On March 1, 2021, the White House Office of Management and Budget (OMB) received for review under Executive Order 12866 (Regulatory Planning and Review) from the U.S. Environmental Protection Agency (EPA) a proposed rule entitled “Reporting and Recordkeeping for Perfluoroalkyl or Polyfluoroalkyl Substances Under Section 8(a)(7) of the Toxic Substances Control Act (TSCA)” (Proposed Rule). This action is required under Section 7351 of the National Defense Authorization Act for Fiscal Year 2020 (NDAA) that amended TSCA Section 8(a). NDAA Section 7351 and TSCA Section 8(a)(7) require EPA to promulgate a rule by January 1, 2023, requiring each person who has manufactured a perfluoroalkyl or polyfluoroalkyl substance (PFAS) in any year since January 1, 2011, to submit to EPA a report that includes, for each year since January 1, 2011, the information described in TSCA Section 8(a)(2)(A)-(G). This includes, to the extent known or reasonably ascertainable to the manufacturers (including importers) of the PFAS:

(A) The common or trade name, the chemical identity, and the molecular structure of each chemical substance [] for which such a report is required.

(B) The categories or proposed categories of use of each such substance [].

(C) The total amount of each such substance [] manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance [].

(E) All existing information concerning the environmental and health effects of such substance [].

(F) The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance [] in their places of employment and the duration of such exposure.

(G) In the initial report under [TSCA Section 8(a)(1)] on such substance [], the manner or method of its disposal, and in any subsequent report on such substance [], any change in such manner or method.

Commentary

OMB’s 90-day review period for the Proposed Rule ends on May 30, 2021. Publication in the Federal Register can be generally anticipated to occur soon after completion of the review.

The details of the Proposed Rule’s reporting requirements and any reporting exemptions remain unclear. It is likely that EPA will include in the Proposed Rule specifics beyond what are included in TSCA Section 8(a)(7) to clarify what must be reported. For example, TSCA Section 8(a)(2)(E) requires the reporting of “[a]ll existing information concerning the environmental and health effects of the substance [].” Considered broadly, this could include information not needed by EPA, or already reported or available (e.g., published studies) to EPA. EPA might also clarify what is included in the category. For example, is a substance with two fluorine atoms a “polyfluoro” substance?

Concerning possible exemptions and other specifics, we anticipate that the rule will be proposed for inclusion in 40 C.F.R. Part 704 Subpart B (Chemical-Specific Reporting and Recordkeeping Rules), where standard definitions, exemptions, and other provisions/procedures currently codified at 40 C.F.R. Part 704 Subpart A would apply, unless made inapplicable or replaced by terms in the specific PFAS rulemaking. General exemptions at 40 C.F.R. Section 704.5 apply to persons that manufacture (including import) or process a covered substance solely as part of an article; as a byproduct, an impurity, or a non-isolated intermediate; or in small quantities for research and development. Additionally, there is a general exemption for “small manufacturers and importers.”

We hope that EPA considers carefully the boundaries of the information that it will require for submission. While EPA has the authority under TSCA to require a very broad set of information, reporting is not a trivial task for submitters and EPA has limited resources to review the information that will be submitted. It has not been that long since EPA received significant information on nano materials that were required to be reported under TSCA Section 8(a), the disposition of which remains unclear. We recognize there is significant interest in all things PFAS. EPA should work with stakeholders to ensure its data gathering efforts are prioritized and well understood.