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Understanding EPA’s Prioritization Process

The procedure for assessing the safety of existing chemicals is set forth in the Toxic Substances Control Act (TSCA), which was substantially amended in 2016. Under this process, prioritization is the fist step in evaluating chemicals for safety. TSCA provides that the EPA must identify at least 20 chemicals as high priority and 20 chemicals as low priority by December 22, 2019.

The EPA’s guide to prioritization is described in “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization.” This guide provides both the immediate goals of identifying chemicals and the long-term goals of evaluating risks for the broader TSCA chemical inventory. The prioritization process aims to classify chemicals into one of two categories: high-priority, which requires further risk assessment, or low-priority, which means that further evaluation is not necessary at this time. A high priority chemical designation does not automatically imply that the substance presents a high risk and a low priority chemical does not indicate that the substance is nontoxic or nonhazardous.

Initiation. The prioritization process begins with the EPA’s formal announcement of a substance that will undergo the prioritization identification. This is announced in a Federal Register Notice and submitted to the public for a 90-day comment period. The “initiation” phase kicks off a nine to twelve-month statutory time frame. During this time, the EPA is required to identify the substance as either high or low priority.  The Agency’s designation is based on screening the chemical under its “conditions of use” against certain criteria specified in TSCA. According to TSCA, “conditions of use” is defined as “the circumstances, as determined by the Administrator, under which a chemical substance in intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used or disposed of.”

Proposed designation.  The EPA will propose to designate a chemical as high or low priority and publish the proposed designation with the background information utilized to determine that designation. The EPA then accepts comments on the designation for the next 90 days.

Final designation. The EPA evaluates the public comments on the proposed designations. The EPA then finalizes a high-priority designation and begins risk assessments or finalizes a low-priority designation and does not perform a risk assessment at that time. The final designation of priority is then published in the Federal Register along with the information that was used to make that decision.

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 regulatory 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.