Complying With EPA's New PFAS Reporting And Recordkeeping Requirements

The Environmental Protection Agency (EPA) has finalized reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). In accordance with obligations under TSCA, the EPA is requiring any person that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.

For most impacted companies, the 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

As discussed in prior articles, the EPA continues to increase oversight over PFAS, with several significant rulemakings in recent years. According to the EPA, its Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Final Rule) aims to better understand who is using PFAS, how they are being used, and in what quantities. While this is a laudable goal, the new reporting requirement creates significant compliance burdens for impacted entities.

TSCA section 8(a)(7) specifically required the EPA to promulgate a rule requiring each person who has manufactured (including imported) PFAS in any year since 2011 to report certain data to EPA, including:

• 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;
• The 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

The EPA finalized the PFAS reporting rule on October 11, 2023. Below are several key provisions that potentially impacted businesses must understand:

• PFAS Definition: Rather than providing a discrete list of chemicals, the EPA has 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; CF3C(CF3)R′R′′, where R′ and R′′ can either be F or saturated carbons. The EPA has identified at least 1,462 PFAS 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 (including imported) for commercial purposes in any year since January 1, 2011, is reportable.

• Reporting Entities: Anyone who has manufactured (including 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 means: (1) any person who imports any chemical substance or any chemical substance as part of a mixture or article into the customs territory of the United States, and includes: (i) The person primarily liable for the payment of any duties on the merchandise, or (ii) An authorized agent acting on his behalf. (2) Importer also includes, as appropriate: (i) The consignee. (ii) The importer of record. (iii) The actual owner if an actual owner's declaration and superseding bond have been filed in accordance with 19 CFR 141.20. (iv) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.

• "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 the EPA's Frequently Asked Questions document, 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). The 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."

• Required Reporting: Entities subject to the EPA's Final Rule must submit a report that includes, for every year since January 1, 2011, detailed information on manufactured or imported PFAS, including company and site information, chemical-specific information, categories of use, total amounts manufactured/imported of each PFAS (including the amounts manufactured in each calendar year for each category of use), number of individuals exposed, byproducts and disposal information, and health and environmental effects.

• 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 TCSA 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.

Additional Considerations for Impacted Entities

In preparing to comply with the new PFAS reporting obligations, impacted entities must devise a comprehensive due diligence protocol. 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.

Covered 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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.