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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

Regulation of emerging gene technologies in India

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Ahuja, V.,  BMC Proceedings,  12:14. 2018.
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 ...

Gene drives and the management of agricultural pests

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R. F. Medina,  Journal of Responsible Innovation,  5:S255-S262. 2018.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

Gene drives and the expanding horizon of governance

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E. Fisher,  Journal of Responsible Innovation,  5:S1-S3. 2018.
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 ...

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.
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, ...

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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

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.
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 ...

Making policies about emerging technologies

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Kaebnick, G. E. and M. K. Gusmano,  Hastings Center Report,  48:S2-S11. 2018.
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 ...

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