Risk, Regulation, and Policy

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

New molecular genetic techniques: regulatory and societal considerations

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

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

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

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 ...
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AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application

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

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 ...
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Ecological vulnerability analysis for suppression of Drosophila suzukii by gene drives

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

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

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 ...
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Gene Drive Organisms: A new dimension of genetic engineering

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 ...
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The international governance of gene drive organisms

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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Knowing and Controlling: Engineering Ideals and Gene Drive for Invasive Species Control in Aotearoa New Zealand

C. H. Ross,  Nature Remade: Engineering Life, Envisioning Worlds,  2021.
On the islands of Aotearoa, also called New Zealand, invasive species have been a prominent and persistent concern for local ecosystems. Traditional methods of biological control, though, can be difficult to implement and often have harmful side- effects for the environment and ...
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Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control

C. E. Schairer, J. Najera, A. A. James, O. S. Akbari and C. S. Bloss,  Pathogens and Global Health,  2021.
ABSTRACTIn response to growing concerns regarding mosquito-borne diseases, scientists are developing novel systems of vector control. Early examples include Oxitec?s OX513A genetically-engineered mosquito and MosquitoMate?s Wolbachia-infected mosquito, and systems using ...
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‘Nigeria has capacity for safe application of modern biotechnology’

M. Adewale,  The Guardian,  2021.
Director-general of the National Biosafety Management Agency (NBMA), Dr. Rufus Ebegba, has declared that Nigeria has the capacity to deploy safe biotechnology products for agricultural development and environmental safety. Ebegba, who gave the assurance at the opening of a ...
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European Parliament calls for ban on gene drive technology

Save Our Seeds,  Save Our Seeds,  2021.
The European Parliament yesterday confirmedi it‘s precautionary stance towards the use of a new genetic engineering technology called gene drive. In its report on the EU’s Biodiversity Strategy for 2030, adopted at the European Parliament’s plenary on 08.06.2021, ...
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Guidance framework for testing of genetically modified mosquitoes, second edition

WHO,  WHO-TDR,  2021.
For more than 2 decades, scientists have been working to harness the promise of molecular biology to develop genetically modified mosquitoes (GMMs) for use as public health tools to prevent the transmission of vector-borne diseases. Responding to a need for additional standards ...
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Ethics of Genome Editing

European Group on Ethics,  European Group on Ethics in Science and New Technologies,  2021.
This Opinion addresses the profound ethical questions raised and revived by them. It analyses various domains of application, from human health to animal experimentation, from livestock breeding to crop variety and to gene drives. With its wide view across areas, it identifies ...
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Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies

J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach,  Elementa: Science of the Anthropocene,  9. 2021.
Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a ...
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Thirteenth meeting of the WHO Vector Control Advisory Group

Vector Control Advisory Group,  WHO,  2021.
VCAG experts met virtually with product developers, innovators and researchers from 7 to 10 December 2020 for the 13th VCAG meeting. This report details the proceedings and outcomes of the meeting, including advice provided to the following applicants: bait stations; lethal house ...
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Emergent challenges for CRISPR: biosafety, biosecurity, patenting, and regulatory issues

Braddick, D. , and Ramarohetra, R. F.,  Genome Engineering Via Crispr-Cas9 System,  2021.
The recent advancements of CRISPR-Cas technologies have transformed this simple and efficient gene editing technique into an extraordinarily powerful tool. The most anticipated applications could create novel therapeutics against mankind's most serious afflictions and help ...
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