Keywords: Risk assessment
“Target species complex” concept: Strengthening environmental risk assessment of engineered gene drives
35531J.B. Connolly, Y. Devos, D.C.M. Glandorf, and J. Romeis, Proc. Natl. Acad. Sci., 2026-03-30 19:11:30.
The recent opinion piece of Christophe Boëte critiqued the concept of the target species complex (TSC) in environmental risk assessment (ERA) of engineered gene drives (EGDs) (1). While constructive debate is essential, the piece misrepresents the purpose of TSC and conflates unrelated mechanisms, creating misconceptions that merit clarification. Malaria-transmitting mosquitoes often belong to species complexes, comprising vector and nonvector species, where hybridization can be detected in laboratory settings and occasionally in the field (2–4). Low-threshold EGDs are self-sustaining and nonlocalizing (5). Should such EGD be released in a species complex where target genomic sequences are conserved, in the event of interspecific mating in the field vertical gene drive transfer (VGDT) to nonvector species could occur, potentially harming biodiversity protection goals. Conversely, VGDT to vector species could advance health objectives (6).
CRISPR-Cas9 suppression gene drives for Nile tilapia control: prospects in sub-Saharan African freshwater ecosystems
35509Bobo, E. D., All Life, 19. 2026-03-16 15:14:01.
CRISPR-based suppression gene drives represent a promising tool for managing invasive Nile tilapia (Oreochromis niloticus) populations in sub-Saharan Africa’s freshwater ecosystems. Introduced through aquaculture, Nile tilapia supports livelihoods but also causes severe biodiversity loss. This review explores the technical feasibility of CRISPR-Cas9 suppression gene drives, specifically homing and Driving-Y drive systems, as species-specific, potentially self-sustaining biocontrol strategies. The theoretical effectiveness of these gene drive systems in reducing invasive Nile tilapia and restoring ecological balance is discussed within a precautionary framework. This study addresses the urgent need to protect native tilapia species, which are listed as Critically Endangered, Endangered, and Vulnerable by the IUCN. Gene drives have the potential to reduce invasive populations and restore ecological balance. However, their effectiveness can be compromised by extensive hybridization with native Oreochromis species and resistance evolution in genetically diverse populations. Therefore, the ecological, ethical, and socioeconomic risks of gene drive systems were examined in the context of the Convention on Biological Diversity and Cartagena Protocol. Hence, integrating molecular innovations with strong policy frameworks, stakeholder engagement, and comprehensive risk assessment is essential. CRISPR-Cas9 suppression drives deployment requires careful evaluation across ecological, ethical, and governance contexts to safeguard native ichthyofauna.
Precision pest management: Genome editing tools, specifically CRISPR/Cas9 and future prospects
35424Ankush Saini, Neha Sharma, Nidhi Sharma, et al., Pesticide Biochemistry and Physiology, 218. 2026-02-03 15:42:17.
The growing resistance to synthetic insecticides and Bt toxins, alongside persistent crop losses despite heavy pesticide application, highlights the urgent need for safer, sustainable and efficient pest management strategies. This review presents genome editing as a precise and versatile approach to reduce pest impact by altering fertility, feeding patterns or vulnerability, while protecting beneficial organisms. Among the genome editing tools, CRISPR/Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9) is one of the most promising genome editing techniques in insects. It facilitates targeted functional studies, integration with RNAi and dual-expression systems and gene drive applications. Deployment is envisioned in two phases, initial laboratory modification followed by regulated field release, with a strong emphasis on biosafety through terminator genes, marked individuals for gene flow monitoring, optimized dosages, stringent screening and long-term ecological surveillance, along with transparency and adherence to international safety protocols. Significant challenges encompass delivery efficiency, identification of edits, off-target mutations, dose-related efficacy and sterility, unstable transmission and resistance development. Innovations such as base and prime editing minimize unintended mutations by circumventing double-stranded breaks (DSBs), while paratransgenic strategies targeting gut symbionts offer supplementary avenues; plant-mediated insect gene editing emerges as a promising frontier. Overall, carefully regulated trials aligned with policy frameworks and stakeholder involvement are vital to assess effectiveness in natural environments and achieve targeted, dependable and ecologically responsible pest control.
Gene drives, species complexes, and the risks of collateral damage
35296C. Boëte, Proc. Natl. Acad. Sci., 122. 2025-11-09 18:26:26.
The development of engineered gene drive systems continues to garner significant interest. Theoretically, these systems could spread traits in a target species (an approach known as population replacement) or eliminate a population within a few generations (population suppression). Some researchers have promoted this disruptive technology for potential applications ranging from public health (e.g., malaria control) to conservation (e.g., protection of endangered species, elimination of invasive ones) to agriculture (e.g., pest control). But in the case of a gene drive intended to target a specific species, the risk of affecting non-target species must be taken into account, and researchers must strive to minimize collateral damage. Hybridization between a target and a non-target species could result in unintended gene flow, as could the horizontal transfer of the gene drive cassette (1). While some researchers have proposed the “Target Species Complex” (TSC) framework to account for off-target effects, the concept is unlikely to provide a safeguard. Rather, it risks reframing collateral impacts as intentional outcomes, narrowing, rather than broadening, the scope of ecological and regulatory considerations. Researchers must therefore make sure to incorporate risk assessments that take into account the effects on numerous species and make a concerted effort to understand the downstream effects.
Integrating mosquito genomics into simulation modeling: Opportunities for better-informed biocontrol
35282Gordana Rašić, John M. Marshall, Current Opinion in Insect Science, 2025-11-03 11:25:51.
Mosquito-borne diseases remain a major global health burden, and novel biocontrol tools are quickly advancing from the laboratory to the field. Mathematical models play a central role in evaluating these interventions, yet their predictive accuracy depends on robust parameterization. Population genomics presents a powerful opportunity to address this challenge. Here, we review progress at the interface between mosquito genomics and biocontrol modeling, highlighting how genomic data have informed our understanding of mosquito population structure, standing genetic variation at gene drive target sites, and sources of resurgence for suppressed populations. We also discuss frontiers, including new approaches to quantifying gene flow, mating behaviors, and inbreeding depression, all of which shape intervention outcomes. By tapping this potential to better quantify our understanding of mosquito ecology, modelers can develop context-specific models with better predictive accuracy, supporting efficacy and risk assessment, design of field trials and interventions, and promotion of regulation and public trust.
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.
EPA assessing risk of releasing genetically engineered mosquitoes
35046Gary West, Capital Press, 2025-08-22 17:02:34.
The Environmental Protection Agency has convened a scientific panel to help assess whether genetically engineered mosquitoes could pose a risk to humans. In a paper released Aug. 21, the EPA said that as science advances it expects more proposals to control mosquitoes by releasing males with an implanted trait that prevents their offspring from surviving. Male mosquitoes don’t bite humans, only female mosquitoes bite. But if a female mosquito picks up the genetic flaw, such as a new protein, the protein could be passed onto humans, according to the EPA. The EPA expects the number of genetically engineered female mosquitoes to be low, and it hasn’t determined whether the proteins would be hazardous to humans. But it’s looking to identify the best way to confirm a female mosquito’s salvia doesn’t have novel proteins. The test will help the EPA to assess the risk of exposure to humans. “Female mosquitoes bite humans as a means of reproductive survival and, as a result, this interaction results in a plausible pathway of exposure to novel proteins,” the EPA stated.
Mozzie: a computationally efficient simulator for the spatio-temporal modelling of mosquitoes
34916Wilkins et al., Journal of Open Source Software, 10. 2025-06-16 13:04:27.
Mozzie enables simulation of the lifecycle and spatial spread of mosquitoes. Mozzie can be used to assess risks associated with disease-control strategies at local, regional or continental scales. Most particularly, strategies involving genetic alterations of mosquitoes to eliminate malaria, are of prime interest. More technically, Mozzie simulates a population-dynamics model that uses differential equations or delay differential equations (Bohner et al., 2018; El-Hachem & Beeton, 2024) to describe the spread and persistence of mosquitoes that may be genetically altered. Genetic alterations are flexibly modelled: these can involve any number of alleles; Mendelian or non-Mendelian inheritance, including gene drives; they can be self-limiting or self-sustaining; and can include the emergence of resistant allelles. The model allows simulation of 𝑁 mosquito species. It incorporates mate-choice, hybridisation and intra-specific competition that occur within complexes of mosquito species (Beeton et al., 2020). This fills a gap that currently exists among similar models, allowing researchers to assess potential transfer of the genetic alterations between (sub-)species. Mozzie supports spatial and temporal variations in lifecyle parameters, and local diffusion andwind-assisted, long range, advection. For example, wind patterns and the capacity of the landscape to support mosquitoes can vary spatially and temporally, reflecting daily variations, seasonality, and local conditions. Conversely, Mozzie does not contain human agents, nor does it consider the effect of genetic control strategies on the prevalence of pathogens such as the malaria parasite, among human or animal populations. Mozzie has been used by the authors to simulate the spread across sub-Saharan Africa of a theoretical, population-modifying, gene drive in Anopheles gambiae s.s. and Anopheles coluzzii (Beeton et al., 2022) (that paper also describes the mathematics of a particular mosquito lifecycle model that is contained in Mozzie). It has also been used to predict the spread of Target Malaria’s Paternal Male Bias construct (Galizi et al., 2014) following a proposed field-release of genetically modified Anopheles coluzzi male mosquitoes in Burkina Faso (Hosack et al., 2023).
Biased tertiary sex ratios enhance the efficacy of sex-ratio distorting genetic techniques to control invasive species
34843Michael L. Jones, Ronald E. Thresher, Nicholas J. Bax, Journal of Theoretical Biology, 2025-05-12 20:32:40.
Genetic biocontrol strategies are increasingly being developed and tested for reducing the effects of invasive species, and are highly likely to be an important tool of integrated pest management in the future. Included among such strategies are those that distort the sex ratio of the target species. Models used to forecast the efficacy of such strategies generally assume, implicitly, that the tertiary sex ratio of the target population is 50:50. We present evidence that this assumption is important, and that if the tertiary sex ratio is biased towards females, a sex-distorting construct introduced into the population that produces phenotypic males will become fixed at a level determined by the magnitude of the bias, even after further introductions cease. We show, first using a simple logistic population model, and second using a realistic simulation of an important aquatic invasive species – the sea lamprey Petromyzon marinus – how this effect can greatly increase the effectiveness of a sex-distorting construct at population suppression, but also increase the risk of such strategies due to reduced reversibility. We also present evidence that biased tertiary sex ratios might be present in many invasive species, particularly when their population sizes are low relative to environmental carrying capacity.
International perspectives on the meaning of engagement in biotechnology risk assessment: the case of gene drive
34789Hartley, S., Stelmach, A., Kokotovich, A., & Smith, R. D. J., Journal of Risk Research, 2025-04-23 10:10:43.
Biotechnology remains challenging for risk assessors. The risk assessment of genetically modified organisms was the locus of considerable, acrimonious, and politicised debate and subjected to intense scrutiny. Since then, biotechnology has evolved to include new tools, such as genome editing and gene drive, and risk assessors are more sensitive to stakeholder and public views. While engagement is increasingly recognised as important in risk governance, it is underrepresented in the governance literature, remains challenging in risk assessment, and needs empirical cases to develop theory. Imagining engagement in risk assessment will require thinking about when, where, and how to engage people in risk assessment processes in both research and regulatory contexts. However, current risk assessment methods and processes make engagement of non-technical experts challenging and risk assessors may need to innovate and diverge from the norms of risk assessment. Gene drive presents a case of risk assessment that has generated a plethora of prescriptive calls and recommendations for engagement. We use this case study to explore how both technical and non-technical experts and stakeholders involved in gene drive risk assessment are imagining engagement. We conduct qualitative, interpretive research, drawing on 30 interviews with participants across five continents. We show that the people involved with engagement in risk assessment are talking about drastically different things when they talk about engagement. Placing an empirical and theoretical spotlight on engagement in risk assessment, we argue that conversations need to draw on our insights to move beyond simply recognising, justifying, and calling for engagement.
