Keywords: risk assessment

Genetically modified mosquitoes for better health

D. Devis,  COSMOS,  2021.
One method of preventing these mosquito-born diseases is to use insecticides to kill the mozzies and remove them, but sometimes this only works as a short term solution, or has unintended devasting effects on the ecosystem. Another method for decreasing the number of ...
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Quantifying the risk of vector-borne disease transmission attributable to genetically modified vectors

G. R. Hosack, A. Ickowicz and K. R. Hayes,  Royal Society Open Science,  8:201525. 2021.
The relative risk of disease transmission caused by the potential release of transgenic vectors, such as through sterile insect technique or gene drive systems, is assessed with comparison with wild-type vectors. The probabilistic risk framework is demonstrated with an assessment ...
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Ecological Modeling in Risk Assessment of Gene Drives

Hector Quemada and David O'Brochta,  ,  2021.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on ...
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GeneConvene Webinar Series on: Ecological Modeling in Risk Assessment of Gene Drives

Hector Quemada and David O'Brochta,  ,  2021.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on ...
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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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Further guidance required for assessment of gene drive technology, says EFSA

N. Foote,  Euractiv,  2020.
After being mandated by the European Commission, EFSA’s experts on genetically modified organisms (GMOs) published the scientific opinion related to engineered gene drives on Thursday (12 November), specifically focusing on gene drive modified disease-transmitting insects, ...
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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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EFSA advises on risk assessment of engineered gene drives

EFSA,  European Food and Safety Authority,  2020.
EFSA’s existing guidelines for the risk assessment of genetically modified animals are adequate for evaluating risks associated with gene drive modified insects. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk ...
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Embracing Dynamic Models for Gene Drive Management

A. J. Golnar, E. Ruell, A. L. Lloyd and K. M. Pepin,  Trends in Biotechnology,  2020.
We describe how quantitative tools can reduce risk uncertainty, streamline empirical research, guide risk management, and promote cross-sector collaboration throughout the process of gene drive technology development and implementation.
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Gene drives: Navigating perils of engineered eradication, with Christoph Then.

IEAM Podcast,  Integrated Environmental Assessment and Management,  2020.
Imagine a world without natural enemies like parasites or deadly pathogens. Where crops grow unfettered by rodent and insect pests. Advances in genetic engineering now hold the possibility to alter genomes at the population level, but is it too good to be true? A critical review ...
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Incorporating Characteristics of Gene Drive Engineered Ae. aegypti as Methods to Reduce Dengue and Zika Virus into the Bayesian Network – Relative Risk Model, Using Ponce, Puerto Rico as a Case Study

S. R. Eikenbary,  WWU Graduate School Collection,  2020.
The Bayesian network relative risk model can perform the risk assessment of gene drive engineered Ae. aegypti for vector control and as part of an adaptive management strategy to reduce dengue and Zika transmission. This study illustrates how the BN-RRM can integrate gene drive ...
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EPA Grants First Permit to Test Genetically Modified Mosquitoes

Adam Allington,  Bloomberg Law,  2020.
British biotech company Oxitec Ltd was granted an experimental use permit to release a genetically engineered type of the mosquito species Aedes aegypti, which is a known vector of Zika virus and viruses that cause yellow fever and dengue fever, the Environmental Protection ...
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EPA Approves Experimental Use Permit to Test Innovative Biopesticide Tool to Better Protect Public Health

EPA,  EPA,  2020.
Today, after extensive evaluation of the best available science and public input, the U.S. Environmental Protection Agency (EPA) has granted an experimental use permit (EUP) to Oxitec Ltd. to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce ...
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Limits of Knowledge and Tipping Points in the Risk Assessment of Gene Drive Organisms

Arnim von Gleich and Winfried Schröder,  Gene Drives at Tipping Points,  2020.
New challengesTipping point in the risk assessment of genetically engineered (GE) organisms are expected to emerge in the context of so-called ‘gene drives’. Based on a review of findings from current knowledge of GE organisms, it is concluded that the risk assessment of gene ...
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Case Study 2: Oilseed Rape (Brassica napus L.)

