Risk, Regulation, and Policy

Risk assessments, regulation of gene drive, and thought leadership on gene drive policy

Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development

W. K. Tonui, V. Ahuja, C. J. Beech, J. B. Connolly, B. Dass, D. C. M. Glandorf, et al.,  Transgenic Research,  2022.
Novel genetically modified biological control products (referred to as “GM biocontrol products”) are being considered to address a range of complex problems in public health, conservation, and agriculture, including preventing the transmission of vector-borne parasitic and ...
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Toward product-based regulation of crops

F. Gould, R. M. Amasino, D. Brossard, C. R. Buell, R. A. Dixon, J. B. Falck-Zepeda, M. A. Gallo, K. E. Giller, L. L. Glenna, T. Griffin, D. Magraw, C. Mallory-Smith, K. V. Pixley, E. P. Ransom, D. M. Stelly and C. N. Stewart,  Science,  377:1051-1053. 2022.
Current process-based approaches to regulation are no longer fit for purpose Much effort has been expended globally over the past four decades to craft and update country-specific and multinational safety regulations that can be applied to crops developed by genetic engineering ...
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Call for public consultation ̶ Development of Target Product Profiles (TPPs) for Wolbachia infected Aedes aegypti population replacement intervention

World Health Organization,  WHO,  2022.
WHO aims to reduce the global burden of dengue by 25% by 2030. To reach this goal, it is imperative to provide control programmes with sustainable vector control tools. Wolbachia, a symbiotic bacterium that occurs naturally in many insects, has been successfully transferred into ...
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ISAAA Policy Brief: Risk Assessment for Gene Drive Organisms

Anonymous,  ISAAA,  2022.
Gene drive is a genetic phenomenon that occurs in nature and causes a selected trait to spread rapidly through a species via sexual reproduction over generations, potentially becoming increasingly common within a specific species. Gene drive systems are being developed in the ...
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Infravec2 guidelines for the design and operation of containment level 2 and 3 insectaries in Europe

E. Pondeville, A.-B. Failloux, F. Simard, P. Volf, A. Crisanti, R. E. Haghighat-Khah, N. Busquets, F. X. Abad, A. J. Wilson, R. Bellini, S. Marsh Arnaud, A. Kohl and E. Veronesi,  Pathogens and Global Health,  2022.
ABSTRACTWith the current expansion of vector-based research and an increasing number of facilities rearing arthropod vectors and infecting them with pathogens, common measures for containment of arthropods as well as manipulation of pathogens are becoming essential for the design ...
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Natural selfish genetic elements should not be defined as gene drives

M. A. Wells and R. A. Steinbrecher,  Proceedings of the National Academy of Sciences,  119:e2201142119. 2022.
Gene drives are increasingly discussed in the political realm,and how the term is defined therefore has important impli-cations. The opinion piece from Alphey et al. (1) identifies alack of consensus on the definition and makes explicitchanges in how the terminology is being used ...
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What do we mean by “Target Organism” in Target Malaria’s gene drive research?

J. B. Connolly,  Target Malaria,  2022.
In the wild and in laboratory settings, sibling mosquito species can successfully mate to produce viable offspring, regardless of whether they are vectors or not. Importantly, females, but not males, of these offspring can be fertile. Nonetheless, the likelihood of finding such ...
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Operationalizing stakeholder engagement for gene drive research in malaria elimination in Africa-translating guidance into practice

L. Pare Toe, B. Dicko, R. Linga, N. Barry, M. Drabo, N. Sykes and D. Thizy,  Malaria Journal,  21:225. 2022.
Gene drive mosquitoes are increasingly considered a potential transformational tool for vector control of malaria mosquitoes. As part of efforts to promote responsible research in this field, a number of guidance documents have been published by the World Health Organization, ...
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Gene Drive in Species Complexes: Defining Target Organisms

J. B. Connolly, J. Romeis, Y. Devos, D. C. M. Glandorf, G. Turner and M. B. Coulibaly,  Trends in Biotechnology,  2022.
Engineered gene drives, which bias their own inheritance to increase in frequency in target populations, are being developed to control mosquito malaria vectors. Such mosquitoes can belong to complexes of both vector and non-vector species that can produce fertile interspecific ...
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Larval mosquito management and risk to aquatic ecosystems: A comparative approach including current tactics and gene-drive Anopheles techniques

R. K. D. Peterson and M. G. Rolston,  Transgenic Research,  2022.
Genetic engineering of mosquitoes represents a promising tactic for reducing human suffering from malaria. Gene-drive techniques being developed that suppress or modify populations of Anopheles gambiae have the potential to be used with, or even possibly obviate, microbial and ...
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Public perspectives towards using gene drive for invasive species management in Australia

