The U.S. Environmental Protection Agency (EPA) recently announced its proposal of new reporting requirements under the Toxic Substances Control Act (TSCA) for a wide range of per- and polyfluoroalkyl substances (PFAS). In accordance with obligations added by the 2020 National Defense Authorization Act, EPA is issuing a proposed rule that would require all manufacturers — including importers — of PFAS in any year since Jan. 1, 2011 to electronically report certain PFAS information to EPA. Information related to specific chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal would all be reportable under the proposed rule. EPA states that the proposed rule is intended to help it better understand the sources and quantities of PFAS manufactured in the U.S. and to support the agency’s PFAS research, monitoring, and regulatory efforts.
EPA proposes that manufacturers report information to the extent that the information is known to or reasonably ascertainable by the manufacturer. “Known or reasonably ascertainable” includes “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” Such a broad reporting standard will require regulated entities to (re)evaluate their current level of knowledge of their manufactured products — including imports — and the chemical nature of raw materials, ingredients, supplies, and other products that are used in the manufacturing/production process. Regulated entities should expect the proposed rule to result in a flurry of PFAS-related activity and communications/requests throughout supply chains, including among upstream suppliers, downstream users, employees, contract manufacturers, and/or distributors.
For purposes of the proposed rule, any PFAS that fall within a particular structural definition are subject to the reporting requirements. To assist regulated entities with determining what substances may be covered under this structural definition, EPA has identified a non-exhaustive list of examples of PFAS subject to the proposed rule. Currently, the scope of PFAS includes those listed as “active” on the TSCA Inventory and those that are subject to TSCA Section 5 low-volume exemption applications per 40 CFR 723.50 that have been granted by EPA — at present count, this represents at least 1,364 different PFAS. EPA also anticipates including in the proposed rule structural diagrams to capture other PFAS that cannot be identified because of confidentiality claims. While some typical TSCA exemptions may apply to excuse a manufacturer from the reporting requirements (e.g., substances that are excluded from the definition of “chemical substance” in TSCA 3(2)(B), including, but not limited to, FIFRA- and FDA-regulated products), not all potential exemptions will be available under the proposed rule. Importantly, exemptions would not be available for the manufacture of PFAS as a “byproduct” or for small manufacturers/processors.
Manufacturers will have one year after the effective date of the final rule to collect and submit all required information to EPA. Based on EPA’s previous experience with TSCA reporting, and the agency’s understanding of disposal and other waste management methods involving PFAS, most entities affected by these new reporting requirements will be from the following North American Industrial Classification System (NAICS) code categories:
- NAICS 324 — Petroleum and Coal Product Manufacturing;
- NAICS 325 — Chemical Manufacturing;
- NAICS 326113 — Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing;
- NAICS 327910 — Abrasive Product Manufacturing;
- NAICS 333999 — All Other Miscellaneous General Purpose Machinery Manufacturing;
- NAICS 334511 — Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing;
- NAICS 336111 — Automobile Manufacturing;
- NAICS 423510 — Metal Service Centers and Other Metal Merchant Wholesalers;
- NAICS 424690 — Other Chemical and Allied Products Merchant Wholesalers;
- NAICS 447190 — Other Gasoline Stations;
- NAICS 551112 — Offices of Other Holding Companies; and
- NAICS 562 — Waste Management and Remediation Services.
However, the above list is not exhaustive, and other entities may also be affected if they manufactured — including imported — PFAS at any time since 2011. Manufacturers should closely review EPA’s structural definition and list of PFAS examples to determine whether the proposed rule applies to them.
Publication of the proposed rule in the Federal Register via docket EPA-HQ-OPPT-2020-0549 at www.regulations.gov will begin a 60-day comment period. A pre-publication version of the proposed rule can be found here.
Potentially affected entities should consider the implications of the proposed rule and ensure EPA is aware of the impacts and concerns during the comment period. EPA has specially requested comments on topics such as whether imported articles containing PFAS should be within the scope of the new rule, concerns regarding potentially duplicative reporting under TSCA or other federal statutes, specific substances of interest that may not be in scope, whether reporters can provide generic information when they cannot identify specific PFAS, and whether EPA should make the reported data available to the public. Further, given the limited amount of time (i.e., one year after the effective date of the final rule) to submit all required information to EPA, and the potentially significant amount of information — especially for any manufacture dating back to 2011 — entities likely to be affected should begin familiarizing themselves with the reporting requirements and gathering data.