On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication copy of its final rule promulgating “Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”
Section 8(b) of the Toxic Substances Control Act (TSCA) requires the substantiation (i.e., justification) of all confidential business information (CBI) claims for the specific identities of chemicals reported as “active” on the TSCA Chemical Substance Inventory (Inventory). This statutory provision also requires EPA to establish a process for reviewing such claims within a certain timeframe.
Importantly, the Agency’s final rule adopts two new “reverse engineering” questions that must be addressed by all chemical identity CBI claimants (See Environmental Defense Fund v. EPA, 922 F.3d 446 (D.C. Cir. 2019)). As a result, prior submitters of a TSCA section 8(b) Notice of Activity (NOA) Form A or B that have already substantiated chemical identity CBI claims must supplement the substantiation by addressing the reverse engineering questions. Form A submitters have 180 days after the effective date of the final rule (i.e., 240 days after publication of the final rule in the Federal Register) to provide the supplemental substantiation, while Form B submitters have only 30 days after the effective date of the final rule (i.e., 90 days after publication of the final rule in the Federal Register) to do so.
Form A submitters that did not previously (and voluntarily) substantiate chemical identity CBI claims must do so within 180 days after the effective date of final rule (i.e., 240 days after publication of the final rule in the Federal Register). Re-substantiation is not required if one previously substantiated a chemical identity CBI claim, including addressing the two reverse engineering questions, in the last five years (i.e., five years before the date that is 240 days after publication of the final rule in the Federal Register). However, for this exemption to apply one must report to EPA the date, the submission type, and a case number, transaction ID, or equivalent identifier for the previous substantiation by the 180-day compliance deadline.
The final rule also aims to clarify several substantiation questions and settles the question of how EPA will handle the failure to submit any substantiation for a chemical identity CBI claim previously asserted in an NOA Form A. EPA will provide the submitter written notice of denial and an opportunity to seek judicial review. In contrast, EPA had proposed to consider the claim waived, in which case it could immediately release the chemical identity without providing any notice to the submitter.
All submissions must be made electronically through EPA’s Central Data Exchange (CDX) system. EPA aims to complete its review of all NOA Form A chemical identity CBI claims by February 19, 2024, but is permitted to extend this deadline for good cause.