Regulation and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
Gene Drives: Experience with gene drive systems that may inform an environmental risk assessment
Tags: Gene drive synthetic, Policy, Regulation, Risk and safetyRüdelsheim, PKJS, G., COGEM, 2019.
Gene drives are genetic mechanisms that allow for a trait to be propagated throughout a population; beyond Mendelian inheritance. Active in sexually-reproducing species, they are powerful tools to “drive”; a gene, i.e. increase its frequency, independent of external selection ...
Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives
Tags: Containment, Gene drive synthetic, Genetically modified organisms, Oceania, Policy, RegulationOffice of the Gene Technology Regulator, Australian Government, Department of Health, 2019.
This document provides guidance for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’, including the physical containment (PC) level of facilities for notifiable low risk dealings ...
Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives
Tags: Gene drive synthetic, Policy, Regulation, Risk and safety, Stakeholder engagementZ. Meghani, Global Policy, 10:554-568. 2019.
This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self-determination. The environmental release of such animals ...
Synthetic Biology: Research Needs for Assessing Environmental Impacts
Tags: Gene drive, Governance, Policy, Risk assessment, Synthetic biologyC. M. Warner, S. R. Carter, R. F. Lance, F. H. Crocker, H. N. Meeks, B. L. Adams, M. L. Magnuson, T. Rycroft, K. Pokrzywinski and E. J. Perkins, Synthetic Biology 2020: Frontiers in Risk Analysis and Governance, 2019.
Synthetic biology and its applications have the potential to greatly improve economic development, public health, environmental stewardship, technological advancement, and many other areas. In May 2017, sixty individuals gathered in Lexington, Massachusetts for a workshop ...
Synthetic Biology and the United Nations
Tags: Biodiversity/Conservation, Gene drive synthetic, Policy, Regulation, Synthetic biologyH.-E. Lai, C. Canavan, L. Cameron, S. Moore, M. Danchenko, T. Kuiken, Z. Sekeyová and P. S. Freemont, Trends in Biotechnology, 37:1146-1151. 2019.
Synthetic biology is a rapidly emerging interdisciplinary field of science and engineering that aims to redesign living systems through reprogramming genetic information. The field has catalysed global debate among policymakers and publics. Here we describe how synthetic biology ...
Gene drives and the international biodiversity regime
Tags: Biodiversity/Conservation, Ethics, Policy, RegulationF. Rabitz, Review of European, Comparative & International Environmental Law, 2019.
Gene drives are genetic modifications designed for rapidly diffusing traits throughout a target population. They are currently being proposed as biological control agents to combat, for instance, invasive alien species and disease vectors. They also raise concerns regarding their ...
Gene drive organisms: What Africa should know about actors, motives and threats to biodiversity and food systems
Tags: Ethics, Gene drive synthetic, Policy, Risk and safetySirinathsinghji, E., African Centre for Biodiversity., 2019.
In this briefing paper, we set out the key issues that our governments should have addressed with African civil society before endorsing positions and setting the benchmark for Africa-wide policy. In this regard, we point out that, while the impetus for the AU position might well ...
RISCOS BIOTECNOLÓGICOS AMBIENTAIS E PARTICIPAÇÃO SOCIAL: POR UMA GESTÃO DEMOCRÁTICA DA BIOTECNOLOGIA GENE DRIVE NA ATUAÇÃO DA CTNBIO
Tags: Gene drive synthetic, Policy, Risk assessment, Stakeholder engagementL. C. Rodrigues, Revista Jurídica (FURB), 22. 2019.
This research aims to study the way in which the environmental risks of Gene Drive biotechnology challenge forms of effective social participation, inserted in the management of biotechnological risks, whose responsibility lies with the organs ...
An overview of OECD activities related to modern techniques of biotechnology and genome editing
Tags: Gene drive synthetic, Policy, Risk and safetyKearns, P, Transgenic Research, 28:41-44. 2019.
Since commercial use of genetically-engineered (genetically- modified) plants started in 1996, many agricultural products have been developed to improve crop traits. The foods and feeds derived from these commodities have drastically increased worldwide. However, answering health ...
