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

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 The Cartagena Protocol MEXT, MAFF, MOE Others 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)

Apply

MHLW Minister

Report, announce Request evaluations Report the results

Public Food Safety Commission (FSC)

Report the results Evaluate, discuss

GMO Applicant

Exchange public opinions, information

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

Agricultural Material Council Request evaluations Report the results

Cabinet Office (CAO) Food Safety Commission (FSC) Investigation group for GM foods

Apply Report, announce Opinions, information

GMO Applicant

Opinions, information

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 Collectors of raw material Processors (if processed)

D

Shipping companies

D Exporters

Food Manufacturers

D

Processors

D

Wholesalers

D Importers D 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 Japan EU USA

Data Source

MAFF GMO Compass APHIS

Defined Approval Date

Food Hygiene Law European Commission’s decision Federal Register Ruling and determination • Generally, a GMO is approved first in the US, second in Japan, and finally in the EU.

100 90 80 70 60 50 40 30 20 10 0 4. International Comparison b. The number of approved GMOs

Number of GM events approved over time

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.