With the new proposal, EPA seeks to limit the reporting burden on the chemical industry.

By Julia A. Hatcher, Tom Lee, and Hunter J. Kendrick

On November 10, 2025, the US Environmental Protection Agency (EPA) released its much anticipated proposed changes to what is often referred to as the “8(a)(7) Rule” that requires businesses to report on the manufacture and import of certain per- and polyfluoroalkyl substances (PFAS).1 As the name suggests, the rule derives from Section 8(a)(7) of the Toxic Substances Control Act (TSCA), a statutory provision in which Congress mandated EPA to promulgate a rule specially for PFAS reporting.2

The proposal would significantly reduce reporting obligations by establishing several exemptions. The proposal would also extend — for the third time since the original rule was first promulgated in 2023 — industry’s PFAS reporting timeline to begin 60 days after the effective date of a new final rule and to last for three months before the reporting portal closes.

Summary of the Proposed Changes

The proposal would add several new and significant exemptions from the scope of reportable PFAS manufacturing activities, as summarized below.

Imported Articles

EPA proposes to exempt PFAS imported as part of an article3 from reporting requirements. This proposal is based on EPA’s expectation that manufacturers are unlikely to possess known or reasonably ascertainable information about PFAS in imported articles.4 Moreover, EPA states that:

“[m]anufacturers that report pursuant to this rule are required to provide downstream processing and use information about the use of PFAS in consumer and commercial products, including articles. Thus, despite the provision of de minimis and imported article exemptions … EPA anticipates it will receive information on low concentrations and articles from original manufacturers of PFAS who are most likely to have such information and who are likely to report pursuant to this rule should the proposed exemptions be finalized. Such information from these manufacturers will help the Agency identify situations in which more information about PFAS in articles may be necessary, and EPA will address such needs when they are identified.”5

De Minimis Threshold

EPA proposes a de minimis exemption where PFAS is present in concentrations at or below 0.1%. If this change is adopted, PFAS found in any domestically manufactured or imported chemical substance or mixture at or below 0.1% would be exempt from reporting, regardless of the total production volume. In addition, PFAS domestically manufactured in the production of an article at or below a 0.1% concentration likewise would come within this de minimis exemption.

Notably, this de minimis exemption could also extend to importers of articles, even though importers of articles would not need to rely on the exemption because of EPA’s separate proposal for imported articles, described above. EPA acknowledges this redundancy:

“[i]n some scenarios, more than one of these proposed exemptions may provide the same regulatory relief from importing. For example, an importer of articles which contain low levels of PFAS may be exempt from reporting by virtue of both the imported articles and de minimis exemptions.”6

If EPA were to decline to proceed with the imported articles exemption for any reason, importers of articles could potentially still take relief from the de minimis exemption for at least some imported articles.

EPA suggested it was proposing the de minimis exemption to relieve manufacturers from onerous investigative burdens, among other reasons.7 EPA further explained that, for concentrations in past imports that “would have been below the Safety Data Sheet (SDS) or the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) notification levels … companies would not have known that they have manufactured (including imported) PFAS below the de minimis concentration.”8

Byproducts, Impurities, and Non-Isolated Intermediates

EPA proposes to exempt reporting on the manufacture of PFAS as a byproduct, impurity, or non-isolated intermediate9 when such substance is not manufactured for a commercial purpose. EPA explains that this exemption would more closely align the 8(a)(7) Rule with other existing TSCA exemptions for “substances not manufactured and used for a separate commercial purpose and is consistent with the approach taken in EPA’s [Chemical Data Reporting] rule.”10

Research and Development (R&D) Chemicals

EPA proposes to exempt PFAS manufactured and imported in small quantities for R&D purposes. EPA does not propose a specific threshold for what qualifies as “small quantities,” but under the R&D exemption that has long applied to TSCA’s new chemicals program, “small quantities” means that the amount manufactured or imported must be “no greater than reasonably necessary” for the R&D purpose.11 EPA explains that the proposed exemption is consistent with the Trump administration’s efforts to reduce the regulatory costs that impede R&D and economic development.12

Takeaways

The proposal would do much to alleviate the substantial reporting burden that industry has warned of since EPA’s original 8(a)(7) Rule proposal in 2021. Notably, the statute mandates PFAS reporting, and affected companies must still diligently prepare for their reporting obligations. However, the proposal would provide companies with additional time to complete inventories of potentially reportable PFAS, map supply chains, and either continue or begin standing up systems and processes to help ensure complete, accurate, and timely reports.

Companies should be prepared to document and defend the steps they have taken to review internal records relating to everything from purchase and importation documents, current and historical product specifications, supplier communications, and existing analytical and monitoring data. Whenever relying on estimates instead of actual data, companies should be prepared to demonstrate that the estimates they developed were reasonable and consistent with EPA’s guidance.

Public Comment

Public comments on the proposal will be due 45 days after it is published in the Federal Register, which we expect will occur by the end of November.

