Genetic Engineering and Society Center

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Regulatory Decision-Making Tools for Novel Food Technologies

While the sections of the Federal Food, Drug, and Cosmetic Act governing food ingredient regulation have remained largely unchanged since the passage of the Food Additives Amendment of 1958, the FDA has shown that it is able to effectively regulate ingredients manufactured using new technologies under these existing broad statutory authorities to ensure the safety of substances added to food. As emerging technologies are adopted in food ingredient production, FDA’s Office of Food Additive Safety will continue to rely on these long-standing statutory authorities in combination with policy and scientific knowledge to regulate the safe use of food ingredients. To illustrate how the agency has developed science-based policy within its authority under existing federal law as science and technology evolve, we will describe the 1992 Policy Statement: Foods derived from new plant varieties and the 2014 Guidance to Industry: Assessing the effects of significant manufacturing process changes, including emerging technologies, on the safety and regulatory status of food ingredients and food contact substances

Guest Speaker

Dr. Jeremiah Fasano is a Senior Policy Advisor in the Office of Food Additive Safety’s Regulatory Review Branch at the Center for Food Safety and Applied Nutrition. He has worked on a variety of issues during his time at CFSAN, including premarket safety evaluation of new food ingredients, assessment of genetically engineered new plant varieties, strategies for tracking sodium reduction in the US food supply, and development of safety assessment frameworks for new food technologies and functionalities. He received his doctorate in plant cell physiology and molecular biology from the Pennsylvania State University.

Links & Resources - Office of Food Additive Safety, Center for Food Safety and Applied Nutrition at the US Food and Drug Administration https://www.fda.gov/about-fda/fda-organization/center-food-safety-and-applied-nutrition-cfsan

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