U.S. FDA’s Approach to the Safety Assessment of Bioengineered Plants Used as Food

1. U.S. FDA’s Approach to the Safety Assessment of Bioengineered Plants Used as Food Mary Ditto, Ph.D. October 21, 2002 Food and Drug Administration Center For Food Safety and Applied Nutrition

2. U.S. Federal Oversight for Bioengineered Foods • Coordinated Framework for the regulation of foods • Involves three federal agencies

3. U.S. Regulatory System for the Evaluation of Bioengineered Food Products • United States Department of Agriculture (USDA) • Environmental Protection Agency (EPA) • Food and Drug Administration (FDA)

4. U.S. Federal Statutory Authority • USDA/APHIS - Federal Plant Protection Act (FPPA) and Plant Quarantine Act (PQA) • regulation of the introduction (importation, interstate movement, or release into the environment) of genetically engineered organisms

5. U.S. Federal Statutory Authority • EPA – Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and FFDCA - regulation of pesticidal substances including those produced in plants - sets tolerances (or establishes exemptions from tolerance) for pesticides in or on food

6. U.S. Federal Statutory Authority • FDA - Federal Food, Drug and Cosmetic Act (FFDCA) • regulation of foods, feeds, food additives, and labeling of foods • Ensuring the safety and proper labeling of foods and food substances

7. FDA Food Biotechnology Policy • Federal Food, Drug, & Cosmetic Act • Science based regulation • Ensure safe and wholesome food supply • ‘92 policy; scientific guidance

8. FDA’s 1992 Policy Statement • Published in the Federal Register, May 29, 1992, (57 FR 22984) • Applies to all methods of breeding, including recombinant DNA • New foods must be as safe as foods on the market today • All foods regulated under existing paradigm, FFDCA

9. Two provisions of FFDCA gives FDA authority to regulate foods: • Post market adulteration provisions --(Section 402(a)(1)) • Premarket approval of food additives --(Section 409)

10. Objectives of 1992 Policy • Develop guidance for industry on food safety assessment • Establish procedures for consultations with FDA on scientific and regulatory issues • Ensure a safe and wholesome food supply

11. General Safety Assessment Approach • Today’s food is the standard • New varieties are evaluated relative to traditional counterparts • Multi-disciplinary approach: Agronomic and quality characteristics; genetic, chemical, nutritional analyses • If questions remain — toxicological tests

12. Food Safety Assessment Intended Modification • New Substance(s) — • Identity; structure/function • Source (allergenicity) • digestibility • Dietary exposure • Nutrition

13. Food Safety Assessment Unintended Modifications • Genetic stability • Composition — • Nutrients • Toxicants

14. FDA’s 1992 Policy Statement • “Standard of Care” • Policy statement addresses food safety assessment allergenicity of newly introduced proteins nutrient composition and anti-nutrients known toxins and new toxins antibiotic resistance markers unintended effects

15. Has there been an intentional alteration in the identity, structure, or composition of fats or oils in the new variety? New or modified fats or oils Yes Have the intentional alterations been in a fat or oil that will be a macroconstituent in the diet? Consult FDA Yes No No Are any unusual or toxic fatty acids produced in the new variety? Consult FDA Yes No No concerns

16. Consultation Procedure • FDA established a consultation procedure to ensure that new products are safe and lawful. • FDA believes that all developers of commercially marketed bioengineered foods sold in the U.S. have consulted with FDA prior to marketing their products.

17. Consultation procedure • Firms submit a summary of safety and nutritional data of the product. • When all safety and regulatory issues have been resolved firms receive a letter stating that FDA has no questions at this time. • Completed consultations are listed on the FDA’s Internet site.

18. New Bioengineered Varieties

19. Herbicide Tolerance Insect Resistance Insect Resist./Herb. Tolerance Pollen Modified/Herb. Tolerance Virus Resistance Insect & Virus Resistance Delayed Ripening Other Introduced Traits

20. International Approach • ‘90 FAO/WHO Expert consultation • ‘93 OECD report • ‘96 FAO/WHO Expert consultation • ‘00 OECD report to G-8 • ‘02 FAO/WHO Expert consultation • ‘02 Codex Task Force Draft Guidelines

21. Biotech 2000 and Beyond • FDA held three public meetings in 1999 • Communicate policy and solicit opinions on current policy and procedures • Requested comments • Received over 50,000 comments

22. Public Comments • No new data to question safety of bioengineered foods currently marketed • Divergent views on labeling • Consultation process is voluntary • Lacked transparency • Concern that current procedures may not be sufficient to deal with future developments

23. New Initiatives: Proposed Rule Premarket Notice Concerning Bioengineered Foods • Published in the Federal Register, January 18, 2001 (66 FR4706)

24. Proposed Requirement for Premarket Notice (PMN) • Requirement for premarket notification for bioengineered plant derived foods • If finalized, would require developers of bioengineered foods to notify FDA 120 d before commercial distribution. • Would enhance FDA’s ability to assess whether new bioengineered plant varieties comply with FFDCA on an on-going basis.

25. Proposed Requirement for Premarket Notice (PMN) • Plant-derived bioengineered foods consumed by humans and animals • If a pesticidal substance- EPA evaluates pesticide; FDA evaluates other issues • Timing: 120 days before market • Recommend Presubmission Consultation Safety Standard: “As safe as comparable foods”

26. Proposed Requirement for Premarket Notice (PMN) • Recommended testing in accordance with the 1992 policy • Proposed codified requires a specific format and content for a submission • Notifier attests that the food is as safe as comparable food and is otherwise lawful • FDA will post notices on the internet when first filed

27. Current Status • FDA received over • 100,000 comments to the proposed rule for premarket notification • FDA is reviewing comments • Working towards a final regulation

28. New Initiatives • Increased transparency • Issued draft guidance for voluntary labeling • Guidance on allergenicity and antibiotic resistance marker genes • Supplement FACs with scientists with agricultural biotechnology expertise • Enhance research

31. Draft Guidance for Labeling • Issued January 18, 2001 • Agency is considering comments received • On web at • http://www.cfsan.fda.gov/~dms/biolabgu.html

32. FDA’s Labeling Authority • Federal Food, Drug and Cosmetic Act (FFDCA) -Sections 403(a) and 201(n) • Fair Packaging and Labeling Act (FPLA)

33. Draft Guidance for Labeling • Restates agency’s policy regarding when special labeling is required for bioengineered foods. • Truthful and not misleading • Misleading if fails to reveal facts that are material in light of representations made

34. FDA’s position on labeling of bioengineered foods • Food must be labeled when there is a significant change in the food, i.e., • nutritional • compositional • change in conditions of use • or when an allergenic component has been introduced in a food where it does not naturally occur

35. Status of Initiatives • Finalize the proposed rule for mandatory premarket notification • Finalize guidance on labeling • Finalize guidance on the use of antibiotic resistance marker genes • Developing guidance for the assessment of allergenicity • Recent meeting of Biotech subcommittee of FAC

36. International Activities • International activities - promote harmonization • Codex • OECD • Interact with foreign governments to provide information and expertise

37. Information about FDA • FDA Main Web site: www.fda.gov • FDA Biotechnology Web site www.cfsan.fda.gov/~lrd/biotechm.html