Gene-edited organisms 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 organism contains foreign DNA, but each time a gene-edited organism is crossed with another conventional or gene-edited organism, a separate notification process must occur. Local governments may also set additional regulatory requirements for gene-edited organisms.
Four ministries regulate genetically engineered organisms: 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).
There has been no commercial production of gene-edited animals.
- Meatier fish: Kyoto University researchers developed red sea bream with more edible flesh using CRISPR.
- Less aggressive fish: Researchers from the Seikai National Fisheries Research Institute used a gene editing technique called TALENs to develop tuna that swim more slowly, which reduces deaths from high-speed wall collisions. Other research is ongoing to develop less aggressive mackerel for aquaculture.
- Disease-resistant cattle: Researchers from the National Agriculture and Food Research Organization (NARO) used CRISPR to develop cattle resistant to IARS syndrome, a genetic disease that causes weakness and growth retardation in calves.
- Pigs with more muscle: NH Foods researchers used TALENs to develop piglets with double the number of muscle fibers.
- Human organs in animals: University of Tokyo researchers received approval to grow human organs in rats and mice. The research is in early stages, but the goal is to develop human pancreases that can be transplanted into humans.
- Anchovy research: Kyushu University researchers studied gene editing in anchovies using two techniques, CRISPR and TALENs.
2020: Ministry of Health, Labour and Welfare (MHLW) publishes final guidelines stating that gene-edited organisms 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.
2019: Japanese science ministry allows scientists to grow human-animal chimeras (human cells in an animal embryo that are transferred to an animal’s uterus), reversing an earlier ban on the practice. The goal is to use animals to grow organs that can be transplanted into humans.
2019: Advisory panel publishes final report recommending that gene-edited organisms 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: Government of Japan (GOJ) begins monitoring plan for genetically engineered AquAdvantage salmon, which is currently not approved for commercial sale in Japan.
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.