From Bio Journal - November 2003

New Developments Concerning GM rice in Japan

It has recently become known that a disease tolerant GM rice has been cultivated for three years at the National Agricultural Research Center for the Western Region (researcher in charge: Koichi Ishikawa) in Zentsuji, Kagawa. A gene from the rice stripe virus (RSV) coat protein was introduced into rice in order to express a vaccine-like effect. It uses the plant's interferential action, which is similar to the human immunoreaction. The R&D was conducted at the beginning of the 90's by a research organization of MAFF and Mitsubishi Chemical, and at that time two types of rice "Nihonbare" and "Kinuhikari" were targeted. The former researcher in charge once said that to commercialise this GM rice could be difficult, since there are many patents involved and on top of that the merit for the farmer is scarce, since the GM rice is only tolerant to 1 particular disease. It is surprising that such research has been continued.

Concerning other GM rice developments, MHLW has stated that it will not approve the hay fever treatment GM rice, which was supposed to be a "hyposensitization therapeutic" food, since it produces an allergenic protein in the food. In the US, Bayer CropScience's herbicide resistant GM "LL Rice" may possibly be commercially cultivated next year. This GM rice's principal uses are for processed foodstuffs and for animal feed.

Task Force on GM Food established within Food Safety Commission

On October 6, 2003, one of the emerging foods assessment groups under the Food Safety Commission that deals with genetically modified foods met for the first time. The chairperson is Takao Hayakawa, who is the deputy director of the National Institute of Health Sciences (NIHS). Until 30 June 2003, MHLW was in charge of the safety assessment of GM foods, but from July 1, the Food Safety Commission took over with renewed members. However the new membership is rather unbalanced since five of the 15 members are from the NIHS.

This GM food assessment group is currently formulating an independent safety evaluation standard based on the Guideline for the conduct of Food Safety Assessment of Foods derived from Biotechnology, which was adopted by the Codex Alimentarius Commission in July 2003. Safety reviews will resume following completion of the new standard.

Biotechnology related budgetary requests sharply increase

The budget demand for next year is in place, and the budget related to biotechnology has increased considerably to cover 25% of the entire governmental budget. MAFF is conspicuous, requesting an 87% increase. It has demanded 4.6 billion yen to support development of practical applications of an independent administrative agency's technical seeds. The agricultural use of GM crops is part of this application.
(Nikkei Biotech 2003/09/29)

METI finalises national law to enforce the Cartagena Protocol

On September 29, 2003, a meeting of the subcommittee on GMO management (of the Industrial Structure Council, an advisory panel to the Minister of Economy, Trade and Industry) was held, and finalised a proposal, which defines a concrete procedure and technical standards for preparation of domestic laws in order to ratify the Cartagena Protocol. The Protocol went into effect on September 11, after reaching the number of 50 signatory nations. The first meeting of the signatory nations has been set for February 2004. The enforcement regulations summarized under the METI will be proclaimed in forms, such as a ministerial ordinances and notifications, by November 21, and complete enforcement of national law will take place from February 2004.

MAFF completes guidelines on prion disease animal experiments

A meeting of the investigative commission on experimental guidelines for transmissible spongiform encephalopathy in animals was held on 1 October 2003 to complete the guidelines for animal experiments concerning prion disease that have been under discussion since June (see June 2003 article). The draft guidelines were slightly modified after opinions from researchers at the National Institute of Infectious Diseases (NIID) and others were received during the period allowed for public comment. These guidelines will be applied to research facilities under the jurisdiction of MAFF, and therefore not to NIID, which is under the jurisdiction of the MHLW. Experiments that would be classified as Level 2 under NIDRI regulations are to be classified as the stricter Level 3 experiments under the new MAFF guidelines. NIDRI researchers' comments concerning the tightening of the regulations were not adopted in the final text. With the completion of the guidelines, the road is now open for full implementation of one of MAFF's big projects for the five-year-plan period from fiscal 2003, "Technical Development to Control Prion Diseases such as BSE".

MHLW assesses environmental impact of gene therapy

The Science and Technology Panel (a consultative body under the MHLW Health Sciences Council) held a meeting on 2 October 2003 at which the establishment of a specialist committee to assess the environmental impact of virus vectors used in gene therapy in the run-up to the enforcement of domestic laws in February 2004 in order to comply with the Cartagena Biosafety Protocol. Vectors are "gene carriers" which are used when inserting a new ("target") gene into a genome. Retroviruses and adenoviruses are used. The human gene to be inserted is first inserted into one of these viruses, which is then introduced into a human cell where it inserts the target gene. Virus vectors are therefore GMOs which have been produced by genetic engineering technology, and which are released into the environment. Thus far discussions of genetic therapy have focused on safety and effectiveness, but now it seems that it will also be assessed from the new point of view of environmental impact.

Appeal on discontinuation of GM crop cultivation adopted in Kanagawa Prefecture

In late September 2003, an appeal for discontinuation of the cultivation of GM crops, one of many appeals that have appeared recently, was adopted. The appeal that has been adopted was at Ayase City and Chigasaki City, and its contents were as follows. 1) immediate discontinuation of all field trials of GM crops currently taking place, 2) a moratorium on all field cultivation of GM crops now being planned, 3) a moratorium on all new plans to cultivate GM crops. This is the first time that such an appeal has been adopted in Japan.

Closeup: Preimplantation Genetic Diagnosis

A faculty meeting of the Medical School of Nagoya City University was held on 22 July 2003 at which the application by a group under Obstetrics and Gynecology Department Professor Kaoru Morisuzu to carry out preimplantation diagnosis was approved. The diagnosis is requested by a woman in her thirties who resides in western Japan and whose husband suffers from muscular dystrophy. A further application will be made to the Japan Society of Obstetrics and Gynecology on 10 September, and if this is approved the diagnosis (screening) will apparently be carried out as soon as possible.

Genetic screening has been used in fetal screening since the latter half of the 1980s. Fetal screening is commonly known as "prenatal screening" and is associated with abortions in the case of fetuses with disease or abnormality. Preimplantation genetic diagnosis is one step earlier than prenatal screening and has been carried out in the USA and UK since the early 1990s. In Japan, the Japan Society of Obstetrics and Gynecology stated in 1998 that it would grant conditional approval for preimplantation genetic diagnosis, but there have been no actual cases thus far. Resistance to abortion is deflected by preimplantation genetic diagnosis as external fertilization is carried out and one cell is removed for screening from the fertilized ovum when it reaches the four to eight cell stage. Disease or abnormality will then lead to the embryo being disposed of rather than reintroduced to the uterus. The opportunity for screening is becoming earlier and earlier, from postnatal, to prenatal, and now to preimplantation. The right to life being denied to the diseased and abnormal could possibly contribute to a widening discrimination based on genetic information.

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