Problem formulation for a small-scale field study of non-gene drive, genetically modified, male bias mosquitoes in Burkina Faso
34758Hayes, K. R., & Hosack, G. R., Human and Ecological Risk Assessment: An International Journal, 2025-04-10 09:17:32.
This article documents the problem formulation step of a risk assessment for a proposed small-scale field release in Burkina Faso of genetically modified (GM) An. coluzzii mosquitoes that carry a Paternal Male Bias (PMB) construct. These mosquitoes are part of the pathway developed by Target Malaria to provide a new cost-effective control strategy for malaria vectors in Africa. The problem formulation describes 7 potentially harmful outcomes that might occur through 19 pathways to harm and identifies 22 types of desk-based analysis, 6 laboratory tests, and 5 field observations that can be used to test the risk hypotheses associated with these pathways. The problem formulation forms the basis of a prerelease risk assessment that meets the standards stipulated under the Cartagena Protocol and guidance provided by the World Health Organization, the African Union Development Authority, and the European Food Safety Authority. The Problem Formulation reflects the concerns expressed about the proposed field release by relevant stakeholders, although stated concerns are not always specific enough to be unambiguously associated to a single pathway. The presentation of the pathways to harm emphasizes the types of evidence that supports the steps within each pathway, and so portrays the speculative nature of some pathways.
What if GM mosquitoes could help limit the tiger mosquito population?
31311Anonymous, All News Press, 2024-09-03 15:23:03.
What if the fight against the tiger mosquito, this invasive species originating from Southeast Asia and established in France for about twenty years, was not totally lost in advance? The exploratory project of Éric Marois, research officer Inserm, within the Institute of Molecular and Cellular Biology (CNRS) in Strasbourgoffers some hope. This fundamental biology researcher explains to 20 Minutes that thanks to Crispr/Cas9 molecular scissors it is possible to cut DNA at a specific location to create a transgenic mosquito. This will either transform female tiger mosquitoes into males or make their offspring sterile. To sort the insects thus modified, they are made fluorescent in the laboratory. An update on this work, funded for at least four years by the national research agency and which could make headlines in the coming years. Genetic engineering, or the idea of using genetic elements to modify the characteristics of mosquitoes, dates back to the 1960s. But at the time, there were no tools at all to carry it out in the laboratory. It was in 2012, with the discovery of the Crispr/Cas9 molecular scissors, which earned Emmanuelle Charpentier and Jennifer Doudna the Nobel Prize in Chemistry, that its application was truly made possible. It involves artificially producing a guide RNA (as exists in nature) and thus directing the Cas9 protein to a chosen DNA sequence within the desired genome.
CBD/SBSTTA/26/5/Add.1 Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives
32166Convention on Biological Diversity, 2024-06-15 12:17:42.
Cartagena Protocol Annex III: risk assessment
32169Convention on Biological Diversity, Cartagena Protocol (2000), 2024-03-13 12:21:01.
Flight Against Infections: The Role of Genetically Engineered Mosquitoes, with Dr. Stephanie James
28997EeKs on Health, YouTube, 2024-03-11 10:40:20.
In this episode of Causes or Cures, Dr. Eeks chats with Dr. Stephanie James about the potential use of genetically modified mosquitoes (GMMs) to fight diseases that mosquitoes carry and spread, such as Malaria and Dengue Fever. In the podcast, Dr. James provides an overview on GMMs, as well as what something called Gene Drive Modified Mosquitoes (GDMMs) are. She talks about the current state of research, testing, and describes the GeneConvene Global Collaborative "GeneConvene", which was created to advance best practices and informed decision making for developing GMMs and GDMMs. She talks about the potential benefits versus the potential risks, how they are conducting risk assessments, how they plan to test GMMs, the ethical and safety concerns, and how local communities will be included in the decision-making process.
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.
Benefits and risks of gene drives for invasive plant management – the case for common tansy
28162L. Croghan, A. G. Smith, M. A. Tancos, N. O. Anderson and R. L. Becker, Frontiers in Agronomy, 5. 2023-10-20 12:05:59.
Invasive plants cause significant environmental and economic damage, but land managers have few control options. Common tansy (Tanacetum vulgare) is prevalent in many US states and is one of the most reported invasive plants in Minnesota. Controlling common tansy poses a challenge due to its extensive distribution and association with diverse plant communities. A gene drive is being explored as a genetic biocontrol method for the management of several non-native invasives, including common tansy in North America. Gene drives have emerged as a novel biotechnology application with potential to improve public health, promote conservation, and increase agricultural productivity. In common tansy, gene drives could be developed to target genes that would reduce or eliminate female fertility and consequently inhibit common tansy seed production. Using common tansy as an example, we outline risks associated with the use of gene drive technology for invasive plant control and explain how risks may be mitigated. Understanding potential benefits and risks associated with gene drives in the early stages of development is crucial. Mitigating risks, receiving stakeholder input, and navigating the regulatory environment will play an important role in gene drive development and deployment.
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.
Off Target: Gene Drives and the Balance of Life
26295Save Our Seeds, 2023-06-28 09:25:43.
This is a compilation of conversations with experts about gene drive technologies and the science/social questions it raises.
World malaria report 2023
34046Geneva: World Health Organization, Licence: CC BY-NC-SA 3.0 IGO. 2023-06-15 00:00:00.
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.
Defining transformation events for gene drive in species complexes
25001J. B. Connolly, IOBC-WPRS Bulletin, 163:8-20. 2023-04-13 15:11:40.
Engineered gene drives (EGDs) that allow the super-Mendelian inheritance of genetic traits could one day be used to reduce the vectorial capacity of Anopheles species that transmit human malaria in Africa. Many Anopheles species belong to complexes of closely related sibling species that can produce fertile interspecific hybrid females. In cases where the genomic target locus of the EGD is conserved amongst sibling species from the same complex as the released target species, it would therefore be plausible that the EGD could be vertically transmitted from the target species to sibling species by interspecific mating. To differentiate genetically modified organisms, the term ‘transformation event’ is used, based on the specific genomic location of the transgenic construct, as a result of random genomic integration. In contrast, an EGD is generated via its precise and reproducible insertion in its specific genomic target locus. These considerations pose two key questions for the use of EGD in species complexes: (i) what does the definition of “transformation event” mean in the context of vertical gene drive transfer of the EGD to sibling species in species complexes and (ii) does de novo transformation of an EGD into a sibling species constitute the same transformation event as introgression by backcrossing into a sibling species of an EGD that had been originally transformed in the target species? While definitions of the term transformation event that have been provided by national and intergovernmental organisations are somewhat ambiguous, they do provide scope for broad interpretation of vertical gene drive transfer of a specific EGD to different sibling species of the target species as the same transformation event. There also appears to be some consensus that definitions of transformation event support the notion that de novo transformations of an EGD in sibling species constitute the same transformation events as introgression by backcrossing into sibling species of an EGD that had been originally inserted in the target species.
A gene drive is a gene drive: the debate over lumping or splitting definitions
24910S. L. James, D. A. O'Brochta, F. Randazzo and O. Akbari, Nature Communications, 2023-03-29 12:22:20.
Gene drive technologies are being considered as a new approach to address a variety of currently intractable global problems, including to prevent disease transmission, reduce crop loss, and preserve biodiversity1. There are some outside the genetics research community who argue that wide use of the term “gene drive” to encompass selfish genetic elements found either in extant organisms (natural gene drives) or assembled in the laboratory (synthetic gene drives) will discourage the necessary scrutiny of risks that may be associated with the introduction of synthetic gene drives into free-living populations of target organisms2,3. Here we argue that the current definition is both scientifically sound and promotes good governance.
Gene Drives: Target Malaria is underestimating the risks
24867C. Then, Testbiotech, 2023-03-17 07:55:56.
The Target Malaria consortium has for several years been planning to conduct field trials using genetically engineered mosquitoes in Burkina Faso. The aim is to transfer artificial gene constructs, i. e. the so-called ‘X-shredder’, into wild populations of the mosquitoes. This gene construct is meant to reduce the number of female offspring, and thus bring about a decline in the overall population of mosquitoes (Anopheles gambiae) known to transmit malaria. However, as recent research shows, the planned releases are based on flawed data and incorrect assumptions.
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.
Assessing the hybridization potential between a hypothetical gene drive-modified Drosophila suzukii strain and non-target Drosophila species
24990J. Romeis, S. Wolf, J. Collatz, J. Enkerli and F. Widmer, IOBC-WPRS Bulletin, 163:108. 2023-03-13 14:49:23.
Genetically engineered gene drives (GD) are a potentially powerful tool to control pest insects by population suppression or even elimination. Before living GD modified insects can be released into the environment, they must pass an environmental risk assessment (ERA). A key question to be addressed is the potential acquisition of functional GD elements by nontarget species as this may lead to the 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 GD insect strain and closely related species that co-occur in the area of release. Using the invasive Drosophila suzukii as a case study, we demonstrate how the potential for hybridization can be assessed.
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.
Review of gene drive modelling and implications for risk assessment of gene drive organisms
24722J. L. Frieß, C. R. Lalyer, B. Giese, S. Simon and M. Otto, Ecological Modelling, 478:110285. 2023-02-13 09:34:10.
Synthetic gene drive (GD) systems constitute a form of novel invasive environmental biotechnology with far-reaching consequences beyond those of other known genetically modified organisms (GMOs). During the last 10 years, the development of GD systems has been closely linked to mathematical modelling which can provide feedback on how to achieve gene drive spread but also may be used to predict the ecological consequences of a gene drive release. GMOs, thus also GD systems, need to pass an environmental risk assessment (ERA) prior to a release into the environment. Models in this respect may play an important role because a release of GD organisms, even at a small scale, may not be reversible. In our review, we analyse the scope and structure of existing models to examine how they may assist the ERA. Our analysis reveals that a majority of models so far are deterministic, non-spatial and not tailored for a specific target organism. Models often use simplified assumptions on the biology of the species and seem to be made to test the effectiveness of the drive. Few models go beyond this and verify whether model predictions may be realistic under field conditions. We identified four advanced models that we judged to be the most ecologically realistic and compared the implemented parameters with ERA requirements by the European Food Safety Authority (EFSA) and World Health Organization (WHO) for genetically modified insects and mosquitoes. Although a number of abiotic and biotic factors are already considered in these models, mating-related factors and traits relevant to the interactions between the GMO and target organisms and with other species are largely excluded. Overall, our results show that biological and ecological realism are still poorly realized in current models and that most models aim to predict efficacy rather than ecological effects. Given the complexity of natural ecosystems, it may not be possible to compile a single model to cover all complexities. Thus, models should be further developed with the purpose to assist specific questions related to the risk assessment of GDs. Moreover, uncertainty will be a key issue for any model used in RA and we see the need to improve this aspect when modelling gene drives.
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.
WORLDWIDE: EXPERTS ON GENE DRIVES
23840Stop Gene Drive, STOP GENE DRIVES, 2022-11-07 09:51:54.
We are travelling the world speaking to some of the world’s leading thinkers, activists and academics on the impact of gene drives. We interviewed more than 20 experts from around the world
What are gene drivers and why do 300,000 people want them banned?
23828Anika, Social Bites, 2022-10-21 23:39:53.
Ecologists in Action and Madrid Agroecologico submitted 300,000 citizen signatures to the Ministry of Ecological Transition and Demographic Challenge, asking Minister Teresa Ribera to give Spain a boost. International moratorium on technology for the release of organisms modified with gene drives (OIG) It will be discussed during the negotiations of the XV Conference on the Convention on Biological Diversity to be held in December. During the delivery of the signatures, the participants risks to human health and the environment of this new gene technology. Activists claimed with a banner that this genetic engineering technology contained an international moratorium and “danger” for environmentalists.
