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Regulatory Decision-Making Tools for Novel Food Technologies

Speaker: Jeremiah Fasano, PhD, Senior Policy Advisor, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition at the US Food and Drug Administration

Website | Email | Twitter @FDAfood

Description: 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.

Abstract

The genetic engineering technologies used to produce food ingredients have undergone rapid advances over the last half-century. For example, the first food ingredients derived from transformation of bacteria, fungi, and plants were developed in the 1980s and 1990s. More recently, food scientists have begun to apply traditional engineering principles and innovative precision genome editing to design biology-based ingredient manufacturing systems.

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.

Speaker Bio

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.