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EPA Announces Section 5 Notices to Be Posted without EPA Review – Filers Should Be Extra Diligent about Proper CBI Redactions

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the CDX reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.

©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