[Federal Register Volume 90, Number 217 (Thursday, November 13, 2025)]
[Proposed Rules]
[Pages 50923-50937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-19882]
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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 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:
[email protected].
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:
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
[[Page 50924]]
considered to be a ``chemical substance'' pursuant to the TSCA
definition may require reporting for such uses.
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 one-time 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
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 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.
[[Page 50925]]
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 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 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
[[Page 50926]]
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
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 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.
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.
[[Page 50927]]
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 minimis concentrations in mixtures and
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/pfas-analytical-methods-development-and-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.
[[Page 50928]]
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 future TSCA actions.
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.
3. Byproducts, Impurities, and Non-Isolated 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 resource-
intensive 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
[[Page 50929]]
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 byproducts. That is, a manufacturer of a 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 non-PFAS.
In addition, under the 2023 final rule, a processor would need to
report as a manufacturer for any PFAS-containing 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 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 non-isolated 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
[[Page 50930]]
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
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.
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.
[[Page 50931]]
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 article-related
codes in the PFAS Data Reporting Rule (see Table 5 at 40 CFR
705.15(c)(4)). For example, under 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
Code ------------------------------------------------------------------------------------------
Name Description Name Description
----------------------------------------------------------------------------------------------------------------
CC217................ Construction and Floor decking, Wood and engineered Floor decking,
building materials claddings, toys wood articles: flooring, lumber,
covering large outdoor equipment, Construction and plywood, walls,
surface areas, walls, flooring. building materials claddings, outdoor
including wood covering large playground
articles. surface areas. equipment, indoor
toy structures/play-
gyms.
CC218................ Construction and Construction and Non-metal and non- Insulation panels,
building materials building materials; wood articles not wall papers, roof
covering large e.g., insulation covered elsewhere: shingles/tiles,
surface areas, panels, wall papers, Construction and siding, synthetic
including paper roof sheets, building materials flooring/composite
articles; metal drinking water covering large floor decking (non-
articles; stone, pipes, sewer pipes, surface areas, wood), climbing
plaster, cement, cement flooring, including but not walls, drinking
glass and ceramic mirrors. limited to paper water pipes (non-
articles. articles; plastic, metal), sewer pipes
rubber, fiberglass, (non-metal), cement
and other composite flooring, windows,
articles; stone, mirrors, boat hulls
asphalt, plaster, (non-metal, such as
cement, glass, and fiberglass),
ceramic articles. automobile panels
(non-metal).
CC219................ Machinery, mechanical Refrigerators, Small-scale complex Refrigerators,
appliances, washing machines, (i.e., mixed washing machines,
electrical/ vacuum cleaners, material) machinery, vacuum cleaners,
electronic articles. computers, mechanical computers,
telephones, drills, appliances, and telephones, drills,
saws, smoke electrical/ saws, smoke
detectors, electronic articles. detectors,
thermostats, thermostats,
radiators. radiators,
motorcycles, motor
scooters, e-bikes/
electric bicycles,
remote-control cars/
drones, portable
solar panels.
CC220................ Other machinery, Large-scale Large-scale complex Large-scale
mechanical stationary (i.e., mixed stationary
appliances, industrial tools. material) machinery, industrial tools,
electronic/ motor vehicles, heavy machinery/
electronic articles. mechanical vehicles, trucks,
appliances, and tractors, ships,
electrical/ planes, solar
electronic articles. panels/arrays, wind
turbines,
electrical
infrastructure,
large computer
servers/network
systems, heating/
cooling/AC systems.
CC221................ Construction and Roof sheets, drinking Metal products, Shipping containers,
building materials water pipes, sewer including steel framing,
covering large pipes. construction/ rebar, roof sheets,
surface areas, building materials, heating/cooling/air-
including metal parts, or other exchange ductwork,
articles. metal articles not drinking water
covered elsewhere. pipes (metal),
sewer pipes
(metal), wheels,
aircraft wings,
boat hulls,
automobile frames/
panels.
CC303................ Packaging (excluding Phone covers, Articles without Phone covers,
food packaging), personal tablet routine direct personal tablet
including rubber covers, styrofoam contact, such as covers, styrofoam
articles; plastic packaging, bubble packaging (excluding packaging, bubble
articles (hard); wrap. food packaging), wrap.
plastic articles including rubber
(soft). articles; plastic
articles (hard);
plastic articles
(soft).
CC304................ Other articles with Gloves, boots, Other articles with Gloves, boots,
routine direct clothing, rubber routine direct clothing, rubber
contact during handles, gear lever, contact during handles, gear
normal use including steering wheels, normal use, lever, steering
rubber articles; handles, pencils, including rubber wheels, handles,
plastic articles handheld device articles; plastic pencils, handheld
(hard). casing. articles (hard). device casing.
