2023-10735: Updates to New Chemicals Regulations Under the Toxic Substances Control Act (TSCA)

Summary

The United States Environmental Protection Agency (EPA) is proposing amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). These amendments are intended to align the regulatory text with the amendments to TSCA's new chemicals review provisions contained in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted on June 22, 2016, improve the efficiency of EPA's review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program. The proposal includes amendments that would reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review. EPA is also proposing several amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA's 1999 PBT policy.

The agency’s own summary, as published.

What this changes

Amends 4 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 40 CFR 720 Premanufacture Notification
• 40 CFR 721 Significant New Uses of Chemical Substances
• 40 CFR 723 Premanufacture Notification Exemptions
• 40 CFR 725 Reporting Requirements and Review Processes for Microorganisms