From Bio Journal - April 2003
Virus-resistant GM papaya could be allergenic
MHLW is performing a food safety review on a virus-resistant GM papaya called Rainbow, which has been developed through collaboration between Cornel University, University of Hawaii and The Upjohn Company (now Pharmacia Corporation). The approval is expected after three years of consideration since the developers first applied for it in 1999. However, a recent study has indicated that this GM papaya, which carries genes for a papaya ringspot virus coat protein, is a potential allergen because it contains a string of amino acids identical to a known allergen. If the GM papaya is approved as the first perishable GMO, it could cause increasing allergic episodes.
Hokkaido U. prof. to sell GM natto on Internet
A group under Professor Fusao Tomita of the Agricultural Science Research Department of Hokkaido University Graduate School has announced its intention to manufacture and sell natto (a Japanese fermented soybean food item) manufactured from GM soybeans via the Internet. This will be the first case of a food item going on sale with labeling that states clearly that the item is made using GM soy. The plan is to use imported GM soy, commission a Hokkaido natto manufacturer to produce the natto, and then sell it either through the Hokkaido Bio-Industry Association or by setting up their own venture enterprise, "A-HIT Bio".
MHLW holds international symposium on molecular epidemiology
An international symposium entitled Bioethics in Molecular Epidemiology was held on 26 February 2003 at the MHLW auditorium in Kasumigaseki, Tokyo. Sponsored by Japan's National Cardiovascular Center and the US National Heart, Lung & Blood Institute, the symposium was held as part of MHLW's Millennium Project on Disorders and the Genome. Researchers from deCODE Genetics, which has carried out a survey of genetic information among the population of Iceland, were also expected to participate, but did not due to unwillingness to make public statements during their ongoing court case. In Japan, samples for genetic sequencing research have also been taken from the local population in the town of Hisayama, Fukuoka Prefecture, and it is thought likely that the number of such research projects will increase rapidly in the future.
MHLW postpones decision on Kyushu U gene therapy plan
A meeting of the science and technology sub-committee of MHLW's Health Sciences Council was held on 27 February 2003, at which the implementation plan for clinical research on gene therapy submitted by the University Hospital of Kyushu University Faculty of Medicine was discussed. The plan involves the regeneration of blood vessels in patients suffering from ASO (arteriosclerosis obliterans) or Buerger's disease (tromboangitis obliterans) by direct administration of Fibroblast Growth Factor (FGF-2 - known to be related to blood vessel growth) which has been genetically engineered onto a vector (a gene carrier), the Sendai virus. Several committee members expressed doubts about the safety and effectiveness of this procedure, and it was decided to refer the plan back to the subordinate commitee, the working group on gene therapy, for further discussion.
On paper, Kyushu University's plan looks like an intramural research project, but similar to other ongoing gene therapy programs, it is essentially an experiment using a vector developed by a commercial company. In this case, the vector was developed by the DNAVEC Research Inc. (a company set up to further national bioscience policy) who commissioned the British Bio Reliance company to manufacture the vector.
Closeup: Codex Task Force on Biotech ends
The Joint FAO/WHO Food Standards Program Codex ad hoc Intergovernmental Task Force On Food Derived From Biotechnology (TFBT) was held between 11 and 14 March 2003, in Yokohama, Japan. The aim of the TFBT was to draft guidelines for the safety assessment of genetically modified foods based on the principle of a Joint FAO/WHO Expert Consultation on Risk Analysis. This year was the fourth and the last session of the TFBT, and the outcome of these four years (2000 to 2003) of work will be presented for adoption to the Codex Alimentarius Commission in July 2003.
The TFBT has already discussed the safety assessment of genetically modified plants during the first three years, and reached consensus at the last session. Therefore the main focus of the fourth session was to discuss the draft principles for the risk analysis of foods derived from recombinant-DNA microorganisms, e.g. cheese and yogurt. The safety assessment of foods derived from genetically modified animals, including fish, was shelved for possible future work. The issue concerning the scope of foods produced from r-DNA microorganisms received heated discussion. Also the matter of whether or not the safety assessment of foods produced from r-DNA microorganisms should be evaluated in the same way as genetically modified plants fired up the debate.
There had been some conflict of views between the EU and the US during these four years of TFBT. However at the end of the day, it is not too much to say that the US and biotech industry were more positive about getting what they wanted. Consequently, there is no reference to the precautionary principle in the document, and traceability has been replaced by "tracing". Nevertheless, due to a reference to Risk Communication in the proposed draft, consumers will be able to demand more public release of information from MHLW, and more open discussion between the authorities and consumers. There are further points which have been strengthened, yet it is still very unclear whether MHLW will reconsider its own food safety review or not.