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SOT FDA Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety

Alternative Toxicological Approaches for Process-Formed Constituents in Food

January 19, 2023 • Webcast • 9:00 AM–1:00 PM Eastern US, UTC -5

Co-Chairs: Steven J. Hermansky, Pharm D, PhD, DABT, FDA CFSAN; and Paul Hanlon, PhD, DABT, Abbott Nutrition

The Society of Toxicology (SOT) in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The colloquia present scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees. These webcasts are open to the public at no charge. These sessions are not a public forum for discussion of toxicology regulatory issues.

Webcast Registration
A plate of french fries

Compounds such as acrylamide, 4-MEI, furan, PAH, and 3-MCPD created during food processing including cooking at home have been identified as constituents of food. Hundreds of such process-formed compounds have been identified in food, and improvements in analytical methodology are likely to lead to identification of more in the future. While the discovery of these compounds in food has been relatively recent, it is recognized that most have been a component of food for centuries. Never-the-less, there is increasing interest to understand the potential human health risk associated with these compounds and using risk-based prioritization, developing techniques to reduce or eliminate compounds from the diet that could be expected to pose risk to consumers. Experience with acrylamide and other process-formed compounds demonstrate that the resources expended for traditional toxicology studies are not practical for the high number of these compounds known to exist in food. Furthermore, when compounds such as these are found unexpectedly in the diet, there can be a need for a rapid risk assessment that would benefit from methods that can be executed faster than traditional in vivo methods. Thus, these compounds represent an interesting test case to leverage New Approach Methods (NAMS) to help risk assessors and regulators better understand the biological effects of these compounds and prioritize them for additional investigation. This colloquium brings together researchers, risk assessors, and regulators to discuss opportunities to leverage a mixture of traditional testing and NAMS to help solve real-world, complex toxicology problems.

9:00 AM–9:10 AM

Welcome
Kristi Muldoon Jacobs, Current Director, US FDA Office of Food Safety; and Dori Germolec, SOT Vice President, NIEHS-NTP, Durham, NC

9:10 AM–9:25 AM

Introduction of Topic and Speakers
Steven Hermansky, Pharm D, PhD, DABT, US FDA CFSAN, College Park, MD

9:25 AM–9:55 AM

Analytical Challenges Related to the Analysis of Processing Contaminants in Foods and Impacts on Risk Assessment
Jessica Beekman, PhD, US FDA CFSAN, College Park, MD

9:55 AM–10:30 AM

Next Generation Systemic Toolbox
Matthew Dent, PhD, IDT, Unilever, Sharnbrook, UK

10:30 AM–10:40 AM

Break

10:40 AM–11:05 AM

Codex Alimentarius: Guidelines for Rapid Risk Analysis Following Instances of Detection of Contaminants in Food Where There Is No Regulatory Level
Lauren Robin, PhD, US FDA CFSAN, College Park, MD

11:05 AM–11:35 AM

The Challenge of Assessing Minor Constituents: An Example from the Flavor Industry
Sean Taylor, PhD, Verto Solutions, Washington, DC

11:35 AM–12:00 Noon

Summary and Current Challenges of New Approach Methods for Industry
Paul Hanlon, PhD, DABT, Abbott Nutrition, Columbus, OH

12:00 Noon–1:00 PM

Roundtable Discussion
Moderator: Paul Hanlon
Panelists: Speakers and Suzanne Fitzpatrick, PhD, US FDA CFSAN, College Park, MD

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For registration questions contact Jim Dailey.

Paul Hanlon

Paul Hanlon, PhD, DABT, Co-Chair

Dr. Paul Hanlon earned his doctorate in molecular toxicology from the University of Wisconsin Madison and is Diplomate of the American Board of Toxicology. After postdoctoral work at the National Institute of Environmental Health Sciences, he has worked as a toxicologist in both the pharmaceutical and food industries.

Dr. Hanlon is currently a Director of Regulatory Affairs at Abbott Nutrition where his primary roles are overseeing the regulatory approvals of novel food ingredients as well as providing guidance to food safety programs that govern the control of chemical contaminants. He has developed, managed, and interpreted the toxicology studies conducted in support novel food approvals in multiple countries, including the United States, Canada, Taiwan, and Malaysia. He has also participated in the creation of regulatory guidance and maximum levels with regulatory agencies, including serving as a delegate to the Codex committees managing chemical contaminants and food additives.

