From Bio Journal - October 2018

Ministry of the Environment fails to regulate most genome editing

Based on the result of the investigative panel on genome editing technology, etc. and the Cartagena laws held on 7 and 20 August 2018 (see BJ September 2018), a meeting of the specialist panel on genome editing technology, etc. (under the Ministry of the Environment's Central Environment Council) was held and approved the original policy leaving outside the scope of regulation by the Cartagena laws cases in which DNA is cleaved but no gene is inserted. This means that at the present stage the greater part of genome editing technology will not be subject to any MoE restrictions.

MHLW begins consideration of Food Sanitation Act

Following on from the deliberations by the Ministry of the Environment, a meeting of the investigative panel on GM food, etc. of the MHLW's Pharmaceutical Affairs and Food Sanitation Council was held on 19 September 2018 to determine policy on the Food Sanitation Act. As with MoE, thinking on genome editing technology was summarized and deliberations begun on regulation under the Food Sanitation Act. The discussions on that day were pushed forward in the direction of even less regulation than under the MoE's Cartagena laws. Moreover, while discussions would be limited to genome editing, the discussions moved forward in the direction of placing no restrictions on the whole of "new plant breeding techniques (NPBT)," which have become subject to restrictions in Europe.

MoE has made the case of introducing one or more bases subject to restrictions, but MHLW's policy is to remove this from the scope of restriction. This signifies the creation of an exemption in GM technology. In other GM technology restrictions, self-cloning and natural occurrence, which have been placed outside the scope of restrictions regarding microorganisms alone, will now not stop at microorganisms but will be expanded to plants and others. Furthermore, the discussion proceeded to the policy of removing restrictions on cases where the inserted DNA does not remain in the final product or is removed from it. If this is formally decided on, the greater part of NPBT (other than genome editing), which is subject to restrictions in Europe, will escape restriction in Japan.

Cabinet Office requests budget for coordinating genome editing regulations

It has become clear that the Cabinet Office has requested budget for coordinating regulations for foods developed using "new plant breeding techniques (NPBT)." Based on the Integrated Innovation Strategy approved by the cabinet in June, coordination and improvement of regulations of the Cartagena laws and Food Sanitation Act relating to organisms produced by genome editing and so on, to be completed during this fiscal year, and testing technologies related to these, are being pushed forward at a rapid pace.

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