Food produced using new breeding techniques (NBTs), including CRISPR gene editing, are held to similar standards as conventional foods. Plants produced through the use of NBTs are regulated based on the end product, not the means of creating them.
Oversight of gene-editing technology is jointly managed by the U.S. Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency in a byzantine structure known as the Coordinated Framework. Because genetically edited crops do not incorporate ‘foreign’ DNA, such as those derived from viruses or bacteria, they are not mandated to undergo the scrutiny or testing still required for cisgenic genetically modified (GMO) crops.
The more relaxed rules date to 2019 when President Donald Trump signed an executive order directing federal agencies to streamline the regulatory process for genetically engineered plants by exempting low-risk products from existing rules. That order led to the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) Rule finalized in 2020 and now called the Revised Biotechnology Regulations.
The USDA’’s Animal and Plant Health Inspection Service (USDA-APHIS) exempts from regulation seeds that contain minor “edits”—a change to a pair of amino acid bases or a deletion of a chunk of DNA, also known as SD-1—that could create a trait that theoretically could have been produced through traditional breeding. Product developers do not need agency approval if they produce a trait in a crop that exists naturally in a breeding- compatible plant. Developers can request a confirmation from APHIS that a modified plant qualifies for an exemption and is not subject to the regulations.
APHIS has stated that these exemptions were intended to bring the regulation of future plants produced using NBTs more in line with the guidelines for conventionally-bred crops, which, while not “risk free” have risks determined to be “manageable by accepted standards.” Some plants developed using genome editing techniques will be regulated if it’s determined they pose a plausible plant pest risk.
Plants with ‘foreign genes’ — transgenic genetically modified crops (GMOs) — still face tighter restrictions and must continue to be labeled, although labeling regulations have been relaxed. Transgenic crops produced through minor variations, such as tailoring them to different climates, will not need to undergo a new risk evaluation. The rule also provides mechanisms to adapt to future innovations that cannot yet be anticipated.
Previously, the FDA had in place a voluntary plant biotechnology consultation process for gene editing in which developers were required to submit a summary of their safety and regulatory assessment to the agency after which it would provide feedback, and worked with developers to resolve safety issues. Under a May 2023 EPA document, the agency could in rare cases require limited safety tests. Companies and research institutions must submit evidence that NBTs don’t increase pesticide levels and health risks beyond those found in food from conventional crops
Products/Research (partial list as many products are in development)
To date three gene-edited products have been commercialized in the US, and two others have been approved or did not face regulation but have not been commercialized.
- Non-browning avocado, 2023: GreenVenus, a biotechnology company specializing in sustainable agrotechnology, successfully engineered a key gene associated with fruit browning using CRISPR.
- Less pungent mustard greens, 2023: Developed by Pairwise and marketed as “Conscious Greens”.
- Amylopectin enriched waxy corn, 2023: Developed by Corteva Agriscience, the waxy corn has nearly 100% amylopectin in the starch, compared to traditional corn, where the starch is typically 75 percent amylopectin and 25 percent pectin. Already approved for commercialization in Japan, it awaits US approval.
- Non-browning lettuce, 2023: Also developed by GreenVenus, acquired commercial status. The romaine lettuce has improved shelf life up to two weeks and a potential for higher marketable yield with no tip burn.
- Powdery mildew resistant grapes, 2023: The VitisGen3 research project, funded by the USDA in connection with multiple US universities and companies, uses CRISPR to remove candidate genes to test the effects.
- Increased antioxidant tomato, 2023: The ‘purple tomato’ developed by Norfolk Healthy Produce, a subsidiary of the John Innes Center. The tomato host intended increased levels of anthocyanins, which also results in its harmless purple color.
- Mechanized harvesting compatible cowpea, 2023: First successful gene editing of a cowpea by the Israeli company Betterseeds would open the door to mechanical harvesting, something not previously possible.
- High yield pennycress, 2022: Scientists from Covercress reduced erucic acid and fiber concentration, using CRISPR. This resulted in higher yield and better agronomics for pennycress, a cash cover crop that has potential as aviation fuel. The crop is FDA approved, but commercialization is pending.
- Purple tomato’ with high GABA, 2021: Developed by Norfolk Healthy Produce, which has increased antioxidant properties.
- Higher yield waxy corn, 2020: Using CRISPR–Cas9 gene editing researchers from Corteva Agriscience created corn hybrids with superior performance to those obtained using modern trait introgression methods.
- Cereal crops that don’t need fertilizer, 2020: MIT researchers devise 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 ongoing.
- Salt-resistant rice, 2020: Agrisea, an ocean agriculture startup, developed rice that can be grown in the ocean.
- Virus-resistant gene-edited tomato, 2019: Developed by Nexgen Plants, an Australian research company, and cleared by the USDA to start field trials.
- Virus resistant tomato, 2019: USDA determined that six gene-edited virus-resistant tomato lines developed by Nexgen Plants of Australia aren’t potential plant pests and therefore do not fall under the agency’s jurisdiction for regulating biotech crops. The lines have not yet been commercialized.
- Less fatty Soybean oil, 2019: Developed by Calyxt, the TALENs-edited soybeans contain up to 20% less saturated fatty acids compared to other soybean oils.
- Tiny tomato, 2019: 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, 2019: Research ongoing using CRISPR by scientists at Rutgers University.
