[Federal Register Volume 63, Number 56 (Tuesday, March 24, 1998)]
[Notices]
[Pages 14115-14117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7639]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-5985-7]


Risk Assessment Guidance for Superfund: Volume I--Human Health 
Evaluation Manual (Part D, Standardized Planning, Reporting, and Review 
of Superfund Risk Assessments) (RAGS Part D)

AGENCY: Environmental Protection.

ACTION: Notice of availability of RAGS Part D.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) has developed 
Risk Assessment Guidance for Superfund: Volume I--Human Health 
Evaluation Manual (Part D, Standardized Planning, Reporting, and Review 
of Superfund Risk Assessments) RAGS Part D), which is now available. 
This guidance is intended to assist remedial project managers (RPMs), 
risk assessors, site engineers, and others in standardizing risk 
assessment planning, reporting, and review at Comprehensive, 
Environmental Response Compensation and Liability Act (CERCLA) sites.
    This guidance is the fourth part (Part D) in the series Risk 
Assessment Guidance for Superfund: Volume I--Human Health Evaluation 
Manual (RAGS/HHEM). Part A describes how to conduct a site-specific 
baseline risk assessment and provides the necessary background for Part 
D. Part B provides guidance for calculating risk-based concentrations 
that may be used, along with applicable or relevant and appropriate 
requirements (ARARs) and other information, to develop preliminary 
remediation goals (PRGs) during project scoping. The analyses in Part C 
utilize PRGs (and final remediation levels set in the Record of 
Decision [ROD]) to assist in evaluating the human health risks of 
remedial alternative. Part D complements the guidance provided in Parts 
A, B, and C, and presents approaches to standardize risk assessment 
planning, reporting, and review. Part D guidance spans the CERCLA 
remedial process from project scoping to periodic review of the 
implemented remedial action.

DATES: RAGS Part D was conveyed to EPA Superfund National Managers by 
memorandum from Stephen D. Luftig (Director, Office of Emergency and 
Remedial Response) and Barry Breen (Director, Office of Site 
Remediation Enforcement) on December 17, 1997, and is now being 
published by National Technical Information Service (NTIS).

ADDRESSES: Copies of RAGS Part D can be downloaded from the Internet 
immediately by going to the RAGS Part D website, located at http://
www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html. In approximately 
three weeks, a hard copy of the document can be obtained by contacting 
NTIS at (703) 487-4650. Members of the public are invited to inspect 
the docket developed to support the RAGS Part D guidance at the 
Superfund Docket, U.S. Environmental Protection Agency, 1235 Jefferson 
Davis Highway, Arlington, Virginia. [Docket Number RAGS Part D]. The 
docket is available for inspection between 9:00 a.m. and 4:00 p.m. 
Monday through Friday, excluding Federal holidays. Appointments to 
review the docket can be made by calling (703) 603-9232. The public may 
copy a maximum of 266 pages from the docket at no charge; each page 
thereafter will cost 15 cents, plus a $25 administrative fee.
    In addition to the guidance document, the Part D guidance and 
corresponding information may be accessed electronically on the RAGS 
Part D website. Updates to Part D will also appear on the website along 
with an index of the current version of each Chapter or Appendix.
    Questions or comments regarding Part D usage should be directed to 
an EPA regional risk assessor or to the EPA RAGS Part D Workgroup 
through the RAGS Part D website. Questions or comments received through 
the website will be considered by the Workgroup and a response will be 
developed and forwarded via telephone or E--mail as appropriate. 
Frequently asked questions will be assembled and displayed on the 
website with corresponding responses.

FOR FURTHER INFORMATION CONTACT: Contact the RCRA/Superfund Hotline at 
(800) 424-9346; from the Washington, D.C. metropolitan area call (703) 
412-9810. The Telecommunications Device for the Deaf (TDD) Hotline 
number is (800) 553-7672; from the Washington, D.C. metropolitan area 
the number is (703) 412-3323. You may also contact the Senior Process 
Manager for Risk, RAGS Part D, Office of Emergency and Remedial 
Response (5202G), U.S. Environmental Protection Agency, 401 M Street, 
SW, Washington, D.C. 20460.


[[Page 14116]]


SUPPLEMENTARY INFORMATION:

Background

    The March 21, 1995 memorandum on Risk Characterization Policy and 
Guidance from Administrator Browner directed improvement in the 
transparency, clarity, consistency, and reasonableness of risk 
assessments at EPA. EPA, over the years, has identified opportunities 
for improvement in presentation of Superfund risk assessments. 
Furthermore, the General Accounting Office (GAO), members of Congress, 
and others have called for 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 Standard Tools and other approaches to support 
standardization. Preliminary draft Standard Tools developed by the 
Workgroup in 1996 were tested and subjected to regional and state 
review in the fourth quarter of FY 96. Additional developing and 
testing were performed by the Workgroup in FY 97, and a second regional 
review occurred in fourth quarter FY 97. The Workgroup also coordinated 
extensively with the development team for the National Superfund 
Database (CERCLIS 3) during FY 97, concurrent with CERCLIS 3 
development and testing efforts. The Standard Tools in RAGS Part D 
(Technical Approach for Risk Assessment, Standard Tables, and 
Instructions for the Standard Tables) reflect the results of continued 
development, testing, and CERCLIS 3 interaction, and are now available 
for use immediately.

