The committee was asked to consider the interpretation of uncertainty and specifically the selection and use of uncertainty factors to account for lack of data. However, before the committee can answer the question about uncertainty factors, it must consider how uncertainty has been treated in past assessments. The committee addresses the question about uncertainty factors in Chapters 4 and 5.
In the context of this report, risk is defined as the probability of adverse effects on listed species or their critical habitats due to anticipated pesticide use that is consistent with label requirements. Ultimately, the adverse effect is jeopardy to the continued existence of a listed species defined in terms of demography, habitat, or other resources. The risk is estimated on the basis of predicted future pesticide exposure concentrations and the type and magnitude of effects (as determined by exposure-response functions) that the pesticide could have on the species. The risk estimate reflects uncertainty due to natural variability, lack of knowledge, and measurement and model errors in the host of underlying assumptions and variables used to predict exposure and effects. Natural variability or variation is true heterogeneity that might be better defined (but never eliminated) through increased sampling. Lack of knowledge (ignorance) is due to an absence of data or incomplete knowledge of important variables or their relationships; it can be reduced through additional data collection or further research. As indicated in Box 2-1, uncertainty will need to be characterized in the exposure estimation (Item 2.6) and the effect-response estimation (Item 3.5) analyses, then propagated, and finally integrated (Item 4.3) to provide the risk as a probability with an estimate of uncertainty.
The committee has concluded that achieving such integration will require that the ERA process in Steps 2 and 3 adopt a probabilistic approach that allows uncertainty in exposure and effect to be explicitly recognized and then combined to yield a risk as a probability with associated uncertainty (see Chapter 5). The present practice of relegating the consideration of uncertainty to a separate, often qualitative, narrative at the end of an assessment is of marginal value because doing so has little notable effect on risk estimation itself or on a decision-maker’s ability to understand the confidence that should be placed in a risk estimate. Although the committee is aware of the administrative and other nonscientific hurdles that will need to be overcome to implement such an approach, it nonetheless has concluded that moving the uncertainty analysis from a narrative addendum to an integral part of the assessment is both possible and necessary to provide realistic, objective estimates of risk. Because a core dataset is required for all pesticide registration decisions, there should be sufficient information to conduct a quantitative assessment, which can include a quantification of the associated uncertainty.
The committee recognizes that the quantitative propagation of uncertainty through ecological risk assessments is not a new concept, particularly in the context of pesticide assessments. The topic was addressed by EPA’s Scientific Ad-