[[Page 50932]]
CC305................ Toys intended for Stuffed toys, Toys intended for Outdoor playground
children's use (and blankets, comfort children's use (and equipment/parts,
child dedicated objects, dolls, car, child-dedicated swing sets, slides,
articles), including animals, teething articles), including play forts/tree
fabrics, textiles, rings. but not limited to houses, indoor toy
and apparel; or fabrics, textiles, structures/play
plastic articles and apparel; metal gyms, skates,
(hard). articles; wood baseball gloves,
articles; paper stuffed toys/
articles; plaster, animals, blankets,
glass, and ceramic comfort objects,
articles; and/or dolls, action
plastic, rubber, figures, balls, toy
fiberglass, and cars/trucks,
other composite wagons, teething
articles (hard). 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 non-isolated
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 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. 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
production-volume 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.
[[Page 50933]]
threshold for chemical substances subject to specific TSCA activities
(see 40 CFR 711.8). However, EPA is not proposing to provide a
production-volume 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 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-2020-0549-0123.
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-test-strategy.pdf.
7. European Chemicals Agency (ECHA). ``Per-and 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.'' January 2025. Available at https://www.epa.gov/system/files/documents/2025-01/fact-sheet-draft-sewage-sludge-risk-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-toxicity-assessment_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/tsca-gme/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/laws-regulations/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.
[[Page 50934]]
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: Non-exempt 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 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 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.
[[Page 50935]]
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
0
1. The authority for part 705 continues to read as follows:
Authority: 42 U.S.C. 2607(a)(7).
0
2. Amend Sec. 705.3 by revising the introductory paragraph to read as
follows:
Sec. 705.3 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.
* * * * *
0
3. Amend Sec. 705.5 to read as follows:
Sec. 705.5 Substances for which reports must be submitted.
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 Sec. 705.3, except as described in
Sec. 705.12.
* * * * *
0
4. Amend Sec. 705.12 by revising the introductory paragraph and adding
paragraphs a, b, c, d, e, and f in alphabetical order to read as
follows:
Sec. 705.12 Activities for which reporting is not required.
A person described in Sec. 705.10 is not subject to the
requirements of this part with respect to any chemical substance
described in Sec. 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.
(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.
* * * * *
0
5. Amend Sec. 705.15 by:
0
a. Revising the introductory paragraph;
0
b. Revising the introductory text paragraph in (b);
0
c. Revising and replacing Table 5; and
0
d. Revising paragraph (f)(1).
The revisions to read as follows:
Sec. 705.15 What information to report.
For the one-time submission, persons identified in Sec. 705.10
must report to EPA, for each site of each of the chemical substances
identified in Sec. 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
------------------------------------------------------------------------
CC101.................... Construction and building materials covering
large surface areas including stone,
plaster, cement, glass and ceramic articles;
fabrics, textiles, and apparel.
CC102.................... Furniture & furnishings including plastic
articles (soft); leather articles.
CC103.................... Furniture & furnishings including stone,
plaster, cement, glass and ceramic articles;
metal articles; or rubber articles.
CC104.................... Leather conditioner.
CC105.................... Leather tanning, dye, finishing, impregnation
and care products.
CC106.................... Textile (fabric) dyes.
CC107.................... Textile finishing and impregnating/surface
treatment products.
CC108.................... All-purpose foam spray cleaner.
CC109.................... All-purpose liquid cleaner/polish.
CC110.................... All-purpose liquid spray cleaner.
CC111.................... All-purpose waxes and polishes.
CC112.................... Appliance cleaners.
CC113.................... Drain and toilet cleaners (liquid).
CC114.................... Powder cleaners (floors).
CC115.................... Powder cleaners (porcelain).
CC116.................... Dishwashing detergent (liquid/gel).
CC117.................... Dishwashing detergent (unit dose/granule).
CC118.................... Dishwashing detergent liquid (hand-wash).
CC119.................... Dry cleaning and associated products.
CC120.................... Fabric enhancers.
CC121.................... Laundry detergent (unit-dose/granule).
CC122.................... Laundry detergent (liquid).
CC123.................... Stain removers.
CC124.................... Ion exchangers.
CC125.................... Liquid water treatment products.
CC126.................... Solid/Powder water treatment products.
CC127.................... Liquid body soap.
CC128.................... Liquid hand soap.
CC129.................... Solid bar soap.
CC130.................... Air fresheners for motor vehicles.
CC131.................... Continuous action air fresheners.
CC132.................... Instant action air fresheners.
CC133.................... Anti-static spray.
CC134.................... Apparel finishing, and impregnating/surface
treatment products.
[[Page 50936]]
CC135.................... Insect repellent treatment.
CC136.................... Pre-market waxes, stains, and polishes
applied to footwear.
CC137.................... Post-market waxes, and polishes applied to
footwear (shoe polish).
CC138.................... Waterproofing and water-resistant sprays.
------------------------------------------------------------------------
Chemical Substances in Construction, Paint, Electrical, and Metal
Products
------------------------------------------------------------------------
CC201.................... Fillers and putties.
CC202.................... Hot-melt adhesives.
CC203.................... One-component caulks.
CC204.................... Solder.
CC205.................... Single-component glues and adhesives.
CC206.................... Two-component caulks.
CC207.................... Two-component glues and adhesives.
CC208.................... Adhesive/Caulk removers.
CC209.................... Aerosol spray paints.
CC210.................... Lacquers, stains, varnishes and floor
finishes.
CC211.................... Paint strippers/removers.
CC212.................... Powder coatings.
CC213.................... Radiation curable coatings.
CC214.................... Solvent-based paint.
CC215.................... Thinners.
CC216.................... Water-based paint.
CC217.................... Wood and engineered wood articles:
Construction and building materials covering
large surface areas.
CC218.................... 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.
CC219.................... Small-scale complex (i.e., mixed material)
machinery, mechanical appliances, and
electrical/electronic articles.
CC220.................... Large-scale complex (i.e., mixed material)
machinery, motor vehicles, mechanical
appliances, and electrical/electronic
articles.
CC221.................... Metal products, including construction/
building materials, parts, or other metal
articles not covered elsewhere.
CC222.................... Electrical batteries and accumulators.
------------------------------------------------------------------------
Chemical Substances in Packaging, Paper, Plastic, Toys, Hobby Products
------------------------------------------------------------------------
CC990.................... Non-TSCA use.
CC301.................... Packaging (excluding food packaging),
including paper articles.
CC302.................... Other articles with routine direct contact
during normal use, including paper articles.
CC303.................... Articles without routine direct contact, such
as packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles (soft).
CC304.................... Articles without routine direct contact, such
as packaging (excluding food packaging),
including rubber articles; plastic articles
(hard); plastic articles (soft).
CC305.................... 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).
CC306.................... Adhesives applied at elevated temperatures.
CC307.................... Cement/concrete.
CC308.................... Crafting glue.
CC309.................... Crafting paint (applied to body).
CC310.................... Crafting paint (applied to craft).
CC311.................... Fixatives and finishing spray coatings.
CC312.................... Modelling clay.
CC313.................... Correction fluid/tape.
CC314.................... Inks in writing equipment (liquid).
CC315.................... Inks used for stamps.
CC316.................... Toner/Printer cartridge.
CC317.................... Liquid photographic processing solutions.
------------------------------------------------------------------------
Chemical Substances in Automotive, Fuel, Agriculture, Outdoor Use
Products
------------------------------------------------------------------------
CC401.................... Exterior car washes and soaps.
CC402.................... Exterior car waxes, polishes, and coatings.
CC403.................... Interior car care.
CC404.................... Touch up auto paint.
CC405.................... Degreasers.
CC406.................... Liquid lubricants and greases.
CC407.................... Paste lubricants and greases.
CC408.................... Spray lubricants and greases.
CC409.................... Anti-freeze liquids.
CC410.................... De-icing liquids.
CC411.................... De-icing solids.
CC412.................... Lock de-icers/releasers.
[[Page 50937]]
CC413.................... Cooking and heating fuels.
CC414.................... Fuel additives.
CC415.................... Vehicular or appliance fuels.
CC416.................... Explosive materials.
CC417.................... Agricultural non-pesticidal products.
CC418.................... Lawn and garden care products.
------------------------------------------------------------------------
Chemical Substances in Products Not Described by Other Codes
------------------------------------------------------------------------
CC980.................... Other (specify).
CC990.................... 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 exposure-related
information the manufacturer is otherwise submitting through the
reporting application described in Sec. 705.35.
* * * * *
0
5. Remove and reserve Sec. 705.18.
Sec. 705.18 [Reserved]
* * * * *
0
6. Revise Sec. 705.20 to read as follows:
Sec. 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 Sec. 705.15, the
submission period shall 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].
* * * * *
0
7. Amend Sec. 705.30 by:
0
a. Revising paragraph (a)(2) in numerical order;
0
b. Revising paragraph (a)(2)(ii);
0
c. Reserve paragraph (a)(2)(iv)
0
d. Revise paragraph (b)(2)(i)
0
e. Revising paragraph (f);
0
f. Revising paragraph (g); and
0
g. Revise paragraph (h).
The revisions to read as follows:
Sec. 705.30 Confidentiality claims.
(a) * * *
(1) * * *
(2) * * *
(i) * * *
(ii) For processing and use data elements required by Sec. Sec.
705.15(c)(1) through (7);
(iii) * * *
(iv) [Reserved]
* * * * *
(b) * * *
(1) * * *
(2) * * *
(i) Volume. Production volume information required pursuant to
Sec. Sec. 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 Sec. 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 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 Sec. 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