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

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Rüdelsheim, PKJS, G.,  COGEM,  2019-09-05 00:00:00.
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 pressure. They have been proposed; as offering solutions for many challenges in public health, agriculture, conservation and others. They have; inspired researchers to use gene drives to combat diseases transmitted by insects such as malaria,; dengue and Zika.; For decennia attempts have been made to use or modify naturally occurring gene drive mechanisms. Yet,; natural gene drives have their limitations. Transposable element-based drives turned out to be not efficient; enough. Moreover, they cannot be directed. Translocation drives are hard to establish and suffer from a; high fitness cost. Others are only active in specific species (e.g. meiotic drive, MEDEA).

Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives

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Office of the Gene Technology Regulator,  Australian Government, Department of Health,  2019-09-01 15:35:42.
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 (NLRDs). Gene drives are genetic elements that are favoured for inheritance, and which can therefore spread through populations at a greater rate than genes with standard Mendelian inheritance. Gene drives can only spread from sexually reproducing parents to their offspring. If gene technology is used to introduce or create a gene drive in an organism, the resulting organism will be a GMO and subject to regulation under the Gene Technology Act 2000.

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

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Z. Meghani,  Global Policy,  10:554-568. 2019-08-05 18:30:26.
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 has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political-economic-legal problems that would arise with the environmental release of such organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected.

Synthetic Biology: Research Needs for Assessing Environmental Impacts

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C. 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,  2019-08-01 18:23:43.
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 sponsored by the U.S. Army Engineer Research and Development Center (ERDC) to discuss applications of synthetic biology with likely or intended interaction with the environment. Representatives from academia, government agencies, industry, and non-governmental organizations convened to identify knowledge gaps and research needs to assess potential environmental impacts from these technologies. The group discussed challenges in environmental risk assessment, regulation, and community engagement for emerging synthetic biology technologies. The workshop was structured around four hypothetical case studies, including the use of gene drive engineered organisms to control infectious disease vectors, engineered microbes for bioremediation, cell-free applications for advanced chemical production, and engineered viruses for water treatment. Meeting these research needs will facilitate appropriate environmental risk assessment and informed decision making for the development and potential deployment of synthetic biology organisms and components in the environment.

Synthetic Biology and the United Nations

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H.-E. Lai, C. Canavan, L. Cameron, S. Moore, M. Danchenko, T. Kuiken, Z. Sekeyová and P. S. Freemont,  Trends in Biotechnology,  37:1146-1151. 2019-06-27 14:42:54.
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 relates to these international deliberations, particularly the Convention on Biological Diversity (CBD).

Gene drives and the international biodiversity regime

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F. Rabitz,  Review of European, Comparative & International Environmental Law,  2019-05-17 17:30:54.
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 potential adverse effects on biological diversity. This text assesses gene drive governance under the Convention on Biological Diversity (CBD) and its Cartagena Protocol on Biosafety. While gene drives are directly relevant for the objectives of both agreements, their regulatory frameworks have not kept up with the pace of technological change. The focus of this article is on the analysis of gaps and inconsistencies within both agreements. It highlights numerous elements of the CBD and the Cartagena Protocol that raise challenges for gene drive governance, such as matters related to regulatory scope, transboundary movements, precaution and invasive alien species.

Gene drive organisms: What Africa should know about actors, motives and threats to biodiversity and food systems

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Sirinathsinghji, E.,  African Centre for Biodiversity.,  2019-05-13 16:51:45.
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 have been gene drive technologies proposed by the Gates-funded Target Malaria consortium, as a tool to reduce the transmission of malaria on the continent, the debate about gene drive organisms goes well beyond gene drive mosquitoes. Plans by gene drive developers target pests, pollinators, weeds and the speeding up of plant breeding programmes. The logic of using these technologies in agriculture relies on the continued deception that exceedingly complex problems in the food system in Africa can be resolved simply by new high-tech innovations, while downplaying their potential risks to biodiversity and livelihoods.

