September 20, 2020

Volume X, Number 264

September 18, 2020

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September 17, 2020

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EPA Updates Data on TSCA CBI Reviews

The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics.  These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020:

CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)
Cases in which the specific chemical identity is subject to CBI review 3,326
Cases in which information other than the specific chemical identity is subject to CBI review 2,523
Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review 734
Total cases subject to CBI review 6,583

 

Cases resulting in final CBI determinations
Cases with all CBI claims subject to review, approved 882
Cases with all CBI claims subject to review, denied 602
Cases with CBI claims subject to review, approved-in-part/denied-in-part 97
Total cases resulting in final CBI determinations 1,581

 

Cases reviewed with no final CBI determination necessary
Cases with all CBI claims screened and found to be exempt from review 1,078
Cases with all CBI claims withdrawn by submitter 430
Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review) 1,500
Total cases reviewed/screened with no final CBI determination necessary 3,008

 

Cases currently undergoing CBI review
Cases currently undergoing CBI review 1,994

 
In August 2020, EPA published an updated list of cases with completed CBI reviews under TSCA Section 14.  The spreadsheet includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 227

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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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