What makes gene drives a biosecurity concern and how can monitoring help address dual-use risks and governance gaps?
This version (Version 1) was created on 19 May 2026.
Muris Hodzic and Felix Moronta-Barrios
Imagine that an unusual genetic element is detected in a wild mosquito population near a national border. It appears to be designed to spread through inheritance. Was it part of an authorised field trial? An accidental escape from a laboratory? A poorly governed experiment? Or a deliberate release? Who should be notified, how far has it spread, and who is responsible for finding out?
Or imagine a more troubling scenario: a gene drive designed to alter an insect population so that it becomes capable of spreading a harmful toxin or disease.
These hypothetical scenarios capture why gene drive biosecurity matters. The issue is not only that gene drives could be misused. It is that a self-propagating genetic technology can raise difficult questions of access, oversight, containment, attribution and response even before intent is clear.
Gene drives are being explored for possible applications in public health, conservation, agriculture and pest management, including the suppression of disease vectors, invasive species and organisms that damage crops or ecosystems. Their public health relevance is often illustrated by malaria, which caused an estimated 282 million cases and 610,000 deaths in 2024 (World Malaria Report 2025), while genetically modified mosquitoes have been under development for more than two decades as potential tools against vector-borne diseases. Their potential value comes from a distinctive feature: they are designed to bias inheritance, increasing the likelihood that a genetic trait will spread through sexually reproducing populations over generations.
That same feature creates biosecurity questions. Unlike many conventional genetic modifications, a gene drive may not remain confined to a single organism, breeding line, laboratory or release site. Depending on the construct, the target species and the ecological context, it could spread, persist, mutate or affect population dynamics in ways that are difficult to predict or reverse (Courtier-Orgogozo, 2025; Rabitz et al., 2023; Rode et al., 2019).
Biosecurity is related to, but distinct from, biosafety. Biosafety focuses mainly on preventing accidental harm to humans, animals, plants or the environment during research, testing or release. Biosecurity focuses on preventing misuse, unauthorised access, irresponsible development, deliberate harm or weak oversight of biological tools, materials and knowledge. In gene drive research, the two often overlap because the same properties that make gene drives potentially useful for population-level interventions (inheritance bias, persistence and spread) can also make accidental or unauthorised releases difficult to detect, attribute, contain or reverse.
Why are gene drives a biosecurity concern?
Gene drives complicate conventional approaches to biological risk because their intended function is inheritance bias. If they work as designed, they may increase in frequency in a population over generations. This is the basis of their potential utility, but also the reason why containment, reversibility, oversight and attribution become central biosecurity concerns.
Six features are especially relevant:
- Gene drives are self-propagating. Unlike a standard genetic modification, a gene drive is designed to promote its own inheritance. Suppression drives may contribute to population decline or local elimination, while modification drives aim to spread a trait through a target population. In both cases, misuse or poor oversight could have population-level consequences.
- Gene drives are environmentally embedded. Proposed applications often involve mosquitoes, agricultural pests, invasive rodents or other organisms that interact with ecosystems and human-managed environments. A release may therefore raise questions not only about the modified organism itself, but also about ecological relationships, pest control, food systems, conservation and public health.
- Gene drives can be transboundary. Target organisms may move across institutional, ecological or national boundaries. Even without hostile intent, uncontrolled or accidental cross-border spread could be interpreted as negligence, environmental interference, liability or even hostile action, depending on the circumstances (Frieß et al., 2020; Stasi and Thongpravati, 2024).
- Gene drives create attribution challenges. If an unusual genetic element is detected in a wild population, it may be difficult to determine whether it came from an authorised trial, an accident, negligence, private research or deliberate release. Attribution becomes especially important as gene drive research expands and genome-engineering tools become more accessible (CHS, 2020). Detection alone may not be enough; monitoring may also need to support traceability, provenance and accountability.