Dr. Hanlon is active in the food toxicology community and over the past years has published multiple papers on the risk assessment of food substance, as well as given presentations on these topics to audiences around the world. He has been a member of the Toxicology Forum planning committee for two years, in which time he has coordinated and given presentations at several sessions on a range of topics.

Steven Hermansky

Steven Hermansky, Pharm D, PhD, DABT, Co-Chair

Dr. Steven J. Hermansky joined US FDA in April 2022 to help the agency evaluate and move to New Alternative Methods in their continuing effort to reduce, refine, and even replace animal use in toxicology. Previously Dr. Hermansky worked at Conagra Brands beginning in 2007. He directed and oversaw the corporation’s toxicology and product safety risk assessment programs as well as headed the Food Protection, Regulatory Affairs, and Analytical and Applied Sciences departments. In these roles, Dr. Hermansky led teams of scientists in the safety sciences including microbiology, toxicology, and analytical chemistry as well as directing global regulatory affairs and food safety corporate audit functions. Prior to joining Conagra, he worked in the pharmaceutical industry as a toxicologist with responsibilities in drug safety clinical trials and adverse event tracking, trending, and reporting. He started his career as a toxicologist conducting contract laboratory animal studies with Union Carbide.

Dr. Hermansky has a Doctor of Pharmacy degree as well as Master of Science and Doctor of Philosophy degrees in toxicology from the University of Nebraska. He is a Diplomate of the American Board of Toxicology and has published over 40 textbook chapters, peer reviewed publications, and scientific abstracts. He is an adjunct professor at the University of Nebraska College of Public Health and has served on the advisory or editorial boards of several organizations.

Jessica Beekman

Jessica Beekman, PhD, Speaker

Dr. Jessica Beekman is a Research Chemist in the Office of Regulatory Science at the Center for Food Safety and Applied Nutrition (CFSAN) within the US Food and Drug Administration. Her work focuses on the development of analytical methods for the analysis of chemical contaminants in food products. In particular, Jessica has spent the last seven years on the development of methods for the analysis of monochloropropanediol (MCPD) and glycidyl esters in infant formula and other processed foods. She has authored numerous publications regarding MPCD and glycidyl esters research and has presented her work at meetings and conferences worldwide.

Dr. Beekman received her PhD in Inorganic Chemistry from the University of Florida in 2014. She completed postdoctoral fellowships in the College of Pharmacy at the University of Florida and the Center for Food Safety and Applied Nutrition (CFSAN) at the US FDA.

Lauren Robin

Lauren Robin, ScD, Speaker

Dr. Lauren Posnick Robin is Chief of the Plant Products Branch, Office of Food Safety, at US FDA. From October-December 2022, she is on detail as Acting Branch Chief, Scientific Development Branch, Office of Food Additive Safety, US FDA. Dr. Robin is also the US Delegate to the Codex Committee for Contaminants in Foods, representing the United States in international discussions on chemical contaminants. She has a BA in Biology from Swarthmore College and an ScD in Molecular and Cellular Toxicology from the Harvard School of Public Health. She was an AAAS Risk Policy Fellow at US FDA from 1999–2000.

Matthew Dent

Matthew Dent, PhD, IDT, Speaker

Dr. Matthew Dent is a science leader in Unilever’s Safety and Environmental Assurance Centre. Matt started his career as a study director for reproductive and developmental toxicology studies before joining Unilever in 2004. His current role focuses on leading research into novel (non-animal) approaches for systemic toxicology risk assessment and their application. He has served in various international task forces and working groups including with the OECD, ECVAM and Cosmetics Europe, and is currently the industry co-chair of the International Cooperation on Cosmetics Regulation’s Joint Regulators-Industry Working Group on Integrated Approaches to Safety Assessment of Cosmetics. He has published several peer-reviewed papers predominantly concerned with the development and application of new approaches in toxicological risk assessment.

