Wednesday, August 3, 2022
12:00 p.m. - 1:00 p.m. (EDT)
The 2016 amendments to the Toxic Substances Control Act (TSCA) require the U.S. Environmental Protection Agency (EPA) “to reduce and replace” vertebrate animals to the extent practicable, scientifically justified, and consistent with TSCA policies. EPA is also required to “develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures.”
These are tall orders, and EPA has worked hard to fulfill Congress’s expectations. This webinar will:
- Highlight examples of EPA’s use of non-vertebrate testing strategies, commonly referred to as “new approach methodologies” or NAMs, in its evaluation of new and existing chemical substances under TSCA Sections 5 and 6, respectively;
- Provide examples of successful collaborations between EPA and external partners to advance the understanding and use of NAMs for informing regulatory scientific questions;
- Provide perspectives from former EPA scientists and non-governmental organization scientists on the types of data needs required to advance the acceptance and use of NAMs over existing vertebrate alternatives; and
- Provide a proposed roadmap for engaging EPA scientists on the types of questions EPA scientists will likely ask when considering proposals for utilizing NAMs as part of regulatory filings.
Register now to join Lynn L. Bergeson, Richard E. Engler, Ph.D., James W. Cox, M.S., and Kristie Sullivan, MPH, as Bergeson & Campbell, P.C. (B&C®) presents “TSCA New Approach Methodologies.”
Lynn L. Bergeson, Managing Partner, B&C, has earned an international reputation for her deep and expansive understanding of how regulatory programs pertain to industrial biotechnology, synthetic biology, and other emerging transformative technologies. She 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.
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 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 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.
James W. Cox, M.S., Senior Scientist, B&C, developed risk assessments and advised on hazard characterization processes under TSCA while working as Acting Lead Biologist in EPA’s OPPT New Chemicals Division. While at EPA, he helped develop a framework to complete risk assessments for novel petroleum alternatives and evaluated the hazard and risks to human health from exposure to industrial chemicals, biological agents, and nanomaterials.
Kristie Sullivan, MPH is the Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), a nationwide organization of physicians and laypersons that promotes preventive medicine and ethics in research. As Vice President of Research Policy, Ms. Sullivan directs PCRM’s efforts to promote human-relevant alternatives to the use of animals in medical research, education, and the testing of drugs, chemicals, and other products through scientific scholarship and outreach to companies, federal agencies, legislators, and others. Ms. Sullivan has 15 years’ experience in legislative, policy, science, and training activities related to the implementation of New Approach Methodologies, including by engaging with EPA, the Organization for Economic Cooperation and Development, and the regulated industry.