Several studies have identified a variety of factors important to consumers regarding gene-edited foods (GEFs) and genetically modified (GM) foods that are crucial in shaping their acceptance and decision-making processes. While it is sensible to believe that people primarily make decisions about food based on cost, appearance, taste, and nutritional content, recent studies by Cummings and Peters (2022a, 2022b) show that other factors influence perceptions and levels of acceptance, including social and ethical values, trust in agricultural biotechnology companies and government, and science and technology beliefs. These factors were found to greatly influence both consumers’ willingness to eat GEFs as well as purposeful avoidance of GEF products. In addition, in these studies, individuals who are more willing to eat GEFs generally view science and technology as a primary means to solve society’s problems, they place high levels of trust in government food regulators and the agriculture biotechnology industry, and generally do not have strong beliefs about food production. These views were also associated with younger (<30) individuals with higher-than-average education and household incomes. Conversely, individuals who reported they would prefer to purposefully avoid eating GEFs are more skeptical of the value of science and technology, they place greater value on the way their food is produced, and they more readily trust environmental groups rather than government and industry. This group tends to have lower incomes, are more religious, older and female, with approximately 60% of the women surveyed reporting that they would purposefully avoid eating GEFs. Both groups agree that they would prefer that GEFs be mandated by the federal government to be labelled, with approximately 75% of the entire sampled population desiring labeling regardless of whether they would consume the products. Although the transparency of labeling is preferred by consumers, the effect of providing additional scientific information on consumer acceptance of GM foods in surveys demonstrates mixed findings. In addition, some studies report that information provision increases acceptance (Dolgopolova et al., 2017a; Dolgopolova et al., 2017b; Carrasson, et al., 2021) while others demonstrate that providing new information about GM foods does not improve consumer acceptance (Mcfadden and Wilson, 2018; Scott et al., 2018).

GEFs is also intertwined with the history of genetically modified organisms (GMOs) (Cummings, 2017; Friedrichs et al., 2019; Kuzma, 2022; Cummings et al., 2023; Lindberg et al., 2023). Public trust in GMOs has shown a significant discrepancy between scientific experts and the public. For instance, in 2015, 88% of scientists believed GMO foods were safe for human consumption compared to only 37% of the public (Pew Research Center, 2015). Recent stakeholder studies show that proponents of GEFs are seeking to cultivate public acceptance by focusing on shared values and transparency in their communication while also seeking to define GEFs as heterogeneous to GMOs (Cummings et al., 2023). Critics, on the other hand, view many of the concerns of GEFs as similar to GMOs and often seek to define GEFs as analogous to GMOs so that regulatory oversight and labeling mandates for GEFs are the same as GMOs (Cummings et al., 2023).

In a study comparing GM foods to GEFs, consumers viewed CRISPR and GM food similarly and substantially less positively than conventional food (Shew et al., 2018). Other studies show that cisgenic crops (genetic changes introduced from the same species, such as those produced by some gene-editing technologies) may be more acceptable to consumers than transgenic crops (genetic changes introduced from a different species), but that consumers may be less willing to accept cisgenic crops in comparison with conventionally bred crops (Edenbrandt et al., 2018; De Marchi et al., 2019). In Denmark, Edenbrandt et al. (2018) found a preference for cisgenic over transgenic rye bread production methods, while Marette et al. (2021) observed that French consumers would avoid gene-edited apples if given the choice. However, certain benefits associated with GEFs and GM foods can also outweigh negative perceptions among consumers, such as improved nutrition or safety (Yue et al., 2015a; Yue et al., 2015b). Furthermore, Kato-Nitta et al. (2019) found that Japanese consumers were more concerned about gene-edited livestock (pigs) than they were gene-edited vegetables (tomatoes). This study also found that the public was more willing to accept gene-edited products that provided direct-to-consumer benefits (increased nutritional value in the tomato) than products that benefited farmers (size enlargement of livestock). Only a subset of consumers reject cisgenic and transgenic crops under any circumstance (typically less than 20 percent), and other groups chose them based on health, safety and nutritional benefits, irrespective of whether they were cisgenic or transgenic (Yue et al., 2015b; Siegrist, 2008; Edenbrandt et al., 2018; De Marchi et al., 2019; Busch et al., 2022). For GM foods, benefits of increased health, safety and nutrition, particularly for those with food security needs, tend to be favored by consumers over improved taste and environmental benefits (Yue et al., 2015a). Animal welfare is another benefit from gene-edited agricultural products that can trump negative consumer perceptions. McConnachie et al. (2019) found positive consumer attitudes towards hornless gene-edited cattle, and Kilders and Caputo, (2021) found that animal welfare had the strongest positive impact on consumer willingness to purchase GM or GEF milk. In general however, other surveys show more negative attitudes towards animal gene-editing and genetic engineering than plant-based biotechnology (Frewer et al., 2014).

