Publication 92S5 7-47
September 2001
Risk Assessment Guidance
for Superfund:
Volume I
Human Health Evaluation Manual
(Part D, Standardized Planning,
Reporting, and Review of Superfund
Risk Assessments)
Final
Office of Emergency and Remedial Response
U.S. Environmental Protection Agency
Washington, DC 20460
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NOTICE
This document provides guidance to EPA Regions regarding National policy on the planning,
reporting, and review of Superfund risk assessments Some of the statutory provisions described in this
document contain legally binding requirements. However, this document does not substitute for EPA's
statutes or regulations, nor is it a regulation itself. Thus, it cannot impose legally-binding requirements on
EPA, States, or the regulated community, and may not apply to a particular situation based upon the
circumstances. Any decisions regarding a particular situation will be made based on the statute and
regulations, and EPA decisionmakers retain the discretion to adopt approaches on a case-by-case basis that
differ from this guidance where appropriate. EPA may change this guidance in the future, as appropriate.
This guidance is based on the National Oil and Hazardous Substances Pollution Contingency Plan
(NCP), which was published on March 8, 1990 (55 Federal Register 8666). The NCP should be considered
the authoritative source.
Library
US EPA Region 3
1650 Arch St
Philadelphia, PA 19103
Revision No. 1 ii September 2001
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CONTENTS
Page
NOTICE . . . . ...
CONTENTS - ,,i
EXHIBITS . vi
DEFINITIONS VH
ACRONYMS/ABBREVIATIONS \i,
ACKNOWLEDGMENTS MV
PREFACE xv
1.0 INTRODUCTION 1-1
1.1 OVERVIEW OF PART D 1-1
1.1.1 Background 1-1
1.1.2 Revision 1 Changes 1-1
1.1.3 Elements of Part D Approach 1-3
1.2 APPLICABILITY OF PART D APPROACH 1-4
1.3 PROCESS IMPROVEMENTS RESULTING FROM
PART D APPROACH 1-4
1.4 ORGANIZATION OF DOCUMENT 1-6
1.5 ADDITIONAL INFORMATION 1-6
2.0 RISK CONSIDERATIONS DURING PROJECT SCOPING 2-1
2.1 PLANNING , 2-1
2.2 WORKPLAN DEVELOPMENT 2-2
2.2.1 RI/FS Workplan/Baseline Risk Assessment Workplan 2-2
2.2.2 SAPandQAPP 2-1
3.0 RISK ASSESSMENT DATA NEEDS AND TASKS DURING
THE REMEDIAL INVESTIGATION 3-1
3.1 INTERIM DELIVERABLES 3-1
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CONTENTS (Continued)
Page
3.1.1 Standard Tables, Worksheets, and Supporting Information . . 3-2
3.1.2 Assessment of Confidence and Uncertainty . 3-13
3.1.3 Probabilistic Analysis Information ... 3-13
3.2 DRAFT BASELINE RISK ASSESSMENT REPORT 3-13
3.3 FINAL BASELINE RISK ASSESSMENT REPORT 3-14
3.4 INFORMATION TRANSFER TO SUPERFUND RISK DATA COLLECTION . ..3-14
4.0 RISK EVALUATIONS DURING THE FEASIBILITY STUDY 4-1
4.1 INTRODUCTION 4-1
4.1.1 Remedial Action Objectives 4-1
4.1.2 Remediation Goals 4-1
4.1.3 Preliminary Remediation Goals 4-3
4.2 DEVELOP REMEDIAL ACTION OBJECTIVES 4-3
4.3 DEVELOP REMEDIATION GOALS 4-3
4.3.1 Identify Values Considered as Preliminary Remediation Goals 4-3
4.3.2 Select Preliminary Remediation Goals 4-4
4.4 SUMMARIZE RISKS AND HAZARDS ASSOCIATED
WITH PRELIMINARY REMEDIATION GOALS 4-4
4.5 EVALUATE REMEDIAL TECHNOLOGIES AND
ALTERNATIVES FOR RISK CONSIDERATIONS 4-4
4.5.1 Identification and Screening of Technologies
and Alternatives 4-5
4.5.2 Detailed Analysis of Alternatives .. . 4-5
5.0 RISK EVALUATIONS AFTER THE FEASIBILITY STUDY 5-1
5.1 RISK EVALUATION FOR THE PROPOSED PLAN 5-1
5.2 RISK EVALUATION ASSOCIATED WITH THE RECORD
OF DECISION 5-1
5.2.1 Baseline Risk Summary in the Record of Decision 5-1
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CONTENTS (Continued)
Page
5.2.2 Risks Associated with Cleanup Levels in the Record of Decision
5.3 RISK EVALUATION DURING REMEDIAL DESIGN AND
REMEDIAL ACTION
5.4 RISK EVALUATION ASSOCIATED WITH
