Regulation and Policy

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

Informed consent in field trials of gene-drive mosquitoes

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P. A. Kolopack and J. V. Lavery,  Gates Open Research,  2017-12-11 14:46:00.
We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.

Report of the ad hoc technical expert group on synthetic biology

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Ad Hoc Technical Working Group,  Convention on Biological Diversity,  2017-12-08 14:12:31.
In decision XIII/17, the Conference of the Parties to the Convention on Biological Diversity commended the work of the online forum and the Ad Hoc Technical Expert Group on Synthetic Biology (AHTEG) and welcomed the conclusions and recommendations of the report of the AHTEG as a basis for further discussion. The Conference of the Parties also considered the operational definition useful as a starting point for the purpose of facilitating scientific and technical deliberations under the Convention and its Protocols and took note of the conclusion of the AHTEG that living organisms developed through synthetic biology are similar to living modified organisms (LMOs) as defined in the Cartagena Protocol. The Conference of the Parties noted that the general principles and methodologies for risk assessment under the Cartagena Protocol and existing biosafety frameworks provide a good basis for risk assessment of living organisms developed through synthetic biology, but such methodologies might need to be updated and adapted.

ASSEMBLY OF THE UNION Twenty-Ninth Ordinary Session: DECISIONS, DECLARATIONS AND RESOLUTION

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African Union,  African Union,  2017-07-04 14:45:50.
Assembly/AU/Dec.649(XXIX): COMMITS to sustain the gains made in the fight against Malaria and monitor antimalarial drug resistance and insecticide resistance; COMMITS ALSO to invest in the development and regulation of the gene-drive technology as well as other new innovations including next generation insecticides for Indoor Residual Spraying and Long Lasting Insecticidal Nets, Rapid Diagnostic Tests and Artemisinin-based Combination Therapy for the elimination of malaria and REQUESTS the Commission, WHO and NEPAD Agency to support these initiatives;

The use of gene editing to create gene drives for pest control in New Zealand

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Royal Society Te Apārangi Gene Editing Panel,  Royal Society of New Zealand,  2017-06-06 13:54:28.
to explore the implications of gene editing technology for New Zealand, the Royal Society Te Apārangi has convened a multidisciplinary panel of some of New Zealand’s leading experts to consider the social, cultural, legal and economic implications of revolutionary gene-editing technologies for New Zealand to: • Raise awareness of the scientific possibilities and associated public issues of new gene editing technologies to inform debate • Provide information and guidance for policy makers to address current and new issues needing to be clarified or resolved • Show where gene-editing applications are covered by established policies and regulations and where changes are needed • Provide a New Zealand perspective to the global discussion on this technology and identify where global consensus is important T

SCIENTIFIC OPINION: In response to the referral of 12 October 2015 concerning use of genetically modified mosquitoes for vector control

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High Council for Biotechnology,  High Council for Biotechnology (France),  2017-05-31 13:46:03.
The Scientific Committee’s opinion describes emerging vector control techniques using GM mosquitoes, the current state of research into and development of these techniques and the outcomes of initial experiments worldwide. To date, only one technique has been developed to an operational level: Oxitec’s RIDL technique, which sets out to reduce a mosquito population by repeated mass releases of sterilising transgenic males. Two other techniques at an earlier stage of research and development are based on gene drive, seeking to spread a genetic trait in a wild population, either to make the mosquitoes incapable of transmitting pathogens (gene drive for population modification) or to eliminate the population by spreading sterility (gene drive for population elimination).

Genome editing: scientific opportunities, public interests and policy options in the European Union

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EASAC,  European Academies Science Advisory Council,  2017-03-01 14:41:21.
In many of the areas in which EASAC, the European Academies’ Science Advisory Council, works, where a large and solid body of knowledge is needed to inform the action of our societies, it is important to recognise that there is an intimate mix of science and values involved in discussion. Such discussions are most fruitful when both knowledge and values are well identified. This report presents a broad synthesis of genome editing, one of the newer aspects of the biosciences. It is our hope that presenting clearly the science involved – the duty of academies – will serve the ongoing discussions within society that the report recommends be vigorously pursued.

