Regulation and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
Governance Landscape of Gene Drive for Malaria
35069GeneConvene Global Collaborative, 2025-08-28 10:24:11.
This infographic presents a hypothetical example of how real governance mechanisms could work to make decisions about gene drive field trials.
A bumpy road ahead for genetic biocontainment
28833George, D.R., Danciu, M., Davenport, P.W. et al, Nature Communications, 2024-01-23 18:15:26.
The environmental release of bioengineered organisms is increasingly being suggested for a variety of applications, including bioremediation, biosequestration, bio-mining, environmental biosensing and conservation. The objectives of many environmental release applications shift the goals of biocontainment from preventing organism spread outside of closed spaces (e.g., laboratories or bioreactors) to managing the persistence of engineered organisms and their genetic material in open, dynamic environments. In the scientific literature, discussions of environmental release are often accompanied by calls for robust “intrinsic biocontainment”, where containment mechanisms are genetically engineered into the organism to limit and control its spread and persistence. A number of intrinsic biocontainment approaches have so far been proposed, and can be grouped into two overarching strategies. First, gene-flow barriers attempt to limit the spread of genetic material through lateral gene transfer, which refers to the ability of cells to directly exchange DNA molecules with one another or absorb DNA from external environmental sources. This can be accomplished through conditional lethality strategies (such as toxin anti-toxin systems or targeted DNA degradation), or through limiting plasmid replication or deleting natural competence genes from target cells. Second, strain/host control strategies seek to prevent survival and growth of engineered microbes outside specific environmental conditions using growth restriction and fitness control strategies such as metabolic auxotrophy, kill switches, and conditional essentiality. Over the past decade, researchers and developers have expanded the technical toolkit of intrinsic biocontainment techniques, with new approaches using orthogonal sequences, synthetic auxotrophy, CRISPR-based kill switches, sequence-entanglement, and “cell-free” systems.
Consultation on a draft National Gene Drive Policy Guide
28786Commonwealth of Australia (Department of Health and Aged Care), National Gene Technology Scheme, 2024-01-02 13:43:01.
The term gene drive is used to describe organisms which have been genetically modified to increase the rate for a particular trait to spread through a sexually reproducing population, spreading the genes or traits through a species at a faster rate than normal inheritance. An example might be a trait to increase likelihood of offspring to be female and thereby suppress the population of the targeted pest species. The concept of a gene drive is not a new one; these dominant genes – sometimes called selfish genes – are abundant in nature. However, GM gene drive organisms have the potential to be useful for addressing some of the environmental, agricultural, and public health challenges currently faced by Australia, such as conserving native populations, controlling significant exotic pests, or providing public health benefits. As an evolving technology, gene drives may pose risks that are not yet fully understood, including the potential to alter the ecosystem in unpredictable ways. These risks should be acknowledged and managed in a structured and systematic way if Australia wishes to be a future beneficiary of this technology. The Third Review (the Review) of the National Gene Technology Scheme (Scheme), endorsed by all Australian governments on 11 October 2018, recommended “clarifying, and where necessary strengthening, the mechanisms for regulating the environmental release of GM gene drive organisms in Australia” (Recommendation 7b). Review Recommendation 7b and development of the National Gene Drive Policy Guide (Policy Guide) cannot be considered in isolation.
What are gene drives, and how can they help eradicate invasive species in Australia?
28563Dr. Ellen Cottingham, ABC News (Australia Broadcasting Corporation), 2023-11-29 13:52:33.
The impact of feral cats and other invasive species is felt across Australia. Not only do they threaten native species, but they can also spread diseases to humans and livestock. Invasive species are estimated to cost Australia an eye-watering $25 billion annually, while the global cost is a staggering $423 billion. Feral cats are everywhere — the nation is home to up to 6.3 million of them, and they are responsible for killing millions of native mammals, reptiles, and birds each day. Minister for the Environment and Water Tanya Plibersek recently declared "war on feral cats", announcing plans involving cat curfews, desexing regulations, and caps on cat numbers in homes. But what can we do about the millions of feral cats already wreaking havoc across Australia? And what about other pests such as foxes, rabbits, cane toads, carp, pigs, deer, or goats? One technique with the potential to help fight not just cats but all invasive species is called a "gene drive".
