CONFERENCE PROCEEDINGS ‘‘DECISION MAKING AND SCIENCE’’ The proposed release of the yellow fever mosquito, Aedes aegypti containing a naturally occurring strain of Wolbachia pipientis, a question of regulatory responsibility Paul J. De Barro • Brendan Murphy • Cassie C. Jansen • Justine Murray Published online: 5 May 2011 Ó CSIRO (2011) published by Springer Basel AG 2011 Abstract In 2010 a proposal to release the yellow fever mosquito, Aedes aegypti, containing an intra- cellular symbiotic bacterium, Wolbachia, as a means of reducing the severity of outbreaks of dengue fever was lodged in Australia. The mosquito was infected with Wolbachia through embryonic microinjection. This proposal uncovered a gap in the regulatory process normally used to assess the release of species into Australia. Firstly, while the association between the mosquito and the bacterium was new, both spe- cies naturally occurred in Australia and so legislation governing the introduction of new species into Aus- tralia was ruled not relevant. Secondly, the infection of the mosquito with Wolbachia did not involve gene technology and so was not subject to legislation governing the approval of genetically modified organisms. The solution came through the decision to use existing legislation to regulate Wolbachia as a veterinary chemical product. This was a good out- come as it overcame the barrier that a lack of regulatory oversight may have posed to field trials taking place. Furthermore, the approach taken demonstrated a very high level of scrutiny with regard to biosafety. This case is an example of how science is leading to advances that outstrip existing regulatory frameworks. An acceptable regulatory solution has been found, but the novelty of the sci- ence is such that the appropriateness of the regulatory process now needs to be reviewed to ensure that it is no more onerous for both the pro- ponents and the regulators than it needs to be. Keywords Biological control Á Dengue Á Arboviruses Á Genetically modified organism Á Legislation Á Wolbachia Á Aedes aegypti Á Risk assessment 1 Introduction The introduction of species into a country is usually a regulated process. However, there are instances where the release request falls outside normal regu- latory pathways. In such instances, the proponent is placed in a regulatory ‘no man’s land’. One response could be to simply go ahead with the release, but this leaves the proponent vulnerable should the intro- duction lead to adverse consequences. On the other hand, they can attempt to cobble together a ‘work around’ that enables regulators to bring the request under their jurisdiction. An example is the 2009/2010 request to release into Australia a mosquito that had been infected with a symbiotic bacterium, Wolbachia pipientis, as a means of reducing the incidence of dengue fever. The complication was that both the mosquito and the Wolbachia used occur naturally in Australia, but not as a mosquito containing the bac- terium. The challenge was to find a regulatory process that could assess the release proposal. Conference Proceedings ‘‘Decision Making and Science—the Balancing of Risk Based Decisions that Influence Sustainability of Agricultural Production’’ 7th and 8th October 2010 in Berlin, Germany. Sponsored by the OECD Co-operative Research Programme. P. J. De Barro (&) Á B. Murphy Á C. C. Jansen Á J. Murray CSIRO Ecosystem Science, EcoSciences Precinct, PO Box 2583, Brisbane 4001, Australia e-mail: paul.debarro@csiro.au J. Verbr. Lebensm. (2011) 6 (Suppl 1):S33–S40 DOI 10.1007/s00003-011-0671-x Journal fu ¨ r Verbraucherschutz und Lebensmittelsicherheit Journal of Consumer Protection and Food Safety 123