On October 11, 2023, the United States Environmental Protection Agency (EPA) promulgated a final rule pursuant to section 8(a)(7) of the Toxic Substances Control Act (TSCA) imposing a one-time reporting obligation on entities that manufactured (including imported) per- and polyfluoroalkyl substances (PFAS) at any time between January 1, 2011 and December 31, 2022, to the extent the information is “known or reasonably ascertainable.” “Manufacture” is defined to mean manufacture (including import) “for a commercial purpose.” Information required to be reported includes company and plant site information, chemical-specific information, categories of use, manufactured amounts, by-product reporting, environmental and health effects, worker exposure data, and disposal data; reporting is required on a chemical-specific basis and for each “site” where the chemical is manufactured/imported. This rule is the direct result of a provision in the National Defense Authorization Act (NDAA) for fiscal year 2020, which required EPA to require reporting by PFAS manufacturers. EPA therefore did not have flexibility with respect to whether to finalize the rule; they did, however, have discretion with respect to the scope of the rule, including whether to apply exemptions found in other TSCA contexts (for example, exemptions for article importers, the manufacture of by-products and impurities, and manufacture for research and development (R&D) purposes). Despite overwhelming public comment regarding the need for such exemptions, EPA declined to apply any of these exemptions in the 2023 final rule.
Application to “Chemical Substances”; Exclusion of FDA-Regulated Substances – The PFAS reporting rule applies to “chemical substances,” which is defined by TSCA § 3 to exclude “any food, food additive, drug, cosmetic, or device (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act) when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device.” As a general matter, the rule’s direct impact on companies working under FDA oversight, including those in the drug, biologics, food, medical device, and cosmetics sectors, may be relatively limited. Companies should consider what manufacturing activities (including import of any PFAS chemicals or import of PFAS-containing mixtures or articles) may fall outside of this exclusion and therefore be subject to reporting under the PFAS reporting rule. For example, applicability of the exemption is less clear when PFAS are produced (or PFAS/PFAS-containing articles are imported) for multiple end uses.
Companies evaluating potential reporting obligations under the PFAS reporting rule should evaluate their operations and records in light of the “known or reasonably ascertainable” standard. Data reported under the rule (unless covered by a valid and timely confidential business information (CBI) claim) will be publicly available and available to competitors, advocacy groups, and plaintiffs’ attorneys.
The November 2025 Proposal: Proposed Exemptions; Proposed Change to Reporting Window
EPA has now proposed significant changes to the scope of the TSCA PFAS reporting rule. Specifically, in a November 13, 2025 notice of proposed rulemaking (NPRM), EPA announced that it is proposing to exempt the following “manufacture” from the scope of reportable PFAS manufacturing activity under the rule:
- Import of PFAS in articles
- PFAS in mixtures or articles below 0.1% (a “de minimis” exemption)
- Manufacture of PFAS as by-products, impurities, and non-isolated intermediates and
- Manufacture (including import) of PFAS in small quantities for R&D purposes (specifically, in such “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”)
EPA has also proposed changing the reporting window. Currently, the reporting window is currently set to open April 13, 2026; most reporting entities have 6 months to report, except that small manufacturers that are required to report only because of their import of PFAS-containing articles have a full year. In the current proposal, EPA proposes opening the reporting window 60 days after the effective date of a final rule; EPA also proposes shortening the window allowed for reporting from 6 months to 3 months. (Because, under the proposal, article importers would not be required to report, there would be no need for a longer reporting window for small manufacturer article importers.)
Next Steps and Looking Ahead
EPA will accept comments on the proposal through December 29, 2025. Companies should evaluate potential obligations under the existing rule and whether the proposed revisions align with operational and strategic priorities; consider submitting comments to individually or through industry associations to ensure relevant stakeholder perspectives are reflected in the administrative record.
The TSCA PFAS reporting rulemaking highlights the breadth of federal PFAS oversight, as well as the growing intersection between EPA’s PFAS-focused initiatives and the FDA’s ongoing oversight of chemicals and materials used in food and medical products. Parallel monitoring of both agencies’ regulatory initiatives is essential to effectively manage compliance, supply chain transparency, and associated liability considerations.
Venable’s Food and Drug Law team is monitoring these developments as they relate to FDA-regulated industries and companies. Venable’s Environmental Law team is tracking EPA’s PFAS-focused actions under the Agency’s chemicals, water, remediation, and other programs. Together, we can assist companies in assessing and mitigating exposure and risk, obtaining and verifying supplier information, achieving compliance objectives, and pursuing advocacy in the form of comments on the TSCA PFAS reporting proposal and other significant rulemakings.