1. The Approval Process of GMOs: the Japanese Case Ayako Ebata, Maarten Punt, Justus Wesseler Technische Universität München Presented at the 16 th ICABR Conference Ravello, Italy, June 24-27, 2012

2. Outline of the presentation 1. Introduction 2. GMO approval process in Japan 3. Identity Preservation 4. International Comparison 5. Summary and Conclusion

3. 1. Introduction No GMO production; Large amount of imported GMOs; On-going research on biotechnological development including some GMOs; Little understanding of the GMO approval process in Japan.  Importance in understanding the situations regarding GMOs in Japan.

4. 1. Introduction Summarize the GMO approval process for food, feed, and imports; Explain the Identity Preservation regime in Japan; Compare the Japanese GMO regulations to those in the US and EU.

5. 2. GMO Approval Process Food Animal Feed Others The Cartagena Protocol MEXT, MAFF, MOE Food Hygiene Law MHLW Animal Feed Safety Law MAFF Commercialization

6. Submit “Biological Diversity Risk Assessment Report” Request safety approval 2. GMO Approval Process a. Cartagena Protocol Type 1 Use: an open usage where the GMOs may influence the local environment Developers/ importers of GMOs Developers/ importers of GMOs Ministers MAFF MOE Approve the safety on local biodiversity Define necessary information in handling GMOs Announce publically

7. 2. GMO Approval Process a. Cartagena Protocol Type 2 Use: restricted to a closed environment; If procedures for safe handling are already defined, utilizers of GMOs must comply with the defined process and report the situations to the MAFF and MOE; If procedures are not defined, application to approve the GMOs must be submitted.

8. 2. GMO Approval Process b. National Laws for food and feed Food GMOs: Food Hygiene Law (FHL) GMO Applicant MHLW Minister Cabinet Office (CAO) Food Safety Commission (FSC) Investigation group for GM foods Apply Request evaluations Report, announce Report the results Exchange public opinions, information Public Report the results Evaluate, discuss

9. 2. GMO Approval Process b. National Laws for food and feed Feed GMOs: Animal Feed Safety Law (AFSL) GMO Applicant Cabinet Office (CAO) Food Safety Commission (FSC) Investigation group for GM foods Apply Request evaluations Report, announce Report the results Opinions, information Public MAFF Minister Opinions, information Agricultural Material Council Agricultural Material Council

10. 2. GMO Approval Process c. Imports Before importing, GMOs need to be approved for the Type 1 Use in the Cartagena Protocol; The MHLW can conduct random inspection at ports of entry.

11. 3. Identity Preservation a. IP Handling Farm Shipping companies Farm Collectors of raw material Processors (if processed) ImportersExporters Processors Wholesalers Food Manufacturers D D D D D D D

12. 3. Identity Preservation b. Labeling of GMOs Mandatory labeling for all GM food products and their derivatives; The Law on Standardization and Proper Labeling of Agricultural and Forestry Products since April 2001; Traceability not enforced; 5 % impurity; Voluntary labeling can be found.

13. 4. International Comparison a. Timing of GMO approval Data description Generally, a GMO is approved first in the US, second in Japan, and finally in the EU. Data SourceDefined Approval Date JapanMAFFFood Hygiene Law EUGMO CompassEuropean Commission’s decision USAAPHISFederal Register Ruling and determination

14. 4. International Comparison b. The number of approved GMOs

15. 5. Summary and Conclusion All GMOs have to be approved through the Cartagena Protocol and national laws; Identity preservation is done through IP Handling process as well as labeling; Japan’s regulatory regime lies between the EU and the US.