Tomorrow, January 11, 2024, the U.S. Environmental Protection Agency (EPA) will finalize a Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) to require that companies notify EPA and seek approval before manufacturing, importing, or processing over 300 per- and polyfluoroalkyl substances (PFAS) listed on the TSCA Inventory but assumed not to be actively manufactured (including import) or processed because the substances are designated on the Inventory as “inactive.” Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule. The final rule becomes effective 60 days after publication in the Federal Register, on March 11, 2024. A petition for judicial review of the final rule must be filed within 60 days of the rule’s promulgation date, by March 25, 2024. 15 U.S.C. § 2618.

Scope of the Final Rule

As in the proposed rule, EPA defines the category of PFAS that are included in the final rule as those that, at the time of the proposed rule, (1) were designated as inactive on the TSCA Inventory, (2) were not already subject to a SNUR, and (3) meet the working definition of PFAS used by EPA’s Office of Pollution Prevention and Toxics, in which the PFAS must contain 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; or
• CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.

EPA has identified 329 chemicals that it believes meet these criteria. All are listed in the docket (HQ-OPPT-2022-0867), except for 30 for which both the specific identity and “fluor” in a generic name have been claimed as Confidential Business Information (CBI).

Exemptions

A company’s specific use of any of the 329 PFAS may still be exempt from the SNUR requirements. The specific exemptions include the following: 

• Importing or processing of the inactive PFAS-containing articles and/or
• Manufacture (including import) or processing of the inactive PFAS:
  • As impurities,
  • As byproducts not used for commercial purposes,
  • As byproducts which are burned as a fuel or disposed of as a waste (including in a landfill or for enriching soil), or from which component chemical substances are extracted for commercial purposes, 
  • In small quantities solely for research and development,
  • For test marketing purposes,
  • For use as a non-isolated intermediate, or
  • Solely for export from the United States as described in 40 CFR 720.30(e) or 721.3, except where the Administrator has made a finding described in TSCA section 12(a)(2).

SNUR Requirements

The significant new uses are manufacture (including import) or processing for any use so long as none of the exemptions apply. The SNUR will require companies to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the 329 PFAS for any use. Upon receiving a Significant New Use Notice (SNUN), EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury to health or the environment, or take such regulatory action as is associated with an alternative determination under TSCA section 5 before manufacturing or processing for the significant new use may commence.

In addition, companies exporting any of the 329 PFAS subject to the SNUR will be subject to the export notification requirement under TSCA section 12(b).