4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US EPA EPA Toxic Substance Control Act Follow the quidelines of the US Federal enables EPA to regulate commercialization Insecticide,Fungicide,and Rodenticide of GM organisms that possess pesticidal Act activities controls allowable residues levels of requires EPA to review and issue a permit herbicides in areas planted with GM- for field testing of a protectant>10 derived herbicide resistant crops hectares of land before commercialization,EPA reviews the application and asks for public opinion and scientific expert feed-back Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA ensures the food safety and wholesomeness for follows the guidelines of the Food,Drug all foods excluding those regulated by the USDA and Cosmetic Act of 1938 agencies that regulate GM foods has authority to remove by seizure and Center for Food Safety and Applied forced recall any food that does not Nutrition meet the safety standards Center for Veterinary Medicine relies on companies to notify them Center for Drug Evaluation and Research before marketing new items
4/6/2017 6 Regulation of GM Foods in the US EPA • Follow the guidelines of the US Federal Insecticide, Fungicide, and Rodenticide Act - controls allowable residues levels of herbicides in areas planted with GMderived herbicide resistant crops Regulation of GM Foods in the US EPA • Toxic Substance Control Act - enables EPA to regulate commercialization of GM organisms that possess pesticidal activities - requires EPA to review and issue a permit for field testing of a protectant > 10 hectares of land - before commercialization, EPA reviews the application and asks for public opinion and scientific expert feed-back Regulation of GM Foods in the US FDA • ensures the food safety and wholesomeness for all foods excluding those regulated by the USDA • agencies that regulate GM foods - Center for Food Safety and Applied Nutrition - Center for Veterinary Medicine - Center for Drug Evaluation and Research Regulation of GM Foods in the US FDA • follows the guidelines of the Food, Drug and Cosmetic Act of 1938 • has authority to remove by seizure and forced recall any food that does not meet the safety standards • relies on companies to notify them before marketing new items
4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA Once notification of new product is addresses labeling requirements of food received: oponents of GM foods cite that these FDA provides consultation to help foods are misleading or misbranded developers of new food products to according to the FDCA meet safety requirements FDA does not regulate GM foods as new products or new food additives goal is to evaluate safety before product becomes commercial FDA does not considered these products mislabeled or misbranded Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA requlation of GM foods is based on "substantial addresses labeling requirements of food equivalence" if the GM food has significantly altered 1992 policy-Statement of Policy:Foods Derived nutritional properties from its conventional from New Plant Varieties counterpart,then it needs to be reflected provides guidance to the industry regarding in the label FDA's position on biotechnology and GM foods 、 FDA encourages yoluntary labeling of foods basic premise is that there are no special indicating if they are GM foods labeling requirements for GM foods as they are not seen to be different if they are substantially equivalent to their conventional counterparts
4/6/2017 7 Regulation of GM Foods in the US FDA • Once notification of new product is received: - FDA provides consultation to help developers of new food products to meet safety requirements - goal is to evaluate safety before product becomes commercial Regulation of GM Foods in the US FDA • addresses labeling requirements of food - oponents of GM foods cite that these foods are misleading or misbranded according to the FDCA - FDA does not regulate GM foods as new products or new food additives - FDA does not considered these products mislabeled or misbranded Regulation of GM Foods in the US FDA • addresses labeling requirements of food - if the GM food has significantly altered nutritional properties from its conventional counterpart, then it needs to be reflected in the label - FDA encourages voluntary labeling of foods indicating if they are GM foods Regulation of GM Foods in the US FDA • regulation of GM foods is based on ”substantial equivalence” • 1992 policy – Statement of Policy: Foods Derived from New Plant Varieties - provides guidance to the industry regarding FDA’s position on biotechnology and GM foods - basic premise is that there are no special labeling requirements for GM foods as they are not seen to be different if they are substantially equivalent to their conventional counterparts