Keywords: assessment

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

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

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 ...

Benefits and risks of gene drives for invasive plant management – the case for common tansy

L. Croghan, A. G. Smith, M. A. Tancos, N. O. Anderson and R. L. Becker,  Frontiers in Agronomy,  5. 2023.
Invasive plants cause significant environmental and economic damage, but land managers have few control options. Common tansy (Tanacetum vulgare) is prevalent in many US states and is one of the most reported invasive plants in Minnesota. Controlling common tansy poses a ...

Defining transformation events for gene drive in species complexes

J. B. Connolly,  IOBC-WPRS Bulletin,  163:8-20. 2023.
Engineered gene drives (EGDs) that allow the super-Mendelian inheritance of genetic traits could one day be used to reduce the vectorial capacity of Anopheles species that transmit human malaria in Africa. Many Anopheles species belong to complexes of closely related sibling ...

A gene drive is a gene drive: the debate over lumping or splitting definitions

S. L. James, D. A. O'Brochta, F. Randazzo and O. Akbari,  Nature Communications,  2023.
Gene drive technologies are being considered as a new approach to address a variety of currently intractable global problems, including to prevent disease transmission, reduce crop loss, and preserve biodiversity1. There are some outside the genetics research community who argue ...

Gene Drives: Target Malaria is underestimating the risks

C. Then,  Testbiotech,  2023.
The Target Malaria consortium has for several years been planning to conduct field trials using genetically engineered mosquitoes in Burkina Faso. The aim is to transfer artificial gene constructs, i. e. the so-called ‘X-shredder’, into wild populations of the mosquitoes. ...

Assessing the hybridization potential between a hypothetical gene drive-modified Drosophila suzukii strain and non-target Drosophila species

J. Romeis, S. Wolf, J. Collatz, J. Enkerli and F. Widmer,  IOBC-WPRS Bulletin,  163:108. 2023.
Genetically engineered gene drives (GD) are a potentially powerful tool to control pest insects by population suppression or even elimination. Before living GD modified insects can be released into the environment, they must pass an environmental risk assessment (ERA). A key ...

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

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 ...

WORLDWIDE: EXPERTS ON GENE DRIVES

Stop Gene Drive,  STOP GENE DRIVES,  2022.
We are travelling the world speaking to some of the world’s leading thinkers, activists and academics on the impact of gene drives. We interviewed more than 20 experts from around the world

IMPACTOS AMBIENTAIS DA TÉCNICA DE GENE DRIVE PARA O CONTROLE DE EPIDEMIAS: ALCANCES E LIMITES DO PRINCÍPIO DA PRECAUÇÃO

N. R. Furtado,  PERI Revista de Filosofia,  13. 2022.
The paper discusses the application of the precautionary principle in the management of environmental risks arising from the use of gene drives to control epidemics. Gene drives consist of a technique for creating genetically modified organisms, which are released into an ...

Laboratory Biosafety in Handling Genetically Modified Mosquitoes

J. Charles,  Genetically Modified and other Innovative Vector Control Technologies,  2021.
One of the novel approaches in controlling vector-borne diseases is to release genetically modified mosquitoes in nature. Trial studies are done in different phases by the researches, both in the laboratory and in the fields. Before a GM mosquito is validated to be ready for ...

Safety Assessment of Novel Genetic Technologies for Vector Control: National and International Perspectives

V. Ahuja,  Genetically Modified and other Innovative Vector Control Technologies,  2021.
Novel genetic technologies provide an alternative approach for control of vectors particularly those carrying deadly pathogens. Genetic control technologies aim to either suppress target populations or modify the vector by introducing a heritable factor that reduces or blocks ...

Measuring Public Attitudes to Releases of Transgenic Mosquitoes for Disease Control, with Special Reference to Dengue and Malaria

L. A. De Las Llagas and M. S. T. Gunigundo,  Genetically Modified and other Innovative Vector Control Technologies,  2021.
Since the advent of DDT in public health and agriculture, science leaped forward with revolutionary technology such as gene drive or editing, thus making it possible to develop alternative approaches to address vector-borne diseases. However, their utilization and sustenance in ...

Safe Application of Genetically Modified Mosquito (GMM) to Combat Dengue and Chikungunya Depends on Socioeconomic Status and Social Acceptance in the Developing Countries: A Comprehensive Analysis

M. N. Islam,  Genetically Modified and other Innovative Vector Control Technologies,  2021.
The emerging and re-emerging vector-borne diseases are a serious public health problem throughout the world. It has been observed that more than 100 countries and approximately half of the world’s population are at risk on vector-borne diseases (VBDs). The global burden of the ...

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) ...

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 ...

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, ...

Environment Agency Austria,  EPA Network,  2021.
Gene drive applications are likely to entail considerable ethical and ecological implications. Apart from societal issues, they pose challenges for environmental risk assessment (ERA), monitoring and risk management: 1)GDOs differ fundamentally from classical GMOs. Notably, GDOs ...

The viral era

B. Giese,  EMBO reports,  22:e53229. 2021.
New biotechnologies such as gene drives and engineered viruses herald a viral era that would give humans exceptional power over any organism at the level of the genotype. In synthetic biology, orthogonality—in the sense of lack of interference—between different systems or ...

