On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the 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” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule 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 proposed several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), 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, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Comments are due July 25, 2023. More information on the proposed rule is available in our May 24, 2023, memorandum.
When EPA receives a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), EPA states that it is required to assess the risk associated with the new chemical substance or significant new use that is the subject of the notice under the conditions of use and make a determination for the chemical substance pertaining to the likelihood of such risk. EPA notes that under TSCA, the term “chemical substance” includes microorganisms. To improve the effectiveness and efficiency of these reviews, EPA proposes to amend the procedural regulations at 40 C.F.R. Parts 720, 721, and 725 to align with the requirements in TSCA Section 5, as amended by the Lautenberg Act, and to make additional updates. In particular, EPA proposes to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing of the chemical substance, and to list the five possible determinations and the actions required in association with those determinations. In addition, EPA proposes to 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. EPA also proposes amendments to the procedures for reviewing PMNs and SNUNs; specifically, procedures for addressing PMNs and SNUNs that have errors or are incomplete or that are amended during the applicable review period. Additionally, EPA is proposing to make several amendments to the regulations at 40 C.F.R. Section 723.50 for LVEs and LoREXs. According to EPA, these amendments would require EPA approval of an exemption notice before the submitter may commence manufacture, allow EPA to inform an LVE or LoREX holder when the chemical substance that is the subject of the exemption becomes subject to a significant new use rule (SNUR) and the chemical identity is confidential, make PFAS categorically ineligible for these exemptions, and codify EPA’s use of the 1999 PBT policy for these exemptions by making certain PBTs ineligible for these exemptions. Finally, EPA proposes to amend 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 e-mail request.