- Gene drive research can be dual use. The same tools, organisms and knowledge developed for vector control, conservation or pest management could raise concerns if applied irresponsibly or maliciously. Early discussions by Gurwitz (2014) and Oye et al. (2014) already raised the possibility that civilian gene drive research could be misused. This does not make every project suspicious, but it does mean that dual-use assessment should be part of responsible oversight.
- Gene drives are shaped by enabling technologies. CRISPR-Cas9, commercial DNA synthesis, modelling, automation and internet-based access to reagents have changed how biological materials and information circulate. Several authors therefore argue that gene drive biosecurity is shaped not only by the construct itself but also by the surrounding technical ecosystem that may make design, ordering, testing, or dissemination more accessible (Coltoff and Davis, 2025; Stasi and Thongpravati, 2024; Trump et al., 2021, 2020).
Artificial intelligence is part of this wider enabling environment. In synthetic biology, AI tools are increasingly discussed for literature synthesis, protein and sequence analysis, design tasks, experiment planning and integration with laboratory automation (de Lima et al., 2024; NASEM, 2025; Sandbrink, 2023; Wheeler, 2025). For gene drives, the biosecurity-relevant question is whether such tools could make it easier to identify candidate target genes, compare sequence conservation across populations, design guide RNAs, anticipate resistance alleles or explore population-genetic models of drive spread. These tasks remain organism-specific and require experimental validation, breeding systems and ecological knowledge, but they may still affect the threshold between published knowledge and plausible design options.
These enabling factors should not be overstated. Gene drive development still requires technical skill, laboratory capacity, organism-specific expertise and population knowledge. Designing a guide RNA is not the same as producing a functional drive, and producing a functional drive is not the same as achieving predictable spread in the environment. Coltoff and Davis (2025) emphasise that experimental capacity and proximity to advanced institutions remain important barriers. A credible biosecurity review therefore needs to track both what is becoming easier and what remains difficult.
A final feature is regulatory fit. Many biosecurity systems were built around pathogens, toxins or listed agents. A harmful gene drive does not necessarily need to be pathogenic or toxin-producing; its significance may come from inheritance, spread, ecological effect or interference with food systems, vector control or conservation goals.
Dual-use risks and misuse scenarios in gene drive research
Gene drive research is usually discussed in relation to beneficial or peaceful applications. Yet the same features that make gene drives useful also explain why they appear in biosecurity debates: a technology designed to spread a genetic trait through a population could, in principle, be used irresponsibly or deliberately misused.
This is the core of the dual-use concern. Dual-use research involves knowledge, tools, organisms or methods that may support both beneficial and harmful applications. In gene drive research, this concern was raised early by Gurwitz (2014) and Oye et al. (2014), while König et al. (2024) and Frieß et al. (2020) discuss how gene drive consequences could become politically sensitive even when hostile intent is absent or difficult to establish.
Misuse does not refer to one scenario. It may involve unauthorised or negligent release, cross-border spread, deliberate ecological disruption, interference with agriculture, modification of disease vectors, informal research settings or actions intended to create social, economic or political harm. Table 1 summarises examples discussed in the literature that are most directly relevant to gene drive biosecurity.
Table 1. Examples of gene drive biosecurity scenarios discussed in the literature. The table summarises selected scenarios relevant to dual-use concerns, misuse, unauthorised release, weak oversight and potential impacts on agriculture, public health, ecosystems or cross-border governance. These examples vary in plausibility and technical feasibility and should not be interpreted as equally likely or as near-term threats.
