On October 11, 2023 the Environmental Protection Agency (EPA) finalized new reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS).
Under these new requirements, any person that manufactures (including imports) or has manufactured (or imported) PFAS or PFAS-containing articles in any year since January 1, 2011, must electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards and must maintain related records for five years. For most impacted companies, the reporting submission deadline is May 8, 2025. For a smaller number of impacted companies, the deadline is November 10, 2025. While these deadlines may seem far off, the time to start preparing is now.
EPA Stepping Up PFAS Regulation
The Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Final Rule) is designed to clarify who is using PFAS, how PFAS is being used, and in what quantities it is being used. More specifically, those required to report to EPA must provide a significant amount of detailed information that includes:
- The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
- Categories or proposed categories of use for each substance or mixture;
- Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
- Descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture;
- All existing information concerning the environmental and health effects of each substance or mixture;
- The number of individuals exposed, and reasonable estimates on the number of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure, and;
- The manner or method of disposal of each substance or mixture, and any change in such manner or method.
PFAS Reporting Obligations Under Final Rules
In addition to the elements of information required to be reported to EPA, subject companies should be aware of several other key provisions of the Final Rule:
- PFAS Definition: EPA established a structural definition under which PFAS is defined as including at least one of these three structures: R-(CF2)-CF(R′)R′′ where both the CF2 and CF moieties are saturated carbons; R–CF2OCF2-R′ where R and R′ can either be F, O, or saturated carbons; and CF3C(CF3)R′R′′ where R′ and R′′ can either be F or saturated carbons. EPA has identified more than 1,000 subject PFAS compounds under this structural definition.
- Reporting Threshold: There is no minimum reporting threshold or concentration for PFAS under the Final Rule. Any amount of PFAS manufactured (or imported) for commercial purposes in any year since January 1, 2011, is reportable.
- Reporting Entities: Anyone who has manufactured (or imported) a PFAS for a commercial purpose in any year since January 1, 2011, is covered by the Final Rule. Notably, the term ‘‘manufacture for a commercial purpose’’ is not limited to intentional PFAS manufacturing, but also includes the coincidental manufacture of PFAS as byproducts or impurities. The Final Rule does not apply to entities who have only processed, distributed in commerce, used, and/or disposed of PFAS. For instance, if a wastewater treatment plant is simply processing PFAS they received domestically, and not also manufacturing PFAS, including as a byproduct, then the entity is not covered by the rule. Additionally, non-commercial R&D activities, such as science experimentation, research, or analysis conducted by academic, government, or independent non-profit research organizations, are also excluded.
- Definition of “Importer”: Because the Final Rule requires manufacturers and importers to report PFAS, the definition of “importer” is significant. Under the Final Rule, importer has several meanings, including any person who imports any PFAS or PFAS within a mixture or article into the United States, including anyone chiefly liable for payment of merchandise duties, an authorized agent of such person, consignees, importers of record, and in some cases the actual owner of the entity at issue
- “Known or Reasonably Ascertainable” Information: Information must be reported to the extent it is known or reasonably ascertainable, which includes all information in a person’s possession or control and all information a reasonable person similarly situated may be expected to possess, control, or know. According to EPA, when determining whether they have imported a PFAS-containing article, an article importer should consider information such as their knowledge of the material and chemicals in the articles they have imported, existing records in their company related to those imports (e.g., import records, communications with suppliers, SDSs, invoices or receipts), knowledge of the supplier’s operations or materials sources, and information gleaned from outside sources (e.g., conferences, technical publications). EPA has also acknowledged that this standard “carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.”
- Recordkeeping Obligations: Entities subject to the Final Rule must retain records that document information reported to EPA for five years, which is calculated from the last date of the information submission period.
- Penalty for Violations: Separate violations of the reporting requirement are subject to a maximum penalty of $46,989 per violation per day, and this amount will be adjusted upwards for inflation no later than 2025.
PFAS Reporting Timeline
Most submitters have until May 8, 2025 (18 months following the effective date of the final rule) to submit their information to the EPA. Small manufacturers reporting exclusively as article importers have until November 10, 2025 (24 months following the effective date of the final rule) to report. All reports must be submitted electronically through EPA’s Central Data Exchange.
Additional Considerations for Impacted Entities
Subject entities must devise a comprehensive protocol to prepare to comply with the Final Rule,. To help ensure that this protocol stands up to legal scrutiny, it should be consistent across the organization and any subsidiaries. For example, if reasonable estimates will be used when exact calculations are unavailable, the methodology used should be the same across all divisions, departments, and subsidiaries. Care must also be taken to fully document the due diligence process. Subject entities should also be prepared to address the consequence of their PFAS reporting disclosures, even if the company name is kept confidential in a submission. For instance, some companies may have been unaware that their products contain PFAS and may now need to disclose this information to customers, retailers, shareholders, employees, insurers, investors, and others.
Dan McKillop is a partner within the Environmental and Land Use Section at Scarinci Hollenbeck LLC. Dan’s biography is here: https://scarincihollenbeck.com/attorneys/daniel-t-mckillop and he can be reached directly at dmckillop@sh-law.com.