While ongoing studies investigate potential risks associated with GEFs, including off-target effects, unintended on-target effects, and unintended consequences (Kawall et al., 2020), scholars suggest that trust in emerging technologies for food is influenced by factors beyond technical risks and benefits, including past experiences with technology controversies, transparency and openness on the part of those who manage the technology, and provision of consumer control and choice (Slovic, 1987; Yawson and Kuzma, 2010; Kuzma and Kokotovich, 2011; Brown and Kuzma, 2013; Dietz, 2013; Yue et al., 2015a; Brown et al., 2015; Yue et al., 2015b; Cummings et al., 2023). For example, institutional trust plays a pivotal role in public perceptions and acceptance of both GEFs and GM foods (Frewer et al., 2014; Yue et al., 2015a; Cummings and Peters, 2022a; Cummings and Peters, 2022b). In summary, trust in those who manage the technology which is fostered by openness, transparency, assurance of safety, as well as consumer choice are important to consumers as well as tangible benefits that improve safety, transparency, and animal welfare when it comes to attitudes and acceptance of GEFs and GM foods by consumers.

As a part of a USDA/NIFA-funded research project (Grant number 2022-67023-36730, PI/CoPI = Grieger/Kuzma), our research team conducted an online survey to investigate stakeholder views of parameters that would be important when evaluating novel technologies in food and agriculture, including gene editing. The approach and overview of results are provided below.

The parameters in Table 1 are classified into four categories, i.e., environmental, human health, animal health, and ethical, legal and social-economic implications (ELSI). These categories also reflect the pillars of sustainability, which was popularized by the United Nations (2015) through mainstreaming sustainable development goals on a global scale (environment, health, social-economic). Agriculture and food production is one of the most challenging issues for human society regarding sustainability, given the limited natural resource capacities of the planet. Thus, in order to achieve sustainable agriculture through biotechnology, we argue that a more holistic assessment based on these parameters of sustainability should be employed before commercializing gene-edited crops and foods on a large scale in order to ensure the biotechnology products’ contribution to sustainability (see also Wei et al., 2023).

We note here that many of the parameters and their categories may likely overlap with one another and may be difficult to measure (e.g., impacts on climate change). For example, social-economic considerations address the overlapping intersections of ethical, legal, as well as economic issues that may have multiple impacts on society. Similarly, impacts on human health are also known to influence socio-economic issues, etc. In addition to intersections, the perceptions of these key parameters may also interact with one another. For example, consumer views towards human health may directly influence perceptions of food quality as well as ELSI considerations (e.g., transparency).

The parameters in Table 1 also encompass the dimensions that consumers value when it comes to acceptance of gene-edited foods (Section 2.1), including benefits such as improvements in safety and nutrition and process criteria such as transparency and openness for decision-making that creates choice for them. Thus, these parameters may serve as a set of criteria for evaluating the recent oversight of three gene-edited products in the U.S. (Figure 2).

