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conceptual model and analysis plan, developed during the "Problem
formulation" phase, provide the basis for this "Analysis phase." A
characterization of exposure must be conducted during this phase. This
characterization can be quantitative or qualitative, depending on the
stressor and the scope of the assessment. Exposure is defined as "contact
or co-occurrence of stressors with ecological receptors." Exposure can be
analyzed by describing "the source and releases of stressors, the spatial
and temporal distribution of the stressor in the environment, and the
extent and pattern of contact or co-occurrence between the stressor and
receptor." Intensity, time, and space are three important factors to
consider when estimating exposure. After these factors are taken into
consideration in an exposure analysis, an exposure profile should be
written to convey the "likelihood that exposure will occur."
Also in the "Analysis Phase," the assessor should identify the ecological
effects of interest and conduct an ecological response analysis. The
analysis should show how the magnitude of ecological effects changes
with varying stressor levels, present evidence that the stressor causes the
effect (show "causality"), and link the effects to the assessment end
points. Stressor-response relationships can be difficult to assess,
especially if multiple stressors are present. However, if the assessor can
repeatedly demonstrate cause-effect relationships between the stressor and
the effect, then he or she has strong evidence for causality. The document
also includes several considerations when linking effects to assessment
end points. Judgment approaches, empirical approaches and process-
based approaches are presented as general categories of methods to
extrapolate effects to assessment end points. The most useful
extrapolation approach depends on the parameters outlined in the analysis
plan and the conceptual model used. At the end of the ecological response
analysis, a stressor-response profile is written to present the results,
rationale, and uncertainty of the analysis.
d. Risk characterization phase. The third phase of an ecological risk
assessment is "risk characterization." The three components of this phase
are risk estimation, risk description, and reporting results. The purpose of
risk estimation is to "determine the likelihood of adverse effects to
assessment end points [identified in the "Problem formulation" phase] by
integrating exposure and effects data [from the "Analysis phase"] and
evaluating any associated uncertainties." The authors outline the
advantages and disadvantages of six approaches for conducting a risk
estimate. A risk estimate approach should be chosen based on the amount
of data available, the scope of the assessment, and usefulness for risk
management. The results of the risk estimate as well as the degree of
confidence in the estimate should be included in the risk characterization
report.
The goals of the risk description component of this third phase are to
make conclusions "about risks to the assessment endpoints," to evaluate
the "lines of evidence supporting or refuting the risk estimate(s)," and to
interpret the "adverse effects on the assessment end point." Examples of
A5
Appendix A Summary of Federal, State, and Regional Guidance
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