Regulation and Policy

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

A bumpy road ahead for genetic biocontainment

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George, D.R., Danciu, M., Davenport, P.W. et al,  Nature Communications,  2024.
The environmental release of bioengineered organisms is increasingly being suggested for a variety of applications, including bioremediation, biosequestration, bio-mining, environmental biosensing and conservation. The objectives of many environmental release applications shift ...

Consultation on a draft National Gene Drive Policy Guide

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Commonwealth of Australia (Department of Health and Aged Care),  National Gene Technology Scheme,  2024.
The term gene drive is used to describe organisms which have been genetically modified to increase the rate for a particular trait to spread through a sexually reproducing population, spreading the genes or traits through a species at a faster rate than normal inheritance. ...

What are gene drives, and how can they help eradicate invasive species in Australia?

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Dr. Ellen Cottingham,  ABC News (Australia Broadcasting Corporation),  2023.
The impact of feral cats and other invasive species is felt across Australia. Not only do they threaten native species, but they can also spread diseases to humans and livestock. Invasive species are estimated to cost Australia an eye-watering $25 billion annually, while the ...

Ghana publishes its guidelines on Genome Editing

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Anonymous,  BusinessGhana,  2023.
Ghana's National Biosafety Authority (NBA) has published its guidelines on Genome Editing and Gene Stacks with regards Genetically Modified Organisms (GMOs) joining Nigeria, Kenya, and Malawi, as the fourth country in Africa with the guidelines. Genome editing is an emerging and ...

Framing Challenges and Opportunities for Canada: Expert Panel on Regulating Gene-Edited Organisms for Pest Control

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CCA (Council of Canadian Academies),  Framing Challenges and Opportunities for Canada,  2023.
Gene-editing technologies are changing approaches to pest management. Rapidly evolving but unproven gene-editing tools could potentially mitigate the impacts of pests in public health, conservation, and agricultural contexts. The use of these tools, however, is accompanied by ...

Transformative Novel Technologies and Global Environmental Governance

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F. Rabitz,  Cambridge University Press,  2023.
Transformative Novel Technologies are potential gamechangers for confronting climate change, biodiversity loss, and many other elements of the global environmental crisis, allowing us to achieve a more sustainable future. The contemporary and future international governance of ...

Conceptual risk assessment of mosquito population modification gene-drive systems to control malaria transmission: preliminary hazards list workshops

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A. Kormos, G. Dimopoulos, E. Bier, G. C. Lanzaro, J. M. Marshall and A. A. James,  Frontiers in Bioengineering and Biotechnology,  11. 2023.
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 ...

General science-technology orientation, specific benefit–risk assessment frame, and public acceptance of gene drive biotechnology

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X. Liu, C. L. Goldsmith, K. E. Kang, A. Vedlitz, Z. N. Adelman, L. W. Buchman, E. Heitman and R. F. Medina,  Risk Analysis,  2023.
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 ...

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

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A. 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 ...

Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

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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 ...

Guerrilla eugenics: gene drives in heritable human genome editing

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A. 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 ...

Draft environmental assessment for use of Wolbachia-based incompatible insect technique for the suppression of nonnative southern house mosquito populations on Kauaʻi

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Hawai'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 ...

The attitudes of young adults towards mammalian predator control and Predator Free 2050 in Aotearoa New Zealand

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L. 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 ...

Leveraging eco-evolutionary models for gene drive risk assessment

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M. 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 ...

updated: Genetically Engineered Mosquitoes Research Authorization Application

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California 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 ...

Guidelines and Standard Operating Procedures for Research on Genetically Engineer Insects, 2023

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Government 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 ...

Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission

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S. L. James, B. Dass and H. Quemada,  Transgenic Research,  32:17. 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 ...

Alleviating the burden of malaria with gene drive technologies? A biocentric analysis of the moral permissibility of modifying malaria mosquitoes

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N. 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 ...

Engagement on risk assessment for gene drive mosquitoes by EFSA and Target Malaria

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S. 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 ...

The Anthropocene as the End of Nature? Why Recognizing Interventionism Is Key in Coming to Terms with the Anthropocene

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K. 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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