Regulation and Policy

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

Bednets or Biotechnology: To Rescue Current Persons or Research for the Future?

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D. E. Callies,  Fudan Journal of the Humanities and Social Sciences,  14. 2020-08-13 13:44:08.
After an exploration of the duty to rescue and cost-effectiveness analysis, I suggest we look towards the literature on intergenerational justice for a justifiable answer to the question of how we ought to allocate our malaria resources.

Incorporating Characteristics of Gene Drive Engineered Ae. aegypti as Methods to Reduce Dengue and Zika Virus into the Bayesian Network – Relative Risk Model, Using Ponce, Puerto Rico as a Case Study

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S. R. Eikenbary,  WWU Graduate School Collection,  2020-08-10 19:24:02.
The Bayesian network relative risk model can perform the risk assessment of gene drive engineered Ae. aegypti for vector control and as part of an adaptive management strategy to reduce dengue and Zika transmission. This study illustrates how the BN-RRM can integrate gene drive related information within a risk assessment framework suitable for adaptive management of these novel stressors.

Global Governing Bodies: A Pathway for Gene Drive Governance for Vector Mosquito Control

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A. Kelsey, D. Stillinger, T. B. Pham, J. Murphy, S. Firth and R. Carballar-Lejarazú,  American Journal of Tropical Medicine and Hygiene,  2020-08-05 12:34:11.
We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool.

Biotechnologies in pest wasp control: taking the sting out of pest management for Māori businesses?

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S. Palmer and O. R. Mercier,  New Genetics and Society,  2020-07-31 19:13:18.
A Maori-centered mixed-method study gauged the perceptions of eight Maori businesses about the potential use of five specific new biotechnological controls in pest management.

Lettre ouverte a Monsieur le Premier Ministre demandant l’interdiction de la production, de l’utilisation et de la dissémination de tout OGM issu du forçage génétique

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A. Bossu, N. Laarman, D. Houdebine, H. Le Meur, F. Jacquemart and F. Warlop,  Open Letter,  2020-07-22 15:04:01.
A. Bossu, N. Laarman, D. Houdebine, H. Le Meur, F. Jacquemart and F. Warlop (2020). Open Letter. An open letter from French civil society organizations urging the French Parliament to support a resolution at the upcoming Convention on Biodiversity that would call for a moratorium on the release of organisms containing engineered gene drive technologies.

Providing a policy framework for responsible gene drive research: an analysis of the existing governance landscape and priority areas for further research

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D. Thizy, I. Coche and J. de Vries,  Wellcome Open Research,  2020-07-20 12:19:36.
D. Thizy, I. Coche and J. de Vries (2020). Wellcome Open Research. doi: 10.12688/wellcomeopenres.16023.1 In this manuscript, we review the existing regulatory landscape around gene drive research and map areas of convergence and divergence, as well as gaps in relation to guidelines for community engagement in gene drive research.

Genome Editing in Food and Farming: Risks and unexpected consequences

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J. Cotter and D. Perls,  Canadian Biotechnology Action Network,  2020-07-14 17:53:41.
J. Cotter and D. Perls (2020). Canadian Biotechnology Action Network. In this report, we provide an overview of genome editing techniques being explored in agriculture, and the range of potential unexpected effects that can arise from them. The report draws on recent scientific publications, in a rapidly evolving field of research including gene drive and genetic biocontrol.

Groups warn against release of genetically-engineered mosquitoes in Nigeria

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C. Onyesi,  Daily Post,  2020-07-07 14:52:15.
C. Onyesi (2020). Daily Post. Over 75 Civil Society Organizations from Nigeria, Africa and the world have condemned moves to open the way for the release of genetically modified mosquitoes in Nigeria.

Please support a global moratorium on the environmental release of gene drive organisms

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J. Riss, J. Munic and B. Harlin,  Open Letter,  2020-06-30 14:34:22.
J. Riss, J. Munic and B. Harlin (2020). Open Letter. We, the undersigned civil society organizations, write to you to request that the EU Commission fully supports the EU Parliament's call for a global moratorium on the release of Gene Drive Organisms (GDOs). This is in view of the EU preparation for the upcoming Conference of the Parties (COP15) to the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety (COP-MOP10).

Translating gene drive science to promote linguistic diversity in community and stakeholder engagement

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C. Cheung, S. Gamez, R. Carballar-Lejarazú, V. Ferman, V. N. Vásquez, G. Terradas, J. Ishikawa, C. E. Schairer, E. Bier, J. M. Marshall, A. A. James, O. S. Akbari and C. S. Bloss,  Global Public Health,  2020-06-26 18:55:10.
Information about genetic engineering (GE) for vector control in the United States is disseminated primarily in English, though non-English speakers are equally, and in some geographic regions even more affected by such technologies. Non-English-speaking publics should have equal access to such information, which is especially critical when the technology in question may impact whole communities. We convened an interdisciplinary workgroup to translate previously developed narrated slideshows on gene drive mosquitoes from English into Spanish, reviewing each iteration for scientific accuracy and accessibility to laypeople. Using the finalised stimuli, we conducted five online, chat-based focus groups with Spanish-speaking adults from California. Overall, participants expressed interest in the topic and were able to summarise the information presented in their own words. Importantly, participants asked for clarification and expressed scepticism about the information presented, indicating critical engagement with the material. Through collaboration with Spanish-speaking scientists engaged in the development of GE methods of vector control, we translated highly technical scientific information into Spanish that successfully engaged Spanish-speaking participants in conversations about this topic. In this manuscript, we document the feasibility of consulting Spanish-speaking publics about a complex emerging technology by drawing on the linguistic diversity of the scientific teams developing the technology.

