Carrie McMahon, Ph.D. Center for Food Safety and Applied Nutrition Office of Food Additive Safety. October 14, 2015
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1 Carrie McMahon, Ph.D. Center for Food Safety and Applied Nutrition Office of Food Additive Safety October 14, 2015
2 FDA s Oversight of Food and Feed Safety food safety requirements how food safety requirements apply to food and feed from genetically engineered crops plant biotechnology consultation programs 2
3 OIP (international) ORA (enforcement) CDER drugs CBER biologics CDRH med. devices CFSAN food cosmetics CVM animal drugs/feed CTP tobacco Office of Food Additive Safety College Park, Maryland 3
4 Food and Drug Administration Federal Food Drug and Cosmetic Act (FD&C Act): protects the public health by requiring the safety and proper labeling of food FDA regulates foods and food ingredients introduced into or sold in interstate commerce food means food or drink for man or other animals food ingredients, whether directly added or food contact materials 4
5 Labeling Labeling must be truthful and not misleading (misbranding) FD&C Act Safety Food must be safe (adulteration) Endogenous Substances Must not contain substances at levels that are harmful Added Substances Ingredients must meet safety criteria, may require FDA review and approval 5
6 Labeling Labeling must be truthful and not misleading (misbranding) FD&C Act Safety Food must be safe (adulteration) Endogenous Substances Must not contain substances at levels that are harmful Added Substances Ingredients must meet safety criteria, may require FDA review and approval Legal without premarket review If safety info is publically available and widely accepted by experts (GRAS) Premarket review and approval required If safety info is NOT publically available or NOT widely accepted by experts 6
7 FD&C Act Endogenous Substances Must not contain substances at levels that are harmful Above 200 milligrams total glycoalkaloid per kilogram of potato Below 200 milligrams total glycoalkaloid per kilogram of potato 7
8 FD&C Act Endogenous Substances Must not contain substances at levels that are harmful Above 200 milligrams total glycoalkaloid per kilogram of potato Below 200 milligrams total glycoalkaloid per kilogram of potato 8
9 FD&C Act Safety Food must be safe (adulteration) Added Substances Ingredients must meet safety criteria, may require FDA review and approval Legal without premarket review If safety info is publically available and widely accepted by experts (GRAS) new sweetener? Premarket review and approval required If safety info is NOT publically available or NOT widely accepted by experts 9
10 FD&C Act Safety Food must be safe (adulteration) Added Substances Ingredients must meet safety criteria, may require FDA review and approval Legal without premarket review If safety info is publically available and widely accepted by experts (GRAS) new sweetener? Premarket review and approval required If safety info is NOT publically available or NOT widely accepted by experts 10
11 FD&C Act Labeling Labeling must be truthful and not misleading (misbranding) Common or usual name Material facts: safety, composition, or usage Historically, plant breeding techniques have not been considered material 11
12 FD&C Act Labeling Labeling must be truthful and not misleading (misbranding) conventional soybean oil 40 GE soybean oil olive oil Oleic acid content 12
13 Statement of Policy (1992): Foods Derived from New Plant Varieties Is the new plant variety intended for use in food or feed? Could it contain an endogenous substance at levels that are harmful? Could it contain an added substance that requires premarket review and approval? Could its composition, safety, or usage be different? 13
14 Statement of Policy (1992): Foods Derived from New Plant Varieties Endogenous substances Added substances Labeling??? 14
15 New Protein Consultation (NPC) Purpose? To evaluate safety of new proteins prior to inadvertent entry into food supply Biotechnology Final Consultation (BNF) To resolve safety, nutritional, and regulatory issues prior to marketing When to consult? What is considered? During development when the new protein could inadvertently enter food supply Information about protein (potential for toxicity or allergenicity) After the developer has completed its safety assessment, prior to marketing Information about endogenous and added substances 15
16 Developer submits safety and regulatory assessment FDA team of experts evaluates the data and information FDA requests additional information as needed Repeat until safety and regulatory questions are resolved FDA summarizes evaluation in a memo FDA ends the consultation by sending a letter to the developer 16
17 Biotechnology Final Consultation Basic Information: plant, DNA donor, intended modification, intended use Endogenous Substances New Protein Consultation Added Substances Labeling 17
18 Biotechnology Consultations on Food from GE Plant Varieties 18
19 FDA s Consultation Processes: Consultation with FDA is voluntary - no fees The FD&C Act places a legal burden on those who develop and sell food to ensure the food is safe - compliance is mandatory Consultation protects the public health ensures safety and regulatory issues are resolved before the product enters the food supply without being needlessly burdensome Consultation builds consumer confidence ensures transparency of the safety and regulatory conclusions 19
20 Internet: FDA FDA India Office Biotech Program... NPC Program... 20
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