TCSA-Based Requirement Covers Manufactured and Imported Items

The U.S. Environmental Protection Agency recently released a final rule under the Toxic Substances Control Act (TSCA) requiring reporting of historic manufacturing of per- and polyfluoroalkyl substances (“PFAS”).

The final rule on PFAS reporting, released on Sept. 28, 2023, contains the following key takeaways for affected companies to consider.

The Rule Requires Reporting of PFAS Manufactured Since 2011. EPA’s rule extends to any person who has “manufactured for commercial purposes” a PFAS substance during the period of January 1, 2011, and December 31, 2022, requiring them to report on PFAS manufacturing activities during that period. The rule defines “manufacturing” as producing, manufacturing, or importing covered PFAS for commercial purposes. Significantly, this does not extend to “processing” or use of PFAS, meaning companies that acquired PFAS domestically and utilized it in their operations would not be required to report. EPA’s language specifies that “entities who solely process, distribute, and/or use PFAS…are not required to report under this rule.”

Imported Articles Containing PFAS are Covered by the Rule. Manufacturing commonly includes importation, so imports of any covered PFAS are subject to the reporting requirements. PFAS contained in articles (such as finished consumer products) is also subject to the rule. Consequently, companies that imported articles and know, or can reasonably confirm, those articles contained PFAS covered by the rule, are subject to the rule and must report.

Not All PFAS Covered. EPA is using a technical definition of PFAS, as opposed to a list of covered PFAS, to delineate the boundaries of its reporting requirement. According to EPA’s release summary, its definition encompasses “at least 1,364 substances,” and indicates that the agency will be publishing that list of substances online. Fluoropolymers are not exempted from the rule. Companies will need to determine whether any PFAS they may have manufactured fall within the rule’s limits.

Reasonable Diligence, But Not Surveys or Testing Required. The rule only requires reporting of information “known to or reasonably ascertainable by” the reporting entity. This is characterized 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 indicates that this will obligate companies to conduct reasonable due diligence to gather information, including potential inquiries outside their organizations (e.g., upstream suppliers). EPA specifies that companies are not required to conduct “surveys,” meaning that they are not required to send “a comprehensive set of identical questions to multiple recipients” in order to comply with the rule. Similarly, companies are not required to conduct testing due to EPA’s statement that “this rule is not a product testing requirement.” Nonetheless, affected entities will need to focus their diligence efforts in order to ensure they are in compliance with the rule, documenting those efforts in a manner that protects the attorney-client privilege.

No Small Business or Small Volume Exemption. While the rule provides for a later reporting date for small businesses, it does not contain an exemption for small businesses. Similarly, there is no exemption for de minimis quantities of PFAS.

2025 Submission Deadline. As it currently stands, submissions for non-small businesses will be due 548 days after the rule is officially published in the Federal Register, meaning it will likely be due in the spring of 2025. The small business deadline will be 730 days from date of Federal Register publication, meaning these reports will be due in the fall of 2025. These dates could be impacted by a court challenge or reconsideration by EPA. In the meantime, companies should be preparing for their submittal deadline in order to meet the rule’s complex reporting obligations.

Enforcement and Penalties. EPA’s broad authority to investigate and punish under 15 U.S.C. §2610 is reflected by the current statutory-maximum penalty of $46,989 per-day penalty (likely to be further inflation-adjusted by 2025).

Companies should be consulting with qualified attorneys and technical consultants in developing a compliance strategy. It is critical they prepare a plan for conducting the necessary diligence to determine what PFAS-related information is known or reasonably ascertainable, and then collect and analyze it. Once completed, the extent of required reporting can be determined, particularly since some portion of collected information may qualify as confidential information unsuitable for unlimited public disclosure.