Problem formulation for a small-scale field study of non-gene drive, genetically modified, male bias mosquitoes in Burkina Faso
Problem formulation for a small-scale field study of non-gene drive, genetically modified, male bias mosquitoes in Burkina Faso
Tags: Africa, Genetic biocontrol, Malaria, Risk assessment, Target malariaHayes, K. R., & Hosack, G. R., Human and Ecological Risk Assessment: An International Journal, 2025.
This article documents the problem formulation step of a risk assessment for a proposed small-scale field release in Burkina Faso of genetically modified (GM) An. coluzzii mosquitoes that carry a Paternal Male Bias (PMB) construct. These mosquitoes are part of the pathway developed by Target Malaria to provide a new cost-effective control strategy for malaria vectors in Africa. The problem formulation describes 7 potentially harmful outcomes that might occur through 19 pathways to harm and identifies 22 types of desk-based analysis, 6 laboratory tests, and 5 field observations that can be used to test the risk hypotheses associated with these pathways. The problem formulation forms the basis of a prerelease risk assessment that meets the standards stipulated under the Cartagena Protocol and guidance provided by the World Health Organization, the African Union Development Authority, and the European Food Safety Authority. The Problem Formulation reflects the concerns expressed about the proposed field release by relevant stakeholders, although stated concerns are not always specific enough to be unambiguously associated to a single pathway. The presentation of the pathways to harm emphasizes the types of evidence that supports the steps within each pathway, and so portrays the speculative nature of some pathways.