RISCOS BIOTECNOLÓGICOS AMBIENTAIS E PARTICIPAÇÃO SOCIAL: POR UMA GESTÃO DEMOCRÁTICA DA BIOTECNOLOGIA GENE DRIVE NA ATUAÇÃO DA CTNBIO

23872
L. C. Rodrigues,  Revista Jurídica (FURB),  22. 2019-03-15 09:15:24.
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 linked to the State (CTNBio performance). The method of hypothetical-deductive approach, the method of topical and systematic juridical interpretation and the technique of bibliographic research were used. The conclusion reached was that the need to strengthen the objective sharing of information in an advisory manner to the general public in the face of Gene Drive's biotechnology risks within the framework of the CTNBio from the modification of the current Public Hearings legal model, which gives indications of omissions and lags before the complexity of the theme..

An overview of OECD activities related to modern techniques of biotechnology and genome editing

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Kearns, P,  Transgenic Research,  28:41-44. 2019-01-21 00:00:00.
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 and environmental safety concerns associated with the agricultural use of biotechnology is essential in countries producing the products, as well as in countries using them. To address these concerns, the OECD conducts programmes of work for sharing information, developing tools to facilitate a harmonised approach of risk assessment, and contributing to building consensus between national authorities. This report provides background information on some OECD activities related to safety considerations associated with the use of biotechnology in agriculture (covering applications to crop plants, trees, animals, micro-organisms), including the recent emergence of genome editing techniques.

Safe CRISPR: Challenges and Possible Solutions

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Pineda, ML, A.; Collins, J. P.; Kiani, S.,  Trends in Biotechnology,  37:389-401. 2019-01-15 00:00:00.
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 technologies and forethought in various applications of CRISPR are essential for using this technology safely. Here, we review environmental and health-related safety concerns associated with using CRISPR and ways proposed to minimize risk.

The ethical landscape of gene drive research

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Callies, DE,  Bioethics,  33:1091-1097. 2019-01-15 00:00:00.
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 and ethical issues. This article aims to introduce gene drive technology, some of its potential applications, and some of the social and ethical issues that arise during research into the technology. For example, is investigation into gene drives hubristic? Would applications of gene drives count as technological fixes? Or does research into such a technology sit on a slippery slope or lock us in to its full-scale use? Are there perverse effects of engaging in research, and, most importantly, who ought to be included in the decision-making process regarding research and field trials? Understanding the basic ethical landscape of this technology will prove invaluable to the public, scientists, and policy-makers as research moves forward.

CRISPR in sub-Saharan Africa: Applications and education

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Ogaugwu, CEA, S. O.; Adekoya, M. A.,  Trends in Biotechnology,  37:234-237. 2019-01-13 00:00:00.
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 health, medicine, and agriculture in sub-Saharan Africa (SSA) and offer recommendations for successful implementation.

The EU regulatory framework on genetically modified organisms (GMOs)

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Bruetschy, C,  Transgenic Research,  28:169-174. 2019-01-11 00:00:00.
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 use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

Promises and perils of gene drives: Navigating the communication of complex, post-normal science

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Brossard, DB, Pam; Gould, Fred; Wirz, Christopher D.,  Proceedings of the National Academy of Sciences of the United States of America,  116:7692-7697. 2019-01-10 00:00:00.
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 the issue from each of their unique perspectives. This paper builds on the ideas and conversations from the session to provide a more nuanced discussion about the context surrounding responsible communication and decision-making for cases of post-normal science. Deciding to use gene drives to control and suppress pests will involve more than a technical assessment of the risks involved, and responsible decision-making regarding their use will require concerted efforts from multiple actors. We provide a review of gene drives and their potential applications, as well as the role of journalists in communicating the extent of uncertainties around specific projects. We also discuss the roles of public opinion and online environments in public engagement with scientific processes. We conclude with specific recommendations about how to address current challenges and foster more effective communication and decisionmaking for complex, post-normal issues, such as gene drives.

