Regulation and Policy

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

Genetically Engineered Fish: Potential Impacts on Aquaculture, Biodiversity, and the Environment

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R. A. Dunham and B. Su,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020-12-02 17:03:48.
Studies on transgenic fish for the aquaculture industry have focused on improving growth rates, enhancing disease resistance, altering body composition, acting as biological factories for medical proteins, and even altering temperature tolerance and coloration. The future impact of transgenesis will likely be quite large. Growth hormone-transgenic salmon has been approved for human consumption and has been introduced to the market in Canada and soon to the USA. This is the first human consumption of approved transgenic meat. Transgene insertion has many pleiotropic effects. Several studies have projected the fitness of transgenic fish to be low, in general, compared to non-transgenic and wild fish; thus, their environmental risk is likely low and they would have minimal, if any, long-term impact on ecosystems or biodiversity. However, there have been no actual escapements; thus, only projections of risk are available based on small-scale experiments and the characteristics of transgenic fish compared to controls. An active area of research is repressible transgenic sterilization and sterilization using gene editing, both of which would allow application of transgenic fish with only short-term consequences for ecosystems in the worst-case scenario. Transgenic technology could also be potentially used to reduce or eliminate populations of nuisance species.

Invasive Species Control and Resolution of Wildlife Damage Conflicts: A Framework for Chemical and Genetically Based Management Methods

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L. Clark, J. Eisemann, J. Godwin, K. E. Horak, K. Oh, J. O’Hare, A. Piaggio, K. Pepin and E. Ruell,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020-12-02 16:52:40.
Vertebrate wildlife damage management relates to developing and employing methods to mitigate against damage caused by wildlife in the areas of food production, property damage, and animal or human health and safety. Of the many management tools available

GMOs: Implications for Biodiversity Conservation and Ecological Processes

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Chaurasia, Anurag , Hawksworth, David L., Pessoa de Miranda, Manoela.,  GMOs: Implications for Biodiversity Conservation and Ecological Processes,  2020-12-02 16:45:05.
This book covers a broad spectrum of topics related to GMOs and allied new gene-based technologies, biodiversity, and ecosystem processes, bringing together the contributions of researchers and regulators from around the world. The aim is to offer a clear view of the benefits and effects of genetically modified crops, insects, and other animals on the soil microbiome and ecological processes. Contributors examine issues related to the development of risk assessment procedures and regulations designed to maximize benefits while minimizing risks. Beyond the scientific challenges of GMOs, the book explores the broad and contentious terrain of ethical considerations. The contributors discuss such questions as the unintended, possibly unforeseen, consequences of releasing GMOs into ecosystems, and the likelihood that the full effects of GMOs could take years, even decades, of close monitoring to become evident. The importance of developing a precautionary approach is stressed.

Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

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E. Panel o. G. M. Organisms, H. Naegeli, J.-L. Bresson, T. Dalmay, I. C. Dewhurst, M. M. Epstein, P. Guerche, J. Hejatko, F. J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J. J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, M. B. Bonsall, J. Mumfor,  EFSA Journal,  18:e06297. 2020-11-12 19:24:46.
As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC,ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.

Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives

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European Food Safety Authority, Y. Devos, M. B. Bonsall, F. Nogué, K. Paraskevopoulos, E. A. Wimmer and L. G. Firbank,  EFSA Supporting Publications,  17:1939E. 2020-11-12 19:10:10.
The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of genetically modified insects containing engineered gene drives. This draft scientific opinion was endorsed by the EFSA Panel on Genetically Modified Organisms (GMOs) for public consultation on 29 January 2020, and prepared by EFSA'sGene Drive expert Working Group and scientific officers. The public consultation was open from 17 February 2020 until 24 April 2020.

Gene drives, species, and compassion for individuals in conservation biology

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Y. Rohwer,  Ethics, Policy and Environment,  2020-11-10 18:20:29.
In this paper I argue that these compassionate conservationists have a moral obligation to support the investigation and development of genetic modification technologies because of their potential to minimize suffering and eliminate killing in conservation. Furthermore, I will end the paper by suggesting that these genetic technologies can help avoid actions that could be damaging to one's moral character.

