A US company Dupont will begin GM maize field trials in Japan. The targeted GM maize has both herbicide (glufosinate) tolerant and insect resistant (Cry34AB1) genes developed by Dupont's subsidiary, Pioneer Hi-Bred, together with Dow AgroScience. Dupont has applied for this GM maize trial to MAFF, in collaboration with the Society for the Techno-innovation of Agriculture, Forestry and Fisheries (STAFF - a MAFF-affiliated organization), and has received approval. The trial will involve 4 lines of GM maize, which have genes inserted at different positions.

The National Institute of Health Sciences is to embark on pharmaceutical drug producing GM crops research. The Tsukuba Medicinal Plant Research Station (National Institute of Health Sciences, Ministry of Health and Welfare) will establish a facility for this purpose, and the research is expected to begin in the summer of 2004. The facility is to be used for both R&D of its own GM pharm crops and also for development of evaluation methods for imported GM pharm crops.

On 4th July 2003, 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 the application from Gifu University Faculty of Medicine's plan to use ES cells, which was deferred at the previous meeting, was reexamined (See BJ May 2003). The aim is to research into the production of heart muscle (myocardium) cells using ES cells imported from Monash University in Australia. Several members of the committee pointed out that there was an "inappropriate statement" contained in the minutes of the university's ethics committee, which were appended to the application. The deliberations ran aground on the statement by one of the researchers stating that the use of ES cells from surplus embryos "was a way of helping something that would normally have died." In the end, a comment was appended pointing out the offending entry and the plan was approved.

On June 30, the Subcommittee on Management of Genetically Modified Organisms (under the Chemicals and Biochemistry Committee within the Industrial Structure Council) held a meeting, and announced the procedures for ratifying the Cartagena Protocol on Biosafety in Japan. The Protocol reached the landmark 50 signatory nations on 14 June 2003, and will therefore enter into force on September 11. The government of Japan will presumably ratify the Protocol in the autumn of this year, after issuing related domestic decree-laws for prescribing specific measures and technical standards. The Protocol will become effective 90 days after ratification. Currently, related government ministries and agencies are reviewing the decree-laws.

The big industrial-government-university joint projects which started up in Japan in 2003 include the regenerative medicine project and the "program for a bank of genetic information from 300,000 people" (See BJ June 2003) conducted by MEXT as well as MAFF's "rice genome performance analysis research". In the rice genome project, two independent administrative institutes, the National Institute of Agrobiological Sciences (NIAS) and the National Agricultural Research Organization (NARO), together play a central role, and Nagoya University, Meiji University, RIKEN and the National Institute of Genetics (NIG) participate as endowed institutions. From industry, Mitsubishi Chemicals, Hitachi, NEC and JT are expected to join the project. The project leader will be Kousuke Nakajima (Vice President, NIAS), and the budget is estimated to be 45 billion yen over 5 years (the fiscal 2003 budget request is 10.3 billion yen).

In December 2002, decoding of the most important regions of the rice genome (PHASE2) was completed (See: http://rgp.dna.affrc.go.jp/). Japan analysed about 60% of the main part of the genome and was the leading country involved in the International Rice Genome Sequencing Project (IRGSP), a consortium of 10 member countries. At the moment, Japan has filed 50 patent applications concerning rice genome, and among them 36 are filed as rice genome performance. Targets of 100 patents before the end of 2004, and 200 patents before the end of 2008 have been set under the rice genome performance analysis research. According to MAFF's estimates, the results of this research will bring about a market of around 400 billion yen in high functional varieties, 200 billion yen in treatment products for specified diseases, and 100 billion yen in health food materials.

Corn harvested in the Gisborne region, New Zealand, by Sunrise Coast New Zealand Company was found to be contaminated with genetically modified material. The corn seed was bought from Syngenta (Switzerland). The GM contamination became public after a Japanese pizza producer notified its exporter, Kiwi, that the corn had showed up as GM positive. Sunrise Coast New Zealand Company announced that the corn was only for the Japanese market, and therefore not to be sold in New Zealand.

