The Approval Process of GMOs: the Japanese Case Ayako Ebata, Maarten Punt, Justus Wesseler Technische Universität München Presented at the 16th ICABR Conference Ravello, Italy, June 24-27, 2012 Outline of the presentation 1. Introduction 2. GMO approval process in Japan 3. Identity Preservation 4. International Comparison 5. Summary and Conclusion 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. 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. 2. GMO Approval Process Food Animal Feed Others The Cartagena Protocol MEXT, MAFF, MOE Food Hygiene Law MHLW Animal Feed Safety Law MAFF Commercialization 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 • Submit “Biological Diversity Risk Assessment Report” • Request safety approval Ministers MAFF MOE • Approve the safety on local biodiversity • Define necessary information in handling GMOs • Announce publically 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. 2. GMO Approval Process b. National Laws for food and feed Food GMOs: Food Hygiene Law (FHL) Cabinet Office (CAO) MHLW Request evaluations Minister Report the results Apply Report, announce GMO Applicant Public Exchange public opinions, information Food Safety Commission (FSC) Report the results Evaluate, discuss Investigation group for GM foods 2. GMO Approval Process b. National Laws for food and feed Feed GMOs: Animal Feed Safety Law (AFSL) MAFF Minister Request evaluations Agricultural Material Council Apply Report, announce Report the results Cabinet Office (CAO) Food Safety Commission (FSC) Investigation group for GM foods Opinions, information Opinions, information GMO Applicant Public 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. 3. Identity Preservation a. IP Handling Farm Farm Farm Food Manufacturers D Collectors of raw material Processors (if processed) D Processors Wholesalers D Shipping companies D D Exporters D Importers D 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. 4. International Comparison a. Timing of GMO approval • Data description Data Source Defined Approval Date Japan MAFF Food Hygiene Law EU GMO Compass European Commission’s decision USA APHIS Federal Register Ruling and determination • Generally, a GMO is approved first in the US, second in Japan, and finally in the EU. 4. International Comparison b. The number of approved GMOs Number of GM events approved over time 100 90 80 70 60 50 40 30 20 10 0 JPN EU US 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.