From Bio Journal - November 2019

Trend: October 1: Genome edited foods also allowed on Japanese market with no labelling

The ban on domestic distribution of genome edited foods was lifted on October 1 and each of the ministries and agencies have announced their policies for the handling of genome edited foods.

On September 19, 2019, in its "Labelling of Foods Applying Genome Editing Technology," the Consumer Affairs Agency (CAA) stated, 1) For foods in which there are no remaining foreign genes, it is impossible to determine scientifically if a food has been produced using genome editing technology or conventional breeding technology, 2) In the current situation, both domestically and overseas, the system for communicating information by transaction record documentation, etc. of foods applying genome editing technology is insufficient, and 3) While noting that among consumers there are voices demanding labelling to enable choice regarding foods that apply genome editing technology, at present "foods that are not genetically modified are not subject to labelling."

On October 2, MHLW, in its "Q&A on the method of handling foods that apply genome editing technology," illustrated its handling method by giving examples of 1) prior consultation, 2) notification, 3) hybrid progeny, 4) food additives, etc. However, notification itself is never anything more than voluntary. For hybrid progeny, MHLW says since there may be cases which differ from ordinary cases, consultations should first be held with the ministry. Food additives will be handled in the same way as ordinary additives.

On October 9, MAFF announced its "Initiation of information provision on biodiversity impacts of living organisms produced by use of genome editing technology in the fields of agriculture, forestry and fisheries." This document is based on the "Handling under the Cartagena Laws – In the case that there has been no insertion of nucleic acid processed outside the nucleus of the cell, the product is not subject to the Cartagena Laws, and even in the case that there has been an insertion, the product is not subject to the Cartagena Laws if the nucleic acid has been eliminated," previously announced by the Ministry of the Environment on February 8, 2019.

Deliberations begin on expansion of genome editing application to human fertilized ova

On June 19, 2019, the Council for Science, Technology and Innovation (CSTI) finalized its second report on a review, etc. of "Basic Thinking on the Handling of the Human Embryo" As indicated in the report's title, "Use of Genome Editing Technology, etc. in the Human Fertilized Embryo," the report aims for an expansion of gene manipulation through genome editing on the human fertilized ovum. Having received the report, MEXT and MHLW have put together the following two policy items and have begun deliberations on a structure for promotion of this expansion of genome editing.

1) Basic research using genome editing technology, etc. on surplus embryos for the purpose of research into genetic and congenital diseases.

2) Basic research using genome editing technology, etc. on gametes and newly created embryos for the purpose of research into auxiliary reproductive medicine.

The three specialist panels under MEXT and MHLW held a total of four joint meetings up to October 21. They will now finalize their report and attempt to move toward expansion of the application of genome editing technology.

GM vaccine as a countermeasure for swine fever; evaluation of the safety of meat for human consumption

MAFF has begun an investigation on the efficacy of new "marker vaccines" that use GM technology in addition to the attenuated ("live") vaccines that have been used thus far against swine fever (classical swine fever, CSF), and has requested that the Food Safety Commission provide an evaluation of the safety of the meat for human consumption following vaccination. In contrast to attenuated vaccine, since marker vaccines make it possible to distinguish the antibodies of an infected pig and a vaccinated pig, it is easier to grasp an overall picture of the state of the infection. Expansion of the use of the new vaccine is anticipated following its approval. The Food Safety Commission was consulted on September 24, 2019, and with hardly any discussion at all produced the conclusion that "there is no concern regarding food" on October 7.

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