EPA Proposes To Narrow Scope Of TSCA Section 8(a)(7) PFAS Reporting Rule; Exemptions Would Include De Minimis Amounts, Imported Articles

On November 13, 2025, the U.S. Environmental Protection Agency (EPA) issued a proposed rule to amend the Toxic Substances Control Act (TSCA) Section 8(a)(7) regulation for reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS). 90 Fed. Reg. 50923. As reported in our October 3, 2023, memorandum, the final rule requires manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 through 2022 to report information related to chemical identity, uses, volumes made and processed, byproducts, environmental and health effects, worker exposure, and disposal to EPA. The proposed rule would incorporate exemptions to the scope of reportable manufacturing activities for a de minimis exemption of 0.1 percent; imported articles; byproducts; impurities; research and development (R&D); and non-isolated intermediates. According to EPA's proposed rule, 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." Comments are due December 29, 2025. According to the proposed rule, 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 (OIRA) on or before December 15, 2025.

Proposed Exemptions to the Scope of Reportable Manufacturing Activities

EPA proposes to add certain exemptions to the scope of reportable PFAS manufacturing activities under 40 C.F.R. Part 705. EPA states that it intends these exemptions to be similar to the TSCA Chemical Data Reporting (CDR) rule (40 C.F.R. Part 711) and, in addition, proposes to include a de minimis exemption. EPA notes that in some scenarios, more than one of the proposed exemptions may provide the same regulatory relief from reporting. For example, an importer of articles that contain low levels of PFAS may be exempt from reporting by 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."

De Minimis

EPA proposes a de minimis concentration exemption for reportable PFAS in mixtures or articles under which PFAS concentrations below 0.1 percent would be exempt from reporting. EPA notes that this exemption would apply regardless of total production volume of the mixture or article. According to EPA, the proposed de minimis level of 0.1 percent is appropriate because of the retrospective nature of the reporting and contemporary recordkeeping practices. During the lookback period for reporting, reporters are unlikely to have records of PFAS amounts below 0.1 percent due to the U.S. and international requirements at the time for labeling and recordkeeping.

EPA states that it also proposes to exempt these de minimis concentrations of PFAS in mixtures and articles from the scope of the rule based on the Agency's information needs under TSCA Section 8(a)(5)(A). According to EPA, it "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." EPA additionally notes that it does not anticipate evaluating PFAS that may only be manufactured in de minimis levels in the near future under TSCA.

Imported Articles

EPA proposes to exempt PFAS imported as part of an article from the scope of reportable activities. EPA states that it recognizes that importing PFAS in articles between 2011 and 2022 is an activity about which manufacturers are unlikely to have known or reasonably ascertainable information. As EPA noted in its discussion of the de minimis exemption, safety data sheet (SDS) and European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation 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 [Small Business Advocacy Review (SBAR)] Panel." According to EPA, it "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))."

EPA also proposes the 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." EPA states that, on balance, it "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 its authority under TSCA Section 8(a)(7). In the fiscal year (FY) 2020 National Defense Authorization Act (NDAA), Congress directed EPA to require reporting from "each person who has manufactured a chemical substance that is a [PFAS]." (Emphasis in original.) EPA notes that "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')."

Byproducts, Impurities, and Non-Isolated Intermediates

EPA proposes to exempt the manufacture of PFAS as byproducts, impurities, nonisolated 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 C.F.R. Section 720.30(h). EPA notes that 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. EPA states that "[o]verall, 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." According to EPA, as proposed, the 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."

Byproducts

The regulation currently requires a manufacturer of PFAS to report in separate chemical reports each PFAS that is manufactured, without exception. EPA proposes to exempt any byproduct not used for commercial purposes. "Byproduct" is defined in 40 C.F.R. Section 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 states that it proposes 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 notes that it is interested in learning about the intended commercial uses of PFAS, including PFAS 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. According to EPA, the exemption would not apply to component substances extracted from a byproduct when the extracted substances are reportable PFAS.

