Genetically modified rice developed by the Plant Biotechnology Department of the National Institute of Agrobiological Sciences (NIAS), an Independent Administrative Institution (IAI) supervised and financially supported by MAFF, to alleviate cedar pollen hay fever will undergo full testing using animals. Researcher Fumio Takaiwa and his team developed the GM rice with an allergenic substance in order to ease patients' symptoms of the disease through the eating of this GM rice. The team has already conducted a pilot study by testing the GM rice on mice jointly with Jikei University School of Medicine and Tokyo University's Medical Science Laboratory. The pilot study showed good results, and they are therefore working toward practical introduction of the GM variety. The animal tests will be conducted with additional involvement by Nippon Paper Industries and Japan Agricultural Cooperatives (JA), as a part of the MAFF's project on technological development for the creation of agri-business, with the full involvement of private sector interests.
(Nikkei Biotech 2004/02/16)

On February 19, 2004, the domestic laws to regulate the transboundary movements of living modified organisms (LMOs) in accordance with the Cartagena Protocol on Biosafety to the Convention on Biological Diversity took effect in Japan. Antecedent to the enforcement, a public debate was held on Feb. 17, at an assembly hall of the House of Representatives, inviting officials from the MAFF and the Ministry of Environment. According to a MAFF official, the law is only applicable to wild fauna and flora, and not to farm products. Therefore it cannot be used to counteract unregulated GM crop cultivation. Presumably, the matter concerning farm products will be regulated in Japan in accordance with another international treaty.

In an opinion regarding wild fauna and flora, an official mentioned the GM maize contamination case in Mexico, stating, "Since there are no wild species existing in Japan, no such incident can occur". Thus, there are hardly any subjects for this regulation actually existing in Japan.

The FAO Conference adopted the International Treaty on Plant Genetic Resources for Food and Agriculture, in November 2001, agreed by 116 countries. This treaty's objectives are the conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of benefits derived from their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security. Japan has been refusing to sign the treaty, because it might block the possibility of patenting gene maps. However, since the treaty will enter into force this year, the government has changed its position and decided to ratify the treaty, and to advocate that genetic parts or components which have undergone innovation be the subject of intellectual property rights.

The Japanese CRO Association (The Japanese Contract Research Organization Association) has set up a working group on foodstuffs in order mainly to formulate independent industry guidelines for clinical tests to assess "tokuho" health foods, health foods recognized by MHLW as having appropriate health benefits and which have approval to label as such. JCROA also expects to reassess food ingredients that have received MHLW approval to label in the past once their system is up and running.

The Health Food and Nutrition Food CRO Liaison Group (within the Japan Health Food and Nutrition Food Association, JHNFA) was also set up in August 2003 as an organization for the clinical testing of health foods. The relationship between the two organizations is unclear. What does seem to be clear is that we are now entering an era in which scientific appraisal will be required for health foods.
(Nikkei Biotech 2004/2/2)

The National Institute of Agrobiological Sciences (NIAS), an Independent Administrative Institution (IAI) supervised and financially supported by MAFF, set up an "Office to Promote GE Research" (Director, Yutaka Tabei) in December 2003. The purpose of this new office is to strengthen the efforts for PA (Public Acceptance) of GE research among the general public. They have announced plans to increase personnel and to "go on the attack" against regulations concerning the cultivation of GE crops which are being introduced by local governments and other bodies. (See Closeup)
(Nikkei Biotech 2004/2/16)

A meeting of the Liberal Democratic Party (LDP) Investigation Committee on Brain Death, Bioethics and Organ Transplants (Chairman, Upper House Diet Member Hideki Miyazaki) was held on 25 February 2004, at which a draft for a revised law on organ transplants was finalized. The current law came into effect in October 1997, and was to be revised within three years. Discussions have been continuing with an aim to revise the law. The revised draft would allow organ donation from children under 15, saying that, "if there were no refusal on the part of the person involved, then donation could be carried out with the consent of the family (of the deceased person)." Concerning implementation of diagnosis of brain death, the draft states, "Neither a written statement from the person involved, nor consent of the family is necessary." The contents of the draft law are a fundamental revision of the of the current law, which upholds "respect for the wishes of the individual involved" as its basic principle. It is expected that the draft will be discussed in the all-party bioethics research group (Chairman, Lower House Diet Member Taro Nakayama) in order to be introduced as a bill in this session of the Diet.

The secretariat of the Cabinet Office Council for Science and Technology Policy sponsored a "Symposium on the Human Embryo" in Tokyo on 8 February 2004. The symposium was an opportunity to explain the interim report published late in 2003 by the specialist panel on bioethics, entitled "Basic Thinking on the Handling of Human Embryos", and for a panel discussion to be held by the members of the specialist panel as part of the activities concerned with the soliciting of public comment on the interim report. One of the panelists, Professor Susumu Shimazono of the Graduate School of Tokyo University, criticized the way in which the interim report was finalized, stating, "The content of the discussions are not sufficiently reflected in the report," and further that, "Bioscience has advanced such as to have a strong potential regarding the manipulation of human life. There is great danger in promoting research by concentrating only on the beneficial aspect of treatment of incurable diseases." The symposium was also held in Kobe on 15 February 2004.

On 13th February 2004, a 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 and a new application for a program utilizing ES cells was approved. This program concerns research using human ES cells which have been previously produced.

The program concerned is a joint research program between Tanabe Seiyaku (Pharmaceutical) Co. Ltd's Advanced Medical Research Laboratories and the Department of Medicine of Jichi Medical School. The program will use human ES cells imported from the Swedish company Therapeutics Scandinavia AB, and will attempt to develop differentiation-inducing therapy for nervous system cells, and subsequently transplant these into model animals (rat, monkey) for Parkinson's disease. This program application was first submitted at this meeting, and was approved the same day, the deliberations having been very speedy in this case.

Regulation GM crop cultivation is intensifying among local governments. Since Fujishima Town in Yamagata Prefecture adopted its bylaw in December 2002, the wave to restrict GM crop farming is spreading from local authorities to prefectural governments, e.g. Hokkaido, Ibaraki, Iwate and Shiga. (see: Closeup, BJ January 2004 Jan journal0401.html)

In Iwate prefecture, "a guideline to regulate cultivation of GM food crops (tentative name)" to restrict GM crop farming on farmland was presented at a Food Safety & Security Committee meeting on 9 February 2004. The guideline is expected to be drawn up before the year end.

Under these circumstances, Hokkaido's move has attracted the most attention. Hokkaido's plan is to enforce its regulations from April 2005. However it has revealed plans to restrict both farmland and experimental trials fields during the transitional period.

Demands for the tightening of regulations concerning GMOs have been growing, and on 13 February 2004, citizens handed in a petition to the governor of Hokkaido containing 370,000 signatures opposing GM rice.

On the other hand, Japanese government and business circles have expressed a sense of crisis concerning such regulations. MAFF has tried to put pressure on Hokkaido. Officials from MAFF were sent to Hokkaido's Agricultural Policy Planning Department in order to communicate MAFF's opinion, and even asked the head of the Department to come to the office of MAFF in Tokyo. Furthermore, researchers at the Agricultural Academy of Japan and others submitted an appeal opposing Hokkaido's GM crop cultivation restrictions, since such regulations might possibly limit their research and development of GMOs.

The guideline was drastically revised and presented on March 5. The next focal point will be to see how GM crop cultivation on experimental trials fields will be restricted by bylaws.