On January 11,2024, the EPA issued the final version of a new significant new use rule (SNUR) applying to 329 PFAS chemicals designated as inactive on the Toxic Substance Control Act (TSCA) Chemical Substance Inventory (the “Inventory”). A number of PFAS chemicals are already subject to SNURs. This rule omits those to avoid redundancy. The TSCA exists to regulate the use of chemical substances whose manufacture, processing, distribution, use and “disposal may present an unreasonable risk of injury to health or the environment.” The TSCA applies to most industrial chemicals in the United States, but notably excludes pesticides, food, drugs, and cosmetics. The Inventory list, which contains approximately 86,000 chemicals, tracks all chemicals and mixtures subject to the TSCA.

SNURs can require notice to be submitted to the EPA before entities use certain chemicals or mixtures in new ways that may create concerns for humans or the environment. The new SNUR provides analysis of the criteria on which the EPA is to determine whether a proposed new use of a chemical is a significant new use. Almost all new uses of the related PFAS chemicals would be considered significant except a few uses specifically allowed in the rule. The import “or processing of inactive PFAS-containing articles . . .” is not considered a significant new use. Manufacture, import, or processing of the 329 PFA chemicals “as impurities, as byproducts not used 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” are also not necessarily considered significant new uses.

The rule requires that notice be given to the EPA ninety days in advance related to any new use of the 329 inactive PFAS chemicals included in the rule, except for those specific exclusions. Once a notice proposing a new use is submitted, the EPA must review the notice to “assess whether the new use may present unreasonable risk to health or the environment and ensure that EPA takes appropriate action as required to protect health or the environment.” The EPA must assess the risk to the population as a whole, as well as relevant subpopulations, and make a determination to allow the use, or regulate the proposed activity before the activity begins. The new rule becomes effective on March 11, 2024.