1. AGRICULTURALBIOTECHNOLOGY Conflicting Regulatory Paradigms & A Global Reality Check Heritage Club Bangkok, Thailand 28 August, 2003

2. L. Val Giddings, Ph.D. Vice President for Food and Agriculture Biotechnology Industry Organization Washington, DC USA

3. The continuing growth of human population creates or exacerbates a host of challenges to the responsible stewardship of the environmental health and biodiversity of planet Earth.

4. “The greatest challenge of the 21st century: feeding 9 billion people with a sustainable agricultural production system.” --Chrispeels, 2000

5. To meet these challenges in the 21st Century and beyond, humanity will need ever tool it can find.

6. What has been the global experience thus far in terms of regulatory oversight for the products of agricultural biotechnology; and how are these products scrutinized by regulatory authorities?

7. PROBLEM: Our high degree of technical understanding has not been translated into either harmonization or equivalence among the approval systems in the major trading nations.

8. Two Models for Biotechnology Regulation: • An earned trust in the competency and independence of scientifically based risk assessments • United States, Australia – New Zealand, Japan • Political reliance on the validity of current public opinion • European Union

9. Scientifically, both systems rely on risk assessment using the same types of data concerning the identity molecular characterization food safety environmental impact of new crop varieties.

10. U.S. – Style System The recommendations of technical reviewers are presented to administrative agencies for acceptance or rejection • U.S. Department of Agriculture • Environmental Protection Agency • Food and Drug Administration

11. U.S. – Style System • Policy officials are regularly selected for their familiarity with the subject matter • Applications are made to central authorities and all evaluations and interaction with the applicant is conducted through that agency

12. E.U. – Style System The recommendations of technical reviewers are subject to several layers of political review by authorities who are not versed in the scientific or technical aspects of the application.

13. E.U. – Style System • There are 6 distinct steps of evaluation involving agencies in individual member states, several levels of the European Commission and the European Council of Ministers. • Each stage offers an opportunity for individual member states or the Commission to delay or prevent action or an application.

14. Results… E.U. – Style System • Since October 1998, the EU has not approved any applications to grow or import transgenic crops. • 13 applications for new products have been stalled

15. Results… U.S. – Style System • Since 1986, the 11 transgenic crops most commonly field tested have been planted under more than 6,504 permits on more than 30,000 test plots.

16. Results… U.S. – Style System • USDA found crops pose risks no different then their conventional counterpart • FDA found crops to be safe for human consumption • EPA evaluated licensed crops improved to resist insect pests

17. This effective and functioning regulatory regime is the best explanation for the global preponderance of biotech crop land in the U.S.

18. “Current regulatory scrutiny, plus the excellent track record of GM food safety, gives us confidence that GM foods are rigorously scrutinized and that the technology is safe.” • American Council on Science and Health, • Biotechnology and Food, 2002

19. Universal Principles for Sound Regulation • Regulatory review must be grounded in sound science

20. Universal Principles for Sound Regulation • Regulatory review must be grounded in sound science • Appropriate standards of risk avoidance must be applied

21. Universal Principles for Sound Regulation • Regulatory review must be grounded in sound science • Appropriate standards of risk avoidance must be applied • Regulators must distinguish between what they need to know vs. what would be nice to know

22. What is the ground truth reality of our experience with crops improved through biotechnology to date?

23. Global Area of Transgenic Crops, 1996 to 2001 Increase of 19%, 8.4 million hectares (20.8 million acres) between 2000 and 2001. Source: Clive James, 2001

24. Global Area of Transgenic Crops, 1996 to 2001 Source: Clive James, 2001

25. “A cumulative total of over 175 million hectares (almost 440 million acres) of transgenic crops were planted globally in 16 countries.” - Clive James, 2001

26. The majority of the land devoted to transgenic crops: • United States (68%) • Argentina (22%) • Canada (6%) • China (3%)

27. Crops improved through biotechnology that are grown most frequently: • Soybeans • Corn • Cotton • Canola

28. Global Area of Transgenic Crops, 1996 to 2000: By Crop(million hectares) Source: Clive James, 2000

29. U.S. Biotech Crops Acres Planted 1996-2002 * Planting Estimate based on USDA/NASS report 3/28/02 ** Overall cotton plantings decreased but % of acres increased. *** Corn acreage fluctuates based on presence of European corn borer.

30. U.S. Biotech Crops in 2002 % of Acres Planted 1999 figures are based on a survey of BIO member seed sales. 2000-2001 figures are based on USDA/NASS 2002 figures are estimates of USDA, NASS 3/28/02 * Corn acreage fluctuates based on presence of European corn borer.

31. Improvements most often delivered through biotechnology • Herbicide tolerance • Enable improved weed control measures • Insect resistance • Enable improved pest management

33. Global Area of Transgenic Crops, 1996 to 2000: By Trait(million hectares) Source: Clive James, 2000

34. Global Area of Transgenic Crops, 1996 to 2000; Industrial and Developing Countries(million hectares) Source: Clive James, 2000

35. Global Area Adoption Rates (%) for Principal Transgenic Crops (million hectares) Source: Clive James, 2000

36. Most Frequent Categories Source: U.S. Department of Agriculture

37. Most Frequent Crops Source: U.S. Department of Agriculture

40. Summary of US Experience to date • 9,284 permits + notifications • 38,899 test plots & fields • ~45 crops approved for wide scale planting • 0 unexpected, unpleasant surprises

41. “Mobilization of these substantial resources to address developing world needs is fundamental to the future well being of the world, its natural resources, and its people.” -Taylor and Fauquet, 2000

42. Human Health Impacts • There has not been a single claim of a negative health impact that has survived scrutiny • Real potential for eliminating from known allergens the genes encoding for the proteins that evoke the allergenic response • Biotechnology produces safer corn harvests than conventional corn by decreasing risks posed by carcinogenic mycotoxin contamination

43. “It seems perverse, even criminal, to walk away from an increased source of food when we need it desperately.” • Provessor Derek Burke • Nuffield Council on Bioethics

44. Crops and foods improved through biotechnology are subjected to more extensive and detailed prior scrutiny than any others in history.

45. “The American Society for Cell Biology vigorously supports research and development in the area of genetically engineered organisms, including the development of genetically modified crop plants…New products from genetically modified crops promise significant improvement in human health and the environment.” American Society for Cell Biology, Statement in Support of Research on Genetically Modified Organisms

46. “Instead of rejecting the solutions offered by science, we should change policies to assure that the solutions benefit the poor…Condemning biotechnology for its potential risks without considering the alternative risks of prolonging the human misery caused by hunger, malnutrition and child death is unwise and unethical.” - Per. Pinstrup-Anderson Director General, International Food Policy Research Institute

47. Environmental Impacts The fundamental threat to biodiversity comes from the destruction of native habitat

48. “The primary cause of the decay of organic diversity is not direct human exploitation or malevolence, but the habitat destruction that inevitably results from the expansion of human populations and human activities.” - Paul Ehrlich, 1988

49. “It is this broad-scale clearing and degradation of forest habitats that is far and away the main cause of species extinctions.” - Norman Myers, 1988

50. Biotechnology promises to reduce threats to biodiversity by: • Improving crop production on existing lands • Decreasing the environmental impacts of agricultural practices • Reducing the pressure to convert more of the remaining wilderness to agriculture