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

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

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

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

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

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

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

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

9. NDSU Agriculture Decision Making Process 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.

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

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

12. NDSU Agriculture 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. NDSU Agriculture Number of World GM Wheat Field Trials by Year

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

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

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

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

18. NDSU Agriculture 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. NDSU Agriculture U.S. HRS Exports and GM Aversion

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

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

23. NDSU Agriculture Determining Risk Food, Feed, and Environmental Risk Gene/Protein RiskCrop Risk 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 Bob Peterson Agricultural & Biological Risk Assessment Montana State University

24. NDSU Agriculture Product Characterization Gene source(s) Molecular characterization Insert, copy number, gene integrity Function, specificity, mode of action Protein levels in plant Toxicity/Allergenicity Digestibility of protein Heat stability of protein Similarity to known allergens Acute toxicity – mouse, rat History of safe use and consumption Environmental Safety Ecotoxicity, Birds, Mammals, Fish Soil & aquatic invertebrates, Soil degradation, Beneficial insects Insect Resistance Management Crop Safety Crop development Crop yield Food Composition Nutrients Anti-nutrients Biotechnology Crop Regulatory Requirements Conventional Crop NO Regulatory Requirements 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 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 Agriculture Bringing in New Technologies to Wheat 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:

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

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

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

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

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

32. NDSU Agriculture “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. NDSU Agriculture Questions & Discussion