Keywords: Governance
Engineered Gene Drives
35221Convention on Biological Diversity, 2025-10-05 20:11:01.
This page is dedicated to living modified organisms containing engineered gene drives and was developed further to decision CP-10/10 of the Conference of the Parties serving as a meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP).
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.
The state of regulatory and governance frameworks for gene drives outside of Africa
34865African Genetic Biocontrol Consortium, YouTube, 2025-05-26 21:12:33.
Regional and global perspectives on gene drive regulation. Discussion on the state of regulatory and governance frameworks for gene drives outside of Africa, covering regional priorities and challenges.
Global and regional updates on gene drive governance; AUDA-NEPAD update on regional work
34860African Genetic Biocontrol Consortium, YouTube, 2025-05-26 21:04:00.
AUDA-NEPAD update on regional work. Presentation on AUDA-NEPAD’s initiatives and progress in governance and capacity-building efforts related to synthetic biology, particularly on gene drives.
Exploring new tools to fight vector-borne diseases: research and governance implications
32541Alekos Simoni, Outreach Network for Gene Drive Research, 2024-10-08 12:24:29.
I recently had the honor and pleasure of attending an event co-organized by the Outreach Network for Gene Drive Research at the European Parliament in Brussels, and delivering a presentation on our work at Target Malaria to develop new genetic tools to reduce malaria transmission in Africa. The event was an opportunity to discuss advancements in the development of gene drive technologies and governance implications related to these new tools. With climate change creating favorable conditions for the spread of disease-carrying mosquitoes, and challenges such as drug and insecticide resistance threatening the efficacy of current interventions, a global, coordinated response is needed to tackle vector-borne diseases. In this context, gene drive technologies could offer a promising addition to existing approaches. MEP Charles Goerens opened the session by highlighting the global burden of vector-borne diseases, such as malaria and dengue, which cause over 700,000 deaths every year. He stressed the importance of innovation to address global health challenges and the critical role of the European Parliament in ensuring responsible oversight of new tools, such as gene drive technologies.
Gene drive mosquitoes designed to eliminate malaria – but governance is complex, new film shows
29897Russell Parton, University of Exeter, 2024-05-07 16:59:05.
A radical new biotechnology could eliminate the mosquitoes that cause malaria, but in Uganda – where malaria is the leading cause of death – a lack of information and debate is undermining public debate on the issue. Professor Sarah Hartley’s new research documentary Gene Drive Mosquitoes for Malaria Control, which will be screened at Exeter Phoenix on 29 April, looks at this potentially game-changing technology through conversations with Ugandan stakeholders and explores the complexities of governance. Gene drive mosquitoes are being researched in Uganda by scientists at the Ugandan Virus Research Institute, and could soon be trialled in the wild – making Uganda one of the first countries to do so. Gene drive targets the particular genes in the malaria-transmitting female mosquito, making it unable to reproduce or transmit malaria. But unlike in other forms of genetic modification, the altered gene is inherited by more than 95% of offspring, which means the trait increases over time – allowing it to spread through a whole population. This means we could change the mosquito at a scale never seen before. Gene drive offers the possibility of controlling malaria, but the decision to release gene drive mosquitoes into the wild hinges not only on the science but on social, political and environmental issues and the support of the public.
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.
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.
Situating the social sciences in responsible innovation in the global south: the case of gene drive mosquitoes
28148K. Ledingham, C. Opesen, S. Hartley and S. Neema, Journal of Responsible Innovation, 10:2264100. 2023-10-01 11:32:46.
There has been growing attention in recent years on the potential reconfiguration of responsible innovation (RI) to increase its relevance for global challenges in the Global South. This reconfiguration will require a broad and empowered role for social scientists. Yet RI has been preoccupied with public and stakeholder inclusion, rather than social science inclusion. We probe this gap through a case study of the social sciences in the development of gene drive mosquitoes for malaria control in Mali and Uganda. Our data reveals potential diverse roles and future research agendas for the social sciences. We outline some challenges facing the social sciences in this space and ways to promote and support them. Lastly, we argue that RI?s predilection for reflexive and critical social science obscures a richer repertoire of social science roles that are an imperative and fundamental part of efforts to address global challenges in the Global South.
Engineered and natural gene drives: mechanistically the same, yet not same in kind
27995R. F. Medina and J. Kuzma, Nature Communications, 14:5994. 2023-09-26 08:18:08.
We propose the use of the terms natural gene drive (NGD) and engineered gene drive (EGD) arguing against James et al.1, who think both should be included within the term “gene drive”, based on their mechanistic similarities. Thanks to CRISPR-Cas-based gene editing, engineered gene drive has suddenly become feasible as a potential cost-effective pest control tool that could help us resolve wicked challenges2,3 . In nature, several organisms harbor genes that “selfishly” drive themselves into populations. This natural gene drive uses similar mechanisms to the ones use today to drive engineered genes into laboratory populations4 article we disagree with James et al.1 .In this who have recently proposed that because natural and engineered gene drives are mechanistically indistinguishable from a molecular standpoint, they should both be referred as “gene drives” because “a gene drive is a gene drive.” We instead propose that two terms be used to distinguish between natural and engineered gene drives, we second Wells and Steinbrecher5 arguments, and propose to use the terms natural gene drive (NGD) and engineered gene drive (EGD).
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.
Ethical dilemma: Should we get rid of mosquitoes?
24650Talya Hackett, TED-Ed, 2023-01-30 09:59:15.
Mosquitoes are responsible for more human deaths every year than any other animal, but very few of the 3,500 mosquito species actually transmit deadly diseases to humans. Scientists have been conducting experiments using engineered technologies called gene drives that could theoretically get rid of the most lethal mosquitoes. So, should we eradicate these pesky insects? Talya Hackett investigates.
Assessing potential hybridization between a hypothetical gene drive-modified Drosophila suzukii and nontarget Drosophila species
24610S. Wolf, J. Collatz, J. Enkerli, F. Widmer and J. Romeis, Risk Analysis, 2023-01-24 09:02:35.
Genetically engineered gene drives (geGD) are potentially powerful tools for suppressing or even eradicating populations of pest insects. Before living geGD insects can be released into the environment, they must pass an environmental risk assessment to ensure that their release will not cause unacceptable harm to non-targeted entities of the environment. A key research question concerns the likelihood that nontarget species will acquire the functional GD elements; such acquisition could lead to reduced abundance or loss of those species and to a disruption of the ecosystem services they provide. The main route for gene flow is through hybridization between the geGD insect strain and closely related species that co-occur in the area of release and its expected dispersal. Using the invasive spotted-wing drosophila, Drosophila suzukii, as a case study, we provide a generally applicable strategy on how a combination of interspecific hybridization experiments, behavioral observations, and molecular genetic analyses can be used to assess the potential for hybridization.