| Example | Description | References |
| Accidental or unauthorised release | Gene drive organisms could escape containment or be released irresponsibly, anonymously or without adequate oversight, leading to unintended spread in wild populations. | Courtier-Orgogozo (2025); CHS (2020); Furrow (2017) |
| Cross-border spread | A gene drive released in one jurisdiction could spread into another, affecting agriculture, ecosystems, disease control or public trust, and raising questions of liability or hostile interpretation. | Frieß et al. (2020); Stasi and Thongpravati (2024); Hefferon and Herring, (2020) |
| Suppression of pollinators or beneficial species | A suppression drive could theoretically target pollinators, natural predators or other beneficial species, with consequences for food security, livelihoods and ecosystems. | König et al. (2024); Courtier-Orgogozo (2025); Pilz et al. (2023); Sirinathsinghji (2019); Lalyer et al. (2021) |
| Modification of pests or disease vectors | A modification drive could make pest or disease-carrying insects harder to control, for example by spreading resistance to insecticides or other interventions. | König et al. (2024); Courtier-Orgogozo (2025) |
| Insects as carriers of harmful traits | A gene drive could, in theory, alter pest or disease-carrying insects so that they spread harmful toxins or diseases to plants, animals, or humans. | König et al. (2024); Courtier-Orgogozo (2025) |
| Targeting natural crop plants | Gene drive misuse could target natural crop plants, especially if introduced into self-sustaining plant populations or non-GMO environments. | Mueller (2019) |
| Disruption of protective traits in GM crops | A misuse scenario could involve deleting, silencing or weakening genes or mechanisms that protect genetically modified crops. | Mueller (2019) |
| Strategic contamination of seed systems | Seed systems could be contaminated in ways that promote unwanted volunteers, feral populations or persistence of modified traits. | Mueller (2019) |
| Interference with pest-resistant GMO crop | A misuse scenario could alter interactions between pest-resistance-inducing proteins and insect pest targets, potentially undermining crop-protection strategies. | Mueller (2019) |
| Increased susceptibility to pests or pathogens | Disruption of protective mechanisms could make plants more vulnerable to pests, toxic fungi, bacteria or other pathogens. | Mueller (2019); König et al. (2024) |
| Gene drives in yeasts or sexually reproducing fungi | Scenarios involving yeasts or fungi have been discussed in relation to prion production or spread, illustrating concerns beyond mosquitoes and insects. | König et al. (2024) |
| Targeting species outside the attacker’s region | A malicious actor might target insects or rodents not native to their own region, reducing the risk of local consequences for the attacker. | Courtier-Orgogozo (2025) |
| Mosquito salivary-gland toxin scenario | A mosquito gene drive could theoretically be linked to expression of a harmful protein in salivary glands and secretion during biting. | König et al. (2024) |
| Gene drives as vectors for engineered pathogens | Gene drives have been discussed as possible vectors for engineered pathogens targeting wildlife, ecosystems, humans or food supplies. | Millett et al. (2022) |
| DIY or informal misuse | DIY gene drives are raised as a concern because informal settings may have weaker oversight, lower containment standards or greater vulnerability to irresponsible use. | Stasi and Thongpravati (2024); Furrow (2017) |
These examples vary widely in plausibility and technical feasibility. Some concern relatively general governance problems, such as accidental release, poor oversight or cross-border spread. Others describe more specific misuse scenarios involving agriculture, disease vectors or engineered traits. A few are best read as speculative examples that test the boundaries of current biosecurity thinking rather than as near-term threats.
For this reason, the purpose of discussing dual-use is not to present gene drives as imminent weapons. It is to identify where plausible misuse pathways intersect with weak oversight, limited detection capacity or unclear responsibility. Which organisms are being targeted? Which constructs would be difficult to contain? Which research settings lack review? Which ecological or agricultural systems would be vulnerable after an unauthorised release? These questions turn dual-use concern into a monitoring issue rather than a catalogue of worst-case scenarios.
Technical and biological limits to gene drive misuse
The misuse potential of gene drives is constrained by several biological, technical, ecological and practical factors. These constraints do not remove biosecurity concerns, but they help distinguish plausible risks from more speculative scenarios.
The first limitation is biological. Gene drives require sexual reproduction and are therefore not suitable for viruses or bacteria. Even among sexually reproducing organisms, not every species is a practical target. A gene drive must be designed and tested for a specific organism, and its performance depends on reproductive biology, generation time, mating behaviour, population structure, genetic diversity and the ability to rear and crossbreed the organism in the laboratory. Target-site variation, resistance alleles, fitness costs and poor laboratory tractability can all prevent a plausible design from becoming a functional drive.