Ghana publishes its guidelines on Genome Editing
28538Anonymous, BusinessGhana, 2023-11-28 11:06:04.
Ghana's National Biosafety Authority (NBA) has published its guidelines on Genome Editing and Gene Stacks with regards Genetically Modified Organisms (GMOs) joining Nigeria, Kenya, and Malawi, as the fourth country in Africa with the guidelines. Genome editing is an emerging and affordable biotechnology tool that has great promise to deliver high-yielding crop varieties, able to withstand various stresses such as droughts, floods, insect pests, or diseases and possessed quality traits for use as food, feed, or for processing. "Biotechnology is a fast-developing business with new trends of technologies and when the law was being passed, there was nothing like Genome editing, gene drive, or synthetic biotechnology, but we have them now."
Framing Challenges and Opportunities for Canada: Expert Panel on Regulating Gene-Edited Organisms for Pest Control
28486CCA (Council of Canadian Academies), Framing Challenges and Opportunities for Canada, 2023-11-21 11:21:00.
Gene-editing technologies are changing approaches to pest management. Rapidly evolving but unproven gene-editing tools could potentially mitigate the impacts of pests in public health, conservation, and agricultural contexts. The use of these tools, however, is accompanied by uncertainties about possible impacts on species and ecosystems, along with broader socioeconomic and cultural risks. Increased globalization and climate change are intensifying pest problems. These factors, combined with the waning effectiveness of many common pest-control tools, will contribute to growing pressure from both native and invasive pests if left unchecked. Opportunities to manage pests with greater effectiveness, lower costs, and increased safety therefore require consideration.
Transformative Novel Technologies and Global Environmental Governance
28377F. Rabitz, Cambridge University Press, 2023-11-13 09:55:21.
Transformative Novel Technologies are potential gamechangers for confronting climate change, biodiversity loss, and many other elements of the global environmental crisis, allowing us to achieve a more sustainable future. The contemporary and future international governance of these technologies has crucial implications for managing the global transition towards sustainability. This book is the first to present a comprehensive assessment of the impact of these technologies on international politics. The author examines the responses of international institutions to the emergence of these technologies, focusing on three broad domains: biotechnology, climate engineering, and mineral extraction in areas beyond national jurisdiction (the ocean floor or near-Earth asteroids). This book is aimed at a non-specialist, academic audience with interest in the international and environmental politics of sustainability and technology. This title is part of the Flip it Open Programme and may also be available Open Access. Check our website - Cambridge Core - for details.
Conceptual risk assessment of mosquito population modification gene-drive systems to control malaria transmission: preliminary hazards list workshops
28220A. Kormos, G. Dimopoulos, E. Bier, G. C. Lanzaro, J. M. Marshall and A. A. James, Frontiers in Bioengineering and Biotechnology, 11. 2023-10-26 14:54:57.
The field-testing and eventual adoption of genetically-engineered mosquitoes (GEMs) to control vector-borne pathogen transmission will require them meeting safety criteria specified by regulatory authorities in regions where the technology is being considered for use and other locales that might be impacted. Preliminary risk considerations by researchers and developers may be useful for planning the baseline data collection and field research used to address the anticipated safety concerns. Part of this process is to identify potential hazards (defined as the inherent ability of an entity to cause harm) and their harms, and then chart the pathways to harm and evaluate their probability as part of a risk assessment. The University of California Malaria Initiative (UCMI) participated in a series of workshops held to identify potential hazards specific to mosquito population modification strains carrying gene-drive systems coupled to anti-parasite effector genes and their use in a hypothetical island field trial. The hazards identified were placed within the broader context of previous efforts discussed in the scientific literature. Five risk areas were considered i) pathogens, infections and diseases, and the impacts of GEMs on human and animal health, ii) invasiveness and persistence of GEMs, and interactions of GEMs with target organisms, iii) interactions of GEMs with non-target organisms including horizontal gene transfer, iv) impacts of techniques used for the management of GEMs and v) evolutionary and stability considerations. A preliminary hazards list (PHL) was developed and is made available here. This PHL is useful for internal project risk evaluation and is available to regulators at prospective field sites. UCMI project scientists affirm that the subsequent processes associated with the comprehensive risk assessment for the application of this technology should be driven by the stakeholders at the proposed field site and areas that could be affected by this intervention strategy.
