Most gene-edited crops are regulated as conventional plants, so they don’t face the heavier restrictions of GMOs.
The US lightly 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 recombinant DNA (rDNA) in the product (which results in the presence of ‘foreign’ genes and triggers 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. 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.
- Soybean oil with no trans-fat: First commercially-available gene-edited plant product, in 2019. Contains no trans-fat and lower saturated fat. Gene edited by Calyxt using a technique called TALENs.
- Virus-resistant tomato: Developed by Nexgen Plants, an Australian research company, and approved by the USDA to start field trials.
- Tiny tomato: Developed using CRISPR by researchers at the University of California, Riverside to be used on the International Space Station as well as indoor farming and other space-restricted areas.
- Mildew-resistant wine grapes: Research ongoing using CRISPR by scientists at Rutgers University in New Jersey.
- Non-browning apple: Arctic Apple developed by Okanagan Specialty Fruits using a technique called RNA interference. Arctic Golden, Granny Smith and Fuji apples are approved and Galas are in development.
- High-fiber wheat: Calyxt developed the wheat hoping it can be a healthier wheat option. Approved in 2018 but not commercialized.
- Camelina (plant in the mustard family used for oil) with enhanced omega-3-oil: Developed using CRISPR by Yield10 Bioscience and approved in 2017.
- Drought- and salt-tolerant soybean: Developed at the University of Minnesota using CRISPR; approved in 2017.
- High-yield tomato: Developed in 2017 by researchers at Cold Spring Harbor Laboratory to produce more fruit and fewer leaves and branches.
- Improved-quality alfalfa: Developed by Calyxt using TALENs; approved in 2017.
- Mildew-resistant wheat: Developed by Calyxt using TALENs; approved in 2016. Field trials began in 2017.
- Non-browning potato: Developed by Calyxt using TALENS and approved in 2016.
- Corn with extra starch: Corn with high starch content (called waxy corn) was developed by DuPont using CRISPR and has been planted in test fields. Approved in 2016, but is not yet available commercially.
- Non-browning mushroom: Developed at Pennsylvania State University using CRISPR and approved in 2016.
- Cold-storable potato: Developed by Calyxt, this potato does not produce the unhealthy compounds typically produced when potatoes are stored at cold temperatures. Field trials completed in 2015.
- Bruise-resistant potato: The Innate potato developed using RNA interference by Simplot and was approved in 2015.
- Herbicide-tolerant canola: Developed by Cibus using oligonucleotide-directed mutagenesis (ODM) and approved in 2013.
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 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.
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.
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.
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of United States gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- USDA-APHIS list of inquiries includes any genetically engineered products developers have submitted to the USDA and whether the USDA has decided to regulate them