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EPA Releases Final Review Plan for Certain CBI Claims under TSCA

The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims.  EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders.  Following the procedures set forth in the final rule, EPA states that it will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory.  These procedures and requirements are intended to help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA.

The final rule is a follow-on to EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision.  The final 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 its 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.  According to EPA, 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.

Information on EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

©2020 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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