From Bio Journal - June 2003

Trend: External field trials for GM rice approved

MAFF approved external trials and so on as meeting the requirements of the guidelines for three GMOs on 3 April 2003. One of the three approvals was for a trial in an isolated experimentation field of a low-temperature resistant rice variety (Sub29-17) developed by the Iwate Biotechnology Research Center. The Research Center held a local explanatory meeting in Hojo City on 20 April 2003.

This transgenic rice variety contains the glutathione-S-transferase gene, which imparts herbicide resistance and cold resistance, and which has already passed trials with tobacco.

The Iwate Biotechnology Research Center was established in April 1992 with 100% funding from Iwate Prefecture. Despite withdrawals from GM crop development by nearly all local governments, Iwate is one of the few local governments, along with Shimane Prefecture, which is developing a GM melon, that is still actively involved in the development of GE crops. Thus far the Research Center has compiled a database on genes involved in cold resistance and disease resistance in rice, and has conducted research on rice blast disease (imochi-byo) resistant rice, the use of GE yeast for sake brewing, papayas, strawberries, shiitake mushrooms, soya, and so on.

On 28 April 2003, MAFF approved a further nine cases of GM crops for external field trials, two of which were for rice varieties. One approval was for a general use rice from the National Institute of Agrobiological Sciences (NIAS) and the other from the National Institute of Crop Science (NICS) of the National Agricultural Research Organization (NARO) for use in an isolated experimentation field.

The NIAS rice varieties (PE2, PE84) have genes from corn (maize) inserted in order to stimulate photosynthesis, control growth and increase the size of the grain. The NICS varieties (HW1, HW5), produced using rice genes, store high levels of the essential amino acid tryptophan. The features of these rice varieties approved recently is that they were all developed using Japanese technology and all differ in some way from the previous herbicide resistant or insect resistant varieties.

"Cloned cattle are safe" - MHLW research team

On 11 April 2003, a MHLW research team finalized a report stating that somatic cell cloned cattle were "safe". The report concludes that there is no possibility of a new toxic or pathogenic protein arising from cloned cattle when compared with conventional cattle on the basis of experiments carried out by the Livestock Biochemistry Safety Research Institute showing that rats and so on that were fed meat and milk from somatic cell cloned cattle exhibited no signs of abnormality (see 2002/10), from research papers on the chemical constituents of milk and meat, and from an analysis of the domestic and overseas literature. Deliberations have begun to allow distribution of the milk and meat as human food on the basis of the report.

On 6 May 2003, the "Draft Basic Law on Food Safety" passed the regular session of the Japanese Upper House. Under the new law, a food safety committee (commission) will be established in July. In contrast, a citizens' food safety watchdog committee (representative: Michiko Kamiyama, lawyer, secretariat: the Japan Consumers' Union) was set up on 19 April 2003.

It looks as though the first big job for both the official safety committee and the watchdog committee will be somatic cell cloned cattle products.

MAT vector used for GE rice

On 3 April 2003, Nippon Paper Industries announced at a meeting of the Japanese Society of Breeding that they had developed in cooperation with the National Institute of Agrobiological Sciences and Sanwa Kagaku Kenkyusho Co., Ltd. (Sanwa Chemicals Research Institute Co., Ltd.), a rice variety incorporating the insulin secretion promoting peptide hormone GLP-1, which accumulated high levels of GLP-1 in the rice. The interesting feature of this GE rice variety is that the insertion method used the MAT vector developed by Nippon Paper Industries. The important point concerning this vector is that it does not use an antibiotic-resistance gene as the selection marker. This has the advantage of reducing concern about antibiotic resistant bacteria spreading in the environment, but the disadvantage that the insertion rate of the target gene is significantly lower than methods which use the antibiotic resistant gene as the selection marker, which helps to promote gene insertion. The high-level GLP-1 variety was produced this time by using an improved MAT vector to which an antibiotic resistant gene had been tagged to help insert the target gene, and then later removing the antibiotic resistant gene.

ES cell manipulation at Kyoto University and Tokyo Metropolitan Institute of Technology

The exploratory medicine team under Asst. Professor Masayo Takahashi at Kyoto University Hospital have succeeded in making an eye lens from ES cells taken from crab-eating macaque. ES cells are sometimes called "master cells" because of their potential to differentiate into any kind of tissue or organ.

Further, researchers under Professor Kanji Miyamoto at Tokyo Metropolitan Institute of Technology have developed a method of culturing ES cells from monkey using human placenta cells. Previously, fibroblasts from mouse fetuses were used. This had the disadvantage of possible infection from mouse viruses.

(Nikkei Keizai Shinbun 14 April 2003, and others)

The 2 May 2003 issue of Science also notes that a French and American research group have produced an ovum from mouse ES cells.

Heated discussions over 300,000 person gene bank program

The "program for a bank of genetic information from 300,000 people", into which MEXT is pouring 20,000,000,000 yen, began this fiscal year, April 2003 (see previous issue). A meeting of the life ethics and safety subcommittee in the Life Ethics Committee of the Council for Science and Technology (MEXT) was held on 6 May 2003 to consider the ethical aspects of this program. Some committee members strongly criticized MEXT for creating a fait accompli by making budget appropriations first and then later requesting the committee to consider ethical issues. Kyoto graduate school professor Ida Ryuichi stated, "In the first place the process is all wrong. If they are going to carry out a large-scale research project on 300,000 people, they should of course have it thoroughly discussed beforehand. That's what has been happening in the UK and Iceland." In the end, MEXT was forced to accept the following two points: 1) A group should be established within the project working committee to oversee ethical aspects, such as appropriate use of informed consent, and 2) That when similar research is carried out in the future, ethical aspects should be considered beforehand.