For this reason, insects currently raise more immediate biosecurity questions than mammals. Gene drive research has advanced furthest in some insects, especially mosquitoes, and gene conversion rates in flies and mosquitoes are generally more promising for population-level applications than those demonstrated in mammals. Although CRISPR-mediated biased inheritance has been shown in mice, mammalian systems face longer generation times, slower population spread and greater technical constraints (Bier, 2022; Grunwald et al., 2022)
A second limitation is expertise. Access to CRISPR reagents is not enough to create a working gene drive. Successful development requires organism-specific knowledge, molecular biology skills, breeding capacity, containment practices and the ability to interpret failed or partial results. Designing guide RNAs, selecting target sites, validating constructs and working with relevant species remain significant barriers, even as genome editing becomes more accessible (Coltoff and Davis, 2025).
A third limitation is ecological uncertainty. A drive that performs well in the laboratory may not spread as expected in wild populations. Environmental conditions, population structure, seasonal dynamics, migration, resistance, fitness effects and ecological interactions can all alter outcomes. Models can support assessment, but they often rely on simplified assumptions about gene drive genetics and remain limited in their ability to predict ecological effects (Frieß et al., 2020; Lunshof and Birnbaum, 2017). For misuse, this uncertainty matters because actors seeking predictable harm may prefer faster and more controllable tools.
Time also limits misuse potential. Gene drives work over generations, so their effects may be delayed, especially in organisms with longer life cycles or complex population structures. This makes many scenarios less attractive from a tactical perspective. König et al. (2024) notes that military and terrorist actors generally favour weapons that are rapid, effective and predictable; gene drives often offer delayed effects, ecological uncertainty and limited control after release.
Agriculture illustrates these constraints. Some scenarios imagine interference with crops, pests, pollinators or protective traits, but many crops and livestock are managed through seed systems, breeding programmes, controlled mating or in vitro fertilisation. These systems can restrict the uncontrolled spread that gene drives require. Agricultural biosecurity concerns may remain relevant for pests, wild relatives, fungi or beneficial species, but direct crop or livestock scenarios are less straightforward than they may first appear.
Detectability is another constraint. Depending on the drive design and target population, a malicious release may require producing, transporting and releasing large numbers of organisms, which may be difficult to hide when breeding infrastructure or repeated releases are needed. Defensive tools such as high-throughput sequencing, environmental metagenomic sampling and immunising or reversal drives have also been proposed, although they may be costly, unevenly available or incomplete in their effects (CHS, 2020; Courtier-Orgogozo, 2025; Esvelt, 2018; Min et al., 2018).
Finally, safeguards and research culture shape misuse potential. Insects and arthropods have gene-drive-specific containment recommendations focused on fertile escape, local establishment and onward spread. Mammalian gene drive research remains closer to proof-of-principle and is often managed through genetic safeguards and restricted designs rather than specialised facility standards. Public criticism of mouse gene drive studies for insufficiently explicit safeguards (Cohen, 2018) shows that containment is not only a technical issue but also a matter of transparency, norms and independent review.
Biosecurity governance gaps for gene drive research
Gene drive biosecurity raises a narrower governance question than gene drive regulation in general: are existing systems able to prevent, detect and respond to misuse, unauthorised development, accidental escape or hostile use?
This question is difficult because many biosecurity frameworks were designed around pathogens, toxins, controlled agents or contained laboratory risks. Gene drives may not fit these categories. A harmful gene drive would not necessarily be pathogenic or toxin-producing; its significance could instead come from inheritance bias, environmental spread, ecological disruption or interference with systems such as agriculture, conservation or vector control. (Millett et al., 2022) therefore argue that gene drive risks may fall outside operational biosecurity frameworks based mainly on listed agents and toxins.