Johnannes L. Frieß, Broder Breckling, Kathrin Pascher and Windfried Schröder,  Gene Drives at Tipping Points,  2020.
SPAGESelf-Propagating Artificial Genetic Elements (SPAGE) (Self-Propagating Artificial Genetic Element) technologies allow for a proliferation of genetic information on the populationPopulation level at a higher rate than usual Mendelian inheritanceMendelian inheritance. ...
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Vulnerability Analysis of Ecological Systems

Carina R. Lalyer, Arnim von gleich, Bernd Giese,  Gene Drives at Tipping Points,  2020.
Vulnerability analysis can be seen as the counterpart to technology characterization. Technology characterisation scrutinises the intervening technology. Vulnerability analyses potentially affected systems. That may be socio-ecological, socio-technical, socio-economic or other ...
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Gene Drives Touching Tipping Points

Brodee Breckling, Arnim von Gleich,,  Gene Drives at Tipping Points,  2020.
Tipping points and tipping elements, phase transitions and similar critical phenomena are widely discussed in scientific as well as socio-economic contexts as components to understand unforeseen far reaching changes and critical transitions from one stage into another in complex ...
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Gene Drives at Tipping Points

Amin von Gleich and Winfried Schroder,  Gene Drives at Tipping Points,  2020.
This open access book reports on a pilot project aiming at collecting information on the socio-ecological risks that could arise in the event of an uncontrolled spread of genetically engineered organisms into the environment. The researchers will, for instance, be taking a closer ...
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Spatio-temporal controllability and environmental risk assessment of genetically engineered gene drive organisms from the perspective of EU GMO Regulation

C. Then, K. Kawall and N. Valenzuela,  Integrated Environmental Assessment and Management,  2020.
Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the ...
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Auditing preparedness for vector control field studies

C. M. Collins and M. M. Quinlan,  American Journal of Tropical Medicine and Hygiene,  102:707-710. 2020.
The value of baseline entomological data to any future area-wide release campaign relies on the application of consistent methods to produce results comparable across different times and places in a stepwise progression to larger releases. Traditionally, standard operating ...
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Evaluating the Probability of CRISPR-based Gene Drive Contaminating Another Species

V. Courtier-Orgogozo, A. Danchin, P.-H. Gouyon and C. Boëte,  Evolutionary Applications,  Early Online. 2020.
he probability D that a given CRISPR-based gene drive element contaminates another, non-target species can be estimated by the following Drive Risk Assessment Quantitative Estimate (DRAQUE) Equation: D = (hyb + transf).express.cut.flank.immune.nonextinct with ...
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A potential new tool for the toolbox: assessing gene drives for eradicating invasive rodent populations

K. J. Campbell, J. R. Saah, P. R. Brown, J. Godwin, F. Gould, G. R. Howald, A. Piaggio, P. Thomas, D. M. Tompkins, D. Threadgill, J. Delborne, D. Kanavy, T. Kuiken, H. Packard, M. Serr and A. Shiels,  Island invasives: scaling up to meet the challenge,  2019.
Invasive rodents have significant negative impacts on island biodiversity. All but the smallest of rodent eradications currently rely on island-wide rodenticide applications. Although signifi cant advances have been made in mitigating unintended impacts, rodent eradication on ...
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Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito

Z. Meghani and J. Kuzma,  Journal of Responsible Innovation,  5:S203-S222. 2018.
In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. Given the profound impact that gene drives could have on species and ecosystems, their use is a ...
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Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

K. R. Hayes, G. R. Hosack, G. V. Dana, S. D. Foster, J. H. Ford, R. Thresher, A. Ickowicz, D. Peel, M. Tizard, P. De Barro, T. Strive and J. M. Dambacher,  Journal of Responsible Innovation,  5:S139-S158. 2018.
In this paper, we outline methods to identify hazards and detect potentially adverse ecological outcomes at the individual (genotype, phenotype), population, community and ecosystem level, when progressing Gene Drive Modified Organisms through a phased test and release pathway. ...
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Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

Hayes, KRH, G. R.; Dana, G. V.; Foster, S. D.; Ford, J. H.; Thresher, R.; Ickowicz, A.; Peel, D.; Tizard, M.; De Barro, P.; Strive, T.; Dambacher, J. M.,  Journal of Responsible Innovation,  5:S139-S158. 2018.
Synthetic gene drives could provide new solutions to a range of old problems such as controlling vector-borne diseases, agricultural pests and invasive species. In this paper, we outline methods to identify hazards and detect potentially adverse ecological outcomes at the ...
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Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment

Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management,,  Convention on Biological Diversity,  2016.
This document was developed by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, with input from the Open-ended Online Expert Forum, in accordance with terms of reference set out by the Conference of the Parties serving as the meeting of the ...
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Can systematic reviews inform GMO risk assessment and risk management?

Kohl, CF, G.; Sweet, J.; Spok, A.; Haddaway, N.R.; Wilhelm, R.; Unger, S.; Schiemann, J.,  Frontiers in Bioengineering and Biotechnology,  3:113. 2015.
Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and ...
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Guidance framework for testing of genetically modified mosquitoes

WHO,  WHO-TDR,  2014.
As the research progresses, a need has been expressed both within the scientific community and by the public for additional standards and guidance. WHO-TDR and the Foundation for the National Institutes of Health (FNIH) co-sponsored a technical consultation meeting in 2009 to ...
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Regulatory experience and challenges for the release of GM insects

Beech, C,  Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety,  9:S71-S76. 2014.
Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. ...
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