This case study was chosen because it is the first gene-edited crop available in the market. In 2015 a gene-edited soybean line with increased levels of oleic acid and decreased levels of linoleic acid was cleared by the USDA through its “Am I Regulated” process (USDA, 2015a; b), which was in place from 2010 to 2020 prior to the SECURE rule being implemented (USDA, 2020a). Potential benefits of increasing the levels of oleic acid in soybean include benefits to food manufacturers, as higher oleic soybean oil provides higher heat stability and may extend product shelf lives (Huth et al., 2015). Additional benefits includes serving as a potentially healthier replacement of saturated fats in foods to ones that may reduce risks of coronary heart disease (FDA, 2018). The company that produced this product, Calyxt, consulted with the FDA a few years later under the agency’s voluntary notification process for biotechnology-derived novel foods (FDA, 2019a; b, c). The product was generated using Agrobacterium-mediated transformation of TALEN site directed nucleases (gene-editing proteins that were precursors to CRISPR-Cas9) into the host soybean to make deletions in two FAD2 genes (USDA, 2015a; USDA, 2015b; FDA, 2019a; FDA, 2019b; FDA, 2019c). Then the transgenic sequences from Agrobacterium and the TALENs were backcrossed out to leave only the two deletions. As a result, USDA decided it did not have to go through its Plant Production Act regulations (prior to SECURE) (USDA, 2015a; b) as it did not contain DNA sequences from plant pests. Therefore, the plant did not have to undergo the plant pest risk assessment process or an environmental assessment under the National Environmental Protection Act. The decision document authored by USDA conveys the focus of the USDA determination as to whether the oil-altered gene-edited soybean is a regulated article (USDA, 2015b; Box 1). The focus of USDA’s determination is on the presence of plant pest sequences and that soybean plants are not considered plant pests. Weediness of soybeans was also considered, although it should be noted that weediness is not included as a primary risk endpoint in USDA’s regulations for genetically engineered plants (USDA, 2020a; Kuzma and Grieger, 2020).

Several parameters from Table 1 and Figure 2 are missing from this assessment including environmental impacts such as ecotoxicity, climate change impacts, resource use, and chemical use. Rather, USDA’s authority for GM plants is limited to plant pest risks under its GE plant regulations and the Plant Protection Act, and to a certain extent noxious weed risks under the PPA. This leaves several gaps for environmental toxicity and ecological sustainability that would only be considered under a broader Environmental Impact Statement under the National Environmental Policy Act (NEPA). EIS’s have been done for only a handful of decisions for GM plants in their 30 years history (see Kuzma, 2022) and NEPA analyses only take place when GM plants come under USDA’s plant pest risk authorities, which the gene edited soybean did not. It should be noted that the EPA has no authority for the gene-edited soybean as it did not introduce a “plant-incorporated protectant” or increase a pesticidal compound in the engineered plant (EPA, 2023). Some ecotoxicity parameters would have been considered under EPA’s FIFRA regulations for “plant-incorporated protectants” introduced or altered via genetic engineering (EPA, 2023).

As far as ELSI parameters and important parameters to consumers, transparency and stakeholder inclusion in the USDA decision making process was lacking. The Am I regulated? process under the former USDA plant pest regulations for GM crops involved letters published on the website and some of the information may be considered confidential business information (USDA, 2015a; b; Kuzma and Kokotovich, 2011; Kuzma, 2018; Kuzma, 2022). There was no publication in the Federal Register, no external advisory committee or external scientific input, and little risk or benefit information provided. Furthermore, the gene-edited soybean or oil derived from it would not need to be labeled under the National Bioengineered Food Disclosure Standards as there is no foreign DNA in the final product (Jaffe and Kuzma, 2021). This also means that consumers and other stakeholders will not be able to track where the product is being used in the marketplace and would remain unaware of it being gene-edited (Kuzma and Grieger, 2020).

