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 plants, instead 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.
- 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 cleared 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.
- Non-browning apple: Arctic Apple developed by Okanagan Specialty Fruits using RNA interference, a more traditional New Breeding Technique (NBT) known as agrobacterium-mediated transformation. Arctic Golden, Granny Smith and Fuji apples are approved and Galas are in development.
- Salt-resistant rice: Agrisea, an ocean agriculture startup, developed rice that can be grown in the ocean.
- High-fiber wheat: Calyxt developed the wheat hoping it can be a healthier wheat option. Cleared by the USDA 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 cleared by the USDA in 2017.
- Drought- and salt-tolerant soybean: Developed at the University of Minnesota using CRISPR; cleared by the USDA 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; designated by the USDA as non-regulated in 2017.
- Mildew-resistant wheat: Developed by Calyxt using TALENs; designated by the USDA as non-regulated in 2016. Field trials began in 2017.
- Non-browning potato: Developed by Calyxt using TALENS and cleared by the USDA 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. Designated by the USDA as non-regulated in 2016, but is not yet available commercially.
- Non-browning mushroom: Developed at Pennsylvania State University using CRISPR and designated by the USDA as non-regulated in 2016.
- Drought-resistant maize: Developed by DuPont using CRISPR in 2016.
- Cold-storable potato: Developed by Calyxt, this potato does not produce the unhealthy compounds typically produced when cold-stored potatoes are cooked (acrylamide). Field trials completed in 2015.
- Bruise-resistant potato: The Innate potato was developed using RNA interference by Simplot and was deregulated in 2015.
- Herbicide-tolerant canola: Developed by Cibus using an NBT called somaclonal variation and cleared in 2013.
- Disease-resistant rice: Iowa State University researchers used TALENs to develop rice resistant to a specific bacteria in 2012.
- Cereal crops that don’t need fertilizer: MIT researchers devised an approach to develop cereal crops like corn, wheat, and rice that can absorb nitrogen from the soil instead of requiring added nitrogen fertilizer. Research is still ongoing.
- Using pollen to gene edit staple crops: Syngenta researchers developed a new method for gene editing crops by including the genetic changes in pollen that then fertilizes the crop, with the goal to speed up the creation of better and more versatile crops.
- Toolset for more efficient plant gene editing: NC State University researchers made a toolset publicly available that allows more researchers to use a technique called recombineering, used to gene edit organisms with very large genomes, which many plants have.
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.
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
- US regulators grapple with oversight of New Breeding Techniques (NBTs) by Marc Brazeau
- What’s in the CRISPR drawer for farming and food? by Marc Brazeau
- 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
- Regulation of Genome Editing in Plant Biotechnology