Jan 32025

U.S. Environmental Protection Agency Amends New Chemicals Review Process Under Toxic Substances Control Act

Samuel B. Boxerman and Riley Desper
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On December 18, 2024, the U.S. Environmental Protection Agency (EPA) published a final rule modifying regulations governing the new chemicals review process under the Toxic Substances Control Act (TSCA) (Final Rule). As amended by the 2016 Lautenberg Amendments, TSCA Section 5 establishes prior notice requirements before a new chemical can be manufactured or an existing chemical can be used in new ways.[1] The Final Rule updates EPA practices guiding its review of exemptions and safety determinations, as well as a submitter’s request to start manufacturing, and aligns the implementing regulations with the 2016 amendments.

  • Low volume exemptions and low release and exposure exemptions. First, EPA is amending the implementing regulations governing low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs). Generally, LVE and LoREX regulations provide that EPA may exempt manufacturers from all or part of Section 5 requirements. In addition to now requiring EPA approval of an exemption notice before the submitter may commence manufacture, the Final Rule makes per- and polyfloroalkyl substances (PFAS) categorically ineligible for these exemptions. PFAS are manmade chemicals—of which there are thousands—commonly found in textiles, cookware, packaging, plastics, and firefighting foams. In addition, certain chemical substances that EPA has found to be persistent, bioaccumulative, and toxic (PBT) are now ineligible for these exemptions.[2]
  • Process for Pre-Manufacture Notice, Significant New Use Notice, and Microbial Commercial Activity Notice. The amendments clarify that EPA must make a determination on each Pre-Manufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) received before the submitter may begin manufacturing a new chemical or start a new use. Before the 2016 TSCA amendments, at least 90 days of advance notice had to be provided—but EPA was not obligated to make a determination for each notice. The Final Rule also clarifies the level of detail a submitter must include in PMNs, SNUNs, and MCANs and sets out additional procedures for correcting incomplete notices or those with errors.

The Final Rule is one of several regulations that the Biden EPA has pushed out in an effort to ensure that the rules become effective before the new administration begins on January 20, 2025.

[1] 15 U.S.C. § 2604.

[2] EPA found that there could be instances where PBT chemical substances can be managed under an exemption and thus did not implement a categorical exemption in the Final Rule.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.

Samuel B. Boxerman

Washington, D.C.

sboxerman@sidley.com

Riley Desper

Washington, D.C.

rdesper@sidley.com

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