EPA Finalizes Rule on Inactive PFAS

The US Environmental Protection Agency (EPA) finalized a rule that prevents companies from starting or resuming the manufacture or processing of 329 per- and poly-fluoroalkyl substances (PFAS) that have not been made or used for many years without a complete EPA review and risk determination.

In the past, these chemicals, known as “inactive PFAS,” may have been used without review in many industries, including as binding agents, surfactants, in the production of sealants and gaskets, and may also have been released into the environment.

Without this rule, companies could have resumed use of these PFAS without notification to and review by EPA. The rule builds on three years of progress on the Biden-Harris Administration’s commitment to advancing environmental justice, protecting public health, and addressing the impacts of these “forever chemicals,” and is a key action under EPA Administrator Michael S. Regan’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, which 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 FDA 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.

If a company wants to use any of these 329 chemicals, it is 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 would 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.

EPA finalized a rule to gather data on PFAS, has issued three TSCA test orders under its National PFAS Testing Strategy to advance the Agency’s understanding of the impacts of these chemicals, and made more PFAS subject to Toxics Release Inventory reporting.