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Japanese Regulatory Policy of Genome Editing Technology

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Japanese Regulatory Policy of Genome Editing Technology by Takeshi Urao during the Regional Expert Consultation on Gene Editing in Agriculture and its Regulations Technical Session II

Published in: Government & Nonprofit
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Japanese Regulatory Policy of Genome Editing Technology

  1. 1. 地球と食料の未来のために Japanese Regulatory Policy of Genome Editing Technology 2019/10/10 1
  2. 2. Japanese Regulatory Framework of GMO 2019/10/10 2 Source: MOE, MHLW, MAFF Impact Assessment on Biodiversity (Cartagena Act) Type2 Use: Under the closed condition (e.g., in laboratory) Type1 Use: Under the open condition (e.g., in confined field) Food Safety Assessment (Food Sanitation Act) Commercialization Non-Food (Flower etc.) Feed Safety Assessment (Feed Safety Law)
  3. 3. Policy for the Regulation of Genome Editing Technology 2019/10/10 3 The organism is GMO The organism is non-GMO Containmentmeasures No Type 1 Use: Use the organism by following the regulations approved by the Minister based on the assessment of adverse effect of biological diversity, in accordance with Article 4 of the Act. Use the organism after providing information concerning the traits and discussions on adverse effect of biological diversity of the organism to the competent government agencies. Yes Type 2 Use: Use the organism by taking the containment measures stipulated in the ordinances based on Article 12 of the Act or containment measures approved by the Minister based on Article 13 of the Act Use the organism by taking the containment measures stipulated in the ordinances based on Article 12 of the Act or measures approved by the competent government agencies as measures that can prevent dispersal of the organism. Is a foreign DNA introduced in organisms? Is the DNA or its replicated product still remains in the host genome? Source: MOE No No Yes Yes
  4. 4. Specific Examples Indicating Whether a Genome Edited Organism is GMO or non-GMO 2019/10/10 4 Source: MOE Genome-edited organism (non-GMO) GMO DNA is cut with artificial nucleases Extracellularly processed nucleic acid is inserted Inserted nucleic acid is incorporated Deletion, insertion, substitution during the natural DNA repairing Artificial nuclease lacking foreign nucleic acid Artificial nuclease containing foreign nucleic acid Note: The organism is not regarded as a GMO, if it is confirmed that it possesses no remnants of inserted nucleic acid or its replicated product. DNA is cut with artificial nucleases DNA is cut with artificial nucleases Deletion, insertion, substitution during the natural DNA repairing XX X
  5. 5. Information on the Items Should be Provided 2019/10/10 5 Source: MOE The fact that the organism does not have foreign DNA or its replicated product. • Method to remove the integrated DNA. • Method to confirm the absence of foreign DNA (a. PCR method, b. Southern blotting, c. Others). Taxonomical species of the modified organism. Purpose of use of the organism.
  6. 6. Information on the Items Should be Provided 2019/10/10 6 Source: MOE Method of genome editing used for the modification. • Types of nucleases (a. CRISPR/Cas9, b. TALEN, c. ZFN, d. Others). • Transfer method of nuclease (a. Transfer the artificial nuclease composed only of protein into the host cell, b. Transfer the artificial nuclease gene into the host cell for transient expression, c. Integrate the artificial nuclease gene into the host genome, d. Others). Modified gene and its function.
  7. 7. Information on the Items Should be Provided 2019/10/10 7 Source: MOE Change in traits added by genome editing. • Types of mutations in the modified gene (a. Insertion, b. Deletion, c. Substitution) • Physiological and ecological characteristics of the modified organisms. Presence or absence of change in other traits. Possible impacts on biodiversity when the organism is used.
  8. 8. Regulatory Policy for Genome Edited Food Products 2019/10/10 8 Source: MHLW GM food Non-GM food Foods that contain extracellularly processed DNA. Foods that does not contain that contain extracellularly processed DNA, even if foods that have naturally occurring gene deletion, insertion of one to several base pairs, and substitution. These foods are required to undergo a food safety assessment in accordance with the Food Sanitation Act. Developer are encouraged to provide information on the foods, and some of the information will be published for public understanding.
  9. 9. Information That Should be Provided by Developers 2019/10/10 9 Source: MHLW Crop type, cultivar name, how to use/eat, the purpose of use. The method of genome editing, modified gene and its function. Information confirming that the foods have no toxic substances or no allergens as well as no adverse effect on human health. Information confirming that the foods have no extracellularly processed DNA. Information on the changes in major components (e.g., nutrients.), if the metabolic pathway that increase or decrease specific substances have been modified.
  10. 10. www.jircas.go.jpwww.jircas.go.jp Thank you for your attention. 2019/10/10 10

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