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Follow Up to Release of Final Rule on TSCA User Fees: Identifying Manufacturers Subject to Fees

The Environmental Protection Agency (EPA) released a final fees rule under the Toxic Substances Control Act (TSCA). The TSCA authorizes the EPA to collect fees from chemical manufacturers for designated activities including creating risk analysis for chemicals, reviewing and processing toxicity and exposure information for certain chemicals, examining Confidential Business Information, and rendering decisions about the safety of new chemicals in an expedient manner prior to their release into the marketplace. While the EPA can collect fees from both manufacturers and processors of chemicals, the rule emphasizes fee collection from manufacturers since it believes that this fee structure is the most prudent for performing risk evaluations and testing procedures.

One of the areas of revision from the proposed rule is the process of identifying manufacturers subject to fees under TSCA sections 4 and 6. The final rule envisions that the EPA will identify manufacturers who have fee requirements through the following steps:

  • Publication of a list that includes manufacturers subject to the rule based on data supplied by Chemical Data Reporting, information gathered under Section 5, Toxic Release Inventory data, U.S. Customs and Border Patrol information and other public sources;
  • Public comment period to give manufacturers the opportunity to identify themselves, correct errors or make certifications about their manufacturing; and
  • Development of a final list of manufacturers who are subject to the obligation to make payment.

On the requirement for public comment by manufacturers, the final rule allows exemption from paying the fee if the company can provide certification to the EPA that it no longer manufactures the substance, has no intention of manufacturing the substance in the next five years, or did not engage in manufacturing the chemical in the five years prior to the publication of the list.

Only two fee-triggering events will be subject to this process: TSCA Section 4 test rules and Section 6 EPA-initiated risk evaluations. For risk evaluations triggered by the EPA under Section 6, the requirement for manufacturers to pay the fee arises when the EPA initiates prioritization (the initial process of assessing the safety of a chemical by labeling it high or low priority for subsequent testing). Thus, companies cannot avoid fee payment for a risk evaluation by exiting the market after prioritization has been initiated.

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.