Gene editing and agrifood systems
24291FAO, FAO, 2022-12-20 09:22:56.
Gene-editing technologies represent a promising new tool for plant and animal breeding in low- and middle-income countries. They enhance precision and efficiency over current breeding methods and could lead to rapid development of improved plant varieties and animal breeds. However, as for any new technology, they have their merits and demerits. There is, as yet, no international consensus regarding if and how gene-edited organisms should be regulated, and whether their release would fall under the regulatory framework of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. This science- and evidence-based Issue Paper on gene editing and agrifood systems presents a balanced discussion of the most pertinent aspects of gene editing, including the consequences for human hunger, human health, food safety, effects on the environment, animal welfare, socioeconomic impact and distribution of benefits. Intrinsic ethical concerns and issues of governance and regulation are addressed, and the roles of the public and private sectors, alone and in partnership, are summarized. Various scenarios are also presented for how gene editing might be used in the future to help transform agrifood systems.
Exploring the value of a global gene drive project registry
24279R. I. Taitingfong, C. Triplett, V. N. Vásquez, R. M. Rajagopalan, R. Raban, A. Roberts, G. Terradas, B. Baumgartner, C. Emerson, F. Gould, F. Okumu, C. E. Schairer, H. C. Bossin, L. Buchman, K. J. Campbell, A. Clark, J. Delborne, K. Esvelt, J. Fisher, R., Nature Biotechnology, 2022-12-15 14:15:40.
Recent calls to establish a global project registry before releasing any gene-drive-modified organisms (GDOs) have suggested a registry could be valuable to coordinate research, collect data to monitor and evaluate potential ecological impacts, and facilitate transparent communication with community stakeholders and the general public. Here, we report the results of a multidisciplinary expert workshop on GDO registries convened on 8–9 December 2020 involving 70 participants from 14 countries. Participants had expertise in gene drive design, conservation and population modeling, social science, stakeholder engagement, governance and regulation, international policy, and vector control; they represented 45 organizations, spanning national and local governmental agencies, international organizations, nonprofit organizations, universities, and district offices overseeing local vector control. The workshop aimed to gather perspectives on a central question: “In what ways could a gene-drive project registry both contribute to and detract from the fair development, testing and use of GDOs?” We specifically queried the perceived purpose of a registry, the information that would need to be included, and the perceived value of a registry. Three primary findings emerged from the discussion: first, many participants agreed a registry could serve a coordinating function for multidisciplinary and multisector work activities; second, doing so may require different design elements, depending on the target end-user group and intended purpose for that group; and third, these different information requirements lead to concerns about information sharing via a registry, suggesting potential obstacles to achieving transparency through such a mechanism. We conclude that any development of a gene-drive project registry requires careful and inclusive deliberation, including with potential end-users, to ensure that registry design is optimal.
Experts urge caution over biotech that can wipe out insect pests
24153L. Fauvel, Phys Org, 2022-12-09 07:09:45.
Dozens of scientists, experts and campaigners called for a ban on the release of genetically-edited organisms into the wild, in a statement Friday warning of potentially severe risks to the world's pollinators. The appeal was launched at crunch biodiversity talks in Montreal, where delegates from almost all the world's countries were meeting to negotiate a strategy to halt human environmental destruction, which threatens the natural life support systems of the planet. A host of new genome-editing tools that modify the genetic material of living beings have emerged in recent years, and are being researched and developed largely to target insects and plants in agriculture. Supporters argue that they could help human health, agriculture and even species conservation. But their use in the wild carries "understudied risks which could accelerate the decline of pollinator populations and put entire food webs at risk," according to the letter drafted by the French non-governmental organization Pollinis.
East African policy dialogue on research of genetically modified mosquitoes for malaria control and elimination
24112C. Mugoya, Target Malaria, 2022-12-02 09:27:43.
The East African Community Secretariat, in collaboration with the East African Health Research Commission; NEPAD, AFIDEP and IFAKARA Health Institute recently convened an East African regional dialogue in Dar es salaam, Tanzania from 17-19 November 2022 to deliberate the way forward on the legal and regulatory frameworks guiding research on genetically modified mosquitoes to solve the problem of malaria in the East African region. The dialogue was attended by legislators from the seven countries of the East African Community partner states – Kenya, Uganda, Tanzania, Burundi, DR Congo, Rwanda and South Sudan, policy makers, government officials, and health experts including biotechnology/biosafety regulators.
Gene drive technologies: navigating the ethical landscape
24074N. d. Graeff, Utrecht University, 2022-11-04 10:41:56.
Gene drives are technologies that modify a particular genetic element in animals or insects so that this genetic element does not follow the typical rules of heredity, and is passed onto future generations with an increased likelihood. Gene drive technologies could be used to tackle intractable problems such as vector-borne diseases like malaria or the biodiversity impact of invasive species. At the same time, the development and governance of gene drives raise a range of ethical questions and concerns that warrant proactive ethical evaluation. In the PhD thesis ?Gene drive technologies: navigating the ethical landscape?, Nienke de Graeff analyzes these questions and concerns. In Part I, she outlines the ?ethical landscape? of gene drive technologies by identifying the associated ethical challenges through literature review and empirical ethical research. Important challenges concern how the uncertainty and risks of these technologies should be navigated, whether it is morally permissible to intervene in nature in this way, and how the development, governance, and potential deployment of gene drive technologies should be guided. In Part II, De Graeff normatively analyzes various of these challenges and provides guidance to navigate them. In Part III, she stipulates recommendations for researchers and policymakers in the gene drive field as well as lessons learned for ethics parallel research as an approach for early ethical guidance of new and emerging technologies more generally.
Genetically Modified Mosquitoes to Fight Malaria in Nigeria, Burkina Faso, Mali and Uganda: What Legal Response?
23275O. J. L. Tung, Potchefstroom Electronic Law Journal, 25:1-42. 2022-06-07 10:05:47.
