Risk, Regulation, and Policy

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

Assessing potential hybridization between a hypothetical gene drive-modified Drosophila suzukii and nontarget Drosophila species

S. Wolf, J. Collatz, J. Enkerli, F. Widmer and J. Romeis,  Risk Analysis,  2023.
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 ...
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Environmental, Socio-economic, and Health Impact Assessment (ESHIA) for Gene Drive Organisms

isaaa Inc. and Outreach Network for Gene Drive Research,  ISAAA,  2023.
Understanding the possible positive and negative impacts that gene drive organisms could have on the environment and people is essential before these technologies are considered for release, whether for research purposes or for use. Different impacts are assessed through ...
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Trust in science and scientists: Effects of social attitudes and motivations on views regarding climate change, vaccines and gene drive technology

H. G. W. Dixson, A. F. Komugabe-Dixson, F. Medvecky, J. Balanovic, H. Thygesen and E. A. MacDonald,  Journal of Trust Research,  2023.
Trust in science and scientists (TSS) is an increasingly important topic with respect to how science is applied within society. However, its role regarding specific issues may vary depending upon other psychosocial factors. In this study, we investigated how trust interacts with ...
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Genes drive organisms and slippery slopes

D. B. Resnik, R. F. Medina, F. Gould, G. Church and J. Kuzma,  Pathog Glob Health,  2022.
The bioethical debate about using gene drives to alter or eradicate wild populations has focused mostly on issues concerning short-term risk assessment and management, governance and oversight, and public and community engagement, but has not examined big-picture- 'where is this ...
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Gene editing and agrifood systems

FAO,  FAO,  2022.
Gene-editing technologies represent a promising new tool for plant and animal breeding in low- and middle-income countries. They enhance precision and efficiency over current breeding methods and could lead to rapid development of improved plant varieties and animal breeds. ...
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Exploring the value of a global gene drive project registry

R. I. Taitingfong, C. Triplett, V. N. Vásquez, R. M. Rajagopalan, R. Raban, A. Roberts, G. Terradas, B. Baumgartner, C. Emerson, F. Gould, F. Okumu, C. E. Schairer, H. C. Bossin, L. Buchman, K. J. Campbell, A. Clark, J. Delborne, K. Esvelt, J. Fisher, R.,  Nature Biotechnology,  2022.
Recent calls to establish a global project registry before releasing any gene-drive-modified organisms (GDOs) have suggested a registry could be valuable to coordinate research, collect data to monitor and evaluate potential ecological impacts, and facilitate transparent ...
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Experts urge caution over biotech that can wipe out insect pests

L. Fauvel,  Phys Org,  2022.
Dozens of scientists, experts and campaigners called for a ban on the release of genetically-edited organisms into the wild, in a statement Friday warning of potentially severe risks to the world's pollinators. The appeal was launched at crunch biodiversity talks in Montreal, ...
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Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control the human malaria mosquito vector Anopheles gambiae

A. Qureshi and J. B. Connolly,  Malaria Journal,  2022.
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, (i) T1 guide RNA (gRNA) targeting the doublesex ...
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No Environmental Release of Gene Drive Organisms

Anonymous,  STOP GENE DRIVES,  2022.
We urge governments to prevent the environmental release of gene drive organisms and to establish a global moratorium on the release of gene drive organisms at the UN Convention on Biological Diversity (CBD). Gene drives work against natural rules of inheritance forcing nearly ...
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Laboratory Containment of Arthropods Capable of Gene Drive: Best Practices and Recommendations

Hector Quemada,  GeneConvene Global Collaborative,  2022.
This webinar is presented by members of the American Society of Tropical Medicine and Hygiene's American Committee of Medical Entomologists who were involved in drafting a recent Addendum to the ASTMH's Arthropod Containment Guidelines that specifically consider arthropods with ...
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Risk Assessment on the Release of Wolbachia-Infected Aedes aegypti in Yogyakarta, Indonesia

D. Buchori, A. Mawan, I. Nurhayati, A. Aryati, H. Kusnanto and U. K. Hadi,  Insects,  13. 2022.
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 ...
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Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development

W. K. Tonui, V. Ahuja, C. J. Beech, J. B. Connolly, B. Dass, D. C. M. Glandorf, et al.,  Transgenic Research,  2022.
Novel genetically modified biological control products (referred to as “GM biocontrol products”) are being considered to address a range of complex problems in public health, conservation, and agriculture, including preventing the transmission of vector-borne parasitic and ...
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Justifying an Intentional Species Extinction: The Case of Anopheles gambiae

D. E. Callies and Y. Rohwer,  Environmental Values,  31:193-210. 2022.
Each year, over 200 million people are infected with the malaria parasite, nearly half a million of whom succumb to the disease. Emerging genetic technologies could, in theory, eliminate the burden of malaria throughout the world by intentionally eradicating the mosquitoes that ...
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Toward product-based regulation of crops

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

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

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

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

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

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

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