Reviewing New Chemicals under Amended TSCA: Impact on Innovation

Price: $0 OnDemand

Meet The Speakers

Jeffery Morris, Ph.D.
Director, Office of Pollution Prevention and Toxics, United States Environmental Protection Agency
Charles M. Auer
Senior Regulatory and Policy Advisor, Bergeson & Campbell P.C.
Richard E. Engler
Ph.D., Senior Chemist, Bergeson & Campbell P.C.
Lynn L. Bergeson
Managing Partner, Bergeson & Campbell P.C.
Beth D. Bosley
President, Boron Specialties LLC
Robert Mott
Manager, Global Regulatory, Sun Chemical Corporation


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

Bergeson & Campbell, P.C. Horizontal

Since enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act last June a logjam of new chemicals under review at EPA unable to enter commerce developed. EPA's Office of Pollution Prevention and Toxics is adjusting to new requirements in the 2016 amendments to the nation’s primary chemicals law, the Toxic Substances Control Act, and making progress in diminishing the backlog.

Former EPA officials have analyzed the types of decisions the Agency is considering making for these new chemicals, the types of toxicity data being requested, and the marked change that represents from past practice.

The panel will discuss those findings and the challenges facing small and large chemical manufacturers as well as their customers. They will offer suggestions for companies, trade associations, and EPA. The goal is to ensure new chemicals are responsibly reviewed, but continue bringing innovative chemicals to market.

Educational Objectives:
• EPA’s prior practices for reviewing new chemicals
• What new requirements the 2016 TSCA amendments established
• EPA’s interpretation of the amendments and what it means for the chemical review process
• What you can do to ensure a better chance at getting your chemical to market

Who would benefit most from attending this program?
Small and large chemical manufacturers and the trade associations that serve them; downstream customers; retailers, OEMs (original equipment manufacturers); consultants, attorneys; and government affairs representatives.

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Jeffery Morris, Ph.D., Director, Office of Pollution Prevention and Toxics, United States Environmental Protection Agency

Jeffery Morris is director of the United States Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), which regulates chemicals under the Toxic Substances Control Act as well as administers the Pollution Prevention Act. Dr. Morris has been with the EPA since 1992. Prior to his current position, Dr. Morris was OPPT’s deputy director.  Before coming to OPPT, he served as the National Program Director for Nanotechnology, responsible for managing EPA’s Nanomaterials Research Program in EPA’s Office of Research and Development (ORD). Prior to his position as the National Program Director for Nanotechnology, Dr. Morris served as the Acting Director in the ORD Office of Science Policy.

Charles M. Auer, Senior Regulatory and Policy Advisor, Bergeson & Campbell P.C.

For more than three decades, Charles M. Auer, Senior Regulatory and Policy Advisor with Bergeson & Campbell, P.C. (B&C®), has provided sagacious, informed, and deeply insightful guidance on legal, policy, and scientific matters related to the regulation of chemicals under the Toxic Substances Control Act (TSCA) and related domestic and international chemical control laws.  Mr. Auer’s experience includes over 32 years at the U.S. Environmental Protection Agency (EPA), most recently as the Director of the Office of Pollution Prevention and Toxics (OPPT), responsible for implementation of TSCA. He offers clients a truly exceptional level of policy and technical expertise in domestic and international chemical regulation, including chemical testing, assessment, and management of new and existing chemicals under TSCA; strategies for compliance with major U.S. trading partners and under multilateral environmental agreements such as the Stockholm Convention; approaches such as green chemistry, pollution prevention, Safer Choice, and other safer substitutes to meet corporate product stewardship goals; and commercialization of products from emerging chemical technologies, including nanotechnology, synthetic biology, and intergeneric microorganisms.


Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell P.C.

Richard E. Engler, Ph.D. is Senior Chemist 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.

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.

Lynn L. Bergeson, Managing Partner, Bergeson & Campbell P.C.

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 process allows her to develop client-focused strategies whether advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

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 pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

Beth D. Bosley, President, Boron Specialties LLC

Few people globally have Beth Bosley's experience and expertise in the product and process development, large-scale manufacture, and hazard characteristics of polyhedral boranes, borane complexes, and organoborane compounds.

Boron Specialties is a member of the Society of Chemical Manufacturers and Affiliates. Beth led SOCMA’s regulatory committee and served as its representative to the US EPA. In partnership with SOCMA, Beth Bosley has testified several times before the United States House of Representatives and the U.S. Senate in relation to reform of the Toxic Substances Control Act.

Before starting Boron Specialties in 2010, she had twenty years in specialty chemical manufacturing, pilot operations, and in technical marketing and business development targeting both pharmaceutical and industrial markets. Beth earned her chemistry degree from UCLA under noted boron scientist & National Medal of Science winner Prof. M. Frederick Hawthorne.

Robert Mott, Manager, Global Regulatory, Sun Chemical Corporation

Robert Mott has been in the color business for more than 35 years. After graduating from Michigan Technological University with a B.S. in Chemistry and a Ph.D. in Chemistry from the University of Idaho he completed a one year Post-Doc at Virginia Tech. On joining the Bayer Corporation organization Mott worked in various roles in the Development Laboratory starting with dyes and progressing to pigments and their intermediates, he then moved into Manufacturing Support covering strategic supply and product costing issues and then returned to the laboratory as the head of Analytical R&D.