EPA Finalizes Review Plan for Certain Confidential Business Information Claims under TSCA

For Release: February 16, 2020

Today, the U.S. Environmental Protection Agency (EPA) is releasing the final process companies must follow to make certain confidential business information (CBI) claims and the agency’s plan for reviewing those claims. EPA’s final rule laying out these new requirements creates an efficient process for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and provides clarity for affected stakeholders. EPA is committed to fostering transparency about information on chemicals while protecting verified confidential information.

Following the procedures set forth in the final rule, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. These procedures and requirements will help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA. Additionally, this action fulfills a requirement of the 2016 Lautenberg Act amendments to TSCA and is designed to ensure public transparency while minimizing regulatory burden. 

The final rule is a follow-on to the 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision. This rule applies to manufacturers and processors who made CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory (Active-Inactive) Notification Rule. The final rule describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing certain previously filed substantiations.

The final rule also describes EPA’s plan to review these CBI claims for “active” chemicals, including procedures for the agency’s publication of annual review goals and results. Manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange. Providing this information electronically supports more efficient data transmittal, improves data quality, and minimizes respondent burden and EPA administrative costs associated with information submission and recordkeeping.

Further information on how to address the requirements of the rule, including supplementing previously filed substantiations, is available on the Procedures for the Review of CBI Claims for Active Chemicals on the TSCA Inventory page.