PFAS update: Summary from the USA - European Sealing Association

EPA proposes targeted amendments to TSCA PFAS reporting: who’s exempt, what still applies, and why it matters

The U.S. Environmental Protection Agency (EPA) has proposed amendments to the 2023 one-time PFAS data reporting rule under TSCA §8(a)(7). The proposal keeps the core requirement for manufacturers (including importers) that made PFAS for commercial purposes in any year 2011–2022 to report known or reasonably ascertainable information, but narrows what counts as a reportable manufacturing activity and clarifies several mechanics. EPA’s goal is to focus reporting on entities most likely to hold useful information, reduce duplicative or low-value submissions, and ease burden—particularly on small businesses—consistent with TSCA §8(a)(5) and TSCA §2(c).

What EPA is proposing to change

 1) New exemptions to the scope of reportable “manufacture”.

EPA would add the following activity-based exemptions:

• De minimis concentration (0.1%) — PFAS present below 0.1% in mixtures or articles would be exempt from reporting, regardless of production volume.
  A uniform 0.1% threshold avoids case-by-case determinations and still preserves higher-value reporting.
• Imported articles — Importing an article that contains PFAS would be exempt.

The regulation proposal is that manufacturers outside the U.S. would not need to report PFAS produced articles; the importer of record of the material into the U.S. would be required to report to the US EPA.  For U.S. production of PFAS, the manufacturers of the PFAS would report to the EPA.

• Byproducts (non-commercial) — PFAS made solely as byproducts and not used for a commercial purpose (as in 40 CFR 720.30(h)) would be exempt. If the byproduct PFAS is later used commercially (e.g., land-applied or burned as fuel), it remains reportable.
• Impurities — PFAS that are impurities (unintentionally present and not manufactured for separate commercial use) would be exempt.
• Non-isolated intermediates — PFAS intermediates created and consumed within a closed system and not intentionally removed from equipment would be exempt.
• Research & development (R&D) PFAS — PFAS manufactured or imported solely in small quantities for R&D (no more than reasonably necessary) would be exempt. No specific mass threshold is proposed; the definition in 40 CFR 704.3 governs.

Important: These exemptions don’t eliminate all reporting on PFAS used in articles or made as byproducts. Original PFAS manufacturers still must report processing and use information (including incorporation into articles) for their reportable PFAS, and must disclose byproducts associated with manufacturing/processing/use/disposal of those reportable PFAS.

2) Submission window reset

If finalised, the data-submission period would begin 60 days after the final rule’s effective date and run for three months. Because article importers would be exempt, EPA would remove the special, later deadline that had applied to small manufacturers reporting exclusively as article importers.

What does not change

•  Any person who manufactured (including imported) PFAS for a commercial purpose in 2011–2022 remains potentially subject to the rule, limited by the proposed exemptions above.
• PFAS definition: The structural PFAS definition at 40 CFR 705.3 remains the touchstone.
• TSCA §3(2)(B) exclusions: Uses already excluded from the TSCA “chemical substance” definition (e.g., pesticides as pesticides, foods/drugs/cosmetics as such, tobacco, certain nuclear materials, taxed firearms articles) remain outside the rule.

Why the EPA says it’s doing this

•  TSCA §8(a)(5) requires EPA, to the extent feasible, to avoid unnecessary/duplicative reporting and minimise small-entity burden.
• TSCA §2(c) directs EPA to act reasonably/prudently, considering economic and social impacts.
• Implementation experience and comments indicate that much of the cost fell on entities least likely to know sub-0.1% PFAS content or legacy article content, and that some byproduct reporting would duplicate information captured via reports on the primary PFAS.

Estimated impacts

•  Industry burden reduction:
• Cost savings: $786–$843 million versus the 2023 final rule.
• Small business relief: 9.3–9.9 million hours and $703–$761 million in savings.
• EPA costs: No expected incremental costs, and the EPA notes that 6–12% of costs from the 2023 rule may already have been incurred.

Summary

The proposal narrows TSCA PFAS reporting to exclude low-concentration content, imported articles, non-commercial byproducts, impurities, non-isolated intermediates, and small-quantity R&D—while preserving reporting from primary PFAS manufacturers on uses (including articles) and byproducts tied to those PFAS.

The final rule is expected around April 2026, and companies (if required) will have only three months to submit reports to the EPA.

If finalised as proposed, it would significantly reduce compliance burden and costs without abandoning the core objective of capturing known or reasonably ascertainable information about historically manufactured PFAS.

Source: U.S. EPA, Federal Register, FR Doc. 2025-19882.

Sandy Van den Broeck,
ESG Director, ESA