Sir

The Cartagena Protocol on Biosafety (http://www.biodiv.org/biosafety), formulated in 2000, is concerned with standardizing the movement of genetically modified organisms (GMOs) across national boundaries. As of January 2003, more than 100 countries have signed and 41 ratified the protocol. Only nine more countries need to ratify the protocol for it to become internationally and universally binding.

Further discussions are needed to reach agreement on the details of each article within the protocol. Article 18, which I discuss here, concerns the handling, transport, packaging and identification of living modified organisms (as GMOs are legally termed) across boundaries. Because the protocol seems likely to be ratified soon, we are very close to requiring internationally standardized documentation and instruction for transboundary movements of these organisms.

Global scientific communities need to pay careful attention to future practices, rules and standards in international movements of these organisms, even if they are being used only for research. We must, of course, have a proper method for considering potential risks to the environment and human health in handling, transport, packaging and identification. Also, it is vital to avoid confusion, unfounded fear and consequent negative perceptions of biotechnology associated with genetic engineering.

There is particular concern among Japanese scientists and industry about the present status of legislation, proposed by the government, on research and development (R&D) and industrial uses of living modified organisms, in the light of the biosafety protocol. Although commercial imports are unlikely to suffer from any new laws passed to meet consumer demands and concern, it may be impossible to regulate R&D and industrial applications, because of confusion about administrative responsibility and inadequate numbers of inspectors. Establishing comprehensive and workable rules under the protocol is urgent to avoid delays to R&D and commercial activities, which would set Japan back further in relation to North America and Europe.

So far, there has been no commercial cultivation of GM crops in Japan, although government-approved GM cultivars could be planted and sold to consumers without major regulations. Public concern in Japan discourages interest in commercial crop cultivation R&D. Work that has been carried out by academic research institutions and the private sector, and past investment in genetic engineering, may be wasted because of these concerns and the impending regulations.

Japan has less experience in field evaluation of GM crops than countries in the European Union; there have been four times more evaluations in Italy and eight times more in France, where commercialization is unpopular but research is tolerated (http://www.olis.oecd.org/biotrack.nsf). In commercial cultivation of GM crops, Japan lags behind other Asian countries. India and China have far more experience at the local farmers' level, with thousands of hectares of GM crops and much accumulated knowledge and experience for future development of crop technology and associated risk management.

Although there is high-quality basic research on plant molecular biology and genetic engineering in Japan, these valuable results have remained unexploited because of regulations and lack of support systems for implementing the environmental release of GM plants or a biosafety assessment. Japan needs regulatory agencies that have clear responsibilities, and clear, workable risk-management schemes in R&D institutions.