Challenges for environmental risk assessment and associated impact assessments for gene drive mosquitoes

Development of new tools for vector control, such as gene drive mosquitoes, creates new challenges for environmental risk and impact assessments. Developers need to engage with regulators and scientific peers within a structured framework to ensure these important regulatory processes are done effectively and efficiently. This process parallels engagement with affected communities and stakeholders, using different approaches. The Target Malaria project has created a framework to support technical engagements through Problem Formulation and Pathways to Harm, leading to Analysis Plans and Responses (descriptions, data and/or tools) that support regulatory evidence or iteration of product design or use. Analysis Plans involve literature review or experimental observation, and many Analysis Plans rely on computational modelling. For models to be useful they should be transparent and presented as disaggregated components that support broad understanding for relevant stakeholder groups. We illustrate this with an interactive calculator tool for vectorial capacity that demonstrates effects of individual biological parameters and control scenarios, with graphical outputs. To facilitate engagement, developers need well-articulated plans for intended open field studies, logical pathways for impacts, analysis plans in discrete steps, and interactive tools for interpretation and dialogue about the response evidence. While regulators are legally obliged to engage with developers in the assessment and approval process, developers need to make evidence and the rationale for risk and impact assessment accessible. Scientific peers are not obliged to engage, so developers need to provide stimulation and encouragement to participate and to show how input from peers contributes to wider scientific development.