A qualitative binary risk assessment model for regulating the biosecurity and environmental risk of endophytes

We present a model for the regulation of endophytes that focuses on the hazard identification and risk assessment components. The goal was to develop a model that can identify and characterise risk, and quantify the level of risk. Our model takes a binary approach, either categorising risk into 'acceptable' or 'unacceptable' levels, as regulators are often left with a choice of approving or declining a proposal when an organism is unable to be contained after it is released. This model provides a framework for practitioners to use in order to identify and quantify the risks and benefits to be derived from endophytes and plants with novel traits systematically. We present two case studies of the model in practice in New Zealand legislation under the Hazardous Substances and New Organisms (HSNO) Act, and indicate how the model might be used by researchers and regulators to allow for the safe introduction of new traits for biocontrol.