Following several extensions to its statutory deadline, the US Environmental Protection Agency (EPA) released its final Toxic Substances Control Act (TSCA) Reporting and Recordkeeping Requirements for Per- and Polyfluoroalkyl Substances (PFAS) on September 28, 2023. While the final rules largely track the draft rules released in June 2021, they include changes to address concerns raised during the comment period about the rule’s potential breadth and associated compliance burdens and a slightly expanded definition of what PFAS are covered by the new rule.
Any entity that has manufactured or imported PFAS—including “articles” containing PFAS—will have either 18 or 24 months to submit a report of PFAS usage to EPA from the date the final rule is published in the Federal Register.
Reports submitted under the program are anticipated to provide a vast amount of information to EPA, and the public at large, about how (and in what products) PFAS are used, where and how they may be released into the environment, and what the potential risks to human health associated with this class of chemicals are.
In addition to evaluating whether they have manufactured or imported PFAS chemicals or articles containing PFAS during the reporting period, regulated entities should consider and begin planning for foreseeable next steps after submission of their report.
As part of the National Defense Authorization Act for FY 2020, the US Congress amended TSCA Section 8(a) with instruction to EPA to develop a PFAS reporting program by January 1, 2023. The statute required that the program apply to “each person who has manufactured a [PFAS] in any year since January 1, 2011” and that covered entities submit “a report that includes, for each year since January 1, 2011, the information described in [TSCA Section 8(a)(2)].”
Throughout the rulemaking process, EPA took the position that Congress’s directive did not give EPA discretion to incorporate certain exceptions that are built into TSCA’s Chemical Data Reporting (CDR) rules for other, non-PFAS substances. These include, most notably, exceptions for small businesses, de minimis usage, and reporting on chemical substances found in “articles,” defined generally to mean manufactured items intended as end-use products.
Comments submitted to EPA following the June 2021 release of the draft rules raised concerns about the regulatory burden that such measures would impose, particularly (but not exclusively) on smaller businesses, which may not have the resources or in-house expertise needed to provide the wealth of information required under the rule.
These comments prompted EPA to form a small business advocacy review panel to gather additional feedback, and to later revise an early economic assessment that was found to have significantly underestimated compliance costs. These issues are thought to be the reason for the delay in the final rules, which were released nearly 10 months after the statutory deadline.
Similar to the draft, the final rules require that regulated entities submit a retrospective report containing numerous categories of information relating to the manufacture and import of PFAS chemicals for each year in which PFAS was manufactured or imported, starting in 2011. The final rules do not exempt small businesses, do not include de minimis exceptions, and do not exempt manufacturers or importers of articles containing PFAS.
In an effort to alleviate some of the burden, however, the final rule includes an option for article importers to use a “streamlined reporting form” if they do not know, and cannot reasonably ascertain, the information otherwise required. In addition, reporting of production volumes for imported articles may be based on the article volume, rather than the volume of PFAS contained in the article—a potentially significant change for some regulated entities, relative to the draft rules.
The definition of “PFAS” was another concern raised during the rulemaking process. The proposed rule used a “structural definition” of PFAS as opposed to a discrete chemical list, leading some industry observers to note that entities without sophisticated knowledge of the chemistry of their products may not be aware that certain articles are covered. EPA acknowledges the concern in the final rule but retains the same, albeit slightly expanded, “structural definition” approach to avoid limiting the scope of information gathered. [1]
The proposed rule also required that the reports include numerous categories of information that are statutorily prescribed and thus largely outside of EPA’s control. However, one required category of information—“all existing information concerning environmental and health effects” of the PFAS at issue—was particularly concerning to potentially regulated entities due to the virtually unlimited breadth of the requirement.
EPA addresses this concern in the final rule by clarifying that regulated entities are only required to report information in the submitter’s possession or control. Effectively, this clarification means that reporting entities need not search for and provide all information about a particular PFAS chemical available in the public realm, but they must still provide responsive data or information in their or their employees’ files and undertake some external outreach to suppliers.
As anticipated, EPA did not make sweeping changes to the proposed rule; instead, it targeted specific areas of particular concern to regulated entities with modest adjustments intended to reduce compliance burdens, without meaningfully limiting EPA’s access to PFAS data. This approach was expected not just due to the breadth of the authorizing statute, but also because it is most consistent with the “research” objective of EPA’s PFAS Strategic Roadmap—a key initiative of EPA introduced early in the Biden administration.
For many regulated entities, the preparation of the report under these rules may appear to be a daunting task. While the report will not be due until 18 months after the rule is officially promulgated (24 months for small manufacturers whose obligations are exclusively from article imports), regulated entities would be well advised to familiarize themselves with the information that will need to be provided and begin the legwork of collecting it well in advance.
Further, the challenge of preparing the report may only be the beginning. The information EPA is gathering can, and likely will, be used to inform future regulation and enforcement actions concerning PFAS—and, because the reports will be publicly accessible (apart from redactions of business-sensitive information), they may influence public perception of products and businesses. Responding to these challenges will require careful consideration and preparation to mitigate both legal and business risks.
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[1] The definition in the final rule, while still structural, includes a broader range of chemicals than in the proposed rule, as outlined in Part III, Sections 1 and 2 of the final rule.