On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its final Toxic Substances Control Act (TSCA) Section 8(a) reporting rule. It expands reporting and recordkeeping requirements for companies that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for a commercial purpose—whether as a chemical substance or in a mixture or article—since January 1, 2011. Entities subject to this rule will need to submit reporting forms for retrospective data either 18 or 24 months following the rule's effective date, which is 30 days after its publication in the Federal Register.

Background

Congress first mandated the new rule's creation as a policy rider to the National Defense Authorization Act for fiscal year 2020. This amended TSCA Section 8(a) by adding Section 8(a)(7), titled "PFAS Data," which explicitly obligates 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 PFAS information described in TSCA Section 8(a)(2).

Under this authority, EPA began the rulemaking process in June 2021. It collected comments on a draft rule, many of which raised concerns about the burden the rule would impose on small businesses without the resources or know-how to navigate the proposed reporting requirements. Environmental groups, on the other hand, expressed support for a broad interpretation of Congress' mandate to collect data from "each person" who manufactures or imports PFAS.

The final rule released in September attempts to strike a balance between these concerns. For example, it contains an option for entities importing articles—products containing PFAS—to use a "streamlined reporting form, if they do not know or cannot reasonably ascertain information requested [in the ordinary reporting process]." The final rule, however, does not contain exemptions for small businesses nor large-volume manufacturers or importers.

This new requirement differs in several respects from the existing Toxics Release Inventory (TRI) reporting for PFAS initiated in 2020. While some of the information required to be reported under the new rule and the TRI is overlapping, the new rule requires reporting on a broader class of PFAS than required under TRI; the new rule requires reporting during the entire "lookback" period dating back to January 1, 2011, whereas the TRI did not include PFAS until the 2020 reporting year. Additionally, the new rule does not contain a reporting threshold or similar de minimis reporting exemption like that currently provided in the TRI (although the EPA has proposed removing the de minimis exemption for PFAS under the TRI).

EPA believes the rule will allow it to more effectively research and monitor PFAS. As a result, the data collected by EPA may lead to further laws and policies regulating entities that manufacture or handle PFAS.

Who Is Affected?

The rule applies to entities that have manufactured or imported PFAS for a commercial purpose at any time since January 1, 2011. It applies retroactively to 2011, and to any entity currently manufacturing or importing PFAS. The rule also encompasses PFAS manufactured or imported in a mixture or article, meaning entities that manufacture or import mixtures, compounds or articles where one or more PFAS are present are subject to reporting requirements.

EPA provided a list of North American Industrial Classification System (NAICS) codes as a guide to help determine whether the rule applies to a particular entity. The list includes construction (NAICS code 23), manufacturing (NAICS codes 31 through 33), wholesale trade (NAICS code 42), retail trade (NAICS codes 44 through 45) and waste management and remediation services (NAICS code 562). This list is not exhaustive; it merely "details the types of entities that EPA is aware could potentially be regulated."

Definition of "PFAS" Under the New Rule

EPA slightly expanded its definition of PFAS from its proposed version to the final one, explaining that after reviewing comments, it "determined that the proposed definition may not include all substances for which EPA believes reporting of information is necessary." It estimates that the rule now applies to at least 1,462 PFAS, an increase from the 1,364 known PFAS covered by the proposed definition. The final rule defines PFAS as any substance:

[I]ncluding 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.

Entities subject to PFAS regulation are tasked with determining whether their products or imports necessitate reporting, a task EPA acknowledges may be challenging. Accordingly, EPA is expected to release guidance documentation and hold public meetings and webinars to assist entities that may be regulated under the new rule.

Increased Reporting Obligations

Regulated entities are required to produce the following information pursuant to TSCA Sections 8(a)(2)(A) through (G) for all manufacturing or importing PFAS data since 2011:

  • The common or trade name, chemical identity and molecular structure of each chemical substance or mixture for which a report is required;
  • 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.

Importantly, the rule allows regulated entities to submit "confidentiality claims" for protected information like trade secrets. EPA further explains that regulated entities need only report information in their "possession or control." If manufacturers or importers do not know or cannot make reasonable estimates for certain data, except for production volumes, they may report such information is "not known or reasonably ascertainable."

When Is the Rule Effective?

Since the rule is finalized but not yet published, it will become effective 30 days after publication in the Federal Register. Whether entities have 18 or 24 months following the effective date to report PFAS data to EPA depends on the entities' status as a large or small manufacturer or importer. Small article importers, as defined in 40 CFR 704.3, must submit reporting forms 24 months after the effective date, whereas all other entities subject to reporting requirements must submit their forms 18 months after the effective date. Entities must report information from January 1, 2011, through the end of the calendar year that precedes the final effective date―likely December 31, 2022, if the final rule is published in 2023.

What This Means for Companies

  • Manufacturers and importers may not realize they now have reporting requirements, especially those manufacturing or importing articles containing PFAS, and may be subject to civil administrative penalties up to $25,000 per day of violation for failure to comply with EPA's reporting and recordkeeping requirements.
  • Users of PFAS in products will likely need to better understand their supply chain and quantities to determine the impact on their products given the lack of a reporting threshold or de minimis quantities exemption and the rule's new definition of PFAS, which differs from the definitions used under other rules and regulations.
  • Manufacturers and importers with limited knowledge concerning the information sought by EPA should carefully evaluate whether and to what extent the "not known or reasonably ascertainable" designation applies.
  • Going forward, manufacturers and importers will need to create, maintain and update their recordkeeping capabilities. This may include incorporating new software to track and verify what chemicals are involved in their processes for future reporting, as current software will need to be upgraded, particularly for companies not already focusing in the space.
  • The rule will lead to increased customer demand for better or more robust reporting of inputs and outputs, and this demand is highly likely to drive future innovation in the measurement and verification space.

For More Information

If you have any questions about this Alert, please contact Sharon L. Caffrey, Lindsay Ann Brown, Brad A. Molotsky, any of the attorneys in our PFAS Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.