implausible, exposure scenarios. The flaw in that approach is that there is no accounting for what the probability of an adverse effect was before the application of assumptions, and there is no calculation of how their use modifies that probability. Accordingly, the committee concludes that adding uncertainty factors to RQs to account for lack of data (on formulation toxicity, synergy, additivity, or any other aspect) is unwarranted because there is no way to determine whether the assumptions that are used overestimate or underestimate the probability of adverse effects. Furthermore, the committee concludes that RQs are not scientifically defensible for assessing the risks to listed species posed by pesticides or indeed for any application in which the desire is to base a decision on the probabilities of various possible outcomes.
Instead, the committee recommends using a probabilistic approach that requires integration of the uncertainties (from sampling, natural variability, lack of knowledge, and measurement and model error) into the exposure and effects analyses by using probability distributions rather than single point estimates for uncertain quantities. The distributions are integrated mathematically to calculate the risk as a probability and the associated uncertainty in that estimate. Ultimately, decision-makers are provided with a risk estimate that reflects the probability of exposure to a range of pesticide concentrations and the magnitude of an adverse effect (if any) resulting from such exposure.
The committee recognizes the pragmatic demands of the pesticide-registration process and encourages EPA and the Services to consider the probabilistic methods that have already been successfully applied to pesticide risk assessments, that have otherwise appeared often in the technical literature, that are familiar to many risk-assessment practitioners, that can be implemented with commercially available software, and that are most readily explicable to decision-makers, stakeholders, and the public. The committee also recognizes that administrative and other nonscientific hurdles will need to be overcome to implement this approach, but moving the uncertainty analysis from the typical narrative addendum to an integral part of the assessment is possible and necessary to provide realistic, objective estimates of risk.