The Environmental Protection Agency (EPA) has issued a proposed rule to amend its October 2023 regulation requiring manufacturers of per- and polyfluoroalkyl substances (PFAS) to report data on production, use, and effects from 2011 to 2022. Published in the Federal Register on November 13, 2025, this proposal introduces exemptions for activities unlikely to yield significant new information, adjusts the data submission period, and makes technical clarifications. Attributed to directives from President Trump under Executive Order 14219, the amendments aim to align with statutory obligations under the Toxic Substances Control Act (TSCA) while minimizing unnecessary burdens on industry, particularly small businesses. This development reflects a broader push for deregulatory efficiency without compromising core data needs for environmental and health assessments.
Background and Legal Context
The original rule, promulgated under TSCA section 8(a)(7) as added by the 2019 National Defense Authorization Act, mandates one-time reporting from entities that manufactured PFAS since January 1, 2011. It requires details on chemical identity, production volumes, uses, byproducts, exposures, and health effects, as outlined in TSCA section 8(a)(2)(A) through (G). EPA finalized the rule on October 11, 2023, without exemptions common in other TSCA reporting frameworks, such as those in the Chemical Data Reporting rule.
The proposal revisits this approach in light of TSCA sections 8(a)(5) and 2(c), which emphasize feasible reporting, minimizing small business burdens, and considering economic impacts. It also aligns with President Trump's Executive Order 14219, directing agencies to review regulations impeding innovation and economic development. EPA cites stakeholder feedback from the 2021 proposed rule and a 2022 Small Business Advocacy Review Panel, which highlighted disproportionate burdens on small entities and article importers. The agency now proposes exemptions to focus reporting on activities where manufacturers are most likely to have relevant data.
Key Proposed Exemptions
EPA proposes several exemptions to narrow the scope of reportable activities, drawing parallels to exemptions in 40 CFR 720.30(h) and the Chemical Data Reporting rule.
A de minimis exemption would exclude PFAS in mixtures or articles below 0.1% concentration, regardless of total volume. This threshold reflects historical recordkeeping practices under OSHA's Hazard Communication Standard and the EU's REACH regulation, where notifications were not required for such low levels during the 2011-2022 period. EPA argues this is consistent with the de minimis principle in statutory interpretation, as affirmed in cases like Wisconsin Department of Revenue v. William Wrigley, Jr., Co. (505 U.S. 214, 1992), and unnecessary under TSCA section 8(a)(5)(A) given low exposure potential.
Imported articles containing PFAS would be exempt, addressing concerns that importers often lack knowledge of such content. EPA notes that downstream use data from original manufacturers will still inform the agency on PFAS in articles. The proposal also reinterprets TSCA section 8(a)(7) as targeting manufacturers of PFAS substances themselves, not articles, based on the statutory phrase "a chemical substance that is a [PFAS]."
Additional exemptions cover PFAS manufactured as byproducts, impurities, or non-isolated intermediates under conditions in 40 CFR 720.30(h), and small quantities solely for research and development (R&D). These align with longstanding TSCA exemptions, as manufacturers are unlikely to have detailed records. EPA deems such data unnecessary or duplicative, citing TSCA section 8(a)(5)(A), and notes relief for small manufacturers under section 8(a)(5)(B). The R&D exemption supports Executive Order 14219 by reducing burdens on innovation.
Adjustments to Reporting Timeline and Clarifications
The proposal shortens the data submission period to three months, starting 60 days after the final rule's effective date, to account for the narrowed scope. This eliminates the extended deadline for small article importers, as they would be exempt.
Technical clarifications include refining consumer and commercial product category codes for clarity (e.g., distinguishing wood from non-wood construction materials) and specifying that OECD Harmonized Templates are required only for unpublished health and environmental effects studies, not exposure data already fielded in the application. These changes aim to reduce confusion without altering core requirements.
Economic and Regulatory Impacts
EPA's Economic Analysis estimates net cost savings of $786-$843 million compared to the 2023 rule, primarily from reduced burden on 127,469 small article importers and 241 small manufacturers. Total industry hours saved are projected at 10-11 million, with no incremental agency costs. This reflects assumptions that 5-12% of original costs are sunk, based on inquiries and professional judgment.
The proposal maintains most reporting to fulfill TSCA obligations, potentially informing future actions like risk assessments or regulations under TSCA section 6. However, it defers collection on exempted activities, acknowledging EPA's authority to request such data later if needed, as supported by cases like South Coast Air Quality Management District v. EPA (554 F.3d 1076, D.C. Cir. 2009).
Forward-Looking Considerations
In summary, these amendments balance data collection needs with regulatory efficiency, potentially setting a precedent for targeted TSCA reporting. Potential next steps include public comments due by December 29, 2025, and finalization, with EPA seeking input on alternative de minimis levels or scope adjustments. Ongoing debates may focus on whether exemptions adequately capture exposure risks, especially for persistent PFAS. Future challenges could involve integrating this data into broader PFAS strategies, such as the National PFAS Testing Strategy, while addressing any gaps through targeted follow-up rules.