On December 20, 2024, the U.S. Court of Appeals for the District of Columbia Circuit denied the Environmental Defense Fund’s (EDF) petition and granted the American Chemistry Council (ACC) and American Fuel and Petrochemical Manufacturers’ (AFPM) petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule updating the requirements concerning the assertion and treatment of confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). EDF v. EPA (No. 23-1166). EDF claimed that the CBI rule’s regulatory definition of health and safety study was impermissibly narrow and should encompass the entirety of a study document or report. EDF also challenged EPA’s decision not to require substantiation and routine review of pre-commercialization CBI claims after commercialization, as well as EPA’s use of language in certain provisions of the rule. The industry petitioners argued that the final rule allows for the unlawful disclosure of CBI if a downstream reporting entity submits information to EPA that includes only non-confidential information, such as a chemical substance’s accession number, and does not reassert a CBI claim. The court vacated the final rule to the extent it allows for the unlawful disclosure of CBI.
The court states that EPA’s regulatory definition of health and safety study “properly excludes matters that do not bear on the effects of a chemical substance on health or the environment” and that EPA’s definition is neither arbitrary nor capricious. According to the court, EPA is correct that TSCA Section 14(c)(2)(G) exempts CBI claims for specific chemical identities asserted prior to the date on which the chemical substances are first offered for commercial distribution. Under TSCA, specific chemical identities remain exempt from substantiation and review until EPA receives a post-commercialization CBI claim or some other statutory trigger applies. The court held that EPA’s use of permissive language in select provisions of the rule is consistent with TSCA and reasonably explained.
Regarding the claim made by ACC and AFPM, the court states that the final rule’s assertion and substantiation requirements are unlawful as applied to entities reporting by accession numbers and without knowledge of the underlying chemical identity. According to the court, reporting entities that lack knowledge of specific chemical identities are unable to assert or substantiate CBI claims for such identities. The court notes that these entities are required by the rule to assert and substantiate CBI claims for already protected specific chemical identities, however, otherwise they waive confidentiality for the specific chemical identity. This then causes an upstream entity that properly asserted and substantiated a CBI claim to lose confidentiality protection. More information on EPA’s final rule is available in our June 12, 2023, memorandum.
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