In addition to inviting public comment on the proposed revisions discussed above, EPA has also solicited public comment on related topics that could result in further revisions to the 8(a)(7) Rule, as well as other agency actions. These include:

  • “Should EPA amend the scope of reportable chemicals?”13 The 8(a)(7) Rule requires reporting for three structural definitions of PFAS compounds. As EPA notes, it “was unable to publicly identify all PFAS on the TSCA Inventory”14 and instead published a non-comprehensive list of thousands of chemicals that it has so far been able to identify.15 In the current proposal, EPA requests public comment on “limiting reporting to those PFAS with a Chemical Abstracts Service Registry Number (CASRN), or, in the case of a PFAS listed and confidential on the TSCA Inventory, a TSCA Accession Number or Low-Volume Exemption Number.”16 In the same section, EPA invites public comment on a production volume threshold, but indicates that “EPA does not believe that incorporating a minimum threshold would enable the Agency to meet its information needs.”17
  • “Should EPA modify any assumptions or cost savings calculations in its Economic Analysis?”18 EPA estimates that 5% of the total industry cost of compliance with the 8(a)(7) Rule has already been incurred “based on inquiries EPA has received specifically related to this rule’s imported article scope.” EPA is asking industry to comment on whether that assumption is correct and whether the “sunk costs” are more or less significant.

Latham & Watkins will continue to monitor this proposal, as well as ongoing efforts by EPA and other jurisdictions to regulate PFAS. Please contact us if you would like to engage on this proposal or if you have questions about this development or any other chemical regulatory matter.

Appendix

History of the 8(a)(7) Rule

Congress added TSCA’s 8(a)(7) provision through the Fiscal Year 2020 National Defense Authorization Act.19 The provision directed EPA to promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to submit a report that included, for each year since 2011, the information described in TSCA subsections 8(a)(2)(A) through 8(a)(2)(G).20 That directive includes a broad range of information, including trade names; chemical identities and structures; total amounts of each substance manufactured or processed; details on how the substances are used; descriptions of the byproducts resulting from manufacture, processing, use, or disposal of the substances; estimates of the number of people exposed to the substances in their places of employment, as well as estimates about the duration of their exposure to the substances; and all information on the health and environmental effects that the substances pose.21

EPA first proposed the 8(a)(7) rule in June 2021.22 The proposal included a structural definition of PFAS, a reporting requirement for PFAS included in articles, and covered PFAS created or present as byproducts or impurities. The proposal also anticipated reporting “of all known or reasonably ascertainable information” dating back to 2011, per the statute’s temporal requirement. Notably, the proposal did not include a de minimis exclusion or a broad small business exemption.

The proposal received significant public comment. Among other things, commenters split on EPA’s proposed structural definition. Some stakeholders believed the definition was too broad, scientifically unsound, and would lead to unnecessary reporting.23 Based on those critiques, some commenters suggested that, instead of using a structural definition, EPA should create a distinct list of PFAS subject to the reporting requirements.

Commenters on the opposite end of the spectrum protested that EPA’s definition was underinclusive and urged EPA to adopt a broader definition, like the one used by the Organisation for Economic Co-operation and Development24 that has since been adopted by the EU’s European Chemicals Agency.

EPA’s proposal to include a reporting requirement for PFAS-containing articles was also debated. Supporters commented that EPA needed to require reporting about articles to fully understand their uses and potential exposures, while opponents commented that reporting would be excessively burdensome.25

EPA finalized the rule in October 2023. The final rule retained much of the proposal, but it included some changes in response to public comments. EPA stuck with a structural definition of PFAS, but it expanded the definition from one structural pattern to three structural patterns.26 Under the final rule, any substance that meets at least one of the three structural patterns is considered a PFAS for reporting purposes, which increased the number of chemicals subject to the rule but also clarified the rule’s scope.27 EPA also retained an articles reporting requirement, while creating a streamlined reporting pathway for articles manufacturers.28 Similarly, EPA declined to exempt low-volume producers, but it streamlined reporting options for PFAS produced in low quantities for research and development.29 And while small businesses are still subject to the rule, EPA provided small businesses whose data was limited to imported articles with a longer timeline to report.30 As for the ultimate timeline, the rule originally created a one-year information-gathering period to be followed by a six-month reporting window (for a total of 18 months from the rule’s effective date), with an additional six months for small businesses reporting exclusively as article importers.31

In September 2024, EPA published a direct final rule and a parallel proposed rule to delay the reporting period, which had been scheduled to begin in November 2024, until July 2025.32 EPA cited budgetary constraints as the reason for the delay.33 EPA stated that, because of budgetary shortfalls, it had stopped “ongoing software development,” which meant that the software application the Agency planned to use to collect the PFAS data would not be ready in time for the opening of the original reporting period in November 2024.34

Under the new Trump administration EPA delayed the reporting again, this time via an interim final rule in May 2025.35 The interim final rule created an October 13, 2026, submission deadline for most manufacturers, while small businesses reporting only on imported PFAS-containing articles had until April 13, 2027.36