Risk Assessment on the Release of Wolbachia-Infected Aedes aegypti in Yogyakarta, Indonesia
23707D. Buchori, A. Mawan, I. Nurhayati, A. Aryati, H. Kusnanto and U. K. Hadi, Insects, 13. 2022-10-12 08:16:52.
Wolbachia-infected Aedes aegypti is the latest technology that was developed to eliminate dengue fever. The Ministry of Research and Technology of the Republic of Indonesia (Kemenristekdikti) established an expert group to identify future potential risks that may occur over a period of 30 years associated with the release of Wolbachia-infected Ae. aegypti. The risk assessment consisted of identifying different hazards that may have impacts on humans and the environment. From the consensus among the experts, there were 56 hazards identified and categorized into 4 components, namely, ecological matters, efficacy in mosquito management, economic and sociocultural issues, and public health standards. There were 19 hazards in the ecological group. The overall likelihood in the ecology of the mosquito is very low (0.05), with moderate consequence (0.74), which resulted in negligible risk. For the efficacy in mosquito management group, there were 12 hazards that resulted in very low likelihood (0.11) with high consequence (0.85). The overall risk for mosquito management efficacy was very low (0.09). There were 14 hazards identified in the public health standard with very low likelihood (0.07), moderate consequence (0.50) and negligible risk (0.04). Lastly, 13 hazards were identified in the economic and sociocultural group with low likelihood (0.01) but of moderate consequence (0.5), which resulted in a very low risk (0.09). The risk severity level of the four components leading to the endpoint risk of “cause more harm” due to releasing Wolbachia-infected Ae. aegypti is negligible (0.01).
Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development
23648W. K. Tonui, V. Ahuja, C. J. Beech, J. B. Connolly, B. Dass, D. C. M. Glandorf, et al., Transgenic Research, 31:607. 2022-10-04 08:24:50.
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 viral diseases as well as the spread of invasive plant and animal species. These interventions involve release of genetically modified organisms (GMOs) into the environment, sometimes with intentional dissemination of the modification within the local population of the targeted species, which presents new challenges and opportunities for regulatory review and decision-making. Practices developed for GMOs, primarily applied to date for GM crops may need to be adapted to accommodate different types of organisms, such as insects, and different technologies, such as gene drive. Developers of new GM biocontrol products would benefit from an early understanding of safety data and information that are likely to be required within the regulatory dossier for regulatory evaluation and decision making. Here a generalizable tool drawing from existing GM crop dossier requirements, forms, and relevant experience is proposed to assist researchers and developers organize and plan their research and trialing. This tool requires considering specifics of each investigational product, their intended use, and country specific requirements at various phases of potential product development, from laboratory research through contained field testing and experimental release into the environment. This may also be helpful to risk assessors and regulators in supporting their systematic and rigorous evaluation of new biocontrol products.
Gene Drive in Species Complexes: Defining Target Organisms
23207J. B. Connolly, J. Romeis, Y. Devos, D. C. M. Glandorf, G. Turner and M. B. Coulibaly, Trends in Biotechnology, 2022-07-12 06:21:17.
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 hybrids, making vertical gene drive transfer (VGDT) to sibling species biologically plausible. While VGDT to other vectors could positively impact human health protection goals, VGDT to non-vectors might challenge biodiversity ones. Therefore, environmental risk assessment of gene drive use in species complexes invites more nuanced considerations of 'Target Organisms' and ‘Non-Target Organisms' than for transgenes not intended to increase in frequency in target populations. Incorporating the concept of ‘Target Species Complexes’ offers more flexibility when assessing potential impacts from VGDT.
Larval mosquito management and risk to aquatic ecosystems: A comparative approach including current tactics and gene-drive Anopheles techniques
23152R. K. D. Peterson and M. G. Rolston, Transgenic Research, 2022-07-07 09:39:09.
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 synthetic insecticides. However, these techniques are new and therefore there is attendant concern and uncertainty from regulators, policymakers, and the public about their environmental risks. Therefore, there is a need to assist decision-makers and public health stewards by assessing the risks associated with these newer mosquito management tactics so the risks can be compared as a basis for informed decision making. Previously, the effect of gene-drive mosquitoes on water quality in Africa was identified as a concern by stakeholders. Here, we use a comparative risk assessment approach for the effect of gene-drive mosquitoes on water quality in Africa. We compare the use of existing larvicides and the proposed genetic techniques in aquatic environments. Based on our analysis, we conclude that the tactic of gene-drive Anopheles for malaria management is unlikely to result in risks to aquatic environments that exceed current tactics for larval mosquitoes. As such, these new techniques would likely comply with currently recommended safety standards.
Bayesian network-based risk assessment of synthetic biology: Simulating CRISPR-Cas9 gene drive dynamics in invasive rodent management
22516E. A. Brown, S. R. Eikenbary and W. G. Landis, Risk Analysis, 2022-05-14 07:22:34.
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 Sciences, Engineering, and Medicine. To conduct a risk assessment of gene drives, we employed the Bayesian network-relative risk model to calculate the risk of mouse eradication on Southeast Farallon Island using a CRISPR-Cas9 homing gene drive construct. We modified and implemented the R-based model "MGDrivE" to simulate and compare 60 management strategies for gene drive rodent management. These scenarios spanned four gene drive mouse release schemes, three gene drive homing rates, three levels of supplemental rodenticide dose, and two timings of rodenticide application relative to gene drive release. Simulation results showed that applying a supplemental rodenticide simultaneously with gene drive mouse deployment resulted in faster eradication of the island mouse population. Gene drive homing rate had the highest influence on the overall probability of successful eradication, as increased gene drive accuracy reduces the likelihood of mice developing resistance to the CRISPR-Cas9 homing mechanism.
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.
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.
IMPACTOS AMBIENTAIS DA TÉCNICA DE GENE DRIVE PARA O CONTROLE DE EPIDEMIAS: ALCANCES E LIMITES DO PRINCÍPIO DA PRECAUÇÃO
23875N. R. Furtado, PERI Revista de Filosofia, 13. 2022-01-19 09:24:19.
The paper discusses the application of the precautionary principle in the management of environmental risks arising from the use of gene drives to control epidemics. Gene drives consist of a technique for creating genetically modified organisms, which are released into an ecosystem with the aim of spreading certain genetic elements and prevailing over native organisms. Among the possible uses of this technique are the control of epidemics. Despite its benefits, assessing the impact of gene drives on the environment proves to be a challenge. In the field of biotechnology, the socalled precautionary principle was formulated as a strategy to ground decisions whose consequences are uncertain. However, its application raises discussions about the ability to prevent damage from new technologies. Its critics argue that the precautionary mentality could lead to inaction, obstructing scientific development. Thus, this article highlights the contributions of such principle to guide the use of gene drives, while reflecting on its limits, confronting it with an alternative risk management model: the proactionary principle.
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.
Information Sharing in Senegal on the Gene Drive Technology as a potential Complementary Tool for Malaria Vector Control
19902AUDA-NEPAD, AUDA-NEPAD, 2022-01-04 08:23:49.
AUDA-NEPAD in partnership with the National Biosafety Authority (Autorité Nationale de Biosécurité (ANB) in Senegal organized an Information sharing meeting on the gene drive technology as a complementary tool for malaria vector control, from 22-23 December 2021, in Somone, Senegal. The key objective of the meeting was to discuss the opportunities offered by gene drive technology for malaria control, based on the current state of art of knowledge and experiences from countries that are testing this approach. Sixty people, including key stakeholders from relevant institutions in Senegal and experts from Burkina Faso and Mali took part in the meeting. In his opening remarks, Mr. Ousseynou Kassé, Executive Director of ANB thanked AUDA-NEPAD for the support provided in the organization of this meeting. He also thanked the experts from Burkina Faso and Mali who came to share their experiences on the subject. “We started the discussions on the Gene Drive approach some years ago at the COP-MOP meeting held in Mexico and we continued it in the past years in the sub-region. Recently we were in Accra twice to discuss the same topic ahead of the next COP-MOP meeting”, he said. Mr. Yero Dé, Chairperson of the Orientation Council of ANB, highlighted that the meeting seeks to improve stakeholders’ understanding of the gene drive technology as a novel malaria control approach. “We need to consider adopting this new approach through an open discussion on how this technology could be used in the health sector and in particular in malaria control and elimination. Malaria mortality rate is very high in most of our countries and the efforts deployed so far to control the disease face important challenges, including the resistance of the vector to the current treatments”, he further stated.
Integrated Management of Malaria Vectors in Africa
19971R. Mbabazi, K. Maredia, B. B. El-Sayed, A. K. Babumba, M. Savadogo and O. Akinbo, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:36:56.
Malaria disease is a major public health burden in Africa. The control of malaria vectors is a critical component for prevention, management, and eradication of malaria disease. This chapter presents information on the current status of malaria vector control in Africa with emphasis on integrated vector management (IVM) programs. The chapter highlights innovative and emerging technologies such as sterile insect technique, gene drive, Wolbachia-based biological control, and other technologies for malaria vector control in Africa which can be integrated into IVM programs. The chapter also provides global resources on malaria vector management programs.
Laboratory Biosafety in Handling Genetically Modified Mosquitoes
19963J. Charles, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:19:52.
One of the novel approaches in controlling vector-borne diseases is to release genetically modified mosquitoes in nature. Trial studies are done in different phases by the researches, both in the laboratory and in the fields. Before a GM mosquito is validated to be ready for field release, the same has to rigorously go through several phase studies, and Phase I being the laboratory is the most significant to set the future of the GM mosquito for future investigations. Though the risk of handling GM mosquitoes in laboratory is low, nevertheless there is a prescribed list of DOs and DON’Ts, and the laboratory workers are needed to strictly follow the SOPs or basic principles of biosafety like handling administrative controls, using biosafety equipment, wearing personal protective equipment, etc. The laboratory also should have a proper design as per the risk assessment. Accordingly, the biosafety laboratories (BSL) are classified into four types: type 1, 2, 3 and 4. The risks are assessed as per the factors in the host, vector and donor sequences and the environmental factors and their activities in such environments. As GMMs are of low risk, BSL 1 and 2 are enough for their manipulation, but occasionally BSL 3 may be needed. There may be chances of spillage on the working surfaces during manipulation of the genes which can be remedied by the spill management protocols. Biological wastes may be generated in all areas of manipulation. These can be properly treated by either chemical disinfection or autoclaving and disposed of by incineration. These wastes should be segregated in colour-coded bags before disposal. There may be some risks while transporting GMMs to distant places. They should be packed securely in triple-layer pack and sent for disposal following IATA and other road rules. For each process of the manipulation of gene, a separate standard operating procedure (SOP) should be maintained which has to be updated whenever any change in the procedure is made.
Safety Assessment of Novel Genetic Technologies for Vector Control: National and International Perspectives
19961V. Ahuja, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:15:26.
Novel genetic technologies provide an alternative approach for control of vectors particularly those carrying deadly pathogens. Genetic control technologies aim to either suppress target populations or modify the vector by introducing a heritable factor that reduces or blocks their ability to transmit the diseases. These technologies are thus referred to as population suppression or population modification approaches. Both these approaches offer significant advantages for vector control; however, there are associated biosafety concerns related to possible ecosystem interactions. Therefore, extensive testing on a case-by-case basis is required before these can be used as a public health intervention. This paper provides details of the international initiatives towards development of guidelines and status of regulations in India.
Measuring Public Attitudes to Releases of Transgenic Mosquitoes for Disease Control, with Special Reference to Dengue and Malaria
19958L. A. De Las Llagas and M. S. T. Gunigundo, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:10:05.
