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Risk assessment for release of genetically modified organisms: a virus to reduce the fertility of introduced wild mice, Mus domesticus.

Risk assessment is a key task in developing genetically modified organisms (GMOs) intended for release into the environment. A risk assessment protocol is described, focusing on genetically modified biological control agents intended to reduce fertility in mammalian pests. The protocol is being applied to development of an immunocontraceptive murine cytomegalovirus vaccine intended to reduce the frequency and extent of costly troublesome plagues of introduced house mice, Mus domesticus, in southern Australia. Success of the agent, including regulatory approval for release to target populations, will depend on demonstrated biosafety, on the biophysical consequences of releasing the agent, and on public perceptions of the consequences and ongoing risks. The proposed risk assessment protocol addresses biosafety and the biophysical and social risks. It elicits perceptions of interaction and risk from the project scientists and from representatives of interested or affected sectors of society. The perceptions are documented for examination interactively in subsequent socially inclusive formal risk assessments. Representatives of the relevant social sectors participate with the scientists, iteratively if needed, in a workshop to assess the risks of releasing the particular GMO into the environment, using a formal inductive procedure, GENHAZ, designed specifically for assessment and management of the risks of GMOs. Use of this protocol is intended to precede and complement risk assessment and risk management procedures specified by gene technology legislation and regulations.