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 framework for genetically modified mosquitoes (hereafter GMM), but the beneficiaries of such insect technologies to control insect-borne diseases are most likely to be in malaria-endemic countries where the regulation of GM insect technologies is inadequate. Although no commercial release of GMM has been conducted in Africa yet, there may be prospects for the use of GMM to control malaria in malaria-endemic countries such as Nigeria, Burkina Faso, Mali and Uganda. Nigeria has the highest rate of deaths related to malaria in Africa and will potentially be targeted by companies seeking to introduce GMM as a public health tool in African countries. Research is being carried out on GMM in Burkina Faso, Mali and Uganda in collaboration with foreign companies. Whereas the control of diseases is certainly needed and there are potential public health benefits for GM insect technologies to address mosquito control, there are environmental and health concerns, and there is also the potential of the misuse of such technologies. Consequently, the use of GMM requires prior robust domestic, regional and international regulation. While the Cartagena Protocol on Transboundary Movements of Living Modified Organisms (LMOs) to the Convention on Biological Diversity (hereafter the Cartagena Protocol)and voluntary guidelines on the testing of GM mosquitoes are applicable with respect to GM insect technologies, there is a lack of international and regional guidance on the regulation of such technologies. Domestic legislation tends to focus on GM crops and is inadequate for regulating GMM. This paper discusses the legal response for the above Africancountries which may perhaps use GMM as a public health tool and makes recommendations for the necessary regulatory response
The principles driving gene drives for conservation
22295S. Hartley, R. Taitingfong and P. Fidelman, Environmental Science and Policy, 135:36-45. 2022-05-04 08:30:40.
Gene drive technology is an emerging biotechnology with the potential to address some of the most intractable global biodiversity conservation issues. Scientists are exploring potential gene drive applications for managing invasive species and building resilience in keystone species threatened by climate change. The possibility to use gene drive for these conservation purposes has triggered significant interest in how to govern its development and eventual applications. This includes a plethora of documents prescribing governance principles, which can be a sensible response to the governance gap created by emerging technologies and help shore up legitimacy. We conducted qualitative documentary analysis to examine the range and substance of principles emerging in the governance of conservation gene drive. Such analysis aimed to better understand the aspirations guiding these applications and how scientists and other experts imagine their responsibility in this field. We found a collection of recommendations and prescriptions that could be organised into a set of seven emerging principles intended to shape the governance of gene drive in conservation: broad and empowered engagement; public acceptance; decision-making informed by broad ranging considerations, state and international collaboration; ethical frameworks; diverse expertise; and responsible self-regulation by developers. We lay bare these emergent principles, analyzing the way in which they are valued, prioritized, and their strengths and weaknesses. By identifying these prescriptive principles, stakeholders can further interrogate their merits and shortcomings and identify more concrete ways that governance frameworks might embody them.
GeneConvene Global Collaborative Webinar Series | Demystifying the Convention on Biological Diversity – Seven Videos
21940Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2022-04-28 12:39:49.
The Convention on Biological Diversity (CBD) is an international agreement aimed at providing the legal framework for country cooperation to conserve biodiversity, while also enabling its sustainable use, and providing for fair and equitable sharing of the benefits derived from that use. It became effective in 1993 when the first 30 countries signed it, but now has 196 parties. Biotechnology figures prominently in this agreement, since one of its major goal is to "promote and advance priority access on a fair and equitable basis by Contracting Parties, especially developing countries, to the results and benefits arising from biotechnologies." The CBD provides the basis for regulations on biotechnologies, particularly genetically engineered organisms (including gene drive organisms). While the convention, and its subsidiary agreements, have a significant impact on the regulatory environment within which synthetic gene drive research takes place, the procedures and decision-making processes connected with the CBD are often not transparent to researchers and others who do not closely follow the proceedings.
Governing Gene Drive Technologies: A Qualitative Interview Study
23410N. de Graeff, K. R. Jongsma, J. E. Lunshof and A. L. Bredenoord, AJOB Empirical Bioethics, 13:107-124. 2022-04-04 12:10:12.
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 in the debate on GDTs relates to what governance is appropriate for these technologies. While governance mechanisms for GDTs are to a significant extent proposed and shaped by professional experts, the perspectives of these experts have not been explored in depth.Methods A total of 33 GDT experts from different professional disciplines were interviewed to identify, better understand, and juxtapose their perspectives on GDT governance. The pseudonymized transcripts were analyzed thematically.Results Three main themes were identified: (1) engagement of communities, stakeholders, and publics; (2) power dynamics, and (3) decision-making. There was broad consensus amongst respondents that it is important to engage communities, stakeholders, and publics. Nonetheless, respondents had diverging views on the reasons for doing so and the timing and design of engagement. Respondents also outlined complexities and challenges related to engagement. Moreover, they brought up the power dynamics that are present in GDT research. Respondents stressed the importance of preventing the recurrence of historical injustices and reflected on dilemmas regarding whether and to what extent (foreign) researchers can legitimately make demands regarding local governance. Finally, respondents had diverging views on whether decisions about GDTs should be made in the same way as decisions about other environmental interventions, and on the decision-making model that should be used to decide about GDT deployment.Conclusions The insights obtained in this interview study give rise to recommendations for the design and evaluation of GDT governance. Moreover, these insights point to unresolved normative questions that need to be addressed to move from general commitments to concrete obligations.
Prescribing engagement in environmental risk assessment for gene drive technology
21689S. Hartley, A. Kokotovich and C. McCalman, Regulation and Governance, 2022-03-29 08:17:38.
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 assessment guidelines to determine what form future gene drive risk assessments take, including whether and how they involve engagement. To explore who is developing these guidelines and how engagement in risk assessment is being prescribed, we conduct a document analysis of gene drive risk assessment guideline documents from 2014 to 2020. We found that a narrow set of organizations have developed 10 key guideline documents and that with only one exception the documents prescribe a narrow, vague, or completely absent role for engagement in gene drive risk assessment. Without substantively prescribed engagement in guidelines, the relevance, rigor, and trustworthiness of gene drive risk assessment and governance will suffer.
Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis
20480Z. Meghani, Globalization and Health, 18:21. 2022-02-21 08:33:18.
In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools.
A preliminary framework for understanding the governance of novel environmental technologies: Ambiguity, indeterminateness and drift
20412F. Rabitz, M. Feist, M. Honegger, J. Horton, S. Jinnah and J. Reynolds, Earth System Governance, 12:100134. 2022-02-16 16:13:59.
We propose a conceptual framework to explain why some technologies are more difficult to govern than others in global environmental governance. We start from the observation that some technologies pose transboundary environmental risks, some provide capacities for managing such risks, and some do both. For “ambiguous” technologies, potential risks and risk management capacities are uncertain, unknown or even unknowable. Governance systems are indeterminate towards ambiguous technologies, as existing norms, rules, scripts and routines do not imply default solutions under institutional focal points. Indeterminateness can lead to institutional drift, with risks accordingly remaining unmitigated and risk management capacities remaining unexploited. We use the cases of solar geoengineering, gene drive systems and bioinformatics for illustrating this framework. As technological ambiguity may often be irresolvable, we conclude that it might force us to confront the limits to anticipatory global decision-making on matters of long-term environmental sustainability.
A Closing Window of Opportunity for Gene Drive Governance in the United States
20445K. L. Warmbrod, M. Montague and G. K. Gronvall, Health Security, 20:3-5. 2022-02-15 09:35:05.
