EPA Amends the New Chemicals Regulations Under TSCA

By John Kowalski, regulatory affairs lead, Supply Chain team, UL Solutions

On Dec. 18, 2024, the U.S. Environmental Protection Agency (EPA) published a final rule to amend the new chemicals regulations under the Toxic Substances Control Act (TSCA). The final rule amends the procedural regulations at 40 CFR Parts 720, 721 and 725 to align with the requirements in TSCA Section 5, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and to make additional updates. More specifically, the EPA is amending the regulations to require that the EPA make a determination on each Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) that it receives before the submitter may commence manufacturing, importing or processing of the chemical substance that is the subject of the notice and to list the five possible determinations and the actions required in association with those determinations. In addition, the EPA is finalizing amendments that will clarify the level of detail expected for the information that a submitter is required to include in a PMN, SNUN or exemption notice for the notice to be considered complete. The EPA is also finalizing amendments to the procedures for reviewing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period.

Additionally, the EPA is finalizing several amendments to the regulations at 40 CFR 723.50 for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs). These amendments will:

• Require EPA approval of an exemption notice before the submitter may commence manufacture or import.
• Allow the EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of an exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential.
• Make per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions.
• Make certain persistent, bioaccumulative and toxic (PBT) chemical substances ineligible for these exemptions.

However, the EPA is not revoking previously granted LVEs for PFAS at this time. Finally, the EPA is amending the regulations pertaining to suspensions for all TSCA Section 5 notices to allow submitters to request suspensions for up to 30 days via oral or email request. The final rule is effective on Jan. 17, 2025.

Reference

Environmental Protection Agency; Updates to New Chemicals Regulations under the Toxic Substances Control Act; Final Rule