On 27 November 2003, the Task Force on Prions under the Food Safety Commission approved the lifting of the import ban on bovine embryo from countries affected by bovine spongiform encephalopathy (BSE). Meanwhile, however, there have been several BSE occurrences among calves after the banning of the feed use of meat-and-bone meal in Japan, in particular the October 2003 case of a 23-month-old calf, which involved a new type of BSE of unknown contagion source.

In the UK, the number of BSE occurrences among cows born after the banning of the feed use of meat-and-bone meal in October 1996 has been growing. The causes of this BSE are also unknown. Moreover, a BSE case was officially confirmed in the US at the end of last year.

In the Guardian article on 6 December 2003, Professor Malcolm Ferguson-Smith of Cambridge University was quoted as saying, "I have suggested that the recent (born after the feed ban) cases may be the direct descendants of the original animal which carried the novel mutation that started the epidemic over 30 years ago". Importing bovine embryo into Japan might therefore expand the occurrence of BSE.

In April 2004, a new law concerning the traceability of cows, the "law concerning special measures for information management and communication of the identification of individual of cattle ", will come into force in Japan. However, this law only considers the traceability of cows after birth, and bovine embryo is not covered. If the cause of BSE is related to inherited factors, this law will not be at all effective for investigation of the possible causes of BSE.

The movement towards the approval of somatic cell cloned cattle products for human consumption seems to be strengthening. Under these circumstances, the MAFF announced "The Current Situation on Livestock Animal Cloning Research" on 21 November 2003.

According to the announcement by MAFF, 247 embryonic cloned cattle have been delivered to the market, and adding a further 65 cloned cattle whose data are missing, the total number may be around 300 cloned cattle whose products have reached our tables as human food. Concerning the somatic cell cloned cattle, most of them are stillborn or die shortly after birth. Only one third of the total births survive. There are also cloned swine and cloned goat in the pipeline. Already 36 cloned swine have been born.

In embryonic cloning each blastomere is removed from the 16- to 32-cell stage bovine embryos, transferred beneath the zona pellucida of an enucleated oocyte (recipient cell), and fused with the enucleated oocyte. The reconstructed embryos are transferred into recipient cows after culture. By using nuclear transfer technology, animals with identical nuclear DNA can be multiplied for a short time period.

In somatic cell cloning, somatic cells are taken from an adult cow and maintained in culture conditions. The adult somatic cell is transferred beneath the zona pellucida of an enucleated oocyte (recipient cell), and fused with the enucleated oocyte. The reconstructed embryos are transferred into recipient cows after culture. By using nuclear transfer technology, animals with proven performance can be reproduced for a short time period.

Table 1: Current Situation with Cloned Livestock (Unit: head)
Embryonic cell cloned cattle	Total births	686
	Stillborn	73
	Death immediately after birth	30
	Death from illness and so on	96
	Death from accidents and so on	68
	Cattle sold	319
	Confirmed to have become meat	(247)
	Being raised by farmers	(7)
	Unknown	(65)
	Under care or testing	100
	Impregnated	2
Somatic cell cloned cattle	Total births	367
	Stillborn	58
	Death immediately after birth	50
	Death from illness and so on	66
	Death from accidents and so on	56
	Under care or testing	137
	Impregnated	49
Somatic cell cloned swine	Total births	36
Somatic cell cloned goat	Total births	5

According to the MAFF's livestock animal feed screening, the controversial insecticide GM corn StarLink developed by Aventis (Bayer CropScience) is still arriving in Japan from the US, according to an announcement from the department of consumer and safety at MAFF on 19 December 2003. StarLink corn was considered harmful for consumption and cultivation has not taken place since 2001. The contamination rate is lowering, but is not yet zero.

Table 2: StarLink Contamination
2000 Jan-Jun	20 out of 30 cases (66.7%)
2000 Jul-Dec	34 out of 72 cases (47.2%)
2001 Jan-Jun	8 out of 53 cases (15.1%)
2001 Jul-Dec	5 out of 45 cases (11.1%)
2002 Jan-Jun	4 out of 42 cases (9.5%)
2002 Jul-Dec	5 out of 69 cases (7.2%)
2003 Jan-Jun	3 out of 77 cases (3.9%)

Suntory Ltd. Announced on 2 December 2003 that it intended to buy the Australian venture business Florigene. The two companies had previously jointly developed a blue carnation. In July 2002, Suntory had split off its flower business, forming Suntory Flowers, leaving the basic research unit for the development of GM crops with the parent company. It is thought that the strengthening of basic research is the purpose of the acquisition. (Nikkei Biotech 2003/12/08)

As a fertilized ovum has to be destroyed in order to produce human ES cells, MEXT adopted the "Guidelines on the Establishment and Use of Human ES Cells" in September 2001 to place strict limits on the handling of fertilized ova. ("Establishment" here means the production of an ES cells, and "Use" means the use of ES cells for research and related purposes.) Recently, however, a movement to relax the restrictions has already begun. On 18th December 2003, a meeting of the specialist committee on research into embryos and human ES cells (a consultative body of MEXT under the Council for Science and Technology) was held and discussion concerning the amendment of the guidelines was begun. Research programs approved thus far are one program concerning establishment of ES cells at Kyoto University, and eight programs concerning use of ES cells at Keio University, the pharmaceutical manufacturer Tanabe Seiyaku Co., Ltd, and so on. If the review procedures are simplified under the amendment it may mean that the number of research programs will increase, and that that will lead to facile use of ES cells.

