1. Are They Safe? Biotech Food Crops and Products February 1, 2002 Karen Pesaresi Penner Kansas State University Food Science Institute

2. Biotech Products in Food Supply 1. Fermentation products –Yeasts and molds used to make cheese, bread, wine, beer, soy sauce 2. Enzymes –Lactase tablets to breakdown lactose in milk - for allergies –Chymosin (rennet) for cheese manufacture –Amylase in beer

3. 3. Hormones Bovine growth hormone (rbst) Vitamin D added to milk Insulin

4. 4. Whole foods/crops –FLAVR SAVR, Endless Summer tomatoes –Virus – resistant squash –Insect resistant potatoes, corn –Herbicide resistant soybeans, canola

5. Potential Benefits IFT Expert Report on Biotechnology and Foods, 2000 Enhanced food supply Improved nutritional quality – rice, other foods Improved shelf life of fruits & vegetables Reduced allergenicity – rice, peanuts

6. Improved production agriculture Conversion of toxic soils to productive soils Increased environmentally friendly practices regarding pesticides Development of functional foods, vaccines, other healthful products

7. Public Uncertainty Public is NOT well-informed Public may see little or no benefit from technologies Lack of information and conflicting information leads to confusion, emotional reactions and fear for some

9. Acceptance of Technologies Public accepts new technologies with personal benefits rInsulinvs rBST Benefits of many bioengineered products unknown or not perceived as personal

10. FDA and Food Safety U.S.Food and Drug Law – requires food products to be safe Traditional foods – considered safe, long history Exceptions –some “safe” foods affect specific individuals –“safe” foods may contain small amount of natural toxins New foods – developed with conventional breeding, or from other parts of the world considered safe

11. rDNA Derived Foods and Ingredients Assessed for safety before introduction into marketplace 1992 FDA Risk Assessment – focus on unique characteristics of product Safety standards for bioengineered products actually greater than for conventional

12. Potential Food Safety Effects Toxicants New Substances Nutrients Allergenicity Other Effects - Unintended -- IFT Expert Report on Biotechnology and Foods, 2000

13. Considerations in Safety Evaluations Substantial Equivalence – based on comparison of recombinant product with traditional product –Not an absolute guarantee of safety –Process to establish that no NEW hazards have been introduced into the plant or product Toxins? Nutrient Effects? Proteins, fats, carbohydrates, vitamins, minerals Allergens?

14. Substantial Equivalence: “ A comparative approach focusing on the determination of similarities and differences between the genetically modified food and its conventional counterpart aids in the identification of potential safety and nutritional issues and is considered the most appropriate strategy for the safety and nutritional assessment of genetically modified foods.” (FAO/WHO 2000)

15. Assessment beyond equivalence: Completely new food substance Changes in concentrations of major human dietary nutrients Increased concentrations of “antinutritional factors” Increased concentrations of toxins

16. Safety of Genetic Material Inserted Characterization of Source Size Number Location of insertion Identification of sequences in the plant Safety of DNA itself is not in question

17. Unintended Effects: “… the unintended expression of some unknown or unexpected toxic or antinutrient factor, or the otherwise unintended enhanced production of known toxic constituents.” - (Royal Society, 1998) Evidence of such effects has not been found as result of bioengineering. Effects are less likely in bioengineered than in conventional products.

18. Food Allergens: All food allergens are proteins: only a small fraction of food proteins cause allergic response. Common foods with allergenic proteins: peanuts, milk, seafoods Potential allergenicity of genetic material (proteins) introduced into a plant is an important part of safety assessment.

19. Allergenicity Assessment Follows a decision-tree process Includes: –Source of the gene –Sequence homology of newly introduced protein –Reactivity of newly introduced proteins with Immunoglobulin E (IgE) antibodies from people with known allergies to source material –Other properties, such as digestibility of the protein

20. Safety Assessments Refined and adapted and will continue to change and develop. Safety assessments are an important part of the development process.

21. “FDA’s scientific review continues to show that all bioengineered foods sold here in the U.S. today are as safe as their non- bioengineered counterparts” Dr. Jane Henney, M.D. U.S. Commissioner of Food and Drugs, 2000

22. Questions?