International security law may be relevant in cases of deliberate hostile use, but its application is limited. The Biological Weapons Convention (BWC) prohibits biological agents and toxins intended for hostile purposes, and Frieß et al. (2020) argue that gene drives could fall within its scope if they were developed or used as weapons. Similarly, the Convention on Environmental Warfare (ENMOD) may be relevant if gene drives were used deliberately to modify or damage another state’s environment. However, both frameworks are difficult to apply to ambiguous situations, such as accidental release, negligent containment, unauthorised private activity or cross-border spread from a project with a stated peaceful purpose. In these cases, proving intent and assigning responsibility may be challenging (CHS, 2020; Frieß et al., 2020; König et al., 2024).
This leaves an important gap between peaceful research oversight and hostile-use prohibition. A gene drive project may have a legitimate purpose and still raise biosecurity questions if safeguards are weak, access is poorly controlled, review is inconsistent or the work could be repurposed. Existing biosafety, GMO, and environmental release frameworks may require risk assessment or authorisation, but they do not always address dual-use assessment, attribution, unauthorised development, or malicious release.
Export controls are relevant only in a limited sense. They may apply to some biological materials, equipment, software, technical data or genetic elements associated with controlled agents, and they can shape how states manage dual-use biotechnology (Frieß et al., 2020; König et al., 2024). However, they are not a comprehensive governance tool for gene drives. Many gene drive biosecurity risks concern knowledge, design capacity, DNA synthesis, distributed laboratory services or organisms and traits that may not appear on existing control lists. This is why Himmel (2019) argues for clearer terminology capable of addressing technologically produced biological entities, and why Trump et al. (2020) emphasises the difficulty of governing biosecurity in a dispersed and globalised synthetic biology landscape.
A further gap concerns research outside traditional institutions. University and publicly funded projects may be reviewed by biosafety committees, funders, regulators or ethics bodies. Private laboratories, informal research groups, DIY biology communities or privately funded work may not be subject to the same level of oversight. DIY biology communities have developed some forms of self-regulation, including norms, ethical codes, biosafety standards and informal review mechanisms, but these may not provide consistent project-specific review or enforcement (Stasi and Thongpravati, 2024). Coltoff and Davis (2025) similarly raises concerns that actors outside established oversight systems may evade screening or detection mechanisms used by synthetic DNA providers.
Education is another governance gap. Vinke et al. (2022) found that dual-use awareness amongst life scientists remains limited despite international attention to the issue. For gene drive research, this suggests a need for training that helps researchers, funders, reviewers and institutions recognise when a project raises biosecurity questions, how those questions should be assessed and when additional oversight may be needed.
The governance challenge, then, is not simply the absence of rules. It is that relevant oversight is fragmented across biosafety, GMO regulation, environmental law, export control, institutional review, DNA synthesis screening and security treaties. These systems do not always share the same definitions, triggers or responsibilities. For gene drive biosecurity, the key gaps concern dual-use review, access control, attribution, oversight of private or informal research, responsible communication and preparedness for unauthorised or ambiguous releases.
Monitoring and mitigation strategies for gene drive biosecurity
Monitoring and mitigation are central to gene drive biosecurity because prevention alone is unlikely to be sufficient. A responsible biosecurity framework needs to reduce the likelihood of misuse, accidental escape or unauthorised release, while also improving the capacity to detect, attribute and respond if something goes wrong.
The first layer is a safer research design and containment. Many domestic systems use the four biosafety level framework recommended by the WHO Laboratory Biosafety Manual, but gene drives raise containment questions that do not always map neatly onto standard biosafety categories. Because they are intended to spread through reproduction, the relevant problem is not only exposure of laboratory personnel, but escape, establishment and onward transmission. Risk reduction should therefore combine physical containment with molecular, ecological and reproductive safeguards. Depending on the organism and research stage, this may include split-drive designs, molecular confinement, ecological confinement, reproductive isolation, use of non-local strains, staged testing and lower-risk constructs that can answer the same research question without creating unnecessary spread potential (Beck, 2022; Furrow, 2017; Lunshof and Birnbaum, 2017; Rode et al., 2019).