The Post-Human Genome Project, ENCODE Project, gets underway

The completion of the 6-nation (Japan, USA, UK, Germany, France, China) Human Genome Project to analyze the sequence of bases of human DNA was formally proclaimed on 14 April 2003. With the exception of about 1% of the base sequence, which could not be analyzed for technical reasons, the sequencing of all 2,860,000,000 bases was completed. The number of genes in the genome was found to be about 32,000, far fewer that the 100,000 originally anticipated.

The US government is now preparing a project called the ENCODE Project to identify the functions of all the genes as a follow-up to the genome sequencing project. Under the program, a pilot program to analyze the function of about 1% of the total genetic DNA will be carried out in the first three years, after which the project will get fully underway on the basis of the results from the pilot study. The purposes are to mine the genomic sequence in order to develop new medicines and to obtain patents.

Private enterprises as well as public research institutes are to participate in the project. Researchers from countries which opposed the war in Iraq were not invited to the meeting which took place on 7 March 2003, and researchers from Japan, Spain, Israel, UK, and Switzerland took part in the meeting. Yoshihide Hayashizaki, of RIKEN (The Institute of Physical and Chemical Research, Japan) participated in the meeting from Japan, but it is still unsure whether Japan will play a role in the project. Research assignments will be made on 1 July 2003, and the pilot project is due to begin from 1 September 2003.

(Nikkei Biotech 28 April 2003, and others)

Approval for production and sale of GM mouse

MAFF announced on 3 April 2003 that the transgenetic rat produced by the Japan SLC company met the conditions for the "Guidelines for the use of recombinants in the field of agriculture, forestry and fisheries" as a small laboratory animal. This rat is from the Sprague-Dawley strain of the genus Rattus norvegicus. The vector used was pCAGGS. The inserted gene was the rat regucalcin gene. This gene is involved in information transmission and is said to be reliably inherited. The purpose is to manufacture and sell the rat as a laboratory animal.

Since 1989 there have been 233 cases (to 28 April 2003) of recombinant use programs that have met the conditions of the above Guidelines. Of these, approximately 80% have been plants, and 27 have been small animals, mostly rats. There have also been 26 cases involving bacteria.

Closeup: Two topics concerning regenerative medicine - patentization and economic stimulation

The notion of the patentization of medical treatments was put forward several times last year in various government forums. On 5 June 2002, the research society on industrial competitiveness and intellectual property reported that is was necessary to patentize regenerative medicine and genetic therapies. On 13 June 2002, the Expert Panel on Management of Intellectual Properties of the Cabinet Office Council for Science and Technology Policy (COCSTP) proposed the patentization of the advanced medical field. Then on 3 July 2002, the government's Council on Intellectual Property Strategy completed a an "Outline for Intellectual Property Strategy", which called for an expansion of the areas covered by patent rights.

Following this, the Japan Patent Office announced that patents would be accepted for the previously ineligible field of medical treatments, drew up application criteria, and are due to begin accepting applications this summer (2003). Thus patents will now be granted for genetic therapies and diagnostic techniques, overturning the previous principle of not granting medical patents outside the areas of medicines and medical equipment.

It is thought that the first such patents to be granted will be in the field of regenerative medicine, possibly autotransplantation, where cells taken from a patient are reinserted into the same patient. Sooner or later, as in the USA, it is likely that cases where diagnosis or treatment cannot be carried out due to patent obstructions will occur.

One of the big projects that MEXT is starting up in fiscal year 2003 is the "Regenerative Medicine Realization Project." In the first five years of the project, it is planned to amass several tens of thousands of stem cell types to build up a "human stem cell bank." At the same time, development of cell treatment techniques and hybrid artificial organs using stem cells will be carried out. The research institutions participating in the project are the Center for Developmental Biology of RIKEN (The Institute of Physical and Chemical Research, Japan), The National Institute of Advanced Industrial Science and Technology, Kyoto University, Keio University, and Tokyo University Institute of Medical Science. The project leader is the Kyoto University Professor Shinichi Nishikawa, and the budget for the 15-year project period is 80,000,000,000 yen (12,500,000,000 yen being borne by industry). MEXT has already appropriated 7,000,000,000 yen in the supplementary budget for fiscal 2002, and 1,300,000,000 yen in the regular budget draft for fiscal 2003.

The recent flurry of big projects starting up that require previously unheard of budgetary appropriations is mostly due to the power of the COCSTP. All of MEXT's big projects are those for which the COCSTP called for proposals to all the ministries as part of the "Research and Development Projects for Revitalization of the Economy", which have been given new budgetary arrangements outside the established framework for research funds. The R&D projects to stimulate the economy were proposed by the COCSTP as a "culmination of business-academia-government collaboration" for the purpose of creating new industries. The total budgetary appropriation for these projects over the next 5 years has been set at approximately 1.5 trillion (1,500,000,000,000) yen. MEXT's bioscience-related projects alone account for 21,200,000,000 yen in the supplementary budget for fiscal 2002, and 4,800,000,000 yen in the regular budget draft for fiscal 2003. Discussion of ethical issues has been left behind in the cloud of dust created by the sudden acceleration of Japan's biotech policies, which are surging forward under the banner of economic stimulation.

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