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EPA Publishes TSCA CBI Review Statistics

The U.S. Environmental Protection Agency (EPA) has published statistics concerning its review of confidential business information (CBI) cases received between June 22 2016, and June 25, 2019.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, amended the CBI provisions of the Toxic Substances Control Act (TSCA).  Since then, EPA “has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA's review, and where applicable, determinations on these claims.”  According to EPA, the statistics show EPA's progress toward meeting the requirements of TSCA Section 14(g).  EPA uses “case” to describe a submission made under a specific section of TSCA and all subsequent submissions and amendments by the same submitter that relate back to the first submission. 

CBI Review Statistics (cases received between June 22, 2016 and June 25, 2019)

Cases in which the specific chemical identity is subject to CBI review

2,177

Cases in which information other than the specific chemical identity is subject to CBI review

2,305

Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review

587

Total cases subject to CBI review

5,069

Cases resulting in final CBI determinations

Cases with all CBI claims subject to review, approved

523

Cases with all CBI claims subject to review, denied

5

Cases with CBI claims subject to review, approved-in-part/denied-in-part

34

Cases with all CBI claims subject to review, denial - appeal period pending*

10

Total cases resulting in final CBI determinations

572

 * “Denial - appeal period pending” cases are those for which a CBI determination denying one or more CBI claims in a case has been issued to the submitter of the information, but for which the required 30-day notification period following receipt of the determination under TSCA Section 14(g)(2)(B) has not yet passed.

Cases reviewed with no final CBI determination necessary

Cases with all CBI claims screened and found to be exempt from review

1,068

Cases with all CBI claims withdrawn by submitter

415

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)

1,012

Total cases reviewed/screened with no final CBI determination necessary

2,495

Cases currently undergoing CBI review

Cases currently undergoing CBI review

2,002

EPA states that later this year, it plans to publish a comprehensive list of cases subject to CBI review to be updated quarterly.  The table will include information showing the results of individual cases with completed reviews.

©2019 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

Owner of Bergeson & Campbell, P.C. (B&C®), 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...

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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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