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Japan: Crops / Food

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Lightly Regulated

Gene edited crops must be registered, but do not require safety or environmental testing.

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.

There has been no commercial cultivation of genetically engineered food in Japan, but gene-edited products could go on sale in 2020.

Products/Research

  • 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.

Regulatory Timeline

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).

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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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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