EPA finalizes rule it says will prevent inactive PFAS from reentering commerce

The U.S. Environmental Protection Agency (EPA) has 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 uses of these PFAS absent 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.

“Under President Biden’s leadership, EPA has shut the door on the possibility of anyone restarting use of over 300 PFAS without first ensuring a robust safety review to stop uses that could be harmful to our communities and our planet,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “For far too long, communities – particularly those with environmental justice concerns – have suffered the impacts of exposure to ‘forever chemicals.’ We’re continuing to use every tool at our disposal to better protect communities across the nation from these persistent and dangerous chemicals.”

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 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.

Since EPA proposed this rule in January 2023, one company that held Confidential Business Information claims relating to some of these inactive PFAS relinquished its claims on the chemical identities of twelve of these substances, which were previously listed in the confidential portion of the TSCA Inventory. EPA will be moving them to the public portion of the TSCA Inventory. Read the final rule.

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