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From Bio Journal - January 2021





Japan's first genome-edited food item, a tomato, gets green light for distribution

On December 11, Japan's first genome-edited food item obtained a green light for domestic sales. This was the high-GABA accumulated tomato, the "Sicilian Rouge High GABA," developed by Professor Hiroshi Ezura and his team at Tsukuba University. The green light was obtained when, on December 11, Tsukuba Universityfs venture company Sanatech Seed notified and presented data to MAFF, and notified MHLW. Having these accepted by the two ministries completes the necessary procedure for commercialization of the tomato. As genome-edited foods do not require an environmental impact assessment or safety screening as food or feed, the reality is that it is possible to distribute the food in this way, and that the food will appear on our dining tables without any labelling.

Genome-edited crops that have appeared thus far are limited to the US Calyxt high-oleic acid soybean and the Cibus Canada Inc. canola that is tolerant to the sulfonylurea herbicides. Of these, the herbicide tolerant canola is said by the developing company Cibus to have not been developed by genome editing (as noted in the Japanese version of BioJournal in November 2020), and if this is true, then the only genome-edited crop now being grown is the high-oleic acid soybean. Now, the genome-edited tomato developed in Japan is added to this. According to Sanatech Seed, however, as the intellectual property rights procedures have not yet been completed, sale of the seeds and commercial planting cannot yet be carried out. For this reason, Sanatech Seed has announced that it will provide seeds free of charge from 2021. Thus, a genome-edited crop could be cultivated in many homes leading to the heightened danger of a disorderly spread of the crop.

The approved genome-edited tomato has been modified to include large amounts of GABA, a substance that is said to have the ability to hold down human blood pressure. More precisely, to raise the GABA content, the glutamic acid decarboxylase gene has been partially modified. It is reported that this tomato contains 5 to 6 times the amount of GABA than normal tomatoes. Originally, Sicilian tomatoes are a variety usually used for cooking, but the developed genome-edited tomato was used as the parental line for improving the variety and the generated F1 line is expected to be sold as seeds or seedlings for edible tomatoes.

Still, this tomato has many problems. Agrobacterium was used as the vector and the DNA in the bacteria's plasmid has been spliced to insert a Cas9 gene, a gene tolerant to the antibiotic kanamycin as the marker gene, and, further, a "CRISPR-Cas9 expression cassette" with an inserted cauliflower mosaic virus. Whichever way you look at it, this is nothing but gene modification.

Nevertheless, the MHLW deliberative council did not require safety screening as "genome editing differs from gene modification." In addition, while this crop has been developed as a government project, the deliberations were held in closed-door session.

Regarding offtargets, where DNA may be severed in locations other than the target, something that has been pointed out as a problem with genome editing technology, the whole genome has not been investigated, and this is terribly insufficient. Epigenetic variations have also not been examined, making it very difficult to say that safety has been confirmed. Since foods are not labelled, consumers are unable to make choices. It seems that there are just too many problems for the first genome-edited to appear on the Japanese market





Bill to amend the Plant Variety Protection and Seed Act approved and passed

The bill to amend the Plant Variety Protection and Seed Act was approved and passed On December 2. The purpose of the amendment is to expand to all crops the ban on home seed production and breeding, and to strengthen punitive clauses. The government moved forward on this amendment for the reason that varieties developed in Japan are flowing out to other countries.

Plant Variety Protection and Seed Act is the domestic law corresponding to the UPOV Convention (International Convention for the Protection of New Varieties of Plants - Union Internationale pour la Protection des Obtentions Végétales; See BJ April 2020) From the 1980s, new variety development became centered on gene modification, the UPOV Convention being amended in 1991 for the main purpose of a great expansion of intellectual property rights to strengthen protection. At that time, the protection that had been extended to only a small number of crops was expanded to all crops, and rights came to cover harvested crops that had not been previously covered. In this way, the scope of registered varieties was even extended to seeds and processed foods, and, in principle, a ban was imposed on home seed production and breeding, but as the designation of banned crops was left to the discretion of each country, for a long time Japan simply banned some of the crops. Based on the amendment of the convention, Japan amended the Plant Variety Protection and Seed Act in 1998, strengthening the protection for new varieties. This latest amendment of the Plant Variety Protection and Seed Act expands the scope of banned crops to all crops and is a strengthening of intellectual property rights that is now becoming ever more important.













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