Matt received his PhD from Lancaster University following research into performing non-animal (next generation) safety assessments for anti-androgenic substances and holds the International Diploma in Toxicology.

Sean V. Taylor

Sean V. Taylor, PhD, Speaker

Dr. Sean V. Taylor is the Scientific Director of the International Organization of the Flavor Industry, the Scientific Secretary to the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA), the Senior Science Advisor to the International Association of Color Manufacturers, and is a Managing Director of Verto Solutions, a trade association management and scientific consulting firm based in Washington, DC.

Dr. Taylor’s work with food ingredients is broadly focused in toxicology, and over the years he has worked to address requests for data on flavorings and color additives made by the European Food Safety Authority (EFSA) and the UN FAO/WHO Joint Expert Committee on Food Additives (JECFA), among others. As the Scientific Secretary to the FEMA Expert Panel, Dr. Taylor administers the FEMA Generally Recognized as Safe (GRAS) program. Through his work with the FEMA GRAS program and the color additive and flavor industries, Dr. Taylor has co-authored publications describing genetic toxicity and repeat-dose toxicity studies, but also foundational publications that describe refinements in the use of chemical grouping, read across, and exposure assessment for flavor safety evaluation.

Dr. Taylor received a bachelor’s degree in Chemistry from Pennsylvania State University in 1992, a master’s degree from Cornell University in 1995, and a PhD in Chemistry from Cornell in 1998. From 1998-2002, he conducted postdoctoral research in the Laboratory of Organic Chemistry at the Swiss Federal Institute of Technology in Zürich, Switzerland. Dr. Taylor was an Assistant Professor in the Department of Chemistry at The Ohio State University from 2002 to 2005 before beginning his work with the food and food ingredient industries. .

Suzanne Fitzpatrick

Suzanne Fitzpatrick, PhD, DABT, Panelist

Dr. Suzanne Fitzpatrick is the Senior Advisor for Toxicology at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). A board-certified toxicologist in the US and in Europe, Dr. Fitzpatrick is the FDA lead for the federal collaboration among FDA, EPA, and NIH. She also has lead Toxicology Testing in the 21st Century (Tox 21), which looks to develop alternatives to animal testing, and chaired the FDA Predictive Toxicology Roadmap Committee. Dr. Fitzpatrick played a pivotal role in helping launch the organs-on-a-chip tool, a revolutionary testing technology being evaluated by FDA. Dr. Fitzpatrick is an adjunct professor at Johns Hopkins University, the FDA representative to the Johns Hopkins Center for Alternatives to Animal Testing Board, and past president of the American College of Toxicology. She served as the Society of Toxicology (SOT) Secretary and as president of the SOT National Capital Area Chapter. Dr. Fitzpatrick received her BA from the University of California at San Diego and her PhD from Georgetown University.

  • Stephen W. Edwards, PhD, 2022-2023 Colloquium Series Chair, RTI International, Chapel Hill, NC
  • David C. Dorman, DVM, PhD, DABT, DABVT, ATS, 2022–2023 Colloquium Series Co-chair, North Carolina State University, Raleigh, NC
  • Udayan M. Apte, PhD, DABT, University of Kansas Medical Center, Kansas City, KS
  • Jason L. Aungst, PhD, FDA Liaison, US FDA, College Park, MD
  • Omari Bandele, PhD, US FDA, Rockville, MD
  • Suzanne C. Fitzpatrick, PhD, DABT, US FDA, College Park, MD
  • Paul Hanlon, PhD, DABT, Abbott Nutrition, Columbus, OH, Colloquium Co-Chair
  • Steven J. Hermansky, Pharm D, PhD, DABT, FDA CFSAN, College Park, MD, Colloquium Co-Chair
  • Willie McKinney, PhD, DABT, McKinney Regulatory Science Advisors, LLC, Henrico, VA
  • Jason R. Richardson, PhD, DABT, ATS, Florida International University, Miami Beach, FL
  • Jeffrey J. Yourick, PhD, DABT, ATS, US FDA, Laurel, MD
  • Christine Perdan Curran, PhD, Council Contact, Northern Kentucky University, Highland Heights, KY
  • Betty Eidemiller, PhD, SOT Staff, Reston, VA