1. Risk assessment of GMOs FOEs view Werner Müller, GLOBAL 2000

2. Reg EC 1829/2003 recital 9 Genetically modified food and feed should only be authorised after a scientific evaluation of the highest possible standard taking uncertainty into account Reg EC 178/2002

3. FOE has long criticised the poor scientific standard of risk assessment of GMOs Sound science: The evidence against Aventis GM maize (February 2001) The great Food Gamble – an assessment of genetically modified food safety (May 2001) Bt 11 Briefing (Nov 2003)

4. 1.The choice of the method and design of the experiment predetermines the result 2.Data is not knowledge Without rules “Sound science” is like a game

5. Source: ttp://europa.eu.int/comm/health/ph_determinants/environment /EMF/conf24_26feb2003/gee.pdf

6. Strengths of the study Method –Consistent methodology for all dossiers –Based on state of the art science and not on assumptions or outdated data

7. Strengths of the study Analysed Parameter –Good separation of tests and arguments in the dossier –Detailed evaluation of assumptions made by the applicant –Detailed analysing of tests and corresponding extrapolation made by the applicant –Good analyses of test-design, statistical analyses provided by the applicant

8. Strengths of the study Recommended Risk Assessment Protocol –Standardization (side by side comparison) –New Protocol for Allergenicity Testing –Whole Food Tox studies

9. What we miss – to complete the picture Identify knowledge gaps in Nutrition science –Role/Fate of Food-DNA/RNA in mammalians E.g. corn DNA (199bp) in lymphocytes (Einspanier et al 2001) Identify knowledge gaps in cell biology –Role of introns? (which have regulatory functions) (Hare et al. 2003, Giacopelli 2003 ) –the role of lacking introns in synthetic transgenes? –Synthetic transgenes stability in F2, F3 Assessment plant / environment –Synthetic transgenes and heat stress (e.g. VR sugar beet, HT soybeans, IR cotton) Identifying NEW Risk Qualities –Role of Food DNA/RNA with Cell Nucleus Malatesta et al 2003 increased nucleus

10. Poor testing of GMOs is not the exemption but seems to be the standard Long history of hiding facts is prolonged

11. Implications

12. Scientific implications Need to END assumptions based risk assessment Need for a detailed risk assessment protocol Need for risk research which supports the competent authorities –Verifying methods –Literature recherché –Identifying knowledge gaps and common patterns

13. Political implications Food safety unclear - Consumers a still at risk There is a need for immediate reassessment of approved GMOs/ or the approval must be withdrawn The EU-Commission is not able or unwilling to guarantee a risk assessment of the “highest possible standard” (e.g Bt 11, NK 603) SCF/EFSA was/is not able or unwilling to perform a risk assessment of the “highest possible standard” (e.g Bt 11, NK 603) Public trust in EU-Commissions, in Industry and Scientific panels will further decline

14. Poor Standard of risk assessment is no longer acceptable

15. Political implications Definition of detailed risk assessment guidance/methods is part of risk management EFSA must not define its own rules for risk assessment There is a need for supervising EFSA through an Independent Science Panel which should be nominated by NGOs

16. What next

17. Risk assessment protocol New risk concept: Exposure profile Effect profile Uncertainty profile (see Decis 2002/2715/EC) Definition of –Basic requirements for design and statistically analyses –Methods –Endpoints

18. Methods

19. Substantial Equivalence Tox Testing Basic Methods Assumption based risk assessment SCIENCE/Evidence based risk assessment

20. EVENT-Specific Whole Food Tox testing Tox Testing with Protein (from E.coli) Methods (Unproved) model testing risk assessment Test as consumed risk assessment

21. Late lessons from Eprex case or The real meaning/implications of “EVENT”

22. Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)www.bio.org

23. Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)www.bio.org

24. Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)www.bio.org

25. Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)www.bio.org

26. Source: Jimenez 2003 / www.bio.org (Biotech industries organisation)www.bio.org

27. GM Micro- organism A GM Micro- organism B GM Plant A GM Micro- organism B RISK ARISK B RISK ARISK B GENE

28. Tox testing with the whole food must be the common minimal standard

29. Endpoints

30. Reg EC 178/2002 Article 14(4) to take into account not only short or middle term effects but also effects on future generations probable cumulative toxic effects and effects on health sensitive consumers.

31. The game called “sound science” Monsanto and Syngenta proofed in a test-tube design that Bt-Protein is digested within seconds to minutes Einspanier 2001 Chowdhurry 2003 detected Bt-Protein in intestine, rectal content of cows, pigs and chicken There is no need for chronic toxicological studies There is a need for chronic toxicological studies

32. GM Food consumption 3 x day 7 days a week Full Lifespan/young and old, fit and ill Chronic ExposureChronic Effect testing

33. Chronic toxicological tests with the whole food must be the common minimal standard

34. Evidence based risk assessment protocol Methods Whole Food Tox Testing Endpoints Chronic Effects, Cancerogenicity Addressing knowledge gaps Role and Fate of FOOD- DNA/RNA in mammalians e.g. maize DNA in lymphocytes Research funding Early warning system Detection of NEW risk qualities e.g. increase of size nucleus in liver cells Reliable Institutions Include alternative risk assessment by NGOs in risk decision making Transparency Public Full access to risk assessment parts of dossier RA RM RC RP/EW

35. Source: ttp://europa.eu.int/comm/health/ph_determinants/environment /EMF/conf24_26feb2003/gee.pdf