EPA faces suit over plan to release genetically engineered mosquitoes

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R. Frazin,  The Hill,  2020-06-15 20:36:28.
The Environmental Protection Agency (EPA) is facing a lawsuit over its approval of a plan to release genetically modified mosquitoes in Florida and Texas

Gene drives: benefits, risks, and possible applications

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A. Deplazes-Zemp, U. Grossniklaus, F. Lefort, P. Müller, J. Romeis, A. Rüegsegger, N. Schoenenberger and E. Spehn,  Swiss Academies Factsheets,  15. 2020-06-05 19:48:13.
Gene drives are genetic elements that skew the pattern of inheritance of a given characteristic in sexually reproducing organisms. They can be used to spread a characteristic that can alter or even reduce the numbers of individuals in wild populations of a certain species. As they spread by being inherited from one generation to the next, they could persist in populations long-term. The spreading property of gene drives could be a source of great potential in areas as diverse as the control of disease vectors, invasive species, agricultural pests and predators of endangered species. However, the same property may make containment challenging and therefore may also pose novel environmental risks. The evaluation, distribution of risks and benefits and the fact that gene drives may be seen as a particularly profound interference with nature raises further novel ethical considerations.

Genetically modified mosquitoes could be released in Florida and Texas beginning this summer – silver bullet or jumping the gun?

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B. Allan, C. Stone, H. Tuten, J. Kuzma and N. Kofler,  The Conversation,  2020-06-03 18:53:50.
On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population. However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Position Paper on Integrated Vector Management: Strengthening AU Members’ Regulatory Capacities for Responsible Research Towards Elimination of Malaria in Africa

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African Union Development Agency - NEPAD,  AUDA-NEPAD,  2020-06-01 13:48:16.
Africa continues to bear a heavy brunt of the malaria which is a disease transmitted by the female Anopheles mosquito. Thousands of lives, mostly of young children, are lost every year; which undermines efforts deployed at various levels for increased life expectancy and improved wellbeing for the socio-economic transformation of the continent. Accelerated changes and complementary tools are urgently needed to ensure effective elimination of malaria on the continent. Genetic engineering has been identified as one of such promising tools when applied to mosquito populations to reduce the transmission of the malaria parasite. The African Union Development Agency – NEPAD (AUDA-NEPAD), based on recommendations from the African Union High-Level Panel on Emerging Technologies (APET), continues to provide African Union Members States with the necessary support to ensure that research on and development of new genetically-based vector control tools are conducted in a responsible manner and in full compliance with safety requirements for human health and the environment for the benefit of African communities.

Gene Drives: Pursuing opportunities, minimizing risk

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K. L. Warmbrod, A. Kobokovich, R. West, G. Ray, M. Trotochaud and M. Montague,  Center for Health Security,  2020-05-18 18:14:50.
This study analyzed the current state of gene drive technologies, the ways in which they might be deployed in the field, and the state of regulatory policy governing their development.

Beyond limits – the pitfalls of global gene drives for environmental risk assessment in the European Union

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M. Dolezel, C. Lüthi and H. Gaugitsch,  BioRisk,  15:1-29. 2020-05-04 14:58:37.
We evaluate the novel features of GDOs and outline the resulting challenges for the environmental risk assessment.

The development of complex and controversial innovations. Genetically modified mosquitoes for malaria eradication

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V. Cisnetto and J. Barlow,  Research Policy,  49:103917. 2020-05-04 13:32:20.
e use a longitudinal process approach and qualitative system dynamics modelling to study the development of genetically modified (GM) mosquitoes for malaria eradication in an African country.

EPA Approves Experimental Use Permit to Test Innovative Biopesticide Tool to Better Protect Public Health

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EPA,  EPA,  2020-05-01 14:02:09.
Today, after extensive evaluation of the best available science and public input, the U.S. Environmental Protection Agency (EPA) has granted an experimental use permit (EUP) to Oxitec Ltd. to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations to protect public health from mosquito-borne illnesses.

Guidance Framework for Testing the Sterile Insect Technique as a Vector Control Tool against Aedes-Borne Diseases

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WHO & IAEA,  WHO & IAEA,  2020-04-23 20:31:06.
This document is intended to be a comprehensive guide for programme managers tasked with recommending a “go/no-go” decision on testing, full deployment and scale-up of the sterile insect technique (SIT) in regions of the world affected by diseases transmitted by Aedes mosquitoes. However, the authors hope that the material presented herein will be used more widely—by scientists, decision makers, review groups and others.

Opinions of key stakeholders on alternative interventions for malaria control and elimination in Tanzania

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M. F. Finda, N. Christofides, J. Lezaun, B. Tarimo, P. Chaki, A. H. Kelly, N. Kapologwe, P. Kazyoba, B. Emidi and F. O. Okumu,  Malaria Journal,  19:164. 2020-04-23 15:13:29.
Malaria control in Tanzania currently relies primarily on long-lasting insecticidal nets and indoor residual spraying, alongside effective case management and behaviour change communication. This study explored opinions of key stakeholders on the national progress towards malaria elimination, the potential of currently available vector control interventions in helping achieve elimination by 2030, and the need for alternative interventions that could be used to supplement malaria elimination efforts in Tanzania.

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