Regulatory Status of Genome-Edited Organisms Under the Japanese Cartagena Act

• Main Authors: Mai Tsuda, Kazuo N. Watanabe, Ryo Ohsawa
• Format: Article
• Language: English
• Published: Frontiers Media S.A. 2019-12-01
• Series: Frontiers in Bioengineering and Biotechnology
• Subjects: genome editing; regulatory status; Japan; Cartagena Protocol; LMOs
• Online Access: https://www.frontiersin.org/article/10.3389/fbioe.2019.00387/full

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.