Principles for gene drive research

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Emerson, CJ, Stephanie; Littler, Katherine; Randazzo, Filippo,  Science,  358:1135. 2017-01-19 00:00:00.
The recent outbreak of Zika virus in the Americas renewed attention on the importance of vector-control strategies to fight the many vector-borne diseases that continue to inflict suffering around the world. In 2015, there were ?212 million infections and a death every minute from malaria alone (1). Gene drive technology is being explored as a potentially durable and cost-effective strategy for controlling the transmission of deadly and debilitating vector-borne diseases that affect millions of people worldwide, such as Zika virus and malaria. Additionally, its suitability is being evaluated for various potential applications in conservation biology, including a highly specific and humane method for eliminating invasive species from sensitive ecosystems (2, 3).

Gene drives do not always increase in frequency: from genetic models to risk assessment

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de Jong, TJ,  Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety,  12:299-307. 2017-01-14 00:00:00.
Homing genes encode endonucleases that make a double stranded break in the DNA, destroying a target site on the homologous chromosome. When the cell repairs the break the homing allele is copied, converting a heterozygote into a homozygote. This results in gene drive (GD), an overrepresentation of the homing allele in the next generation. GD may propel CRISPR-Cas9 genes and new genes physically coupled to the GD through natural populations. I revisit the population genetic models of GD with the aim of making these models more understandable to non-specialists. What can we learn about risk evaluation from the models? A GD with no or a small effect on fitness (viability) always spreads in the population and goes to fixation. That is provided that no resistance mechanism evolves, for instance due to a mutation in the target site. However, when GDs have a large negative effect on fitness, their spread depends on a threshold or they may not spread at all. The chance of GDs increasing until fixation is much higher in systems with meiotic drive than in systems with embryo conversion. The presence or absence of a meiotic promoter is therefore relevant to take into account in the environmental risk assessment.

Agricultural pest control with CRISPR-based gene drive: time for public debate: Should we use gene drive for pest control?

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Courtier?Orgogozo, VM, Baptiste; Boëte, Christophe,  EMBO Reports,  18:878-880. 2017-01-13 00:00:00.
Gene drive based on the CRISPR/Cas-9 gene editing system is a powerful technology that promotes the inheritance of the gene drive tool itself via sexual reproduction and can therefore spread quickly through a population. It holds great potential for public health and humanitarian purposes, such as reducing the burden of vector-borne diseases like malaria. Here, we discuss another potential application of CRISPR-based gene drive, namely the control of pest species to increase crop production. We argue that gene drive-based pest control strategies should receive more attention from policymakers and the public given their enormous potential impact on the environment, their easy accessibility, and the current dearth of regulations.

Unintended consequences of 21st century technology for agricultural pest management

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Young, SL,  EMBO reports,  18:1478-1478. 2017-01-13 00:00:00.
Comment on Agricultural pest control with CRISPR-based gene drive: time for public debate by Courtier-Orgogozo et al.

Adaptive risk management of gene drive experiments: Biosafety, biosecurity, and ethics

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Lunshof, JEB, A.,  Applied Biosafety,  22:97-103. 2017-01-12 00:00:00.
Emerging technologies in the life sciences call for new models of biosafety risk management. We examine the question of how to; address new developments in the life sciences and biosciences in a bottom-up manner—that is, from the concrete level of; biosafety practice with a focus on the risk management and risk assessment of emerging technologies in the biology laboratory.; We use research on “gene drives” as an example of challenging work with new constructs that have major biosafety implications; for the work in the laboratory and beyond. Gene drives are intended for use in ecosystems and require, at an early stage, the; consideration of potential future biosafety, biosecurity, and societal impact. We argue for an integrative approach, a truly collaborative; model that involves scientists, biosafety officers, institutional leadership, and ethics consultants, with the aim of; maximizing safety as well as scientific progress.