EXPLANATIONS OF SIGNIFICANT DIFFERENCES
(ESDs) AND AMENDED RODs
5.5 RISK EVALUATION DURING
FIVE-YEAR REVIEWS
REFERENCES
APPENDIX A
APPENDIX B
APPENDIX C
APPENDIX D
5-2
5-2
5-2
. 5-2
R-l
STANDARD TABLES
INSTRUCTIONS FOR COMPLETION OF THE STANDARD
TABLES
STANDARD WORKSHEETS
EXAMPLE SCENARIOS
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EXHIBITS
Exhibit Page
1 -1 RELATIONSHIP OF THE HUMAN HEALTH EVALUATION
TO THE CERCLA PROCESS 1-2
1-2 GUIDELINES FOR PART D APPLICABILITY .1-5
1-3 ROLE OF RISK ASSESSOR IN THE CERCLA REMEDIAL PROCESS . . 1-7
3-1 INTERIM DELIVERABLES FOR EACH SITE 3-15
3-2 STANDARDIZED RISK ASSESSMENT REPORTING 3-18
3-3 SUMMARY OF RAGS PART D REVISION 1 CHANGES 3-20
3-4 RAGS PART D INFORMATION SOURCES FOR ROD RISK GUIDANCE
HIGHLIGHTS 3-22
4-1 EXAMPLE TABLES TO STANDARDIZE REPORTING OF
FS RISK EVALUATIONS 4-6
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DEFINITIONS
Term
Definition
Applicable or Relevant and
Appropriate Requirements (ARARs)
Conceptual Site Model
Deterministic Analysis
EPA Risk Assessor
Exposure Medium
''Applicable" requirements are those clean-up standards of
control, and other substantive environmental protection
requirements, criteria, or limitations promulgated under federal
or state law that specifically address a hazardous substance.
pollutant, contaminant, remedial action, location, or other
circumstance at a Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) site "Relevant
and appropriate" requirements are those clean-up standards
which, while not "applicable" at a CERCLA site, address
problems or situations sufficiently similar to those encountered
at the CERCLA site that their use is well-suited to the particular
site. ARARs can be action-specific, location-specific, or
chemical-specific.
A ''model" of a site developed at scoping using readily
available information. Used to identify all potential or
suspected sources of contamination, types and concentrations
of contaminants detected at the site, potentially contaminated
media, and potential exposure pathways, including receptors
This model is also known as "conceptual evaluation model."
Calculation and expression of health risks as single numerical
values or "single point" estimates of risk. In risk assessments,
the uncertainty and variability are discussed in a qualitative
manner.
The risk assessor responsible for reviewing the risk assessment
on behalf of EPA. The individual may be an EPA employee or
contractor, a State employee, or some other party, as
appropriate for an individual site.
The contaminated environmental medium to which an
individual may be exposed. Includes the transfer of
contaminants from one Medium to another.
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DEFINITIONS (Continued)
Term
Definition
Exposure Pathway
Exposure Point
Exposure Point Concentration
Exposure Route
Interim Deliverables
Medium
The course a chemical or radionuclide takes from the source to
the exposed individual. An exposure pathway analysis links
the sources, locations, and types of environmental releases with
population locations and activity patterns to determine the
significant pathways of human exposure. Within the Standard
Tables, an Exposure Pathway is defined as each unique
combination of Scenario Timeframe, Medium, Exposure
Medium, Exposure Point, Receptor Population, Receptor Age,
and Exposure Route.
An exact location of potential contact between a person and a
chemical or radionuclide within an Exposure Medium.
The value, based on either a statistical derivation of measured
data or modeled data, that represents an estimate of the
chemical or radionuclide concentration available from a
particular Medium or route of exposure.
The way a chemical or radionuclide comes in contact with a
person (e.g., by ingestion, inhalation, dermal contact).
A series of Standard Tables, Worksheets, and Supporting
Information, identified in the Workplan for each site, that
should be developed by the risk assessment author, and
evaluated by the EPA risk assessor, prior to development of the
Draft Baseline Risk Assessment Report. After review and
revision, as necessary, these documents should be included in
the Baseline Risk Assessment Report. The Standard Tables
should be prepared for each site to achieve standardization in
risk assessment reporting. The Worksheets and Supporting
Information should also be prepared to further improve
transparency, clarity, consistency, and reasonableness of risk
assessments.
The environmental substance (e.g, air, water, soil) that is a
potential source of contaminants in the Exposure Medium.
(The Medium will sometimes equal the Exposure Medium.)
Usually the Medium is that targeted for possible remediation.
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DEFINITIONS (Continued)
Term
Definition
Preliminary Remediation Goals
(PRGs)
Probabilistic Analysis
Risk Assessment Author
Receptor Age
Receptor Population
Scenario Timeframe
Initial cleanup goals that (1) are protective of human health and
the environment and (2) comply with ARARs They are
developed early in the remedy selection process based on
readily available information and are modified to reflect results
of the baseline risk assessment. They also are used during
analysis of remedial alternatives in the remedial
investigation/feasibility study (RI/FS). Remedial goals.
selected as part of the risk management decision, replace PRGs
in the Record of Decision.
Calculation and expression of health risks using multiple risk
descriptors to provide the likelihood of various risk levels.
Probabilistic risk results approximate a full range of possible
outcomes and the likelihood of each, which often are presented
as a frequency distribution graph, thus allowing uncertainty or
variability to be expressed quantitatively.
The risk assessor responsible for preparing the risk assessment.
This individual may be an EPA employee or contractor, a State
employee, a PRP employee or contractor, or some other party,
as appropriate for an individual site.
The description of the exposed individual as defined by the
EPA Region or dictated by the site.
The exposed individual relative to the Exposure Pathway
considered.
The time period (current and/or future) be ing considered for the
Exposure Pathway.
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DEFINITIONS (Continued)
Term
Definition
Standard Tables
Standard Tools
Supporting Information
One of the Standard Tools under the HAGS Part D approach.
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 have been developed in Lotusฎ and Excelฎ for ease of
use by risk assessors. For each site-specific risk assessment,
the Standard 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
Standard Tables may be found in Appendix A. Use of the
Standard Tables will standardize the reporting of human health
risk assessments. The Standard Table formats should not be
altered (i.e., columns should not be added, deleted, or changed);
however, rows and footnotes may be added as appropriate.
Standardization of the Tables is needed to achieve Superfund
program-wide reporting consistency.
A basic element of the RAGS Part D approach. The Standard
Tools have been developed to standardize the planning,
reporting, and review of Superfund risk assessments. The three
Standard Tools contained in the Part D approach include the
Technical Approach for Risk Assessment (TARA), the
Standard Tables, and Instructions for the Standard Tables.
Information submissions that substantiate or summarize
detailed data analysis, calculations, or modeling and associated
parameters and assumptions. Examples of recommended
Supporting Information include: derivations of background
values, exposure point concentrations, modeled intakes, and
chemical-specific parameters. Supporting Information should
be provided as Interim Deliverables for EPA risk assessor
review prior to the development of the Draft Baseline Risk
Assessment Report.
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DEFINITIONS (Continued)
Term
Definition
Technical Approach
for Risk Assessment
(TARA)
Worksheets
One of the Standard Tools under the RAGS Part D approach
The TARA is a road map for incorporating continuous
involvement of the EPA risk assessor throughout the CERCL A
remedial process. Risk-related activities, beginning uith
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. The TARA should be customized
for each site and the requirements identified should be included
in project workplans so that risk assessment requirements and
approaches are clearly defined. The TARA Schedule
Worksheet may be found in Appendix C with the other
worksheets. Chapters 2 through 5 of Part D present the TARA.
Formats for documenting assumptions, input parameters, and
conclusions regarding complex risk assessment issues. Data
Useability, TARA Schedule, Lead, Dermal, Radiation Dose
Assessment, and ROD Risk Worksheets are found in Appendix
C and should be developed as Interim Deliverables. for all risk
assessments, as applicable.
