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EPA Releases Additional Approach for Assigning and Applying “Unique Identifiers”

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) announced it is releasing a third alternative approach for assigning and applying unique identifiers (UID) to reconcile the competing requirements of Toxic Substances Control Act (TSCA) Section 14(g) for comment.  83 Fed. Reg. 5623.  EPA’s first and second alternative approaches were released for comment in its notice on May 8, 2017 (82 Fed. Reg. 21386).  Under amended TSCA, EPA is required to develop a system to assign a “unique identifier” whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance, to apply this unique identifier to other information concerning the same substance, and to ensure that any non-confidential information received identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure.

Under the third alternative approach, EPA would assign one UID per chemical substance.  EPA states that in most cases it would apply the UID to all non-confidential information concerning the same chemical substance from any company except in cases where doing so might reveal the identity of confidential substance.  In those cases, which EPA expects to be rare, EPA would not apply the UID to non-confidential documents if doing so would result in a linkage that undermines the CBI claim.  EPA reiterates that the basic criterion for application of the UID to submissions made by different submitters is that EPA’s act of applying the UID must not disclose to the public the confidential specific chemical identity that the UID was assigned to protect.

©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...

202-557-3801
Richard Engler PhD, Bergeson Campbell Law Firm, Senior Chemist
Senior Chemist

Richard E. Engler, Ph.D. is Senior Chemist with Bergeson & Campbell, P.C.  Dr. Engler is a 17-year veteran of the U.S. Environmental Protection Agency (EPA) and is one of the most widely recognized experts in the field of green chemistry, having served as senior staff scientist in EPA's Office of Pollution Prevention and Toxics (OPPT) and leader of EPA's Green Chemistry Program.  He has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, as well as pre-notice and post-review meetings with submitters to resolve complex or difficult cases, and he draws upon this invaluable experience to assist B&C clients as they develop and commercialize novel chemistries. 

Dr. Engler's expansive understanding of the specific challenges and opportunities TSCA presents for green and sustainable chemistry is a powerful asset for clients during regulatory review.  He assists clients in performing toxicological reviews, performing environmental fate modeling using Sustainable Futures tools, and preparing scientific and test data for regulatory submission.  He is particularly skilled in preparing Pollution Prevention (P2) statements to highlight the concrete environmental benefits of biobased or renewable chemicals, as well as other sustainable chemistry products and processes.

202-557-3808