A. Mankad, E. V. Hobman and L. Carter,  CSIRO,  2022.
Many pest animal species live and reproduce in high numbers across Australia. This includes animal species, such as cane toads, feral cats, foxes, rodents, wild pigs, wild rabbits. These species significantly damage Australia’s agricultural industries, natural landscapes, and ...
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Public deliberation and the regulation of gene drive in the USA

W. F. West, L. W. Buchman and R. F. Medina,  Science and Public Policy,  scac032. 2022.
Gene drive is a new form of biotechnology designed to bias the inheritance of selected traits in animal or plant species that reproduce sexually and have relatively short reproductive cycles. Unlike traditional breeding techniques and other forms of biotechnology, gene drive is ...
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Genetic Approaches for Controlling CRISPR-based Autonomous Homing Gene Drives

P. R. Chennuri, Z. N. Adelman and K. M. Myles,  Frontiers in Bioengineering and Biotechnology,  10:897231. 2022.
CRISPR-based autonomous homing gene drives are a potentially transformative technology with the power to reduce the prevalence of, or even eliminate, vector-borne diseases, agricultural pests, and invasive species. However, there are a number of regulatory, ethical, ...
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Genetically Modified Mosquitoes to Fight Malaria in Nigeria, Burkina Faso, Mali and Uganda: What Legal Response?

O. J. L. Tung,  Potchefstroom Electronic Law Journal,  25:1-42. 2022.
Advanced applied research on genetically modified (hereafter GM) insects is being undertaken to control insect vectors of human diseases such as mosquitoes. GM insect technologies are being developed in countries where there is a legal ...
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Recommendations for environmental risk assessment of gene drive applications for malaria vector control

J. B. Connolly, J. D. Mumford, D. C. M. Glandorf, S. Hartley, O. T. Lewis, S. W. Evans, G. Turner, C. Beech, N. Sykes, M. B. Coulibaly, J. Romeis, J. L. Teem, W. Tonui, B. Lovett, A. Mankad, A. Mnzava, S. Fuchs, T. D. Hackett, W. G. Landis, J. M. Marshall,  Malar J,  21:152. 2022.
Building on an exercise that identified potential harms from simulated investigational releases of a population suppression gene drive for malaria vector control, a series of online workshops identified nine recommendations to advance future environmental risk assessment of gene ...
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Bayesian network-based risk assessment of synthetic biology: Simulating CRISPR-Cas9 gene drive dynamics in invasive rodent management

E. A. Brown, S. R. Eikenbary and W. G. Landis,  Risk Analysis,  2022.
Gene drive technology has been proposed to control invasive rodent populations as an alternative to rodenticides. However, this approach has not undergone risk assessment that meets criteria established by Gene Drives on the Horizon, a 2016 report by the National Academies of ...
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Governing Gene Drive Technologies: A Qualitative Interview Study

N. de Graeff, K. R. Jongsma, J. E. Lunshof and A. L. Bredenoord,  AJOB Empirical Bioethics,  13:107-124. 2022.
Gene drive technologies (GDTs) bias the inheritance of a genetic element within a population of non-human organisms, promoting its progressive spread across this population. If successful, GDTs may be used to counter intractable problems such as vector-borne diseases. A key issue ...
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Prescribing engagement in environmental risk assessment for gene drive technology

S. Hartley, A. Kokotovich and C. McCalman,  Regulation and Governance,  2022.
Abstract Gene drive technology is a nascent biotechnology with the potential to purposefully alter or eliminate a species. There have been broad calls for engagement to inform gene drive governance. Over the past seven years, the gene drive community has been developing risk ...
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Opening up, closing down, or leaving ajar? How applications are used in engaging with publics about gene drive

A. W. Russell, A. Stelmach, S. Hartley, L. Carter and S. Raman,  Journal of Responsible Innovation,  2022.
Public engagement and responsible innovation are strongly emphasised in gene drive research, together with the goal of addressing societal challenges, notably, malaria and environmental conservation. We aim to explore whether public engagement is used to ‘open up' or ‘close ...
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Could species-focused suppression of Aedes aegypti, the yellow fever mosquito, and Aedes albopictus, the tiger mosquito, affect interacting predators? An evidence synthesis from the literature

J. A. S. Bonds, C. M. Collins and L.-C. Gouagna,  Pest Management Science,  2022.
The risks of Aedes aegypti and Aedes albopictus nuisance and vector-borne diseases are rising and the adverse effects of broad-spectrum insecticide application has promoted species-specific techniques, such as sterile insect technique (SIT) and other genetic strategies, as ...
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