On September 28, 2023, the U.S. Environmental Protection Agency (EPA) announced it will be publishing its final rule for the reporting and recordkeeping of per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). PFAS are a category of manufactured chemicals used in a wide variety of industrial and consumer products since the 1940s. PFAS have characteristics that make them useful in a variety of products, including nonstick cookware, waterproof clothing, and firefighting foam, as well as in certain manufacturing processes. The final rule will require any entity manufacturing or importing PFAS—including any “article” containing PFAS—to submit a report of PFAS usage to the EPA within 18 months from the date the final rule is published in the Federal Register.
The final rule will require entities to submit a retrospective report containing numerous categories of information relating to the manufacture and import of PFAS chemicals for each year in which PFAS were manufactured or imported, beginning in 2011. For each year, manufacturers will have to report information regarding PFAS identity, production volumes, industrial uses, commercial and consumer uses, byproducts, worker exposure, disposal, and any existing information related to environmental and health effects. The rule covers manufacturers of PFAS chemicals as well as product manufacturers and product importers of articles containing PFAS. Thus, importers of articles such as clothing, cookware, sporting goods, equipment, or equipment parts which contain PFAS, regardless of whether PFAS were intentionally added or used in the manufacturing process, will have to report information on the PFAS contained in those products. The final rule does not exempt small businesses, does not include de minimis exceptions, and does not exempt manufacturers or importers of articles containing PFAS.
Notably, the EPA is not choosing to publish a comprehensive list of compounds subject to the final PFAS rule. Rather, the EPA opted for a “structural” definition of PFAS covered by the final rule and is estimating that at least 1,462 PFAS will be subject to regulation. Thus, regulated entities must determine for themselves whether PFAS in their products meet the “structural” definition of PFAS under the rule. The final rule requires manufacturers and importers to make “reasonable efforts” to ascertain what is in the substances or articles they manufacture or import.
Manufacturers will have one year from the rule’s effective date (the date of publication in the Federal Register—which has not occurred as of this writing) to gather information after which there will be a six-month reporting period. (Small manufacturers whose reporting obligations arise exclusively from importing articles containing PFAS may have an additional six months to report.) However, regulated entities should familiarize themselves with the information that will need to be reported now to begin the legwork of collecting it well in advance of the regulatory reporting deadline. Companies that fail to comply with the PFAS reporting rule are subject to enforcement.
The primary purpose of the rule is to allow the EPA to identify manufacturers and importers of PFAS and understand how these chemicals are being distributed in commerce. This information will not only help the Agency prioritize which PFAS to regulate in the future, but it could be the basis for governmental investigations and enforcement actions against companies that, for example, have significant PFAS usage or a connection to areas of known PFAS contamination. Further, because the reports will be publicly available, private-party plaintiffs may use the reported information for enforcement and litigation purposes.
Stites & Harbison, PLLC can assist your business in identifying regulated PFAS in your products and with making the required reports to the EPA under the final rule. Additional information about the final rule can be found here.