Regulation and Policy

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

Report of the ad hoc technical expert group on risk assessment

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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 ...

GENE DRIVE ORGANISMS: Implications for the environment and nature conservation

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M. Dolezel, S. Simon, M. Otto, M. Engelhard and W. Zughart,  Umweltbundesamt,  2020.
Recent advances in biotechnology aim at the genetic modification of wild living populations. Some potential applications consider self-propagating genetic elements to generate gene drive organisms (GDOs), also for nature conservation. Due to the potential of GDOs to spread ...

The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drive

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J. Romeis, J. Collatz, D. C. M. Glandorf and M. B. Bonsall,  Environmental Science & Policy,  108:19-36. 2020.
The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive ...

Stakeholder workshop “Problem formulation for the environmental risk assessment of gene drive modified insects” (15 May 2019, Brussels)

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European Food Safety, A., Devos, Y., Gallani, B. & Firbank, L. G,  A. European Food Safety, Y. Devos, B. Gallani and L. G. Firbank,  17:1819E. 2020.
Recent advances in molecular and synthetic biology are enabling the engineering of gene drives that spread genes of interest through interbreeding populations at a frequency greater than the rate expected by simple Mendelian inheritance. At present, insects represent the most ...

Toward the definition of efficacy and safety criteria for advancing gene drive-modified mosquitoes to field testing

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S. L. James, J. M. Marshall, G. K. Christophides, F. O. Okumu and T. Nolan,  Vector Borne and Zoonotic Diseases,  20:237. 2020.
Mosquitoes containing gene drive systems are being developed as complementary tools to prevent transmission of malaria and other mosquito-borne diseases. As with any new tool, decision makers and other stakeholders will need to balance risks (safety) and benefits (efficacy) when ...

Risk assessment challenges of synthetic gene drive organisms

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E. Sirinathsinghji,  TWN Biosafety Briefing,  2020.

Regulation of GM Organisms for Invasive Species Control

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H. J. Mitchell and D. Bartsch,  Frontiers in Bioengineering and Biotechnology,  7:1-11. 2020.
Invasive species can cause significant harm to the environment, agriculture, and human health, but there are often very limited tools available to control their populations. Gene drives (GD) have been proposed as a new tool which could be used to control or eliminate such ...

Irreversible ecosystem engineering with Gene Drive Organisms

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Save Our Seeds,  Save Our Seeds,  2020.
Gene drive technology is a particular application of the new genetic engineering tool CRISPR/Cas9. It is designed to genetically modify, replace or eradicate wild populations or entire species. So far it works in mosquitos, mice, flies, yeast and nematodes. But in principle it ...

Metaphor, Trust and Support for Non-native Species Control

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P. A. Kohl, S. J. Collins and M. Eichholz,  Environmental Communication,  14:672-685. 2020.
This experimental study used a representative sample of U.S. residents (N = 1,042) to test whether the use of the term "invasive" increases support for non-native species control efforts. The term invasive had a small influence on support for two out of three non-native species ...

Technology Factsheet: Gene Drives

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J. Lunshof, C. Shachar, R. Edison, A. Jayanti,  Belfer Center for Science and International Affairs,  2020.
Gene drives can be defined as genetic elements that pass from parents to unusually high numbers of their offspring due to biased inheritance (sometimes referred to as the possession of “selfish” genetic elements).1,2 There are different ways of achieving this biased ...

A typology of community and stakeholder engagement based on documented examples in the field of novel vector control

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C. E. Schairer, R. Taitingfong, O. S. Akbari and C. S. Bloss,  PLoS Neglected Tropical Diseases,  13:e0007863. 2019.
Background Despite broad consensus on the importance of community and stakeholder engagement (CSE) for guiding the development, regulation, field testing, and deployment of emerging vector control technologies (such as genetically engineered insects), the types of activities ...

Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives

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George, D. R., T. Kuiken and J. A. Delborne,  Proceedings of the Royal Society B: Biological Sciences,  286:20191484.. 2019.
Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land ...

