deterministic concentration-ratio approach, which compares point estimates of exposure and effect concentrations, and the other is a probabilistic approach, which evaluates the probability that exposure to a chemical will lead to a specified adverse effect at some future time. The latter is technically sound, and the former is ad hoc (although commonly used) and has unpredictable performance outcomes. EPA uses the concentration-ratio approach for its assessments. In biological opinions on salmon, the National Marine Fisheries Service appears to favor a probabilistic approach that is based on population modeling. The Fish and Wildlife Service seems not to use a quantitative approach, either concentration-ratio or probabilistic, for risk characterization.

CONCENTRATION-RATIO APPROACH

The concentration-ratio approach, which is commonly used by EPA for Step 1 and 2 assessments (see Figure 2-1), does not estimate risk (the probability of an adverse effect) itself but rather relies on there being a large margin between a point estimate of the most likely maximum pesticide environmental concentration and a point estimate of the lowest concentration at which a specified adverse effect might be expected (EPA 2004). The superficial attraction of this approach is that one feels confident that a decision will not lead to an adverse effect (that is, a Type II error will be avoided) if sufficiently large margins are used. There is a belief that the larger the margin between the estimated exposure and the response threshold, the greater the certainty (or the smaller the uncertainty). The flaws in that approach are that it does not account for the probability of an adverse effect before worst-case assumptions are applied and that it does not calculate how the use of the assumptions modifies that probability. Given that approach, decision-makers do not know what the probability of an adverse effect is, but they hope that they can assume (or be reassured) that it is small. However, such an assumption is not reliable. If they or their constituencies have doubts, the common response is to widen the margin with additional conservative assumptions, including addition of specific uncertainty factors or more stringent, and possibly implausible, exposure scenarios. However, simply widening the gap indefinitely might lead to decisions that limit pesticide use to a greater extent than is intended by policy and will not meaningfully express the underlying probability of an adverse effect.

For pesticides, as evaluated by EPA, the concentration ratio is quantified in the form of a risk quotient (RQ) that might be less or greater than some specified level of concern (LOC). However, an RQ is not actually a risk estimate in that it provides no information about the probability of an adverse effect. Thus, although an RQ of 10 is several times higher than most numerical LOCs, there is no fixed relationship between RQs and the probability of an adverse effect on a listed species. Therefore, it is not possible to determine what an RQ of 10 means with respect to a possible adverse effect on a listed species. Nor is there a fixed relationship for comparing the difference between, for example, RQs of 10 and



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