Summary
This D.C. Circuit opinion reviews challenges to an EPA final rule implementing confidentiality claim procedures under the Toxic Substances Control Act. The court largely upheld the agency's regulatory definition of "health and safety study," its exemption from post-commercialization substantiation requirements, and its use of permissive language for disclosure. However, the court vacated the rule to the extent it required downstream reporting entities lacking knowledge of a chemical's specific identity to assert and substantiate confidential business information claims, finding this scheme impermissibly allowed unlawful disclosure.
Topics
Practice areas
Questions Presented
- Whether EPA's regulatory definition of health and safety study unlawfully excluded ancillary information contained in study documents.
- Whether the TSCA requires pre-commercialization confidentiality claims for specific chemical identities to be reasserted and substantiated, and reviewed, upon commercialization.
- Whether EPA's use of permissive language concerning deficient claims and disclosure of non-confidential information violated mandatory duties under the TSCA or was inadequately explained.
- Whether the CBI Rule lawfully required entities reporting by non-confidential accession number and lacking knowledge of the underlying specific chemical identity to assert and substantiate a confidentiality claim for that identity.
Holdings
- EPA's definition was lawful because a health and safety study means the evaluation of a chemical's effects on health or the environment, including underlying information, rather than the entire document containing that evaluation. Ancillary information such as the submitting company's identity, laboratory identity, and marketing or financial information may remain eligible for confidential treatment.
- The TSCA does not require a reporting entity to reassert and substantiate a pre-commercialization CBI claim for a specific chemical identity solely because the chemical is later offered for commercial distribution. The exemption continues unless a statutory trigger applies or a post-commercialization claim for the same chemical is submitted.
- EPA's use of permissive language was lawful and reasonably explained. EPA may reserve its final determination on a deficient CBI claim until the end of the statutory ninety-day review period, and the TSCA permits but does not generally require disclosure of all non-confidential information absent an express disclosure mandate.
- The CBI Rule was unlawful as applied to entities that report a chemical substance by non-confidential accession number and lack knowledge of the underlying specific chemical identity. Such entities are not required to assert and substantiate a CBI claim for that identity, and their failure to do so cannot waive an upstream entity's valid confidentiality protection.
Key quotations
“We deny EDF’s petition for review and grant ACC’s petition for review.” (4-5)
“This regulatory scheme cannot be squared with the commands of the statute.” (30-31)
“The CBI Rule is unlawful to the extent it allows a downstream entity reporting on a chemical substance by accession number and without knowledge of the underlying specific chemical identity to waive confidentiality for that specific chemical identity.” (31)
Factual background
EPA promulgated a rule governing confidentiality claims for information submitted to or obtained by EPA under the Toxic Substances Control Act. The rule defined health and safety study, exempted certain pre-commercialization chemical-identity claims from substantiation and routine review, used permissive language concerning review and disclosure, and required entities reporting by non-confidential accession number to assert and substantiate claims for the underlying chemical identity. The latter requirement could cause an upstream entity's valid confidentiality claim to be waived by a downstream reporter that lacked knowledge of the confidential identity.
Procedural history
EPA issued the proposed CBI Rule on May 12, 2022, and the final rule on June 7, 2023. EDF filed its petition for review on June 29, 2023, and ACC filed a separate petition on August 4, 2023; the court consolidated the challenges. The court denied EDF's petition, granted ACC's petition, and vacated the challenged requirements to the extent they permitted waiver of protected chemical-identity confidentiality by entities reporting only by accession number without knowledge of the identity.
Remand instructions
EPA's CBI Rule is vacated only to the extent it requires entities reporting by non-confidential accession numbers and without knowledge of the underlying specific chemical identity to assert CBI claims for that identity in order to preserve its confidentiality.