As far as human health parameters are concerned for the gene-edited soybean, these would come under the FDA’s authorities under the FDCA. However, the FDA process is a voluntary consultation process which may decrease trust in consumers. Regardless, the company did take the step to consult with FDA and submitted information about the composition of the product in comparison to conventionally bred soybeans and oil derived from them for consideration by FDA for its suitability for food and feed (FDA, 2019a; b, c). These tests are generally designed to demonstrate nutritional “substantial equivalence” to the conventional counterpart. Endpoints in these documents that were considered include the fatty acid composition and its alteration; moisture, crude protein, crude fat, ash, and carbohydrates by calculation; fiber; amino acids, six fatty acids, three isoflavones (daidzein, genistein, and glycitein), four lecithins, and five anti-nutrients (lectin, phytic acid, raffinose, stachyose, and trypsin inhibitor) in whole seeds; and six fatty acids and lecithins. The FDA notes that “Calyxt states that the genetic modifications (inactivation of the FAD2-1A and FAD2-1B proteins, which are primarily expressed in developing seeds) do not meaningfully affect composition and nutrition of the meal derived from FAD2KO soybeans except for the intended changes in the levels of specific fatty acids” (FDA, 2019b). However, it is important to note that FDA relies on company data and does not make a determination of safety through this process, but states that it has “no further questions” (Box 2). These could reduce consumer trust in the oversight process. Although animal welfare, another important parameter to stakeholders and consumers (Section 2.1, 2.2), was not explicitly considered, impacts on animal health from consumption were according to the review of compositional data by FDA’s Center for Veterinary Medicine (CVM) (FDA, 2019b).

The presence of nontarget edits was considered through Whole Genome Sequencing (WGS) and FDA states that the company found no evidence of new mutations in the seven genes with greatest similarity to the target sites. Although there is a low probability off target edits that would increase or decrease endogenous plant secondary compounds that may be allergenic or toxic to humans and animals, toxicity tests were not required. A priori, the product would not be expected to be any less safe for consumption than conventionally bred soybeans, however, unintended biochemical changes due to the change in the oil composition of the product or off-target edits outside of the seven genes with the greatest similarity could lead to a change in the toxicity or allergenicity profile of the product. There would be no way to determine the negligible health risk without whole food testing in animals or comprehensive metabolomic, proteomic, and gene expression testing (as suggested by the National Academies, see NASEM, 2016). The FDA review of gene-edited products and the company’s presentation of data are generally based on arguments about “substantial equivalence” yet based on macronutrients. In general, substantial equivalence is ill-defined and not a proxy for equivalent risk to conventional products (Millstone et al., 1999), as the limited nutritional and biochemical analyses done for FDA review may not account for unintended changes in the product (Cellini et al., 2004).

Another important set of parameters missing on the human health side are health benefits to consumers and impacts on food security and improved nutrition. The public has to rely on the company’s assessment that high-oleic acid soybean oil may be better for health than regular soybean oil from conventionally bred plants. FDA does not have a mandate to consider health benefits and claims from GM foods.

The PRLR-SLICK cattle is the first gene edited animal to hit the market. In particular, CRISPR-based gene editing has been used in two founder beef calves to alter the prolactin receptor gene (PRLR gene) which shortens the prolactin receptor protein (PRLR protein) in cattle to obtain a short and slick haircoat (FDA, 2022). This intentional genomic alteration (IGA) is heritable and can therefore be passed to their offspring (FDA, 2022). However, the developed cattle are mosaic, therefore first-generation progeny may not all inherit the SLICK phenotype (FDA, 2022). The goal is to make beef cattle more tolerant to heat, similarly to several cattle breeds raised in the tropics which naturally developed this desired mutation as an adaptation response to the environment in which they have been bred (FDA, 2022). As reported in the FDA risk evaluation document, previous studies found that cattle with slick hair are more suitable for hot weather (FDA, 2022). In addition to improving heat tolerance, gene-edited slick hair cattle could also help expand cattle production to new areas as well as better adapting to increased temperatures related to climate change (Karavolias et al., 2021).

Although the slick mutation naturally occurs in some breeds of cattle, the use of gene editing makes the introduction of this mutation in other beef cattle breeds faster compared to traditional breeding, while also avoiding the loss of other desirable traits and potentially minimizing the introduction of undesirable traits (Parliamentary Office of Science and Technology, 2022).

