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EPA Proposes Procedures for Identifying Chemicals to Prioritize for Risk Evaluations

Under the 2016 amendments to the Toxic Substances Control Act (TSCA), by December 22, 2019, the US Environmental Protection Agency (EPA) must designate at least 20 chemical substances as “high priority” and 20 chemical substances as “low priority.” Chemicals designated as high priority will undergo further risk evaluation, whereas those designated as low priority will not. EPA must finalize its risk evaluations within three years after formal identification of a chemical as a high priority substance, with an option to extend for 6 months.

Risk evaluations for high priority chemicals are used to determine whether the substance poses an unreasonable risk of harm to human health or the environment; depending on the outcome of these evaluations, the substances may become the subject of additional regulation under TSCA. Accordingly, the EPA has developed a “working approach” document for procedures to pinpoint the chemicals that are suitable for prioritization for risk evaluation.

The “working approach” document outlines “near-term” methods for identifying chemicals warranting high priority status. First, the EPA would review the 2014 Update to the TSCA Work Plan to locate candidates warranting high priority status. A minimum of 50% of the substances prioritized by next December must be on the work plan list. Other chemicals not listed on the work plan may also be chosen by the EPA if they are selected as “particularly suitable” by other agencies or public comment. Possible candidates are selected based on priorities (evaluation of EPA and other regulatory goals), information availability (elimination of candidates with low quality information), and workload (managing the process by selecting chemicals that are similar to the ten previous substances being evaluated).

The document also provides a long-term plan for handling TSCA activities, such as categorizing approximately 40,000 substances into various groups. The substance groups would be used at a later time to determine prioritization based on risk profiles and available information for these substances. The “binning” process would be based on several factors including dangers relative to exposure risk, ecological hazard, genotoxicity, susceptible populations, and bioaccumulation and persistence.

In the meantime, EPA already has initiated risk evaluations for ten substances, as required by the 2016 TSCA amendments. Among the chemicals that the EPA selected in these first ten evaluations are asbestos, methylene chloride, and carbon tetrachloride.

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 Prop 65 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.