Risk, Regulation, and Policy

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

Genetic Control of Insect Pests in Africa – Past, Present, and Future

,  2024.
Explore that history as well as contemporary and planned applications of genetic biocontrol to control a variety of medically and agriculturally significant insects in Africa.

African Biotechnology Regulatory Landscape – Genetic Biocontrol Readiness

,  2024.
Gene editing, gene drives and synthetic biology are being developed for better food production, healthcare and sustainable environment conservation. Africa stands to gain much from these developments. African countries are at various levels of establishing, implementing, and ...

A bumpy road ahead for genetic biocontainment

George, D.R., Danciu, M., Davenport, P.W. et al,  Nature Communications,  2024.
The environmental release of bioengineered organisms is increasingly being suggested for a variety of applications, including bioremediation, biosequestration, bio-mining, environmental biosensing and conservation. The objectives of many environmental release applications shift ...

Consultation on a draft National Gene Drive Policy Guide

Commonwealth of Australia (Department of Health and Aged Care),  National Gene Technology Scheme,  2024.
The term gene drive is used to describe organisms which have been genetically modified to increase the rate for a particular trait to spread through a sexually reproducing population, spreading the genes or traits through a species at a faster rate than normal inheritance. ...

Rescue by gene swamping as a gene drive deployment strategy

Keith D. Harris, Gili Greenbaum,  Cell Reports,  42. 2023.
Gene drives are genetic constructs that can spread deleterious alleles with potential application to population suppression of harmful species. As gene drives can potentially spill over to other populations or species, control measures and fail-safe strategies must be considered. ...

What are gene drives, and how can they help eradicate invasive species in Australia?

Dr. Ellen Cottingham,  ABC News (Australia Broadcasting Corporation),  2023.
The impact of feral cats and other invasive species is felt across Australia. Not only do they threaten native species, but they can also spread diseases to humans and livestock. Invasive species are estimated to cost Australia an eye-watering $25 billion annually, while the ...

Ghana publishes its guidelines on Genome Editing

Anonymous,  BusinessGhana,  2023.
Ghana's National Biosafety Authority (NBA) has published its guidelines on Genome Editing and Gene Stacks with regards Genetically Modified Organisms (GMOs) joining Nigeria, Kenya, and Malawi, as the fourth country in Africa with the guidelines. Genome editing is an emerging and ...

Framing Challenges and Opportunities for Canada: Expert Panel on Regulating Gene-Edited Organisms for Pest Control

CCA (Council of Canadian Academies),  Framing Challenges and Opportunities for Canada,  2023.
Gene-editing technologies are changing approaches to pest management. Rapidly evolving but unproven gene-editing tools could potentially mitigate the impacts of pests in public health, conservation, and agricultural contexts. The use of these tools, however, is accompanied by ...

Transformative Novel Technologies and Global Environmental Governance

F. Rabitz,  Cambridge University Press,  2023.
Transformative Novel Technologies are potential gamechangers for confronting climate change, biodiversity loss, and many other elements of the global environmental crisis, allowing us to achieve a more sustainable future. The contemporary and future international governance of ...

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 ...

Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control Anopheles gambiae the mosquito vector of human malaria

A. Qureshi and J. B. Connolly,  Malaria Journal,  22:234. 2023.
Population suppression gene drive is currently being evaluated, including via environmental risk assessment (ERA), for malaria vector control. One such gene drive involves the dsxFCRISPRh transgene encoding (i) hCas9 endonuclease, (ii) T1 guide RNA (gRNA) targeting the doublesex ...

Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

National Institutes of Health,  Federal Register,  2023.
The National Institutes of Health (NIH) seeks input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive ...

Guerrilla eugenics: gene drives in heritable human genome editing

A. D. Cutter,  J Med Ethics,  2023.
CRISPR-Cas9 genome editing can and has altered human genomes, bringing bioethical debates about this capability to the forefront of philosophical and policy considerations. Here, I consider the underexplored implications of CRISPR-Cas9 gene drives for heritable human genome ...

Draft environmental assessment for use of Wolbachia-based incompatible insect technique for the suppression of nonnative southern house mosquito populations on Kauaʻi

Hawai'i Department of Land and Natural Resources,  Hawai'i Department of Land and Natural Resources,  2023.
The State of Hawai'i Department of Land and Natural Resources hereby transmits the Draft Environmental Assessment and Anticipated Finding of No Significant Impact (DEAEnvironmental Assessment for use of Wolbachia-based Incompatible Insect Technique for the suppression of ...

The attitudes of young adults towards mammalian predator control and Predator Free 2050 in Aotearoa New Zealand

L. Dickie and F. Medvecky,  Australasian Journal of Environmental Management,  2023.
Predator Free 2050 (PF2050) is an ambitious goal that aims to remove three types of invasive mammals from New Zealand by 2050. It will require a significant amount of funding, research, and support. Young adults will have an important role to play for this programme to be ...

Leveraging eco-evolutionary models for gene drive risk assessment

M. A. Combs, A. J. Golnar, J. M. Overcash, A. L. Lloyd, K. R. Hayes, D. A. O’Brochta and K. M. Pepin,  Trends in Genetics,  2023.
As development of gene drive systems accelerates and diversifies, predicting outcomes for target populations and the potential for human and environmental risks requires accounting for numerous eco-evolutionary processes.Gene drive dynamic models quantify the influence of ...

Leveraging eco-evolutionary models for gene drive risk assessment

M. A. Combs, A. J. Golnar, J. M. Overcash, A. L. Lloyd, K. R. Hayes, D. A. O’Brochta and K. M. Pepin,  Trends in Genetics,  2023.
As development of gene drive systems accelerates and diversifies, predicting outcomes for target populations and the potential for human and environmental risks requires accounting for numerous eco-evolutionary processes.Gene drive dynamic models quantify the influence of ...

updated: Genetically Engineered Mosquitoes Research Authorization Application

California Department of Pesticide Regulation,  California Department of Pesticide Regulation,,  2023.
In May 2023, Oxitec voluntarily withdrew its research authorization application to test the use of genetically engineered mosquitoes in California. DPR did not issue a decision on the application. For more information on Oxitec’s withdrawal and future plans for research in ...

Gene Drives

D. M. Berube,  Pandemics and Resilience,  2023.
A “gene drive” is a version of gene editing—a newer, more precise way to change a DNA (or RNA) sequence; in this case, combining a guide RNA with an enzyme that can make a gene drive takes this to another level, making sure that a new or altered genetic sequence has a ...
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