A second layer is review and oversight. Gene drive biosecurity depends on whether researchers, institutions, funders and regulators can identify dual-use concerns before work progresses. Review should determine not only whether a project is scientifically valid, but whether the organism, construct, containment strategy, publication plan and access to materials create avoidable security risks. The iGEM approach is useful in this regard because it requires gene drive self-declaration, prior approval for certain activities, repeated safety and security reporting, and third-party biorisk review before projects proceed (Millett et al., 2022).
A third layer is responsible information and access management. Gene drive biosecurity is not only about organisms in laboratories; it is also about designs, protocols, sequence information, reagents, organism strains and services that may lower barriers to misuse. Transparency remains essential for public trust and scientific scrutiny, but some technical details may require careful handling if they substantially increase misuse potential. The same logic applies to supply chains. DNA synthesis providers, reagent suppliers and service laboratories can contribute to biosecurity by screening orders, identifying unusual requests and maintaining channels for reporting concerns, although such systems are uneven and may be easier to bypass outside established institutions (Coltoff and Davis, 2025; Trump et al., 2020).
A fourth layer is environmental detection. If a gene drive organism is released without authorisation, early detection may determine whether the event can be investigated or mitigated. High-throughput sequencing, targeted genomic assays and environmental metagenomic sampling could help identify unexpected constructs in organisms or environmental samples (Courtier-Orgogozo, 2025; Min et al., 2018). However, detection is not automatic. It requires baseline knowledge of target populations, reference genomes, sampling strategies, laboratory capacity, bioinformatics expertise and data-sharing systems. This is a major preparedness issue, especially in regions where gene drive applications may be considered but genomic surveillance capacity is limited.
Detection also needs to support attribution. Finding a gene drive construct does not by itself reveal whether the release was authorised, accidental, negligent or malicious. Attribution may depend on construct characterisation, sequence databases, project registries, laboratory records, synthesis-order information and international cooperation. Without these capacities, it may be difficult to assign responsibility, establish liability, deter misuse or distinguish a security incident from a poorly documented research activity (CHS, 2020).
A fifth layer is response planning. Proposed countermeasures include immunising or reversal drives that could overwrite or block an unwanted gene drive, but these should not be treated as simple fixes. They may not reach all individuals in a population, may require large-scale release themselves and may introduce new ecological and governance questions (CHS, 2020; Courtier-Orgogozo, 2025; Esvelt, 2018; Min et al., 2018; Rode et al., 2019).
The practical goal is not to monitor every possible gene drive scenario equally. It is to identify where risks are becoming more actionable: organisms that are technically tractable, constructs with higher spread potential, research settings with weak oversight, supply chains with limited screening, regions with low detection capacity and applications with transboundary implications.
Open questions for gene drive biosecurity
Gene drive biosecurity remains an evolving area. The main questions are not whether gene drives could be misused, but how plausible different misuse pathways are, how quickly relevant capabilities are changing, and whether governance and monitoring systems are keeping pace.
Several uncertainties deserve continued attention. Which target organisms are becoming tractable enough for gene drive development beyond the current focus on mosquitoes and other insects? Are tools such as improved genome assemblies, population models, DNA synthesis services, automation and AI-assisted design making it easier to move from candidate target genes to plausible drive constructs? Can oversight systems assess risks linked to inheritance bias, resistance formation, ecological spread and transboundary movement before research progresses? And if an unauthorised gene drive was detected in a wild or managed population, would current monitoring systems be able to determine where it came from, how far it had spread, and what response would be proportionate?
These questions should be approached with caution. Potential gene drive misuse is constrained by biology, technical difficulty, ecological uncertainty and the need for organism-specific expertise. At the same time, responsible biosecurity cannot rely only on those constraints remaining in place. As the field develops, monitoring can help distinguish speculative risks from actionable concerns, identify gaps in preparedness and support safer research practices.
