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Japan: Animals

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Lightly Regulated

Gene-edited animals that do not contain DNA from another species are regulated as conventional animals, so they don’t face the tighter restrictions of transgenic GMOs.

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.

Products/Research

  • 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.

Regulatory Timeline

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).

NGO Reaction

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.

Additional Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

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Mexico

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Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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