On December 18, 2024, EPA published a final rule revising the new chemicals review provisions under the Toxic Substances Control Act (TSCA). The rule:
- Requires an EPA determination on each notice before a submitter may begin manufacturing or processing the chemical, as mandated by amended TSCA;
- Clarifies the level of detail expected for premanufacture notices (PMNs), significant new use notices (SNUNs), and exemption notices;
- Modifies EPA’s review process for PMNs and SNUNs, including procedures for handling incomplete or inaccurate submissions;
- Revises the regulations for low volume exemptions (LVEs) and low releases and low exposures exemptions (LoREXs) to require submitters to wait for EPA approval prior to manufacture; and
- Prohibits PFAS and certain PBTs from qualifying for LVE and LoREX exemptions.
EPA’s clarification of existing PMN requirements includes greater detail on products that would contain the chemical, manufacturing processes, worker exposures, and releases. To effectuate these changes, EPA is introducing new reporting fields to the PMN form.
One key change to the procedures for handling incomplete submissions is that EPA will now declare a submission incomplete and restart the review process if a submitter provides required information that was known or reasonably ascertainable at the time of the original submission. Previously, EPA’s “longstanding practice” was to accept the amendments along with a request to suspend the review period.
Restrained Approach
The final rule largely follows EPA’s May 2023 proposal. In response to comments, EPA agreed to proactively notify current LVE and LoREX holders about significant new use rules (SNURs) that apply to their chemicals, rather than only providing notice prospectively as originally proposed. EPA also agreed to expressly codify that the agency has authority to strengthen protections in TSCA section 5 orders based on new information from any source.
Environmental organizations urged EPA to revoke previously granted LVEs for PFAS, but the agency declined to do so in the rule. However, EPA left open the possibility of future revocations, stating that it “may take future action on a case-by-case basis.” In general, EPA has not granted new LVEs for PFAS since 2021.
Industry groups, on the other hand, unsuccessfully pushed for more streamlined TSCA section 5 notices. Among their rejected proposals was a request that EPA only require specific data elements on a case-by-case basis.
The rule takes effect January 17, 2025, shortly before the presidential transition.