Environmental concerns:
Japanese domestic laws in accordance with the Cartagena Protocol on Biosafety to the Convention on Biological Diversity will come into effect on 19 February 2004. Guidelines to regulate open-air research on GM crops at research facilities of the former MAFF - now independent administrative corporations - will be completed by this time, in order to be consistent with the law. For the time being, the guidelines will only cover the research facilities, however, and guidelines regulating GM crop cultivation at experimental stations established by local government bodies and GM crop cultivation on private farmland are also expected to be completed. This will possibly put a brake on the unregulated release of GM crops into the environment.

Food safety issues:
The GM food assessment group under the Food Safety Commission is currently formulating a standard for safety evaluation, in accordance with the Guidelines for the conduct of Food Safety Assessment of Foods derived from Biotechnology, which was drafted by the Codex Biotech Task Force and was adopted by the Codex Alimentarius Commission last year. Safety review work has been temporarily suspended, but will be resumed based on the new safety standard.

GM food labelling:
The government is currently waiting for the Codex Commission to come forward with its proposals. A working group under the Codex Committee on Food Labelling will be finalising a draft proposal on GM food labelling by May 2004, and the proposal will be discussed at the Food Labelling Committee. At the moment, the momentum for labelling on a voluntary basis appears to be strong enough to eliminate other rival systems.

Other considerations:
Bylaws and resolutions regarding GM crop cultivation are expected to be introduced in different local governments. On the other hand, GM seed contamination has been in the news and there is particular concern over GM oil seed rape (canola) contamination. In addition, the issues surrounding GM wheat will be drawing strong international attention.

A remarkable report was given during the session for presentation of research activities at the 6th liaison conference of the Network of Organizations for Research on Nature Conservation (Ishikawa Prefecture), held on October 16 and 17. The chief scientist, Masanori Tamaoki, from the National Institute for Environmental Studies (NIES ) reported that their study indicated that at the biomolecular level GMOs might not be substantially equivalent to conventional plant organisms.

The safety of a GM plant is first assessed on the basis of the concept of Substantial Equivalence, which compares composition, configuration, ecological characteristics and so on, in order to see if the GM plant is similar to its conventional counterpart, except for the direct products of the introduced genes. However, there have not been any studies conducted at the molecular level based on this concept. In the study mentioned, two different GM plants were used, and by investigating the transcription and translation of about 4,000 genes, in all cases a disordering of gene expression was observed following the insertion of novel genes. This is a significant finding that might shake the foundation of the safety assessments upon which the promotion of GM food is premised. Verification of these research results is awaited.

The specialist panel on GM foods of the Food Safety Committee, which has taken over the safety review work for Gm foods from MHLW, has formulated a draft for the new safety appraisal standards.

At the second meeting of the specialist panel on 19 November 2003, it was agreed to add foods produced by genetic changes involving "self-cloning" and "natural occurrence" to those subject to a safety review.

Self-cloning is where the basic materials of the host, vector, and donor used in the genetic modification are all from the same species. Natural occurrence is where the genetically modified organism has the same genetic makeup as a naturally occurring organism. These cases were formerly not subject to a safety review.

At only the third meeting of the panel on 1 December 2003, a draft for the new safety appraisal standards was presented to the panel. The contents of the draft are based on the international standards produced by the ad hoc Intergovernmental Task Force On Food Derived From Biotechnology of the Codex Alimentarius Commission last March (see BJ April 2003). The draft will come into force following fine tuning of the details, and thereafter will be appraisal standards by which all new GM foods will be reviewed in Japan.

The first meeting of the newly-established "Exploratory Committee on the Limitation of the Use of Genetically Engineered Organisms Involved in Gene Therapy Clinical Research," which will appraise the environmental impact of vectors used in gene therapy for MHLW, was held on 25 November 2003. The committee consultative body under the Health Sciences Council of MHLW, and is chaired by Hiroshi Yoshikura, Director-General of the National Institute of Infectious Diseases. One of the backgrounds to the establishment of the committee is the work in progress of adjusting the details of domestic laws to come in line with the Cartegena Protocol, which will come into full enforcement in Japan on 19 February 2004.

Most of the vectors used in gene therapy are viruses which have had a human gene inserted into them by recombination technology, and are therefore naturally subject to restrictions applied to genetically engineered organisms. Of the 18 cases of gene therapy carried out in Japan so far, 15 have used a genetically engineered virus. The committee will now collect information necessary to appraise environmental impacts of these vectors.

Suspension of development of GE rice by Iwate Prefecture
The "National Meeting Opposing GM Crops in Iwate" was held in Morioka City, Iwate Prefecture on 28 November 2003. 407,212 signatures had been received for a petition up to this date, and following a march through the city, the petition was submitted to the department of agriculture, forests, and fisheries of Iwate Prefecture. At the time of the submission of the petition, the director of the department of agriculture, forests, and fisheries, Masakatsu Sasaki, promised that the GM rice field trials that been carried out in 2003 would be shortened from the planned two years to one and suspended from January 2004(?), and that no further field trials of GM rice would take place.

Suspension of the Shimane Prefecture GM melon
Cultivation trials of the GM melon being developed by Shimane Prefecture (see BJ October 2003) have also been suspended. This was made clear during a statement by Takami Yuichi, director of the biotechnology department of the Agricultural Experimental Station of Shimane Prefecture, at the meeting of the symposium to "Consider GM and the Agriculture of Shimane," held in Izumo City on 7 December 2003. This was also mentioned in a report to the director of the department of agriculture, forests, and fisheries of Shimane Prefecture from the director of the Agricultural Experimental Station of Shimane Prefecture, which was made available through a freedom-of-information request. The document states that, "We believe that trials beyond isolation field trials should be suspended for the time being."

Delay in enactment of Shiga Prefecture GM crop cultivation restriction bylaw
GM soy was discovered to have been planted in Chuzu Town, Shiga Prefecture in August 2003, and when it was mowed and ploughed under, Governor Yoshitsugu Kunimatsu of Shiga Prefecture announced at a press conference that he would "produce independent guidelines for the regulation of cultivation of GM crops." (see BJ October 2003) As the laws concerning the Cartegena Protocol are to come into force in Japan in February 2004, the governor has now decided to wait to see how regulations concerning GM crop cultivation work out before working on the independent guidelines. A preliminary draft will be produced, followed by solicitation of opinions from the public, after which the draft bill will be prepared. Enactment is now expected to take place around the spring of 2005.

Hokkaido bylaw to restrict the cultivation of GM crops?
Hokkaido has signaled its intention of regulating the cultivation of GM crops on the island at the Hokkaido council special budget committee on 5 December 2003. It is expected that the regulations will be included in a proposed "Food Bylaw" due to be formulated in 2004. Hokkaido's agricultural policy planning department says, "We intend to determine the content of the bylaw after seeing the national laws concerning the Cartagena Protocol to come into force in February 2004. If the bylaw is enacted it will be the first of its kind at the prefectural level. (Hokkaido is a "do," which is an administrative region equivalent to a prefecture.)