Risk, Regulation, and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
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Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control Anopheles gambiae the mosquito vector of human malariaA. Qureshi and J. B. Connolly, Malaria Journal, 22:234. 2023.
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 ... |
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Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)National Institutes of Health, Federal Register, 2023.
The National Institutes of Health (NIH) seeks input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive ... |
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Guerrilla eugenics: gene drives in heritable human genome editingA. D. Cutter, J Med Ethics, 2023.
CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome ... |
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Draft environmental assessment for use of Wolbachia-based incompatible insect technique for the suppression of nonnative southern house mosquito populations on KauaʻiHawai'i Department of Land and Natural Resources, Hawai'i Department of Land and Natural Resources, 2023.
The State of Hawai'i Department of Land and Natural Resources hereby transmits the Draft Environmental Assessment and Anticipated Finding of No Significant Impact (DEAEnvironmental Assessment for use of Wolbachia-based Incompatible Insect Technique for the suppression of ... |
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The attitudes of young adults towards mammalian predator control and Predator Free 2050 in Aotearoa New ZealandL. Dickie and F. Medvecky, Australasian Journal of Environmental Management, 2023.
Predator Free 2050 (PF2050) is an ambitious goal that aims to remove three types of invasive mammals from New Zealand by 2050. It will require a significant amount of funding, research, and support. Young adults will have an important role to play for this programme to be ... |
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Leveraging eco-evolutionary models for gene drive risk assessmentM. 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.
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 ... |
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Leveraging eco-evolutionary models for gene drive risk assessmentM. 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.
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 ... |
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updated: Genetically Engineered Mosquitoes Research Authorization ApplicationCalifornia Department of Pesticide Regulation, California Department of Pesticide Regulation,, 2023.
In May 2023, Oxitec voluntarily withdrew its research authorization application to test the use of genetically engineered mosquitoes in California. DPR did not issue a decision on the application. For more information on Oxitec’s withdrawal and future plans for research in ... |
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Gene DrivesD. M. Berube, Pandemics and Resilience, 2023.
A “gene drive” is a version of gene editing—a newer, more precise way to change a DNA (or RNA) sequence; in this case, combining a guide RNA with an enzyme that can make a gene drive takes this to another level, making sure that a new or altered genetic sequence has a ... |
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Guidelines and Standard Operating Procedures for Research on Genetically Engineer Insects, 2023Government of India, Government of India, 2023.
Department of Biotechnology, Government of India is delighted to release "Guidelines and Standard Operating Procedures for Research on Genetically Engineered Insects, 2023". This document is pertinent for enabling potential of genetic engineering in insect research to ... |
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Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmissionS. L. James, B. Dass and H. Quemada, Transgenic Research, 2023.
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 ... |
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Alleviating the burden of malaria with gene drive technologies? A biocentric analysis of the moral permissibility of modifying malaria mosquitoesN. de Graeff, K. R. Jongsma and A. L. Bredenoord, Journal of Medical Ethics, 2023.
Gene drive technologies (GDTs) have been proposed as a potential new way to alleviate the burden of malaria, yet have also raised ethical questions. A central ethical question regarding GDTs relates to whether it is morally permissible to intentionally modify or eradicate ... |
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Engagement on risk assessment for gene drive mosquitoes by EFSA and Target MalariaS. Hartley, A. Kokotovich, Y. Devos and J. Mumford, Environmental Science and Policy, 142:183-193. 2023.
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 ... |
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The Anthropocene as the End of Nature? Why Recognizing Interventionism Is Key in Coming to Terms with the AnthropoceneK. Boersma, ENVIRONMENTAL ETHICS, 44:195-219. 2023.
In this article, I address and argue against the tendency to understand the anthropocene as inaugurating the end of nature. I conduct two key moves. First, by way of an engagement with the concept of anthropocene technology I explain how understanding the anthropocene as the end ... |
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Moving beyond narrow definitions of gene drive: Diverse perspectives and frames enable substantive dialogue among science and humanities teachers in the United States and United KingdomS. Hartley, A. Stelmach, J. A. Delborne and S. K. Barnhill-Dilling, Public Understanding of Science, 2023.
Gene drive is an emerging biotechnology with applications in global health, conservation and agriculture. Scientists are preparing for field trials, triggering debate about when and how to release gene-drive organisms. These decisions depend on public understandings of gene ... |
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Assessing potential hybridization between a hypothetical gene drive-modified Drosophila suzukii and nontarget Drosophila speciesS. 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 Organismsisaaa 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 technologyH. 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 slopesD. 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 systemsFAO, 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. ... |
