124 F.4th 1
D.C. Cir.2024Background
- The EPA issued a final rule implementing section 2613 of the Toxic Substances Control Act (TSCA), as amended by the Lautenberg Amendments, governing how confidential business information (CBI) claims are treated for chemical substances.
- The rule establishes procedures for asserting and substantiating CBI claims and clarifies what information is eligible for confidentiality under TSCA.
- The Environmental Defense Fund (EDF), an environmental organization, and the American Chemistry Council (ACC), a trade association, both challenged different elements of the rule in court.
- EDF argued that the EPA’s definition of "health and safety study" was too narrow, and that the rule did not require adequate substantiation and review of CBI claims after commercialization.
- ACC argued that the rule permitted unlawful disclosure of protected chemical identities when downstream entities reporting by accession number lacked knowledge of the underlying chemical identity.
- The D.C. Circuit denied EDF’s petition and granted ACC's petition in part, vacating the rule as it applied to reporting by accession number without knowledge of the chemical identity.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Definition of "health and safety study" | EDF: EPA’s definition is too narrow; should include full report | EPA: Definition properly excludes info not relevant to health/environmental effects | Narrow definition proper; EPA's reading reasonable |
| Substantiation/review of pre-commercialization CBI claims | EDF: Claims must be reasserted and substantiated after commercialization | EPA: Statute exempts such claims from substantiation/review unless a new claim is made after commercialization | EPA’s exemption consistent with statute |
| Use of permissive language in CBI claim process | EDF: EPA must exercise mandatory duties under TSCA; permissive language is unlawful | EPA: Statute allows discretion in certain circumstances, such as timing or deficiencies | EPA’s use of permissive language reasonable and lawful |
| CBI requirements for entities reporting by accession number without knowledge | ACC: Rule unlawfully forces disclosure by treating non-assertion as waiver, even when entity has no knowledge | EPA: Entities must assert CBI claims or lose confidentiality | Rule unlawful in this respect; vacated to extent it allows such disclosures |
Key Cases Cited
- FCC v. Prometheus Radio Project, 592 U.S. 414 (2021) (sets out the standard for reasonable agency explanation under APA)
- Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary and capricious review standard under the APA)
- NLRB v. Bell Aerospace Co., 416 U.S. 267 (1974) (congressional reenactment without change presumed to endorse agency interpretation)
- Encino Motorcars, LLC v. Navarro, 579 U.S. 211 (2016) (agency must provide a reasoned explanation for policy changes)