Compared to last year, numerous field trials on GM crops have been planned this year. This because investigations on ecological impact on wild fauna and flora related to GM crop cultivation became obligatory under the domestic laws concerning biodiversity introduced in accordance with the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, which took effect in February 2004. Moreover, in order to be consistent with the "guidelines", which also took effect in February, regarding open-air cultivation on GM crops at research facilities under the jurisdiction of the MAFF, briefings have been held in several different locations. (See: BJ January 2004) Such briefings have not been held before.

At the University of Tokyo farm briefing, NIAS, the developer, could not give accurate answers to the questions raised by participants, and it became clear that the developer did not comprehend changes in metabolism of the GM potato they were using. The director of the University of Tokyo farm, Ritsu Ohsugi, therefore decided to call off the planned GM potato trials in West Tokyo City. (See: BJ June 2004) Also, a briefing held by Syngenta Seed and DuPont in Ushiku, Ibaraki, became entangled when facile descriptions and an aggressive approach to meeting procedure ended with participants being very dissatisfied with the companies' presentation. The companies agreed to hold another briefing, which was not forthcoming, and therefore the planned trials were called off. In Hiratsuka, Kanagawa, a planned open-air trial was switched to a glasshouse research trial due to a request by the Prefecture. On-site confusion continues. (See Closeup article)

Table 1: GM crop field trials
Crop	Location	Developer
Cancelled trials:
High-yield GM potato	Field Production Science Center, Graduate School of Agricultural and Life Sciences, University of Tokyo (West Tokyo, Tokyo)	NIAS
Insect resistant GM maize	JAPR (Ushiku, Ibaraki)	Syngenta Seed
Herbicide tolerant & insect resistant GM maize	JAPR (Ushiku, Ibaraki)	DuPont
Cancelled open-air trial:
Cedar pollen allergenic GM rice	JA (Hiratsuka, Kanagawa)	NIAS
Planned open-air trials:
Erect-leaved semidwarf GM rice	NIAES (Tsukuba, Ibaraki)	NIAS
Semidwarf GM rice	NIAES (Tsukuba, Ibaraki)	NIAS
Herbicide tolerant & insect resistant GM maize	NIAES (Tsukuba, Ibaraki)	Dow Chemical
High-yield GM potato	NIAES (Tsukuba, Ibaraki)	NIAS
Herbicide tolerant GM soybean (*1)	NIAES (Tsukuba, Ibaraki)	Monsanto
Tryptophan high-accumulation GM rice	NARC (Tsukuba, Ibaraki)	NICS
Herbicide tolerant GM cotton	Monsanto (Kawachi, Ibaraki)	Monsanto
Herbicide tolerant GM soybean (*1, *2)	Monsanto (Kawachi, Ibaraki)	Monsanto
Herbicide tolerant GM maize	NILGS (Nishinasuno, Tochigi)	Monsanto
Herbicide tolerant GM maize	NILGS (Nishinasuno, Tochigi)	Bayer CropScience
Herbicide tolerant GM soybean (*1)	NILGS (Nishinasuno, Tochigi)	Monsanto
(*1) Approved GM crop (*2) Unapproved GM crop Abbreviations and links: Field Production Science Center, Graduate School of Agricultural and Life Sciences, University of Tokyo. The Japan Association for Advancement of Phyto-regulators (JAPR) National Institute for Agro-Environmental Sciences (NIAES) National Agricultural Research Center (NARC) National Institute of Agrobiological Sciences (NIAS) National Institute of Crop Science (NICS) National Institute of Livestock and Grassland Science (NILGS)

"Informal Council on Bio-crops" (representative, Katsutoshi Nagatomo), which promotes domestic cultivation of GM soybeans, announced that it will conduct GM soybean cultivation again this year. However, in order to avoid causing troubles with neighbouring farmers, as well as receiving requests to destroy GM soybeans from local authorities as occurred last year, it will only cultivate the GM soybeans in Monsanto's own research facility in Kawachi, Ibaraki. (See Table 1) According to the cultivation plan, the research will be carried out by Monsanto. There is no mention of "Informal Council on Bio-crops" in the plan. According to the company, Monsanto intends to share the data with the Informal Council after the beans are harvested.

A "Citizens Meeting to Oppose the Worsening of the Organ Transplant Law" was held at Shinagawa National Consumer Affairs Center (NCAC, Tokyo) on 23 May 2004. The meeting was organized by the Consumers Union of Japan in conjunction with 19 other organizations, and individual citizens. Following a keynote address by Makoto Kondo of the Keio University School of Medicine, each organization gave a report and fielded questions. The Liberal Democratic Party Investigation Committee's revised organ transplantation draft law contains (among others) the following four serious problems: (see also previous article in BJ April 2004)

1. Concerning conditions for organ transplantation, organ donation may be carried out even if the desires of the donor are not clear,
2. Concerning conditions for the diagnosis of brain death, neither a written statement from the person involved, nor consent of the family is necessary,
3. For children under 15, organ donation may be carried out with the consent of the family,
4. Widening of the implementation of brain death diagnosis to cover children.

Some people stated that before this law is worsened in an attempt to increase the number of donors by any means available, the 28 cases of organ transplantation carried out thus far should be thoroughly investigated to see if there has been no breach of human rights, and the information made available to the public. The Liberal Democratic Party draft is opposed by many groups, including the Japan Medical Association. Although it is unclear how the draft will be finalized, the meeting agreed that the task for the time being was to carry out broad campaigning to prevent the enactment of the diluted organ transplant law.

