It has been revealed that GM soybeans were cultivated and sold in 1998 and 1999 in Hokkaido, and will be cultivated again next year. Yoshimasa Miyai, owner of the 85-hectare Seinan Farm in Naganuma Town, near Sapporo, cultivated Monsanto's herbicide resistant GM soybeans on 4.6 hectares in 1998 and sold the GM beans. He has made an agreement for cultivation with Monsanto. This means that the company has concealed the fact that its GM soybeans were commercially cultivated in Japan. The harvested GM soybeans were sold to a private company in Sorachi. The reason why Miyai stopped cultivating GM soybeans after two years was that the yield was reduced 25% and the price was categorised low as "et alia", and as a result revenue was reduced 40% compared to conventional soybeans. However, Miyai has announced that he will re-start full-scale cultivation from next year, because yield has been increased due to improvements in breeding. Currently, the Hokkaido government is preparing a "bylaw" to regulate the cultivation of GM crops (see BJ October 2004, so this farmer is being supported by proponents of GM crop cultivation who are trying to make the bylaw toothless.

At the moment, Hokkaido is asking for voluntarily restraint from GM crop cultivation in accordance with the guidelines concerning GM crop cultivation that were put into effect provisionally in April 2004. Hokkaido, being Japan's leading soybean-production area, even the local agricultural cooperative, JA Naganuma, has suggested to Miyai that he should not re-start GM soybean cultivation, but he is not listening, and the Hokkaido government is endeavouring to prevent the cultivation going ahead. For the time being, the problem has everyone's attention.

On 7 September 2004, Iwate Biotechnology Research Center (IBRC) in Kitakami City, Iwate prefecture, released the result of its research on a low-temperature resistant GM rice variety called "Sub29". According to the IBRC trial result, there was little difference in yield compared to a conventional rice variety, Sasanishiki. The result also mentioned that no cross-pollination occurred to ordinary rice fields by pollen dispersal. Local citizens groups have pointed out from the beginning that the method used by IBRC to investigate pollen propagation is unsuitable.

On 17 September, 2004, an independent administrative institution, the National Institute for Agro-Environmental Sciences (NIAES) in Tsukuba, Ibaraki prefecture, held a briefing announcing the start of an outdoor experiment on Monsanto's herbicide (glyphosate) tolerant GM oil seed rape (rapeseed) "RT73" from October. This GM OSR variety has already gone through the safety assessment in accordance with the MAFF guidelines, and therefore has permission to be cultivated. This is the last year of the outdoor experiment, which has been conducted since 2001 as monitoring test to investigate long-term impacts on ecosystems. Over the three years, no briefings have been held, and therefore NIAES has never obtained consent from local farmers and citizens. The briefing was held for the first time this year since the government has set guidelines for outdoor experiments involving GM crops, in which researchers are instructed to gain public understanding for field trials.

A research group under Professor Shinji Iijima of the School of Engineering of the Graduate School of Nagoya University announced at the meeting of the Japan Biotechnology Research Association which began on 21 September 2004 that they had introduced a gene into a chicken using a retrovirus vector which resulted in the production of a protein at high concentrations in the subsequent generation. In the development of GM livestock it is often the case that "gene silencing" takes place so that even if the gene is transferred to the following generation it is not expressed (the protein is not produced). Now a technique to avoid this problem has been developed and it is thought that this will make possible the mass production of GM livestock. (Nikkei Biotech 2004/9/27)

At a plenary meeting of the Biodiversity Impact Assessment Commission held on 7 October 2004, an application for a GM cotton from Monsanto Japan and an application for a GM maize from DuPont were approved under the Type 1 Use Regulations. Type Use is an assessment of no impact on wildlife and gives permission for open-field cultivation. The two varieties approved this time contain both insecticidal and herbicide resistance traits.

On the basis of the final report on the human embryo published in July by the Cabinet Office Council for Science and Technology Policy specialist panel on bioethics, MEXT has established a "Working Group on the Use of the Human clone Embryo in Research," which is a specialist committee on embryo and human ES cell research, for the purpose of initiating considerations towards the production of human clone embryos.

Since the final report on human embryos approves the production and use of human clone embryos for research purposes, MEXT must now revise its two current sets of guidelines on the subject, the guidelines on embryos and the guidelines on human ES cells, and this will be the task of the new working group. The discussions in the working group will concern the research facilities that may handle human clone embryos and the conditions under which they must work, the method for obtaining the ova for the human clone for the purpose of establishing the ES cells, and so on.

Three ministries, MEXT, MHLW, and METI, are currently working jointly towards enactment of the Law on Personal Genetic Data Protection.

A law consisting of strong restrictions concerning the protection of personal data held by companies holding personal data on more than 5000 people was established in May 2003. This law will become fully implemented on 1 April 2005 and provides for up to 6 months imprisonment for offenders.

The "Basic Guidelines Concerning Protection of Personal Data," the establishment of which was mandated by Clause 7 of the above-mentioned law, was approved by the Cabinet on 2 April 2004. In the Basic Guidelines, three areas which require the formulation of particularly strong measures concerning the nature and use of personal data, medical, financial and credit, and data transmission, were mentioned. On this basis the three ministries have begun to formulate a separate law concerning the handling of genetic data, known as the "ultimate personal data".

The focus of the discussions towards formulation of the law is how to define "personal data" and how far to make the law applicable. A piece of personal data with a name attached to it is of course personal data, but the problem is with data that has been rendered anonymous.

There are also two types of anonymous data; that from which the names have been totally erased (unidentifiable), and that for which a separate chart enabling linking of data with the individual concerned is available (identifiable).

In the case of the sequencing of the human genome, there is no problem with categorizing it as unidentifiable since there is no need to link the information (the sequence of the four bases) with any identifiable individual, but in post-genomic research (See BJ July 2004), genetic data (the functions of particular genes and single nucleotide polymorphisms [SNPs], which differ between individuals), and in order to investigate for treatment data such as clinical history or the possibility of side effects, although anonymity would be required for the purposes of obtaining the consent for a sample from a donor, it would be necessary to be able to identify the individual.

In the discussions involving the three ministries, three categorizations of anonymity are used; 1. unidentifiable, 2. identifiable, 3. identifiable (through a separate cross-referencing chart), and agreement has been reached that only 2. being within the scope of the law, 1. and 3. would be covered by guidelines. However, one could say that this is a "trick" to include in the guidelines (which carry no enforceable punishments) large amounts of data which currently exist and which are identifiable through cross-referencing charts. The "Project to Realize Order-Made Medical Treatments" which MEXT initiated in 2003 (Representative, Prof. Yuusuke Nakamura of Tokyo University) has amassed data on 300,000 identifiable individuals, and is preparing to bank these. In spite of amassing genetic and treatment data from 300,000 individuals, the law will not apply simply because there is no cross-referencing chart immediately to hand. The aim of the ministries is to amass large amounts of data in which genetic data and treatment data exist as a corresponding set, to identify and protect by patents the genes involved in diseases and the SNPs which determine the sensitivity to pharmaceuticals, and to contribute to the profits of companies that are trying to develop genomic drug development techniques and genetic or SNP diagnostic techniques.