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) . The Japanese Diet approved a bill that made drastic changes to existing national guidelines to fulfill the requirements of the Cartagena Protocol . Ministries associated with aspects of biosafety discussed the bill and its integration with the overall system for environmental and laboratory safety , 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 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 compliance.
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 . 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
One result is that local prefectures in Shiga, Iwate, Hokkaido, and Ibaraki are considering instituting their own regulations 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 .
However, the paradigm shift toward comparable developments in Japan may not occur because of extreme feeling against transgenic crops. 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 .
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 .
However, their sessions have not had follow- up. Approaches to risk communication need to be re-examined.
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.
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.
Kazuo N.Watanabe, Mohammad Taeb, Haruko Okusu