Regulation and Policy

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

Informed consent and community engagement in open field research: lessons for gene drive science

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Singh, JA,  BMC Medical Ethics,  20:54. 2019-01-03 00:00:00.
The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings.

Two minutes to midnight-what international law can do about genome editing

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Lee, TL,  Asian Journal of Wto & International Health Law and Policy,  14:227-265. 2019-01-03 00:00:00.
With its ability to transform the ecosystem, gene drives, a powerful genome-editing technology, poses nuanced regulatory challenges. In particular, as gene drives can override the normal rule of inheritance, where the impacts of gene-drive modified organisms on the environment could be irreversible, leading to a permanent population change. Moreover, as these gene-drive modified organisms are designed to spread to large populations, they can also penetrate national and geographic borders, with global implications. Insofar as gene drive applications could be both potentially beneficial as well as hazardous to the world, this article seeks to explore ways in which international law could provide a useful platform to engage the relevant stakeholders in general, and encourage responsible science in specific.

An introduction to the proceedings of the environmental release of engineered pests: Building an international governance framewor

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Brown, Z. S., L. Carter and F. Gould,  BMC Proceedings,  12:10. 2018-12-17 17:44:54.
In October 2016, a two-day meeting of 65 academic, government and industry professionals was held at North Carolina State University for early-stage discussions about the international governance of gene drives: potentially powerful new technologies that can be used for the control of pests, invasive species and disease vectors. Presenters at the meeting prepared seven manuscripts elaborating on the ideas raised. This BMC Proceedings issue presents the collection of these peer-reviewed manuscripts.

Towards inclusive social appraisal: risk, participation and democracy in governance of synthetic biology

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Stirling, A., K. R. Hayes and J. Delborne,  BMC Proceedings,  12:15. 2018-12-17 17:05:25.
Frameworks that govern the development and application of novel products, such as the products of synthetic biology, should involve all those who are interested or potentially affected by the products. The governance arrangements for novel products should also provide a democratic mechanism that allows affected parties to express their opinions on the direction that innovation does or does not take. In this paper we examine rationales, obstacles and opportunities for public participation in governance of novel synthetic biology products. Our analysis addresses issues such as uncertainties, the considering of alternative innovations, and broader social and environmental implications. The crucial issues in play go beyond safety alone, to include contending social values around diverse notions of benefit and harm. The paper highlights the need for more inclusive social appraisal mechanisms to inform governance of Synthetic Biology and alternative products, and discusses a few practical methods to help achieve this goal.

Public engagement pathways for emerging GM insect technologies

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Burgess, M. M., J. D. Mumford and J. V. Lavery,  BMC Proceedings,  12(Suppl 8):12. 2018-12-17 17:02:52.
Policy and management related to the release of organisms generated by emerging biotechnologies for pest management should be informed through public engagement. Regulatory decisions can be conceptually distinguished into the development of frameworks, the assessment of the release of a specific modified organism, and implementation decisions such as location and timing. Although these decisions are often intertwined in practice, the negotiation takes place at different stages of technology development and suggests different roles for public engagement. Some approaches to public engagement are more appropriate for different purposes and situations, and it is not always obvious how to go about matching the approach to the purpose. In addition to the diverse technologies involved in generating modified organisms, there are diverse publics with particular interests and different kinds of knowledge. Institutional interests range from commercial development to public regulation and future uptake. Contextual features, such as agency mandates, may limit or structure the extent and approach to public engagement. Different convening groups (government agencies, public interest groups, academics, businesses) and the kind of decision that is being considered determine what kind of input is needed and how the engaging groups will be constituted. This paper considers how the context of the release of genetically modified insects for pest control requires expanding approaches to the design of the public engagement.

GM insect pests under the Brazilian regulatory framework: development and perspectives

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Andrade, P. P., M. A. da Silva Ferreira, M. S. Muniz and A. de Casto Lira-Neto,  BMC Proceedings,  12:15. 2018-12-17 17:00:23.
The emergence of new technologies for genetic modification has broadened the range of possible new products. The regulations of many countries that could benefit from these new products may not be prepared to assess risks and enable science-based decision-making. This is especially acute in the case of genetically modified insects with potential use in public health and agriculture. Modifications of the regulatory framework, sometimes necessary to allow a proper risk assessment of products from new technologies, are strongly influenced by political decisions derived from the balance of power and interest among stakeholders. This article discusses the genesis of the Brazilian regulatory framework, its applicability for the risk assessment of genetically modified insects and the scenarios that have shaped the two biosafety laws that established the basis for the use of modern biotechnology in the country. It is concluded that, for the adoption of the new technologies, it is important to carefully navigate the political tensions by seeking the engagement and empowerment of stakeholders supporting science-based decision-making in order to gather the necessary support for adoption of risk assessment as the basis for final decisions, allowing the use of new technologies.

