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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 as outlined under the 1986 US Coordinated Framework for Biotechnology. The US regulates the characteristics of the product itself 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 regulatory evaluation.

For years, it was unclear how gene editing would be regulated as gene editing techniques engineer new plants without foreign DNA. In 2018, the USDA’s Animal and Plant Health Inspection Service (USDA-APHIS) announced it would not regulate gene-edited plants “similar to those found naturally” but there remained much confusion. In 2019, USDA proposed a reduction in regulatory requirements for most gene-edited plants and a more efficient regulatory pathway. This new regulation would reaffirm a focus on regulating characteristics of gene-edited plants, instead of the process used to create them, as is the case in the EU. The FDA (which oversees food safety) and EPA (which regulates pesticides) have not announced if they will regulate gene-edited crops and food, although the EPA regulates any gene-edited crops developed with disease resistance. 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 regulation and creating a unified platform that clearly outlines all regulatory requirements (from all three agencies) for approval of products developed with biotechnology.

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

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.

Hotspots Background

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

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
*Gene editing regulated under existing legislation with no unique restrictions, except Argentina, which passed new, flexible regulations.

†Decrees under consideration, but not yet passed, to regulate gene-edited crops or animals as conventional.

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
India888
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

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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