Bergeson & Campbell, P.C. (B&C®) is pleased to present “TSCA CBI Re-substantiation: When, Why, and How to Prepare.” The Toxic Substances Control Act (TSCA) provides critical protections for commercially sensitive information related to a company’s business, processes, and chemicals. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments included a ten-year cap on many confidential business information (CBI) claims, absent a U.S. Environmental Protection Agency (EPA)-approved extension request. As a result, these CBI claims will begin to expire on a rolling basis in June 2026 unless further reasserted and re-substantiated.
B&C has been tracking this important provision closely, including how EPA intends to provide the statutorily-required notices of expiring CBI claims; the systems, processes and criteria to request and substantiate an extension; and the practical steps companies should be taking now to prepare. During this webinar, Richard E. Engler, Ph.D., Director of Chemistry, B&C; Ryan N. Schmit, Of Counsel, B&C; and Lynn L. Bergeson, Managing Partner, B&C, will discuss EPA’s implementation efforts to date and the significant implications these provisions will have on the regulated community moving forward.
Topics Covered:
- Background on CBI Expiration Provisions in TSCA
- Process and Criteria for Requesting and Substantiating an Extension
- Practical Tips for Companies to Prepare Now
- Frequently Asked Questions
Speakers:
Richard E. Engler, Ph.D., Director of Chemistry, B&C, is a 17-year veteran of EPA and is one of the most widely recognized experts on TSCA, with over 25 years’ experience engaged in interpretation and implementation of this complicated yet foundational law for American innovation and productivity. He participated in thousands of 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.
Ryan N. Schmit, Of Counsel, B&C, has substantial expertise and experience on TSCA, including more than 15 years in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). During his tenure at EPA, Mr. Schmit supported congressional efforts leading to the pivotal 2016 TSCA amendments and worked on the front lines of EPA’s TSCA implementation efforts, including significant and precedent-setting policy matters; the establishment of TSCA procedural frameworks; new chemical premanufacture reviews; the prioritization, evaluation, and management of existing chemicals; TSCA-related litigation; and more. Mr. Schmit assists clients with understanding regulatory complexities and developing and defending robust compliance strategies.
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters. She served as chair of the American Bar Association (ABA) Section of Environment, Energy, and Resources and as chair of the International Bar Association (IBA) Agriculture and Food Section. She has served on the Board of Directors of the Environmental Law Institute (ELI), the NanoBusiness Commercialization Association, and is a recent past President of the Product Stewardship Society. Ms. Bergeson is a Fellow of the American College of Environmental Lawyers (ACOEL) and serves as a Regent and on its Executive Committee.
