1. Genetically Modified Foods Beth Roberson November 19, 2004 FST 490

2. Objectives Describe GM Foods History of regulation Labeling Processes to assess safety Discuss US regulations and compare to those of the EU

3. Genetic Engineering Genetically engineered (GE) foods are developed by modifying DNA in some way GE foods are also referred to as transgenic foods and genetically modified organisms (GMOs).

4. Benefits Reduce pesticide and herbicide use Increase crop yields Improve nutritional quality Reduce waste Disease resistance Reduce ecological impact Reduce cost

5. Existing GM Foods Available for human consumption  Soybeans  Corn  Potatoes Not for humans  Fish- not on market yet Fish  Starlink corn- animal feed (EPA) Starlink

6. US Regulation of GM Foods FDA- Safe for consumption. CFSANCFSAN EPA- Pesticides, Environmental Safety USDA- Several agencies involvedagencies

7. History of US Regulation 1974- NIH sets up the Recombinant DNA Advisory Committee (RAC) 1976- RAC guidelines for GE research 1980- US Supreme Court in Diamond v. Chakrabarty rules that genetically altered life forms can be patented 1986- Coordinated framework for regulation of biotechnology. Proposed in 19841984 1990- FDA approved first GE food ingredient, chymosinchymosin

8. History of US Regulation May 29,1992 Federal Register vol. 57  Foods derived from new plant varieties produced by genetic engineering essentially will be regulated no differently than foods created by conventional means, unless special circumstances apply.  Created a voluntary process under which producers could consult with the agency about safety and regulatory issues prior to marketing GE foods.

9. History of US Regulation 1992- FlavrSavr, the first commercially grown GM food crop submitted to FDA. Released into market 1994FlavrSavr 1996- FDA gave additional guidance to industry on procedures for consultationsprocedures for consultations 2001-FDA proposed regulations on two subjects:  A mandatory pre-market notification process for GM foodspre-market notification  Voluntary labeling GM foods Voluntary labeling

10. Labeling of GM Foods FDCA- Product described by its common name and all important facts associated with claims made or suggested are shown on the label Not all GE food products are required to be labeled as such solely because they involved genetic engineering Certain situations require labeling

11. FDA Safety Requirements GRAS Toxicity standards Allergy testing “Substantially equivalent”

12. Toxicity Standards for GM Foods Established tests for potential toxins  Ames, cell cultures  Feeding studies EPA responsible for pesticides Compare to database of known toxins

13. Allergenicity of GM Foods Assessment decision tree (Metcalfe et al., 1996) Adapted from FAO/WHO 2001

14. Substantial Equivalence (SE) Compare GM food to GRAS food Consider chemical composition, macro and micro nutrients, toxins, and antinutrients. Look for protein and/or metabolite differences Feeding studies GM crop “as safe as” its counterpart

15. Process-based assessment Separate regulations SE used to limit toxicology testing All GE proteins tested for toxicity, carcinogenicity, and teratogenicity 90-day feeding studies on ‘whole plant’ Allergen assessment tree Labeling required for all products Product-based assessment Existing food regulations Established SE is sufficient for approval Novel proteins are assessed for adverse effects Feeding studies required for non- SE products Allergen assessment tree Labeling required for potential allergens US RegulationsEU RegulationsVS

16. QUESTIONS??