December 23, 2024
On December 18, 2024, the U.S. Environmental Protection Agency (EPA) finalized a rule amending the regulations that apply to new chemicals review under the Toxic Substances Control Act (TSCA). With the new amendments, certain chemicals identified as persistent, bioaccumulative, and toxic under TSCA will be subject to the full safety review process before manufacture and will not be eligible for a low volume exemption (LVE) or low release and exposure exemption (LoREX). This includes per- and polyfluoroalkyl substances (PFAS).
The rule amends regulatory text to conform to Congress’s 2016 amendments to TSCA through the Frank R. Lautenberg Chemical Safety for the 21st Century Act. TSCA Section 5 (15 USC 2604) requires that any person (defined at 40 CFR 720.3) who wishes to manufacture (including import) a new chemical substance or manufacture or process an existing chemical for a significant new use must submit to EPA a notice meeting the requirements of TSCA § 5(d) at least 90 days before manufacture or processing.
Upon receipt, EPA must review the notice and make one of five determinations assessing the likelihood of unreasonable risk of injury to health or the environment. The amended regulations state that EPA must make this determination on any Pre-Manufacture Notice, Significant New Use Notice, and Microbial Commercial Activity Notice before the submitter may commence manufacture or processing. Before the 2016 amendments to TSCA, a person could commence manufacture or processing upon expiry of the review period if EPA had not made an affirmative finding of unreasonable risk. EPA’s amendments to the LVE and LoREX similarly include a requirement that EPA approve the exemption before the submitter may commence manufacture or processing. The final rule makes PFAS compounds categorically ineligible for the LVE and LoREX.
The rule also contains additional amendments to the new chemicals regulations, including outlining requirements for the content of notices submitted and procedural updates for amending or requesting suspension of notices.
The rule goes into effect January 17, 2025.