Exterminator genes: The right to say no to ethics dumping

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Bassey-Orovwuje, M., J. Thomas and T. Wakeford,  Development,  62:121-127. 2019.
The scientific-industrial complex is promoting a new wave of genetically modified organisms, in particular gene drive organisms, using the same hype with which they tried to persuade society that GMOs would be a magic bullet to solve world hunger. The Gates Foundation claims that ...

A cross-sectional survey of biosafety professionals regarding genetically modified insects

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O’Brochta, D. A., W. K. Tonui, B. Dass and S. James,  Applied Biosafety,  2019:1-9. 2019.
Background:Genetic technologies such as gene editing and gene drive create challenges for existing frameworks used to assess risk and make regulatory determinations by governments and institutions. Insect genetic technologies including transgenics, gene editing, and gene drive ...

Plasmodium falciparum (Haemosporodia: Plasmodiidae) and O’nyong-nyong virus development in a transgenic Anopheles gambiae (Diptera: Culicidae) strain

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Mumford, J. D., C. A. Long, S. C. Weaver, K. Miura, E. Wang, R. Rotenberry, E. M. Dotson and M. Q. Benedict,  " Journal of Medical Entomology,  56:936-941. 2019.
ransgenic Anopheles gambiae Giles (Diptera: Culicidae) mosquitoes have been developed that confer sexual sterility on males that carry a transgene encoding a protein which cuts ribosomal DNA. A relevant risk concern with transgenic mosquitoes is that their capacity to transmit ...

What risk assessments of genetically modified organisms can learn from institutional analyses of public health risks

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Rajan, S. R. and D. K. Letourneau,  Journal of Biomedicine and Biotechnology,  2012:8. 2019.
The risks of genetically modified organisms (GMOs) are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO ...

Genetic frontiers for conservation: An assessment of synthetic biology and biodiversity conservation

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K. H. Redford, T. Brooks, M., B. W. Nicholas and J. S. A. Macfarlane,  International Union for Conservation of Nature,  2019.
This assessment is the beginning of a process that will lead to the development of an IUCN policy to guide the Union’s Director General, Commissions, and Members. The draft policy will be discussed in many fora before it is brought to vote at the World Conservation Congress in ...

Efforts to enhance safety measures for CRISPR/Cas-based gene drive technology in Japan

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T. Tanaka, N. Tanaka, Y. Nagano, H. Kanuka, D. S. Yamamoto, N. Yamamoto, E. Nanba and T. Nishiuch,  Journal of Environment and Safety,  2019.
Gene drive is a powerful system that can spread a desirable genetic trait into an entire species and/or population of a certain region, bypassing Mendelian rules of inheritance. Recently, one of the genome editing technologies, CRISPR/Cas, has been developed, making it easier to ...

Gene Drives: Dynamics and Regulatory Matters-A Report from the Workshop “Evaluation of Spatial and Temporal Control of Gene Drives,” April 4-5, 2019, Vienna

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B. Giese, J. L. Friess, N. H. Barton, P. W. Messer, F. Debarre, M. F. Schetelig, N. Windbichler, H. Meimberg and C. Boete,  Bioessays,  41:3. 2019.
Gene Drives are regarded as future tools with a high potential for population control. Due to their inherent ability to overcome the rules of Mendelian inheritance, gene drives (GD) may spread genes rapidly through populations of sexually reproducing organisms. A release of ...

Malaria eradication within a generation: ambitious, achievable, and necessary

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R. G. A. Feachem, I. Chen, O. Akbari, A. Bertozzi-Villa, S. Bhatt, F. Binka, M. F. Boni, C. Buckee, J. Dieleman, A. Dondorp, A. Eapen, N. Sekhri Feachem, S. Filler, P. Gething, R. Gosling, A. Haakenstad, K. Harvard, A. Hatefi, D. Jamison, K. E. Jones, C.,  Lancet,  394:1056-1112. 2019.
50 years after a noble but flawed attempt to eradicate malaria in the mid-20th century, the global malaria community is once again seriously considering eradication. Momentum towards eradication has been building for decades, and more than half of the world’s countries are now ...

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