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The U.S. Environmental Protection Agency (EPA) has released a
pre-publication edition of its much-anticipated proposal to amend
the Toxic Substances Control Act (TSCA) reporting and recordkeeping
regulation for per- and polyfluoroalkyl substances (PFAS). The term
PFAS, as defined in the current rule, could include potentially
thousands of individual chemical substances. The amendments
proposed could substantially reduce the reporting burdens imposed
by the 2023 edition codified during the Biden administration.
In October 2023, EPA finalized its rule requiring manufacturers and
importers to report detailed information on PFAS domestically
manufactured or imported between 2011 and the end of 2022. The PFAS
reporting rule implements a provision of the National Defense
Authorization Act for Fiscal Year 2020, which added TSCA section
8(a)(7).1 As currently codified, the rule established
the first comprehensive PFAS reporting program under TSCA,
capturing PFAS manufacturing and importing information covering a
period of more than 10 years. The information currently required to
be reported includes chemical identities, uses, production volumes,
potential human exposures, and existing health or safety data
previously not submitted to EPA. The scope of the 2023 final rule
covers PFAS that may have been produced or imported during the
period covered, even when present only as an unintended impurity or
byproduct in other products or imported in manufactured
articles.
The new proposal would substantially narrow the scope of the
October 2023 final rule by adding key exemptions and technical
corrections that are expected to reduce the reporting burden,
particularly for importers, small entities, and companies that
manufacture or import certain products and formulations that might
contain trace levels of PFAS. EPA estimates total industry cost
savings of $786 million to $843 million, with small entities
realizing over $700 million in reduced compliance costs.
Key Proposed Exemptions
EPA proposes adding key categories of exemptions to 40 C.F.R.
Part 705 that would relieve reporting obligations for activities
unlikely to yield relevant information related to human or
environmental risks. These include:
1. De Minimis Concentration (≤ 0.1%). PFAS
present below 0.1% by weight in any mixture or article would be
exempt from reporting. EPA has determined that information below
this threshold is not reasonably ascertainable for the 2011-2022
timeframe covered and that Safety Data Sheet (SDS) or the European
Union Registration, Evaluation, Authorization and Restriction of
Chemicals (REACH) frameworks did not require disclosures of PFAS
below that level. EPA further notes that a uniform 0.1% cutoff
aligns with existing hazard communication standards and reduces
reporting burdens without materially affecting data quality.
2. Imported Articles. PFAS contained in imported
articles would be excluded from reportable activities. EPA now
proposes to interpret TSCA section 8(a)(7) as requiring reporting
by "manufacturers of PFAS" themselves, not importers of
articles that merely contain PFAS. This change would significantly
reduce the burden for importers of electronics, textiles,
automotive parts, garments, consumer products, and other
items.
3. Byproducts, Impurities, and Non-Isolated
Intermediates. PFAS produced as byproducts,
unintentionally present as impurities, or used only as non-isolated
intermediates (meaning that PFAS formed and consumed entirely
within enclosed chemical manufacturing equipment) would be exempt,
aligning the rule's exemptions with those provided in other
existing TSCA reporting rules, such as the Chemical Data Reporting
(CDR) requirements. However, manufacturers would still be required
to report on any PFAS byproducts used for a commercial
purpose.
4. Research and Development (R&D) Chemicals.
PFAS manufactured solely in quantities "no greater than
reasonably necessary" for R&D purposes would be exempt
from reporting. EPA notes that R&D-related reporting would not
contribute information important to an understanding of exposures
attributable to commercial uses of PFAS, and thus these activities
would not need to be reported under the amended rule.
EPA acknowledges that certain entities may qualify for multiple
exemptions (e.g., PFAS below 0.1% and PFAS in an imported article),
and the EPA invites comment on consolidating one or more of the
exemptions provisions for clarity.
Additional Proposed Changes
Submission Period. The proposed reporting
period would occur during a three-month window beginning 60 days
after the final rule's effective date. This adjustment replaces
the prior staggered schedule established in the October 2023 final
rule and eliminates the extended 12-month deadline previously
granted to small manufacturers reporting solely as article
importers.
Clarifications. EPA proposes to clarify that the
use of Organization for Economic Co-operation and Development
Harmonized Templates for data reporting applies only to unpublished
study reports. The proposed rule would also revise and clarify
consumer and commercial product categories to reduce overlap and
confusion among reporters.
Confidential Business Information Provisions. EPA
proposes minor adjustments to specify how confidentiality claims
apply to specific data elements, including production volumes,
chemical identity, and joint submissions.
Expected Burden Reduction Benefits
The proposed exemptions are expected to relieve substantial
reporting burdens for importers, laboratories, and manufacturers
that handle trace or incidental PFAS. EPA states that "an
estimated 127,469 small article importers would no longer be
subject to the regulation." Entities producing or formulating
PFAS for commercial use will continue to report production, use,
and byproduct data. EPA reserves the ability to revisit exemptions
in future rulemakings if data gaps hinder TSCA
implementation.
EPA's proposed PFAS amendments would better align TSCA PFAS
reporting with the existing CDR framework, which requires
manufacturers to report chemical production information to EPA
every four years for the preceding reporting period. The CDR rule
already includes many of the same exemptions — such as for
impurities, byproducts, and research and development substances
— that EPA now proposes to extend to PFAS reporting. By
harmonizing these provisions, EPA will create greater consistency
across TSCA data collection programs.
EPA is accepting comments for 45 days following publication in the
Federal Register.
Arnold & Porter will continue to track EPA's implementation
of this proposal and any subsequent regulatory actions.
Based on EPA pre-publication version signed November 10,
2025.
Footnote
1 For more information on the October 2023 PFAS reporting rule, see Arnold & Porter's Advisory, EPA Issues Exhaustive Requirements for Collecting Detailed Information on PFAS (Oct. 17, 2023).
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