May 232023

EPA Proposes Updates to Toxic Substances Control Act Review Process, Including Removal of PFAS Exemptions

Samuel B. Boxerman, Maureen F. Gorsen, Andrew R. Stewart, Marshall R. Morales and Aaron L. Flyer
,

On Tuesday, May 16, 2023, the U.S. Environmental Protection Agency (EPA) released a prepublication version of a proposed rule instituting reforms to EPA’s regulations implementing the Toxic Substances Control Act (TSCA). EPA maintains a TSCA Chemical Substance Inventory, which lists all chemical substances known to be in commerce in the United States. Under TSCA, manufacturers and importers must submit a premanufacture notice for a new chemical substance unless an exemption applies (e.g., research and development). EPA must complete its risk determination for the new chemical substance before manufacture or import may commence. The proposed rule now makes clear that EPA must complete its risk determination on 100% of new chemical substances or approve an exemption notice before the associated product can enter the market, which aligns with amendments to TSCA made in 2016.

The proposed rule also removes existing exemptions from EPA’s full review process for new per- and polyfluoroalkyl substances (PFAS), categorically prohibiting PFAS manufacturers from relying on the low-volume exemption or the low release and exposure exemption. Removing PFAS from those two exemptions follows EPA’s goals set forth in its 2021-2024 PFAS Strategic Roadmap issued on October 18, 2021. In addition to EPA’s push to increase PFAS-related manufacturing restrictions, California’s passage of Assembly Bill 2771 last year bans the sale of any cosmetic product that contains intentionally added PFAS starting on January 1, 2025.

Finally, the proposed rule adds efficiencies to EPA’s new chemical review process to , most notably, allow EPA to declare premanufacture notices incomplete and restart the review period rather than allowing manufacturers to amend notices submitted with errors or incomplete information known or reasonably ascertainable at the time of initial submission. EPA intends for these efficiencies to promote more complete submissions and reduce the need to redo all or part of its risk assessment; however, it remains to be seen whether EPA’s approach will result in frequent rejections of minor errors and omissions that would otherwise be most efficient to correct without restarting the review period.

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

Maureen F. Gorsen

Century City

maureen.gorsen@sidley.com

Andrew R. Stewart

Washington, D.C.

satewart@sidley.com

Marshall R. Morales

Washington, D.C.

mmorales@sidley.com

Aaron L. Flyer

Washington, D.C.

aflyer@sidley.com

You might also like
Fifth Circuit Limits EPA’s Attempts to Regulate PFAS Under Toxic Substances Control Act in Inhance Technologies v. EPA

On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated two U.S. Environmental Protection Agency (EPA) orders under Section 5 of the Toxic Substances Control Act (TSCA), holding that EPA had exceeded its statutory authority when it issued the orders in an attempt to regulate the manufacture of per- and polyfluorinated substances (PFAS) by petitioner Inhance Technologies, LLC (Inhance). The Fifth Circuit’s decision comes after EPA’s Office of Enforcement and Compliance Assurance announced its National Enforcement and Compliance Initiatives for Fiscal Years 2024 – 2027, which involve increased emphasis on addressing PFAS exposure and contamination through enforcement actions and potential additional regulations.

U.S. Environmental Protection Agency Releases Draft Risk Evaluation Under the Toxic Substances Control Act for Formaldehyde

On March 15, 2024, the U.S. Environmental Protection Agency (EPA or the Agency) published its draft risk evaluation under the Toxic Substances Control Act (TSCA) for formaldehyde. This proposal is one of a series of risk evaluations EPA is conducting as required by the 2016 amendments to TSCA.

U.S. EPA Proposes Nine PFAS Compounds as Resource Conservation and Recovery Act Hazardous Constituents

The Environmental Protection Agency (EPA or the Agency) is proposing to expand its authority under the Resource Conservation and Recovery Act (RCRA), including to extend its corrective action powers over an additional list of per- and polyfluoroalkyl substances (PFAS). Specifically, as part of the EPA PFAS Strategic Roadmap, EPA has prioritized development of a framework to regulate PFAS. In the June 2023 Spring Unified Agenda of Regulatory and Deregulatory Actions (Agenda), which lists federal agencies’ planned “short-term” and “long-term” regulatory actions, EPA included the short-term action of a proposed rule listing certain PFAS as hazardous constituents under RCRA.