In October 2023, the U.S. Environmental Protection Agency (EPA) published a final rule under the Toxic Substances Control Act (TSCA) Section 8(a)(7) that requires any person that has manufactured or imported per- and poly-fluoroalkyl substances (PFAS) at any time since 2011 to report certain information regarding such PFAS. Notably, the rule applies to the importation of PFAS present in “articles,” such as a doorknob, steering wheel, or O-ring. Compliance with the new rule will be a potentially challenging and lengthy process for many companies, particularly for those that directly import thousands of articles. EPA expects companies to exercise due diligence to collect the information required by this rule, but the rule does not require parties to go so far as to conduct testing to confirm the presence of PFAS. With the reporting deadline looming, companies will need to evaluate whether the rule applies to their operations and maintain detailed records of their diligence and compliance-related efforts.
Who must report?
Companies that have “manufactured for commercial purposes” a chemical substance or mixture containing PFAS between January 1, 2011 and December 31, 2022 are subject to this rule. Manufacturing for commercial purposes includes importing, producing, or manufacturing with the purpose of obtaining an immediate or eventual commercial advantage. Manufacturing also includes the coincidental production of byproducts and impurities that occurs during the course of manufacturing, processing, use, or disposal activities.
Are there any exemptions?
There are no exemptions based on the volume of PFAS manufactured (or imported) or for small manufacturers. Entities that import municipal solid waste streams for the purpose of disposal or destruction of the waste are not required to report under this rule.
What is the reporting deadline?
Parties that are subject to the rule must report by May 8, 2025. “Small manufacturers” that are reporting exclusively as article importers must report by November 10, 2025. A “small manufacturer” (as defined under 40 CFR § 704.3) is a manufacturer whose annual sales and/or production volumes are below certain thresholds.
What must be reported?
Manufacturers (including importers) must report information “to the extent known to or reasonably ascertainable by” them, including chemical-specific information; categories of use; manufactured amounts; a description of byproducts resulting from the manufacture, processing, use, or disposal of each PFAS; environmental and health effects; worker exposure data; and disposal data.
What does “known to or reasonably ascertainable by” mean?
“Known to or reasonably ascertainable by” means all information in a person’s possession or control, including information that a reasonable person similarly situated might be expected to possess, control, or know. EPA has acknowledged that the scope of the information that is known to or reasonably ascertainable by a party will vary for different entities. EPA has indicated that article importers should consider information such as their knowledge of the material and chemicals in the articles imported, existing records in the company’s possession related to the imported articles (e.g., information from the Chemical Abstracts Service and in safety data sheets, communications with suppliers, import records), knowledge of the supplier’s operations or material sources, information gleaned from outside sources (such as technical publications and conferences), and files maintained by the manufacturer (e.g., marketing studies, sales reports, or customer surveys).
What are the recordkeeping requirements?
Parties that are subject to the reporting requirements under this rule are required to retain records that document any relevant information reported to EPA for five years, beginning on the last day of the submission period.
How can Godfrey & Kahn help?
Godfrey & Kahn’s Environmental team continues to assist clients with navigating the nascent and rapidly evolving PFAS regulatory scheme, including the TSCA PFAS reporting and recordkeeping rule. For more information on this topic, whether the rule applies to your company, or other compliance questions, contact a member of our Environmental practice.