The U.S. EPA has finalized a rule that prevents companies from some of the manufacture or processing of 329 inactive per- and polyfluoroalkyl substances (PFAS).
Inactive PFAS are PFAS that have not been made or used in many years. The new rule prevents companies from starting or resuming the manufacture of processing 329 inactive PFAS without first a complete EPA review and risk determination.
EPA says that, in the past, these inactive PFAS may have been used without review in many industries, and may also have been released in the environment.
EPA first proposed this rule in January 2023. With this rule, companies resuming use of these PFAS will need notification to and review by EPA. The rule’s finalization is a key action under the agency’s PFAS Strategic Roadmap.
When the Toxic Substances Control Act (TSCA) was first enacted in 1976, thousands of chemicals were grandfathered in under the statute and allowed to remain in commerce without additional EPA review.
During the first 40 years of the law’s existence, EPA completed formal reviews on only about 20% of new chemicals and had no authority to address new chemicals about which the agency lacked sufficient information. EPA says that this is part of the reason why many chemicals, including PFAS, were allowed into commerce without a complete review.
Under the 2016 TSCA amendments through the bipartisan Frank R. Lautenberg Chemical Safety for the 21st Century Act, the agency must formally review the safety of all new chemicals before they are allowed into commerce. Under this new significant new use rule (SNUR), EPA must now conduct modern, robust reviews before any of these inactive PFAS could be used again.
TSCA requires EPA to compile, keep current, and publish a list of each chemical that is manufactured (including imported) or processed in the United States for uses under TSCA, known as the TSCA Inventory. TSCA also requires EPA to designate each chemical on the TSCA Inventory as either “active” or “inactive” in commerce. An “inactive” designation means that a chemical substance has not been manufactured (including imported) or processed in the United States since June 21, 2006.
The final rule applies to all PFAS that are designated as “inactive” on the TSCA Inventory and which are not already subject to a SNUR. EPA has aligned the rule with reporting requirements for the Active-Inactive rule, which designated these “inactive” chemicals.
If a company wants to use any of these 329 chemicals, they are required to notify EPA first. The agency would then be required to conduct a robust review of health and safety information under the modernized 2016 law to determine if the new use may present unreasonable risk to human health or the environment and put any necessary restrictions in place before the use could restart
Any new uses of PFAS would be considered under EPA’s framework for evaluating new PFAS and new uses of PFAS, announced in June 2023.