On 16 May 2003, the food sanitation biotechnology sub-committee of the MHLW Pharmaceutical Affairs and Food Sanitation Council completed a report proclaiming as "safe" two crops and two food additives. The Council is expected to approve the report, allowing the crops and food additives to be marketed.

The two crops were a potato variety and a beet variety from Monsanto Japan, and the additives were lypase from Novozymes Japan and chymosin from Nozawagumi. The Monsanto potato variety was the NewLeaf Y (with insecticide and virus resistant characteristics), which became a big problem when it was discovered in the House Foods potato snack "O-zack" despite lack of approval for use as human food. The beet is a herbicide (Roundup) resistant variety.

Review of the papaya, the first GM crop for direct consumption, and therefore thought to be the focus of the meeting, had to be deferred. The explanation was that the required additional materials had not been submitted, but it has been pointed out that this papaya has a new problem connected to allergy induction, and this may have had an effect on the proceedings. This completes the safety review work of the MHLW, which moves over to the Food Safety Commission of the Cabinet Office from July.

The State Council of China (Guowuyuan) formulated new management regulations which include regulations on GMOs, and these came into operation on 20 March 2003. As an big exporter of soy the USA has put pressure on China, saying that this is in effect an attempt to regulate imports, and therefore imports into China have continued on the basis of a provisional approval (see Biojournal, June 2002, not translated).

The provisional approval was due to expire on 15 December 2002, but USA won an extension of the approval until 20 September 2003 (see Biojournal December 2002, not translated). However, it has recently become clear that the USA has gained a further extension of the provisional approval until 20 April 2004. China's GMO regulations are losing their effectiveness due to repeated extensions of the of the provisional approval.

The Belgian plant biotech company Crop Design has announced that it has developed 36 new varieties of GM crops for yield increase and so on. It has stated that the rice variety included in these new varieties will begin field trials this year at an undisclosed location. Since the company has carried out trials in China previously (see Biojournal October 2002, not translated), it is very possible that the trials will take place in China and/or other Asian countries.

The company has unique genome screening technology, the Trait Mill, which can pick out genes useful for improved varieties and pharmaceutical development from the genomes of plants. Japanese corporations are expressing interest in this technology and it has been decided that Marubeni will be the representative of Crop Design in Japan. (Nikkei Biotech, 26 May 2003)

The agribiotech division of Mitsubishi Chemicals, the Plantech Research Institute, has thus far produced and marketed such rice varieties as "Yumegogochi" and so on using protoplast culturing technology. However, Mitsubishi has now totally withdrawn from rice variety development, transferring its rights to Nakajima Yoshio Trading of Shiga Prefecture. The company had already suspended development of GM rice varieties due to lack of acceptance by consumers.

Of the private companies involved in the development of new rice varieties in Japan, Japan Tobacco Industries and Kirin Beer have already pulled out, and with the recent withdrawal of Mitsubishi Chemicals, the sole remaining company is Mitsui Chemicals. Mitsui focuses on the development and marketing of hybrid varieties and has already suspended the development of GM rice. Thus, GM rice development in Japan is now being carried out only by a former research institute of the MAFF (now an independent body) and Iwate Prefecture (see Close-up in this issue).

Hepatitis B vaccine is receiving attention in the field of molecular agriculture - the production of pharmaceuticals from plants. A hepatitis B vaccine-producing potato has been developed by Roswell Park Cancer Institute of New York State. This potato expresses hepatitis B surface antigens, and it is reported that mice which ingested the raw potato developed resistance to hepatitis B. Because effectiveness is diminished when cooked, similar tomato and banana varieties are being developed. In Japan, a hepatitis B vaccine-producing rice variety is under development at the Tokyo University of Science. (Bio21, 28 May 2003)

A working group for the purpose of producing a draft bill for the reform of the organ transplantation law was set up inside the Liberal Democratic Party on 3 June 2003. The current law, effective from October 1997, carries a clause which states that the law should be reviewed roughly three years after coming into force. The current law restricts the donation of organs resulting from brain death to persons over 15 years of age, and requires written consent from the person involved prior to death and consent from the deceased person's family. The working group is reportedly now considering such changes as removing the 15-year-old restriction, and removing the deceased person's written consent restriction so that organs can be extracted providing the deceased person did not express an objection to organ donation before death and that the family consent to the donation. (Kohno Taro Mail Magazine 3 June 2003)

The first meeting of the investigative commission on guidelines for experimentation on transmissible animal spongiform encephalopathy, whose task it will be to formulate safety standards for the handling of abnormal prion proteins, took place on 3 June 2003. The guidelines will refer to experiments with small animals, such as mouse, and large animals such as cattle. MAFF has already established, in October 2002, a prion research center within the National Institute of Animal Health (NIAH) of National Agricultural Research Organization (NARO), and is in the process of setting up an isolated rearing facility for conducting BSE experiments with cattle and so on within the grounds of the prion research center. The investigative commission is expected to have its second meeting in late June, and complete draft guidelines during July.

Low-temperature resistant rice

On 3 April 2003, MAFF approved external trials and so on for a low-temperature resistant rice variety developed by the Iwate Biotechnology Research Center (see Biojournal June 2003). This GM rice variety (Sasanishiki) contains the glutathione-S-transferase gene, which imparts multiple functions such as herbicide resistance and cold resistance. The problem with this rice variety is that it produces enzymes with multiple functions, and thus contains many uncertain factors. Simply anything could happen, and it is possible that previously unknown problems will arise in with this variety in the future.

Rice variety with an incorporated maize gene

On 28 April 2003, MAFF approved external trials for a rice variety developed by National Institute of Agrobiological Sciences (NIAS) (see Biojournal June 2003). This rice variety contains a corn (maize) gene (c4 phosphoenolpyruvate carboxylase (pepc) gene) in order to stimulate photosynthesis, control growth and increase the size of the grain. The variety used was "Kitaake" and the experiments will be carried out at the National Agricultural Research Center for Hokkaido Region (NARCH) of the National Agricultural Research Organization (NARO). It is uncertain what kind of morphological changes will take place in the natural environment. Because there is a possibility that resistance to acidic soils will be obtained through the expression of this gene, it is proposed to confirm this trait through trials. The problem with this rice variety is that it is being tested in the open despite the fact that no one knows what will happen.

High-level tryptophan storage rice

One further rice variety approved for external trials by MAFF on 28 April 2003 was the high-level tryptophan storage variety developed by the National Institute of Crop Science (NICS) of the National Agricultural Research Organization (NARO). The high-level accumulation of the essential amino acid tryptophan is achieved by use of a rice gene (rice anthranilate synthase ƒ¿-subunit gene). It will apparently be used for feed. Normally, the synthesis of tryptophan is blocked by bonding with anthranilate synthase if the level of tryptophan in the rice increases above the required level. Tryptophan excess arises when this block is removed, but other related plant hormones and so on will also be continually produced as well as the tryptophan. There is a possibility that phenomena such as rice growth and food safety problems will arise as chain reactions resulting from this gene manipulation.