Regulation of emerging gene technologies in India

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Ahuja, V.,  BMC Proceedings,  12:14. 2018-12-17 16:57:35.
In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc.

Gene drives and the management of agricultural pests

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R. F. Medina,  Journal of Responsible Innovation,  5:S255-S262. 2018-01-24 16:01:13.
Like all pest control strategies, gene drives are not hazard-free. Ecological risk assessment of gene drives designed to control agricultural pests should be conducted before their deployment. The present commentary provides some thoughts on some of the issues one should consider when contemplating using gene drives in the management of agricultural pests.

Anomaly handling and the politics of gene drives

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S. W. Evans and M. J. Palmer,  Journal of Responsible Innovation,  5:S223-S242. 2018-01-24 15:56:09.
Decisions about the development and use of gene drives are framing broader debates about the need for fundamental changes to biotechnology regulatory systems. We summarize this debate and describe how gene drives are being constructed as potential anomalies within the regulatory landscape.

Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito

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Z. Meghani and J. Kuzma,  Journal of Responsible Innovation,  5:S203-S222. 2018-01-24 15:52:57.
In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. The rigorous regulation of insects and other animals with gene drive systems is crucial.

A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context

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J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye and S. Stauffer,  Journal of Responsible Innovation,  5:S13-S39. 2018-01-24 15:34:37.
This paper reports on a workshop held in February 2016 to explore the complex intersection of political, economic, ethical, and ecological risk issues associated with gene drives. Workshop participants were encouraged to use systems thinking and mapping to describe the connections among social, policy, economic, and ecological variables as they intersect within governance systems. In this paper, we analyze the workshop transcripts and maps using the Institutional Analysis and Development (IAD) framework to categorize variables associated with gene drive governance and account for the complexities of socio-ecological systems.

Mapping research and governance needs for gene drives

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J. Delborne, J. Kuzma, F. Gould, E. Frow, C. Leitschuh and J. Sudweeks,  Journal of Responsible Innovation,  5:S4-S12. 2018-01-24 15:28:09.
This special issue represents both deep and broad thinking about gene drives. The papers were first drafted nearly two years ago, and since then have been reviewed and revised to flesh out key arguments and take account of ongoing developments in the field. This field has moved very fast indeed! Technical research publications have increased in number; NASEM released a major report in June 2016; and workshops have proliferated.

Gene drives and the expanding horizon of governance

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E. Fisher,  Journal of Responsible Innovation,  5:S1-S3. 2018-01-24 15:23:59.
Like other areas of emerging science and technology that trigger prolonged public debate over their transformative prospects, gene drives simultaneously generate prospects for new knowledge, hoped-for benefits, and formidable concerns. Their ability to bias inheritance of and in theory spread a genetic trait throughout an entire population of organisms—even to the point of extinction—is driving home the need for their responsible governance. Significantly, it is also driving home the need to develop capacities for such governance.

Means and ends of effective global risk assessments for genetic pest management

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Turner, GB, Camilla; Roda, Lucia,  BMC Proceedings,  12:13. 2018-01-20 00:00:00.
The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, animal health and the environment in which it will be released. Some countries also require information on socio-economic and trade impacts. One of the key elements that assists decision-making under those legal frameworks is the use of risk assessments. The risk assessment paradigm of problem formulation based on risk hypothesis, and the assessment of plausible scientific pathways leading to potential environmental and human harms being realised, has been used widely to assess potential risks of genetic technologies to human health and the environment, from crops to mosquitoes. This paper uses the case study of a genetically modified self-limiting olive fly (Bactrocera oleae) for a first deliberate release in Spain to examine the regulatory processes and stakeholders involved in the assessment of risk. It is anticipated that existing risk assessment frameworks are equally applicable to gene drive technologies that may spread and persist in the environment and cross-national borders, but it is the governance structures surrounding the involvement of civil society in regulatory processes that must be administered in a more transparent and defined manner.

Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as cases

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Trump, BF, C.; Rycroft, T.; Wood, M. D.; Bandolin, N.; Cains, M.; Cary, T.; Crocker, F.; Friedenberg, N. A.; Gurian, P.; Hamilton, K.; Hoover, J.J.; Meyer, C.; Pokrzywinski, K.; Ritterson, R.; Schulte, P.; Warner, C. ; Perkins, E.; Linkov, I.,  Environmental Systems and Decisions,  38:517-527. 2018-01-19 00:00:00.
Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly characterized and prioritized hazard, exposure, and dose–response considerations associated with the development and use of synthetic biology-derived organisms. Where quantitative risk assessment approaches are necessarily to fulfill regulatory requirements for review of products containing genetically modified organisms, this paper reviews one potential avenue for early-stage quantitative risk assessment for biosafety considerations of synthetic biology organism deployment into the environment. Building from discussion from a March 2018 US Army Engineer Research and Development Center workshop on developing such quantitative risk assessment for synthetic biology, this paper reviews the findings and discussion of workshop participants. This paper concludes that, while synthetic biology risk assessment and governance will continue to refine and develop in the coming years, a quantitative framework that builds from existing practice is one potentially beneficial option for risk assessors that must contend with the technology’s limited hazard characterization or exposure assessment considerations in the near term.

