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United States: Crops / Food

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Determined: No Unique Regulations*

Most gene-edited crops are regulated as conventional plants, so they don’t face the heavier restrictions of GMOs.

The US loosely regulates gene edited crops and food, although the situation is complicated by the overlapping roles of three different agencies (USDA, FDA and EPA), each with separate regulations related to genetically engineered organisms (aka GMOs), as outlined under the 1986 US Coordinated Framework for Biotechnology. The US has no specific underlying legislation related to the regulation of GMOs but uses existing authority for regulating food, plant pests and pesticides.  The three agencies regulate the characteristics of the products themselves and not the process to develop it. Gene edited crops lacking foreign genes (which trigger regulation as GMOs) and that do not pose a risk to other plants, and gene-edited food showing no food safety attributes different from those of traditionally bred crops, are not subject to pre-market regulatory evaluation. It remains the responsibility of the developer to assure that products placed on the market are safe for use and consumption.

In 2019, the President signed an executive order directing federal agencies to streamline the regulatory process for genetically engineered plants by exempting low-risk products from existing rules and creating a unified platform that clearly outlines all regulatory requirements (from all three agencies) for review and authorization of products developed with biotechnology. In 2020, the USDA’s Animal and Plant Health Inspection Service (USDA-APHIS) finalized what it called the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) Rule, which would exempt (not regulate) gene-edited plants that otherwise could have been developed through conventional breeding under existing GMO regulations. This reaffirms a focus on regulating characteristics of gene-edited plantsinstead of the process used to create them, as is the case in the EU. APHIS states that these exemptions are intended to bring the regulation of potential GE plants more in line with the guidelines for conventionally bred crops, which while not “risk free” have risks determined to be “manageable by accepted standards.” For example, revised Part 340 exempts plants that have a single base pair substitution, because such an effect could also be created by conventional breeding.

Except for the USDA, that has had a process to provide opinions on the regulatory status of gene edited products for many years, it is unclear how gene-edited products will be regulated as gene editing techniques develop new variations in plants without leaving in any “foreign” DNA.  The FDA (which oversees food safety) and EPA (which regulates pesticides) have not announced if their existing policies and regulations related to GMOs would be used to regulate gene-edited crops and food.

To date only one gene-edited product has been commercialized, a soybean oil that contains “up to 20% less saturated fatty acids” compared to commodity soybean oil.

Products/Research

Regulatory Timeline

2020: New biotechnology framework, Movement of Certain Genetically Engineered Organisms (also called the SECURE Biotechnology Regulations), finalized by the USDA, which will not impose additional regulation on plants that otherwise could have been developed through conventional breeding.

2019: Modernizing the Regulatory Framework for Agricultural Biotechnology Products, an executive order, directs USDA, FDA and EPA to exempt low-risk products from regulation and to create a unified platform that clearly outlines all regulatory requirements for approval of products developed with biotechnology.

2019:  USDA-APHIS proposes new biotechnology framework, Movement of Certain Genetically Engineered Organisms (also called the SECURE Biotechnology Regulations), which reduces the regulatory requirements for organisms that are unlikely to pose risks to other plants.

2018: FDA announces Plant and Animal Biotechnology Innovation Action Plan, pledging to clarify policies on gene editing and ensure developers have a clear path to efficiently bring a product to market.

2018: US and 12 other nations, including Argentina, Australia, Brazil and Canada, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”

2018: US Secretary of Agriculture, Sonny Perdue, declares that the USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques.

2017: After objections from scientists,  USDA withdraws proposed rule to revise the agency’s regulations of genetically engineered crops, which would have increased regulations on gene edited crops, and instead agrees that gene edited plants should be treated similarly to those developed through conventional breeding techniques.

2017: Office of Science and Technology (ODTP)  issues an Update to the Coordinated Framework (CF) for the Regulation of Biotechnology, which clarifies the current roles and responsibilities of, and coordination among, FDA, EPA, and the USDA-APHIS.

2016: The GMO Labeling Act requires labeling of genetically engineered food products. It gives the option for companies to use a QR code that consumers can scan to see if the product is made from genetically engineered food products. It is not clear whether gene edited ingredients will trigger such a label.

2016: OSTP issues National Strategy for Modernizing the Regulatory System for Biotechnology Products, which presents a vision for ensuring that the federal regulatory system is prepared to assess future products of biotechnology.

2015: The Executive Office of the President (EOP) issues a memorandum directing the EPA, FDA and USDA to update the Coordinated Framework for the Regulation of Biotechnology, develop a long-term strategy and commission an expert analysis of the future landscape of biotechnology.

2000: The Plant Protection Act authorizes APHIS to regulate any plant, plant product or organism that could injure, damage, or cause disease in any plant or plant product.

1986:  Coordinated Framework for the Regulation of Biotechnology outlines the basic federal policy of the agencies (USDA, FDA and EPA) involved with reviewing biotechnology research and products.

1910:  Federal Insecticide, Fungicide and Rodenticide Act authorizes the EPA to regulate pesticide distribution, sale, and use, including plants genetically modified to produce pesticides.

NGO Reaction

Environmental advocacy groups including Greenpeace, Center for Food Safety, Environmental Working Group and Friends of the Earth, have taken the stance that gene editing is just the newest version of transgenic modification (GMO 2.0), arguing that gene editing has not been tested enough for safety and could lead to unintended side effects.

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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