The deliberations concerning the handling of human embryos in the specialist panel on bioethics (which reports to the Cabinet Office Council for Science and Technology Policy) have become quite chaotic. (See previous articles in BJ May 2004) Japan's human clone law (Law concerning Regulation relating to Human Cloning Techniques and Other Similar Techniques) states that a conclusion must be reached within three years of enactment, and the deadline for the final report should have been June 2004. However, there is a wide gap in opinions between the committee members and it has not been possible thus far to reach a conclusion.

There are two main sticking points: Whether or not to allow the production of cloned embryos, and whether or not to allow the production of fertilized ova for research purposes. However, originally the purpose of the specialist panel was to hold comprehensive deliberations concerning human embryos, and it is hard to deny that the discussions have been sidetracked along the way. The intended comprehensive discussions have simply not taken place. At a meeting on 8 June 2004, the panel chairman, Taizo Yakushiji, stated that the disputed points "would have to be settled by a majority vote." Apparently a final report will be completed before a full panel meeting to be held in July.

The basic policy on protection of personal information was approved at a cabinet meeting on 2 April 2004. Following on from this, MEXT has decided to set up a "sub-committee on the handling of human genetic information in life science research" under the Bioethics Committee, and the MHLW has decided to set up a "specialist panel on the handling of personal information in medical research" under the Science and Technology Council. The background to these new committee establishments is that following the sequencing of the human genome the collection of large amounts of personal genetic and treatment data has been occurring in order to carry out sequencing of single nucleotide polymorphisms (SNPs) and so on. A further element is that internationally, an "International Declaration on Human Genetic Data" was approved at UNESCO in October 2003. Apparently, it is intended to rough guidelines for specific laws in time for the full enforcement of the Personal Information Protection Act on 1 April 2005.

The 19th meeting of the specialist committee on research into embryos and human ES cells (a consultative body of MEXT under the Council for Science and Technology) was held on 28 May 2004, and two proposals for the use of human ES cells from the Institute for Frontier Medical Sciences of Kyoto University were approved. The programs will use human ES cells established by the Institute. One proposal is for the development of a new culturing technique, and the other is for an attempt to introduce several foreign genes into human ES cells by use of genetic engineering. According to the outline of the Kyoto University proposal, "the establishment of various kinds of genetic manipulative techniques is indispensable" to the medical application of human ES cells. In other words, the objective is to increase the number of genetically altered cells for future administration into human bodies. This is the second case of approval of a GE experiment on human ES cells, the first being the approval of a Keio University School of Medicine application in October 2002 (see previous article in BJ December 2002).

Field trials were planned for the "cedar pollen allergenic GM rice" developed by National Institute of Agrobiological Sciences (NIAS) at the Japan Agriculture (JA) facility in Hiratsuka City, Kanagawa Prefecture. The GM rice variety has the cedar pollen allergen produced in the rice grain and this is intended to have a preventative effect by gradually accustomizing the consumer by hyposensitization. An explanatory meeting held on 8 May 2004 ended in chaos, and later the Governor of Kanagawa Prefecture, Mr. Matsuzawa, called for voluntary restraint in the field trial of the GM rice variety. Finally, on 26 May, JA announced the suspension of the external field trials.

This rice variety, developed by the research team under Fumio Takaiwa of NIAS, has already undergone a pilot study, testing the GM rice on mice carried out jointly with Jikei University School of Medicine and Tokyo University's Medical Science Laboratory. The pilot study showed good results, and they were therefore working toward practical introduction of the GM variety. The plan this time was to grow the rice necessary for a full animal trial in the near future.

In addition to the two universities, Japan Paper Industries Co. Ltd. and JA were to be involved in the experimentation. The research was to be carried out as a part of the MAFF project for GM crop development, the "Research for Agribio Practical Use and Industrialization," to run from 2004 to 2008 (budget in 2004, 4,580 million yen). Japan Paper Industries has a technique for inserting genes that does not involve an antibiotic gene, and it is intended that this technique be used at the time of commercialization.

The cedar pollen allergenic GM rice contains an artificial gene composed of a chain of seven epitope sequences (the areas that function as allergens) from the two main genes (cryj1 and cryj2) producing the allergenic proteins that are the cause of the cedar pollen allergy.

Up to now GM rice containing three kinds of genes has been developed: 1) the chain of seven epitope sequences, which is the variety due to be used in the proposed experiments, 2) a variety containing a fragment of the cryj1 gene, and 3) a variety containing the epitope which mice showed the greatest reaction to.

1) and 2) were used in the pilot study at Jikei University School of Medicine, and 3) was used in the Tokyo University Medical Science Laboratory pilot study. Currently, animal experimentation concerning allergies are generally carried out by nasal drops to mice, and then sampling and analyzing the blood serum and lymph nodes. The three GM rice varieties were found to be effective when using this method, but it has been pointed out by Masaharu Kawata that "these have been shown to be effective when first administered to healthy mice followed by exposure to the allergen, and this does not prove that they are effective treatment or prevention for mice which have the pollen allergy." Furthermore, it is atmospheric pollution that is the cause of the allergy, not the cedar.

The occurrence of an unintended unknown change in the GM rice variety itself, or cross breeding with rice in the local area through genetic pollution are unknown factors. The external field trials have been suspended, but the rice for the animal experiments is due to be cultivated in greenhouses. Since the project has funding from the massive "Research for Agribio Practical Use and Industrialization," it probably cannot be cancelled.