Frequently asked questions (FAQs)
What is gene drive biosecurity?
Gene drive biosecurity refers to the measures used to prevent, detect and respond to misuse, unauthorised access, irresponsible development, accidental escape or deliberate release of gene drive organisms, tools and knowledge. Because gene drives are designed to spread genetic traits through sexually reproducing populations, biosecurity also includes questions of containment, attribution, monitoring and response if a gene drive appears outside an authorised setting.
How is gene drive biosecurity different from biosafety?
Biosafety focuses mainly on preventing accidental harm during research, testing, containment or environmental release. Biosecurity focuses on preventing misuse, unauthorised development, deliberate harm, weak oversight or irresponsible access to biological tools and materials. In gene drive research, the two often overlap because an accidental escape and an unauthorised release may create similar challenges: detecting the organism, understanding whether the drive can spread, identifying its source and deciding how to respond.
Why are gene drives considered dual-use technologies?
Gene drives are considered dual-use because the same knowledge, organisms and tools developed for beneficial purposes could also be applied irresponsibly or maliciously. For example, gene drives are being studied for vector control, invasive species management and pest management, but similar capabilities could in principle be used to disrupt agricultural systems, alter pest or disease-vector populations, or affect ecologically important species. Dual-use does not mean that every gene drive project is dangerous; it means that oversight should consider both intended benefits and possible misuse pathways.
Could gene drives be used as biological weapons?
Some authors have discussed hostile-use scenarios, including gene drives that could affect disease vectors, agricultural pests, beneficial species or food systems. However, gene drives face important constraints: they require sexually reproducing organisms, organism-specific expertise, laboratory validation, ecological suitability and time to spread. Their effects may also be uncertain and difficult to control. For this reason, the main biosecurity concern is not that gene drives are imminent weapons, but that weak oversight, unauthorised release or ambiguous cross-border effects could create security and governance problems.
What are the main governance gaps for gene drive biosecurity?
The main gaps concern dual-use review, access control, attribution, private or informal research, DNA synthesis screening and preparedness for unauthorised or ambiguous releases. Many existing biosecurity systems were designed around pathogens, toxins or listed agents, while gene drives may raise concerns through inheritance bias, environmental spread and effects on ecosystems, agriculture, conservation or vector control. This makes gene drive biosecurity difficult to manage through any single framework and increases the need for coordinated monitoring, institutional oversight and clear response procedures.
References
The literature map below reflects the set of recent studies included in this review
Literature map showing connections between selected studies on gene drive biosecurity. Nodes represent publications and linked through citation relationships.
Beck, D.F. (2022). Self-Spreading Biotechnology and International Law: Prevention, Responsibility, and Liability in a Transboundary Context. https://doi.org/10.5771/9783748913528
Bier, E. (2022). Gene drives gaining speed. https://doi.org/10.1038/s41576-021-00386-0
CHS, Center for Health Security (2020). Gene Drives: Pursuing Opportunities, Minimizing Risk. https://centerforhealthsecurity.org/sites/default/files/2022-12/200518-gene-drives-report.pdf
Cohen, J. (2018). A ‘gene drive’ makes its debut in mammals. https://doi.org/10.1126/science.361.6398.118