Since the advent of DDT in public health and agriculture, science leaped forward with revolutionary technology such as gene drive or editing, thus making it possible to develop alternative approaches to address vector-borne diseases. However, their utilization and sustenance in public life are dependent on public attitude, i.e., societal awareness and social acceptance. In the face of strong skepticism against genetically modified organisms in both developed and developing countries, public acceptance is therefore a requirement (Boete and Beisel 2013, and Bohannon 2002, as cited in De Souza et al. Understanding the requirements and factors necessary for the acceptance of genetically modified mosquitoes as a potential malaria control tool in Ghana: a questionnaire survey, AsPac J Biol Biotechnol 21(3):76–88, 2013).
Safe Application of Genetically Modified Mosquito (GMM) to Combat Dengue and Chikungunya Depends on Socioeconomic Status and Social Acceptance in the Developing Countries: A Comprehensive Analysis
19898M. N. Islam, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 08:16:32.
The emerging and re-emerging vector-borne diseases are a serious public health problem throughout the world. It has been observed that more than 100 countries and approximately half of the world’s population are at risk on vector-borne diseases (VBDs). The global burden of the vector-borne diseases is unacceptably high. It alludes toward their functional inappropriateness, untimeliness, and irrelevance in controlling vectors and vector-borne diseases. Modern technologies, coupled with other appropriate ones within the precincts of integrated vector management (IVM), can tide over this situation posed by conventional, mostly insecticide-based, methodologies. A lot of challenges, obstacles, and interruptive factors have warranted urgent deployment of new approaches for the control of VBDs keeping in mind the inbuilt ethical, social, and regulatory issues. Genetically modified mosquito (GMM) technology is a complex and highly sophisticated biotechnological intervention for suppression of vector populations. Wolbachia-associated sterile insect technique (SIT) has been proved highly significant and effective for replacement of mosquito populations. Adopting a highly sophisticated GMM technology to suppress or replace the mosquito populations’ density is a big question in developing countries because their priority is directed to foremost fulfill the basic human rights to sustain. Yet, notwithstanding foreseeable bottlenecks, of paramount importance is the need to deploy GMM technology with due consideration to socioeconomic factors and availability of advanced biotechnological facilities during the application of GMM in the developing countries.
New molecular genetic techniques: regulatory and societal considerations
19403Nielsen, K. M., AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 18:07:46.
A rapidly expanding toolbox of techniques available for genome editing provides the basis for a new continuum in types of modifications that can be introduced into a genome and blur the bimodal GMO vs. non-GMO (genetically modified organism) divide. Site-directed nucleases (SDN) are now used to modify existing nucleotides within genomes instead of adding recombined DNA as transgenes. Moreover, new gene drive approaches are in development based on SDNs. A number of potential drive applications have been reported, but uncertainties in trait stability and limitations in knowledge of the affected system at various temporal and spatial levels slow down their current uses. Adoption of new genome targeted technology takes place in a social context. The context will vary between countries and cultures, expressed in values, ethics, politics and priorities - that are translated into different regulatory approaches. Some developed products using new genome editing techniques clearly fall under internationally negotiated regulations of GMOs. However, other product outcomes of editing techniques challenge our current understanding and definition of GMOs. There is an urgent need for further research, for building international consensus and harmonizing regulatory approaches to facilitate categorization, predictability, transparency, trust and trade.
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.
CRISPR-based gene drives for combatting malaria: Need for an early stage technology assessment.
19374Liebert, W., AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 17:09:24.
The potential power of CRISPR-based gene drives makes it necessary to engage in science and technology assessment already in early stages of research and development. In order to argue for efforts to address this urgent need, gene drives to combat malaria-transmitting mosquitoes are discussed using the concept of prospective technology assessment. First, development risks are described, followed by considerations about anticipatable risks and irreversible consequences, as well as unforeseeable effects and uncertainties. Afterwards, fundamental problems in connection with the development of gene drives against malaria mosquitoes are raised. Opportunities for shaping technology are briefly discussed, before alternatives, in particular the World Health Organization's elimination strategy, are considered. Finally, several normative questions are put forward.
Ecological vulnerability analysis for suppression of Drosophila suzukii by gene drives
19082C. R. Lalyer, L. Sigsgaard and B. Giese, Global Ecology and Conservation, 32:e01883. 2021-10-17 20:44:52.
Synthetic gene drives are transgenic constructs that aim to bias heredity and thereby influence the characteristics and fate of populations regarding abundance and evolution. Aside from irreversible effects in ecosystems that could be triggered by the release of a gene drive, research on confinable drives or even the reversibility of gene drives is underway and shows first success under laboratory conditions. However, their effectiveness under realistic conditions is not entirely clear unless first test releases have taken place. Since a potentially irreversible intervention into ecosystems is created, a prospective assessment is needed. We present an approach of prospective ecological vulnerability analysis for the proposed control of the invasive pest Drosophila suzukii by using gene drives. The analysis considers the accidental spread of the gene drive to the native habitat of Drosophila suzukii, with a focus on Japan. It contains a mapping of potential impacts as a consequence of the suppression of the insect. Multiple cascading effects were identified including the potential spread of the gene drive in geographic range or potential hybridization with non-target species. Determining the vulnerability of an ecosystem requires information regarding specific characteristics at different organizational levels. The vulnerability analysis of an affected ecosystem will initially serve to identify gaps in knowledge. Reducing complexity and breaking down the potential events that might arise from a gene drive population suppression enables to better understand endpoints i.e. concrete effects. Three potential effects have been selected for a specific analysis of the vulnerability of populations and species. A high vulnerability was obtained for the suppression of non-target (native) populations of Drosophila suzukii as well as for a decrease in specialized parasitoid abundance. The paper proposes the outline of a comprehensive prospective approach to understand the susceptibility of an ecosystem to unintended and irreversible harm.
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.
Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance
34039Devos, Yann et al. Trends in Biotechnology, Volume 39, Issue 9:853 – 856. 2021-09-15 00:00:00.
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
Gene drive strategies of pest control in agricultural systems: challenges and opportunities
17836M. Legros, J. M. Marshall, S. Macfadyen, K. R. Hayes, A. Sheppard and L. G. Barrett, Evolutionary Applications, 2021-07-26 14:04:32.
Abstract Recent advances in gene editing technologies have opened new avenues for genetic pest control strategies, in particular around the use of gene drives to suppress or modify pest populations. Significant uncertainty, however, surrounds the applicability of these strategies to novel target species, their efficacy in natural populations, and their eventual safety and acceptability as control methods. In this article we identify issues associated with the potential use of gene drives in agricultural systems, to control pests and diseases that impose a significant cost to agriculture around the world. We first review the need for innovative approaches, and provide an overview of the most relevant biological and ecological traits of agricultural pests that could impact the outcome of gene drive approaches. We then describe the specific challenges associated with using gene drives in agricultural systems, as well as the opportunities that these environments may offer, focusing in particular on the advantages of high-threshold gene drives. Overall we aim to provide a comprehensive view of the potential opportunities and the remaining uncertainties around the use of gene drives in agricultural systems.
Risk management recommendations for environmental releases of gene drive modified insects
17829Y. Devos, J. D. Mumford, M. B. Bonsall, D. C. M. Glandorf and H. D. Quemada, Biotechnology Advances, 2021-07-25 13:02:06.
The ability to engineer gene drives (genetic elements that bias their own inheritance) has sparked enthusiasm and concerns. Engineered gene drives could potentially be used to address long-standing challenges in the control of insect disease vectors, agricultural pests and invasive species, or help to rescue endangered species. However, risk concerns and uncertainty associated with potential environmental release of gene drive modified insects (GDMIs) have led some stakeholders to call for a global moratorium on such releases or the application of other strict precautionary measures to mitigate perceived risk assessment and risk management challenges. Instead, we provide recommendations that may help to improve the relevance of risk assessment and risk management frameworks for environmental releases of GDMIs. These recommendations include: (1) developing additional and more practical risk assessment guidance to ensure appropriate levels of safety; (2) making policy goals and regulatory decision-making criteria operational for use in risk assessment so that what constitutes harm is clearly defined; (3) ensuring a more dynamic interplay between risk assessment and risk management to manage uncertainty through closely interlinked pre-release modelling and post-release monitoring; (4) considering potential risks against potential benefits, and comparing them with those of alternative actions to account for a wider (management) context; and (5) implementing a modular, phased approach to authorisations for incremental acceptance and management of risks and uncertainty. Along with providing stakeholder engagement opportunities in the risk analysis process, the recommendations proposed may enable risk managers to make choices that are more proportionate and adaptive to potential risks, uncertainty and benefits of GDMI applications, and socially robust.
West African countries working together to develop framework to regulate genetically engineered mosquitos: Target Malaria
17663Anonymous, Global News, 2021-07-08 19:50:08.
Abdoulaye Diabaté, principal investigator for Target Malaria, says West African countries like Burkina Faso, Mali and Benin are working with the New Partnership for Africa’s Development (NEPAD) to develop a pan-West African framework to regulate gene drive mosquitos.
Potential use of gene drive modified insects against disease vectors, agricultural pests and invasive species poses new challenges for risk assessment
17551Y. Devos, J. D. Mumford, M. B. Bonsall, A. M. Camargo, L. G. Firbank, D. C. M. Glandorf, F. Nogué, K. Paraskevopoulos and E. A. Wimmer, Critical Reviews in Biotechnology, 2021-06-24 13:49:18.
Potential future application of engineered gene drives (GDs), which bias their own inheritance and can spread genetic modifications in wild target populations, has sparked both enthusiasm and concern. Engineered GDs in insects could potentially be used to address long-standing challenges in control of disease vectors, agricultural pests and invasive species, or help to rescue endangered species, and thus provide important public benefits. However, there are concerns that the deliberate environmental release of GD modified insects may pose different or new harms to animal and human health and the wider environment, and raise novel challenges for risk assessment. Risk assessors, risk managers, developers, potential applicants and other stakeholders at many levels are currently discussing whether there is a need to develop new or additional risk assessment guidance for the environmental release of GD modified organisms, including insects. Developing new or additional guidance that is useful and practical is a challenge, especially at an international level, as risk assessors, risk managers and many other stakeholders have different, often contrasting, opinions and perspectives toward the environmental release of GD modified organisms, and on the adequacy of current risk assessment frameworks for such organisms. Here, we offer recommendations to overcome some of the challenges associated with the potential future development of new or additional risk assessment guidance for GD modified insects and provide considerations on areas where further risk assessment guidance may be required.
Fighting mosquitoes with mosquitoes
16825W. Feng, The Daily Targum, 2021-04-21 16:38:39.
When you think about the animal that has killed the greatest number of humans in the world, you generally tend to think of large predators. Is it perhaps the great white shark or maybe the cute but deadly hippopotamus? While these animals are certainly deadly, the number of annual fatalities caused by them are eclipsed by the number of individuals killed by the tiny blood-sucking mosquito. According to the World Health Organization, approximately 725,000 people are killed every year by mosquito-borne diseases. The mosquito has been the center of numerous pathogenic outbreaks over the last couple decades, such as the West Nile virus, malaria and the Zika virus. While conventional control strategies have been employed, these have all failed to stop the spread of these viruses. To combat this issue, one solution that has been proposed is gene drives. While further testing and research is still required to ensure the safety and efficacy of gene drives, the benefits of this technology far outweigh any potential consequences, lending them to be extremely helpful in the battle against insect-borne diseases.
CRISPR-Cas and Its Wide-Ranging Applications: From Human Genome Editing to Environmental Implications, Technical Limitations, Hazards and Bioethical Issues
17324R. Piergentili, A. Del Rio, F. Signore, F. U. Ronchi, E. Marinelli and S. Zaami, Cells, 10:24. 2021-04-21 12:06:42.
