Procedures for the Review of CBI Claims for Active Chemicals on the TSCA Inventory
Section 8(b) of the Toxic Substances Control Act (TSCA) requires EPA to establish a rule on confidential business information (CBI) claims for specific chemical identities for chemicals reported as “active” in U.S. commerce in response to the TSCA Inventory Notification (Active-Inactive) Requirements Rule. On February 19, 2020, EPA finalized a rule on the procedures for companies to substantiate their CBI claims for the specific chemical identities of substances on the TSCA inventory, as well as the plan for how the Agency will review the claims, the timeframes for EPA to complete reviews, and the annual posting of results.
The final rule also includes two additional questions on reverse engineering that manufacturers and processors will be required to answer to substantiate their specific chemical identity CBI claims. These two questions were added as part of the Agency's response to a court-ordered remand of part of the TSCA Inventory Notification (Active-Inactive) Requirements Rule.
Persons who filed a retrospective activity notice (Notice of Activity Form A) under the Active-Inactive rule and claimed the specific chemical identity as confidential will have 180 days from the effective date of the CBI rule (60 days after the publication in the Federal Register) to amend voluntary substantiations or file new ones consistent with the requirements of the final CBI rule. Persons who have already filed a forward-looking activity notice (Notice of Activity Form B) under the Active-Inactive rule and claimed the specific chemical identity as confidential will have 30 days from the effective date of the CBI rule to update their substantiations to address the two new substantiation questions. New forward-looking activity notice filers claiming specific chemical identity as confidential will be required to address all substantiation questions after the effective date of the final CBI rule. Persons that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange.
The CBI reviews covered in this rule must occur by February 19, 2024, which is within five years of the publication of the first TSCA Inventory including a chemical's status as active or inactive in commerce.