In the U.S., the primary federal agency that regulates gene edited animals is FDA through the new animal drug provision of the Food, Drug and Cosmetic Act (FD&C Act). Section 201(g)(1)(C) of the FD&C Act contains the definition of a “drug”, which includes “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (see 21 U.S.C. § 321(g)(1)(C)). Based on the definition of a “drug”, the genetic material inserted in the animals’ DNA that alters their structure or function falls under the drug definition of the FD&C Act (OSTP, 2017). According to the FD&C Act, any new animal drug needs prior approval from the FDA before being commercialized (OSTP, 2017). Genetically engineered animals with foreign genes, such as the AquaAdvantage Salmon, have been regulated under this act according to the 2009 FDA guidance #187 (revised 2015) to industry on the Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (FDA, 2009; FDA, 2015). Under this guidance, a full Investigative New Animal Drug (INAD) or New Animal Drug (NAD) application was required (e.g., see Kuzma and Williams, 2023 for GE salmon; Kuzma, 2021b for GE mosquitos).

FDA put forth a new draft guidance in 2017 to include gene-edited animals under the FDCA, “GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals” (FDA, 2017). Remarkably, in March 2022, the FDA used its enforcement discretion to review the PRLR-SLICK cattle under a less extensive approval process that did not require a full INAD or NAD, but produced a 8 page risk assessment summary authored by FDA. The agency made this first low-risk determination for enforcement discretion for a gene edited animal concluding in the risk assessment document that “there are no identifiable direct or indirect effects of the truncation of the PRLR gene or the IGA on the safety of food derived from the PRLR- SLICK cattle” (FDA, 2022, p 7). FDA also concluded that “the safety of food products made from PRLR- SLICK cattle is no different than the safety of food products made from commercial cattle that do not contain the IGA including those conventionally raised cattle with the naturally occurring slick phenotype” (FDA, 2022, p 7). As a result, the developers are not required to obtain FDA approval for a new animal drug prior to marketing the products derived from the gene edited cattle (Van Eenennaam and Mueller Maci, 2022). The FDA’s decision is limited only to those two founder cattle and their progeny (FDA, 2022).

It is important to note that this determination was made even though both the developer and FDA detected unintended, off-target mutations in the founder calves’ genomes (FDA, 2022). This is because the FDA determined that the types of unintended mutations and their positions would not change the protein expression compared to the non-edited cattle, although no data to demonstrate this was included in the risk assessment (FDA, 2022). Therefore, they were not considered as a risk for those that consume the products derived from these cattle (FDA, 2022).

As it relates to Table 1, the parameters considered for this product in the risk assessment include human health parameters such as the quality, nutrition, and safety of the SLICK cattle derived products. However, no data was shown in the risk assessment on the nutritional “substantial equivalence” of the beef from the cattle or toxicity or allergenicity in comparison to conventionally bred cattle, although conclusions of safety were made (FDA, 2022). FDA concluded that “conventionally raised cattle with the slick phenotype are routinely consumed as human food and therefore FDA does not expect a change in the compositional or nutritional content of the edible tissues derived from the PRLR-SLICK cattle because they are similar in genotype, phenotype, and health status of naturally occurring slick cattle. No hazards were identified that required further characterization” (FDA, 2022, p. 6-7).

In terms of food security and access, this product could be beneficial if beef production would be increased and more resilient from rises in global temperature which have already caused thousands of cattle deaths (Bushard, 2022). At the same time, an increased production and consumption of beef may potentially lead to a detrimental increase in environmental resources and land usage, especially if production is expanded to areas previously not suitable for cattle farming. This may also have adverse effects on climate change. Additionally, although there is unclear data on whether the SLICK cattle could lead to increased production and consumption, there is some data on adverse human health effects associated with high consumption of red and processed meat (World Health Organization, 2015). Data on these indirect implications for sustainability (such as land use, climate change, and agrochemical use in Table 1) were not explicitly included in the risk assessment, although a discussion of whether the cattle would escape and become feral was included in the risk assessment under “Environmental Risk” (FDA, 2022, p. 8). We recognize that these land use and consumption patterns may be hard to predict prior to market release of the cattle; however, they could be modeled under different scenarios upstream of market approval to inform post-market monitoring strategies for detecting these landscape changes and subsequent risk mitigation strategies (see Discussion).

