Summary
The Environmental Protection Agency (EPA) recently finalized the Toxic Substances Control Act (TSCA) Reporting Rule for PFAS— its broadest regulation to-date on per- and polyfluoroalkyl substances (PFAS), commonly known as “forever chemicals,” mandating reporting and recordkeeping for entities involved in the manufacturing or importing of PFAS and PFAS-containing products for commercial purposes since January 1, 2011.
The Upshot
- The reporting rule applies to manufacturers and importers of PFAS, as well as manufacturers or importers of PFAS-containing products.
- The scope of the rule is incredibly broad and requires reporting of over 1,450 types of PFAS—many more than the handful of specific PFAS typically targeted by state and federal regulators.
- Covered entities will be required to report information known to, or reasonably ascertainable by, them in Spring 2025, with an additional six months for certain small businesses.
The Bottom Line
The new rule covers entities that regularly report under TSCA, but also many entities that have little to no experience with the highly technical law. Gathering the reportable data will require both internal and external inquiries for information that may have never been tracked in the first place because few of the covered PFAS were regulated during the applicable reporting period. While the final rule is a milestone for EPA under its PFAS Strategic Roadmap, for many covered entities, finding the mandated data could be like looking for a needle in a decade-old haystack.
In a landmark regulatory development, the Environmental Protection Agency (EPA) finalized the Toxic Substances Control Act (TSCA) Reporting Rule for PFAS, mandating reporting and recordkeeping for entities involved in the manufacturing or importing of per- and polyfluoroalkyl substances (PFAS) and PFAS-containing products for commercial purposes since January 1, 2011. The decision, signed by EPA on September 28, 2023, marks a significant milestone in the agency’s ongoing efforts to address PFAS contamination and exposure across the United States.
To Whom Does This Action Apply?
The new reporting rule applies to all manufacturers or importers of PFAS or PFAS-containing products for commercial purposes since January 1, 2011. The scope of this action is broader than any other EPA rule related to PFAS due to the many types of PFAS covered (more than 1,450). The EPA estimates that this one-time reporting requirement will apply to approximately 130,000 entities across various industries, including manufacturing, wholesale trade, retail trade, construction, and waste management/remediation.
PFAS are man-made chemicals that have been widely used in industry and consumer products since the 1940s. Because these compounds resist grease, water, and oil, they have been used in a wide variety of processes and products, including nonstick cookware, medical devices, water-repellent clothing, stain-resistant fabrics and carpets, cosmetics, and firefighting foams, to name a few. Manufacturers or importers of textiles, food packaging, apparel, electronics, wires and cables, pipes, cooking and bakeware, sporting equipment, automotive products, toys, transportation equipment, and musical instruments may all be subject to the rule if their products contain or contained PFAS since 2011. Even companies that have begun or completed phase-outs of PFAS in their products must comply if they have engaged in importing or manufacturing of PFAS or PFAS-containing products since 2011. Because this rule is applicable to importers of PFAS-containing products, even drop-shippers of imported materials are likely covered entities.
The first step for any potentially covered entity is to determine whether it meets the applicability criteria outlined in 40 CFR 705.10 and 40 CFR 705.12. This determination should be made as quickly as possible, given the extensive factual inquiry that covered entities will need to complete in the next 18 months.
Are There Any Exemptions?
TSCA excludes food, drugs, cosmetics, tobacco, firearms, ammunition, and pesticides, so these products are not subject to the reporting requirements. The rule also includes a specific exclusion for importers of municipal solid waste for disposal or destruction. However, unlike many TSCA rules, there are no other reporting exemptions, production volume thresholds, or exemptions for mixtures. For example, while several TSCA reporting rules exempt certain finished manufactured items known as “articles” that may contain TSCA-regulated substances (e.g., cigarette lighters), this rule is clear that article manufacturers and importers are not exempt. Even finished manufactured products that meet the definition of “article” must be reported if they contain PFAS.
The Rule Applies to You, Now What?
Data is due to EPA within 18 months of the effective date of the final rule, which is yet to be published, but our best estimate is the data will be due in late Spring 2025. Small businesses that are solely reporting data on PFAS-containing products will have an additional six months to report. EPA will issue a standard reporting form for PFAS manufacturers or importers and a streamlined form for those reporting data for only PFAS-containing products or research and development use. A form will need to be submitted for each PFAS.
Manufacturers or importers of PFAS must report information on PFAS uses, production volumes, byproducts, disposal, exposures, and existing data on environmental or health effects. Manufacturers or importers of PFAS-containing products will have a streamlined reporting option that includes chemical identity, import volume, industrial processing and use, and consumer and commercial use.
EPA estimates that 1,462 types of PFAS are covered by the applicable structural definition at 40 CFR 705.3, a significant expansion compared to most regulations that focus on a limited number of high-priority PFAS. Rather than identifying specific applicable PFAS by CAS number, name, or chemical structure, EPA chose to use a structural classification contained in 40 CFR 705.3. EPA plans to provide a non-exclusive list of covered PFAS on the CompTox Chemicals Dashboard.
To many subject to the rule, the scope of reporting will be daunting. First, many companies that manufacture or import PFAS-containing products, rather than PFAS itself, are not familiar with TSCA reporting. Further, given that only a few PFAS have been recognized by EPA as “emerging contaminants” in the last decade, the broader manufacturing community has not been on notice to track these 1,462 PFAS chemicals since 2011. However, the rule contains a reporting standard similar to other TSCA section 8 rules, requiring only information known to or reasonably ascertainable by the covered entity. This will necessitate inquiries within and potentially outside the organization to fill knowledge gaps, but will not require companies to create new information, such as health or exposure studies. The rule also permits reasonable estimates to be used when exact calculations are unavailable or companies may indicate information is “Not Known or Reasonably Ascertainable” (NKRA).
The lawyers in Ballard Spahr’s Environment and Natural Resources Group are able to assist clients in determining whether they must comply with this rule, in fulfilling the rule’s obligations, and in TSCA compliance more generally.
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