February 23, 2024
Agency finalizes rule to ensure recovery of 25% of the costs of chemical safety reviews
On Feb. 5, the Environmental Protection Agency announced finalized changes to the 2018 Toxic Substances Control Act (TSCA) Fees Rule that will ensure the agency can recover 25% of the cost of chemical safety reviews from chemical manufacturers. These amendments clarify how EPA will recover authorized costs and ensure the fees reach 25% of the authorized costs. The final rule will be effective 60 days after publication in the Federal Register.
According to Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff, as quoted in an EPA press release, "This final rule will provide more resources, allowing EPA to review more chemicals more efficiently which means better and faster protections for communities from dangerous chemicals and robust support for American innovation of new chemistries."
Who's affected?
Companies may be affected by the finalized rule if they manufacture, import, process, or distribute into commerce a chemical substance and are required to submit information to EPA under TSCA section 4 or 5 or if they manufacture a chemical substance that is the subject of a risk evaluation under TSCA section 6(b).
EPA identifies the following North American Industry Classification System (NAICS) codes as a guide to the types of businesses affected by the rule:
- Chemical Manufacturing (NAICS code 325)
- Petroleum and Coal Products Manufacturing (NAICS code 324)
- Merchant Wholesalers, Nondurable Goods (NAICS code 424)
Why is EPA strengthening the TSCA fee rule?
The agency states that it only collected half of its baseline costs under the 2018 Fees Rule. EPA based those fees on implementing TSCA before it was amended in 2016, rather than what it cost after the law was revised. The agency states that it did not conduct a comprehensive budget analysis to estimate the costs of implementing the law until spring 2021.
In 2022, EPA published a Supplemental Notice that included the program cost estimate based on a 2021 budget analysis that accounted for the additional costs of implementing the revised law.
What is the total budget estimate for TSCA?
According to EPA, the total TSCA program cost will be approximately $146.8 million, which is 19% less than it proposed in 2022 ($181.9 million). The agency estimates that approximately $36.69 million will be collected annually in fees based on the revised rule.
The agency's revised budget reduced fees for EPA-initiated risk evaluations from $5.1 million to $4.3 million and reduced the fees for review of new chemical submissions from $45,000 to $37,000.
Implications for chemical manufacturers
The finalized rule will revise fee costs for chemical manufacturers and importers in the U.S. Fees for chemical safety reviews are noted in the new publication. However, there is still a window of time before the finalized rule goes into effect during which manufacturers can take advantage of EPA's current, lower fee structure.
What Can We Help You Solve?
Exponent's multidisciplinary teams of chemists, health scientists, epidemiologists, risk assessors, industrial hygienists, ecological and human health toxicologists, and regulatory experts can help you respond to data reporting requests, prepare TSCA new chemical submissions, and conduct human health and ecological hazard and risk evaluations for existing chemicals on the TSCA inventory.
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