NIH NExTRAC (Novel and Exceptional Technology and Research Advisory Committee) | Workshop

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NIH Office of Science Policy,  National Institutes of Health (NIH),  2020-11-09 19:56:25.
NExTRAC provides advice to the Director of the National Institutes of Health (NIH) on matters related to the conduct and oversight of research involving emerging technologies in biomedical science. NExTRAC also makes recommendations on research involving the use of, and developments in, emerging biotechnologies and will address scientific, safety, ethical, and social issues associated with areas of emerging biotechnology research for which the NIH requests advice or guidance. One of the technologies this committee is considering is gene drive. The November 2020 meeting was a workshop:   GENE DRIVES: BIOSAFETY GUIDANCE AND CONDITIONS FOR FIELD RELEASE RESEARCH

When Extinction is Warranted: Invasive Species, Suppression-Drives, and the Worst-Case Scenario

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A. C. Thresher,  Ethics, Policy and Environment,  2020-11-09 19:31:52.
The focus of this paper is on one such risk ? the danger of a suppression-drive escaping containment and wiping out the target species globally. Here, I argue that in most cases this risk is significant enough to warrant holding off on the technology. In some cases, however, we can bypass the precautionary principle by using a dominance approach that hinges on what I term the ?Worst-Case Clause?. This clause, in turn, provides us with a litmus test that can be fruitfully used to determine what species are viable targets for suppression-drives in the wild. Using this metric in concert with other considerations, I suggest that only three species are currently possible viable targets ? the European rabbit, ship rat, and Caribbean Tree Frog.

Inauguration and first meeting of WA-IVM Technical Working Groups

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AUDA-NEPAD,  AUDA-NEPAD News,  2020-10-27 19:37:33.
African Union Development Agency – NEPAD (AUDA-NEPAD) in collaboration with the West Africa Health Organization (WAHO), the Ministry of Health and the Ministry of Environment in Cote d’Ivoire, organized the inaugural meeting of WA-IVM Technical Working Groups (TWGs) from 24 – 26 April, 2019, in Abidjan, Cote d’Ivoire. Dr. ABLE, Inspector General of the Ministry of Health and Public Hygiene, representing the Minister, co-chaired the opening ceremony with Mr LAVRY, Technical Advisor of the Ministry of Environment and Sustainable Development.

Position of ARRIGE Scientific Committee on Gene Drive

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ARRIGE Scientific Committee on Gene Drive,  ARRIGE Newsletter,  2020-10-21 15:16:40.
We are facing a change of paradigm that must lead us to be responsible for altered inheritance and the hybridization between artefacts, considered as natural or artificial, at the very moment when this division itself is blurred by the engineering capacity to act on mutations, without knowing in advance the possibly adverse, short or long term, side effects, on the manipulated and other connected species.

FKMCD-OXITEC Mosquito Project

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FKMCD and OXITEC,  Website,  2020-10-16 18:11:37.
The Florida Keys Mosquito Control District (FKMCD) Board of Commissioners approved the FKMCD-Oxitec Investigational Agreement for the release of Oxitec’s Aedes aegypti mosquitoes. This project will be overseen by FKMCD, the EPA and the Florida Department of Agriculture and Consumer Services (FDACS). Independent evaluation of the project will be provided by the U.S. CDC, University of Florida, Monroe County Department of Health, and local leaders, forming a broad and diverse coalition to support this effort.

Ethics and vector-borne diseases

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Geneva: World Health Organization,  WHO Guidance,  2020-10-14 18:57:10.
The guidance was developed by an international group of experts in vector control, infectious disease ethics, maternal and child health, ecology and climate change, research and vaccine development, and public health communication. It examines a broad range of ethical considerations related to VBD prevention and control, including the social and environmental determinants of health; vector control methods, including emerging technologies; screening, surveillance and research; vaccine campaigns; and mass drug administration.

