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make a good prediction of risk. This document outlines what the basic contents of
a WP and an SAP should be and that they should follow the EPA model for work
plans and SAPs. The end of Step 4 also has an SMDP to approve the work plan
and sampling and analysis plan that will be used in the next steps of the risk
assessment.
Step 5 - Field verification of sampling design
In this step, the information collected thus far is verified and the feasibility of
sampling is evaluated after visiting the site. Some elements of the WP or SAP
may need to be modified to meet the objectives of the risk assessment. These
changes can be made in consultation with the risk assessor and risk manager. If a
reevaluation of the assessment endpoints in the WP or SAP is needed, however,
the assessor must return to Step 3. The SMDP for Step 5 is the signing of the
finalized WP and SAP.
Step 6 - Site investigation and analysis phase
This step involves field sampling and surveys as well as analysis of exposure
and ecological effects. Field sampling implements the plans designed in Step 5 to
collect data. The analytic approach for characterizing exposure effects and
ecological effects is outlined in the WP and SAP and are based on the site
conceptual model. After sample collection and analysis of exposure and
ecological effects, an exposure-response analysis is conducted. This analysis
magnitude of the response." Also, "measurement endpoints [measures of effects]
are related to the assessment endpoints using the logical structure provided by the
conceptual model." An SMDP is needed in Step 6 only if the WP or SAP needs to
be altered.
Step 7 - Risk characterization
The risk characterization is a "qualitative and quantitative presentation of risk
and the associated uncertainties." The risk characterization involves risk
estimation and risk description. In the risk estimation component, the assessor
must describe the methods used and reasoning behind the connections made
between exposure profiles and exposure-effects information. The risk description
provides information important for interpreting risk results and identifies a
threshold for adverse effects on assessment endpoints. One caution that the
guidance makes is to clearly distinguish between uncertainty and variability in the
description of risk.
Step 8 - Risk management
This step is the responsibility of the site risk manager. There must be a balance
of the risk reduction associated with cleanup with the potential ecological impacts
of the cleanup process itself. The decision must be made whether or not to clean
A11
Appendix A Summary of Federal, State, and Regional Guidance
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