1. Safety and Regulation in Agricultural Biotechnology MUPGRET Workshop

2. Comprehensive safety assessments Integrated (coordinated) framework involves three federal agencies to ensure biotech product safety. USDA: environmental safety EPA: environmental, food and feed safety for pest-protected products. FDA: feed and food safety.

3. Public participation Solicited by USDA, EPA and FDA at several steps in the process. Small-scale to commercial testing.

4. Food and Drug Administration Voluntary Labeling Indicates whether foods have or have not been developed using transgenic technology. Pre-market notice concerning food resulting from transgenic technology. www.access.gpo.gov/su_docs/aces/ace s140.html www.access.gpo.gov/su_docs/aces/ace s140.html

5. Comprehensive international safety assessments in key export markets European Union Director of EU Canada Canadian Food Inspection Agency Japan Ministry of Agriculture, Forestry, and Fisheries; Ministry of Health and Welfare

6. Safety is a comparison of Risks and Benefits All technologies are evaluated relative to: Consequences of their implementation Consequences of their non-implementation Comparison to safety of alternative technologies Context of current and historical practices Benefit to human, animal and environmental health

7. Minimizing risk Comprehensive hazard analysis Risk identification Assessment (evaluation) Risk/benefit consideration Develop risk management plan Effective training and communication

8. Assessing Safety Standard is “reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption”.

9. Remember Food is not inherently safe. Safety is based on experience. Relative, not absolute safety.

10. Substantial Equivalence “as safe as” Compare transgenic products to conventional products.

11. Hazard identification Toxicity Allergenecity Safety of antibiotic resistance markers Nutritional equivalence Compositional equivalence Lack of unintended effects

12. Safety-Genetic and Protein Map of vector and its components Position and size of “novel” DNA Function of gene in plant Source of gene Inheritance and stability of trait Changes in amino acid sequence relative to native protein Expected expression Compare to known toxin/allergens Test in mice In vitro digestibility test

13. Compositional Equivalence Fatty acid Amino acid Vitamin Mineral Anti-nutrient How does this compare to the variation present among conventional varieties?

14. Comparison to toxin/allergens Compared in global database against >100,000 proteins. “Macro” analysis of entire protein “Micro” analysis of small stretches of protein (eg. 600 comparisons for the Bt protein).

15. Allergenicity 1-2% of adults are affected by food allergies. Eight major allergens: Peanut Milk Soy Wheat Shellfish Fish Egg Tree Nuts

16. Toxicity Assessment Once safety is established, EPA tests for secondary metabolic activity These products are labeled because they have different composition due to the change in protein.

17. Testing in Mouse Cry1Ac (Cotton, Tomato)4200mg/kg Cry3A (Potato)5200mg/kg Cry1b (Corn)4000mg/kg CP4 EPSPS (Soybean)572 mg/kg

18. CROPS Coordinated screening and testing Regulatory review Other scientific experiments and trials Performance feedback from growers Stewardship and monitoring to ensure responsible use. www.cast- science.org/biotechnology/index.html

19. Coordinated screening and testing Initial screening Early field testing Experimental use permits

20. Regulatory review USDA Composition, Germination, Seed longevity, Growth and Reproduction, Outcrossing, Fitness Assessment, Herbicial Activity, Field Observation EPA Plant gene expression, toxicology, environmental fate

21. Other scientists Land Grant Universities Private Institutions Private Foundations

22. Performance Feedback Compare transgenic and conventional in field setting Environmental stewardship New paradigms, ex. Return of beneficial insects.

23. Stewardship and Monitoring Non-target populations Risk management plan Monitor use accordance with requirements.

24. Nine chances to say no! Biosafety Committee USDA Greenhouse Approval USDA Field Trial Authorization USDA Authorization for transport to field trials USDA Permit to Commercialize EPA Experimental Use Permit EPA Food Tolerance Determination EPA Product Registration FDA Review

25. International Agencies Food and Agriculture Organization and World Health Organization say: “products of plant biotechnology are not inherently less safe than those developed by traditional breeding” “same food safety considerations” “extensive testing provides equal or greater assurance of safety”

26. What is risk? Chance that something will happen over a certain period of time. Factors that can affect risk: Age Gender Genetic constitution Environment

27. Risk and New Technology Public view leans toward no risk associated with new technology. Two case studies: New fuel source New appliance

28. Death Rates for 1998 RankCause% ♂:♀♂:♀ AM:C 1Heart Disease31.01.81.5 2Cancer23.21.41.3 3Cerebrovascular disease6.81.11.8 4COPD4.81.40.8 5Accidents4.22.41.2 6Pneumonia and flu3.91.51.4 7Diabetes melitus2.81.22.4 8Suicide1.34.30.5 13Homicide0.83.55.7

29. Another way to look at health risk See Overheads

30. Risk assessment examples Life insurance Auto insurance Statistics for disease Cigarette smoking Food—E. coli