Risk, Regulation, and Policy

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

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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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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GENE DRIVE ACCEPTANCE SURVEY

YouGov,  Pollinis,  2021.
This representative survey was conducted by the international market research institute YouGov and polled 8.826 citizens from 8 EU countries in December 2020. It was commissioned by WeMove Europe, Save Our Seeds (Germany), Skiftet (Sweden), France Nature Environnement (FNE) ...
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Conservation pest control with new technologies: public perceptions

E. A. MacDonald, M. B. Neff, E. Edwards, F. Medvecky and J. Balanovic,  Journal of the Royal Society of New Zealand,  2021.
We conducted eleven focus groups in New Zealand to explore three questions about novel technologies (gene drive and two others for comparison of pest control tools): (1) what are the risks/benefits? (2) how do they compare to current methods? and (3) who should be represented on ...
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Application of the Relationship-Based Model to Engagement for Field Trials of Genetically Engineered Malaria Vectors

A. Kormos, G. C. Lanzaro, E. Bier, G. Dimopoulos, J. M. Marshall, J. Pinto, A. Aguiar dos Santos, A. Bacar, H. Sousa Pontes Sacramento Rompão and A. A. James,  The American Journal of Tropical Medicine and Hygiene,  2020.
Although guidelines and recommendations for engagement for gene drives have recently been described, we argue here that communities and stakeholders should lead the planning, development, and implementation phases of engagement. The RBM provides a new approach to the development ...
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Core commitments for field trials of gene drive organisms

K. C. Long, L. Alphey, G. J. Annas, C. S. Bloss, K. J. Campbell, J. Champer, C.-H. Chen, A. Choudhary, G. M. Church, J. P. Collins, K. L. Cooper, J. A. Delborne, O. R. Edwards, C. I. Emerson, K. Esvelt, S. W. Evans, R. M. Friedman, V. M. Gantz, F. Gould,,  Science,  370:1417-1419. 2020.
While field trials of gene drive organisms (GDOs) ultimately will depend on public policy decisions, those engaged in GDO work can play critical roles in support of these decisions by generating evidence and developing evaluation strategies in fair and effective partnerships with ...
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Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance

Y. Devos, M. B. Bonsall, L. G. Firbank, J. Mumford, F. Nogué and E. A. Wimmer,  Trends in Biotechnology,  2020.
Risk assessors, risk managers, developers, potential applicants, and other stakeholders at many levels discuss the need for new or further risk assessment guidance for deliberate environmental releases of gene drive-modified organisms. However, preparing useful and practical ...
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Interdisciplinary development of a standardized introduction to gene drives for lay audiences

C. E. Schairer, C. Triplett, A. Buchman, O. S. Akbari and C. S. Bloss,  BMC Medical Research Methodology,  20:15. 2020.
While there is wide consensus that the public should be consulted about emerging technology early in development, it is difficult to elicit public opinion about innovations unfamiliar to lay audiences. We sought public input on a program of research on genetic engineering to ...
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Evaluating Gene Drive Approaches for Public Benefit

M. R. Santos,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
Gene drive approaches—those which bias inheritance of a genetic element in a population of sexually reproducing organisms—have the potential to provide important public benefits. The spread of selected genetic elements in wild populations of organisms may help address certain ...
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Engineered Gene Drives and their Value in the Control of Vector-Borne Diseases, Weeds, Pests, and Invasive Species

K. Hefferon and R. Herring,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
Genetic engineering has created potential for moving medical and agricultural research and application frontiers forward in unprecedented ways. Despite its accepted use as a powerful tool in medical research, genetic modification and genome editing technologies remain ...
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Engineered Gene Drives: Ecological, Environmental, and Societal Concerns

J. Kuzma,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
This chapter overviews the types, purposes, and potential impacts of gene drive organisms (GDOs) and discusses challenges with foreseeing and assessing these impacts prior to their environmental release. It concludes with a few examples of risk analysis methods and governance ...
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Genetically Engineered Fish: Potential Impacts on Aquaculture, Biodiversity, and the Environment

R. A. Dunham and B. Su,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
Studies on transgenic fish for the aquaculture industry have focused on improving growth rates, enhancing disease resistance, altering body composition, acting as biological factories for medical proteins, and even altering temperature tolerance and coloration. The future impact ...
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Invasive Species Control and Resolution of Wildlife Damage Conflicts: A Framework for Chemical and Genetically Based Management Methods

L. Clark, J. Eisemann, J. Godwin, K. E. Horak, K. Oh, J. O’Hare, A. Piaggio, K. Pepin and E. Ruell,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
Vertebrate wildlife damage management relates to developing and employing methods to mitigate against damage caused by wildlife in the areas of food production, property damage, and animal or human health and safety. Of the many management tools available
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GMOs: Implications for Biodiversity Conservation and Ecological Processes

Chaurasia, Anurag , Hawksworth, David L., Pessoa de Miranda, Manoela.,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020.
This book covers a broad spectrum of topics related to GMOs and allied new gene-based technologies, biodiversity, and ecosystem processes, bringing together the contributions of researchers and regulators from around the world. The aim is to offer a clear view of the benefits and ...
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Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

E. Panel o. G. M. Organisms, H. Naegeli, J.-L. Bresson, T. Dalmay, I. C. Dewhurst, M. M. Epstein, P. Guerche, J. Hejatko, F. J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J. J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, M. B. Bonsall, J. Mumfor,  EFSA Journal,  18:e06297. 2020.
As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are ...
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Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

European Food Safety Authority, Y. Devos, M. B. Bonsall, F. Nogué, K. Paraskevopoulos, E. A. Wimmer and L. G. Firbank,  EFSA Supporting Publications,  17:1939E. 2020.
The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), ...
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