Abstract
In 2010 a proposal to release the yellow fever mosquito, Aedes aegypti, containing an intracellular 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 species naturally occurred in Australia and so legislation governing the introduction of new species into Australia 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 outcome 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 science 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 proponents and the regulators than it needs to be.
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Acknowledgments
We thank Prof Scott O’Neill for his comments on an earlier draft and Dr John Owusu, Principal Evaluator, Veterinary Medicines Program, APVMA, for his help with clarifying the decision to regulate Wolbachia as a veterinary chemical product and for provision of the legal advice used by APVMA in relation to the question “Is Wolbachia a veterinary chemical product?”.
Conflict of interest
The authors P.J. De Barro, B. Murphy, C.C. Jansen and J. Murray declare that the research was funded through the Grand Challenges in Global Health Initiative of the Bill and Melinda Gates Foundation and that the authors have no conflict of interest.
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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.
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De Barro, P.J., Murphy, B., Jansen, C.C. et al. The proposed release of the yellow fever mosquito, Aedes aegypti containing a naturally occurring strain of Wolbachia pipientis, a question of regulatory responsibility. J. Verbr. Lebensm. 6 (Suppl 1), 33–40 (2011). https://doi.org/10.1007/s00003-011-0671-x
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DOI: https://doi.org/10.1007/s00003-011-0671-x