Commentary: The Cartagena Protocol in the context of recent releases of transgenic and Wolbachia-infected mosquitoes

* Author for correspondence: John M. Marshall, Imperial College London, Department of Infectious Disease Epidemiology, St Mary’s Campus, London W2 1PG, UK. Email: [email protected]. Abstract. The Cartagena Protocol on Biosafety is the fundamental document of the United Nations on the safe transfer, handling and use of living modified (LM) organisms. Progress is being made in the development of specific guidelines for LM mosquitoes; however, several issues relating to LM mosquitoes with invasive gene drive systems remain unresolved. Recent releases of LM sterile mosquitoes and mosquitoes infected with a non-transgenic strain of Wolbachia allow us to assess the suitability of the Protocol to LM mosquitoes, and to highlight weaknesses of the Protocol that should be addressed prior to an open release of mosquitoes engineered with invasive gene drive systems. One weakness, highlighted by recent exports of LM mosquito eggs from the United Kingdom, is that the Advance Informed Agreement procedure does not apply to LM mosquitoes being considered for release following laboratory studies and/or cage trials in the receiving country. This means that, under the most likely release scenario for any LM mosquito, the exporting country is not required to perform and finance a risk assessment. Another weakness, highlighted by the release of self-propagating Wolbachia-infected mosquitoes by Australia, is that several countries are not signatories to the Protocol and may not feel obliged to abide by terms they did not agree to. Releases in the Cayman Islands also highlight confusion over the applicability of the Protocol to transboundary movements between Parties and non-Parties. Lessons learned from these releases should guide the Protocol to addresses the biosafety concerns posed by self-limiting and selfpropagating varieties of LM mosquitoes.