Animal welfare and health are also other important parameters that need to be considered for gene editing in animals. Among the three calves with the IGA, one founder animal died unexpectedly due to a heart defect (attributed to bovine congestive heart failure; BCHF), although this was assumed not to be caused by the gene edits but a marker gene also present in the non-edited parents (FDA, 2022). Other aspects of the animals’ health were equivalent to non-gene edited comparator cattle (FDA, 2022). In fact, the welfare of cattle could increase because of this mutation, as those animals would tolerate higher temperatures better. At the same time, there is unclear data on the actual welfare of the SLICK cattle, meaning their emotional wellbeing and behavior in industrial living conditions is largely unknown. Although it is reported that the cattle’s nutrition, preventive health, and veterinary observation were representative of typical cattle production practices (FDA, 2022), the cattle subject to the evaluation were kept under rigorous physical containment and housing conditions and were not therefore observed in actual industrial farms conditions (FDA, 2022). This is a relevant knowledge gap because to assess whether the DNA changes affected animal welfare and health or to determine whether adjustments to the management, housing or nutrition are required, a wide set of measures as well as multiple indicators and a multi-disciplinary approach should be used (EFSA Panels on GMO and AHAW, 2012). For example, the European Food Safety Authority (EFSA) suggests a three-stage assessment of gene edited animals before commercialization. Stage A requires a laboratory-level monitoring of the intended effects of the edit and potential effects on the animals’ welfare through a set of health and welfare measurements, chosen between those established by the Welfare Quality^® project, that are tailored to assess the specific gene edit. Stage B requires an experimental farm assessment to assess the effects of the intended and/or any unintended effects of the gene edit on animals’ welfare in specified, licensed farms also called experimental farms. This stage would require a higher number of animals in order to observe the behavior of gene edited animals in relation to other animals. Finally, stage C requires a field trial in farms which practices are common across the European Union (EU).

Animal welfare and health are important parameters for stakeholders given that, and as highlighted by recent studies, consumers appear to be generally more supportive of gene editing applications in animals if those lead to increased animal welfare or health, while are generally less supportive of edits that focus on productivity traits (e.g., improved muscle tissue growth) (Yunes et al., 2021). However at the same time, gene editing may be viewed as a misguided substitute for conventional husbandry practices rather than meaningful welfare improvements. In fact, public opinion studies demonstrate that overall, there is less support for gene editing of animals compared to plant species, with ongoing discussions about the ethical and societal implication of gene editing in animals.

This case study was chosen because it is the first whole vegetable product to be marketed for direct human consumption (i.e., without processing). Gene-edited mustard greens are expected to hit retailers and restaurants in late 2023 (Mullins, 2023). Researchers have gene-edited mustard greens (Brassica juncea) to remove the pungent and bitter flavors (Karlson et al., 2022; Grinstein, 2023). The potential benefits of developing gene-edited leafy greens include the ability for consumers to have access to nutritious leafy green products that taste better, which in turn, may increase consumption of healthy foods. Developers were able to do this by utilizing CRISPR to target and edit genes in order to reduce the production of oils made from glucosinolates that can cause a pungent taste when chewed or cut (Karlson et al., 2022). The genetic manipulation has significantly edited multiple genes across seven chromosomes of mustard greens, including the deletion of two whole genes, blocking the conversion of glucosinolates to these pungent oils.

In terms of regulatory oversight, the gene-edited mustard greens fall would conceivably fall under the jurisdiction of the USDA and the FDA according to the Coordinated Framework on Biotechnology Regulation (OSTP, 2017). However, in August 2020, USDA-APHIS determined that the gene-edited mustard greens do not fall under USDA’s regulations for genetically engineered crops as they do not contain plant pest DNA and thus do not pose a plant pest risk. This was determined as part of the Am I Regulated? process whereby the company sent a letter to USDA inquiring about the regulatory status of the gene-edited mustard greens, and USDA sent a response back as to whether the product would fall under its regulations under the Plant Protection Act (USDA, 2020c; USDA, 2020d; USDA, 2023). In the letter to USDA, the company noted that it “requests formal confirmation from USDA APHIS Biotechnology Regulatory Services (BRS) that Brassica juncea (L.) with improved flavor developed using gene-editing plant breeding tools is not a ‘regulated article’ subject to APHIS oversight under 7 C.F.R. part 340 because it will not contain any inserted genetic material from a plant pest” (USDA, 2020d). The company also described how no species of Brassica is listed as a Federal Noxious Weed and that the gene-edit would not be expected to make it into a weed. However, it should be noted that that certain Brassica species are considered weeds according to the USDA’s own weed risk assessments (e.g., USDA, 2021).

