Regulation and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
Knowing and Controlling: Engineering Ideals and Gene Drive for Invasive Species Control in Aotearoa New Zealand
Tags: Ethics, Gene drive synthetic, Invasive species, Oceania, PolicyC. H. Ross, Nature Remade: Engineering Life, Envisioning Worlds, 2021.
On the islands of Aotearoa, also called New Zealand, invasive species have been a prominent and persistent concern for local ecosystems. Traditional methods of biological control, though, can be difficult to implement and often have harmful side- effects for the environment and ...
Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control
Tags: Genetic biocontrol, Genetically modified mosquitoes, History, Oxitec, Policy, Regulation, Stakeholder engagementC. 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 ...
‘Nigeria has capacity for safe application of modern biotechnology’
Tags: Africa, Gene drive synthetic, Genetic biocontrol, Genetically modified organisms, Policy, Regulation, Risk and safetyM. 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 ...
European Parliament calls for ban on gene drive technology
Tags: Biodiversity/Conservation, Gene drive synthetic, Malaria, Policy, Regulation, Risk and safetySave 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, ...
Guidance framework for testing of genetically modified mosquitoes, second edition
Tags: Ethics, Gene drive synthetic, Genetic biocontrol, Genetically modified mosquitoes, Policy, RegulationWHO, 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 ...
Commercial Release of Genetically Modified Crops in Africa: Interface Between Biosafety Regulatory Systems and Varietal Release Systems
Tags: Africa, Policy, Regulation, Risk and safetyO. Akinbo, S. Obukosia, J. Ouedraogo, W. Sinebo, M. Savadogo, S. Timpo, R. Mbabazi, K. Maredia, D. Makinde and A. Ambali, Frontier in Plant Sciences, 12. 2021.
African countries face key challenges in the deployment of GM crops due to incongruities in the processes for effective and efficient commercial release while simultaneously ensuring food and environmental safety. Against the backdrop of the preceding scenario, and for the ...
Ethics of Genome Editing
Tags: Agriculture, Ethics, Gene drive synthetic, Gene editing, Governance, PolicyEuropean 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 ...
Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies
Tags: Ethics, Genetically modified organisms, Governance, Policy, Regulation, Risk and safetyJ. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, Elementa: Science of the Anthropocene, 9. 2021.
Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a ...
Thirteenth meeting of the WHO Vector Control Advisory Group
Tags: Genetic biocontrol, Vector controlVector 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 ...
Emergent challenges for CRISPR: biosafety, biosecurity, patenting, and regulatory issues
Tags: CRISPR, Gene editing, Policy, Regulation, Risk and safetyBraddick, D. , and Ramarohetra, R. F., Genome Engineering Via Crispr-Cas9 System, 2021.
The recent advancements of CRISPR-Cas technologies have transformed this simple and efficient gene editing technique into an extraordinarily powerful tool. The most anticipated applications could create novel therapeutics against mankind's most serious afflictions and help ...
GENE DRIVE ACCEPTANCE SURVEY
Tags: Gene drive synthetic, Policy, Regulation, Risk and safety, Stakeholder engagementYouGov, 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) ...
Demystifying the Risk Assessment Process for Laboratory-Based Experiments Utilizing Invasive Genetic Elements: It Is More Than Gene Drive
Tags: Containment, Gene drive synthetic, Policy, Regulation, Risk assessmentZ. N. Adelman, Applied Biosafety, 2021.
Advances in recombinant DNA approaches have resulted in the development of transgene architectures that severely bias their own inheritance, a process commonly referred to as ?gene drive.? The rapid pace of development, combined with the complexity of many gene drive approaches, ...
Conservation pest control with new technologies: public perceptions
Tags: Biodiversity/Conservation, Gene drive synthetic, Genetic biocontrol, Oceania, Policy, Regulation, Risk assessment, Stakeholder engagementE. 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 ...
Application of the Relationship-Based Model to Engagement for Field Trials of Genetically Engineered Malaria Vectors
Tags: Ethics, Field trials, Gene drive synthetic, Malaria, Policy, Stakeholder engagementA. 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 ...
Core commitments for field trials of gene drive organisms
Tags: Field trials, Gene drive synthetic, Policy, Regulation, Risk assessmentK. 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 ...
Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance
Tags: Gene drive synthetic, Policy, Regulation, Risk and safety, Risk assessmentY. 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 ...
Interdisciplinary development of a standardized introduction to gene drives for lay audiences
Tags: Field trials, Gene drive synthetic, Genetic engineering, Policy, Stakeholder engagement, Vector controlC. 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 ...
Evaluating Gene Drive Approaches for Public Benefit
Tags: Gene drive synthetic, Governance, Mosquitoes, Policy, Regulation, Risk and safetyM. 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 ...
Engineered Gene Drives and their Value in the Control of Vector-Borne Diseases, Weeds, Pests, and Invasive Species
Tags: Gene drive synthetic, Genetic biocontrol, Policy, Regulation, Risk and safetyK. 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 ...
Engineered Gene Drives: Ecological, Environmental, and Societal Concerns
Tags: Ethics, Gene drive synthetic, Governance, Policy, Regulation, Risk and safety, Stakeholder engagementJ. 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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Alex Sullivan
Foundation for the
National Institutes of Health
geneconvenevi@fnih.org