The COVID-19 pandemic has brought forth a number of biotechnological advances to enhance the public's health: new diagnostic tests, mRNA vaccines, and new antiviral medications. Biotechnology is also being used to address global challenges like climate change, food insecurity, and building the bioeconomy, which directly or indirectly improve public health. Gene drives are one such biotechnology. They are genetically engineered systems that can alter the inheritance patterns in a host species, such as a mosquito, so that a greater percentage of its progeny inherit a specific desired trait. Research and investments in biotechnology have been used to reduce arthropod-borne infectious diseases, such as malaria and Zika, and to manage or eliminate invasive species.2 Funding thus far has been adequate. For example, Target Malaria, a global consortium of researchers developing a gene drive to decrease the burden of malaria, has an average of US$11.5 million per year in funding.3 Although no gene drive has been released into the environment yet, technologies with similar attributes have been released in field trials, notably by Oxitec in Florida
Conditions for Investment in Genetic Biocontrol of Pest Vertebrates in Australia
20264L. Carter, A. Mankad, S. Campbell, W. Ruscoe, K. P. Oh, P. R. Brown, M. Byrne, M. Tizard and T. Strive, Frontiers in Agronomy, 3. 2022-01-31 08:46:53.
Managing pest vertebrate species in Australia is a significant challenge for government, industry, research sectors and land-managers. Innovative tools such as genetic biocontrol offers decision-makers a potentially effective means of reducing the impact of pest species incursions. To determine the conditions for investment in genetic biocontrol, we applied qualitative engagement methodologies to identify and integrate existing knowledge of pest species research and management in Australia. Two facilitated workshops were held to determine key topics related to genetic biocontrol technologies for selected pest species. The topics explored during workshop discussions included: identifying existing knowledge gaps; risk perceptions; social and ethical considerations and; industry and business considerations. The workshops' aim was to assess the potential, the priorities and the risk parameters among expert stakeholders and decision-makers for using genetic biocontrol approaches to reduce the impacts of key pest species in Australia. This paper reports on the design, process and outcomes of each workshop to inform the creation of a decision framework. Stakeholders were cautiously optimistic of pursuing continued research and development for vertebrate pest management in Australia. However, employing an appropriate, transparent process for incorporating diverse stakeholder perspectives on genetic biocontrol technologies is essential to ensure their development and use remains supported. This outcome will require meaningful investment in both social science investigations and well-considered engagement processes concurrent with biotechnology development globally.
iGEM and Gene Drives: A Case Study for Governance
20040P. Millett, T. Alexanian, M. J. Palmer, S. W. Evans, T. Kuiken and K. Oye, Health Security, 2022-01-11 09:49:06.
Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.
Stakeholder engagement to inform the risk assessment and governance of gene drive technology to manage spotted-wing drosophila
20212A. E. Kokotovich, S. K. Barnhill-Dilling, J. E. Elsensohn, R. Li, J. A. Delborne and H. Burrack, Journal of Environmental Management, 307:114480. 2022-01-04 15:32:08.
Emerging biotechnologies, such as gene drive technology, are increasingly being proposed to manage a variety of pests and invasive species. As one method of genetic biocontrol, gene drive technology is currently being developed to manage the invasive agricultural pest spotted-wing drosophila (Drosophila suzukii, SWD). While there have been calls for stakeholder engagement on gene drive technology, there has been a lack of empirical work, especially concerning stakeholder engagement to inform risk assessment. To help address this gap and inform future risk assessments and governance decisions for SWD gene drive technology, we conducted a survey of 184 SWD stakeholders to explore how they define and prioritize potential benefits and potential adverse effects from proposed SWD gene drive technology. We found that stakeholders considered the most important potential benefits of SWD gene drive technology to be: 1) Decrease in the quantity or toxicity of pesticides used, and 2) Decrease in SWD populations. Stakeholders were most concerned about the potential adverse effects of: 1) Decrease in beneficial insects, 2) Increase in non-SWD secondary pest infestations, and 3) Decrease in grower profits. Notably, we found that even stakeholders who expressed support for the use of SWD gene drive technology expressed concerns about potential adverse effects from the technology, emphasizing the need to move past simplistic, dichotomous views of what it means to support or oppose a technology. These findings suggest that instead of focusing on the binary question of whether stakeholders support or oppose SWD gene drive technology, it is more important to identify and assess the factors that are consequential to stakeholder decision making – including, for example, exploring whether and under what conditions key potential adverse effects and potential benefits would result from the use of SWD gene drive technology.
Procedurally Robust Risk Assessment Framework for Novel Genetically Engineered Organisms and Gene Drives
19376Kuzma, J., Regulation and Governance, 15:1144-1165. 2021-11-29 17:13:52.
In this article, a new framework for improving risk assessments of novel genetically engineered organisms (GEOs) is developed and applied. The Procedurally Robust Risk Assessment Framework (PRRAF) provides a set of principles and criteria for assessing and enhancing risk assessment protocols for GEOs under conditions of high uncertainty. The application of PRRAF is demonstrated using the case of a genetically engineered mosquito designed to kill its wild population and therefore decrease disease transmission. Assessments for regulatory approval of this genetically engineered insect fall short of several PPRAF criteria under the principles of humility, procedural validity, inclusion, anticipation, and reflexivity. With the emergence of GEOs designed to spread in ecosystems, such as those with gene drives, it will become increasingly important for regulatory agencies and technology developers to bolster their risk analysis methods and processes prior to field testing. PRRAF can be used as a flexible guide for doing so within a variety of institutional, regulatory, and governance contexts.
Weltnaturschutzunion sucht Position
18803Anonymous, Informationsdienst Gentechnik, 2021-09-22 19:07:43.
Die Weltnaturschutzunion IUCN will in den nächsten drei Jahren eine breite interne Diskussion führen, ob Gentechnik und Gene Drives im Naturschutz eingesetzt werden sollen. Mit diesem Beschluss ist der Versuch gentechnikfreundlicher Organisationen, mit Artenschutz-Argumenten neuen gentechnischen Verfahren die Tür zu öffnen, vorerst abgewehrt. Der 1948 gegründeten International Union for Conservation of Nature gehören über 1300 staatliche und nichtstaatliche Naturschutzorganisationn aus aller Welt an. Sie trafen sich Mitte September in Marseille zu ihrem Weltnaturschutzkongress und verabschiedeten dabei mit der Resolution Nummer 75 auch einen Fahrplan, um zu einer „IUCN-Politik zur synthetischen Biologie in Bezug auf den Naturschutz“ zu gelangen. Der Begriff synthetische Biologie umfasst dabei alle gentechnischen Verfahren, mit denen biologische Systeme künstlich konstruiert oder umgestaltet werden.
