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New Chemicals Program Under TSCA Faces Criticism

The new chemicals program under the Toxic Substance Control Act (TSCA) is facing growing criticism from both industry leaders and consumer advocacy groups. Industry representatives claim that the review process is slow and inefficient and that the Environmental Protection Agency (EPA) is targeting too many substances for use restrictions. At the same time, consumer advocate groups have criticized the agency for a lack of thoroughness in conducting mandatory reviews of the safety of new chemicals. Critics have also said that the streamlined review process may allow approval of a chemical for one use without a comprehensive review of the chemical’s safety profile if it used for a different purpose later on. Much of the tension stems from the EPA’s revised approach to chemical review and how it has been using its expanded authority to determine chemical safety.

The EPA is authorized to identify and regulate unreasonable risks that are posed by chemicals and approve new substances in accordance with the TSCA. Amendments to the TSCA’s process for chemical review passed in 2016 generated additional requirements that have caused the agency’s backlog of cases to swell. Currently the number of chemicals under review at the EPA has reached its peak since the TSCA was amended- 550 cases are now pending. One year following the amendment, in 2017, the EPA had reduced the growing backlog to a manageable number. However, since then, the number of cases subject to review has not fallen below 400.

According to the EPA, the backlog is a result of changes to the law which require the agency to implement new provisions for reviewing chemicals. These include mandates to issue affirmative decisions for all premanufacture notices and evaluate all conditions of use. Industry leaders have labeled the EPA’s new approach as “highly precautionary” and detrimental to the introduction of new chemicals to the marketplace, undermining innovation. One of the consequences of the protracted process is that withdrawal rates for new chemical applications has risen. When a company must wait more than a year to get a specialty chemical to market, the demand for that chemical may no longer exist. This negatively affects innovation and may hinder the development of new and better chemicals.  

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 and other 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.