TSCA Confidential Business Information and Generic Naming Conventions: Analyzing the New Rules
Tracy C. Williamson, Ph.D., Chief, Industrial Chemistry Branch, Chemistry, Economics, and Sustainable Strategies Division, Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
Scott M. Sherlock, Senior Attorney, Environmental Assistance Division, OPPT, EPA
Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C.
Protecting confidential business information (CBI), including chemical identity, has never been easy but remains an essential component of a successful commercial chemical strategy. New Toxic Substances Control Act (TSCA) Section 14 is much more prescriptive about what can and cannot be protected and what submitters must do to substantiate CBI to withstand scrutiny. Importantly, TSCA Section 14(c)(4) required EPA to develop guidance to assist stakeholders in determining structurally descriptive generic names to protect specific chemical identity from disclosure. On June 21, 2018, EPA issued guidance updating and replacing the 1985 guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act. While the new guidance is not fundamentally different from the 1985 version, there are important changes.
This complimentary, hour-long webinar will focus on what’s new, what’s not, and how best strategically to create generic names to protect specific chemical substance identity.
Topics to be covered include an overview of the obligations of submitters claiming CBI, the limits of what may be protected, how to develop a suitable generic name, the criteria upon which EPA relies in determining what constitutes an acceptable name, how best to address class II organic chemical substances, chemical substances of unknown or variable composition, complex reaction products and biological materials (UVCB), and inorganic substances and, most importantly, what is at stake commercially for not understanding the new rules of the game.