Regulation and Policy

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

Genetic Control in Historical Perspective: The Legacy of India’s Genetic Control of Mosquitoes Unit

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R. Wilbanks,  Hastings Center Report,  51:S11-S18. 2021.
Abstract In the early 1970s, a World Health Organization-initiated and United States-funded project released lab-reared mosquitoes outside New Delhi in the first large-scale field trials of the genetic control of mosquitoes. Despite partnering with the Indian Council of Medical ...

Deficits of Public Deliberation in U.S. Oversight for Gene Edited Organisms

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J. Kuzma,  Hastings Center Report,  51 Suppl 2:S25-s33. 2021.
Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, ...

Public Deliberation about Gene Editing in the Wild

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M. K. Gusmano, G. E. Kaebnick, K. J. Maschke, C. P. Neuhaus and B. C. Wills,  Hastings Center Report,  51 Suppl 2:S2-s10. 2021.
Genetic editing technologies have long been used to modify domesticated nonhuman animals and plants. Recently, attention and funding have also been directed toward projects for modifying nonhuman organisms in the shared environment-that is, in the "wild." Interest in gene editing ...

Empowering Indigenous Knowledge in Deliberations on Gene Editing in the Wild

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R. Taitingfong and A. Ullah,  Hastings Center Report,  51 Suppl 2:S74-s84. 2021.
Proposals to release genetically engineered organisms in the wild raise complex ethical issues related to their safe and equitable implementation. While there is broad agreement that community and public engagement is vital to decision-making in this context, more discussion is ...

The Decision Phases Framework for Public Engagement: Engaging Stakeholders about Gene Editing in the Wild

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S. K. Barnhill-Dilling, A. Kokotovich and J. A. Delborne,  Hastings Center Report,  51 Suppl 2:S48-s61. 2021.
Some experts and advocates propose environmental biotechnologies such as genetic engineering, gene drive systems, and synthetic biology as potential solutions to accelerating rates of species loss. While these tools may offer hope for a seemingly intractable problem, they also ...

The economic value of genetically engineered mosquitoes as a Malaria control strategy depends on local transmission rates

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K. Lacy, K. A. Schaefer, D. P. Scheitrum and E. Y. Klein,  Biotechnology Journal,  10. 2021.
This paper assesses the economic value of genetically engineered (GE) Anopheles gambiae mosquitoes as a malaria control strategy. We use an epidemiological-economic model of malaria transmission to evaluate this technology for a range of village-level transmission settings. In ...

Public Perceptions Regarding Genomic Technologies Applied to Breeding Farm Animals: A Qualitative Study

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F. Z. Naab, D. Coles, E. Goddard and L. J. Frewer,  BioTech,  10. 2021.
The societal acceptability of different applications of genomic technologies to animal production systems will determine whether their innovation trajectories will reach the commercialisation stage. Importantly, technological implementation and commercialisation trajectories, ...

New Arthropod Containment Recommendations Provide Essential Guidance for Safety of Gene Drive Research

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S. James and D. O’Brochta,  The American Journal of Tropical Medicine and Hygiene,  tpmd211148. 2021.
Gene drive technologies have not yet been field tested, however, there are no data on the possible environmental or health effects of releasing gene drive–modified organisms. For this reason, there have been widespread calls for additional guidance on risk assessment and ...

New molecular genetic techniques: regulatory and societal considerations

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Nielsen, K. M.,  AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application,  2021.
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) ...

Genome editing and its applications for insect pest control: Curse or blessing?

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Hacker, I. , and Schetelig, M. F,  AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application,  2021.
Gene and genome editing are described as cutting-edge research tools with the potential to tackle urgent global challenges in the management of agricultural pests and human disease vectors such as mosquitoes. The field is defined by the chances and challenges to interlink the ...

Procedurally Robust Risk Assessment Framework for Novel Genetically Engineered Organisms and Gene Drives

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Kuzma, J.,  Regulation and Governance,  15:1144-1165. 2021.
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 ...

CRISPR-based gene drives for combatting malaria: Need for an early stage technology assessment.

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Liebert, W.,  AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application,  2021.
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 ...

AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application

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Hendrichs, J. Pereira, R., Vreysen, M. J. B.,  AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application,  2021.
The concept of area-wide integrated pest management (AW-IPM), in which the total population of a pest in an area is targeted, is central to the effective control of such populations through the integration of genetic, biological and other pest suppression technologies. Insect ...

A Household-Based Survey to Understand Factors Influencing Awareness, Attitudes and Knowledge towards Wolbachia-Aedes Technology

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L. T. Soh, Z. Ong, K. Vasquez, I. Chen, X. Li, W. Niah, C. Panchapakesan, A. Sheldenkar, S. Sim, L. C. Ng and M. O. Lwin,  International Journal of Environmental Research and Public Health,  18. 2021.
In 2016, Singapore introduced the release of male Wolbachia-Aedes mosquitoes to complement vector control efforts and suppress Aedes aegypti mosquitoes in selected study sites. With ongoing expansion of Project Wolbachia-Singapore to cover larger areas, a household-based survey ...

Containment Practices for Arthropods Modified with Engineered Transgenes Capable of Gene Drive Addendum 1 to the Arthropod Containment Guidelines, Version 3.2

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American Committee of Medical Entomology,  Vector-Borne and Zoonotic Diseases,  2021.
Responsible conduct of research is a cornerstone of rigorous scientific discovery. Institutional committees, independent advisory panels, and expert steering groups are among the frameworks in academia meant to provide guidance and assurances that research activities do not ...

Ecological vulnerability analysis for suppression of Drosophila suzukii by gene drives

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C. R. Lalyer, L. Sigsgaard and B. Giese,  Global Ecology and Conservation,  32:e01883. 2021.
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, ...

Gene drive and RNAi technologies: a bio-cultural review of next-generation tools for pest wasp management in New Zealand

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S. Palmer, P. K. Dearden, O. R. Mercier, A. King-Hunt and P. J. Lester,  Journal of the Royal Society of New Zealand,  1-18. 2021.
There is a global need for novel, next-generation technologies and techniques to manage pest species. We review work on potential step-changing technologies for large landscape (>1000 hectares) pest management of social Vespula wasps. We also review M?ori perspectives on these ...

Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey

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L. Pare Toe, N. Barry, A. D. Ky, S. Kekele, W. Meda, K. Bayala, M. Drabo, D. Thizy and A. Diabate,  Malaria Journal,  20:395. 2021.
This study provides a review of engagement activities relevant to field trials on non-gene drive genetically-modified mosquitoes as well as an assessment framework-using both qualitative and quantitative studies as well as an audit procedure. The latter was implemented to ...

Gene Drive Organisms: A new dimension of genetic engineering

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V. Henn and M. Imken,  Save Our Seeds,  2021.
Enabled by new genetic engineering techniques such as CRISPR/Cas9, so-called gene drives have been developed in recent years that enable humans to spread new genes throughout the genome of wild animal populations. Gene drives force the inheritance of newly introduced genes to be ...

The international governance of gene drive organisms

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F. Rabitz,  Environmental Politics,  2021.
Gene Drive Organisms (GDOs) are a proposed biotechnological intervention that might generate significant benefits for the conservation and sustainable use of biological diversity while also raising critical biosafety issues. Despite their inevitable transboundary effects, their ...

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