The Approval Process of GMOs: the Japanese Case

Report
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.

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