Elements for Part D Approach

    Today's Federal Register notice announces the availability of Risk 
Assessment Guidance for Superfund: Volume I--Human Health Evaluation 
Manual (Part D, Standardized Planning, Reporting, and Review of 
Superfund Risk Assessments) (RAGS Part D). The RAGS Part D approach 
consists of three elements: Use of Standard Tools, Continuous 
Involvement of EPA Risk Assessors, and Electronic Data Transfer to a 
National Superfund Database:
     Use of Standard Tools--The Standard Tools developed by the 
EPA RAGS Part D Workgroup and refined through regional review include a 
Technical Approach for Risk Assessment (TARA), Standard Tables, and 
Instructions for the Standard Tables.
     TARA is a road map for incorporating continuous 
involvement of the EPA risk assessor throughout the CERCLA remedial 
process for a particular site. Addressed are risk-related activities 
starting with project 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.
     The Standard Tables have been developed to clearly and 
consistently document important parameters, data, calculations, and 
conclusions from all stages of human health risk assessment 
development. Electronic templates for the Standard Tables are available 
in LOTUS and EXCEL.
     Instructions for the Standard Tables have been prepared to 
ensure standardization in the preparation and/or review of Standard 
Tables for each site-specific human health risk assessment.
     Continuous Involvement of EPA Risk Assessors--Early and 
continuous involvement by the EPA risk assessor is critical in the 
CERCLA remedial process, from scoping through completion of remedial 
activities. EPA risk assessors support reasonable and consistent risk 
analysis and risk-based decision making. Their up-front involvement 
should include scoping, work plan review, and customization of the TARA 
for each site to identify all risk-related requirements. The EPA risk 
assessors will 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 ensure human health 
risk issues are appropriately incorporated in the remedy selection and 
implementation processes.
     Electronic Data Transfer to a National Superfund 
Database--Summary-level site-specific risk information will be stored 
in a National Superfund database (CERCLIS 3) to provide data access and 
data management capabilities to all EPA staff. The CERCLIS 3 risk-
related data represent a subset of the data presented in the Standard 
Tables.
    RAGS Part D is organized into five chapters and three appendices as 
follows:
     Chapter 1: Introduction;
     Chapter 2: Risk Considerations During Project Scoping;
     Chapter 3: Risk Assessment Data Needs and Tasks During the 
Remedial Investigation;
     Chapter 4: Risk Evaluations During the Feasibility Study;
     Chapter 5: Risk Evaluations After the Feasibility Study;
     Appendix A: Standard Tables;
     Appendix B: Instructions for Completion of the Standard 
Tables; and
     Appendix C: Data Useability Worksheet.
    In addition, other useful information is presented in highlight 
boxes placed throughout the document.
    This guidance will be updated periodically in response to user 
comments and suggestions and to address new human health risk 
assessment guidance, as appropriate. A RAGS Part D mailing list will be 
compiled. By using the card found at the back of the Part D package, 
interested parties can add their names to the list for automatic 
notification regarding future updates.

Goals

    The RAGS Part D approach provides numerous advantages over current 
risk assessment practices in the Superfund program at both the site 
level and the overall program level.
    The use of Standard Tools will facilitate planning with TARA, 
reporting with Standard Table formats, and reviewing of Interim 
Deliverables. The Standard Tools will provide consistent content and 
clarity of data, parameters, and assumptions. Transparency will be 
improved by the Standard Tables, making it easier for the public and 
other interested parties to understand the risk assessment, and review 
will be facilitated because the basis for conclusions will be clear. 
Because Interim Deliverables are integral parts of the baseline risk 
assessment, their early review and resolution by EPA risk assessors 
will minimize rework and may reduce project schedules and budgets while 
improving quality of the final product.
    Continuous involvement of the EPA risk assessor throughout the 
CERCLA remedial process will result in holistic consideration of risk 
issues during scoping and will ensure that appropriate and adequate 
data are collected. At later stages of the project, continuous 
involvement of the EPA risk assessor will promote reasonableness and 
consistency in risk management decision making by clearly providing 
risk managers with the information they need.

[[Page 14117]]

    Through submission of electronic Standard Tables, CERCLIS 3 risk 
data reporting requirements will be met electronically. Submission of 
the risk data to CERCLIS 3 will also fulfill the review objectives of 
Superfund Administrative Reform #6A by providing the public and other 
interested parties access to risk data. Use of the data by EPA risk 
assessors will improve consistency in future risk assessments.

    Dated: March 17, 1998.
Timothy Fields, Jr.,
Acting Assistant Administrator,
Office of Solid Waste and Emergency Response.
[FR Doc. 98-7639 Filed 3-23-98; 8:45 am]
BILLING CODE 6560-50-M