Gene-edited crops and food are assessed on a case-by-case basis and require notifying the government, which includes information on the editing technique and genes targeted for modification. No safety or environmental assessments are required unless the plant contains foreign DNA, but each time a gene-edited crop is crossed with another conventional or gene-edited crop, a separate notification process must occur. Local governments may also set additional regulatory requirements for gene-edited crops. The recommendations do not address labelling requirements for gene-edited foods.
Four ministries regulate genetically engineered crops and food: The Ministry of Agriculture, Forestry and Fisheries (MAFF), the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT). The Food Safety Commission (FSC), an independent risk assessment body under the Cabinet Office, performs food and feed safety risk assessment for MHLW and MAFF.
- High-yield rice: Field trials began in 2017 by the National Agriculture and Food Research Organization for rice that produces more than traditional varieties.
- Flower color: Researchers from the University of Tsukuba, the National Agriculture and Food Research Organization (NARO) and Yokohamaa City University changed the flower color of the traditional Japanese garden plant, Japanese morning glory, from violet to white using CRISPR.
- Rain-resistant wheat: Researchers from the National Agriculture and Food Research Organization (NARO) and Okayama University used CRISPR to develop a rain-resistant wheat that may be used as a parent to future wheat used for food.
- Albino apple: Researchers at NARO used CRISPR to developed albino apple strains for research purposes only.
- Seedless tomatoes: Researchers at Tokushima University developed seedless tomatoes for research purposes only.
- Low-starch potato: Hirosaki University researchers developed a potato with reduced starch using epi-genomic modification. Field trials began in 2017.
- Tomato for blood pressure: Tsukuba University researchers used CRISPR to develop a tomato with higher content of a compound that might help lower blood pressure.
- New technique for high-yield crops: University of Tokyo researchers used a technique called mitoTALENs to develop high-yield strains of rice and canola.
2020: Ministry of Health, Labour and Welfare (MHLW) publishes final guidelines stating that gene-edited plants and food can be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, but developers must send notification to the government.
2020: Ministry of Agriculture, Forestry, and Fisheries (MAFF) Animal Products Safety Division releases final guidelines for the handling of gene-edited feed and feed additives.
2019: MHLW releases the final guidelines for the handling of genome edited food and food additives.
2019: Advisory panel publishes final report recommending that gene-edited plants and food can be sold to consumers without safety evaluations as long as the techniques involved meet certain criteria, but the recommendations must still be adopted by the MHLW.
2018: Environment ministry committee recommends regulating only gene edited organisms that have had foreign genes added.
2017: Agricultural Academy of Japan releases recommendation to cultivate genetically engineered crops in Japan, specifically mentioning potential benefits of glyphosate-resistant sugar beets.
2017: Consumer Affairs Agency (CAA) initiates review of genetic engineering labeling requirements.
2004: Japan adopts the Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms (also called the Cartagena Law).
Advocacy groups like the Consumers Union of Japan and Seikatsu Club Consumers’ Co-operative Union have taken the stance that gene editing is just the newest version of transgenic modification, arguing that gene editing has not been tested enough for safety, could lead to unintended side effects and should be labelled for consumers.
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of Japan gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- USDA Agricultural Biotechnology Annual 2019: Japan
- Regulation of Genome Editing in Plant Biotechnology