The Society of Toxicology announces the next colloquium presented in conjunction with the FDA Center for Food Safety and Applied Nutrition (CFSAN), “Considerations for the Determination of Adversity in Food Chemical Safety Evaluations” will be March 27, 2017, from 8:30 AM-1:00 PM in Wiley Auditorium on the CFSAN campus in College Park, Maryland. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of FDA employees.
Open to the public to attend in person or via webcast, these events are not a public forum for discussion of toxicology regulatory issues.
Historically, food safety laws and regulations in the United States were aimed to protect against adulteration and microbial contaminations, but have evolved gradually to also address the safety of food ingredients, food additives, and food contact materials. To prevent adversity, broadly defined as “harm to the biological system” guidelines for conducting chemical and toxicological safety assessments have been established to include the evaluation of food compounds intentionally added to foods (such as food additives or novel ingredients), as well as chemicals that unintentionally may become part of foods (such as food contact materials and environmental contaminants). The resulting food safety frameworks, as well as toxicological assessments driving these frameworks, rely in many cases on extrapolations from animal studies to humans and use endpoint-based no observable adverse effect levels (NOAEL) to derive health-based guidance values such as acceptable daily intake (ADI) and tolerable daily intake (TDI).
This colloquium will begin by introducing current concepts underlying determinations of adversity from food compounds utilizing chemical characterization, in vitro or in silico assays, 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.
SOT welcomes participation from our colleagues who are members of American College of Toxicology (ACT).
The colloquium is open to the public to attend in person or via webcast.
Registration: Visit the Colloquium website
Speakers include:
- 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 Adversity 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. Sabine Franke, US FDA, is the co-chair of this colloquium.
Questions from the audience on-site and participating in the webcast are encouraged.
In addition, the recording and materials from the previous sessions as well as additional information can be accessed at the Colloquia website. Questions? Contact Marguerite Leishman at SOT marguerite@toxicology.org, 703.438.8220.