The independent administrative entity National Institute of Agrobiological Sciences (NIAS) is pursuing the development of second and third generation GM crops. In addition to the pollen allergy rice, now undergoing testing, a co-enzyme Q10 rice has been developed. This is a genetic modification of the ability of the rice plant to produce co-enzyme Q9 to induce it to produce the co-enzyme Q10. Co-enzyme Q10 is a biomolecule involved in the production of energy in the mitochondria of higher animals. It is recently attracting attention as a health food supplement.

The overall biodiversity impact assessment commission (Ministry for the Environment [MfE], MAFF) approved Monsanto's application on 23 March 2005 for three varieties of herbicide resistant alfalfa (J101, J163, and a crossbreed of the two) for type one use (open cultivation) under Japan's Cartagena Protocol domestic laws.

On 31 March 2005, the Food Safety Commission confirmed the same J101 and J163 alfalfa varieties as safe for food consumption. This means that GM alfalfa may now for the first time be distributed in Japan as a foodstuff.

The Western Australia state council election has resulted in a victory for the incumbent Labour Party, which means that the ban on the cultivation of GM rape, the main issue in the 26 March 2005 election, will continue. WA exports about 1.6 million tones of rape to Japan annually. Background to the victory for the Labour Party, which has championed the ban on GM rape, is voter fear that the introduction of GM rape will influence the state's largest crop, wheat.

The General Assembly of the United Nations passed a resolution banning the production of human clones by 84 votes to 37 on 8 March 2005. All countries agree on the banning of the use of clone technology to give birth to a human, but at the strong insistence of the USA the production of cloned embryos was also banned, which caused Japan to oppose the resolution. Because the resolution is not legally binding, Japan has taken the stance that there will be no effect on R&D.

A separate law for the "handling of personal genetic data" has not been formulated in step with the full enforcement of the Personal Data Protection Law on 1 April 2005, and it has been decided to produce only a guideline on human genome ethics. The three ministries, MHLW, MEXT, and METI have been holding joint meetings to discuss these matters since August 2004, but many committee members are opposed to legal enactment because "it would put the brakes on research." The handling of personal data in the problem-ridden gene bank has been put out of bounds of legal regulation with hardly any discussion occurring. In the end, the promotion of research is going to take priority over the protection of personal genetic data.

The appearance of a new leukaemia patient as a side-effect of the gene therapy for X-SCID (X-linked severe combined immunodeficiency) being implemented in France has been reported in January 2005, in addition to the two cases in 2002. The carcinogenic nature of the retrovirus vector had previously been pointed out, but now three cases out of eleven patients have contracted leukaemia. Gene therapy for X-SCID has been suspended in France, but other gene therapies which use the retrovirus vector are ongoing. In Japan, there are plans for five patients to be treated by genetic therapy for X-SCID at Tohoku University (Sendai, N-E Japan), but this has been put on hold for the time being. Gene therapy using the retrovirus vector is also being carried out at Hokkaido University Hospital and at three other institutions in Japan.

Up to now, food additives produced by the use of GM microbes have had to seek approval under the special additive "safety assessment guidelines". Now the Food Safety Commission has given its consent to a relaxation of the approval conditions for food additives other than products which are highly refined proteins. Items covered by the relaxation are amino acids, vitamins, sugars and so on, and as long as the proportion of non-active ingredient does not increase and there is no potentially harmful non-active ingredient included, safety is assumed to have been confirmed.

Greenpeace International held a press conference in Beijing on 13 April 2005 to announce that a non-approved GM rice variety had been cultivated, distributed, and possibly exported to other countries such as Japan. Greenpeace demanded that the Chinese government recall this non-approved GM rice immediately and that it investigate the cause of the contamination.

According to the announcement, a Greenpeace investigative delegation had discovered the non-approved GM rice in Hubei Province. Interviews with the seed retailers and producers revealed that the seeds have been on sale for the last two years. Analysis of the rice variety has shown that it is a Bt (insecticidal toxin) rice variety. (More details in next month's issue)

The Hokkaido assembly passed unanimously Japan's first GM crop cultivation regulation bylaw (see BJ April 2005) on 24 March 2005, and the new law was published on 31 March 2005. Because the new law contains punishment clauses, a familiarization period is necessary and the new law will come into force on 1 January 2006. The detailed regulations will be formulated by August 2005, and applications for permission to cultivate or notification of field trials will be accepted from 1 October 2005.

The introduction of this law will effectively make it impossible to cultivate GM crops in Hokkaido on a commercial basis, and R&D will also be subject to a certain amount of regulation.

On 2 March 2005, before the new law was passed, six biotechnology-related academic associations; The Japanese Society of Plant Physiologists, the Japanese Society for Horticultural Science, The Japanese Society for Chemical Regulation of Plants, the Japanese Society of Breeding, the Japanese Society for Plant Cell and Molecular Biology, and the Japan Society for Bioscience, Biotechnology, and Agrochemistry, submitted a formal letter to the chairman of Cabinet Office Biotechnology Strategy Council, Tadamitsu Kishimoto, requesting understanding for GMO research. Up to now, the academic associations had submitted individual requests, but seeing that these were not very effective have decided to submit a joint request this time, along with a press conference held on 9 March 2005 appealing for the government to put more weight behind biotechnology.

The background to this is the feeling of crisis concerning the ongoing regulation of GM crops by local authorities. The issue felt to be particularly problematic by researchers concerning the Hokkaido bylaw is the fact that punishment clauses for infringments have been included in the law, leading to a strong fear that "research cannot be freely conducted".

In addition to Hokkaido, the regulation of GMOs has also begun with Shiga Prefecture and Iwate Prefecture establishing guidelines for GM crop cultivation, and Tokyo Metropolitan District and Tsukuba City initiating similar deliberations. If this movement accelerates, the public image of GMO research will inevitably continue to decline, and so the six academic associations have decided to get together to try to roll back the situation.

The researchers are demanding that the Cabinet Office, which oversees the Biotechnology Strategy Council, will take the lead in putting strong pressure on the related government offices and local authorities to desist from their policy of regulating GMOs and switch over to a policy of promotion of GMOs. It is thought that when that happens, in order to dilute the impression that this is being forced on people from above, it is necessary to involve academic associations, NPOs, and consumer centres in the process.