CRISPR-based gene drive in agriculture will face technical and governance challenges

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Gutzmann, NE, Johanna E.; Barnes, Jessica Cavin; Baltzegar, Jennifer; Jones, Michael S.; Sudweeks, Jayce,  EMBO reports,  18:1479-1480. 2017-01-03 00:00:00.
Comment on "Agricultural pest control with CRISPR-based gene drive: time for public debate" by Courtier-Orgogozo et al.

National Academies hit the brakes on gene drive-modified organisms

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Abbasi, J.,  JAMA-Journal of the American Medical Association,  316:482-483. 2016-12-17 18:11:25.
Despite their potential for fighting Zika, malaria, and other public health scourges, organisms that have been engineered to quickly spread genetic modifications through a population—and possibly an entire species—are not ready for release into the wild, a committee of interdisciplinary experts concluded in a recent report by the National Academies of Sciences, Engineering, and Medicine (http://bit.ly/1UHuqQk). So-called gene drive–modified organisms “require more research in laboratories and highly controlled field trials,” the committee said in a statement (http://bit.ly/1tkWCTO). Gene drives are systems of “biased inheritance” that enhance a genetic element’s ability to pass from parent organism to offspring through sexual reproduction. These selfish genetic elements could be genes or their fragments, all or parts of chromosomes, or noncoding DNA, the report stated.

Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment

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Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management,,  Convention on Biological Diversity,  2016-09-14 21:27:35.
This document was developed by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, with input from the Open-ended Online Expert Forum, in accordance with terms of reference set out by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) in its decisions BS-IV/11 and BSV/12 in response to an identified need for further guidance on risk assessment of LMOs. 4 It is intended to be a “living document” that may be updated and improved as appropriate and when mandated by the Parties to the Cartagena Protocol on Biosafety.

Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values

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U. S. National Academies of Sciences, Engineering, and Medicine,  The National Academies Press,  2016-07-08 20:32:51.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies. Just prior to the beginning of this study and since the committee was first convened, scientists published four proofs of concept— one in yeast, one in fruit flies, and two in different species of mosquitoes—that demonstrate the successful development of gene drives in the laboratory, at least in these organisms. Proposed applications for gene-drive modified organisms for basic research, conservation, agriculture, public health and other purposes will likely continue to expand as gene editing tools become more refined. Gene-drive modified organisms are on the horizon. The fast moving nature of this field is both encouraging and concerning. While gene-drive modified organisms hold promise for addressing difficult to solve, persistent challenges, such as the eradication of vector-borne diseases and the conservation of threatened and endangered species, these proposed applications are based on limited proof-of-concept studies. The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place. Responding to this fast moving field, the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH)2 asked the National Academies of Sciences, Engineering, and Medicine to convene a committee with a broad range of expertise to summarize the scientific discoveries related to gene drives and considerations for their responsible use. Proof-of-concept in a few laboratory studies is not sufficient in and of itself to support a decision to release gene-drive modified organisms into the environment. Laboratory and field research is needed to refine CRISPR/Cas9-based gene drives and other gene drive mechanisms, and to understand how gene drives might work under different environmental conditions and in a wide variety of organisms. The considerable gaps in knowledge about potential off-target (within the organism) and non-target (in other species or the environment) effects necessitate a collaborative, multidisciplinary approach to research, ecological risk assessment, development of public policy, and decision making for each proposed application of a gene drive technology. General principles to guide responsible practices for gene drives from the laboratory setting through to field release and monitoring are embedded as recommendations throughout the report.