The CRISPR-Cas system is a powerful tool for in vivo editing the genome of most organisms, including man. During the years this technique has been applied in several fields, such as agriculture for crop upgrade and breeding including the creation of allergy-free foods, for eradicating pests, for the improvement of animal breeds, in the industry of bio-fuels and it can even be used as a basis for a cell-based recording apparatus. Possible applications in human health include the making of new medicines through the creation of genetically modified organisms, the treatment of viral infections, the control of pathogens, applications in clinical diagnostics and the cure of human genetic diseases, either caused by somatic (e.g., cancer) or inherited (mendelian disorders) mutations. One of the most divisive, possible uses of this system is the modification of human embryos, for the purpose of preventing or curing a human being before birth. However, the technology in this field is evolving faster than regulations and several concerns are raised by its enormous yet controversial potential. In this scenario, appropriate laws need to be issued and ethical guidelines must be developed, in order to properly assess advantages as well as risks of this approach. In this review, we summarize the potential of these genome editing techniques and their applications in human embryo treatment. We will analyze CRISPR-Cas limitations and the possible genome damage caused in the treated embryo. Finally, we will discuss how all this impacts the law, ethics and common sense.
GeneConvene Global Collaborative Webinar Series | Ecological Relationships of Mosquito Disease Vectors: Anticipating Risk Assessment of Gene Drive Technologies
16713Stephanie James, Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2021-04-14 18:05:39.
An often-raised concern for the development of genetically modified mosquito technologies, particularly those involving gene drive, as tools to prevent disease transmission is the limitation of our understanding of the roles these species may play within the ecosystem. This series of webinars begins to explore what is known about the ecological relationships of mosquito vectors with regard to major types of species interactions. The speakers also will describe some of the methods by which potential interactions that may impact human or animal health and the environment can be examined in the context of case-by-case risk assessment and safety testing.
Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa
16668J. B. Connolly, J. D. Mumford, S. Fuchs, G. Turner, C. Beech, A. R. North and A. Burt, Malaria Journal, 20:170. 2021-03-29 18:49:26.
Population suppression gene drive has been proposed as a strategy for malaria vector control. A CRISPR-Cas9-based transgene homing at the doublesex locus (dsxFCRISPRh) has recently been shown to increase rapidly in frequency in, and suppress, caged laboratory populations of the malaria mosquito vector Anopheles gambiae. Here, problem formulation, an initial step in environmental risk assessment (ERA), was performed for simulated field releases of the dsxFCRISPRh transgene in West Africa.
Genetically modified mosquitoes for better health
16527D. Devis, COSMOS, 2021-03-04 18:24:41.
One method of preventing these mosquito-born diseases is to use insecticides to kill the mozzies and remove them, but sometimes this only works as a short term solution, or has unintended devasting effects on the ecosystem. Another method for decreasing the number of disease-carrying mozzies is to introduce disease resistant, genetically modified mozzies. These transgenic mozzies could be part of a gene drive system where they have a newly introduced disease-resistant gene, linked up with CRISPR mechanisms that help the gene dominate in the population by continuing to copy itself through the genome. All of this requires very thorough risk assessment.
Quantifying the risk of vector-borne disease transmission attributable to genetically modified vectors
16530G. R. Hosack, A. Ickowicz and K. R. Hayes, Royal Society Open Science, 8:201525. 2021-03-03 18:28:51.
The relative risk of disease transmission caused by the potential release of transgenic vectors, such as through sterile insect technique or gene drive systems, is assessed with comparison with wild-type vectors. The probabilistic risk framework is demonstrated with an assessment of the relative risk of lymphatic filariasis, malaria and o'nyong'nyong arbovirus transmission by mosquito vectors to human hosts given a released transgenic strain of Anopheles coluzzii carrying a dominant sterile male gene construct. Harm is quantified by a logarithmic loss function that depends on the causal risk ratio, which is a quotient of basic reproduction numbers derived from mathematical models of disease transmission. The basic reproduction numbers are predicted to depend on the number of generations in an insectary colony and the number of backcrosses between the transgenic and wild-type lineages. Analogous causal risk ratios for short-term exposure to a single cohort release are also derived. These causal risk ratios were parametrized by probabilistic elicitations, and updated with experimental data for adult vector mortality. For the wild-type, high numbers of insectary generations were predicted to reduce the number of infectious human cases compared with uncolonized wild-type. Transgenic strains were predicted to produce fewer infectious cases compared with the uncolonized wild-type.
GeneConvene Global Collaborative Webinar Series | Ecological Modeling in Risk Assessment of Gene Drives
16445Hector Quemada and David O'Brochta, 2021-02-23 18:20:53.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on models will be a more important tool for risk assessors. To date, this work has only started to receive attention. This series of four presentations deals with the development and use of models in ecology generally. Some of these presentations will also deal with the use of models specifically to assess the ecological impacts of gene drive organisms.
GeneConvene Webinar Series on: Ecological Modeling in Risk Assessment of Gene Drives
16435Hector Quemada and David O'Brochta, 2021-02-23 16:59:25.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on models will be a more important tool for risk assessors. To date, this work has only started to receive attention. This series of four presentations deals with the development and use of models in ecology generally. Some of these presentations will also deal with the use of models specifically to assess the ecological impacts of gene drive organisms.
A Code of Ethics for Gene Drive Research
16379G. J. Annas, C. L. Beisel, K. Clement, A. Crisanti, S. Francis, M. Galardini, R. Galizi, J. Grünewald, G. Immobile, A. S. Khalil, R. Müller, V. Pattanayak, K. Petri, L. Paul, L. Pinello, A. Simoni, C. Taxiarchi and J. K. Joung, The CRISPR Journal, 4:19:1-8. 2021-02-10 14:57:13.
A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration for the interest of society and humanity. We have developed a code of ethics for gene drive research with the hope that this code will encourage the development of an international framework that includes ethical guidance of gene drive research and is incorporated into scientific practice by gaining broad agreement and adherence.
Playing God and tampering with nature: popular labels for real concerns in synthetic biology
16201L. Carter, A. Mankad, E. V. Hobman and N. B. Porter, Transgenic Research, 2021-01-27 15:26:41.
We present the findings from a large Australian study (N = 4593) which suggests ‘playing God’ objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of ope
Demystifying the Risk Assessment Process for Laboratory-Based Experiments Utilizing Invasive Genetic Elements: It Is More Than Gene Drive
18156Z. N. Adelman, Applied Biosafety, 2021-01-07 18:05:08.
Advances in recombinant DNA approaches have resulted in the development of transgene architectures that severely bias their own inheritance, a process commonly referred to as ?gene drive.? The rapid pace of development, combined with the complexity of many gene drive approaches, threatens to overwhelm those responsible for ensuring its safe use in the laboratory, as even identifying that a specific transgene is capable of gene drive may not be intuitive. Although currently gene drive experiments have been limited to just a few species (mosquitoes, flies, mice, and yeast), the range of organisms used in gene drive research is expected to increase substantially in the coming years. Here the defining features of different gene drive approaches are discussed. Although this will start with a focus on identifying when gene drive could or could not occur, the emphasis will also be on establishing risk profiles based on anticipated level of invasiveness and persistence of transgenes in the surrounding environment. Attention is also called to the fact that transgenes can be considered invasive without being considered gene drive (and vice versa). This further supports the notion that adequate risk assessment requires information regarding the specific circumstances a given transgene or set of transgenes is capable of invading a corresponding population. Finally, challenges in the review and evaluation of work involving gene drive organisms are discussed.
Conservation pest control with new technologies: public perceptions
15913E. A. MacDonald, M. B. Neff, E. Edwards, F. Medvecky and J. Balanovic, Journal of the Royal Society of New Zealand, 2021-01-04 13:45:38.
We conducted eleven focus groups in New Zealand to explore three questions about novel technologies (gene drive and two others for comparison of pest control tools): (1) what are the risks/benefits? (2) how do they compare to current methods? and (3) who should be represented on a panel that evaluates the tools and what factors should they consider?
Laboratory biosafety manual, fourth edition
34044Geneva: World Health Organization; 2020 (Laboratory biosafety manual, fourth edition and associated monographs), Licence: CC BY-NC-SA 3.0 IGO, 2020-12-21 00:00:00.
Core commitments for field trials of gene drive organisms
15161K. C. Long, L. Alphey, G. J. Annas, C. S. Bloss, K. J. Campbell, J. Champer, C.-H. Chen, A. Choudhary, G. M. Church, J. P. Collins, K. L. Cooper, J. A. Delborne, O. R. Edwards, C. I. Emerson, K. Esvelt, S. W. Evans, R. M. Friedman, V. M. Gantz, F. Gould,, Science, 370:1417-1419. 2020-12-17 20:01:12.
While field trials of gene drive organisms (GDOs) ultimately will depend on public policy decisions, those engaged in GDO work can play critical roles in support of these decisions by generating evidence and developing evaluation strategies in fair and effective partnerships with relevant authorities and other stakeholders. The authorship of this statement reflects the current reality that GDO development is occurring primarily in high-income countries. However, fair partnership with counterparts and communities in low- and middle-income countries where many GDOs have the highest potential for positive impact, as well as recognition of the need for capacity-building and global cooperation, underlies each of our commitments.
Scientists paved the way for field trials of gene-driven organisms
15559K. Winslet, FLORIDA News Times, 2020-12-17 15:01:59.
The recent rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has brought about a wave of transformation throughout science.Developed with selected traits that have been genetically engineered to spread throughout the population, Gene Drive Organisms (GDOs) provide solutions to a variety of difficult health and environmental challenges, from control to protection of dengue and malaria. A crop against plant pests that has the power to dramatically change the way it develops.But before these gene-drive organisms move from laboratory to field testing, scientists are proposing courses for responsible testing of this powerful technology. These issues are addressed in the new Policy Forum article on Biotechnology Governance, “Core Commitment for Field Trials of Gene Drive Organisms,” published December 18, 2020. Science By more than 40 researchers, including several scientists at the University of California, San Diego.“Gene drives have led to rapid research, so we need to take a step back and think about its application and its impact on humankind,” said Akbari, the lead author of the article. Associate Professor, Faculty of Biological Sciences, University of California, San Diego. “A new initiative to tackle field testing is to ensure that testing is conducted safely, transparent, publicly accountable, and scientifically, politically and socially robust.”
Technical Support to Burkina Faso on Gene Drive Stage 2 Dossier Review
15557AUDA-NEPAD, AUDA-NEPAD, 2020-12-17 14:58:32.
AUDA-NEPAD in partnership with the National Biosafety Agency (ANB) in Burkina Faso organised a training workshop to support to the National Biosafety Committee (NBC) on stage 2 dossier review, on December 3 – 5, 2020, in Bobo-Dioulasso, Burkina Faso. In addition to the NBC members, and based on recommendations from previous in-country consultations, the meeting audience was extended to include researchers, faculty members and PhD students. The meeting brought together 25 participants. Amongst the countries piloting the gene drive research in the continent, Burkina Faso has successfully completed the activities in stage 1 of the process nd is now contemplating to commence stage 2. An application has been prepared and submitted to the national regulatory agency, following a successful pre-review by the Institutional Biosafety Committee (IBC).
Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance
15554Y. Devos, M. B. Bonsall, L. G. Firbank, J. Mumford, F. Nogué and E. A. Wimmer, Trends in Biotechnology, 2020-12-17 14:48:35.
Risk assessors, risk managers, developers, potential applicants, and other stakeholders at many levels discuss the need for new or further risk assessment guidance for deliberate environmental releases of gene drive-modified organisms. However, preparing useful and practical guidance entails challenges, to which we offer recommendations based on our experience drafting guidance.
Further guidance required for assessment of gene drive technology, says EFSA
15137Euractiv, The World News Monitor, 2020-11-16 16:25:26.
Existing guidelines are adequate for evaluating risks associated with gene-drive modified insects, but further guidance is needed for some areas, most notably for environmental risk assessments. The evaluation was requested to explore the issue ahead of the consideration of any possible applications of the technology and is also designed to support the EU in discussions on the biosafety of GMOs in international fora such as the United Nations. It found that while existing guidelines are sufficient for evaluating risks associated with technology, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring.
Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives
15043E. Panel o. G. M. Organisms, H. Naegeli, J.-L. Bresson, T. Dalmay, I. C. Dewhurst, M. M. Epstein, P. Guerche, J. Hejatko, F. J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J. J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, M. B. Bonsall, J. Mumfor, EFSA Journal, 18:e06297. 2020-11-12 19:24:46.
As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC,ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.
EFSA advises on risk assessment of engineered gene drives
15069EFSA, European Food and Safety Authority, 2020-11-12 18:15:34.
EFSA’s existing guidelines for the risk assessment of genetically modified animals are adequate for evaluating risks associated with gene drive modified insects. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring, say EFSA’s experts on Genetically Modified Organisms.
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.
Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives
34032EFSA, 2020-10-15 00:00:00.
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.
ESA Position Statement on the Importance of Continued Innovation in Gene Drive Technology
14700Entomological Society of America, Annals of the Entomological Society of America, 2020-10-13 17:39:58.
The risks and benefits of GDTs should be considered with the risks and benefits of continuing current pest control interventions, which may be comparatively less effective or pose exposure risks to human health and the environment.
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.
Embracing Dynamic Models for Gene Drive Management
14596A. J. Golnar, E. Ruell, A. L. Lloyd and K. M. Pepin, Trends in Biotechnology, 2020-09-30 13:54:04.
We describe how quantitative tools can reduce risk uncertainty, streamline empirical research, guide risk management, and promote cross-sector collaboration throughout the process of gene drive technology development and implementation.
Viewpoint: Is there a scientific basis to ban gene drive technology that can rid us of virus-carrying rodents and mosquitoes?
13845K. Vavitas, Genetic Literacy Project, 2020-08-18 13:51:23.
Gene drives may be invaluable tools to control the spread of parasites, invasive species, and disease carriers. But the technology has faced strong opposition from activist groups and some mainstream scientists based on environmental and food safety. Are these concerns valid?
Incorporating Characteristics of Gene Drive Engineered Ae. aegypti as Methods to Reduce Dengue and Zika Virus into the Bayesian Network – Relative Risk Model, Using Ponce, Puerto Rico as a Case Study
16097S. R. Eikenbary, WWU Graduate School Collection, 2020-08-10 19:24:02.
The Bayesian network relative risk model can perform the risk assessment of gene drive engineered Ae. aegypti for vector control and as part of an adaptive management strategy to reduce dengue and Zika transmission. This study illustrates how the BN-RRM can integrate gene drive related information within a risk assessment framework suitable for adaptive management of these novel stressors.
Biosafety in Microbiological and Biomedical Laboratories, 6th Edition
34047Centers for Disease Control and Prevention, National Institutes of Health, 2020-06-15 00:00:00.
The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drives
34040Jörg Romeis, Jana Collatz, Debora C.M. Glandorf, Michael B. Bonsall, Environmental Science & Policy, Volume 108:Pages 19-36. 2020-06-15 00:00:00.
Jonathan Latham on Gene Drives and the Gates Foundation
12259James Corbett, The Corbett Report, 2020-06-09 18:04:09.
Jonathan Latham of Independent Science News joins us to discuss his 2017 article, “Gates Foundation Hired PR Firm to Manipulate UN Over Gene Drives.” We talk about gene drives, the dangers inherent in this technology, how the UN is involved, and why the Gates Foundation and DARPA are so interested in introducing genetic modifications into various species.
Gene Drives: Pursuing opportunities, minimizing risk
11966K. L. Warmbrod, A. Kobokovich, R. West, G. Ray, M. Trotochaud and M. Montague, Center for Health Security, 2020-05-18 18:14:50.
This study analyzed the current state of gene drive technologies, the ways in which they might be deployed in the field, and the state of regulatory policy governing their development.
The EU not ready for the release of Gene drive organisms into the environment.
11602Pensoft Publishers, ScienceDaily, 2020-05-07 15:59:25.
In their study, published in the open-access journal BioRisk, an international group of scientists led by Marion Dolezel from the Environment Agency Austria, discuss the potential risks and impacts on the environment.
Beyond limits – the pitfalls of global gene drives for environmental risk assessment in the European Union
11458M. Dolezel, C. Lüthi and H. Gaugitsch, BioRisk, 15:1-29. 2020-05-04 14:58:37.
We evaluate the novel features of GDOs and outline the resulting challenges for the environmental risk assessment.
EPA Grants First Permit to Test Genetically Modified Mosquitoes
11436Adam Allington, Bloomberg Law, 2020-05-01 14:05:51.
British biotech company Oxitec Ltd was granted an experimental use permit to release a genetically engineered type of the mosquito species Aedes aegypti, which is a known vector of Zika virus and viruses that cause yellow fever and dengue fever, the Environmental Protection Agency office of Chemical Safety and Pollution announced.
EPA Approves Experimental Use Permit to Test Innovative Biopesticide Tool to Better Protect Public Health
11434EPA, EPA, 2020-05-01 14:02:09.
Today, after extensive evaluation of the best available science and public input, the U.S. Environmental Protection Agency (EPA) has granted an experimental use permit (EUP) to Oxitec Ltd. to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations to protect public health from mosquito-borne illnesses.
EFSA discusses risk assessment of gene drives
11606C. Then, Testbiotech, 2020-04-30 16:03:36.
The European Food Safety Authority (EFSA) carried out a public consultation on guidance for the risk assessment of so-called gene drives at the request of the EU Commission. At the same time, a new Testbiotech scientific paper was accepted after peer review. The paper shows that the EFSA concept is insufficient. To control the risks of gene drives, ‘cut-off criteria’ need to be defined to prevent the uncontrolled spread of genetically engineered organisms.
Alternative Techniques and Options for Risk Reduction of Gene Drives
11265Bernd Giese, Arnim von Gleich and Johannes L. Frieß, Gene Drives at Tipping Points, 2020-04-28 18:59:49.
In this chapter, we analyse and compare different types of gene drives as well as promising alternative approaches that may provide a reduced risk.
Limits of Knowledge and Tipping Points in the Risk Assessment of Gene Drive Organisms
11263Arnim von Gleich and Winfried Schröder, Gene Drives at Tipping Points, 2020-04-28 18:50:47.
New challengesTipping point in the risk assessment of genetically engineered (GE) organisms are expected to emerge in the context of so-called ‘gene drives’. Based on a review of findings from current knowledge of GE organisms, it is concluded that the risk assessment of gene drive organisms intended for release into the environment will inevitably suffer from major uncertainties, ‘unknowns’ and methodological problems: subsequent generations of GE organisms might show effects that were not observed or intended in the first generation. Unintended effects can, for example, emerge from interaction with genetic backgrounds within natural populations or be triggered by changing environmental conditions. Due to the increasing spatio-temporal complexity associated with the long-term persistence and propagation of GE organisms, risk assessment can no longer be expected to produce sufficiently reliable results. It has to be assumed that at a certain point in the dissolution of spatio-temporal boundariesa tipping point will be reached, that will make reliable risk assessment impossible. Moreover, methodological problems need to be overcome: the comparative approach that is the starting point for current European Food Safety Authority (EFSA)European Food Safety Authority (EFSA)’s environmental risk assessment might not be applicable due to the lack of suitable ‘comparators’. Despite increasing uncertainties, riskassessors and risk managers need to solve the problems of how to come to robust conclusions and make reliable decisions that take the precautionary principle(PP) into sufficient consideration. The introduction of a new step in the risk assessment of genetically engineered organisms has been suggested to solve these problems—which is the ‘spatio-temporal controllability’ and takes three criteria into account:(1)the biology of the target organisms,(2)their naturally occurring interactions with the environment (biotic and abiotic),(3)the intended biological characteristics (traitsTraits) of the GE organismsGenetically engineered organism.
Steps Towards a Precautionary Risk Governance of SPAGE Technologies Including Gene-Drives
11261Arnim von Gleich, Gene Drives at Tipping Points, 2020-04-28 18:44:32.
In view of the rapid dynamics of genetic engineering development (in particular regarding the ‘new gene-technologies’ gene editing, self-propagating artificial genetic elements (SPAGESelf-Propagating Artificial Genetic Elements (SPAGE)) and synthetic biology), the question is being intensively discussed whether the currently practiced risk governance is sufficient to guarantee the desired high level of health, consumer and environmental safety. Especially the extreme spatial and temporal environmental exposure due to released SPAGEs is identified as a problem because it leads to an enormous expansion of ignorance about possible situations and interactions. Therefore it requires measures based on the precautionary principle. Workable ways to integrate the precautionary principle into environmental risk assessment and risk regulation are being developed.
Case Study 2: Oilseed Rape (Brassica napus L.)
11257Johnannes L. Frieß, Broder Breckling, Kathrin Pascher and Windfried Schröder, Gene Drives at Tipping Points, 2020-04-28 18:36:22.
SPAGESelf-Propagating Artificial Genetic Elements (SPAGE) (Self-Propagating Artificial Genetic Element) technologies allow for a proliferation of genetic information on the populationPopulation level at a higher rate than usual Mendelian inheritanceMendelian inheritance. Currently projected developments of SPAGESelf-Propagating Artificial Genetic Elements (SPAGE) mainly aim at a reduction or suppressionSuppression of animal populationsPopulation which are considered to be harmful or undesirable (Oye et al. 2014). However, the application of SPAGESelf-Propagating Artificial Genetic Elements (SPAGE) is not limited to animals only. In principle, also plant populationsPopulation can be targeted (National Academies of Sciences 2016). The GeneTip case study on oilseed rape (Brassica napus) is intended to assess, which interactions play a role in a plant-specific context to address relevant ecological interactions that need to be fully explored in order to estimate potential risksRisk.
Vulnerability Analysis of Ecological Systems
11253Carina R. Lalyer, Arnim von gleich, Bernd Giese, Gene Drives at Tipping Points, 2020-04-28 18:28:04.
Vulnerability analysis can be seen as the counterpart to technology characterization. Technology characterisation scrutinises the intervening technology. Vulnerability analyses potentially affected systems. That may be socio-ecological, socio-technical, socio-economic or other systems. In this chapter ecological systems are in focus.
Gene Drives Touching Tipping Points
11251Brodee Breckling, Arnim von Gleich,, Gene Drives at Tipping Points, 2020-04-28 18:24:58.
Tipping points and tipping elements, phase transitions and similar critical phenomena are widely discussed in scientific as well as socio-economic contexts as components to understand unforeseen far reaching changes and critical transitions from one stage into another in complex systems caused by small perturbations or gradual changes. For the risk assessment of self-propagating artificial genetic elements in self-sustaining population wild populationsof animals or plants, it is crucial to understand, where tipping elements could become relevant, how they could be anticipated and to what extent surprises and unexpected effects might occur.
Gene Drives at Tipping Points
11247Amin von Gleich and Winfried Schroder, Gene Drives at Tipping Points, 2020-04-28 18:14:49.
This open access book reports on a pilot project aiming at collecting information on the socio-ecological risks that could arise in the event of an uncontrolled spread of genetically engineered organisms into the environment. The researchers will, for instance, be taking a closer look at genetically engineered oilseed rape, genetically engineered olive flies as well as plants and animals with so-called gene drives. The book mainly adresses researchers.
Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives
34033EFSA, 2020-04-24 00:00:00.
Report of the ad hoc technical expert group on risk assessment
16095Ad Hoc Technical Expert Group on Risk Assessment, Convention on Biological Diversity, 2020-04-15 15:54:41.
The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol further decided to extend the Online Forum on Risk Assessment and Risk Management to assist the AHTEG and invited submissions of information relevant to the work of the online forum and the AHTEG from Parties, other Governments, and indigenous peoples and local communities. The AHTEG is to submit the outcomes of its work for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice at its twenty-fourth meeting, prior to the tenth meeting of the Parties to the Protocol.
