1. Introduction to GMOs: Myths and realities Masami Takeuchi, Ph.D. Food Safety Officer

2. GMOs Biotechnology: a wide range of technologies GMO is one of them (plants, microorganisms and animals/fish) Concerns: –Environmental health –Human health (food safety) –Socio-economic issues

3. GMO production Total area of GM crops had risen

4. Share of countries

5. Distribution of GM crops in total GM crop areas

6. Proportion of GM crop as a % of total individual area under the crop

7. Commercialization of GM crops 29 countries planted commercialized GM crops in 2010 Additional 30 countries have granted regulatory approvals for GM crops for import, food and feed use and for release into the environment, since 1996

8. Regulatory issues Regulations and policies on GMOs vary by country –Food safety assessment –Environmental safety assessment –Consideration of socio-economic issues –Authorization process –Control and monitoring policy (including inspection and detection)

9. Food safety principles Are potatoes safe? Is water safe? Is maize safe? Is chicken safe? Food is not inherently safe! Presumption of safety History of safe use –No adverse effect –Knowledge and experience to mitigate hazards

10. Traditional food safety assessment Discrete chemical entity Established studies identifying and characterizing hazard “Safe” levels of exposure Risk of adverse health effect and its impact known

11. Whole Foods = Chemicals Traditional risk assessment not designed for whole foods Whole foods differ from chemicals!

12. How to assess “NEW” and “WHOLE” foods? New foods or added substances with no presumption of safety How to approach novel whole foods? Traditional risk assessment does not fit

13. Questions so far?