May 26, 2023
New proposal to align federal regulations with 2016 Lautenberg Act and expand safety review to all chemical submissions
In a statement released May 16, the Environmental Protection Agency announced proposed amendments to the Toxic Substances Control Act (TSCA) that would streamline the review process the agency makes for each new chemical submission. The amendments would eliminate eligibility exemptions from the full safety review process for new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic chemicals.
Since the 2016 passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has placed increasing focus on regulations that enable "reviewing the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment."
The proposed amendments would bring current EPA federal regulations into alignment with federal law, specifically the TSCA Section 5 requirements. Before the 2016 Lautenberg Act, EPA stated that it only made formal safety determinations on approximately 20% of new chemical submissions. With the new proposed amendments, EPA would be required to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the U.S. market.
The proposed amendment specifies that manufacturers, which also includes importers and processors, "must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications."
In addition, the amendments address a previous provision that allowed EPA to grant exemptions from a complete PMN safety review for the manufacture of chemicals with low production quantities, environmental releases, or human exposures.
The amendment would make per- and polyfluoroalkyl (PFAS) "categorically ineligible" for these low-volume exemptions. Instead, new PFAS would have to go through the full EPA safety findings and review process before they can enter the market. Certain persistent, bioaccumulative, toxic compounds such as polybutylene terephthalates (PBTs) may also be ineligible.
Other updates included in the amendments would clarify the level of detail required in new chemical notices.
If enacted, the amendments would speed up the review and submission process by granting EPA authority to declare incomplete submissions and restart the review period. In doing so, EPA would overhaul its longstanding practice of accepting amended notices "that contain information that was known or reasonably ascertainable at the time of the original submission."
Upon publication of the Federal Register notice, EPA will accept public comments on the proposal for 60 days via docket EPA-HQ-OPPT-2022-0902 at www.regulations.gov.
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