Developing standard operating procedures for gene drive research in disease vector mosquitoes

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Z. N. Adelman, D. Pledger and K. M. Myles,  Pathogens and Global Health,  111:436-447. 2018-01-18 14:41:42.
Here we discuss information to be considered by principal investigators, biosafety officers, and institutional biosafety committees as they work together to develop SOPs for experiments involving gene drive in arthropods, and describe various courses of action that can be used to maintain the effectiveness of SOPs through evaluation and revision. The information provided herein will be especially useful to investigators and regulatory personnel who may lack extensive experience working with arthropods under containment conditions.

Identifying and detecting potentially adverse ecological outcomes associated with the release of gene-drive modified organisms

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Hayes, KRH, G. R.; Dana, G. V.; Foster, S. D.; Ford, J. H.; Thresher, R.; Ickowicz, A.; Peel, D.; Tizard, M.; De Barro, P.; Strive, T.; Dambacher, J. M.,  Journal of Responsible Innovation,  5:S139-S158. 2018-01-18 00:00:00.
Synthetic gene drives could provide new solutions to a range of old problems such as controlling vector-borne diseases, agricultural pests and invasive species. In this paper, we outline methods to identify hazards and detect potentially adverse ecological outcomes at the individual (genotype, phenotype), population, community and ecosystem level, when progressing Gene Drive Modified Organisms through a phased test and release pathway. We discuss the strengths and weaknesses of checklists and structured hazard analysis techniques, identify methods to help meet some of the challenges of detecting adverse ecological outcomes in experiments and confined field trials, and discuss ways to improve the efficiency and statistical rigour of post-release monitoring strategies.

THE NATIONAL BIOSAFETY TECHNICAL COMMISSION (CTNBio) NORMATIVE RESOLUTION No. 16, OF JANUARY 15, 2018

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CTNBio,  National Biosafety Technical Commission of Brasil,  2018-01-15 15:17:02.
Sets forth the technical requirements for submitting an inquiry to the CTNBio concerning Precision Breeding Innovation Techniques. THE NATIONAL BIOSAFETY TECHNICAL COMMISSION (CTNBio), using its legal and regulatory powers and in observance of sections XV and XVI of article 14 of Law No. 11.105 of March 24, 2005; Whereas there is a need to assess Precision Breeding Innovation (PBI) techniques, which also comprise the so-called New Breeding Technologies (NBTs) in the light of Law No. 11.105 of March 24, 2005;

Community engagement and field trials of genetically modified insects and animals

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Neuhaus, C. P.,  Hastings Center Report,  48:25-36. 2018-01-01 16:29:11.
New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally?and has attempted to conduct field trials in the United States?of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito-borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what ?engagement? means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals? preferences. Community engagement foregrounds the community in our thinking about humans? relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy-makers, private companies, research funders, or scientists alone.

Making policies about emerging technologies

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Kaebnick, G. E. and M. K. Gusmano,  Hastings Center Report,  48:S2-S11. 2018-01-01 16:23:19.
Can we make wise policy decisions about still-emerging technologies?decisions that are grounded in facts yet anticipate unknowns and promote the public's preferences and values? There is a widespread feeling that we should try. There also seems to be widespread agreement that the central element in wise decisions is the assessment of benefits and costs, understood as a process that consists, at least in part, in measuring, tallying, and comparing how different outcomes would affect the public interest. But how benefits and costs are best weighed when making decisions about whether to move forward with an emerging technology is not clear. Many commentators feel that the weighing is often inadequate or inappropriate. Those who argue for a ?precautionary? approach to the weighing do so precisely because they feel the need for a restraint on the dominant decision-making tools and processes for assessing outcomes. This Hastings Center special report examines those tools and processes, taking the method known as cost-benefit analysis as a starting point. In U.S. governance, CBA, sometimes informed by risk assessment, is the most widely used and extensively studied method, and authoritative reports on genetic and reproductive technologies often use language suggestive of cost-benefit analysis. There is also a long-running debate about the role of values in CBA and other formal impact assessment mechanisms?and about how those mechanisms compare to the precautionary principle. The guiding idea in the report is to engage in a close examination of the strengths and limits of CBA for ensuring that emerging technologies are used in ways that square with the public's values, drawing on applications of synthetic biology to illustrate and sharpen the analysis and then considering corrections to CBA and some alternative methodologies that handle values differently.

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