ESA Position Statement on the Importance of Continued Innovation in Gene Drive Technology

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Entomological Society of America,  Annals of the Entomological Society of America,  2020-10-13 17:39:58.
The risks and benefits of GDTs should be considered with the risks and benefits of continuing current pest control interventions, which may be comparatively less effective or pose exposure risks to human health and the environment.

Evaluation of genetically modified mosquitoes for the control of vector-borne diseases

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Global Malaria Programme,  WHO - Position Statement,  2020-10-13 15:58:38.
In the spirit of fostering innovation, WHO takes the position that all potentially beneficial new technologies, including GMMs, should be investigated to determine whether they could be useful in the continued fight against diseases of public health concern. Such research should be conducted in steps and be supported by clear governance mechanisms to evaluate the health, environmental and ecological implications

Towards rangatiratanga in pest management? Maori perspectives and frameworks on novel biotechnologies in conservation

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S. Palmer, O. R. Mercier and A. King-Hunt,  Pacific Conservation Biology,  11. 2020-10-09 13:58:04.
We gathered Maori perspectives on novel biotechnological controls for pest wasps through three distinct studies. Study participants included tertiary students, businesses, and spiritual or religiously affiliated groups. All participants drew from their identities as Maori people to help identify their position on these issues.

Gene Drive: Modern Miracle or Environmental Disaster

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K. Brooks,  Journal of Law, Technology and Policy,  2020-09-25 19:57:31.
This Note will show how gene drive technology fits imperfectly into the old regulatory framework through case studies. The Analysis will also describe how the different regulatory agencies handle similar gene drive-like organisms inconsistently, and the inherent danger of this approach considering upcoming developments in the field.

Global citizen deliberation on genome editing

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J. S. Dryzek, D. Nicol, S. Niemeyer, S. Pemberton, N. Curato, A. Bächtiger, P. Batterham, B. Bedsted, S. Burall, M. Burgess, G. Burgio, Y. Castelfranchi, H. Chneiweiss, G. Church, M. Crossley, J. de Vries, M. Farooque, M. Hammond, B. He, R. Mendonça, J.,  Science,  369:1435. 2020-09-18 18:32:40.
Here we show how, as the global governance vacuum is filled, deliberation by a global citizens' assembly should play a role, for legitimate and effective governance.

Responsible innovation in biotechnology: Stakeholder attitudes and implications for research policy

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P. Roberts, J. Herkert and J. Kuzma,  Elementa,  2020-09-01 21:17:09.
Using a mixed methods approach, we analyzed the attitudes of different biotechnology stakeholders, particularly those working in areas related to genetically modified organisms (GMOs) in agriculture and the environment, towards the principles and practices of RI. Homogenous focus groups (organized by stakeholder affiliation) and pre- and post-focus group surveys were used to measure attitudes towards RI. We designed the survey questions according to the Advocacy Coalition Framework (ACF) and examined the agreement of stakeholders with policy core beliefs (general principles of RI) and secondary beliefs (implementation practices of RI). Qualitative analysis of focus-groups revealed barriers for implementing RI practices.

Governing New Biotechnologies for Biodiversity Conservation: Gene Drives, International Law, and Emerging Politics

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J. L. Reynolds,  Global Environmental Politics,  20:28-48. 2020-08-31 14:28:38.
This article describes and analyzes the international law and politics of gene drives’ research, development, and possible use, with an emphasis on their potential biodiversity applications.

FKMCD Board Approves Oxitec Pilot

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C. Huff,  FKMCD in the News,  2020-08-19 15:48:10.
The Florida Keys Mosquito Control District’s (FKMCD) five member board has APPROVED a proposal by Oxitec to utilize non-biting male, genetically modified mosquitoes as part of a trial to determine their effectiveness in controlling the wild population of Aedes aegypti, the mosquito which is responsible for spreading diseases such as dengue fever. FKMCD and Oxitec have both said that the pilot project will not take place until 2021. The FKMCD board’s four to one vote in FAVOR comes after Federal and State approvals of an ‘Experimental Use Permit’ issued earlier this summer by the Environmental Protection Agency and The Florida Department of Agriculture and Consumer Services. F

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