scholarly journals Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation

2020 ◽  
Vol 16 (5) ◽  
pp. 555-568 ◽  
Author(s):  
Christoph Then ◽  
Katharina Kawall ◽  
Nina Valenzuela
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Genetically Modified ◽  
Genetically Modified Organism ◽  
Genetically Engineered ◽  
Gene Drive

scholarly journals Genetically engineered trees for plantation forests: key considerations for environmental risk assessment

2013 ◽  
Vol 11 (7) ◽  
pp. 785-798 ◽  
Author(s):  
Hely Häggman ◽  
Alan Raybould ◽  
Aluizio Borem ◽  
Thomas Fox ◽  
Levis Handley ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Genetically Engineered ◽  
Plantation Forests

Problem Formulation and Option Assessment (PFOA) Linking Governance and Environmental Risk Assessment for Technologies: A Methodology for Problem Analysis of Nanotechnologies and Genetically Engineered Organisms

2009 ◽  
Vol 37 (4) ◽  
pp. 732-748 ◽  
Author(s):  
Kristen C. Nelson ◽  
David A. Andow ◽  
Michael J. Banker
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
New Technologies ◽  
Problem Formulation ◽  
Genetically Engineered ◽  
Problem Analysis ◽  
Cartagena Protocol On Biosafety ◽  
Living Modified Organisms ◽  
Genetically Engineered Organisms

Societal evaluation of new technologies, specifically nanotechnology and genetically engineered organisms (GEOs), challenges current practices of governance and science. When a governing body is confronted by a technology whose use has potential environmental risks, some form of risk analysis is typically conducted to help decision makers consider the range of possible benefits and harms posed by the technology. Environmental risk assessment (ERA) is a critical component in the governance of nanotechnology and genetically engineered organisms because the uncertainties and complexities surrounding these technologies pose such risk potential. However, GEOs are unique technologies, and there is widespread, international recognition (e.g., the Cartagena Protocol on Biosafety of Living Modified Organisms) that many traditional forms of ERA are not well-suited for evaluating them. Nanotechnology products are also likely to need different models of risk assessment, as there is very little information on their fate, transport, and impacts in the environment.

scholarly journals Environmental Risk Assessment for rVSVΔG-ZEBOV-GP, a Genetically Modified Live Vaccine for Ebola Virus Disease

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 779
Author(s):  
Joan G. Tell ◽  
Beth-Ann G. Coller ◽  
Sheri A. Dubey ◽  
Ursula Jenal ◽  
William Lapps ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Ebola Virus ◽  
Virus Disease ◽  
Genetically Modified ◽  
Ebola Virus Disease ◽  
European Medicines Agency ◽  
Low Level ◽  
Animal Populations

rVSVΔG-ZEBOV-GP is a live, attenuated, recombinant vesicular stomatitis virus (rVSV)-based vaccine for the prevention of Ebola virus disease caused by Zaire ebolavirus. As a replication-competent genetically modified organism, rVSVΔG-ZEBOV-GP underwent various environmental evaluations prior to approval, the most in-depth being the environmental risk assessment (ERA) required by the European Medicines Agency. This ERA, as well as the underlying methodology used to arrive at a sound conclusion about the environmental risks of rVSVΔG-ZEBOV-GP, are described in this review. Clinical data from vaccinated adults demonstrated only infrequent, low-level shedding and transient, low-level viremia, indicating a low person-to-person infection risk. Animal data suggest that it is highly unlikely that vaccinated individuals would infect animals with recombinant virus vaccine or that rVSVΔG-ZEBOV-GP would spread within animal populations. Preclinical studies in various hematophagous insect vectors showed that these species were unable to transmit rVSVΔG-ZEBOV-GP. Pathogenicity risk in humans and animals was found to be low, based on clinical and preclinical data. The overall risk for non-vaccinated individuals and the environment is thus negligible and can be minimized further through defined mitigation strategies. This ERA and the experience gained are relevant to developing other rVSV-based vaccines, including candidates under investigation for prevention of COVID-19.

scholarly journals Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018

2019 ◽  
Vol 18 (1) ◽  
Author(s):  
John L. Teem ◽  
Aggrey Ambali ◽  
Barbara Glover ◽  
Jeremy Ouedraogo ◽  
Diran Makinde ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Human Health ◽  
Environmental Risk ◽  
Environmental Risk Assessment ◽  
Early Stage ◽  
Problem Formulation ◽  
Risk Assessments ◽  
Gene Drive ◽  
Starting Point ◽  
Protection Goals

Abstract Background Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an organized and ordered process to identify protection goals and potential pathways to harm to the environment, or animal or human health. Recognizing this need, the New Partnership for Africa’s Development (NEPAD), with support from African and international partners, organized four regional consultative workshops in Africa to initiate this process. Methods The workshops were attended by a diverse set of participants and stakeholders, including scientists, ethicists, health professionals, government regulators in the fields of environment health and biosafety as well government policymakers, who met for 4 days to deliberate on protection goals and pathways relevant to the use of gene drive mosquitoes for malaria control. The goal of the workshops was not to produce a comprehensive and detailed environmental risk assessment of gene drive mosquitoes, but rather to introduce problem formulation as a tool to the stakeholder community, and to serve as a starting point for conducting systematic environmental risk assessments in the future, identifying protection goals related to gene drive mosquitoes that are particular to African stakeholders. Results Participants in the workshops frequently identified human health and biodiversity as being relevant broad protection goals. Results of the deliberations provide insight into the concerns of African participants at an early stage in the development of gene drive organism/products that should be instructive to developers using this technology. Conclusions In general, the African participants of the consultations had a precautionary perspective with regard to environmental risk assessment of gene drive technology. As gene drive technology develops, protection goals will become further refined and candidate products will be further defined. These workshops represent only the beginning of a continuing process that will ultimately inform environmental risk assessment for gene drive mosquitoes to control malaria in Africa.

Sign in / Sign up

Export Citation Format

Share Document