On September 28, 2023, EPA released a final rule under the Toxic Substances Control Act (“TCSA”) mandating reporting relating to past manufacturing of per- and polyfluoroalkyl substances (“PFAS”).  Below are key takeaways companies that may be subject to these reporting requirements should keep in mind.

• The Rule Requires Reporting of PFAS “Manufactured” Since 2011.  The rule requires any person who has “manufactured for commercial purposes” a PFAS substance, between January 1, 2011 and the end of 2022, to report on those past PFAS manufacturing activities.  Manufacturing is defined as producing, manufacturing, or importing covered PFAS for commercial purposes.  Importantly, manufacturing does not encompass “processing” or use of PFAS, so companies that acquired PFAS domestically and used it in their operations (including the domestic manufacturing of products containing PFAS) would not be required to report under the rule.  In other words, “entities who solely process, distribute, and/or use PFAS … are not required to report under this rule.”

• The Rule Applies to Imported Articles Containing PFAS.  Because manufacturing includes importation, imports of any covered PFAS are subject to the reporting requirements.  Importantly, PFAS contained in articles (e.g., finished consumer products) is also subject to the rule—thus, if companies imported articles and know or can reasonably ascertain that those articles contained PFAS covered by the rule, they are subject to the rule and required to report.

• The Rule Covers a Broad, But Bounded, Set of PFAS.  EPA has adopted a technical definition of PFAS, rather than promulgating a specific list of covered PFAS.  According to EPA, its definition encompasses “at least 1,364 substances,” and EPA will be publishing that list of substances online.  Fluoropolymers are not exempt from the rule.  EPA notes that its definition is narrower than that of the OECD, which encompasses thousands of additional PFAS substances.  Companies will thus need to consider whether any PFAS they may have manufactured fall within the rule’s specific definition of PFAS.

• The Rule Requires Reasonable Diligence, But Does Not Require Surveys or Testing. The rule requires reporting of information “known to or reasonably ascertainable by” the reporting party, which is defined as “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.”  EPA has made clear that this requires companies to conduct reasonable due diligence to gather information, including potential inquires outside the organization, such as to upstream suppliers.  However, EPA explained that companies are not required to conduct “surveys”—i.e., they need not send “a comprehensive set of identical questions to multiple” recipients—to comply with the rule.  Nor are companies required to conduct testing: “this rule is not a product testing requirement.”  Companies will thus want to carefully scope their diligence efforts to ensure that they are complying with EPA’s rule while simultaneously not taking steps beyond what the rule requires, and appropriately document those decisions.

• There Is No Small Business or Small Volume Exception.  The rule provides for a later reporting date for small businesses, but does not contain any exception for small businesses.  Nor does the rule contain an exception for de minimis quantities of PFAS.

• The Rule Does Not Apply to Non-TSCA Chemical Uses.  TSCA excludes from its scope various chemicals when they are regulated under other statutory regimes.  For example, most products regulated by FDA, as well as EPA-regulated pesticides, are not subject to TSCA.  15 U.S.C. § 2062(2)(B).  Thus, companies do not need to report on PFAS imported in products that are not subject to TSCA, and should carefully evaluate whether their products are regulated by TSCA.

• Submissions Will Be Due in 2025.  Unless EPA reconsiders or a court overturns the rule, submissions will be due for non-small businesses 548 days after the rule is officially published in the Federal Register, and so will be due in the Spring of 2025.  Small businesses have 730 days from publication to submit information, and so their reports will be due in the Fall of 2025.  Companies should use this time to ensure robust compliance with the rule’s complex set of reporting obligations.

• Enforcement and Penalties.  The rule is subject to the general TSCA regime for enforcement, and does not contain its own unique enforcement provisions.  EPA has broad authority to investigate potential violations of TSCA, including by conducting inspections and requesting information.  15 U.S.C. § 2610.  Each separate violation of the reporting requirements would be subject to a maximum $46,989 per-day penalty (which will be further adjusted upwards for inflation by 2025).  15 U.S.C. § 2615; 40 C.F.R. § 19.4.

Companies should promptly move forward with developing a compliance strategy for the rule.  This would start with preparing a plan for determining what PFAS-related information is “known to or reasonably ascertainable by” the company, and then collection of that information.  Once collected, companies will need to analyze whether any covered PFAS is present in imported products (or otherwise “manufactured”) such that reporting obligations are triggered.  If so, they will then need to evaluate the substantive reporting obligations of the rule, and compile the required information (e.g., relating to amounts of PFAS, the ways in which it is used) for reporting.  Finally, companies will need to determine whether to claim confidentiality over various parts of the submission, and comply with the rule’s requirement to substantiate confidentiality claims.  At each step, companies should rely on sound legal and technical advice to ensure compliance.