Impurities

EPA proposes to exempt the manufacture of PFAS as impurities from the scope of reportable activities. EPA notes that this exemption is also incorporated in the CDR regulation. EPA states that as defined at 40 C.F.R. Section 704.3, an impurity is a chemical substance unintentionally present with another chemical substance. An impurity is not manufactured for distribution in commerce as a chemical substance per se, and it has no distinct commercial purpose apart from the substance, mixture, or article in which it is contained.

EPA proposes that, consistent with TSCA Section 8(a)(5)(A), requiring this information is unnecessary. As explained in CDR guidance, in evaluating whether a PFAS is an impurity, EPA considers the source of the substance in the manufacturing process. According to EPA, a substance arising unintentionally in a final product because it was introduced unintentionally as a component of a raw material may be considered an impurity. EPA notes that this is distinguishable from a byproduct, which is a substance formed as part of the intended chemical reaction or byproduct stream, and if intentionally retained, would not meet the definition of an impurity and may be subject to reporting.

According to EPA, 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 manufacture of PFAS as impurities would only derive from the import of materials with PFAS as impurities. EPA notes that such importers are unlikely to know about the presence of PFAS, let alone any reportable information under TSCA Section 8(a)(7). EPA states that 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.

Non-Isolated Intermediates

Consistent with the proposed exemptions to align with 40 C.F.R. Section 720.30(h), EPA proposes to exempt otherwise-reportable PFAS that are non-isolated intermediates. Non-isolated intermediates, as defined at 40 C.F.R. Section 704.3, are substances manufactured and consumed within a closed system during the production of another chemical substance. These intermediates are not intentionally removed from process equipment and are not stored, packaged, or transported. EPA states that because these substances remain confined within closed systems and are not expected to be released in the environment or handled by workers, it "has determined that reporting on non-isolated intermediates is unnecessary because these intermediates do not result in meaningful human or environmental exposure." EPA proposes this exemption consistent with TSCA Section 8(a)(5)(A). EPA notes additionally that manufacturers have generally not been required to submit reports related to the manufacture of non-isolated intermediates under TSCA. According to EPA, it has exempted non-isolated intermediates in the past, in part because such substances often are extremely difficult to identify.

R&D Chemicals

EPA proposes to exempt PFAS manufactured (including imported) in small quantities for R&D purposes. EPA highlights that 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." EPA states that based on stakeholder input, it 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). Pursuant to TSCA Section 8(a)(5)(A), EPA has determined information about such chemicals is unnecessary but "may consider future data calls for R&D chemicals if the Agency determines a need to do so."

Submission Period

EPA proposes to amend the data submission period to accommodate the changes to the reporting scope in the proposed rule, with the submission period beginning 60 days after the effective date of the final rule and lasting three months. EPA states that the time it 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 final rule, "suggests to the Agency that reporters have had adequate time to consider how they intend to comply with the rule." EPA notes that because no reporting will be required from article importers due to the proposed exemption, EPA proposes to remove the reporting deadline for small manufacturers that would report under the rule exclusively as article importers.

Clarifications and Technical Corrections

Scope of Environmental and Health Effects Information

EPA notes that 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. In addition, certain information is required to be reported using the Organisation for Economic Co-operation and Development (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.

Consumer and Commercial Product Categories

EPA proposes to update the names used for specific consumer and commercial product categories as required under 40 C.F.R. Section 705.15(c)(4). EPA notes that this proposed change would not alter any reporting requirements or introduce new burden but rather aims to clarify existing requirements. EPA states that it 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.

Requests for Comment

EPA requests comment on the content of this proposed rule and the Economic Analysis prepared in support of the proposed rule that will be available in the docket when the proposed rule is published in the Federal Register. In addition, EPA has provided the following list of issues on which it is specifically requesting public comment. EPA requests that commenters include materials supporting their rationale to the extent possible.

• EPA is soliciting comment on the proposed 0.1 percent de minimis exemption for PFAS in mixtures and articles. EPA is also interested in comments on a 1.0 percent de minimis exemption for PFAS in mixtures and articles instead of the proposed 0.1 percent de minimis exemption, or another appropriate de minimis level.