A Gifu University part-time lecturer, Dr Hiroyasu Nakazato, presented a report at a meeting of the Japanese Association of Medical Informatics held in Matsumoto City, Nagano Prefecture, on 21 June 2003 showing that glyphosate used in Roundup and other herbicides may well be responsible for the rapid increase in lack of development of adult teeth among children. 1200 children are treated at Dr Nakazato's clinic each year, and from three years ago the number of children missing one or two adult teeth has been rising to a current level of 85 per year (7%), which is very much higher than the natural rate of deformity (0.1%). It is thus thought that an environmental factor must be at work, and it is suggested that the main cause may be glyphosate. With the increasing use of GM crops, global standards for residual glyphosate have been relaxed, leading to a rapidly rising human intake of the chemical. (Sankei Shinbun, 11 June 2003)

The Iwate Medical University has recently decided to participate in the national project "program for a bank of genetic information from 300,000 people", into which MEXT is pouring 20,000,000,000 yen, bringing the number of participating organizations to eight. The blood samples from 300,000 people will be collected from the 37 hospitals related to the participating organizations, but enthusiasm for the program is apparently not the same in all eight organizations. In university medical faculties, which are divided into departments, it has been difficult to solicit the agreement of all the staff, the current state being that institutes as a whole are unable to participate fully in the program. However, the enormous medical corporation Tokushukai, with a staff of 16,000, is an exception. 21 of the 37 hospitals involved in the collection of blood samples comes under the Tokushukai umbrella, and this number is expected to rise to 25 in five years' time. (Nikkei Biotech 9 June 2003)

The venture company A-HIT Bio, founded by former Hokkaido University professor Fusao Tomita,, will be taking mail orders for natto (a fermented soybean food product) produced from Monsanto's RoundupReady soy (a herbicide resistant soy) from July. The product information for the brand "Natto no susume" states that the product will contain more than 95% GM soy. (Nikkei Biotech 23 June 2003)

The meaning of recent developments with cloned animals

Cloned animals have been in the news recently: On 9 April 2003, two cloned Javan bantengs (a cattlelike creature native to Southeast Asian jungles), an endangered species, were born at San Diego Zoo in the USA. On 30 May 2003, a cloned mule (a cross between a pony and a horse) was born from a horse at Idaho University in the USA.

The techniques used in the "reproduction" of these cloned animals is basically the same as was used with Dolly the sheep. A somatic cell (a cell other than an ovum or sperm cell) is inserted into an unfertilized ovum from which the nucleus has been removed. The ovum is then replaced in the uterus, where it is germinated and brought to term. The issue is the origin of the various cells (see chart).

Animal	ovum	somatic cell	surrogate mother
Dolly	sheep	sheep	sheep
banteng	cow	banteng	cow
mule	horse	mule	horse

In the case of Dolly, it has had an important effect on the pharmaceutical business. In the case of the banteng, the "conservation of endangered species" is involved. The purpose of cloning mules is uncertain, but it seems that researchers have a wish to see if they can succeed in cloning animals from the three elements; the ovum, the somatic cell, and the uterus, using species which are as different as possible. For example they might want to try taking an ovum from an elephant, a somatic cell from a mammoth to see if they can "produce" a mammoth from an elephant mother, and so on.

Humans as a "resource" for ES cell production

On 28 May 2003, the news that a research group at the Kyoto University Regenerative Medicine Research Institute (Director, Norio Nakatsuji) had succeeded in producing the first Japanese-made human ES cell hit the front pages of the newspapers. It has been confirmed that the cells will differentiate into nerve cells, and that they multiply without any problems. A free-of-charge distribution to domestic research establishment will begin as early as October. Some newspapers expressed concerns over ethical issues and information release, but the press coverage was largely favourable. The keyword used was generally "regenerative medicine", and phraseology expressing great promise for the future was used, e.g. the Asahi Shinbun, "a trump card for regenerative medicine."

The market for the "new medicine" of the 21st century, regenerative medicine, is thought to be worth several tens of trillions of yen if related industries are included. One of the merits of regenerative medicine is the solution to the problem of lack of donors. However, even though ES cells can be multiplied at will, the original cells must originally have come from someone, as human ES cells originate from human embryos.

Under MEXT guidelines, embryos used for the production of human ES cells are limited to surplus embryos from fertility treatment, donated free of charge with informed consent. It is not permissible to produce new embryos for the purpose of producing human ES cells. What we must not forget is that even if social objection is alleviated by the use of "surplus embryos", it still represents the promotion of the industrial "resourcification" (the turning into "resources of) the human body.