January 15, 2024
The U.S. Environmental Protection Agency (EPA) finalized a Significant New Use Rule under the Toxic Substances Control Act (TSCA) on January 11, 2024 requiring a complete EPA review and risk determination prior to manufacture or processing of 329 inactive per- and polyfluoroalkyl substances (PFAS). The rule goes into effect on March 11, 2024.
The 329 PFAS that are the subject of the rule are compounds designated as inactive on the TSCA Chemical Substances Inventory (TSCA Inventory), meaning they have not been manufactured, imported, or processed in the United States since June 21, 2006. These chemicals may have historically been used without EPA review. With the new rule, if a company wants to start or resume the use of any of these compounds, it must submit a Significant New Use Notice (SNUN) to EPA at least 90 days before the manufacture (including import) or processing of the chemical.
Upon receipt of a SNUN, EPA has 90 days to review the proposed significant new use to determine whether it presents an unreasonable risk to human health or the environment. Upon review, the Agency’s determination could include: a finding that the use is not likely to present an unreasonable risk, a finding of insufficient information to make a determination, a finding that the use may present an unreasonable risk that must be mitigated through restrictions on use, and a finding that the use may present an unreasonable risk warranting a prohibition on use. Any entity wishing to use one of these PFAS will have to comply with any requirements EPA may set as a result of its SNUN review.
This and other proactive measures by EPA to address the use and proposed use of chemicals in commerce is made possible by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to TSCA. The original statute, which was enacted in 1976 and had not been amended for 40 years, grandfathered in thousands of chemicals without requiring EPA review. The pre-2016 version of TSCA afforded EPA limited authority to regulate the use of chemicals entering commerce, especially chemicals for which there was insufficient information for a robust review. Under the 2016 amendments, EPA must review all new chemicals or significant new uses of chemicals before they can enter into commerce. TSCA also requires EPA to maintain the TSCA Inventory and designate each chemical on the list as active or inactive. In implementing this new rule to address uses of the 329 inactive PFAS, EPA will apply its 2023 framework for reviewing new PFAS and new uses of PFAS under TSCA.