Coltoff, E.C., Davis, A.L. (2025). Emerging biotechnologies: Dual-use potential and strategies to prevent misuse. https://doi.org/10.38105/spr.cb0t0jkorb
Courtier-Orgogozo, V. (2025). Risks associated with CRISPR homing gene drive. https://doi.org/10.5802/crbiol.182
de Lima, R.C., Sinclair, L., Megger, R., Maciel, M.A.G., Vasconcelos, P.F. da C., Quaresma, J.A.S. (2024). Artificial intelligence challenges in the face of biological threats: emerging catastrophic risks for public health. https://doi.org/10.3389/frai.2024.1382356
Esvelt K. (2018). Gene Drive Technology: The Thing to Fear is Fear Itself. https://doi.org/10.13021/MARS/8760
Frieß, J.L., Giese, B., Rößing, A., Jeremias, G. (2020). Towards a prospective assessment of the power and impact of Novel Invasive Environmental Biotechnologies. https://www.jstor.org/stable/27004614
Furrow, B.R. (2017). The CRISPR-Cas9 Tool of Gene Editing: Cheaper, Faster, Riskier? https://lawecommons.luc.edu/annals/vol26/iss2/5/
Grunwald, H.A., Weitzel, A.J., Cooper, K.L. (2022). Applications of and considerations for using CRISPR–Cas9-mediated gene conversion systems in rodents. https://doi.org/10.1038/s41596-021-00646-7
Gurwitz, D. (2014). Gene drives raise dual-use concerns. https://doi.org/10.1126/science.345.6200.1010-b
Hefferon, K., Herring, R. (2020). Engineered Gene Drives and Their Value in the Control of Vector-Borne Diseases, Weeds, Pests, and Invasive Species. https://doi.org/10.1007/978-3-030-53183-6_18
Himmel, M. (2019). Emerging Dual-Use Technologies in the Life Sciences: Challenges and Policy Recommendations on Export Control. https://www.nonproliferation.eu/wp-content/uploads/2019/09/EUNPDC_no-64_FINAL.pdf
König, H., Kolleck, A., Sauter, A. (2024). Gene Drives. Technologien zur Verbreitung genetischer Veränderungen in Populationen. https://doi.org/10.5445/IR/1000179980
Lalyer, C.R., Sigsgaard, L., Giese, B. (2021). Ecological vulnerability analysis for suppression of Drosophila suzukii by gene drives. https://doi.org/10.1016/j.gecco.2021.e01883
Lunshof, J.E., Birnbaum, A. (2017). Adaptive Risk Management of Gene Drive Experiments: Biosafety, Biosecurity, and Ethics. https://doi.org/10.1177/1535676017721488
Millett, P., Alexanian, T., Palmer, M.J., Evans, S.W., Kuiken, T., Oye, K. (2022). iGEM and Gene Drives: A Case Study for Governance. https://doi.org/10.1089/hs.2021.0157
Min, J., Smidler, A.L., Najjar, D., Esvelt, K.M. (2018). Harnessing gene drive. https://doi.org/10.1080/23299460.2017.1415586
Mueller, S. (2019). Are Market GM Plants an Unrecognized Platform for Bioterrorism and Biocrime? https://doi.org/10.3389/fbioe.2019.00121
NASEM, National Academies of Sciences, Engineering, and Medicine (2025). The Age of AI in the Life Sciences: Benefits and Biosecurity Considerations. https://doi.org/10.17226/28868.
Oye, K.A., Esvelt, K., Appleton, E., Catteruccia, F., Church, G., Kuiken, T., Lightfoot, S.B.-Y., McNamara, J., Smidler, A., Collins, J.P. (2014). Regulating gene drives. https://doi.org/10.1126/science.1254287
Pilz, B.C., Kosmehl, N., Härlin, B. (2023). Gambling with nature: Why gene drives are not a viable route to nature conservation. https://doi.org/10.14512/gaia.33.1.8
Rabitz, F., Giese, B., Kelz, R., Otto, M., Potthast, T., Quilodrán, C.S., Teixeira, L.H. (2023). Putting gene drives into context: Risks, depth of intervention, and regulatory challenges. https://doi.org/10.14512/gaia.33.1.9
Rode, N.O., Estoup, A., Bourguet, D., Courtier-Orgogozo, V., Débarre, F. (2019). Population management using gene drive: molecular design, models of spread dynamics and assessment of ecological risks. https://doi.org/10.1007/s10592-019-01165-5
Sandbrink, J.B. (2023). Artificial intelligence and biological misuse: Differentiating risks of language models and biological design tools. https://doi.org/10.48550/arXiv.2306.13952
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