The Environmental Protection Agency (EPA) today published in the Federal Register its final rule establishing reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA), triggering an effective date of November 13, 2023.

Entities that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, have 18 months following the effective date of this rule (24 months for small article importers) to submit information to EPA regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects. This is a one-time reporting requirement that covers 12 calendar years. Records that document any information reported to EPA must be maintained for five years.

The scope of this PFAS reporting rule is broad. EPA expanded its definition of PFAS subject to the rule (which covers 1,462 known TSCA chemical substances), there is no de minimis volume threshold, and the rule lacks typical TSCA exemptions, such as for research and development, byproducts, and impurities.

Furthermore, and despite commentors’ opposition, EPA finalized the requirement to include PFAS-containing articles (which are manufactured goods or finished products, either imported or domestically produced), but clarified that reporting is only required to the extent that the manufacturer (including importer) of PFAS within articles knows or can reasonably ascertain the requested information.

Importantly, EPA further clarified that “entities who solely process, distribute, and/or use PFAS, and do not manufacture (including import) PFAS for a commercial purpose, are not required to report under this rule.” In other words, if a product manufacturer does not manufacture (including import) the PFAS itself, but only uses it (including as part of an article or other product), the product manufacturer wouldn’t be required to report under this rule.

For those who are subject to the rule, it is likely that the required information has not been maintained in the ordinary course of business, particularly given that most PFAS in the supply chain were not reported until recently. However, EPA set a due diligence standard of “information known to or reasonably ascertainable by the manufacturer,” which is the standard used in other TSCA section 8 rules. If, after reviewing known or reasonably ascertainable existing information, a manufacturer does not have knowledge that they have manufactured or imported PFAS, that entity need not report. While not required, EPA does encourage such an entity to document its due diligence.

EPA has published reporting instructions and a Small Entity Compliance Guide, which include information related to this reporting standard.