Calling the latest gene technologies ‘natural’ is a semantic distraction — they must still be regulated
18752J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, The Conversation, 2021-09-22 13:41:22.
Legislators around the world are being asked to reconsider how to regulate the latest developments in gene technology, genome editing and gene silencing. Both the European Court of Justice and the New Zealand High Court have ruled that genome editing techniques should remain under the regulations specific to genetically modified organisms. But a few other countries, including Australia, have exempted some uses of these techniques from their regulations, based on similarities to what occurs in nature. The main argument is that the biochemical processes of editing are like the processes that cause natural mutations. The “equivalent to nature” narrative blurs the boundary between natural processes and technology.
New report demands moratorium on gene drives
18792GM Watch, GM Watch, 2021-09-21 13:49:44.
To help the public understand what's at stake, the Germany-based NGO Save Our Seeds (SOS) has published a report, "Gene Drives: The New Dimension of Genetic Engineering", which can be downloaded as a pdf document. The report provides a scientifically founded overview of how gene drive systems work, their possible areas of application, and the scientific discussion about their risks. It summarises the status of legislation and regulation at the German, European and global levels and recommends urgent political measures. The report explains how gene drives could be used in agriculture – research is focused on controlling pests and weeds and reversing the herbicide resistance in weeds that was caused and exacerbated by the spread of GM herbicide-tolerant crops. Not coincidentally, the report also notes that gene drives could be employed as bioweapons – for example, to eradicate beneficial insects in a region. The report points out, "The US military‘s Defense Advanced Research Projects Agency (DARPA) is one of the largest funders of gene drive research and is financially involved in almost every gene drive research project."
Gene Drive Organisms: A new dimension of genetic engineering
18790V. Henn and M. Imken, Save Our Seeds, 2021-09-21 13:42:53.
Enabled by new genetic engineering techniques such as CRISPR/Cas9, so-called gene drives have been developed in recent years that enable humans to spread new genes throughout the genome of wild animal populations. Gene drives force the inheritance of newly introduced genes to be inherited by all offspring, even if this lowers the survival chances of the affected species. In the most extreme case, gene drive technology could drive an entire species to extinction or replace wild populations with genetically modified organisms.
The viral era
18352B. Giese, EMBO reports, 22:e53229. 2021-09-06 13:54:36.
New biotechnologies such as gene drives and engineered viruses herald a viral era that would give humans exceptional power over any organism at the level of the genotype. In synthetic biology, orthogonality—in the sense of lack of interference—between different systems or system components is sought for new creations. Current approaches to controlling gene drives also aim for orthogonality, but at a higher level of organisms, populations and species. To keep information under control, orthogonality and reversibility have to be guaranteed before any releases. As with chemical substances, where persistence and bioaccumulation are reasons for concern, the same should apply to genetic information released into nature
The international governance of gene drive organisms
18320F. Rabitz, Environmental Politics, 2021-08-29 13:07:16.
Gene Drive Organisms (GDOs) are a proposed biotechnological intervention that might generate significant benefits for the conservation and sustainable use of biological diversity while also raising critical biosafety issues. Despite their inevitable transboundary effects, their implications for international institutions remain undertheorized. This text develops a theoretical analysis of international GDO governance. First, it elaborates the problem-structural characteristics of GDOs that turn them into a novel and distinct governance challenge, focusing on leverage, cost-benefit distributions, irreversibility, as well as uncertainty and unpredictability. Second, it derives the implications of problem structure for institutional design by focusing on pre-release risk assessment and authorization, as well as post-release monitoring and liability. Third, it uses these institutional implications for benchmarking the Cartagena Protocol on Biosafety, the focal point in international biotechnology regulation, for effective GDO governance. The text concludes that institutional reforms are required for folding GDOs into international biodiversity policy.
Earth system interventions as technologies of the Anthropocene
17730J. L. Reynolds, Environmental Innovation and Societal Transitions, 40:132-146. 2021-07-10 15:16:46.
Earth system interventions (ESIs)—intentional large-scale interventions in Earth systems—are not entirely new. However, in response to threats to sustainability, particularly from climate change and biodiversity loss, some scientists and others are researching, developing, and using new, largely technological ESIs. These include carbon dioxide removal, solar geoengineering, in situ genetically modified organisms, gene drive organisms, de-extinction, and high-tech ecosystem restoration. Some emerging ESIs appear to be effective and feasible, both technically and economically, and may be necessary to achieve important sustainability and human welfare objectives. They also pose serious environmental risks. This paper identifies more than a dozen social, political, and ethical challenges that are common across many of the emerging technological ESIs. Governance could mitigate and manage these issues, and it would be made more effective and robust by understanding and treating new ESIs as such and as a potentially transformative set of innovations in human-Earth system relations.
Regulatory and governance considerations for gene drive research
32181ISAAA Inc., 2021-06-22 12:36:13.
The legal regulation of gene drive technologies
16914C. Elves, Univeristy of Oxford, 2021-05-01 13:32:03.
Gene drive technologies purport to provide a panacea and yet in doing so present unprecedented risks that threaten to change, potentially irreversibly, the way in which we live in the world. Gene drive technologies raise questions about what ends societies ought to seek for their citizens, how they are constituted and how those ends might be attained. Despite this, current discussions surrounding gene drive technologies and their regulation focus almost exclusively on the technical implications. Drawing on the work of sociologists and STS scholars, this thesis argues that lawyers ought to think critically about the ways in which they go about developing their understandings of new technologies as regulatory objects. Lawyers need to evaluate and scrutinize the knowledge claims with which they are presented, and work to identify those extending beyond the required technical expertise, if the regulatory frames they build are to bear fidelity to the realities of the technology. This thesis draws out the regulatory disconnection generated by the current regulation of gene drive technologies through the existing European Union GMO regime. It then goes on to describe the ways in which regulatory reconnection might be achieved by constructing broader frames through which we describe gene drive technologies as a regulatory object. In thinking about how lawyers might go about broadening the frames that they build, this thesis takes examples from Public Health Law scholarship and legislation. In response to both the normative and epistemic lacunae highlighted above, this thesis develops an account of why and how ethical enquiry ought to play a significant role in informing our descriptions of gene drive technologies as regulatory objects. Furthermore, this thesis argues that ethical enquiry is capable of articulating questions to which technical experts must provide answers if we are to develop fuller understandings of the technologies we regulate. In this way, ethical enquiry can help lawyers bridge both the normative and epistemic gaps that they are so often faced with in the regulation of emerging technologies.
