend
40 CFR part 705 as follows:
PART 705—REPORTING AND
RECORDKEEPING REQUIREMENTS
FOR CERTAIN PER- AND
POLYFLUOROALKYL SUBSTANCES

The requirements of this part apply to
all chemical substances and mixtures
containing a chemical substance that are
a PFAS, consistent with the definition
of PFAS at § 705.3, except as described
in § 705.12.
*
*
*
*
*
■ 4. Amend § 705.12 by revising the
introductory paragraph and adding
paragraphs a, b, c, d, e, and f in
alphabetical order to read as follows:
§ 705.12 Activities for which reporting is
not required.

■ 1. The authority for part 705

continues to read as follows:
Authority: 42 U.S.C. 2607(a)(7).
■ 2. Amend § 705.3 by revising the

introductory paragraph to read as
follows:
§ 705.3

§ 705.5 Substances for which reports must
be submitted.

Definitions.

The definitions in this section and the
definitions in TSCA section 3 apply to
this part. In addition, the definitions in
40 CFR 704.3 also apply to this part.
*
*
*
*
*
■ 3. Amend § 705.5 to read as follows:

A person described in § 705.10 is not
subject to the requirements of this part
with respect to any chemical substance
described in § 705.5, when:
(a) The person imported municipal
solid waste streams for the purpose of
disposal or destruction of the waste.
(b) The person is a Federal agency
which imports PFAS when it is not for
any immediate or eventual commercial
advantage.
(c) The person manufactured
(including imported) the chemical
substance solely in small quantities for
research and development.

50935

(d) The person imported the chemical
substance as part of an article.
(e) The person manufactured the
chemical substance in a manner
described in 40 CFR 720.30(h).
(f) The person manufactured
(including imported) the chemical
substance in a mixture or article, below
a 0.1% de minimis concentration.
*
*
*
*
*
■ 5. Amend § 705.15 by:
■ a. Revising the introductory
paragraph;
■ b. Revising the introductory text
paragraph in (b);
■ c. Revising and replacing Table 5; and
■ d. Revising paragraph (f)(1).
The revisions to read as follows:
§ 705.15

What information to report.

For the one-time submission, persons
identified in § 705.10 must report to
EPA, for each site of each of the
chemical substances identified in
§ 705.5, the following information to the
extent known to or reasonably
ascertainable by them. In the event that
actual data is not known to or
reasonably ascertainable by the
submitter, then reasonable estimates
may be submitted.

TABLE 5 TO PARAGRAPH (c)(4)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES
Code

Category
Chemical Substances in Furnishing, Cleaning, Treatment Care Products

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CC101 ..............
CC102 ..............
CC103 ..............
CC104 ..............
CC105 ..............
CC106 ..............
CC107 ..............
CC108 ..............
CC109 ..............
CC110 ..............
CC111 ..............
CC112 ..............
CC113 ..............
CC114 ..............
CC115 ..............
CC116 ..............
CC117 ..............
CC118 ..............
CC119 ..............
CC120 ..............
CC121 ..............
CC122 ..............
CC123 ..............
CC124 ..............
CC125 ..............
CC126 ..............
CC127 ..............
CC128 ..............
CC129 ..............
CC130 ..............
CC131 ..............
CC132 ..............
CC133 ..............
CC134 ..............

VerDate Sep<11>2014

Construction and building materials covering large surface areas including stone, plaster, cement, glass and ceramic articles;
fabrics, textiles, and apparel.
Furniture & furnishings including plastic articles (soft); leather articles.
Furniture & furnishings including stone, plaster, cement, glass and ceramic articles; metal articles; or rubber articles.
Leather conditioner.
Leather tanning, dye, finishing, impregnation and care products.
Textile (fabric) dyes.
Textile finishing and impregnating/surface treatment products.
All-purpose foam spray cleaner.
All-purpose liquid cleaner/polish.
All-purpose liquid spray cleaner.
All-purpose waxes and polishes.
Appliance cleaners.
Drain and toilet cleaners (liquid).
Powder cleaners (floors).
Powder cleaners (porcelain).
Dishwashing detergent (liquid/gel).
Dishwashing detergent (unit dose/granule).
Dishwashing detergent liquid (hand-wash).
Dry cleaning and associated products.
Fabric enhancers.
Laundry detergent (unit-dose/granule).
Laundry detergent (liquid).
Stain removers.
Ion exchangers.
Liquid water treatment products.
Solid/Powder water treatment products.
Liquid body soap.
Liquid hand soap.
Solid bar soap.
Air fresheners for motor vehicles.
Continuous action air fresheners.
Instant action air fresheners.
Anti-static spray.
Apparel finishing, and impregnating/surface treatment products.