Spatio-temporal controllability and environmental risk assessment of genetically engineered gene drive organisms from the perspective of EU GMO Regulation
11208C. Then, K. Kawall and N. Valenzuela, Integrated Environmental Assessment and Management, 2020-04-06 14:38:52.
Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms, since subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, ‘next generation effects’ can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA. To deal with these problems, we suggest the introduction of a new additional step in the ERA of GE gene drive organisms that takes three criteria into account: the biology of the target organisms, their naturally occurring interactions with the environment (biotic and abiotic) and their intended biological characteristics introduced by genetic engineering. These three criteria are merged to form an additional step in ERA, combining specific ‘knowns’ and integrating areas of 'known unknowns' and uncertainties, with the aim of assessing the spatio‐temporal controllability of GE gene drive organisms. The establishment of assessing spatio‐temporal controllability can be used to define so‐called ‘cut‐off’ criteria in the risk analysis of GE gene drive organisms: if it is likely that GE gene drive organisms escape spatio‐temporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of the GE gene drive organisms would not be compatible with the precautionary principle (PP).
Auditing preparedness for vector control field studies
11210C. M. Collins and M. M. Quinlan, American Journal of Tropical Medicine and Hygiene, 102:707-710. 2020-04-01 14:52:00.
The value of baseline entomological data to any future area-wide release campaign relies on the application of consistent methods to produce results comparable across different times and places in a stepwise progression to larger releases. Traditionally, standard operating procedures (SOPs) and operational plans support this consistency and, thus, the validity of emergent data. When release plans include transgenic mosquitoes for vector control or other novel beneficial insects, additional factors come into play such as biosafety permits, stakeholder acceptance, and ethics approval, which require even greater coordination and thoroughness. An audit approach was developed to verify the correct use of SOPs and appropriate performance of tasks during mosquito mark, release, recapture (MRR) studies. Audit questions matched SOPs, permit terms and conditions, and other key criteria, and can be used to support subsequent “spot check” verification by field teams. An external team of auditors, however, was found to be effective for initial checks in this example before the use of a transgenic strain of laboratory mosquitoes. We recommend similar approaches for field studies using release of novel beneficial insects, to ensure useful and valid data as an outcome and to support confidence in the rigor of the step-wise process.
The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drive
8194J. Romeis, J. Collatz, D. C. M. Glandorf and M. B. Bonsall, Environmental Science & Policy, 108:19-36. 2020-03-27 20:20:04.
The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive organisms has triggered a heated discussion regarding their environmental impacts and regulatory oversight. However, experience exists in assessing the environmental impacts of a number of established agricultural pest control methods that require the release of living organisms, that provide high levels of area-wide control and that might be irreversible. This includes classical biological control, the sterile insect technique, the incompatible insect technique that is based on the cytoplasmic incompatibility caused by Wolbachia endosymbionts, and genetically modified insects containing self-limiting traits. The different technologies are described, the regulatory practice and experience is summarized and pathways through which these control technologies could harm valued ecosystem services are presented. With a focus on the application of gene drives in agriculture, using the invasive Drosophila suzukii (Diptera: Drosophilidae) as a case study we then discuss to what extent the existing frameworks could assist the risk assessment of insects carrying gene drives. We suggest that drawing on existing practices, experiences and legislative frameworks will provide a pragmatic and proportionate approach to evaluate the environmental risks of novel solutions based on gene drive technologies.
Can a population targeted by a CRISPR-based homing gene drive be rescued?
11269N. O. Rode, V. Courtier-Orgogozo and F. Débarre, bioRxiv, 2020.03.17.995829. 2020-03-20 19:12:23.
CRISPR-based homing gene drive is a genetic control technique aiming to modify or eradicate natural populations through the release of individuals carrying an engineered piece of DNA that can be inherited by all their progeny. Developing countermeasures is important to control the spread of gene drives, should they result in unanticipated damages. One proposed countermeasure is the introduction of individuals carrying a brake construct that targets and inactivates the drive allele but leaves the wild-type allele unaffected. Here we develop models to investigate the efficiency of such brakes. We consider a variable population size and use a combination of analytical and numerical methods to determine the conditions where a brake can prevent the extinction of a population targeted by an eradication drive. We find that a brake is not guaranteed to prevent eradication and that characteristics of both the brake and the drive affect the likelihood of recovering the wild-type population. In particular, brakes that restore fitness are more efficient than brakes that do not. Our model also suggests that threshold-dependent drives (drives that can spread only when introduced above a threshold) are more amenable to control with a brake than drives that can spread from an arbitrary low introduction frequency (threshold-independent drives). Based on our results, we provide practical recommendations and discuss safety issues.Article summary for Issue Highlights Homing gene drive is a new genetic control technology that aims to spread a genetically engineered DNA construct within natural populations even when it impairs fitness. In case of unanticipated damages, it has been proposed to stop homing gene drives by releasing individuals carrying a gene-drive brake; however, the efficiency of such brakes has been little studied. The authors develop a model to investigate the dynamics of a population targeted by a homing drive in absence or in presence of brake. The model provides insights for the design of more efficient brakes and safer gene drives.CRISPRClustered Regularly Interspaced Short Palindromic Repeats
Stakeholder workshop: Problem formulation for the environmental risk assessment of gene drive modified insects (15 May 2019, Brussels)
34038European Food Safety Authority (EFSA): Yann Devos, Barbara Gallani, Leslie G Firbank., EFSA Supporting Publications, Vol 17 (3). 2020-03-16 00:00:00.
Regulation of GM Organisms for Invasive Species Control
6701H. J. Mitchell and D. Bartsch, Frontiers in Bioengineering and Biotechnology, 7:1-11. 2020-01-21 18:17:37.
Invasive species can cause significant harm to the environment, agriculture, and human health, but there are often very limited tools available to control their populations. Gene drives (GD) have been proposed as a new tool which could be used to control or eliminate such species. Here, GD describes a variety of molecular biology applications which all enable the introduction of genetic elements at a higher than expected frequency. These elements can change the genotypes in target populations rapidly with consequences either for (intrinsic) fitness or host-parasite interaction, or both. Beneficial applications are foreseen for human and animal health, agriculture, or nature conservation. This rapidly developing technology is likely to have major impacts in the fight against various diseases, pests, and invasive species. The majority of GD applications involve genetic engineering and novel traits. Therefore, applicants and GMO regulators need to interact to achieve the benefits in innovation while cautiously avoiding unacceptable risks. The release into the environment may include transboundary movement and replacement of target populations, with potential impact on human/animal health and the environment. This article summarizes knowledge-based discussions to identify information gaps and analyzes scenarios for responsible introduction of GD organisms into the environment. It aims to connect the latest scientific developments with regulatory approaches and decision-making.
Genetic frontiers for conservation: An assessment of synthetic biology and biodiversity conservation
16089K. H. Redford, T. Brooks, M., B. W. Nicholas and J. S. A. Macfarlane, International Union for Conservation of Nature, 2019-12-01 15:41:26.
This assessment is the beginning of a process that will lead to the development of an IUCN policy to guide the Union’s Director General, Commissions, and Members. The draft policy will be discussed in many fora before it is brought to vote at the World Conservation Congress in 2020. Far greater public attention to the topic of synthetic biology and biodiversity conservation is essential, given the potential impact of scientific discoveries and policy decisions that may be just over the horizon, and also given the need for broad partnerships to address the challenges that the conservation and synthetic biology communities will inevitably face
An Initial Framework for the Environmental Risk Assessment of Synthetic Biology-Derived Organisms with a Focus on Gene Drives.
16281W. G. Landis, E. A. Brown and S. Eikenbary, Synthetic Biology 2020: Frontiers in Risk Analysis and Governance. Risk, Systems and Decisions., 2019-11-29 17:16:37.
We apply the structure of source-stressor-habitat-effect-impact pathway derived from the relative risk model (Landis and Wiegers 2005) and as was demonstrated to be applicable in the National Academy of Sciences, Engineering and Medicine (NASEM) 2016 report Gene Drives on the Horizon. This relative risk model is now calculated employing Bayesian networks and has been applied to forestry management (Ayre and Landis 2012), infectious disease (Ayre et al. 2014), invasive species (Herring et al. 2015), contaminated sites (Landis et al. 2017a; Johns et al. 2017), and watershed management (Hines and Landis 2014; Graham et al. 2019).
Peri-Urban Community Attitudes towards Codling Moth Trapping and Suppression Using the Sterile Insect Technique in New Zealand
17774G. Paterson, G. L. W. Perry, J. T. S. Walker and D. M. Suckling, Insects, 10. 2019-10-09 15:21:37.
New, more socially-acceptable technologies are being developed to suppress horticultural pests, because suppression is technically difficult with current technologies, especially in urban areas. One technique involves the release of sterile insects to prevent offspring in the next generation. This technology involves aerial or ground release systems, but this could also create issues for the public. This study investigated community perceptions of a recently-introduced response to codling moth control in New Zealand—Sterile Insect Technique (SIT). Community attitudes to SIT were examined in Hastings, New Zealand, in April, 2018. Eighty-six detailed interviews were undertaken with a random sample of households. This community was very willing (98% agreement) to host a sex pheromone trap in their gardens, and condoned regular visits to monitor traps. Attitudes to SIT were very positive (98% in favor). Once explained, the concept of using unmanned aerial vehicles to deliver sterile insects was also acceptable (98%) to the community. Use of unmanned aerial vehicles to release sterile insects during a hypothetical incursion response of an exotic fruit fly was also supported at 98% by respondent householders. Investigation of community attitudes can be valuable to guide practitioners in determining suitable technologies before an area-wide programme is launched.
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.
Arthropod Containment Guidelines, Version 3.2
34042American Committee of Medical Entomology; American Society of Tropical Medicine and Hygiene, VECTOR-BORNE AND ZOONOTIC DISEASES, Volume 19, Number 3. 2019-06-15 00:00:00.
Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors
34034Yann Devos, Wendy Craig, Robert H Devlin, Alessio Ippolito, Rosalind A Leggatt, Jorg Romeis, Richard Shaw, Claus Svendsen and Christopher J Topping, EFSA Journal, 2019;17(S1):e170708. 2019-04-01 00:00:00.
RISCOS BIOTECNOLÓGICOS AMBIENTAIS E PARTICIPAÇÃO SOCIAL: POR UMA GESTÃO DEMOCRÁTICA DA BIOTECNOLOGIA GENE DRIVE NA ATUAÇÃO DA CTNBIO
23872L. C. Rodrigues, Revista Jurídica (FURB), 22. 2019-03-15 09:15:24.
This research aims to study the way in which the environmental risks of Gene Drive biotechnology challenge forms of effective social participation, inserted in the management of biotechnological risks, whose responsibility lies with the organs linked to the State (CTNBio performance). The method of hypothetical-deductive approach, the method of topical and systematic juridical interpretation and the technique of bibliographic research were used. The conclusion reached was that the need to strengthen the objective sharing of information in an advisory manner to the general public in the face of Gene Drive's biotechnology risks within the framework of the CTNBio from the modification of the current Public Hearings legal model, which gives indications of omissions and lags before the complexity of the theme..
A potential new tool for the toolbox: assessing gene drives for eradicating invasive rodent populations
11550K. J. Campbell, J. R. Saah, P. R. Brown, J. Godwin, F. Gould, G. R. Howald, A. Piaggio, P. Thomas, D. M. Tompkins, D. Threadgill, J. Delborne, D. Kanavy, T. Kuiken, H. Packard, M. Serr and A. Shiels, Island invasives: scaling up to meet the challenge, 2019-03-05 14:59:34.
