From Bio Journal - September 2003

Discussion on safety of genetically engineered animals to start in November?

The joint FAO/WHO Food Standards Programme Codex Alimentarius Commission 26th Session was held at FAO Headquarters in Rome, Italy, between 30 June and 7 July 2003, where the "Guidelines for the Food Safety Assessment of Foods Derived from Biotechnology" was adopted. The Codex ad hoc Intergovernmental Task Force on Foods derived from Biotechnology, chaired by the government of Japan, was held over 4 years from 2000, and drew up the draft guidelines. From now on, these Codex Standards will function as an international standard, and will become the basis of safety evaluation in each country (see BJ April 2003).

These are the standards that were adopted at the Commission meeting: "Principles for the Risk Analysis of Foods Derived from Modern Biotechnology", "Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants", "Guidelines for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms" and "Annex on the Assessment of Possible Allergenicity". The Task Force in Japan has ended, but "The Safety Assessment of Foods Derived from Genetically Modified Animals" has not even been discussed yet, and this issue therefore still remains to be tackled.

FAO (the United Nations Food and Agriculture Organization) and WHO (the World Health Organization) Joint Expert Consultation on "The Safety Assessment of Foods Derived from Genetically Modified Fish" will start in November. There is an increasing possibility that the issue on GM livestock will be included in the consultation agenda item as well as GM fish.

Toyobo etc. develop GM sweet potato

The Toyobo Research Center, the Faculty of Bioresources at Mie University, and Ishikawa Agricultural College have jointly developed a sweet potato, which is tolerant to low temperature and has increased resistance to salt by introducing a polyamine synthesized gene. Even by adding polyamine (a simple protein - a storage protein in seed) itself to a sweet potato, they achieved a result giving the same characteristics, according to the research. The researchers said that it will lead to expansion of cultivation of sweet potato, which grows naturally only in warm climates.

Japan Medical Association protests to MEXT concerning genomic medicine

On July 16, 2003, the Japan Medical Association (JMA) submitted a protest letter to MEXT concerning the blood sampling for genomic medicine research, which is being conducted as part of national Millennium Project. The aim of the project is to analyse cancer-related genes among the residents of Kumano Town, Hiroshima Prefecture, and is conducted by the "general overview" group of the "specific area research - cancer epidemiology" under MEXT. Some influential people of the town were involved in the solicitation of participants for the research, and had taken the procedure of obtaining informed consent. At one of local areas, although 24 of 90 people felt uneasy and expressed a wish not to participate, in the end only 4 were able to refuse sampling after persuasion by the influential people to the effect that the honour of the chairman of the residents' association should not be sullied. JMA received an e-mail about this situation, and subsequently submitted the protest to MEXT saying that the privacy and free will of the residents had not been respected. The research will be postponed for at least a year and will be thoroughly reassessed.
(Nikkei Business Publications, "Personalized Medicine Website", 21 July 2003)

MAFF formulates draft experimental guidelines for prion disease

A meeting of the investigative commission on guidelines for experimentation on transmissible animal spongiform encephalopathy was held on 5th August 2003, at which the draft guidelines for safety standards for animal experiments involving abnormal prion proteins, the supposed pathogen in BSE and related diseases, were formulated. (See previous article) Covered in the guidelines are small animals such as mouse, and larger animals such as cat, rabbit, dog, sheep, cattle and horse. The guidelines will be available for public comment for about three weeks, and then are due to be finalized at the next meeting of the commission, due to be held in late September. Preparation of the guidelines will allow full implementation of one of MAFF's big projects for the five-year-plan period from 2003, "Technical Development to Control Prion Diseases such as BSE". Animal experiments are expected to take place at the P3 level facility at the National Agricultural Research Organization (NARO), due to be completed in December, and other locations.

METI to start work on guidelines for the use of genetic information

Following the enactment of the Personal Information Protection Law in May 2003, METI (Ministry of Economy Trade and Industry) will begin from autumn 2003 to draw up guidelines for enforcement of the law with respect to the use of personal information such as genetic information in genomic (genetic) therapies and so on. The law exempts universities and other institutions carrying out research foe academic purposes, but covers personal information held by private companies. The ministry apparently wishes to undertake a comprehensive study of what kinds of information held by companies should be protected under the law, including, for example information contained in medical records taken during clinical trials for pharmaceutical development.

(Nikkei Biotech, 7th July 2003)

The Japan Medical Association also established a Committee on the Use of Human Genetic Information in August 2003. The committee is expected to investigate such matters as social problems arising from genetic discrimination and so on resulting from recent rapid developments in genomic (genetic) therapies, and produce a final report stating the position of the Japan Medical Association on this matter.

(Nikkei BP "Personalized Medicine Website", 22 July 2003)

Closeup: GM soy destroyed

The "Informal Council on Bio-crops" (representative Katsutoshi Nagatomo) has thus far in conjunction with Monsanto promoted the domestic cultivation of GM soy in Japan. GM soy was planted in nine locations in 2001, and in six locations in 2002, but in each case the crop was mowed before the flowering stage.

This year opposition in local areas has been strong, and with MAFF notifying the group that it must a) gain the understanding of the local population, b) provide the local government and Japan Agriculture information about the planting in advance, and c) take preventive measures against hybridization due to wind-distributed pollen, cultivation has been limited to just three locations; Yawara Village, Ibaraki Prefecture; Mizuho City, Gifu Prefecture; and Chuzu Town, Shiga Prefecture. In all three locations the GM soy was forcibly mowed.

In the case of Yawara Village, in spite of numerous requests by the village office not to plant the crop, 0.2 ha was planted. Seeds and other materials were supplied free of charge by Monsanto and the "Council" has received the full cooperation of STAFF (Society for the Techno-innovation of Agriculture, Forestry and Fisheries, a MAFF-affiliated organization).

A meeting sponsored by the "Campaign Against GM Food" and other groups was held in Yawara Village on 23 July 2003 to oppose the planting of the GM soy. After the meeting, the participants visited the field only to find that the soy was already in flower. On 23 June 2003, the chairman of the board of Kariya STAFF had promised Ibaraki Prefecture that the soy would be mowed before flowering, but this promise was not kept.

Sensing impending danger of genetic pollution from wind-distributed pollen, local farmers held a meeting in the vicinity of the field on 26 July 2003 where Katsutoshi Nagatomo and the owner of the field, Michio Takatsu, were requested to take measures to prevent the spread of pollen from the field. Both men refused to carry out the request, and replied that they intended to harvest the crop. As a result, all the participants in the meeting decided to cover the field immediately with a plastic sheet as a pollen countermeasure. However, this proved to be impossible due to strong wind and the meeting broke up. Some of the people who remained behind after the meeting entered the field with a tractor and the crop was mowed and ploughed under. On 3 August 2003, the "Campaign Against GM Food", which had sponsored the 26 July meeting, issued a statement saying that although it was unclear who had carried out the mowing and ploughing under, the "Campaign took responsibility" for the destruction of the crop.

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