Special Issue: Risk assessment and regulation of gene drive mosquitoes

Transgenic organisms containing constructs that have genetic elements biasing inheritance in their favor are a new tool in moving a specific allele into non-transgenic populations, either managed or–more importantly–in the wild. This new type of transgenic organism (gene drive organism) can potentially benefit agriculture, conservation, and public health. The use of gene drive-containing mosquitoes has received special attention because they are the furthest along experimentally, and because they have the potential to provide a new and sorely-needed tool in the toolbox for eliminating malaria in Africa. However, as with previous transgenic organisms, safety and regulatory questions have been raised. These questions are not necessarily new, but will require answers if gene drive-containing mosquitoes are to gain regulatory approval and public acceptance. There is currently little experience with the risk assessment of the environmental release of gene drive organisms. The lack of a real-world example nearing the field trial stage leaves consideration of risks primarily hypothetical. However, several areas of generic concern connected with the release of mosquitoes containing gene drives, have been identified by formal problem formulation exercises, and can be addressed at this early stage. Furthermore, initial efforts to identify data requirements to address these concerns as they have arisen in the context of generic risk assessments have also been made. Those countries where these mosquito gene drive interventions will be first deployed should develop the necessary regulatory frameworks to properly regulate these organisms, balancing risk and benefit. The existing regulatory structures appropriate for regulating gene drive organisms, should be identified, and the experience gained from regulating other more “traditional” genetically engineered organisms, such as the lessons learned from working with genetically engineered crops, should be leveraged to maximize the regulatory oversight and possible successful deployment of these interventions. This special issue features articles that address these issues. The first one in the series recounts the experience of transgenic crop deployment from the initial cases until today, exploring reasons why public acceptance and government approvals, especially in Africa, has been low, despite the record of safety, and economic and environmental benefits. The lessons learned from this experience and how they might be applied to gene drive deployment are presented. Other articles in this issue will explore particular areas of concern and their likelihood of presenting significant risks: horizontal gene transfer from gene drive-containing mosquitoes, the role of mosquitoes as pollinators, and the potential impact of gene drive mosquitoes on water quality. An article on the points for researchers to consider when they are seeking approvals for laboratory research, field testing, and eventual large-scale environmental release of genetic biocontrol products. It is hoped that this collection of articles can be useful to researchers, policy-makers, and regulators as they develop their products, formulate policies regarding the use, and formulate regulations that assure the safe deployment, respectively, of mosquitoes containing gene drives.

Download papers in the Special Issue here