Safe CRISPR: Challenges and Possible Solutions
Tags: Gene drive synthetic, Policy, Risk and safetyPineda, ML, A.; Collins, J. P.; Kiani, S., Trends in Biotechnology, 37:389-401. 2019.
Applications of CRISPR in human health and in gene drives are at the forefront of biological research as tools. This technology will affect humankind and our environment, so as this technology pushes forward, the design and implementation of safety measures is imperative. Novel ...
The ethical landscape of gene drive research
Tags: Ethics, PolicyCallies, DE, Bioethics, 33:1091-1097. 2019.
Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social ...
CRISPR in sub-Saharan Africa: Applications and education
Tags: Gene drive synthetic, PolicyOgaugwu, CEA, S. O.; Adekoya, M. A., Trends in Biotechnology, 37:234-237. 2019.
Clustered regularly interspaced shortpalindromicrepeats (CRISPR) technology has enabled genetic engineering feats previously considered impracticable, offering great hopes for solutions to problems facing society. We consider it timely to highlight how CRISPR can benefit public ...
The EU regulatory framework on genetically modified organisms (GMOs)
Tags: Europe, Gene drive, Genetically modified organisms, Policy, Regulation, Risk and safety, Synthetic biologyBruetschy, C, Transgenic Research, 28:169-174. 2019.
The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their ...
Promises and perils of gene drives: Navigating the communication of complex, post-normal science
Tags: Ethics, Policy, Risk and safetyBrossard, DB, Pam; Gould, Fred; Wirz, Christopher D., Proceedings of the National Academy of Sciences of the United States of America, 116:7692-7697. 2019.
In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss ...
Gene drives as a new quality in GMO releases-a comparative technology characterization
Tags: Policy, Regulation, Risk and safetyFriess, JLvG, A.; Giese, B., Peerj, 7:e6793. 2019.
Compared to previous releases of genetically modified organisms (GMOs) which were primarily plants, gene drives represent a paradigm shift in the handling of GMOs: Current regulation of the release of GMOs assumes that for specific periods of time a certain amount of GMOs will be ...
Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018
Tags: Gene drive synthetic, Policy, Regulation, Risk and safetyTeem, JLA, Aggrey; Glover, Barbara; Ouedraogo, Jeremy; Makinde, Diran; Roberts, Andrew, Malaria Journal, 18:347. 2019.
Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an ...
The Release of Genetically Engineered Mosquitoes in Burkina Faso: Bioeconomy of Science, Public Engagement and Trust in Medicine
Tags: Africa, Ethics, Genetically modified organisms, Malaria, Mosquitoes, Policy, Risk and safetyBeisel, UG, J. K., African Studies Review, 62:164-173. 2019.
Malaria, which is transmitted by mosquitoes, continues to be responsible for a significant number of disease episodes and childhood deaths on the African continent. A variety of mosquito control strategies are currently inplace, but since case numbers are rising again, and drug ...
Governing extinction in the era of gene editing
Tags: Ethics, Gene drive synthetic, Policy, Risk and safetyMonast, JJ, North Carolina Law Review, 97:1329-1358. 2019.
CRISPR-Cas9 genome-editing technology (“CRISPR”) offers a potential solution for some of the world’s critical conservation challenges. Scientists are harnessing CRISPR to expand genetic diversity of endangered species, control invasive species, or enhance species’ ...
Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors
Tags: Policy, Regulation, Risk and safetyDevos, YC, W.; Devlin, R. H.; Ippolito, A.; Leggatt, R. A.; Romeis, J.; Shaw, R.; Svendsen, C.; Topping, C. J., EFSA Journal, 17:e170708. 2019.
Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally ...
Gene driving the farm: who decides, who owns, and who benefits?
Tags: Agriculture, CRISPR, Ethics, Gene drive, Other arthropods, Risk and safetyMontenegro de Wit, M, Agroecology and Sustainable Food Systems, 43:1054-1074. 2019.
This commentary essay explores the social and ecological implications of gene-driving agriculture.
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