1. FDA’s Policy for Evaluating Bioengineered Foods Jeanette Glover Glew Food and Drug Administration Center For Food Safety and Applied Nutrition September, 2003

2. Overview  Regulatory Framework  Policies and Procedures  Public Outreach  Recent Initiatives

3. Regulatory Authority Bioengineered foods are regulated by three Federal agencies United States Department of Agriculture (USDA) Environmental Protection Agency (EPA) Food and Drug Administration (FDA)

4. Roles of Federal Agencies  USDA oversees safety for cultivation –addresses plant protection issues  EPA oversees the safe use of pesticides –Includes pesticidal substances produced in plants –Sets tolerances or establishes exemption from tolerance

5. Food and Drug Administration  Statutory Authority The Federal Food, Drug, and Cosmetic Act (FFDCA)  Function Ensuring the safety and proper labeling of foods and food substances  Oversight Cereals, fruits, vegetables, plant by-products, milk, seafood, and substances added to foods

6. Regulatory Authority Under FFDCA  Post market adulteration provisions (Section 402) –Producers have a legal duty to market products that are safe and wholesome –Primary legal tool for whole foods –FDA has authority to remove food that is a hazard to human health –Ex: would give FDA authority to act if there was an elevated level of toxicant or introduction of allergen that was not obvious to the consumer

7. Regulatory Authority Under FFDCA  Premarket approval of food additives (Section 409) –A food additive that is not GRAS has to undergo premarket review and approval before it can be used in food –This authority may be used for substances added to food that are substantially different (and cannot be presumed to be GRAS) from substances that have been safely consumed

8. Policies and Procedures

9. FDA’s 1992 Policy for Foods Derived from New Plant Varieties  Published in the Federal Register, May 29, 1992, (57 FR22984)  Applies to all methods of breeding, including recombinant DNA  All foods are regulated under existing paradigm

10. Some Basic Principles in the Policy Statement  The regulation of new plant varieties should be based on the objective characteristics or components of the food, rather than the fact that a new development method was used to produce the food.

11. Some Basic Principles in the Policy Statement  Today’s food is the standard – new varieties are evaluated relative to traditional counterparts  Bioengineered foods must be as safe as foods on the market today.

12. Some Basic Principles in the Policy Statement  Provided guidance to industry on scientific and regulatory issues  Recommended voluntary consultation w/ FDA  Purpose of consultation – make sure any safety questions are resolved before go to market

14. Procedures derived from 1996 Consultation Procedures  As part of a consultation: –FDA meets with a notifier early in the development process to discuss potential safety, nutritional or other regulatory issues –FDA recommends testing as necessary –Process is iterative –Prior to commercialization, notifier provides data and information about their safety assessment –FDA evaluates data package and responds by letter

15. Safety Evaluation under 1992 Policy  Approach is multidisciplinary –Agronomic and quality characteristics –Characteristics of new substances –Genetic analysis –Chemical and nutritional analysis

16. Elements of Safety Evaluation  Intended Modification – New Substance –Identity –Source –Digestibility –Dietary Exposure –Altered Nutrition  Unintended Modifications –Genetic stability over multiple generations –Composition Nutrients Anti-nutrients Toxicants

17. Elements of Safety Evaluation  Host Plant –Taxonomy –History of safe use –Presence of harmful constituents –Important nutrients

18. Elements of Safety Evaluation  Donor Organism –Taxonomy –History of use –Presence of harmful constituents –Passage through microbial hosts –Identity and function of introduced material

19. Elements of Safety Evaluation  Substance(s) Introduced Into Host Plant –Concentration of expression product –Potential for allergenicity –Potential for toxicity –Similarity to other substances in the food supply –Alterations in plant metabolism –Posttranslational modifications –Presence of antibiotic resistance marker

20. Elements of Safety Evaluation  Inserted Genetic Material –Method of transformation –Activity of regulatory sequences –Presence of extraneous open reading frames –Number of inserts and insertion sites –Genetic stability

21. Public Outreach Recent Initiatives

22. Public Outreach  In 1999, FDA held 3 public meetings –To communicate policy –To solicit opinions on current policy and procedures  FDA received about 50,000 written comments from those meetings

23. Results of Public Outreach  No new data to question safety of bioengineered foods currently marketed  Some concern from the public about the consultation process - may not be sufficient to deal with future scientific developments

24. Recent Initiatives  Enhance FDA’s science base –Establish food biotech subcommittee –Support research on allergenicity –Support study by the National Academy of Science on unintended effects

25. New Bioengineered Varieties Sugar beet Rice Radicchio Papaya Tomato Potato Canola Soybean Squash Cantaloupe Flax Corn Cotton Oilseed rape

26. New Bioengineered Varieties Herbicide tolerance Pest resistance Other Altered ripening Herbicide tolerance, Other Pest and herbicide resistance

27. Goals To ensure that FDA is prepared to meet scientific and regulatory responsibilities in the future To enhance public confidence in the safety of bioengineered foods

28. Information FDA’s foods web page: http://www.cfsan.fda.gov Click on biotechnology program area