Bergeson & Campbell, P.C. (B&C®) is pleased to present “What’s New with New Approach Methodologies: A Webinar.” New Approach Methodologies (NAM) are being increasingly used throughout the field of toxicology due to scientific, logistical, and ethical advantages, as well as legal requirements. The U.S. Environmental Protection Agency (EPA), as directed by the 2016 amendment to the Toxic Substances Control Act (TSCA), is required to “reduce and replace…the use of vertebrate animals in the testing of chemical substances or mixtures; and promote the development and timely incorporation of alternative test methods or strategies that do not require new vertebrate animal testing.”
This complimentary 90-minute webinar features experts in the toxicology field discussing the state of play as stakeholders take advantage of these new approaches. Adam Bettmann, MS, DABT®, a Toxicology Specialist representing PETA Science Consortium International e.V., navigates the current state of NAMs and their use for submissions to the Office of Pollution Prevention and Toxics (OPPT) by providing an overview of some of the relevant guideline and non-guideline testing approaches, the process of vetting NAMs for readiness, and available training and educational opportunities. Katie Paul Friedman, Ph.D., Acting Director for the Biomolecular and Computational Toxicology Division in the Center for Computational Toxicology and Exposure (CCTE) in EPA’s Office of Research and Development (ORD), provides an overview of the TSCA New Chemicals Collaborative Research Program (NCCRP) as the lead within the ORD. An overview of the proposed research plan and its components (as presented to the U.S. EPA ORD Board of Scientific Councilors in late 2022) is followed by descriptions of early works in progress and publications related to this effort.* Richard E. Engler, Ph.D. wraps up these issues with an overview of TSCA Section 4 authority and chemical testing issues.
*The views expressed in this abstract and presentation are those of the authors and do not necessarily reflect the views or policies of EPA or the institutions associated with co-authors on works described.
For more information or for resources from the webinar, contact Emily Scherer at escherer@lawbc.com.
Speakers:
Katie Paul Friedman, Ph.D. is Acting Director for the Biomolecular and Computational Toxicology Division in the Center for Computational Toxicology and Exposure (CCTE) in the Office of Research and Development (ORD) at EPA, where she has worked since 2016. Dr. Paul Friedman is the lead within ORD for the New Chemicals Collaborative Research Program (NCCRP). Her broad computational research portfolio demonstrates application of new approach methods to chemical safety assessment. She is a subject matter expert for the ToxCast program. Previously, Dr. Paul Friedman was a regulatory toxicologist at Bayer. She is active in multi-stakeholder projects to develop alternatives and their acceptance, including through technical leadership at Federal Advisory Committee reviews and in the consortium Accelerating the Pace of Chemical Risk Assessment. Her previous laboratory background includes development of high-throughput screening assays and combined use of in vitro and in vivo approaches. Dr. Paul Friedman received a Ph.D. in Toxicology from the University of North Carolina at Chapel Hill and has authored more than 65 peer-reviewed publications and mentored over 18 early career trainees.
Adam Bettmann, MS, DABT® is a Toxicology Specialist representing PETA Science Consortium International e.V. where he has worked for the past year to advance non-animal approaches to toxicology testing. Prior to joining the Science Consortium, Mr. Bettmann spent 13 years working as a toxicologist and laboratory study director for a Fortune 100 company where he implemented, performed, and oversaw the testing of a wide variety of industrial chemicals using multiple in vitro toxicology test methods. Mr. Bettmann received his MS in Regulatory Toxicology from the University of Minnesota School of Public Health and is a Diplomate of the American Board of Toxicology.
Richard E. Engler, Ph.D. is Director of Chemistry with B&C. Dr. Engler 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 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&Cclients as they develop and commercialize novel chemistries.
Lynn L. Bergeson, Managing Partner of B&C, has earned an international reputation for her deep and expansive understanding of TSCA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, 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 allow her to develop client-focused strategies whether advocating before Congress, EPA, the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.