Regulations and disclosure of all food and additives produced by genome editing technology

Life club co-op joint society Regulations and disclosure of all food and additives produced by genome editing technology We submitted an opinion to the Ministry of Health, Labor and Welfare and the Ministry of Agriculture and Water ………………………………………………………………………………………… Ministry of Health, Labor and Welfare, “Handling point (food) on food hygiene such as genome editing technology applied food” and “Notice matter (draft) pertaining to notification,” Ministry of Agriculture, Forestry and Fisheries, “Use of genome editing technology in the field of agriculture, forestry and fisheries About concrete procedure about reporting of information of obtained creature (main point) (plan) We make each and raise public comment. After public comment, we are aiming to start operation around this summer. Both ministries keep some of the biological regulation created by genome editing technology, and leave the developer’s notification and information provision to the developer’s initiative. The Life Club Co-op Alliance (Head office: Shinjuku-ku, Tokyo, member co-op: 33 co-ops and 1 union, total membership: about 400,000) is July 17th, with all the food made with the use of genome editing technology We regulated the additives, asked for the disclosure of information, and submitted an opinion. The submitted opinion is as follows. Opinion to the Ministry of Health, Labor and Welfare 1. Regulations based on the precautionary principle should be applied to all genome editing technology applied foods and additives. According to the proposed “Handling Guidelines for Food Sanitation with Food and Additives Applied to Genome Editing Technology (Draft)”, in addition to the fact that foreign genes and part of them do not remain, (baseline) base deletion, number “Subjects that are subject to insertion of 1 to several base mutations as a result of base substitution, insertion and insertion” are subject to notification, but they are seeking the same level of safety review procedures as genetically modified foods. not. Based on the judgment shown by the European Court of Justice in July 2018, as a precautionary measure, all genome editing technology-applied foods and additives should be subjected to a safety review procedure. 2. Mandatory notification and disclosure of all genome editing technology applied food and additives. It is best to request safety review procedures for all genome editing technology-applied foods and additives, and disclose application documents, but if you do not require it and just report it, the notification will be as follows: Think to ・ Don’t leave the developer’s voluntary notification, but make the notification mandatory. If notification is an obligation, it should also be possible to oblige display based on the notification. • In principle, all information submitted should be disclosed, and information not disclosed should have strict restrictions, such as limited to those related to trade secrets. In the draft handling guidelines, “information to be notified” and “information to be released” are defined separately. When they are compared, the information to be released does not include “information on confirmation that there is no remaining foreign gene and part of it”, and “changes in confirmed DNA may have an adverse effect on human health. “Confirmation of absence” is included, but information on the confirmation is not included. As “notice matter (draft) pertaining to notification” does not specify information to be released, we fear that the information to be released will be extremely limited. ・ In the handling guidelines (draft), notification of genome editing technology applied food / additives and progeny of genetically modified technology application organisms for which safety review has been completed are not required. The Ministry of Health, Labor and Welfare is asking the company for a report and publishing it in order to grasp the development status of hybrid varieties of genetically modified technology-applied food etc. (“The announcement of the safety review was made List of cross-breed varieties] “Ministry of Health, Labor and Welfare Drug and Life Sanitation Bureau Food Standards Review Division”. In the same way, please request notification of genome editing technology applied food / additives and progeny of genetically modified technology application organism, and publish it. ・ The method of notification etc. regarding imported goods is said to be the same, but the effectiveness is questionable even if “non- obligated things are widely known to related organizations in addition to embassies in Tokyo”. For example, how do you request a notification for Karykst’s high oleic acid soy, which is said to be processed into oil and put on the US market? In order to carry out effective control over imported goods, please make notification mandatory. ・ About notification after launch, please request notification of producer’s name, seller’s name, product name as well as launch year, and publish those information. 3. Establish a traceability distribution that secures the consumer’s choice right, assuming commercial cultivation and breeding. Food labeling is essential for the consumer’s choice right. It is difficult to scientifically verify from the final product whether a crop or food produced by genome editing technology is the one produced by genome editing. Therefore, it can not be displayed without establishing a traceability system. In order to work on the establishment of the traceability system at the initiative of the Ministry of Health, Labor and Welfare, please make the notification to the developer as described in Opinion 2. 4. Make sure to review the handling procedures. The handling guidelines (draft) will be reviewed as necessary, based on the results of usage regarding genome editing technology applied food etc. Please carefully monitor the current situation in the future, and make sure to carry out the review. that’s all Opinion to Ministry of Agriculture, Forestry and Fisheries In the beginning The purpose of the Cartagena Act is to ensure the appropriate and smooth implementation of the Cartagena Protocol, in order to cooperate internationally to ensure biodiversity. The objectives of the Cartagena Protocol specify that the precautionary approach described in Principle 15 of the Rio Declaration is followed. In light of the purpose of the Cartagena Act, it is appropriate to make all organisms obtained through the use of genome editing technology subject to the regulation under the Cartagena Act, as a precautionary approach. Based on such a premise, we will submit the following comments on the proposed outline. 1. Mandatory to provide information on all organisms obtained by using genome editing technology. If experimental food products are developed without the need to provide information, not only the securing of biodiversity will be threatened, but also tracking can not be performed after the occurrence of an accident, resulting in irreparable problems. You Mandatory to provide information on open use and closed use. 2. Please disclose all provided information promptly. The proposal for use in open systems is to release the information provided except “information that may cause unfair benefits or disadvantages to specific persons if it is released”. As far as this is read, it is unclear what information is excluded. Please define more clearly. At the same time, in principle, ensure that all information is disclosed in the public, and if there is excluded information, please disclose it to the viewer so that what information has been excluded and for what reason. . In addition, please specify that the information will be disclosed promptly after the information is provided. 3. Please disclose the information provided for closed system use. The proposal for use in closed systems is that “the user submits a confirmation of prevention of proliferation measures to the Ministry of Agriculture, Forestry and Fisheries”. Please publish this confirmation on the website etc. promptly. For the closed system use of genetically modified organisms, genetically modified organisms have been released to the environment without taking appropriate measures to prevent the spread, such as Kobe University pouring the genetically modified E. coli into sewage as it is. Accidents are often reported. The same thing is concerned about genome editing technology. Please make public surveillance visible by making it public. 4. Please ensure that similar information is provided to those developed overseas. The main idea is that it is unclear how to provide information on genome editing technology applied organisms developed overseas. It is assumed that organisms based on genome editing technology developed overseas are used for processing in Japan. There is “use of the organism concerned” in item of “information provision book”, and “food” “for feed” “for ornamental” “for cultivation” “others” is mentioned as the concrete contents (the main point plan 6). Is it for “others” for processing? Please specify that genome editing technology applied organisms imported from overseas as processed materials are requested to provide the same information as domestically manufactured ones. that’s all

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