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50936

Federal Register / Vol. 90, No. 217 / Thursday, November 13, 2025 / Proposed Rules

TABLE 5 TO PARAGRAPH (c)(4)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES—
Continued
Code

Category

CC135 ..............
CC136 ..............
CC137 ..............
CC138 ..............

Insect repellent treatment.
Pre-market waxes, stains, and polishes applied to footwear.
Post-market waxes, and polishes applied to footwear (shoe polish).
Waterproofing and water-resistant sprays.
Chemical Substances in Construction, Paint, Electrical, and Metal Products

CC201 ..............
CC202 ..............
CC203 ..............
CC204 ..............
CC205 ..............
CC206 ..............
CC207 ..............
CC208 ..............
CC209 ..............
CC210 ..............
CC211 ..............
CC212 ..............
CC213 ..............
CC214 ..............
CC215 ..............
CC216 ..............
CC217 ..............
CC218 ..............
CC219 ..............
CC220 ..............
CC221 ..............
CC222 ..............

Fillers and putties.
Hot-melt adhesives.
One-component caulks.
Solder.
Single-component glues and adhesives.
Two-component caulks.
Two-component glues and adhesives.
Adhesive/Caulk removers.
Aerosol spray paints.
Lacquers, stains, varnishes and floor finishes.
Paint strippers/removers.
Powder coatings.
Radiation curable coatings.
Solvent-based paint.
Thinners.
Water-based paint.
Wood and engineered wood articles: Construction and building materials covering large surface areas.
Non-metal and non-wood articles not covered elsewhere: Construction and building materials covering large surface areas, including but not limited to paper articles; plastic, rubber, fiberglass, and other composite articles; stone, asphalt, plaster, cement, glass, and ceramic articles.
Small-scale complex (i.e., mixed material) machinery, mechanical appliances, and electrical/electronic articles.
Large-scale complex (i.e., mixed material) machinery, motor vehicles, mechanical appliances, and electrical/electronic articles.
Metal products, including construction/building materials, parts, or other metal articles not covered elsewhere.
Electrical batteries and accumulators.
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products

CC990 ..............
CC301 ..............
CC302 ..............
CC303 ..............
CC304 ..............
CC305 ..............
CC306 ..............
CC307 ..............
CC308 ..............
CC309 ..............
CC310 ..............
CC311 ..............
CC312 ..............
CC313 ..............
CC314 ..............
CC315 ..............
CC316 ..............
CC317 ..............

Non-TSCA use.
Packaging (excluding food packaging), including paper articles.
Other articles with routine direct contact during normal use, including paper articles.
Articles without routine direct contact, such as packaging (excluding food packaging), including rubber articles; plastic articles
(hard); plastic articles (soft).
Articles without routine direct contact, such as packaging (excluding food packaging), including rubber articles; plastic articles
(hard); plastic articles (soft).
Toys intended for children’s use (and child-dedicated articles), including but not limited to fabrics, textiles, and apparel; metal
articles; wood articles; paper articles; plaster, glass, and ceramic articles; and/or plastic, rubber, fiberglass, and other composite articles (hard).
Adhesives applied at elevated temperatures.
Cement/concrete.
Crafting glue.
Crafting paint (applied to body).
Crafting paint (applied to craft).
Fixatives and finishing spray coatings.
Modelling clay.
Correction fluid/tape.
Inks in writing equipment (liquid).
Inks used for stamps.
Toner/Printer cartridge.
Liquid photographic processing solutions.

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Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use Products
CC401 ..............
CC402 ..............
CC403 ..............
CC404 ..............
CC405 ..............
CC406 ..............
CC407 ..............
CC408 ..............
CC409 ..............
CC410 ..............
CC411 ..............
CC412 ..............

VerDate Sep<11>2014

Exterior car washes and soaps.
Exterior car waxes, polishes, and coatings.
Interior car care.
Touch up auto paint.
Degreasers.
Liquid lubricants and greases.
Paste lubricants and greases.
Spray lubricants and greases.
Anti-freeze liquids.
De-icing liquids.
De-icing solids.
Lock de-icers/releasers.

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Federal Register / Vol. 90, No. 217 / Thursday, November 13, 2025 / Proposed Rules

50937

TABLE 5 TO PARAGRAPH (c)(4)—CODES FOR REPORTING CONSUMER AND COMMERCIAL PRODUCT CATEGORIES—
Continued
Code

Category

CC413 ..............
CC414 ..............
CC415 ..............
CC416 ..............
CC417 ..............
CC418 ..............