Selection of Sites for Field Trials of Genetically Engineered Mosquitoes with Gene Drive
16932G. C. Lanzaro, M. Campos, M. Crepeau, A. Cornel, A. Estrada, H. Gripkey, Z. Haddad, A. Kormos, S. Palomares and W. Sharpee, bioRxiv, 2021.04.28.441877. 2021-04-28 15:53:05.
Novel malaria control strategies using genetically engineered mosquitoes (GEMs) are on the horizon. Population modification is one approach wherein mosquitoes are engineered with genes rendering them refractory to the malaria parasite coupled with a low-threshold, Cas9-based gene drive. When released into a wild vector population, GEMs preferentially transmit these beneficial genes to their offspring, ultimately modifying a vector population into a non-vector one. Deploying this technology awaits evaluation including ecologically contained field trials. Here, we consider a process for site selection, the first critical step in designing a trial. Our goal is to identify a site that maximizes prospects for success, minimizes risk, and serves as a fair, valid, and convincing test of efficacy and impacts of a GEM product intended for large-scale deployment in Africa. We base site selection on geographical, geological, and biological, rather than social or legal, criteria. We recognize the latter as critically important but not preeminent. We propose physical islands as being the best candidates for a GEM field trial and present an evaluation of 22 African islands. We consider geographic and genetic isolation, biological complexity, island size, topography, and identify two island groups that satisfy key criteria for ideal GEM field trial sites.Competing Interest StatementThe authors have declared no competing interest.
How do local communities participate in gene drive research?
16680Outreach Network for Gene Drive Research, 2021-04-12 14:39:00.
How do local communities participate in gene drive research?
US Gene Drive Governance: A Special Feature in Health Security
16685L. Warmbrod, A. Kobokovich, R. West, G. K. Gronvall and M. Montague, Health Security, 19:131-132. 2021-04-08 14:51:20.
The novel potential of gene drives and related genetic pest control measures highlights a gap in the oversight of products using such technologies in the United States. The US Coordinated Framework for Regulation of Biotechnology, as applied by US Environmental Protection Agency, the US Food and Drug Administration, and US Department of Agriculture, may not fully encompass modern synthetic biology techniques that have significantly expanded the scope of genetic modification technology applications.
Ethics of Genome Editing
16622European Group on Ethics, European Group on Ethics in Science and New Technologies, 2021-03-19 18:16:09.
This Opinion addresses the profound ethical questions raised and revived by them. It analyses various domains of application, from human health to animal experimentation, from livestock breeding to crop variety and to gene drives. With its wide view across areas, it identifies underlying and overarching issues that deserve our concerted attention, among them, the different meanings that ought to be attributed to humanness, naturalness or diversity. This enables conclusions that provide panoramic perspectives complementing narrower, area-specific analyses. In the same vein, the Opinion is concerned with the global dimension of genome editing and its regulation and formulates recommendations with a particular focus on the international level.
Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies
18750J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, Elementa: Science of the Anthropocene, 9. 2021-03-17 13:35:29.
Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a policy bridge from unproductive descriptions of gene technology to useful methods for identifying sources of significant biological and socioeconomic risk in complex food systems. Farmers and the public could be voluntarily and involuntarily interacting with new techniques of genome editing and gene silencing in entirely new ways, limiting the usefulness of previous gene technology histories to predict safety. What we believe is a more consistent, verifiable, and practical approach is to identify the critical control points that emerge where the scale effects of a human activity diverge between risk and safety. These critical control points are where technical experts can collaborate with publics with different expertise to identify and manage the technology. The use of technical terminology describing biochemical-level phenomena discourages publics that are not technical experts from contesting the embedded cultural perspectives and uncertainty in “scientific” concepts and prejudice the risk discourse by ignoring other issues of significance to society. From our perspective as gene technologists, we confront the use of pseudo-scale language in risk discourse and propose an escape path from clashes over whether risks that arise spontaneously (from nature) can be perfectly mimicked by gene technology to a discussion on how to best control the risks created by human activity. Scale is conceptually implicit and explicit in gene technology regulation, but there is no agreement about what scales are most useful to managing risk and social expectations. Both differentiated governance (risk-tiered) and responsible research and innovation models could accommodate the critical control points mechanism that we describe.
Evaluating Gene Drive Approaches for Public Benefit
15296M. R. Santos, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:14:49.
Gene drive approaches—those which bias inheritance of a genetic element in a population of sexually reproducing organisms—have the potential to provide important public benefits. The spread of selected genetic elements in wild populations of organisms may help address certain challenges, such as transmission of vector-borne human and animal diseases and biodiversity loss due to invasive animals. Adapting various naturally occurring gene drive mechanisms to these aims is a long-standing research area, and recent advances in genetics have made engineering gene drive systems significantly more technically feasible. Gene drive approaches would act through changes in natural environments, thus robust methods to evaluate potential research and use are important.
Engineered Gene Drives: Ecological, Environmental, and Societal Concerns
15292J. Kuzma, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:07:26.
This chapter overviews the types, purposes, and potential impacts of gene drive organisms (GDOs) and discusses challenges with foreseeing and assessing these impacts prior to their environmental release. It concludes with a few examples of risk analysis methods and governance systems that scholars have proposed to cope with the novelty of GDOs and uncertainties associated with their use. With GDOs poised for release in the near future, it is urgent that technologists, ecologists, social scientists, ethicists, stakeholders, and publics work together to grapple with the immense challenges associated with assessments of GDOs and the design of governance systems to ensure their responsible development and potential use.
Transformation and slippage in co-production ambitions for global technology development: The case of gene drive
16634K. Ledingham and S. Hartley, Environmental Science & Policy, 116:78-85. 2020-11-24 17:41:43.
Co-production is an increasingly popular framework for knowledge generation, evaluation and decision making. Despite its potential to open up decisions and practices to the input of others, co-production regularly falls short of its transformative ambitions. Through documentary analysis, we investigate the meaning and dynamics of co-production as it stretches beyond the local into global research and technology spaces. We find that in the case of global gene drive, the meaning of co-production is extended in novel ways and underpinned by new possibilities for meaningful transformation. At the same time, we also identify a simultaneous resurfacing of reductive framings of collaboration. In the paper we present ‘slippage’ as a useful heuristic in helping to understand why co-production fails. We argue that if co-production in these new spaces is to achieve its transformative ambitions, there is a need to engage with new and entrenched knowledge hierarchies that contribute to this slippage.
Engineering biological diversity: the international governance of synthetic biology, gene drives, and de-extinction for conservation
15251J. L. Reynolds, Current Opinion in Environmental Sustainability, 49:1-6. 2020-11-17 18:23:24.
