NDSU Policy on Biotech Research & GM Wheat Update

1. BIOTECH UPDATE NDSU Policy on Biotech Research & GM Wheat Update Duane Hauck Assistant Director – Ag & Natural Resources NDSU Extension Service

2. “to develop and disseminate technology important to the production and utilization of food, feed, and fuel from crop and livestock enterprises” NDSU Policy on Biotech Research Purpose of NDAES:

3. Indicates controlling authorities Guide NDSU scientists Communicate to the public NDSU Policy on Biotech Research

4. Continue to pursue new technologies for enhancing farming, food quality and the environment. Key points of NDSU Policy on Biotech Research NDAES will…

5. Promote the co-existence of various production and marketing systems. NDAES will…

6. Continue to develop genetically improved and environmentally adapted crops. NDAES will…

7. Manage development and propagation of new varieties to insure the availability of pure seed to the fullest extent possible. NDAES will…

8. Follow research protocols that exceed APHIS standards when testing regulated biotech crops. NDAES will…

9. The NDSU Institutional Biosafety Committee will give additional oversight to the approval process for testing regulated biotech material. All regulated biotech research pre-approved by the NDAES Director. All non-regulated biotech research communicated to the Director prior to planting. Policy regarding biotech research at all NDAE locations set by the NDAES Director. Decision Making Process

10. Continue to utilize public variety release meeting for reviewing plant material considered for commercial release. NDAES will…

11. NDSU policies on biotech research do not supercede established rules. However, they may be more restrictive or precautionary.

12. GM Wheat Trait Research • Preliminary analysis/interpretation • Data from Monsanto, North Dakota and South Dakota are still being developed • Extensive research on GM Wheat and much beyond RRW and Monsanto • Sources • www.health.gov.au/ogtr/gmorecord/ir.htm • www1.oecd.org/ehs/biobin/ • www.inspection.gc.ca/english/plaveg/pbo/pbobbve.shtm • www.nbiap.vt.edu/cfdocs/fieldtests1.cfm

13. Number of World GM Wheat Field Trials by Year

14. Number of World GM Wheat Field Trials by Country, 1993-2002

15. Number of World GM Wheat Field Trials by Trait, 1993-2002

16. Number of World GM Wheat Field Trials by Organization, 1993-2002

17. Number of World GM Wheat Field Trials by Type of Organization, (Public vs Private) 1993-2002

18. Major Points • US is dominant, albeit not the only player • HT is only one trait under development, followed by • Product quality • Fusarium Resistance...etc • Diverse organizations in GM wheat with no one likely dominating

19. U.S. HRS Exports and GM Aversion

20. Percent of U.S. HRS Use (Domestic Consumption and Exports), 1999-00

21. Biotech Products Require Different Oversight Regulation should be commensurate with risk, but new technologies often necessitate more rigorous regulation Bob Peterson Agricultural & Biological Risk Assessment Montana State University

22. USDA = Is it Safe to Grow? EPA = Is it Safe to the Environment? FDA = Is it Safe to Eat? Three-Agency Approach Bob Peterson Agricultural & Biological Risk Assessment Montana State University

23. Product Characterization Gene source(s) Molecular characterization Insert / copy number / gene integrity Function / specificity / mode of action Levels in plant Toxicology / Allergenicity Digestibility Homology to allergens Acute Oral - mice / rat History of safe use and consumption Environmental Safety Ecotox, Avian, Aquatic Soil invertebrates, Soil degradation Non-Target Risk Assessment Insect Resistance Management Crop Characteristics Morphology Yield Food / Feed Composition Proximate analysis Key nutrients Key anti-nutrients Food, Feed, and Environmental Risk Gene/Protein Risk Crop Risk Determining Risk Bob Peterson Agricultural & Biological Risk Assessment Montana State University

24. Conventional Crop NO Regulatory Requirements Biotechnology Crop Regulatory Requirements • Product Characterization • Gene source(s) • Molecular characterization • Insert, copy number, gene integrity • Function, specificity, mode of action • Protein levels in plant • Crop Safety • Crop development • Crop yield • Toxicity/Allergenicity • Digestibility of protein • Heat stability of protein • Similarity to known allergens • Acute toxicity – mouse, rat • History of safe use and consumption Food Composition Nutrients Anti-nutrients EPA, FDA, or USDA can remove the crop or food from the market if there is a question of safety for consumers or the environment • Environmental Safety • Ecotoxicity, Birds, Mammals, Fish • Soil & aquatic invertebrates, • Soil degradation, Beneficial insects • Insect Resistance Management EPA, FDA, or USDA can remove the crop or food from the market if there is a question of safety for consumers or the environment Bob Peterson Agricultural & Biological Risk Assessment Montana State University

25. NDSU, SDSU, U of M and Technology Providers meet on a regular basis to discuss progress of biotech wheat research Roundup Ready wheat will be introduced when the following commercialization milestones have been achieved: Bringing in New Technologies to Wheat

26. Commercialization Milestone…….. The food, feed and environmental safety of Roundup Ready wheat is demonstrated, resulting in regulatory approvals in the United States, Canada and Japan *The intent is to commercialize in the U.S. and Canada simultaneously.

27. Commercialization Milestone…….. Appropriate regulatory trade approvals, thresholds or marketing agreements are in place in major export markets.

28. Commercialization Milestone…….. Appropriate grain handling protocols and standardized sampling and detection methods are developed and implemented

29. Commercialization Milestone…….. Comprehensive agronomic stewardship programs and best management practices are developed

30. Commercialization Milestone…….. Varieties meet or exceed industry standards for grain end-use quality

31. Commercialization Milestone…….. Buyers are identified who will procure and use wheat ingredients with biotech traits

32. “to develop and disseminate technology important to the production and utilization of food, feed, and fuel from crop and livestock enterprises” Purpose of NDAES:

33. Questions & Discussion