USEPA Proposes Chemical Review Process Reforms

The U.S. Environmental Protection Agency (USEPA) has proposed amendments to the regulations that govern its review of new chemicals under the Toxic Substances Control Act (TSCA). Under TSCA, the USEPA reviews the potential risks of new chemicals before they enter U.S. commerce and, when necessary, establishing safeguards to protect human health and the environment.

The proposal eliminates eligibility for exemptions from the full safety review process for new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic polybutylene Terephthalate (PBT) chemicals. In April 2021, USEPA announced PFAS would be unlikely to qualify for exemptions, given the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment. The newly proposed rule would make new PFAS categorically ineligible for exemptions, ensuring new PFAS would go through the full robust safety review process before they can enter commerce. The amendments would also ensure that all PBT chemicals are ineligible for the exemptions, codifying USEPA’s decades-long policy for these substances.

The proposed rule also would add efficiencies to the review process for new chemicals, including clarifying the level of detail needed in new chemical notices and amending the procedures for USEPA’s review of notices that contain errors or are incomplete.

In addition, theproposal would amend the regulations to align the regulations with TSCA section 5 requirements to reflect the full extent of new chemical reviews, providing consistency and transparency in new chemical review processes.

Upon publication of the Federal Register notice, USEPA will accept public comments on the proposal for 60 days via docket EPA-HQ-OPPT-2022-0902. A prepublication version of the rule can be accessed here.