In the face of insufficient progress in conserving and restoring biodiversity, the in situ use of advanced genetic modification, gene drives, and other biotechnologies for conservation purposes are being considered, researched, and developed. This paper introduces the methods, applications, environmental risks, and social challenges of ‘conservationist synthetic biology’; reviews existing governance, with an emphasis on international instruments, institutions, and processes; and offers observations of the politics of developing further governance. The most important multilateral environmental agreement is the Convention on Biological Diversity. Governance of such conservationist synthetic biology is vital but gaps remain. The further development of governance is a political process, and conservationist synthetic biology has a political landscape that is atypical for emerging technologies.
Brave New Planet: Reshaping Nature Through Gene Drives
15047E. Lander, Brave New Planet, 2020-11-09 19:26:24.
A new technology, called gene drives, has the power to spread any genetic instructions you wish across an entire animal or plant species in the wild. It might let us restore ecosystems ravaged by invasive species, or help species adapt to climate change. And, it might save millions of children from dying of malaria. But could altering nature in this way, and on this scale, have unintended consequences? And, when it comes reshaping ecosystems, who needs to say yes?
GeneConvene Global Collaborative Webinar Series | Engineered Gene Drives: Policy and Regulatory Considerations Webinar Series October-December 2020
14808Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-22 19:38:17.
In this series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured. Each seminar is ~60 minutes in length followed by questions and answers.
GeneConvene Global Collaborative Webinar Series | Gene Drive Policy and Regulatory Considerations 2020
14677Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-13 17:50:24.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.
GeneConvene Global Collaborative Webinar Series | Gene Drive Policy and Regulatory Consideration
14670Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-13 17:34:35.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.
Global citizen deliberation on genome editing
14607J. S. Dryzek, D. Nicol, S. Niemeyer, S. Pemberton, N. Curato, A. Bächtiger, P. Batterham, B. Bedsted, S. Burall, M. Burgess, G. Burgio, Y. Castelfranchi, H. Chneiweiss, G. Church, M. Crossley, J. de Vries, M. Farooque, M. Hammond, B. He, R. Mendonça, J., Science, 369:1435. 2020-09-18 18:32:40.
Here we show how, as the global governance vacuum is filled, deliberation by a global citizens' assembly should play a role, for legitimate and effective governance.
Responsible innovation in biotechnology: Stakeholder attitudes and implications for research policy
15225P. Roberts, J. Herkert and J. Kuzma, Elementa, 2020-09-01 21:17:09.
Using a mixed methods approach, we analyzed the attitudes of different biotechnology stakeholders, particularly those working in areas related to genetically modified organisms (GMOs) in agriculture and the environment, towards the principles and practices of RI. Homogenous focus groups (organized by stakeholder affiliation) and pre- and post-focus group surveys were used to measure attitudes towards RI. We designed the survey questions according to the Advocacy Coalition Framework (ACF) and examined the agreement of stakeholders with policy core beliefs (general principles of RI) and secondary beliefs (implementation practices of RI). Qualitative analysis of focus-groups revealed barriers for implementing RI practices.
Global Governing Bodies: A Pathway for Gene Drive Governance for Vector Mosquito Control
13605A. Kelsey, D. Stillinger, T. B. Pham, J. Murphy, S. Firth and R. Carballar-Lejarazú, American Journal of Tropical Medicine and Hygiene, 2020-08-05 12:34:11.
We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool.
Providing a policy framework for responsible gene drive research: an analysis of the existing governance landscape and priority areas for further research
13231D. Thizy, I. Coche and J. de Vries, Wellcome Open Research, 2020-07-20 12:19:36.
D. Thizy, I. Coche and J. de Vries (2020). Wellcome Open Research. doi: 10.12688/wellcomeopenres.16023.1 In this manuscript, we review the existing regulatory landscape around gene drive research and map areas of convergence and divergence, as well as gaps in relation to guidelines for community engagement in gene drive research.
Who is afraid of genetically modified mosquitoes?
12738G. Odogwu, The PUNCH, 2020-06-25 13:27:54.
Genetically Modified Organisms have raised concerns in our clime, the same way they have in other countries of the world – where a clear line is drawn between the pro and the anti-GMO citizens. Nonetheless, this modern biotechnological technique is still at its infancy here. As of the moment, we can only boast of the development of the PBR cowpea as the only genetically modified food crop to be approved by the Nigerian government.
Mosquito district workshop focuses on Keys trials
12732S. Matthis, KEYSWEEKLY, 2020-06-25 13:21:52.
Now that the Oxitec “Friendly Mosquito” trials have been approved by the federal and state governments, it’s up to the Florida Keys Mosquito Control District to decide if, when and where to embrace the technology said to decrease the chances of mosquito-borne diseases such as dengue fever (there are two new cases in the Keys; see sidebar) and zika.
Genetically modified mosquitoes to be released in Florida and Texas
12735O. Ron, The Jerusalem Post, 2020-06-24 13:24:12.
A plan to release 750 million genetically modified mosquitoes in Florida and Texas has been approved, The Guardian reported. According to the plan, the Aedes aegypti mosquitoes will be released into the wild, as they contain a special protein that would kill female offspring, which are the ones who bite, and thus preventing the spread of such illnesses as dengue fever and Zika.
Before genetically modified mosquitoes are released, we need a better EPA
12720N. Kofler and J. Kuzma, The Boston Globe, 2020-06-22 13:07:55.
While the attention of the American public has rightfully been focused on the COVID-19 pandemic, its associated racial disparities, and broader issues of structural racism, the US government made a serious public health decision — one that could affect our health and our environment for generations to come. Last month, the US Environmental Protection Agency approved the release of genetically modified mosquitoes. Under a 2-year Experimental Use Permit, a company called Oxitec has been granted permission to release over 1 billion genetically modified mosquitoes across 6,600 acres in Florida and Texas.
Are Genetically Modified Mosquitoes Coming To Florida?
12726M. Taylor, Y100, 2020-06-19 13:13:35.
I'm not even going to lie, mosquitoes should be classified under domestic terrorism. The flying, biting bugs you can barely see wreak havoc on my life every single summer. I'm not sure if I'm allergic to them, but whenever I'm bit by them, that area of my skin swells up. It's the most annoying feeling in the world.
The Florida Keys are one step closer to getting genetically modified mosquitoes
12723D. Goodhue, Miami Herald, 2020-06-19 13:10:57.
An international biotech company is one step closer to being able to release genetically modified mosquitoes in the Florida Keys. The Florida Department of Agriculture and Consumer Services this week granted Oxitec an experimental use permit to release potentially millions of lab-made male Aedes aegypti mosquitoes throughout Monroe County. The goal is to wipe out the Keys population of the invasive bugs, which carry diseases like dengue fever, Zika and yellow fever. The Florida Department of Health reported a case of dengue fever in the Keys in March.
