Presentation Transcript

1. The Approval Process of GMOs:the Japanese Case

   Ayako Ebata, Maarten Punt, Justus Wesseler TechnischeUniversitätMünchen Presented at the 16th 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. 2. GMO Approval Processa. Cartagena Protocol Type 1 Use: an open usage where the GMOs may influence the local environment Ministers MAFF MOE Approve the safety on local biodiversity Define necessary information in handling GMOs Announce publically Submit “Biological Diversity Risk Assessment Report” Request safety approval Developers/ importers of GMOs
7. 2. GMO Approval Processa. 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 Processb. National Laws for food and feed Food GMOs: Food Hygiene Law (FHL) Cabinet Office (CAO) MHLW Minister Request evaluations Food Safety Commission (FSC) Report the results Public Report, announce Evaluate, discuss Report the results Apply Exchange public opinions, information Investigation group for GM foods GMO Applicant
9. 2. GMO Approval Processb. National Laws for food and feed Feed GMOs: Animal Feed Safety Law (AFSL) MAFF Minister Cabinet Office (CAO) Request evaluations Food Safety Commission (FSC) Agricultural Material Council Report the results Investigation group for GM foods Opinions, information Report, announce Apply Opinions, information GMO Applicant Public
10. 2. GMO Approval Processc. 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 Preservationa. IP Handling Farm Farm Farm Food Manufacturers D D Collectors of raw material Processors (if processed) Wholesalers Processors D Shipping companies D D D Exporters Importers D
12. 3. Identity Preservationb. 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 Comparisona. Timing of GMO approval Data description Generally, a GMO is approved first in the US, second in Japan, and finally in the EU.
14. 4. International Comparisonb. 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.