USDA cited the process of the modification and lack of plant pest DNA (and any foreign DNA left in the product) in their decision to exempt the gene-edited mustard from its regulations (USDA, 2020c). Although the USDA considered that the gene-edited mustard was not a plant pest and did not contain plant pest DNA, the assessment did not include investigations into other aspects of plant health such as the environmental consequences of removing genes involved in plant defense and the corresponding potential use of chemicals to control insects in the event of a pest outbreak. The gene-editing process changes glucosinolate metabolism in the plant and may deactivate the plant defense systems by blocking the metabolism of glucosinolate into insect-resistant components (Karlson et al., 2022). These metabolic changes could make the plants more vulnerable to insect pests under certain conditions, although no change was observed in the occurrence of insects in field trials of gene-edited mustard greens in a variety of locations and conditions (Karlson et al., 2022). In addition, environmental gene escape is a potential risk as gene-edited mustard greens may hybridize with other B. juncea or Brassicas (turnips) or may impact nearby related crops or weedy populations as well as surrounding ecosystems (e.g., such as non-target organisms). Information and data on the increased pest and weediness potential of the use of gene-edited mustard greens was not considered in the brief Am I Regulated letters. Also, toxicity to species in the environment from the biochemical changes in the gene edited mustard was not addressed in the brief Am I Regulated letter.

Shortly after USDA’s approval of the gene-edited mustard greens, the USDA’s Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule came into effect at the end of 2020 (Hoffman, 2021). SECURE revised regulations for genetically engineered plants under USDA and the Plant Protection Act under 7 CFR part 340 (USDA, 2020a; Kuzma and Grieger, 2020; Hoffman, 2021). Under the current SECURE rule, the gene-edited mustard greens would also not likely be subject to regulation because the gene editing only deletes genes (USDA, 2020a).

The mustard greens also did not go through the formal, voluntary FDA consultation process ¹ and no Biotechnology Notification Files appear for the product on FDA’s website, although there are reports that the company consulted with FDA in a private meeting about the product (Mullins, 2023). This negated the investigation of any human health parameters in Table 1, including food safety and toxicity as it relates to the increase in glucosinolates. As it relates to the human health parameters in Table 1, the gene-edited mustard greens were developed to have a change in food quality that could also alter consumption patterns. It is anticipated that the less pungent mustard greens may promote the consumption of nutritious and healthy fresh produce, although no published data are available on this aspect. While pungency may currently prevent some consumers from eating mustard greens, the reduced pungency of their gene-edited counterparts may conceivably lead to unintended elevated exposures to glucosinolates when consumed in large amounts. This could become a health issue for vulnerable individuals who may be more impacted by such exposures.

The product would also not be subject to the National Bioengineered Disclosure Standards which mandate labeling as “bioengineered” or “derived from bioengineering” if a genetically engineered food product has foreign DNA in the final product (Federal Register, 2018; Jaffe and Kuzma, 2021). Given a lack of foreign DNA in the final food product from gene-edited mustard, it would not require labeling (Jaffe and Kuzma, 2021). In addition, much information in the company’s letter to USDA was deleted due to confidential business information (USDA, 2020d). Thus, parameters related to consumer transparency and stakeholder inclusion in Table 1 are lacking in the decision making process for this product. However, the developers of the mustard greens have conducted taste tests with consumers to better understand consumer preferences for the gene-edited greens and of gene-editing and CRISPR, and have pushed for transparency in the process of developing and applying this product by making it known publicly that its product is gene-edited. However, attention to many of the ELSI, health and environmental parameters is lacking in the mustard greens case with no FDA review, limited review by the USDA, and a lack of transparency to consumers more broadly.