General science-technology orientation, specific benefit–risk assessment frame, and public acceptance of gene drive biotechnology
28225X. Liu, C. L. Goldsmith, K. E. Kang, A. Vedlitz, Z. N. Adelman, L. W. Buchman, E. Heitman and R. F. Medina, Risk Analysis, 2023-10-23 15:04:31.
Abstract With limited understanding of most new biotechnologies, how do citizens form their opinion and what factors influence their attitudes about these innovations? In this study, we use gene drive biotechnology in agricultural pest management as an example and theoretically propose that given low levels of knowledge and awareness, citizens? acceptance of, or opposition to, gene drive is significantly shaped by two predisposition factors: individuals? general orientation toward science and technology, and their specific benefit-risk assessment frame. Empirically, we employ data collected from a recent US nationally representative public opinion survey (N = 1220) and conduct statistical analyses to test the hypotheses derived from our theoretical expectations. Our statistical analyses, based on various model specifications and controlling for individual-level covariates and state-fixed effects, show that citizens with a more favorable general orientation toward science and technology are more likely to accept gene drive. Our data analyses also demonstrate that citizens? specific gene drive assessment frame?consisting of a potential benefit dimension and a potential risk dimension, significantly shapes their attitudes as well?specifically, people emphasizing more on the benefit dimension are more likely to accept gene drive, whereas those who place more importance on the risk dimension tend to oppose it. We discuss contributions of our study and make suggestions for future research in the conclusion.
Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control Anopheles gambiae the mosquito vector of human malaria
27626A. Qureshi and J. B. Connolly, Malaria Journal, 22:234. 2023-08-14 10:10:18.
Population suppression gene drive is currently being evaluated, including via environmental risk assessment (ERA), for malaria vector control. One such gene drive involves the dsxFCRISPRh transgene encoding (i) hCas9 endonuclease, (ii) T1 guide RNA (gRNA) targeting the doublesex locus, and (iii) DsRed fluorescent marker protein, in genetically-modified mosquitoes (GMMs). Problem formulation, the first stage of ERA, for environmental releases of dsxFCRISPRh previously identified nine potential harms to the environment or health that could occur, should expressed products of the transgene cause allergenicity or toxicity.
Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
27609National Institutes of Health, Federal Register, 2023-08-10 08:09:09.
The National Institutes of Health (NIH) seeks input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMO) in contained research settings. NIH is proposing to update the NIH Guidelines to clarify minimum containment requirements, propose considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biosafety Officers (BSOs). The proposed revisions are specific to GDMO research subject to the NIH Guidelines, conducted in contained settings and are consistent with the recommendations of the NIH Novel and Exceptional Technology Research Advisory Committee report, Gene Drives in Biomedical Research (NExTRAC Report). NIH does not currently support research involving potential field release of GDMOs and the NIH Guidelines pertain to contained research; accordingly, no changes regarding potential field release are being proposed in this Notice. NIH is also proposing revisions to the NIH Guidelines to harmonize with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th edition regarding the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV).
Guerrilla eugenics: gene drives in heritable human genome editing
26475A. D. Cutter, J Med Ethics, 2023-07-04 08:15:56.
CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome editing. Modification gene drives applied to heritable human genome editing would introduce a novel form of involuntary eugenic practice that I term guerrilla eugenics. Once introduced into a genome, stealth genetic editing by a gene drive genetic element would occur each subsequent generation irrespective of whether reproductive partners consent to it and irrespective of whether the genetic change confers any benefit. By overriding the ability to 'opt in' to genome editing, gene drives compromise the autonomy of carrier individuals and their reproductive partners to choose to use or avoid genome editing and impose additional burdens on those who hope to 'opt out' of further genome editing. High incidence of an initially rare gene drive in small human communities could occur within 200 years, with evolutionary fixation globally in a timeframe that is thousands of times sooner than achievable by non-drive germline editing. Following any introduction of heritable gene drives into human genomes, practices intended for surveillance or reversal also create fundamental ethical problems. Current policy guidelines do not comment explicitly on gene drives in humans. These considerations motivate an explicit moratorium as being warranted on gene drive development in heritable human genome editing.
Draft environmental assessment for use of Wolbachia-based incompatible insect technique for the suppression of nonnative southern house mosquito populations on Kauaʻi
26247Hawai'i Department of Land and Natural Resources, Hawai'i Department of Land and Natural Resources, 2023-06-16 07:31:10.
The State of Hawai'i Department of Land and Natural Resources hereby transmits the Draft Environmental Assessment and Anticipated Finding of No Significant Impact (DEAEnvironmental Assessment for use of Wolbachia-based Incompatible Insect Technique for the suppression of nonnative southern house mosquito populations o Kaua'i to be published in the next available edition of The Environmental Notice.
The attitudes of young adults towards mammalian predator control and Predator Free 2050 in Aotearoa New Zealand
26186L. Dickie and F. Medvecky, Australasian Journal of Environmental Management, 2023-06-09 12:31:11.
Predator Free 2050 (PF2050) is an ambitious goal that aims to remove three types of invasive mammals from New Zealand by 2050. It will require a significant amount of funding, research, and support. Young adults will have an important role to play for this programme to be successful. Therefore, understanding the awareness and attitudes of young adults towards PF2050, and predator control, is an essential consideration. A survey of 1479 18- to 24-year-olds was conducted in 2017. The results showed that a higher percentage of young adults than members of the broader public view the small, introduced mammals as threats to New Zealand’s environment. Furthermore, this study highlights support for the control of feral, stray, and domestic cats. More focused research on attitudes towards cats is recommended to gauge which control methods are approved of by young adults. Indeed, methods appear to be a key factor to young adults supporting PF2050. The aerial distribution of poison was largely viewed negatively, and moderate concern was expressed about the targeted animal’s welfare. Interestingly, young adults appeared to be open to the use of gene editing and gene drive, although they expressed caution. Targeted communication towards young adults on toxins and genetic methods is recommended. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
Leveraging eco-evolutionary models for gene drive risk assessment
25157M. A. Combs, A. J. Golnar, J. M. Overcash, A. L. Lloyd, K. R. Hayes, D. A. O’Brochta and K. M. Pepin, Trends in Genetics, 2023-05-15 15:09:00.
As development of gene drive systems accelerates and diversifies, predicting outcomes for target populations and the potential for human and environmental risks requires accounting for numerous eco-evolutionary processes.Gene drive dynamic models quantify the influence of features across genetics (e.g., resistance development and standing genetic diversity), demographics (e.g., mating systems and inbreeding), spatial ecology (e.g., dispersal and competition), biotic and abiotic environments (e.g., climate variation and landscape structure), and implementation strategies (e.g., introduction size and timing) on gene drive outcomes.Synthesizing published gene drive models reveals research trends, knowledge gaps, and emergent principles. Modeling limitations and tradeoffs are discussed.Integrating an iterative modeling approach within the existing phased pathway for gene drive research improves utility for risk assessment.
updated: Genetically Engineered Mosquitoes Research Authorization Application
25149California Department of Pesticide Regulation, California Department of Pesticide Regulation,, 2023-05-11 14:56:36.
