On October 11, 2023, the U.S. Environmental Protection Agency (“EPA”) published a final rule, Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances, at 88 Fed. Reg. 70516 (October 11, 2023).¹ The final rule requires any entity or person that has manufactured per-and polyfluoroalkyl substances (“PFAS”) for a commercial purpose in any year since January 1, 2011 to submit PFAS uses, production volumes, byproducts, disposals, exposures, and existing information on environmental or health effects to the EPA. The rule’s breadth, coupled with its retrospectivity, will likely create new recordkeeping and reporting questions for manufacturers, especially because it does not include de minimis exemptions. As a result, any amount of PFAS that is manufactured (or imported) must be reported to EPA.

Authority and Background

The National Defense Authorization Act for Fiscal Year 2020 amended the Toxic Substances Control Act (“TSCA”) section 8(a) in December 2019, which added section 8(a)(7)² titled “PFAS Data.” This new subsection under TSCA required EPA to promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information set forth in TSCA section 8(a)(2)(A) through (G). EPA has now satisfied TSCA’s statutory imperative by issuing a final rule.

PFAS covered under the Rule

PFAS are a group of synthetic chemicals that have been used in a variety of consumer and industrial products since the 1940s. In the final rule, EPA defines PFAS using a structural definition. It says that PFAS is defined as including at least one of the following 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

Only “manufacturers” (discussed below) that satisfy one of the three structural definitions of PFAS must report. EPA also intends to provide a list of substances that meet the definition at its CompTox Chemical Dashboard at https://comptox.epa.gov/dashboard. However, even if a substance is not on the list, but still falls under EPA’s definition, it remains subject to this rule if manufactured for a commercial purpose since 2011. Thus, questions concerning whether a substance meets the structural definition for PFAS will likely require additional analysis and evaluation.

Manufacturers to which the Rule Applies

TSCA section 8(f) sets forth the scope of “manufacturing” for purposes of this rule, which is limited to entities manufacturing for a commercial purpose. EPA is defining “manufacture for commercial purposes” to align with definitions used in other rules. The rule explains the term “‘manufacture for commercial purposes’ includes the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer.”  EPA has expanded this definition to include the “coincidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use, or disposal of another chemical substance or mixture.” 

Reporting Standard under the Rule

The reporting standard for this rule is information that is “known or reasonably ascertainable by” the manufacturer. This standard is defined to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” See 40 CFR 705.3. The rule explains that the standard carries with it a certain level of due diligence, which can require additional analysis, especially for manufacturers that manufacture, produce or import several different PFAS substances.

EPA Reporting Deadlines

Manufacturers subject to this rule must submit all relevant information to EPA within 18 months (or 24 months if classified as a small manufacturer) after the rule’s effective date, which is November 13, 2023. Therefore, as it currently stands, the two relevant dates to track for reporting purposes are May 8, 2025 and November 10, 2025 (for small manufacturers under the rule). To comply with the reporting deadlines, manufacturers should first determine whether the rule applies to them, and—if so—begin taking steps to comply with the rule.

1. The final rule largely tracks the version proposed at 86 Fed. Reg. 33926 (June 28, 2021), but with a few key modifications, including an expanded, structural definition of PFAS.↩
2. 15 USC § 2607. ↩