4/6/2017 Regulation of GM Foods in the US Regulation of GM Foods in the US FDA FDA M food undergo a safety assessment that compares GM Too Example where substantial equivalence was not found- nts with r molecular. StarLink corn GM corn produces an insecticidal protein from B. .the or effecr of the Thuringiensis 2.Evalutation of the source,identity,function,and stability of the introduce genetic material 3.Analytical studies to determine effects on composition of but pproved for in the food StarLink corn found in taco shells 4.Evaluation of GM substance in food 5.Animal feeding studies or other toxicological tests are done when the analytical methods cannt resolve safety concerns Removed from the market in 2000 Some genetically modified foods Regulation of GM Foods in the US GM food regulation summary:fictional example Very Cherry Company developed GM cherries that include new gene "gene R" Gene enhances the red color but does not affect the products safety as determined by field tests and molecular/chemical evaluations Product was tested on land and shown not to pose an environmental hazard Starlink corn Data was presented to FDA,USDA,and EPA and an exemption was requested4/6/2017 8 Regulation of GM Foods in the US FDA • GM food undergo a safety assessment that compares GM foods to conventional counterparts with respect to molecular, compositional, toxicological, and nutritional data 1. Evaluation of the purpose or technical effect of the modification 2. Evalutation of the source, identity, function, and stability of the introduce genetic material 3. Analytical studies to determine effects on composition of the food 4. Evaluation of GM substance in food 5. Animal feeding studies or other toxicological tests are done when the analytical methods cannt resolve safety concerns Regulation of GM Foods in the US FDA • Example where substantial equivalence was not found – StarLink corn - GM corn produces an insecticidal protein from B. Thuringiensis - Protein digestion and heat stability tests showd that a unique Bt protein was produced and was seen as a potential human allergen - Not approved by FDA but was approved for use in animal feed by EPA - StarLink corn found in taco shells - CDC provided evidence of the corn as potential allergen linking it to 51 illnesses though inconclusively - Removed from the market in 2000 Regulation of GM Foods in the US GM food regulation summary: fictional example • Very Cherry Company developed GM cherries that include new gene ”gene R” • Gene enhances the red color but does not affect the products safety as determined by field tests and molecular/chemical evaluations • Product was tested on land and shown not to pose an environmental hazard • Data was presented to FDA, USDA, and EPA and an exemption was requested