Problem formulation for environmental risk assessment of genetically modified crops.

Environmental risk assessment can provide high certainty of minimal risk by testing theories, “risk hypotheses”, that predict the likelihood of unacceptable harmful events. The creation of risk hypotheses and a plan to test them is called problem formulation. Effective problem formulations seek, as far as possible, to maximize the possibility of detecting effects that indicate potential risk; if such effects are not detected, minimal risk is indicated with high certainty. Two important implications are that artificial test conditions can increase certainty, whereas prescriptive data requirements may decrease certainty if they constrain problem formulation.