• EPA is soliciting comment on an imported articles exemption. EPA is also interested in comments on its reconsidered interpretation of the statutory language of the NDAA and whether the NDAA is best read as excluding articles from the scope of reporting.

• EPA is soliciting comment on exempting certain byproducts, impurities, and non-isolated intermediates by incorporating the exemptions at 40 C.F.R. Section 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 C.F.R. Section 720.30(h)(3)-(7).

• EPA is soliciting comment on an exemption for manufacturing PFAS in small quantities for R&D activities.

• EPA is soliciting comment on whether its proposed amendment to the data submission period is appropriate to accommodate the proposed changes to the PFAS Data Reporting Rule.

• 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 states that it has not quantified and is also soliciting comment on the potential burden with the OHT requirement for unpublished study reports under 40 C.F.R. Section 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 C.F.R. Section 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."

• 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:

• 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 states that it "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^® (CAS RN^®), or, in the case of a PFAS listed as confidential on the TSCA Inventory, a TSCA Accession Number or Low-Volume Exemption Number. Although EPA is not proposing to provide a production-volume threshold, 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."

• Should EPA modify any assumptions or cost savings calculations in its Economic Analysis? EPA specifically seeks comments and data to consider in developing an Economic Analysis for a final rule. EPA states that in this proposed rule's Economic Analysis, it 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. Therefore, EPA estimates that approximately five percent of the estimated total industry cost for the 2023 final rule has already occurred. EPA seeks comment on its assumptions, including on the sunk costs estimates 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.

Commentary

Revisions to EPA's TSCA PFAS reporting rule were both widely expected and hotly anticipated. The October 2023 final rule's steep price tag and reach that extended far beyond the typical set of TSCA regulated entities created significant angst across the business community. These concerns were amplified by the rule's bumpy rollout, including delays in the development of the necessary reporting tool that left EPA scrambling to extend the reporting window — not once, but twice. It was not difficult to predict that EPA would offer some course-corrections in the new Administration. Administrator Zeldin's April 2025 PFAS announcement included a specific reference to TSCA Section 8(a)(7), vowing to implement the provision "smartly" and "without overburdening small businesses and article importers." And in the May 2025 notice extending the reporting window for the second time, EPA foreshadowed that it was considering reopening parts of the final rule to public comment.

Not surprisingly, the proposed rule announced Monday would exempt article importers — a savings to small businesses estimated to exceed $700 million. This exemption, by far, offered the most bang-for-the-buck savings in the proposed rule, purporting to eliminate a whopping 80 percent of the 2023 final rule's $876 million total cost. It was less clear what other exemptions, if any, EPA would choose to put into the proposed rule. EPA had previously taken a firm position that reporting exemptions were inappropriate based on a strict reading of the 2020 NDAA provision that created the impetus for action and the text of TSCA Section 8(a)(7) itself. EPA's prior messaging suggested an overarching view that Congress intended the one-time reporting requirement to be a swift and comprehensive vehicle for EPA's collection of large amounts of PFAS information that would accelerate the pace of efforts to address this issue.

