Risk Assessment Guidance for Superfund (RAGS): Part D
Introduction
[UPDATE] As of June 10, 2002, Risk Assessment Guidance for Superfund (RAGS): Volume I - Human Health Evaluation Manual (Part D, Standardized Planning, Reporting and Review of Superfund Risk Assessments) Final December 2001, will supersede an interim version published in1998 and is effective immediately for all new Comprehensive Environmental Response Compensation and Liability Act (CERCLA) risk assessments.
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Background
The March 21, 1995 memorandum on Risk Characterization Policy Guidance from former EPA Administrator Carol Browner directed improvement in the transparency, clarity, consistency, and reasonableness of risk assessments at EPA. Over the years, we have looked for opportunities for improving the presentation of Superfund risk assessments. In addition, the General Accounting Office (GAO), members of Congress, and others have called for the betterment of Superfund risk assessments. The October 1995 Superfund Administrative Reform #6A directed EPA to establish National criteria to plan, report and review Superfund risk assessments. EPA has developed an approach to respond to these challenges, which is presented in RAGS Part D.
An Agency workgroup of regional and headquarters risk assessors (the RAGS Part D Workgroup) has been active since the second quarter of FY 96 developing Planning Tools and other approaches to support standardization of risk assessments. Preliminary draft Planning Tools developed by the Workgroup in 1996 were tested and subjected to regional and state review in the fourth quarter of FY 96. Additional development and testing were performed by the Workgroup in FY 97, and a second regional review occurred in fourth quarter FY 97. Training on the use of RAGS Part D was conducted during FY 98. The Workgroup coordinated extensively with the development team for the National Superfund Database (CERCLIS 3) during FY 97, concurrent with CERCLIS 3 development and testing efforts. RAGS Part D Revision 0 was released in January 1998 as interim guidance and underwent field testing and evaluation for a 3 -year period. During FY 01 the Workgroup worked extensively to address all comments and concerns raised during field testing and evaluation of RAGS Part D Revision 0. This final guidance considers the comments received from users of RAGS Part D Revision 0 and provides recommended Planning Table and format changes as appropriate. The Planning Tools in RAGS Part D ( Planning Tables, Instructions for the Planning Tables, Planning Worksheets, and Example Scenarios) reflect the results of continued development, testing, and are now available for immediate use.
Elements of the RAGS Part D Approach
The Risk Assessment Guidance for Superfund (RAGS) Part D approach consists of three basic elements: Use of Planning Tools, Continuous Involvement of EPA Risk Assessors, and Information Transfer to a Superfund Risk Data Repository. Brief descriptions of the three components follow:
Use of Planning Tools The Planning Tools developed by the EPA RAGS Part D Workgroup and refined through regional review include a Technical Approach for Risk Assessment or TARA, Planning Tables, and Instructions for the Planning Tables.
- The Technical Approach for Risk Assessment (TARA) is a road map for incorporating continuous involvement of the EPA risk assessor throughout the CERCLA remedial process for a particular site. Risk-related activities, beginning with scoping and problem formulation, extending through collection and analysis of risk-related data, and supporting risk management decision making and remedial design/remedial action issues are addressed. A planning worksheet that can be used to summarize the TARA for a particular site can be found in Appendix C.
- The Planning Tables have been developed to more clearly and consistently document important parameters, data, calculations, and conclusions from all stages of human health risk assessment development. Electronic templates for the Planning Tables have been developed in Lotus® and Excel® for ease of use by risk assessors. For site-specific risk assessments, the Planning Tables, related Worksheets, and Supporting Information should first be prepared as Interim Deliverables for EPA risk assessor review, and should later be included in the Draft and Final Baseline Risk Assessment Reports. The Planning Tables, both a blank set and a fully completed example set, may be found in Appendix A. Additional example scenarios and selected Planning Tables are provided in Appendix D. Use of the Planning Tables will help standardize the reporting of human health risk assessments and improve communication with stakeholders.
- Instructions for the Planning Tables have been prepared corresponding to each row and column on each Planning Table. Definitions of each field are supplied in the Glossary and example data or selections for individual data fields are provided. The Instructions should be used to complete and/or review Planning Tables for each site-specific human health risk assessment, where appropriate. The Instructions may be found in Appendix B.
Continuous Involvement of EPA Risk Assessors
The EPA risk assessor is a critical participant in the CERCLA remedial process for any site, from scoping through completion and periodic review of the remedial action. EPA risk assessors support reasonable and consistent risk analysis and risk-based decision making. Early and continuous involvement by the EPA risk assessors should include scoping, workplan review, and customization of the TARA for each site to identify all risk-related requirements. The EPA risk assessors should review Interim Deliverables and identify corrections needed prior to preparation of the Draft and Final Baseline Risk Assessment Reports. Participation of the EPA risk assessors in all other phases of the CERCLA remedial process will help ensure human health risk issues are appropriately incorporated in the remedy selection and implementation processes.
Information Transfer to a Superfund Risk Data Repository
Summary-level site-specific risk information will be stored in a Superfund Risk Data Repository to provide information access and evaluation capabilities to all EPA staff.
Implementation of RAGS Part D
Applicability
The approach contained in RAGS part D is recommended for all risk assessments commencing after the issuance of Part D. Its use is also encouraged in on-going risk assessments to the extent it can efficiently be incorporated into the risk assessment process. Part D is not applicable to completed risk assessments.
The following table provides guidelines regarding the applicability of RAGS Part D as a function of site lead and site type, so that site-specific applicability may be determined by each region.
| Site Lead | Part D Applicable |
|---|---|
| Fund Lead | ♦ |
| Federal Facility Lead | ♦ |
| PRP Lead | ♦ |
| State Lead | ♦ |