Synthetic Biology: Research Needs for Assessing Environmental Impacts
17467C. M. Warner, S. R. Carter, R. F. Lance, F. H. Crocker, H. N. Meeks, B. L. Adams, M. L. Magnuson, T. Rycroft, K. Pokrzywinski and E. J. Perkins, Synthetic Biology 2020: Frontiers in Risk Analysis and Governance, 2019-08-01 18:23:43.
Synthetic biology and its applications have the potential to greatly improve economic development, public health, environmental stewardship, technological advancement, and many other areas. In May 2017, sixty individuals gathered in Lexington, Massachusetts for a workshop sponsored by the U.S. Army Engineer Research and Development Center (ERDC) to discuss applications of synthetic biology with likely or intended interaction with the environment. Representatives from academia, government agencies, industry, and non-governmental organizations convened to identify knowledge gaps and research needs to assess potential environmental impacts from these technologies. The group discussed challenges in environmental risk assessment, regulation, and community engagement for emerging synthetic biology technologies. The workshop was structured around four hypothetical case studies, including the use of gene drive engineered organisms to control infectious disease vectors, engineered microbes for bioremediation, cell-free applications for advanced chemical production, and engineered viruses for water treatment. Meeting these research needs will facilitate appropriate environmental risk assessment and informed decision making for the development and potential deployment of synthetic biology organisms and components in the environment.
Sustainability as a framework for considering gene drive mice for invasive rodent eradication
3886Barnhill-Dilling, SKS, M.; Blondel, D. V.; Godwin, J., Sustainability, 11:1334. 2019-01-04 00:00:00.
Gene drives represent a dynamic and controversial set of technologies with applications that range from mosquito control to the conservation of biological diversity on islands. Currently, gene drives are being developed in mice that may one day serve as an important tool for reducing invasive rodent pests, a key threat to island biodiversity and economies. Gene drives in mice are still in development in laboratories, and wild release of modified mice is likely a distant reality. However, technological changes outpace the existing capacity of regulatory frameworks, and thus require integrated governance frameworks. We suggest sustainability-which gives equal consideration to the environment, economy, and society-as one framework for addressing complexity and uncertainty in the governance of emerging gene drive technologies for invasive species management. We explore the impacts of rodent gene drives on island environments, including potential conservation and restoration of island biodiversity. We outline considerations for rodent gene drives on island economies, including impacts on agricultural and tourism losses, and reductions in biosecurity costs. Finally, we address the social dimension as an essential space for deliberation that will be integral to evaluating the potential deployment of gene drive rodents on islands.
Anomaly handling and the politics of gene drives
13806S. W. Evans and M. J. Palmer, Journal of Responsible Innovation, 5:S223-S242. 2018-01-24 15:56:09.
Decisions about the development and use of gene drives are framing broader debates about the need for fundamental changes to biotechnology regulatory systems. We summarize this debate and describe how gene drives are being constructed as potential anomalies within the regulatory landscape.
A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context
13790J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye and S. Stauffer, Journal of Responsible Innovation, 5:S13-S39. 2018-01-24 15:34:37.
This paper reports on a workshop held in February 2016 to explore the complex intersection of political, economic, ethical, and ecological risk issues associated with gene drives. Workshop participants were encouraged to use systems thinking and mapping to describe the connections among social, policy, economic, and ecological variables as they intersect within governance systems. In this paper, we analyze the workshop transcripts and maps using the Institutional Analysis and Development (IAD) framework to categorize variables associated with gene drive governance and account for the complexities of socio-ecological systems.
Mapping research and governance needs for gene drives
13788J. Delborne, J. Kuzma, F. Gould, E. Frow, C. Leitschuh and J. Sudweeks, Journal of Responsible Innovation, 5:S4-S12. 2018-01-24 15:28:09.
This special issue represents both deep and broad thinking about gene drives. The papers were first drafted nearly two years ago, and since then have been reviewed and revised to flesh out key arguments and take account of ongoing developments in the field. This field has moved very fast indeed! Technical research publications have increased in number; NASEM released a major report in June 2016; and workshops have proliferated.
Gene drives and the expanding horizon of governance
13786E. Fisher, Journal of Responsible Innovation, 5:S1-S3. 2018-01-24 15:23:59.
Like other areas of emerging science and technology that trigger prolonged public debate over their transformative prospects, gene drives simultaneously generate prospects for new knowledge, hoped-for benefits, and formidable concerns. Their ability to bias inheritance of and in theory spread a genetic trait throughout an entire population of organisms—even to the point of extinction—is driving home the need for their responsible governance. Significantly, it is also driving home the need to develop capacities for such governance.
Harnessing gene drive
3996Min, JS, Andrea L.; Najjar, Devora; Esvelt, Kevin M., Journal of Responsible Innovation, 5:S40-S65. 2018-01-14 00:00:00.
When scientists alter the genome of an organism, we typically reduce its ability to reproduce in the wild. This limitation has prevented researchers from rendering wild insects unable to spread disease, programing pests to ignore our crops, using genetics to precisely remove environmentally damaging invasive species, and much more. Gene drive occurs when a vertically transmitted genetic element reliably spreads through a population over generations despite providing no reproductive advantage to each host organism. Until recently, scientific efforts to take advantage of this natural phenomenon achieved only limited success. The advent of CRISPR genome editing has dramatically accelerated efforts to harness gene drive. Small groups of scientists may now be capable of unilaterally altering entire wild populations, and through them, the shared environment. Determining whether, when, and how to develop gene drive interventions responsibly will be a defining challenge of our time. Here we describe capabilities, safeguards, applications, and opportunities relevant to gene drive technologies.
Ethical, legal and social aspects of the approach in Sudan
25823B. B. El Sayed, C. A. Malcolm, A. Babiker, E. M. Malik, M. A. H. El Tayeb, N. S. Saeed, A. H. D. Nugud and B. G. J. Knols, Malaria Journal, 8:S3. 2009-11-16 10:10:31.
The global malaria situation, especially in Africa, and the problems frequently encountered in chemical control of vectors such as insecticide resistance, emphasize the urgency of research, development and implementation of new vector control technologies that are applicable at regional and local levels. The successful application of the sterile insect technique (SIT) for the control of the New World screwworm Cochliomyia hominivorax and several species of fruit flies has given impetus to the use of this method for suppression or elimination of malaria vectors in some areas of Africa including Northern State of Sudan. The research and development phase of the Northern State feasibility study has been started. Sudanese stakeholders are working side-by-side with the International Atomic Energy Agency in the activities of this important phase. Several ethical, legal and social issues associated with this approach arose during this phase of the project. They need to be seriously considered and handled with care. In this paper, these issues are described, and the current and proposed activities to overcome potential hurdles to ensure success of the project are listed.
