100 with respect to the probability of an adverse effect. Theoretically, an RQ of 100 means a greater probability of an adverse effect than an RQ of 10, but one cannot determine whether the difference in probability between the two RQs is substantial or negligible or whether the final error associated with the risk estimate is appropriate for the management needs.
Thus, although RQs are often used by EPA for Step 2 assessments that might trigger later, more refined and focused assessments for listed species, the committee concludes that RQs are not appropriate for assessments for listed species or indeed for any application in which it is desired to base a decision on the probabilities of various possible outcomes. Furthermore, 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 being used substantially overestimate or underestimate the probability of an adverse effect.
The committee has not been asked about and is not commenting on policy decisions about what level of risk is acceptable or how conservative the agencies should be in establishing an “acceptable” risk level when considering jeopardy to listed species.
Risk is defined as the probability of an adverse effect (Burmaster 1996). Thus, natural tools for quantifying and analyzing risk are probability, statistics, and the algebra of random variables, and an alternative to the deterministic concentration-ratio approach is a probabilistic one. In the probabilistic approach, the probability that a decision will lead to an adverse effect is calculated from the available information and then used to support an informed decision (again, the committee is purposefully refraining from a discussion of what an “acceptable” probability of risk might be). The probabilistic approach requires integration of the uncertainties (from sampling, natural variability, lack of knowledge, and measurement and model error) in the exposure and effects analyses by using probability distributions, rather than single point estimates, for uncertain quantities (EPA 2001). The distributions are then integrated mathematically to calculate the risk as a probability and its 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) to the exposures that answers the fundamental question, What is the probability that registration of this pesticide will lead to a specified adverse effect on a listed species or its critical habitat?
Implementing a probabilistic approach requires three primary actions on the part of a risk assessor:
(1) Describe uncertain variables with distributions and recognize that not all variables in a model or an analysis need be treated this way. The task can be