Invasive rodents have significant negative impacts on island biodiversity. All but the smallest of rodent eradications currently rely on island-wide rodenticide applications. Although signifi cant advances have been made in mitigating unintended impacts, rodent eradication on inhabited islands remains extremely challenging. Current tools restrict eradication eff orts to fewer than 15% of islands with critically endangered or endangered species threatened by invasive rodents. The Genetic Biocontrol of Invasive Rodents partnership is an interdisciplinary collaboration to develop and evaluate gene drive technology for eradicating invasive rodent populations on islands. Technological approaches currently being investigated include the production of multiple strains of Mus musculus with a modifi ed form of the native t-complex, or a CRISPR gene drive, carrying genes or mechanisms that determine sex. These systems have the potential to skew the sex ratio of off spring to approach 100% single-sex, which could result in population collapse. One goal proposed is to test the ability of constructs to spread and increase in frequency in M. musculus populations in biosecure, captive settings and undertake modelling to inform development and potential deployment of these systems. Structured ecologically-based risk assessments are proposed, along with social and cultural engagement to assess the acceptability of releasing a gene drive system. Work will be guided by an external ethics advisory board. Partners are from three countries with significant regulatory capacity (USA, Australia, New Zealand). Thus, we will seek data sharing agreements so that results from experiments may be used within all three countries and treat regulatory requirements as a minimum. Species-specific, scalable, and socially acceptable new eradication tools could produce substantial biodiversity benefits not possible with current technologies. Gene drive innovation may provide such a tool for invasive species management and be potentially transformative and worthy of exploring in an inclusive, responsible, and ethical manner.
Evaluating the Probability of CRISPR-based Gene Drive Contaminating Another Species
3904Courtier-Orgogozo, VD, Antoine; Gouyon, Pierre-Henri; Boëte, Christophe, bioRxiv, 776609:27. 2019-01-02 00:00:00.
The probability D that a given CRISPR-based gene drive element contaminates another, non-target species can be estimated by the following Drive Risk Assessment Quantitative Estimate (DRAQUE) Equation: D = (hyb+transf).express.cut.flank.immune.nonextinct withhyb = probability of hybridization between the target species and a non-target speciestransf = probability of horizontal transfer of a piece of DNA containing the gene drive cassette from the target species to a non-target species (with no hybridization)express = probability that the Cas9 and guide RNA genes are expressedcut = probability that the CRISPR-guide RNA recognizes and cuts at a DNA site in the new hostflank = probability that the gene drive cassette inserts at the cut siteimmune = probability that the immune system does not reject Cas9-expressing cellsnonextinct = probability of invasion of the drive within the population We discuss and estimate each of the seven parameters of the equation, with particular emphasis on possible transfers within insects, and between rodents and humans. We conclude from current data that the probability of a gene drive cassette to contaminate another species is not insignificant. We propose strategies to reduce this risk and call for more work on estimating all the parameters of the formula.CRISPRClustered Regularly Interspaced Short Palindromic RepeatsDRAQUEDrive Risk Assessment Quantitative EstimateHGThorizontal gene transferHTThorizontal transfer of transposable elementTEtransposable element
A Call to Protect Food Systems from Genetic Extinction Technology
12040Global Food and Agriculture Movement, etc Group, 2018-10-16 20:31:12.
Gene drives threaten natural systems. If released experimentally into the environment they may spread engineered genes uncontrollably through wild and domesticated species. This could alter ecological systems and food webs, harm biodiversity and eradicate beneficial organisms such as pollinators. Gene drives could disrupt lands, waters, food and fiber economies and harm Indigenous and peasant agroecological practices and cultures.
Gene drives and the management of agricultural pests
13810R. F. Medina, Journal of Responsible Innovation, 5:S255-S262. 2018-01-24 16:01:13.
Like all pest control strategies, gene drives are not hazard-free. Ecological risk assessment of gene drives designed to control agricultural pests should be conducted before their deployment. The present commentary provides some thoughts on some of the issues one should consider when contemplating using gene drives in the management of agricultural pests.
Summary
13808Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible, Journal of Responsible Innovation, 5:S243-S254. 2018-01-24 15:58:19.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies.
Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito
13804Z. Meghani and J. Kuzma, Journal of Responsible Innovation, 5:S203-S222. 2018-01-24 15:52:57.
In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. The rigorous regulation of insects and other animals with gene drive systems is crucial.
Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms
3980Hayes, KRH, G. R.; Dana, G. V.; Foster, S. D.; Ford, J. H.; Thresher, R.; Ickowicz, A.; Peel, D.; Tizard, M.; De Barro, P.; Strive, T.; Dambacher, J. M., Journal of Responsible Innovation, 5:S139-S158. 2018-01-18 00:00:00.
Synthetic gene drives could provide new solutions to a range of old problems such as controlling vector-borne diseases, agricultural pests and invasive species. In this paper, we outline methods to identify hazards and detect potentially adverse ecological outcomes at the individual (genotype, phenotype), population, community and ecosystem level, when progressing Gene Drive Modified Organisms through a phased test and release pathway. We discuss the strengths and weaknesses of checklists and structured hazard analysis techniques, identify methods to help meet some of the challenges of detecting adverse ecological outcomes in experiments and confined field trials, and discuss ways to improve the efficiency and statistical rigour of post-release monitoring strategies.
Guidance on the use of the weight of evidence approach in scientific assessments
34041EFSA Scientific Committee, Anthony Hardy, Diane Benford, Thorhallur Halldorsson, Michael John Jeger, Helle Katrine Knutsen, Simon More, Hanspeter Naegeli, Hubert Noteborn et al., EFSA Journal, 15 (8): 4971. 2017-08-03 00:00:00.
Area-wide Integrated Pest Management
13603Food and Agriculture Organization of the United Nations (FAO), International Atomic Energy Agency, 2017-05-22 13:34:46.
Throughout history, people have had to fight insect pests to reduce diseases, minimize food losses, protect agricultural trade or simply to avoid the nuisance of stinging, biting and buzzing bugs. Insect pest control is usually implemented locally in individual fields or properties. These uncoordinated efforts often prove inefficient since they only suppress a proportion of the targeted pest population. Pests from nearby untreated areas remain unscathed and can re-enter the treated areas, the damage continues, and people have little choice but to apply the control measures again and again to protect their livelihoods. Area-wide pest management provides a more cost-effective and sustainable approach by proactively targeting entire pest populations. In this way, pest populations can be contained at low levels for longer periods and pest management methods can be integrated that are less reliant on pesticides and that better address ecological and environmental concerns.
Ethical issues associated with vector-borne diseases. Report of a WHO scoping meeting, Geneva, 23–24 February 2017
34043Geneva: World Health Organization, Licence: CC BY-NC-SA 3.0 IGO, WHO Reference Number: WHO/HTM/NTD/VEM/2017. 2017-02-24 00:00:00.
Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment
16062Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management,, Convention on Biological Diversity, 2016-09-14 21:27:35.
This document was developed by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, with input from the Open-ended Online Expert Forum, in accordance with terms of reference set out by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) in its decisions BS-IV/11 and BSV/12 in response to an identified need for further guidance on risk assessment of LMOs. 4 It is intended to be a “living document” that may be updated and improved as appropriate and when mandated by the Parties to the Cartagena Protocol on Biosafety.
Can systematic reviews inform GMO risk assessment and risk management?
4121Kohl, CF, G.; Sweet, J.; Spok, A.; Haddaway, N.R.; Wilhelm, R.; Unger, S.; Schiemann, J., Frontiers in Bioengineering and Biotechnology, 3:113. 2015-01-19 00:00:00.
Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a “gold standard” for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.
Guidance framework for testing of genetically modified mosquitoes
15162WHO, WHO-TDR, 2014-06-01 18:49:50.
As the research progresses, a need has been expressed both within the scientific community and by the public for additional standards and guidance. WHO-TDR and the Foundation for the National Institutes of Health (FNIH) co-sponsored a technical consultation meeting in 2009 to assess current progress and future development of genetically modified mosquito technologies. The meeting was attended by participants from around the world with expertise in molecular biology, medical entomology, ecology, regulatory requirements, ethical, social and cultural issues, as well as staff from WHO, FNIH and other research funders WHO-TDR, 2010). Participants recommended the establishment by WHO and FNIH of a working group to develop a comprehensive guidance framework to provide quality standards for assessing the safety and efficacy of genetically modified xv mosquitoes and addressing legal, ethical, social and cultural issues that arise during their development and deployment. A multidisciplinary effort was subsequently commissioned and over 40 experts recruited to contribute at various stages of development. In accordance with the recommendations, the group included many members who possessed a broad knowledge in their topic areas but were not involved directly in research on GMMs. A draft guidance framework was produced and opened for public comment in late 2012. Responses to public comment have been incorporated into this current version.
Regulatory experience and challenges for the release of GM insects
4135Beech, C, Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety, 9:S71-S76. 2014-01-13 00:00:00.
Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. As with other new genetic technologies, regulatory agencies have often found it challenging to determine the regulatory regime under which they should be evaluated, and have either adapted existing regulatory frameworks or adopted new ones. No country has legislation specifically for GM insects. However, irrespective of the regulatory regime under which they are evaluated, the purpose of their regulation remains the same; to protect human health and the environment. Consequently there are evaluation themes common to their regulatory scrutiny, which are elucidated here. There have also been some challenges and issues encountered during the risk evaluation for field release of GM insects, and this paper will highlight some of these to assist others when considering policy, regulation and assessment of GM insects. Useful regulatory and policy precedents also exist from the regulation of biological control agents and the global protection of plants from pests under the International Standards for Phytosanitary Measures (ISPM) framework. Where countries do not have existing regulations, these evaluation instruments could have the potential to be adapted to form a suitable framework for the assessment of risk for GM insects. Finally, some considerations for future policy and regulation in this area are discussed.
Guidance on the environmental risk assessment of genetically modified animals
16055European Food Safety Authority, European Food Safety Authority, 2013-05-23 20:45:04.
This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds.
Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis
34036EFSA Panel on Genetically Modified Organisms (GMO) European Food Safety Authority (EFSA), Parma, Italy, EFSA Journal, 0 (2): 2561. 2012-06-15 00:00:00.
Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function
34035EFSA Panel on Genetically Modified Organisms (GMO). European Food Safety Authority (EFSA), Parma, Italy., EFSA Journal, 2012; 10 (10): 2943. 2012-06-15 00:00:00.
Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes. Training Manual. A Tool for biosafety training (internet version) based on courses in Africa, Asia and Latin America, 2008-2011
34045World Health Organization, p. 242, 2011-06-15 00:00:00.
RSPM No. 27 Guidelines for Importation and Confined Field Release of Transgenic Arthropods in NAPPO Member Countries
16041NAPPPO, NAPPO Regional Standards for Phytosanitary Measures, 2007-10-22 20:04:03.
This Standard is designed to provide guidance to NAPPO member countries on the importation and confined field release of transgenic arthropods that are known plant pests or have the potential to affect plant health. This includes transgenic arthropods used for biological control and transgenic beneficial arthropods with the potential to affect plant health. Transgenic arthropod species that are not plant pests, but that may pose a phytosanitary risk because of the genetic modification may also be considered under this Standard. Transgenic arthropods that have undergone a previous pest risk analysis by the regulatory authority of the importing country and been determined not to pose a phytosanitary risk may be exempted from importation requirements under this standard.
Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms
16037International Plant Protection Convention, Food and Agriculture Organization, 2005-04-01 19:55:50.
This standard provides guidelines for risk management related to the export, shipment, import and release of biological control agents and other beneficial organisms. It lists the related responsibilities of contracting parties to the IPPC, national plant protection organizations (NPPOs) or other responsible authorities, importers and exporters (as described in the standard). The standard addresses biological control agents capable of self-replication (including parasitoids, predators, parasites, nematodes, phytophagous organisms, and pathogens such as fungi, bacteria and viruses), as well as sterile insects and other beneficial organisms (such as mycorrhizae and pollinators), and includes those packaged or formulated as commercial products.
DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
34037THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2001-03-12 00:00:00.
