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From Bio Journal - February 2019





Genome-edited foods to be distributed with no restrictions

The GM Food, etc. Investigative Panel of the Pharmaceutical Affairs and Food Sanitation Council, MHLW, which was examining the handling of food modified by genome editing to secure safety ended its deliberations on December 5, 2018. (See BJ December 2018) Having reached a conclusion, deliberations began in the superior organization, Investigative Panel on Newly-Developed Foods, on December 12. This panel also held a hearing with related organizations and ended on January 17, 2019. In this rush schedule of just over a month, the conclusion that "genome-edited foods basically do not require regulation" was reached in the wink of an eye.

The Integrated Innovation Plan approved by cabinet resolution in June 2018 urged that the legal regulation problem of genome-edited foods be settled within the fiscal year (by March 2019), and this schedule has been faithfully kept to. The GM Food, etc. Investigative Panel mentioned above concluded that, firstly, for the Food Sanitation Act, since there are only cases of the cleaving of DNA in genome editing technology, and, secondly, for the Cartagena laws, since there are no cases of the insertion of one to several bases, which would be subject to regulation, gthis does not amount to recombination of DNA and is therefore outside the scope of safety screening.h

The reasons given for this relaxation of restrictions were: 1) Cases in which DNA is simply cleaved and one to several bases are inserted, replaced or deleted also occur in nature and are indistinguishable from the same occurrences in nature. 2) No difference can be found between off-targets occurring in the use of mutation and off-targets occurring in genome editing. 3) It is not possible to completely sequence off-targets. 4) Research by the Karolinska Institute in Sweden and by Novartis does not indicate that carcinogenicity is promoted. 5) Adverse impacts that occur at first are eliminated by selective breeding. All of the above are theories that have been negated by scientific knowledge and experience with genome editing technology.

Based on the conclusion of the panel, the final conclusion of the Investigative Panel on Newly-Developed Foods, submitted on January 17, was that neither notification nor punishments were required. This can be said to completely ignore the spirit of the Food Sanitation Act, which is supposed to protect the safety of food. This conclusion is scheduled to be finalized by the end of March, following the solicitation of public comments.

















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