Gene drives as a new quality in GMO releases-a comparative technology characterization

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Friess, JLvG, A.; Giese, B.,  Peerj,  7:e6793. 2019-01-09 00:00:00.
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 released in a particular region. However, now a type of genetic technology arises whose innermost principle lies in exceeding these limits-the transformation or even eradication of wild populations. The invasive character of gene drives demands a thorough analysis of their functionalities, reliability and potential impact. But such investigations are hindered by the fact that an experimental field test would hardly be reversible. Therefore, an appropriate prospective assessment is of utmost importance for an estimation of the risk potential associated with the application of gene drives. This work is meant to support the inevitable characterization of gene drives by a comparative approach of prospective technology assessment with a focus on potential sources of risk. Therein, the hazard and exposure potential as well as uncertainties with regard to the performance of synthetic gene drives are addressed. Moreover, a quantitative analysis of their invasiveness should enable a differentiated evaluation of their power to transform wild populations.

Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018

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Teem, JLA, Aggrey; Glover, Barbara; Ouedraogo, Jeremy; Makinde, Diran; Roberts, Andrew,  Malaria Journal,  18:347. 2019-01-08 00:00:00.
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 organized and ordered process to identify protection goals and potential pathways to harm to the environment, or animal or human health. Recognizing this need, the New Partnership for Africa’s Development (NEPAD), with support from African and international partners, organized four regional consultative workshops in Africa to initiate this process.

The Release of Genetically Engineered Mosquitoes in Burkina Faso: Bioeconomy of Science, Public Engagement and Trust in Medicine

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Beisel, UG, J. K.,  African Studies Review,  62:164-173. 2019-01-08 00:00:00.
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 and insecticide tolerance slow down progress made, there has been a push for innovative strategies. In August 2018, the National Biosafety Agency of Burkina Faso granted approval for the release of a maximum of 10,000 male Anopheles mosquitoes in experimental trials conducted by the multi-country consortium Target Malaria. These mosquitoes are rendered infertile through genetic modification, namely through “re-programming” of endonucleases that “cut through essential genes,” in this case, genes for fertility (Target Malaria 2019). The idea is that through the sterilization of male mosquitoes, the population of malaria-transmitting mosquitoes will be reduced, thereby decreasing the overall number of malaria infections.

Governing extinction in the era of gene editing

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Monast, JJ,  North Carolina Law Review,  97:1329-1358. 2019-01-06 00:00:00.
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’ resiliency to a changing climate. Recreating extinct species is now realistic, as is engineering entirely new species. CRISPR also creates opportunities to address vector-borne infectious diseases such as malaria, dengue fever, and Zika using gene drive techniques that can spread genetic alterations through populations. ; While CRISPR is a powerful tool to address public health and conservation goals, it could allow scientists to bypass longstanding value choices underlying national and international conservation efforts and foster permanent ecosystem impacts before public policy can react. This Article argues that, while current conservation laws do not directly address many of the specific questions that arise with CRISPR, the Endangered Species Act (“ESA”) establishes a framework that can, and should, guide the use of gene editing. The proposal calls for: (1) a presumption against the release of genetically modified organisms that could cause species extinction, (2) exemptions for specific public health and environmental goals, and (3) updates to the ESA to clarify oversight of gene editing.

Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors

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Devos, YC, W.; Devlin, R. H.; Ippolito, A.; Leggatt, R. A.; Romeis, J.; Shaw, R.; Svendsen, C.; Topping, C. J.,  EFSA Journal,  17:e170708. 2019-01-06 00:00:00.
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 devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision-making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference-based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive-modified mosquitoes and classical biological weed control agents on non-target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape-scale population-level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision-making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well-defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision-making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision-making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Gene driving the farm: who decides, who owns, and who benefits?

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Montenegro de Wit, M,  Agroecology and Sustainable Food Systems,  43:1054-1074. 2019-01-05 00:00:00.
This commentary essay explores the social and ecological implications of gene-driving agriculture.

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