The revised MEXT "Guide for Recombinant DNA Experiments" came into force from January 31st this year, and it has become clear that the regulations have been tightened such that, for example, the use of Agrobacterium as a vector (gene carrier) and the introduction of other unknown genes now requires ministerial approval in contrast to the previous agency approval.

Agrobacterium is a bacterium that can cause cancer in plants and its Ti plasmid is in general use in the genetic engineering of plant cells. It is though that this change in the regulations reflects the recent finding that Agrobacterium can also recombine animal cell genes.

A plan for implementation of clinical gene therapy was considered at a meeting of the science and technology sub-committee of MHLW's Health Sciences Council was held on September 27. The term of the plan is three years and involves injection of the beta interferon gene into the foci of malignant melanoma in five patients to try to stem the spread of cancer cells. A vector prepared by the University of Nagoya will be used without any alterations. On paper, the research is being carried out as one part of an intramural research program, but it is essentially a clinical trial for the development of a Japanese-made vector.

A claim against Shinshu University Faculty of Medicine and MEXT by citizens' groups for public disclosure under the national law on information disclosure of the Shinshu University human ES cell utilization program and its application to MEXT was approved by MEXT on September 30th. The contents of the contract concerning distribution of the ES cells and some other material was not disclosed, but the slip-shod behaviour of the university's ethics committee, as previously pointed out, was made apparent.

The application had been pending following several referrals by the ministry and was essentially facing rejection. Several plans for the use of human ES cells have been submitted to MEXT, thos currently under consideration being the three proposals by the Keio University Faculty of Medicine, the Institute of Medical Science Research of Tokyo University, and Tokyo University Faculty of Medicine Hospital.

On Aug. 28, 2002 the Food Sanitation Biotechnology Committee of Pharmaceutical Affairs and the Food Sanitation Council at the Department of Food Safety, Ministry of Health, Labour and Welfare (MHLW) gave approval for insect-resistant Bt cotton (15985) of Monsanto Japan Ltd. as safe for human consumption, after following the approval on 18 July 2002 by FDA (Food and Drug Administration) in the US. This genetically modified Bt cotton (Characteristics: Lepidoptera resistant, Gene: Cry1Ac and Cry2Ab) approval had been on hold in Japan, while awaiting the decision in the US.

On Sep. 19, 2002 the 8th session of the round-table meeting on the environment risk management of genetically modified crops put together the final report on the Cartagena Biosafety Protocol. Since 16 July 2002, four Ministries - the Ministry of Agriculture, Forestry and Fisheries (MAFF), the Ministry of the Environment (ENV), the Ministry of Economy, Trade and Industry (METI) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT) - have established a working group to promote examination of all the required domestic measures toward the early ratification of the Cartegena Biosafety Protocol.

The Cartegena Biosafety Protocol forms part of the framework of the Convention on Biological Diversity (CBD). CBD aims for the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of benefits arising out of the utilisation of genetic resources. The Cartagena Biosafety Protocol, adopted in 2000, provides for such procedures as the appropriate treatment of living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity. Under the Protocol, researchers must specify "genetically modified organisms" when they exchange living modified materials, in the case that the organisms have been modified using biotechnology.

GM crop development is not only being carried out by private companies. Joint development through state-company and local government-company cooperation is quite common. The 9th September 2002 issue if the Nikkei Biotech reports on the state of biotechnology development (crops, fish, livestock) at experimental farms operated by local administrations. Here we focus on just the GM crop development from the report, as follows (in order of Japanese administrative region from north to south:

Ad. Region	GM Crop R&D Project(s)
Hokkaido	Disease-resistant potato
Aomori	herbicide-resistant rice, dwarf apple, low-amylose rice, modified hue rose
Akita	psychrotolerant (cold-resistant) rice, dwarf apple
Yamagata	disease-resistant and long-life balloon flower (Eustoma russellianum), disease-resistant (Western) pear, long-life (Western) pear, psychrotolerant (cold-resistant) houtou (possibly Primula japonica)
Toyama	disease-resistant rice
Ishikawa	bacteria-resistant turnip
Fukui	disease-resistant chrysanthemum
Nagano	disease-resistant balloon flower (Eustoma russellianum)
Shizuoka	virus-resistant chrysanthemum
Aichi	herbicide-resistant rice 'Matsuri-bare', virus-resistant chrysanthemum
Shiga	high nitrogen absorbent reed
Kyoto	disease-resistant flowers and ornamental plants, disease-resistant aubergine, virus-resistant soy
Nara	chitinase-containing strawberries, peroxidase-containing aubergine
Tottori	virus-resistant leeks
Shimane	disease-resistant melon
Hiroshima	dwarf trifoliate orange (Poncirus trifoliata), virus-resistant scallion, disease-resistant asparagus
Ehime	long-life delphinium
Fukuoka	disease-resistant chrysanthemum
Kumamoto	disease-resistant gentian bitter
Miyazaki	virus-resistant sweet potato
Kagoshima	starch-modified sweet potato

Conspicuous are research on well-known products of the various prefectures, and flowers. According to the Nikkei Biotech, research budgets are generally falling because of strong resistance by consumers.