Engineering the wild: Gene drives and intergenerational equity

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J. Kuzma and L. Rawls,  Jurimetrics,  56:279-296. 2016-03-01 16:08:02.
New genetic engineering methods are allowing scientists to insert genes into organisms that have the potential to spread themselves throughout natural populations upon the release of individuals carrying those genes. Gene drive technology is being researched and developed for purposes of reducing or eliminating human, ecological or agricultural pest populations, or immunizing other desirable or endangered species against pests and disease. The ability of humans to alter populations within ecosystems through genetic engineering raises issues associated with biodiversity and conservation that, in turn, may affect the abilities of current and future generations to use and enjoy the benefits of the natural world. Yet, children and future generations are not typically given voice in legal, policy, or ethical debates. This article examines several of the intergenerational equity issues posed by gene drive technologies. A typology of gene drive purposes and their potential ecological impacts is developed, followed by an examination of how they may intersect with concerns about intergenerational equity. To our knowledge, this analysis is the first to explore human intervention through genetically engineering populations in the wild and the impacts on future generations

Science and Technology Committee Genetically Modified Insects

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UK Parliament,  UK Parliament,  2015-12-17 21:18:14.
The UK is a world leader in the development of this technology. The European Union’s regulatory process, however, is likely to hold back progress. There is a moral duty to test the potential of the technology. We therefore support further research and call for action to test the efficiency of the EU process via a trial which should also be used to drive public engagement. GM insect technology has already been trialled for dengue transmitting mosquitoes.

Can systematic reviews inform GMO risk assessment and risk management?

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Kohl, CF, G.; Sweet, J.; Spok, A.; Haddaway, N.R.; Wilhelm, R.; Unger, S.; Schiemann, J.,  Frontiers in Bioengineering and Biotechnology,  3:113. 2015-01-19 00:00:00.
Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a “gold standard” for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.

Safeguarding gene drive experiments in the laboratory

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Akbari, OSB, H. J.; Bier, E.; Bullock, S. L.; Burt, A.; Church, G. M.; Cook, K. R.; Duchek, P.; Edwards, O. R.; Esvelt, K. M.; Gantz, V. M.; Golic, K. G.; Gratz, S. J.; Harrison, M. M.; Hayes, K. R.; James, A. A.; Kaufman, T. C.; Knoblich, J.; Malik, H. S.; Matthews, K. A.; O'Connor-Giles, K. M.; Parks, A. L.; Perrimon, N.; Port, F.; Russell, S.; Ueda, R.; Wildonger, J.,  Science,  349:927-929. 2015-01-05 00:00:00.
Gene drive systems promote the spread of genetic elements through populations by assuring they are inherited more often than Mendelian segregation would predict (see the figure). Natural examples of gene drive from Drosophila include sex-ratio meiotic drive, segregation distortion, and replicative transposition. Synthetic drive systems based on selective embryonic lethality or homing endonucleases have been described previously in Drosophila melanogaster (1–3), but they are difficult to build or are limited to transgenic populations. In contrast, RNAguided gene drives based on the CRISPR/Cas9 nuclease can, in principle, be constructed by any laboratory capable of making transgenic organisms (4). They have tremendous potential to address global problems in health, agriculture, and conservation, but their capacity to alter wild populations outside the laboratory demands caution (4–7). Just as researchers working with self-propagating pathogens must ensure that these agents do not escape to the outside world, scientists working in the laboratory with gene drive constructs are responsible for keeping them confined (4, 6, 7).

Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes (GMMs)

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WHO/TDR,  WHO/TDR Training Manual,  2015-01-01 20:09:55.
This Training manual: Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes (GMMs) is based on biosafety training courses on GMMs undertaken in Africa, Asia and Latin America from 2008–2011. The courses were conceived by Yeya Touré, formerly Unit Leader (Vectors, Environment and Society), WHO/TDR, Geneva, Switzerland. Brij Kishore Tyagi (Asia course coordinator and Principal Investigator of the “Biosafety Manual-GMM Project”) prepared the first draft and compiled the Manual with invaluable assistance from the late Madama Bouaré (Africa course coordinator), Maria Corena-McLeod and Ivan Velez (Latin America course coordinators), and all those involved in preparing the courses

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