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Guidance for Conducting Risk Assessments and Related Risk ...

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• the prioritization of projects/activities;<br />

• the establishment of clean-up criteria that are protective of human health <strong>and</strong> the environment;<br />

• the effectiveness of selected remedies;<br />

• the determination of source terms <strong>and</strong> estimating probability <strong>and</strong> magnitude of release due to<br />

catastrophic events or deterioration of existing structures or containment systems;<br />

• the effectiveness of treatment technologies; <strong>and</strong><br />

• the risk from residual materials, infrastructure, <strong>and</strong> chemicals in building/structures slated <strong>for</strong> re-use.<br />

The risk assessment guidelines outlined in the original document, <strong>Risk</strong> Assessment Strategy at DOE-<br />

ORO (ES/ER/TM-180, LMES 1996c), have been updated <strong>and</strong> incorporated into this document. The focus<br />

of TM-180 was to ensure that all risk assessment <strong>and</strong> related risk activities in support of environmental<br />

restoration ef<strong>for</strong>ts, namely the CERCLA RI/FS process, would be “per<strong>for</strong>med in a consistent <strong>and</strong><br />

technically defensible manner”.<br />

The goal of this document is similar to ES/ER/TM-180, but the scope has been exp<strong>and</strong>ed to address<br />

other uses of risk assessment <strong>and</strong> related risk activities that support decision-making [e.g., waste<br />

management, decontamination <strong>and</strong> decommissioning (D&D), technology demonstration, <strong>and</strong><br />

reindustrialization ef<strong>for</strong>ts].<br />

1.1 PURPOSE AND SCOPE<br />

The purpose of this document is to establish guidelines to ensure that all risk assessments <strong>and</strong><br />

related risk activities <strong>for</strong> the DOE-ORO EM Program are consistent with both program <strong>and</strong> regulatory<br />

guidance <strong>and</strong> are technically defensible. This is especially important under the M & I contracting process<br />

because subcontractors will per<strong>for</strong>m most risk assessment tasks. The use of this document will streamline<br />

the completion of human health risk assessments by providing program <strong>and</strong> project managers with a<br />

framework that integrates risk assessment activities into the life cycle of projects.<br />

The methods outlined in this document are consistent with the U.S. Environmental Protection<br />

Agency’s (EPA) human health evaluation process described in parts A through D of <strong>Risk</strong> Assessment<br />

<strong>Guidance</strong> <strong>for</strong> Superfund Volume I: Human Health Evaluation Manual (RAGS) (EPA 1989, 1991a,<br />

1991b, 1998). Under CERCLA, RAGS serves as the primary regulatory guidance document <strong>for</strong> all risk<br />

assessments <strong>and</strong> its application to risk management. In addition to RAGS, comments provided by state<br />

<strong>and</strong> federal regulators on previously submitted risk assessment reports <strong>and</strong> the most up-to-date scientific<br />

findings related to the evaluation of human health risk have been incorporated into this document.<br />

The Paducah risk assessment guidance document, Methods <strong>for</strong> <strong>Conducting</strong> Human Health <strong>Risk</strong><br />

<strong>Assessments</strong> <strong>and</strong> <strong>Risk</strong> Evaluations at the Paducah Gaseous Diffusion Plant (DOE/OR/07-1506&D1,<br />

DOE 1996) was prepared to incorporate requirements of the State of Kentucky <strong>and</strong> EPA Region IV.<br />

Although the Paducah risk assessment guidance document references this document, the Paducah<br />

guidance is to be considered “site-specific”. All risk assessments <strong>and</strong> risk evaluations at the Paducah<br />

Gaseous Diffusion Plant must comply with the requirements outlined in Methods <strong>for</strong> <strong>Conducting</strong> Human<br />

Health <strong>Risk</strong> <strong>Assessments</strong> <strong>and</strong> <strong>Risk</strong> Evaluations at the Paducah Gaseous Diffusion Plant (DOE/OR/07-<br />

1506&D1, DOE 1996) or its most recent revision.<br />

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