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.
Passed in 1976, TSCA is EPA’s primary framework for regulating chemicals. The law allows EPA to set reporting, recordkeeping, and testing requirements and to set restrictions on chemical substances. CBI arises in various submissions under TSCA, including details about chemical identity, a manufacturer’s processing steps, and production volumes. The CBI designation is an important part of protecting from public disclosure information that could damage a business or place that business at a competitive disadvantage. In 2016, Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended TSCA in several ways including by imposing greater restrictions on CBI designations. EPA asserts that it promulgated the new TSCA CBI rule to ensure consistency with those amendments and to consolidate its TSCA CBI rules.
The new TSCA CBI rule addresses both the assertion of CBI in TSCA submissions and EPA’s review of those CBI requests. The rule maintains requirements that parties assert their claim of confidentiality at the time of submission, describe the risk of harm from disclosure, provide public copies of the submission, and provide a supporting statement and certification. The new rule consolidates various CBI provisions, seeks to prevent companies from asserting overbroad CBI claims, and narrows the types of information in health and safety studies over which parties can assert CBI. The new rule also establishes a framework communicating about purportedly deficient submissions. The new rule does not include an administrative appeal process that had been part of a 2022 proposed version of the rule. That process would have created an administrative process for parties to appeal denials of CBI designations.
EPA was careful to note that the TSCA CBI rule does not change confidentiality protections provided by other statutes. The example the agency provided was certain pesticide information protected under the Federal Insecticide, Fungicide, and Rodenticide Act. The agency confirmed that information protected from disclosure under that act would not be publicly available as a result of the TSCA CBI rule.
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