stated that it “does not believe that all sub-lethal effects or that all levels of a sub-lethal effect on an individual constitute a compromise of individual fitness” (EPA 2012a, p. 3).

EPA’s approach differs from the Services’ approach. For example, FWS “casts a wide net for each potentially affected species to ensure that the most sensitive endpoints are captured and evaluated” (FWS 2012, p. 2). It contends that “at present, data describing ‘sub-lethal’ effects are acknowledged but then set aside and not used by EPA in making effects determinations or characterizing the potential effects of the action, unless other data or studies are available that would enable EPA to quantify a relationship between the ‘sub-lethal’ effect and EPA’s traditional endpoints, survival, growth, or reproduction.” FWS (2012, pp. 2-3) continued that “in contrast, when characterizing the ‘Effects of the Action’ pursuant to the ESA [Endangered Species Act], the FWS does not limit itself to using only those data that quantify changes in survival, growth, or reproduction.”

As discussed in the section on effects models below, assessing the effects of pesticides on listed species requires quantifying the effect of a pesticide on survival and reproduction of a species in the wild. Any effect that results in a change in one component is relevant to the assessment. In contrast, any effect that does not change either component is irrelevant with respect to a quantitative assessment of population effects. The relevance of any particular sublethal effect is likely to depend on the species. Growth, for example, might be a relevant effect in some species but not in others. In mammalian species, retarded growth might increase age of first reproduction but not affect reproductive output thereafter. In many fish species, size of the individual organism is directly related to reproductive output throughout the lifespan. Many plant species do not need to achieve a particular size for maximal reproductive output. Therefore, the committee recommends that EPA in Step 2 (see Figure 2-1) cast a wide net and identify information about sublethal effects of a chemical. If possible, EPA’s assessment should include information about responses at various chemical concentrations (a concentration-response curve) and, at a minimum, include a qualitative assessment of the relationship between sublethal effects and survival and reproduction. In Step 3 (see Figure 2-1), the Services should show how such effects change demographic measures (survival or reproduction) of a listed species and incorporate such information into the population viability analyses or should state that such relationships are unknown but possible and include a qualitative discussion in the uncertainty section of the biological opinion (BiOp). The Services face the greatest challenge in Step 3 in determining whether an observed sublethal effect will change survival or reproduction in the natural population and, if so, the magnitude of such a change in relation to the predicted exposure.

Relationships between sublethal effects and changes in population growth rates span a continuum of uncertainty that depends on the ability to quantify the

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