EPA Finalizes TSCA Confidentiality Rule
The Environmental Protection Agency (EPA) has finalized a rule that establishes procedures for handling information claimed as confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The new regulation is intended to create more transparency and predictability in how the EPA reviews confidentiality claims. Manufacturers submitting data to the agency will need to align their procedures for protecting sensitive information with the new requirements.
- This rule implements key provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which passed with bipartisan support in 2016 to reform the original 1976 Toxic Substances Control Act. - A major change under the Lautenberg Act is that confidentiality claims are not perpetual; they expire after 10 years unless the company reasserts and re-substantiates the claim. The first wave of these expirations for claims made in 2016 is set to begin in 2026. - The new regulations require companies to substantiate most CBI claims at the time of submission, including providing a structurally descriptive generic name for any chemical whose specific identity is claimed as confidential. - Under the amended TSCA, the EPA must review and approve or deny all new claims for confidential chemical identity within 90 days of receipt. The agency is also required to review a representative sample of at least 25% of other non-exempt confidentiality claims. - The reforms extend beyond chemical manufacturers to "processors"—companies that use chemicals in their products or manufacturing processes—who may be affected by new fees and potential supply chain disruptions if a chemical is restricted. - In a December 2024 ruling, the D.C. Circuit Court of Appeals invalidated one part of the EPA's CBI rule in response to a challenge from industry groups, demonstrating that the specific applications of the law are still being shaped through litigation. - The Lautenberg Act gave the EPA the authority to collect fees from chemical manufacturers and importers to defray a portion of the costs for implementing the law and conducting risk evaluations. - Failure to properly substantiate a claim at the time of submission can be interpreted by the EPA as a waiver of the claim, potentially leading to the information being made public.