The 27th meeting of the specialist panel on bioethics in the Council for Science and Technology Policy of the Cabinet Office was held on December 12 2003 and the interim report on the handling of human embryos was finalized. As reported in BJ December 2003, the deliberations at the two previous meetings had become extremely entangled and it was decided to append opinions from each of the panel to the report, while leaving the substance of the draft report largely unchanged. Public comment is being solicited on this matter until the end of February, and the final report is expected to be finalized by June 2004, just three years after the enforcement of the Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques, which stipulates that conclusions concerning the handling of fertilized human embryo must be reached within three years of its enforcement.

A meeting of the specialist sub-committee (under the MHLW's Health Sciences Council) considering clinical research using human stem cells on 12 December, 2003, at which a hearing concerning the use of cells from deceased fetuses resulting from abortions was held. Experts called to give their opinions were Yukiko Saito, a lecturer at the Faculty of Medicine at Kitasato University, Azumi Tsuge, Associate Professor of the Faculty of Sociology and Social Work at Meiji Gakuin University, Makoto Ohhama, Chairman of the Board of Directors of the NPO Japan Spinal Cord Foundation, and three others. The results of a survey taken to assess the current state of human stem cell research in Japan in April 2003 were also announced. Only 42% of the surveys were returned (606 out of 1441 sent out). The results revealed 33 cases of basic research using fetal cells, and 11 cases of research leading towards clinical applications. These figures do not capture the current state of research in this country, but it is apparent that cells from deceased fetuses are being used in research here.

Biodegradable plastic currently manufactured in Japan is mainly polylactic acid, which is imported solely from the American company Cargill Dow. The raw material for polylactic acid is American-produced maize (corn). In 2003, GM corn accounted for 40% of the total area planted to corn in the USA, and therefore the proportion of GM corn used as the raw material for biodegradable plastics is almost certainly increasing.

Coincidentally, the car manufacturer Toyota has begun construction of a plant to produce polylactic acid. The plan originally called for the use of Indonesian sweet potato as raw material, but the use of Brazilian sugar cane is being considered as this is thought to be more efficient.

The specialist panel on GM foods of the Food Safety Committee gave its consent to two drafts, "Safety Assessment Standards for GM Foods (Seed Plants)" and "Policy on Safety Assessment of GM-GM Plant Second-Generation Hybrids", at a meeting on 4 December 2003. It was decided that the drafts would be approved after a period for public comment.

Until 30 June 2003, safety assessment was being carried out under standards set by MHLW, but now food manufacturers and developers will have to have their GM products evaluated according to the new standards. Compared with the previous standards, the new standards include evaluation of possible unpredicted changes, and will therefore require a more in-depth assessment.

However, many basic problems, such as the following, still remain.

1. There is no attention given to prevention of increase of antibiotic resistant bacteria
2. There is no attempt to require either short- or long-term animal trials using GM foods
3. There is no attempt to require clinical trials for evaluation of possible allergenicity
4. There is no attempt to revise the former assessment regime, under which intellectual property rights were used to carry out assessment on the premise of nondisclosure

The new standards are therefore still not sufficiently strong to gain the confidence of consumers.

In accordance with the enforcement from 19 February 2003 of the domestic laws concerning the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, MAFF has been considering the formulation of guidelines for open-air field trials for GM crops taking place at its research establishments (now independent administrative corporations). This measure is intended to redress problems caused by different reactions towards local residents by the various establishments as opposition movements to the trials has spread. The first meeting of the panel to discuss the "Guidelines for Field Trials for GM Crops Approved for Use under Type-1 Regulations" took place on 22 December 2003, at which the content of the first draft was revealed.

According to the draft, with respect to rice, soy, maize (corn), and rapeseed (canola), these must be planted at certain distances from crops in the vicinity in order to prevent hybridization. Further, the content of the trial and the date for an explanatory meeting must be publicized at least one month before the start of the trial.

At present the guidelines will only be applicable to the independent administrative corporations, but it is possible that they will eventually be applied to trials carried out on local government trials fields and ordinary farmland.

Table 3: Specification of Buffer Zones for Field Trials Involving GM Crops
Rice	20m
Soy	10m
Maize	600m (300m in the case of intervening shelterbelt)
Rapeseed	600m (400m if a non-GM rapeseed variety whose flowering period corresponds to the flowering period of the GM variety is planted in a 1.5m band surrounding the GM variety to act as a trap for pollen and flower-visiting insects)