West African countries working together to develop framework to regulate genetically engineered mosquitos: Target Malaria

Anonymous,  Global News,  2021.
Abdoulaye Diabaté, principal investigator for Target Malaria, says West African countries like Burkina Faso, Mali and Benin are working with the New Partnership for Africa’s Development (NEPAD) to develop a pan-West African framework to regulate gene drive mosquitos.

CRISPR-Cas and Its Wide-Ranging Applications: From Human Genome Editing to Environmental Implications, Technical Limitations, Hazards and Bioethical Issues

R. Piergentili, A. Del Rio, F. Signore, F. U. Ronchi, E. Marinelli and S. Zaami,  Cells,  10:24. 2021.
The CRISPR-Cas system is a powerful tool for in vivo editing the genome of most organisms, including man. During the years this technique has been applied in several fields, such as agriculture for crop upgrade and breeding including the creation of allergy-free foods, for ...

A Code of Ethics for Gene Drive Research

G. J. Annas, C. L. Beisel, K. Clement, A. Crisanti, S. Francis, M. Galardini, R. Galizi, J. Grünewald, G. Immobile, A. S. Khalil, R. Müller, V. Pattanayak, K. Petri, L. Paul, L. Pinello, A. Simoni, C. Taxiarchi and J. K. Joung,  The CRISPR Journal,  2021.
A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration for the interest of society and humanity. We have ...

Playing God and tampering with nature: popular labels for real concerns in synthetic biology

L. Carter, A. Mankad, E. V. Hobman and N. B. Porter,  Transgenic Research,  2021.
We present the findings from a large Australian study (N = 4593) which suggests ‘playing God’ objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of ope

Scientists paved the way for field trials of gene-driven organisms

K. Winslet,  FLORIDA News Times,  2020.
The recent rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has brought about a wave of transformation throughout science.Developed with selected traits that have been genetically engineered to spread throughout the population, Gene Drive ...

Technical Support to Burkina Faso on Gene Drive Stage 2 Dossier Review

AUDA-NEPAD,  AUDA-NEPAD,  2020.
AUDA-NEPAD in partnership with the National Biosafety Agency (ANB) in Burkina Faso organised a training workshop to support to the National Biosafety Committee (NBC) on stage 2 dossier review, on December 3 – 5, 2020, in Bobo-Dioulasso, Burkina Faso. In addition to the NBC ...

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 ...

Engineered Gene Drives: Policy and Regulatory Considerations Webinar Series by The GeneConvene Global Collaborative October-December 2020

Hector Quemada and David O'Brochta,  GeneConvene Global Collaborative,  2020.
In this series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured. Each seminar will be ~60 minutes in length followed by questions and answers.

Engineered Gene Drives: Regulatory and Policy Considerations Webinar Series by The GeneConvene Global Collaborative October-December 2020

Hector Quemada and David O'Brochta,  GeneConvene Global Collaborative,  2020.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.

ESA Position Statement on the Importance of Continued Innovation in Gene Drive Technology

Entomological Society of America,  Annals of the Entomological Society of America,  2020.
The risks and benefits of GDTs should be considered with the risks and benefits of continuing current pest control interventions, which may be comparatively less effective or pose exposure risks to human health and the environment.

GeneConvene Global Collaborative Webinar Series Oct-Dec 2020

Hector Quemada and David O'Brochta,  GeneConvene Global Collaborative,  2020.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.

Gene Drives: Pursuing opportunities, minimizing risk

K. L. Warmbrod, A. Kobokovich, R. West, G. Ray, M. Trotochaud and M. Montague,  Center for Health Security,  2020.
This study analyzed the current state of gene drive technologies, the ways in which they might be deployed in the field, and the state of regulatory policy governing their development.

Report of the ad hoc technical expert group on risk assessment

Ad Hoc Technical Expert Group on Risk Assessment,  Convention on Biological Diversity,  2020.
The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol further decided to extend the Online Forum on Risk Assessment and Risk Management to assist the AHTEG and invited submissions of information relevant to the work of the online forum and ...

An Initial Framework for the Environmental Risk Assessment of Synthetic Biology-Derived Organisms with a Focus on Gene Drives.

W. G. Landis, E. A. Brown and S. Eikenbary,  Synthetic Biology 2020: Frontiers in Risk Analysis and Governance. Risk, Systems and Decisions.,  2019.
We apply the structure of source-stressor-habitat-effect-impact pathway derived from the relative risk model (Landis and Wiegers 2005) and as was demonstrated to be applicable in the National Academy of Sciences, Engineering and Medicine (NASEM) 2016 report Gene Drives on the ...

Gene drives and the management of agricultural pests

R. F. Medina,  Journal of Responsible Innovation,  5:S255-S262. 2018.
Like all pest control strategies, gene drives are not hazard-free. Ecological risk assessment of gene drives designed to control agricultural pests should be conducted before their deployment. The present commentary provides some thoughts on some of the issues one should consider ...

Summary

Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible,  Journal of Responsible Innovation,  5:S243-S254. 2018.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the ...

Guidance on the environmental risk assessment of genetically modified animals

European Food Safety Authority,  European Food Safety Authority,  2013.
This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk ...