[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
