It is predicted that world areas planted to GM crops will further expand this year, but especially notable is the problem of China's GM rice approval. China already cultivates GM cotton, but if GM rice is approved this will possibly open the gates for a flood of other GM crop approvals, making China a large GM crop cultivator similar to the USA. If GM crop cultivation expands in China, India will probably be influenced, and this may lead to a wave of GM crop cultivation expansion throughout the whole of Asia.

The trend being observed in Japan is that of a strategic shift on the part of the GM crop developers. As well as the continuation from last year of the anti-pollen allergy rice being developed by NIAS, Syngenta is developing an ethanol-producing corn (maize), and Monsanto has a herbicide-resistant lawn variety in the works. Thus there is a shift towards non-food GM crop applications, including flowers.

In the opposition movement to genetic engineering, the expansion of the GMO-free zone movement is now attracting attention. The movement is now spreading like wildfire in Europe and has also begun anew in North America, Asia, and Australia. It will possibly spread to the whole world. In Japan, Hokkaido has produced a bylaw to regulate GM crop cultivation, and a GMO-free zone movement has begun, showing that not only consumers but also local administrations and farmers are likely to become very active in this movement.

With the spread of genetic pollution from GM crops, contamination of food is continually increasing. The further amplification of consumer anxiety is expected, and with the citizen investigation of rapeseed pollution now well underway, the reality of the situation is expected to come to light during the year. It is also expected that the movement for a review of the GM food labeling system will gather momentum during the year.

The independent administrative organization NIAS (National Institute of Agrobiological Sciences) and the incorporated association STAFF (Society for Techno-innovation of Agriculture, Forestry and Fisheries announced on 10 December 2004 that they had completed the full sequencing of the rice genome. The rice genome has approximately 390 million base pairs, of which about 370 million have been determined. The remaining approximately 20 million base pairs are in the centromeres, the constricted central region on the chromosomes where the two chromatids are held together to form an "X" shape, and which are extremely difficult to analyze with present technology. Now the genome has been sequenced, the order of the base pairs along the DNA chain is known, but what genes are represented by these base pairs and what these genes do is not known. That will be the focus of the gene analysis which will now begin in earnest.

With over 400 deaths from side effects in Japan that will possibly lead to legal action, the manufacturer and distributor of the lung cancer drug Iressa, AstraZeneca, has published an interim report on the results of clinical trials, that took place between July 2003 and August 2004 in 210 institutions in 28 countries, that show that the drug "did not significantly prolong survival in patients". The FDA has apparently said it will "decide whether to recall Iressa from the market or take an appropriate regulatory measure." (Kyodo and others, 2004/12/23)

Concerning the "effect" and "side-effects" of Iressa, the director of the Human Genome Center of the University of Tokyo Institute of Medical Science and project leader of the 300,000 person gene bank project, Yuusuke Nakamura, has been jointly working with AstraZeneca on using SNPs to predict side-effects and so on, and had announced last November (2004) that 5 SNPs connected with side-effects in Iressa had been found. If clinical trials were to be carried out, it would be the venture corporation OncoTherapy Science, Inc., which would work out the practical applications, a company on which Yuusuke Nakamura serves as a director. (Nikkei Biotech, 2004/11/22)

AstraZeneca is due to publish the final report during the first half of 2005. If Iressa is rejected, the MHLW, which has approved the drug well ahead of the rest of the world, will face very heavy claims on its accountability. Further, Yuusuke Nakamura, who has used the connection between SNPs and the side-effect problem of Iressa to promote the efficacy of "order-made" medical treatment, will find his reputation being severely tested.

Last year, JA-Zennoh (the Japanese National Federation of Agricultural Co-operative Associations) changed its plan to conduct an outdoor experiment with cedar pollen allergenic GM rice to a glasshouse experiment at JA's agricultural technical centre in Hiratsuka, Kanagawa Prefecture, after receiving opposition from citizens. (see: BJ Sept. 2004) This year, further experimentation on this GM rice is planned at NIAES's own open-air experimental field in Tsukuba, Ibaraki Prefecture. The GM rice was developed by NIAS et al. The reason for the open-air trial is given as the low yield from last year's glasshouse experiment. Only 7-8 kg was obtained compared with the initial target, of 12 kg (unprocessed rice), and that is far below the 40 kg necessary for research. Two glasshouse cultivations are planned at the JA technical centre for February and the autumn of 2005.

On December 10, 2004, MAFF announced results of its investigation into the actual situation regarding food labelling of processed foods, concerning GM crops and place of origin. 1845 products were objected, and 3 samples of each were purchased and analysed by the IAA Center for Food Quality, Labelling and Consumer Services. Concerning the GM crops, 117 processed food products, which are sold all over Japan, and which carried NON-GM labels, were tested. Traces of GM varieties were found in 37 products (31.6%).

Recently, a research area known as epigenetics has been receiving attention. Advances in this field have begun to explain why it is that many abnormalities occur with cloning techniques. Epigenetics is the study of the processes involved in the unfolding development of an organism other than the base pair sequence of the genes on the DNA strand. Cells which have the same genes differentiate into different kinds of cells, so there must be some information other than the genes that is transmitted to future generations. This is what epigenetics seeks to elucidate.

The current state of somatic cell cloning is that many deaths are seen in the implantation and fetal stages, and though there are differences between species, apparently only around 2 - 3% of attempts result in live births. Further, though the animal may appear to be in good health, there may be some abnormality in genetic expression, leading to obesity or an abnormally short life and so on. In spite of this, the Cabinet Office Council for Science and Technology Policy specialist panel on bioethics, in its final report on the human embryo, published in July 2004, approved the use of cloning techniques for production and use of human embryos (human clone embryos) produced artificially and extra-somatically for research purposes. What the state (Japan) is now promoting is the production of a human clone embryo by insertion of the nucleus of a patient who is to receive a transplant, and then carrying out the transplantation treatment through the production of human ES cells, which do not show rejection effects. However, at present, the effectiveness and safety aspects of this procedure are totally unknown.

Following the publication of the final report on the human embryo, MEXT established a "Working Group on the Use of the Human Clone Embryo in Research," under the Cabinet Office Council for Science and Technology Policy specialist panel on bioethics, and has started work on the revision of the two guidelines that it currently oversees, namely the "specific embryo guideline" and the "ES cell guideline". The first meeting of the working group took place on 21 December 2004, at which a hearing by three of the group members was conducted. The most interesting report was "Problems in Cloning Techniques as seen from Epigenetics", given by Fumitoshi Ishino, a member of the working group and professor at Tokyo Medical and Dental University.

Prof. Ishino estimated that the many abnormalities seen in animal somatic cell cloning may be connected with the epigenetic fact that the initialization which occurs at the stage of the reproductive cell does not take place. The grounds for this are that a somatic cell cloned mouse which subsequently normal sexual reproduction produced a next-generation mouse in which the gene expression abnormalities were not present. It seems that the key is in the reproductive cell, but the details are as yet unknown. In other words, cloning techniques thus far have been only of the level of "we don't really understand how it works, but let's have a go," and this has resulted in a few percent of somatic cell clone births. With the advances in epigenetics we now have a better idea of what it was we did not understand before. Following Prof. Ishino's report several members of the working group expressed the opinion that, "the production of human clone embryos is premature." MEXT, however, apparently wants to take the final report on the human embryo as the main banner in its attempt to lead the discussions on this matter.