Understanding TSCA’s one-time PFAS reporting rule

This is exactly the situation that manufacturers and processors are currently experiencing under the Toxic Substances Control Act (TSCA) Section 8(a)(7) rulei for retrospective reporting for per- and polyfluoroalkyl substances (PFAS) that is required by the 2020 National Defense Authorization Act (NDAA).ii This rulemaking has undergone significant stakeholder feedback over the past several years, through both the extensive rulemaking process and a small business panel review created to assist the U.S. Environmental Protection Agency (EPA) and the regulated community in understanding the significance of this undertaking.

In summary, the rule requires manufacturers, including importers, to retrospectively report any PFAS chemicals identified by the rule with numerous data elements from Jan. 1, 2011. (Note: Section III.B.2 of the rule defines “Manufacture for commercial purposes” to include the import, production or manufacturing of a chemical substance or mixture containing a chemical substance to obtain an immediate or eventual commercial advantage for the manufacturer. This includes, but is not limited to, the manufacture of chemical substances or mixtures for commercial distribution, including test marketing, or for use by the manufacturer itself as an intermediate or for product research and development. “Manufacture for commercial purposes” also includes the coincidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use or disposal of another chemical substance or mixture. As described in Unit III.B.1, simply receiving PFAS from domestic suppliers or other domestic sources is not considered manufacturing PFAS for commercial purposes. Entities that process and use PFAS only need to report on the PFAS they have manufactured [including imported], if any.)

Manufacturers or importers of chemical substances that meet the definition of PFAS under TSCA must report on PFAS information by site, in any quantity (no threshold applies), for each calendar year from 2011 through 2022. The reporting also includes PFAS imported as part of articles, although streamlined reporting is available; PFAS imported or manufactured solely for research and development (R&D), but streamlined reporting is available only for PFAS imported or manufactured for R&D in a quantity below 10 kilograms per year (< 10 kg/year); PFAS imported or manufactured as byproducts, impurities or polymers; and PFAS manufactured as non-isolated intermediates. Each entity subject to reporting must retain records that document any information reported to the EPA for five years beginning on the last day of the submission period. The reporting opens on Nov. 12, 2024, and closes six months later on May 8, 2025. However, “small manufacturers” who have to report solely due to having imported PFAS as part of articles have an extra six months to report (until Nov. 10, 2025).

While this rule is based on the Chemical Data Reporting Rule, it includes additional data elements for each reportable substance. The rule defines PFAS as any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-structures:

1. R-(CF2)-CF(R’)R”—where both the CF2 and CF moieties are saturated carbons.
2. R-CF2OCF2-R’—where R and R’ can either be F, O or saturated carbons.
3. CF3C(CF3R’R”—where R’ and R” can either be F or saturated carbons.

As of February 2023, the EPA has identified at least 1,462 substances that can be defined as PFAS under TSCA that could be covered by the final rule,iii 770 of which are listed on the TSCA Inventory with active commercial status designations. As of December 2023, the EPA’s Office of R&D has identified a much broader list of 11,409 specific PFAS that could be covered by the final rule.iv Given that these lists are non-exhaustive, companies are encouraged to compare against these lists but also perform their own due diligence to ensure no other substances meet the definition of PFAS. It’s important to note that HFC-152a is not within the rule’s scope for the aerosol industry, but other Hydrofluorocarbons (HFCs) and Hydrofluoroolefins (HFOs) meet this definition, so it’s essential to verify.

You may be thinking, “We don’t manufacture PFAS, so would we still need to report?” Therein lies the challenge. While many companies do not need to report, it’s still critical to have documentation of this fact.

To provide a better appreciation for the impact of the rule, when it was originally proposed by the EPA, the economic impact was estimated at a little over $10 million.v However, after stakeholders, especially small business entities, provided feedback, the EPA increased the economic impact to more than $800 million.vi This change was primarily driven by the due diligence that would be required by companies to determine if they have reporting obligations. This is particularly complicated for companies with product formulations or product functionality that may have or likely required PFAS technology or companies that imported ingredients for formulations over the past 14 years.

What should be done to establish due diligence? What records should you have or maintain? How should you document the steps taken to determine whether or not you have ingredients within the scope of the rule? What happens if you don’t have these records? Each of these questions needs to be carefully considered when determining reporting requirements—whether or not you have them.

Important things to consider as you perform due diligence include:

1. Do you meet the definition of manufacturer, including imports? If so, do you have a process, standard operating procedure (SOP) or checklist that documents the steps to determine compliance?
2. Have you utilized raw materials that are/were likely PFAS? If so, were these raw materials from domestic sources or imported?
3. Do you have products within the scope of other regulations, such as personal care products, cosmetics or pesticides? If so, do they contain any PFAS ingredients that might be considered within the scope of TSCA?
4. Do you have the records documenting these raw materials?
5. Do you have a record retention policy?
6. What reasonable efforts can be taken to obtain this information from suppliers?

This one-time reporting rule will clearly impact a majority of companies in the household and commercial products space, including aerosol products. There may also be situations where suppliers or customers will pose questions about your reporting or recordkeeping in response to their own compliance obligations. This is a very significant rule—and one that requires a high level of due diligence to comply. While many companies will have reporting obligations, this will require a similar level of effort from companies to demonstrate that they do not have any reportable PFAS substances.

If you have any questions concerning this information to help determine PFAS reporting requirements, please contact me at sbennett@thehcpa.org. SPRAY

i In the Oct. 11, 2023, Federal Register, EPA finalized a reporting and recordkeeping rule for PFAS to implement TSCA § 8(a)(7). The final rule took effect on Nov. 13, 2023 and is codified as the new 40 C.F.R. pt. 705. link
ii Section 7531 of the National Defense Authorization Act for Fiscal Year 2020, Pub. L. 116–92, added new paragraph 8(a)(7) to TSCA.
iii Public List of TSCA PFAS for 8(a)(7) Rule, link
iv link
v Draft Economic Analysis for the Proposed TSCA Section 8(a) Reporting & Recordkeeping Requirements for Perfluoroalkyl & Polyfluoroalkyl Substances, link
vi Economic Analysis for the Final Rule entitled: “TSCA Section 8(a)(7) Reporting & Recordkeeping Requirements for Perfluoroalkyl & Polyfluoroalkyl Substances” link