EPA Releases Final TSCA § 8(b) CBI Substantiation and Review Plan Rule - Action Likely Required
On March 6, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule under sections 8(a) and 8(b) of the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.) entitled, “Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”
The final rule establishes requirements for the substantiation of confidential business information (CBI) claims to protect the specific chemical identities of substances listed on the confidential portion of the TSCA Chemical Substance Inventory (Inventory), and sets forth the Agency’s plan for reviewing certain CBI claims pertaining to specific chemical identity. The rule is effective May 5, 2020.
Most notably, the Agency’s final rule adopts two new “reverse engineering” questions that must be addressed by all chemical identity CBI claimants to substantiate their claims. The additional questions are required by the U.S. Court of Appeals for the District of Columbia Circuit’s 2019 decision in Environmental Defense Fund v. EPA, 922 F.3d 446 (D.C. Cir. 2019). As a result, the final rule requires the prior submitters of TSCA section 8(b) Notices of Activity (NOA) Form As or Form Bs under the TSCA Inventory active/inactive “reset” rule (82 Fed. Reg. 37,520, Aug. 11, 2017), that previously substantiated their chemical identity CBI claims to supplement their substantiations by addressing the new reverse engineering questions.
Manufacturers, importers, and processors that submitted an NOA Form A have until November 1, 2020 to supplement their prior substantiations. Manufacturers, importers, and processors that have submitted or will submit an NOA Form B before May 5, 2020 have only until June 4, 2020 to do so. Form A submitters that did not previously substantiate their chemical identity CBI claims now must substantiate their claims by November 1, 2020. All submissions under the rule must be made electronically through EPA’s Central Data Exchange (CDX) system.
Re-substantiation under the rule is not required if one previously substantiated a chemical identity CBI claim, including the two reverse engineering questions, in another submission within the last five years (viz., after November 1, 2015). This includes persons that reported (or will report) substances and have claimed (or will claim) and have substantiated (or will substantiate) CBI for the 2016 or 2020 TSCA section 8(a) Chemical Data Reporting (CDR) rule (40 C.F.R. Part 711), or in a TSCA Notice of Commencement (NOC) (40 C.F.R. § 720.102). For this exemption to apply, the claimant must, by November 1, 2020 deadline, report to EPA the date, the submission type, and a case number, transaction ID, or equivalent identifier for the previous substantiation.
EPA will review, and approve or deny, CBI claims for a specific chemical identity submitted under the final rule in accordance with section 14 and 40 C.F.R. Part 2. If a submitter fails to submit a substantiation for a chemical identity CBI claim previously asserted in an NOA Form A, EPA will deny the claim and provide the submitter with notice and an opportunity to seek judicial review of the final confidentiality determination under TSCA section 14(g)(2) and 40 C.F.R. § 2.306(e). In contrast, under the proposal the Agency would have been allowed to release the information to the public without further notice to the submitter.
A specific chemical identity subject to an approved CBI claim will be protected from disclosure for 10-years from the date the claim was first asserted for a particular chemical by any person after June 22, 2016. Claimants are permitted to waive a CBI claim before the end of the 10-year period, in which case the previously claimed information may be released. At the beginning of each calendar year – until all reviews are completed – EPA will publish on its website an annual goal for CBI claim determinations and the number of determinations completed in the prior year. EPA seeks to complete its review of all NOA Form A chemical identity CBI claims by February 19, 2024 but is allowed to extend this deadline for good cause.
 The deadline appearing in the prepublication copy of the final rule at § 710.37 was incorrect but was corrected in the final rule appearing in the Federal Register.