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6-Regulation: Japanese controversies over transgenic crop regulation

-------------------------------- GENET-news -------------------------------

TITLE:  Japanese Controversies over Transgenic Crop Regulation
SOURCE: Science 302: (5690): 1572, by Kazuo N. Watanabe, Mohammad Taeb,
        Haruko Okusu
DATE:   10 Sep 2004 

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Japanese Controversies over Transgenic Crop Regulation

Kazuo N. Watanabe,1,2* Mohammad Taeb,3 Haruko Okusu3

The Cartagena Protocol on Biosafety was enacted in 2003 to regulate
transboundary movement of genetically modified organisms or LMOs (living
modified organisms, the legal term defined by the protocol) (1). The
Japanese Diet approved a bill that made drastic changes to existing
national guidelines to fulfill the requirements of the Cartagena Protocol
(2). Ministries associated with aspects of biosafety discussed the bill
and its integration with the overall system for environmental and
laboratory safety (3), and the Japanese law entered into force in
February 2004.

 This law has made legal procedures more comprehensive and consistent.
However, operational details have not yet been digested by stakeholders,
especially commercial traders and academic researchers. Furthermore,
Japan is at a critical stage in dealing with negative public reaction to
modern biotechnology and its products.

Under the new law, there are specific legal procedures required for
exchange of transgenic organisms with Japan. For importation, it is
necessary to document prior informed consent (PIC) between exporter and
importer. The shipment must clearly indicate on the package and in
accompanying documentation that transgenic materials are included. For
Japanese scientists, importation of transgenic materials is allowed only
after the certification of experiments as safe by the research
institution or, if the risk level is high, by the Ministry of Education,
Culture, Sports, Science, and Technology (MEXT).

For exportation, a PIC document is required from the importer to protect
Japanese research institutions from foreign claims. International
scientists should be aware, for example, that transport of recombinant
microorganisms and seeds from transgenic plants could be rejected for
lack of documentation. For those who are accustomed to a more relaxed
system, the new laws require attention to avoid delays or blocked
shipments. This applies to materials for basic research or commerce.

There is domestic confusion as well over the new rules. To focus
attention on this issue, officials at MEXT (4) have held tutorials for
the academic community and basic research institutions on risk
minimization and the new legal system. This is to avoid procedural
failures that might result in domestic legal prosecution and penalties,
as well as any international perception that Japan has problems with

Importation of transgenic crops is skyrocketing in Japan. For example,
the combined value of imported transgenic soybean, maize, and canola was
nearly US$ 3.5 billion in 2003 (5). However, against the backdrop of food
safety concerns and distrust of government authorities in the wake of
bovine spongiform encephalopathy, avian influenza, and fraudulent food
labeling scandals, public anxiety has been increasing (6). One result is
that local prefectures in Shiga, Iwate, Hokkaido, and Ibaraki are
considering instituting their own regulations (7-10) on the general
release of transgenic organisms, in an attempt to regulate crops that
have already been approved by the central Japanese government. There is
concern that public reaction will adversely affect local farmers and the
tourism industry, as well as fear that products derived from genetic
engineering are not safe and that transgenic crops could contaminate
neighboring fields.

Elsewhere in Asia, national efforts to promote testing and use of
transgenic crops have increased. For example, China has nearly 7 million
acres of Bt cotton (which has Bacillus thuringiensis toxin genes), and
India and Pakistan have developed commercial products from their research
(11-13). However, the paradigm shift toward comparable developments in
Japan may not occur because of extreme feeling against transgenic crops
(14). Although hundreds of experiments on transgenic plants are being
conducted yearly, they could be shut down by fragmented and preventive
regulations, as is happening in the United Kingdom (15).

The biggest problem may be that discussions on transgenic organisms have
never been seen as a long-term, trust-building, and collaborative
exercise among stakeholders. Organizations such as the Japan Bioindustry
Association; the Society for Techno-Innovation of Agriculture, Forestry,
and Fish; and the International Life Science Institute (ILSI) Japan have
met to discuss public education (6, 16, 17). However, their sessions have
not had follow-up. Approaches to risk communication need to be re-
examined (18).

Although academic societies have tried to promote public awareness, there
has been little consensus within or between organizations. Individual
scientists have made public statements, adding to the confusion (19). The
Japanese Society for Plant Cell and Molecular Biology and the Japanese
Society of Breeding have begun to hold discussions on transgenic crops
with consumer groups, stakeholders, and governmental organizations. This
is a step in the right direction, but sustained effort will be needed if
plant biotechnology is to prosper in Japan.

References and Notes

1. 	See
2. 	 K. N. Watanabe, Nature 421, 689 (2003).
3. 	 Law Concerning the Conservation and Sustainable Use of Biological
Diversity through Regulations on the Use of Living Modified Organisms
(Law No. 97 of 2003), available at
4. 	 MEXT, see
5. 	 Ministry of Agriculture, Forestry, and Fisheries of Japan, 30 April
2004, available at
6. 	 Questionnaire on GM crops and food, 6 April 2004, available at http:
7. 	 K. Watanabe et al., Nature Biotechnol. 22, 943 (2004).
8. 	 Mainichi Newspapers, "Trends in GM crops in prefectures," 31 July
2004, available at
9. 	 "Shiga Prefecture examines the need for regulating GM crops," Kyoto
Shimbun News, 11 June 2004, available at
10. 	 For example, Guideline on planting GM crops in Hokkaido, 5 March
2004, available at
11. 	 C. James, Global Status of Commercialized Transgenic Crops: 2003
(ISAAA Briefs. No. 30, International Service for the Acquisition of Agri-
biotech Applications, Ithaca, NY, 2003); available at
12. 	 P. Menon, Frontline 19, 22 June 2002; available at
13. 	 I. A. Rao,
14. 	 K. N. Watanabe, A. Komamine, in Intellectual Property Rights in
Agricultural Biotechnology, F. H. Erbisch, K. M. Maredia, Eds. (Michigan
State Univ., East Lansing, and C.A.B. International, Wallingford, UK, ed.
2, 2004), pp. 187-200.
15. 	 Department for Environment, Food, and Rural Affairs, "Genetic
modification," available at
16. 	 Japan Bioindustry Association, "Biotechnology Q & A," available at
17. 	 ILSI Japan, see
18. 	 A. Kapuscinski et al. Nature Biotechnol. 21, 599 (2003).
19. 	 No! GMO Campaign, see
20. 	 K.N.W. acknowledges the Japanese Society for the Promotion of
Science, grant no. JSPS-RFTF-00L01602.

1 Gene Research Center, University of Tsukuba, Ibaraki, 305-8572, Japan.
2 International Plant Genetic Resources Institute, Rome, Italy.
3 Institute of Advanced Studies, United Nations University, Yokohama,
220-0012, Japan.

*To whom correspondence should be addressed. E-mail:


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