The proposed rule marks a clear shift in EPA's thinking and one likely to invite controversy. First, EPA no longer interprets any sort of statutory limitation to including reporting exemptions — a notable reversal. EPA now seemingly departs from its own prior argument that Section 8(a)(7) operates as freestanding, independent rulemaking authority and instead reads Section 8(a)(7) in the larger context of Section 8(a), including the provisions of TSCA Section 8(a)(5). Section 8(a)(5) mandates explicit considerations regarding burden reduction and small manufacturers. EPA also argues that the previous application of the rule to articles importers exceeded EPA's statutory authority — a position framed narrowly, but one that could have significant implications for the decades-long interpretation by EPA that import of an article containing a chemical substance constitutes "manufacture" of that chemical under TSCA. The exemptions in the proposed rule largely align with a May 2025 industry petition that sought these changes — a petition that was withdrawn after EPA indicated it would reopen the rule. In addition to exemptions typical of other TSCA Section 8(a) reporting rules (e.g., article imports, impurities, certain byproducts), EPA also asserts inherent statutory authority to establish a "de minimis" threshold, noting that the retrospective nature of reporting and the absence of commensurate domestic and international recordkeeping requirements diminish the likelihood that a reporting requirement for de minimis quantities would actually bear any fruit, blunting or eliminating any justification for the burden on reporters. On the whole, EPA's rationale for this and other exemptions include very thoughtful and pragmatic balancing regarding where the Agency expects to be most successful in collecting PFAS information versus areas EPA views as adding burden for little or no foreseeable benefit. EPA addresses the efficacy of testing as a source of information; we are somewhat surprised at this discussion because one cannot test in the past. At best, testing a product that was imported in 2025 might tell you what PFAS is present in the current product. A past product could have very different levels (higher or lower) of PFAS. Second, the substance and tone in the proposed rule reflect a more realistic view of the utility of the data that may be collected. This is apparent both in the extent of reporting exemptions — a significant narrowing of requirements that may or may not also reduce incoming information — and EPA's suggestion of a potential phased or sequenced approach under which it defers additional reporting beyond the narrowed requirements in the proposed rule "until there is a clear role that such information could play to support a program mission of the Agency." PFAS remains a dominant topic in the national conversation and has for years now been a significant focus and priority for Congress, states, industry and non-governmental organization (NGO) stakeholders, the public, and EPA across multiple administrations. It will be interesting to monitor reactions to the proposed rule and assess whether EPA's primary focus on burden reduction will withstand the scrutiny of those who have been relentlessly advocating for more EPA action on PFAS. EPA does not offer exemptions for PFAS polymers or one specific to small businesses, although there is some overlap between some of the proposed exemptions and (in particular) import by small businesses.

As with the active/inactive reporting and quadrennial obligation under the CDR rule, this is yet another opportunity for the potential disclosure of Confidential Business Information (CBI). As always, submitters will have to consider carefully what information must be protected as CBI and how a submitter will be able to substantiate its CBI claims.

Detractors will undoubtedly decry any relief for potential reporters, but as we have discussed previously, the retrospective nature of the reporting and its significant look-back period will make it difficult to find any meaningful information in past records, especially for small quantities and content in articles. In this proposed rule, EPA explicitly acknowledges that the burden is largely felt during the research for reportable information, not in the reporting itself. Each potential reporter must — within the meaning of "reasonably ascertainable" — review records maybe over a decade old to determine if the reporter has any information that is potentially reportable. Recall, however, that this is a proposed rule; time will tell what comments EPA receives and what sticks in the final rule. Time will also tell if EPA issues future reporting requirements, either for retrospective or prospective manufacture or import.

The regulated community will no doubt breathe some collective sighs of relief. But one can assume there are also some simmering frustrations that the rollbacks came so late. Presumably a fair number of regulated entities took steps — and perhaps substantial and expensive steps — to put their business in a position to comply when the reporting window opened, only to have that deadline extended days prior (twice). EPA's proposed rule does not appear to account for burden already incurred in its calculations of burden reduction. We may find ourselves in a similar position in 2026 when the final rule will be published if there are substantial changes and again if litigation requires EPA to make further changes to the rule.

Companies may also lament the apparent waste effort of preparing to report under the previous rule, but Bergeson & Campbell, P.C. submits that any early and/or ongoing due diligence to understand where PFAS is or may be present in your products or supply chain is time well spent. The domestic (federal and state) and international landscape of PFAS reporting and regulatory requirements is growing ever more complex by the day, and companies are urged to stay ahead of the curve. A final related note on the proposed timeframe for reporting: In a clear acknowledgement of reporters' efforts already undertaken to prepare for the previous reporting deadline, EPA is proposing that the reporting window open just two months after publication of a final rule and stay open for only three months. For those who have not yet opened your file cabinets, now is the time. Once final, it will be a scramble to get reporting prepared and submitted.