2018 Chemical Policy Summit Series Part IV: TSCA Confidential Business Information and Generic Naming Conventions: Analyzing the New Rules

Date / Time

Venue

This is a virtual event, accessible on-line and over phone. Access instructions will be provided after registration.

Description

This is a complimentary program sponsored by Bergeson & Campbell, P.C.  

This is Part 4 of the 5-part 2018 Chemical Policy Summit Series.  To learn more about the series, please click here.

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, the U.S. Environmental Protection Agency (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.

Educational Objectives:

• Understanding key legal, regulatory, and scientific issues associated with CBI claims, including generic names; 
• Hearing directly from EPA leaders on how best to create generic names; and
• Enhancing the chemical community’s understanding of the new rules of engagement in generic naming practices and, thus, avoiding mishaps.

Who would benefit most from attending this program?

Executives, business leaders, in-house counsel, outside counsel, and legal professionals working within EHS, sustainability, and related fields.

Presenters

Richard E. Engler, Ph.D.
  • Director of Chemistry
  • Bergeson & Campbell, P.C.

Richard E. Engler, Ph.D. is Director of Chemistry with Bergeson & Campbell, P.C. (B&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.

Tracy C. Williamson, Ph.D.
  • Chief, Industrial Chemistry Branch, Chemistry, Economics, and Sustainable Strategies Division
  • EPA Office of Pollution Prevention and Toxics

Scott M. Sherlock
  • Senior Attorney, Environmental Assistance Division
  • EPA Office of Pollution Prevention and Toxics

Continuing Education

Credits:
1.0 General COA, 1.0 CLE
Practice Areas:
EHS
Prerequisite:
A basic understanding of the TSCA.
Level:
Intermediate
Production Date:
09/18/2018