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Ongoing Research, Regulations In Development

Decree suggests gene editing techniques will not be banned like GMOs.

According to a federal program announced in 2019, some gene editing techniques will be exempt from a 2016 law that banned the cultivation of genetically engineered organisms except for research purposes. The decree establishing the program describes gene editing as equivalent to conventional breeding methods, the view adopted by most of the world except for the European Union. The federal program aims to create 10 new varieties of gene edited crops and animals by 2020 and another 20 by 2027.

Genetically engineered organisms are regulated by the Federal Service for Surveillance of Consumer Rights Protection and Human Welfare (Rospotrebnadzor), which is responsible for developing legislation on genetically engineered products and monitoring the influence of genetically engineered products on people and the environment and the Ministry of Agriculture, which develops policy for the use of genetically engineered organisms in agriculture.

The Organization for Economic Cooperation and Development (OECD) has its own Working Group on Harmonization of Regulatory Oversight in Biotechnology, but there has been no progress in addressing issues around gene editing in many major food-producing countries, including Russia.

Products/Research

None

Regulatory Timeline

2020: Russian Federation President Vladimir Putin signs new Food Security Doctrine, which bans import and distribution of genetically engineered organisms for planting, and prohibits raising and breeding animals whose genetic code has been engineered. The only exception to the ban is the import and planting/breeding of genetically engineered organisms for research purposes.

2019: Federal gene editing program established to create 10 new varieties of gene-edited crops and animals by 2020 and another 20 by 2027 and estimated to cost 111-billion-rouble (US$1.7-billion). The decree announcing the program describes gene editing technologies as equivalent to conventional breeding methods.

2018: Ministry of Agriculture publishes first draft of a set of proposed guidelines for the required safety assessments and testing of genetically engineered animals.

2017: Russian Federation issues Resolution No. 770, On Amending the Resolution of the Government of the Russian Federation No. 839, implementing Federal Law No 358, which bans breeding of genetically engineered animals and amends Russia’s framework of rules for the registration of genetically engineered organisms.

2016: Russian Federation President Vladimir Putin signs Federal Law No. 358-Z that bans breeding of genetically modified animals, except for research purposes.The law formalizes the previous de-facto ban resulting from the lack of a regulatory framework. It defines GMOs as those with gene modifications “that cannot result from natural processes.” The regulation is unclear about whether gene edited animals are included in the ban.

2002: Adopts Federal Law No. 7-FZ, On Protection of the Environment.

1996: Adopts Federal Law No. 86-FZ, On the State Regulation in the Sphere of Genetic Engineering Activities. The foundational federal law on genetic engineering in Russia establishes state control over the release of genetically engineered organisms into the environment and monitoring of effects on the environment and on human health.

NGO Reaction

NGOs, including Greenpeace Russia and the Alliance of the Commonwealth of Independent States for Biosafety, campaign against agricultural genetic engineering, including gene editing, in an attempt to influence consumer choices. According to Russia Today, about 80 percent of Russians opposes legalization of GMOs.

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.

World single states political map

European Union

European Union

Brazil

New Zealand

New Zealand

United States

United States

Australia

Australia

Canada

China

United Kingdom

United Kingdom

Israel

Argentina

Argentina

Japan

Mexico

Russia

Chile

Uruguay

Paraguay

India

Africa

Ukraine

Southeast Asia

Southeast Asia

Central America

Central America

Colombia

Norway

Ecuador

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.