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EPA Withdraws Last of Direct Final Rules

In November, the Environmental Protection Agency (EPA) withdrew a direct final rule related to 26 significant new use rules known as SNURS under the Toxic Substances Control Act (TSCA).  The SNURS cover numerous substances including several polymers and a carbon nanomaterial, but critical comments from industry and non-governmental organizations led the EPA to suspend the direct final rule.

Under Section 5(a), the EPA can identify the use of a chemical substance as a “significant new use” upon consideration of certain factors, and promulgate a SNUR to regulate such use. A company wishing to use a chemical subject to a SNUR must submit a significant new use notice (SNUN) to EPA prior to commencing such new use. With the submission of the SNUN, EPA may evaluate the risks associated with the new use, and on this basis, the EPA may impose additional restrictions on the proposed use.

Direct final rules are often used to fast-track the process for non-controversial regulations.  However, if such rules receive significant adverse public comments, the EPA is required to withdraw the rule and re-start the complete rulemaking process as required under the direct final rulemaking procedures.  The EPA issued the 26 SNURS under both a direct final rule and a proposed rule at the same time. Several other batches of substances had been subject to both a proposed and final rule and received adverse comments from the public.

In the case of the final rule related to the latest 26 SNURS, the criticism came from multiple sources.  The Environmental Defense Fund claimed that the agency was no longer implementing its new chemical policy and instead was using random and incoherent testing procedures without admitting it was doing so.  The Physician Committee for Responsible Medicine (PCRM) echoed criticisms that it attributed to previous SNURS with respect to manufacturing prohibitions.  The PCRM voiced concern for seven substances where animal testing was inadequate.  The American Chemistry Council also weighed in on two SNURS addressing isocyanate-based polymers and prepolymers, claiming that the EPA was basing its proposals on dangers emanating from the use of the substances in mixtures with an excessive amount of isocyanate monomers.

The direct final rule was published on October 10, 2018 and was withdrawn as of December 7, 2018.  The EPA has announced that it would address adverse public comments in a future final rule based on the proposed SNURs.

Grimaldi Law Offices has been advising clients for over 20 years on chemical and product law. For knowledgeable advice and in-depth analysis on your chemical regulation compliance obligations, contact Grimaldi Law Offices at (415) 463-5186 or email us at [email protected].

Ms. Grimaldi maintains a diverse environmental law practice focusing on chemical and product regulation and litigation defense. Her practice areas include Proposition 65, California's Safer Consumer Products Regulations, California's Rigid Plastic Packaging Container Act and the federal Toxic Substances Control Act. Ms. Grimaldi graduated from the University of California Hastings College of the Law magna cum laude and holds a Bachelor of Science Degree in Bacteriology from University of California, Davis. Prior to attending law school, she worked as a research assistant in laboratories at the University of California, San Francisco Cancer Research Institute and at the University of California, San Francisco School of Medicine.