期刊
FRONTIERS IN BIOENGINEERING AND BIOTECHNOLOGY
卷 7, 期 -, 页码 -出版社
FRONTIERS MEDIA SA
DOI: 10.3389/fbioe.2019.00387
关键词
genome editing; regulatory status; Japan; Cartagena Protocol; LMOs
资金
- Innovation Promotion Program (SIP), Technologies for creating next-generation agriculture, forestry and fisheries (funding agency: Bio-oriented Technology Research Advancement Institution, NARO)
- Cooperative Research Grant of the Plant Transgenic Design Initiative (PTraD), Gene Research Center, T-PIRC, the University of Tsukuba
The Japanese government recognizes the substantial values of genome-edited agricultural organisms and has defined in which cases these are covered by the existing regulatory framework to handle this technology. Genome-editing technologies could revolutionize and accelerate plant breeding owing to the simplicity of the methods and precision of genome modifications. These technologies have spread rapidly and widely, and various genome-edited crops have been developed recently. The regulatory status of genome-edited end products is a subject of controversy worldwide. In February 2019, the Japanese government defined genome-edited end products derived by modifications of SDN-1 type (directed mutation without using a DNA sequence template) as not representing living modified organisms according to the Japanese Cartagena Act. Here, we describe the classification and regulatory status of genome-edited end products in this decision. We hope that reporting the progress in Japan toward the implementation of this regulatory approach will provide insight for scientific and regulatory communities worldwide.
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