Robust risk assessment begins with an explicit problem formulation where plausible and relevant exposure scenarios and the potential adverse effects from those exposures are identified.  Risk is then characterized by testing hypotheses about the likelihood and severity of adverse outcomes.  Poor problem formulation, unrealistic exposure context, and prescriptive data requirements can result in unnecessary testing and uninformative data that does not add value to accurate risk assessment.  Such an approach would present alternative risks by inhibiting development of important new technologies and delaying their adoption.  Integrating realistic exposure considerations into hazard identification testing strategies is necessary to realize the full potential of emerging agricultural technologies such as RNAi.  This presentation will discuss the benefits of problem formulation as the initial step in RNAi risk assessment to determine what is known and, importantly, what needs to be evaluated in order to generate information that leads to appropriate risk management decisions.

Problem formulation for the human health and environmental risk assessments of RNAi-based crop protection products

248th National Meeting (2014)

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