- High-fiber wheat, 2018: Calyxt developed the wheat as a healthier wheat option. Cleared by the USDA but not commercialized.
- Camelina (plant in the mustard family used for oil) with enhanced omega-3-oil, 2017: Developed using CRISPR by Yield10 Bioscience and cleared by the USDA.
- Drought- and salt-tolerant soybean, 2017: Developed at the University of Minnesota using CRISPR and cleared by the USDA.
- High-yield tomato, 2017: Developed by researchers at Cold Spring Harbor Laboratory to produce more fruit and fewer leaves and branches.
- Improved-quality alfalfa, 2017: Developed by Calyxt using TALENs; designated by the USDA as non-regulated.
- Mildew-resistant wheat, 2017: Developed by Calyxt using TALENs; designated by the USDA as non-regulated in 2016. Field trials began in 2017.
- Non-browning potato, 2016: Developed by Calyxt using TALENS and cleared by the USDA in 2016.
- Soybean oil with no trans-fat, 2016: First commercially-available gene-edited plant product developed by Calyxt using TALENs. It contains no trans-fat and lower saturated fat.
- Corn with extra starch, 2016: Corn with high starch content (waxy corn) developed by DuPont using CRISPR planted in test fields. Designated by the USDA as non-regulated, but not introduced commercially.
- Non-browning mushroom, 2016: Developed at Pennsylvania State University using CRISPR and designated by the USDA as non-regulated.
- Drought-resistant maize, 2016: Developed by DuPont using CRISPR.
- Non-browning apple, 2015: Arctic Apple Fuji variety developed by Okanagan Specialty Fruits using RNA interference approved by the FDA, and commercialized by 2017. Fuji, Granny and Golden varieties are on sale as of November 2022 with Gala, Pink and Honey approved but not yet commercialized.
- Disease-resistant rice, 2012: Iowa State University researchers used TALENs to develop rice resistant to a specific bacteria.
- ‘Mushroom that resists browning, 2012: Developed by a Penn State University plant pathologist using TALENs, which was invented years before CRISPR debuted in 2012.
Regulatory Timeline
2023: EPA adds additional safety requirements to existing SECURE regulations finalized by the USDA.
2020: New biotechnology framework, Movement of Certain Genetically Engineered Organisms (also called the SECURE Biotechnology Regulations), finalized, exempting some gene-edited plants from government oversight. It is the first comprehensive revision of biotechnology regulations since they were established in 1987. The revised rule focuses on a plant’s properties and not on the method used to produce the seed, enabling the Animal and Plant Health Inspection Service (APHIS) to regulate modified organisms with greater precision, reducing regulatory burden for developers.
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 modify the unified platform to more clearly outline 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 crops with NBTs should be treated similarly to those developed through conventional breeding techniques.
2017: US Office of Science and Technology (OSTP) issues an Update to the Coordinated Framework for the Regulation of Biotechnology, which clarifies the current roles and responsibilities of, and coordination among, FDA, EPA, and the USDA-APHIS.
2016: 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 modified to produce pesticides.
NGO Reaction
Numerous science and environmental advocacy groups are critical of the revised regulations that exempt companies from having to notify USDA of biotech crops they will bring to market that are exempt from regulations. “The result is that government regulators and the public will have no idea what products will enter the market and whether those products appropriately qualify for an exemption from oversight,” wrote the Center for Science in the Public Interest.
Advocacy groups including Greenpeace, Center for Food Safety, Environmental Working Group and Friends of the Earth, take the stance that gene editing is just the newest version of transgenic modification (GMO 2.0), arguing that NBTs have not been safety tested enough and could lead to unintended side effects. Friends of the Earth-US claims in an environmental report that “new studies” reveal “genetic havoc” will result from gene editing.
The Non-GMO Project claims that gene editing is the same as transgenic modification (which is inaccurate). They ‘’recognize that any process in which an organism’s genetic material is engineered in a laboratory is genetic engineering. The products of emerging techniques — including CRISPR, TALEN, RNAi and gene drives — are GMOs’’.
Some researchers and scientists express concern that allowing companies to self-regulate would heighten distrust in gene editing among consumers. Innovative Genomics Institute, founded by CRISPR co-inventor Jennifer Doudna, raises questions of accountability. “While we recognize the agency’s rationale behind self-determination and desire to provide regulatory relief in order to spur innovation,” she writes, we are concerned that rather than stimulating innovation, such an undisclosed step may have the effect of dampening trust through the loss of transparency in the development and oversight process.”
In response to the 2018 regulatory reforms, North Carolina State social scientist Jennifer Kuzma, a crop biotechnology skeptic, claims gene-edited oversight is “fraught with anti-regulatory bias” and that new crops should undergo outside regulatory review.
Additional Resources
- US regulators grapple with oversight of New Breeding Techniques (NBTs)
- What’s in the CRISPR drawer for farming and food?
- Governing gene editing in agriculture and food in the United States: Tensions, contestations, and realignments
- Gene-Edited Food Adoption Intentions and Institutional Trust in the United States: Benefits, Acceptance, and Labeling
- Regulation of CRISPR edited food and feed: legislation and future
- Regulation of Genome Editing in Plant Biotechnology
Updated: 11/09/2023
