U.S. EPA Finalizes Rule Limiting Confidentiality Designations Under the Toxic Substances Control Act
On May 31, 2023, the U.S. Environmental Protection Agency (EPA) finalized a rule designed to tighten confidential business information (CBI) designations in submissions under the Toxic Substances Control Act (TSCA). EPA has touted this rule as providing “transparency” and providing the agency leeway to make “more health and safety data publicly available more quickly.” Given the sensitive nature of the data often provided in TSCA submission, regulated entities should carefully consider the provisions of the new rule and what steps they must take to ensure that confidential information is not subject to public disclosure.
EPA Proposes Updates to Toxic Substances Control Act Review Process, Including Removal of PFAS Exemptions
On Tuesday, May 16, 2023, the U.S. Environmental Protection Agency (EPA) released a prepublication version of a proposed rule instituting reforms to EPA’s regulations implementing the Toxic Substances Control Act (TSCA). EPA maintains a TSCA Chemical Substance Inventory, which lists all chemical substances known to be in commerce in the United States. Under TSCA, manufacturers and importers must submit a premanufacture notice for a new chemical substance unless an exemption applies (e.g., research and development). EPA must complete its risk determination for the new chemical substance before manufacture or import may commence. The proposed rule now makes clear that EPA must complete its risk determination on 100% of new chemical substances or approve an exemption notice before the associated product can enter the market, which aligns with amendments to TSCA made in 2016.