Cooking and heating fuels.
Fuel additives.
Vehicular or appliance fuels.
Explosive materials.
Agricultural non-pesticidal products.
Lawn and garden care products.
Chemical Substances in Products Not Described by Other Codes

CC980 ..............
CC990 ..............

Other (specify).
Non-TSCA use.

*

*
*
*
*
(b) Chemical-specific information.
The following chemical-specific
information must be reported for each
chemical substance that is a PFAS
manufactured for each year since
January 1, 2011. This includes each
chemical substance that is a PFAS and
incorporated into mixtures:
*
*
*
*
*
Table 5 to Paragraph (c)(4)—Codes for
Reporting Consumer and Commercial
Product Categories
*

*
*
*
*
(f) * * *
(1) Organization for Economic
Cooperation and Development (OECD)
Harmonized Templates. For each
unpublished study report, the submitter
shall complete an OECD Harmonized
Templates for Reporting Chemical Test
Summaries and submit the
accompanying study reports and
supporting information. This can be
accomplished by using the freely
available IUCLID software. Templates
need not be prepared for exposurerelated information the manufacturer is
otherwise submitting through the
reporting application described in
§ 705.35.
*
*
*
*
*
■ 5. Remove and reserve § 705.18.
§ 705.18

[Reserved]

*

*
*
*
*
■ 6. Revise § 705.20 to read as follows:

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§ 705.20

When to report.

All information reported to EPA in
response to the requirements of this part
must be submitted during the applicable
submission period. For all reporters
submitting information pursuant to
§ 705.15, the submission period shall

VerDate Sep<11>2014

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Jkt 268001

begin on [DATE 2 MONTHS AFTER
EFFECTIVE DATE OF THE FINAL
RULE], and last for three months:
[DATE 2 MONTHS AFTER EFFECTIVE
DATE OF THE FINAL RULE], through
[DATE 5 MONTHS AFTER EFFECTIVE
DATE OF THE FINAL RULE].
*
*
*
*
*
■ 7. Amend § 705.30 by:
■ a. Revising paragraph (a)(2) in
numerical order;
■ b. Revising paragraph (a)(2)(ii);
■ c. Reserve paragraph (a)(2)(iv)
■ d. Revise paragraph (b)(2)(i)
■ e. Revising paragraph (f);
■ f. Revising paragraph (g); and
■ g. Revise paragraph (h).
The revisions to read as follows:
§ 705.30

Confidentiality claims.

(a) * * *
(1) * * *
(2) * * *
(i) * * *
(ii) For processing and use data
elements required by §§ 705.15(c)(1)
through (7);
(iii) * * *
(iv) [Reserved]
*
*
*
*
*
(b) * * *
(1) * * *
(2) * * *
(i) Volume. Production volume
information required pursuant to
§§ 705.15(d)(1), (5), and (6).
*
*
*
*
*
(f) Additional requirements for
specific chemical identity. A person
may assert a claim of confidentiality for
the specific chemical identity of a
chemical substance as described in
§ 705.15(b)(1)(i) only if the identity of
that chemical substance is treated as
confidential in the Master Inventory File
(or as a confidential LVE) as of the time

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the report is submitted for that chemical
substance, if that substance is currently
on the Inventory or is an LVE. Any
person who asserts a claim of
confidentiality for the specific chemical
identity under this paragraph must
provide a generic chemical name. To
assert a claim of confidentiality for the
identity of a reportable chemical
substance, you must submit with the
report detailed written answers to the
questions from paragraph (b) of this
section and to the following questions.
*
*
*
*
*
(g) Joint submissions. If a primary
submitter asks a secondary submitter to
provide information directly to EPA in
a joint submission under
§ 705.15(b)(1)(i), only the primary
submitter may assert a confidentiality
claim for the data elements that it
directly submits to EPA. The primary
submitter must substantiate those
claims that are not exempt under
paragraph (b)(2) of this section. The
secondary submitter is responsible for
asserting all confidentiality claims for
the data elements that it submits
directly to EPA and for substantiating
those claims that are not exempt under
paragraph (b)(3) of this section.
(h) No claim of confidentiality.
Information not claimed as confidential
business information in accordance
with the requirements of this section
may be made public (e.g., by publication
of specific chemical name and CASRN
on the public portion of the TSCA
Inventory). EPA will provide advance
public notice of specific chemical
identities to be added to the public
portion of the TSCA Inventory.
*
*
*
*
*
[FR Doc. 2025–19882 Filed 11–12–25; 8:45 am]
BILLING CODE 6560–50–P

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