This colloquium will begin by introducing current concepts underlying determinations of adversity from food compounds utilizing chemical characterization, in vitro or in silicoassays, as well as animal and human toxicology studies. Second, the definitions of adversity (harm) will be considered in the context of the laws and regulations that apply to foods and food ingredients. Third, a case study on low calorie sweeteners will be provided to illustrate determinations of adversity by describing what data were used in the assessment of safety. Fourth, alternatives to the current frameworks for adversity determinations will be discussed in terms of their strengths and weaknesses considering a toxicological, decision-making and public perspective. Finally, the colloquium will conclude with a panel discussion addressing the key issues brought up by the speakers and questions from participants.
Considerations for the Determination of Adversity in Food Chemical Safety Evaluations
March 27, 2017
8:30 am–12:50 pm ET (GMT-5)
Wiley Auditorium, US FDA, College Park, Maryland
Register for on-site participation by March 10, 2017
Register to participate in the webcast
The SOT FDA Food Safety Colloquia present scientific training that is high quality, cutting-edge, future-oriented toxicological science for US FDA employees and are open to the public at no cost. However, the colloquia are not a public forum for discussion of toxicology regulatory issues.
Adversity in Regulatory Science: Historical Perspective and Future Challenges
Nigel Walker, National Institute of Environmental Health Sciences, Research Triangle Park, NC
When is Adversity Legally Cognizable?
Ricardo Carvajal, Hyman, Phelps & McNamara PC, Washington, DC
No Observed Adverse Effect Level: Sucralose as a Case Study
Bernadene Magnuson, Health Science Consultants, Inc., Mississauga, ON, Canada
New Approaches to Toxicological Risk Assessment in Food Safety Evaluation
Daniel Krewski, University of Ottawa, Ottawa, ON, Canada
The speakers will conclude the event with a roundtable discussion moderated by colloquium chair, Bernadene Magnuson, Health Science Consultants, Inc., Mississauga, ON, Canada. Questions from the audience on-site and from those participating in the webcast are encouraged. Sabine Francke, US OFAS/CFSAN/FDA, is the co-chair of this colloquium.
Recordings and slides from the previous colloquia are available free via the SOT FDA Colloquia website, including the most recent session, the December 1, 2016, “In Vitro toIn Vivo Extrapolation in Safety Assessment.”