Reflections on uncertainty in risk assessment and risk management by the Society of Environmental Toxicology and Chemistry (SETAC) precautionary principle workgroup.

Quantitative uncertainty assessments and the distribution of risk are under scrutiny and significant criticism has been made of null hypothesis testing when careful consideration of Type I (false positive) and II (false negative) error rates have not been taken into account. An alternative method, equivalence testing, is discussed yielding more transparency and potentially more precaution in the quantifiable uncertainty assessments. With thousands of chemicals needing regulation in the near future and low public trust in the regulatory process, decision models are required with transparency and learning processes to manage this task. Adaptive, iterative, and learning decision making tools and processes can help decision makers evaluate the significance of Type I or Type II errors on decision alternatives and can reduce the risk of committing Type III errors (accurate answers to the wrong questions). Simplistic cost-benefit based decision-making tools do not incorporate the complex interconnectedness characterizing environmental risks, nor do they enhance learning, participation, or include social values and ambiguity. Hence, better decision-making tools are required, and MIRA is an attempt to include some of the critical aspects.