In May 2023, Oxitec voluntarily withdrew its research authorization application to test the use of genetically engineered mosquitoes in California. DPR did not issue a decision on the application. For more information on Oxitec’s withdrawal and future plans for research in California, see their letter, PDF. The company applied for a research authorization from the department in March 2022 to release and study the use of genetically engineered Aedes aegypti mosquitoes to reduce the current Aedes aegypti mosquito population in Tulare County, California. DPR must approve a research authorization application before an unregistered pesticide can be field tested in the state. There is no pending research authorization or active application for the study of genetically engineered mosquitoes in California at this time.
Guidelines and Standard Operating Procedures for Research on Genetically Engineer Insects, 2023
26270Government of India, Government of India, 2023-04-17 09:55:34.
Department of Biotechnology, Government of India is delighted to release "Guidelines and Standard Operating Procedures for Research on Genetically Engineered Insects, 2023". This document is pertinent for enabling potential of genetic engineering in insect research to revolutionize the field of entomology, understanding of role of insects in ecosystems as well as their interactions with humans. These guidelines and standard operating procedures are intended to provide guidance on regulatory requirement and data requirement of genetic engineering research on insects under containment conditions.
Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission
24859S. L. James, B. Dass and H. Quemada, Transgenic Research, 32:17. 2023-03-15 15:00:05.
Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.
Alleviating the burden of malaria with gene drive technologies? A biocentric analysis of the moral permissibility of modifying malaria mosquitoes
24800N. de Graeff, K. R. Jongsma and A. L. Bredenoord, Journal of Medical Ethics, 2023-02-28 08:33:28.
Gene drive technologies (GDTs) have been proposed as a potential new way to alleviate the burden of malaria, yet have also raised ethical questions. A central ethical question regarding GDTs relates to whether it is morally permissible to intentionally modify or eradicate mosquitoes in this way and how the inherent worth of humans and non-human organisms should be factored into determining this. Existing analyses of this matter have thus far generally relied on anthropocentric and zoocentric perspectives and rejected an individualist biocentric outlook in which all living organisms are taken to matter morally for their own sake. In this paper, we reconsider the implications of taking a biocentric approach and highlight nuances that may not be evident at first glance. First, we shortly discuss biocentric perspectives in general, and then outline Paul Taylor's biocentric theory of respect for nature. Second, we explore how conflicting claims towards different organisms should be prioritised from this perspective and subsequently apply this to the context of malaria control using GDTs. Our ethical analysis shows that this context invokes the principle of self-defence, which could override the pro tanto concerns that a biocentrist would have against modifying malaria mosquitoes in this way if certain conditions are met. At the same time, the case study of GDTs underlines the relevance of previously posed questions and criticism regarding the internal consistency of Taylor's egalitarian biocentrism.
Engagement on risk assessment for gene drive mosquitoes by EFSA and Target Malaria
24794S. Hartley, A. Kokotovich, Y. Devos and J. Mumford, Environmental Science and Policy, 142:183-193. 2023-02-27 11:12:07.
As engineered gene drive technologies continue to advance, many actors are actively considering how environmental risk assessments (RAs) for gene drive organisms should be conducted, and how stakeholder engagement opportunities should be provided. There is, however, a lack of clarity concerning what constitutes engagement on gene drive RA and, furthermore, what forms of engagement already exist around gene drive RA. To address this gap, we reflect on the actions of a risk assessor (the European Food Safety Authority, EFSA) and a gene drive developer (Target Malaria) to understand: 1) the RA-related decisions that each are making concerning gene drive technology for mosquitoes and other harmful insects, 2) the existing role of engagement in those decisions, and 3) the implications for our understandings of engagement and RA. We found, first, that both EFSA and Target Malaria have already made many RA-related decisions, even though any preparation and evaluation of a formal RA for gene drive mosquitoes remains far off. This finding supports the idea that gene drive RA involves multiple processes and decisions in different forms across the entire technology and regulatory development process. Second, we found that both EFSA and Target Malaria have already integrated engagement into their respective RA-related decisions in different ways, reflecting their different roles. We conclude by considering how EFSA and Target Malaria could improve their existing RA-related engagement by explicitly considering disciplinary diversity and worldview diversity in their related decision making.