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ACRONYMS/ABBREVIATIONS
Acronym/
Abbreviation
Definition
ARARs
BRAC
CERCLA
'COPCs
CSF
CT
CWA
DQOs
EPA
EPC
ESD
FS
FY
GAO
HEAST
HI
HQ
IEUBK
IRIS
MCLs
NCEA
NCP
NPL
non-TCL
OSWER
PAHs
PCBs
PQLs
PRGs
PRP
QA/QC
QAPP
RAGS
RAGS/HHEM
RAOs
RfC
RfD
RI/FS
Applicable or Relevant and Appropriate Requirements
Base Realignment and Closure
Comprehensive Environmental Response Compensation and
Liability Act
Chemicals of Potential Concern
Cancer Slope Factor
Central Tendency
Clean Water Act
Data Quality Objectives
U.S. Environmental Protection Agency
Exposure Point Concentration
Explanation of Significant Differences
Feasibility Study
Fiscal Year
General Accounting Office
Health Effects Assessment Summary Tables
Hazard Index
Hazard Quotient
Integrated Exposure Uptake Biokinetic Model
Integrated Risk Information System
Maximum Contaminant Levels
National Center for Environmental Assessment
National Contingency Plan
National Priorities List
non-Target Compound List
Office of Solid Waste and Emergency Response
Polynuclear Aromatic Hydrocarbons
Polychlorinated Biphenyls
Procedure Quantitation Limits
Preliminary Remediation Goals
Potentially Responsible Party
Quality Assurance/Quality Control
Quality Assurance Project Plan
Risk Assessment Guidance for Superfund
Risk Assessment Guidance for Superfund. Volume I
Human Health Evaluation Manual
Remedial Action Objectives
Reference Concentration
Reference Dose
Remedial Investigation/Feasibility Study
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ACRONYMS/ABBREVIATIONS (Continued)
Acronym/
Abbreviation Definition
RI Remedial Investigation
RME Reasonable Maximum Exposure
ROD Record of Decision
RPM Remedial Project Manager
SAP Sampling and Analysis Plan
SDWA Safe Drinking Water Act
TARA Technical Approach for Risk Assessment
UCL Upper Confidence Level
URF Unit Risk Factor
UTL Upper Tolerance Limit
Revision No. 1 xiii September 2001
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ACKNOWLEDGMENTS
This manual was developed by EPA's Office of Emergency and Remedial Response A large number
of EPA regional technical staff (see below) participated in the Workgroup that developed the RAGS Part D
Revision 1 approach presented in this manual.
CDM Federal Programs Corporation provided technical assistance to EPA in the development of this
guidance, under contract No. 68-W5-0022.
RAGS PART D REVISION 1 WORKGROUP
OFFICE OF EMERGENCY AND REMEDIAL RESPONSE:
Headquarters: David Bennett
Headquarters. Elizabeth Hofmann
Headquarters: James Konz
Headquarters: Karen Martin
EPA REGIONAL OFFICES:
Region 1:
Region 2:
Region 3:
Region 4:
Region 5:
Region 6:
Region 7:
Region 8:
Region 9:
Region 10:
Sarah Levinson
Marian Olsen
Jennifer Hubbard
Glenn Adams
Andrew Podowski
Ghassan Khoury
Judy Facey
Chris Weis
Stan Smucker
Dana Davoli
Revision No. 1
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PREFACE
Risk Assessment Guidance for Superfund Volume I Human Health Evaluation Manual
(RAGS/HHEM) Part D is the fourth part in the five-part series of guidance manuals on Superfund human
health risk assessment. Part A addresses the baseline risk assessment; Part B addresses the development of
risk-based preliminary remediation goals; Part C addresses the human health risk evaluations of remedial
alternatives; and Part E addresses dermal exposure. Part D provides guidance on standardized risk assessment
planning, reporting, and review throughout the CERCLA remedial process, from scoping through remedy
selection and completion and periodic review of the remedial action. Thus, Part D strives for effective and
efficient implementation of Superfund risk assessment practice described in Parts A, B. C, and E, and in
supplemental Office of Solid Waste and Emergency Response (OSWER) directives and other Agencv risk
assessment guidance. The potential users of Pan D are persons involved in the risk evaluation, remedy
selection, and implementation process, including risk assessors, risk assessment reviewers, remedial project
managers, and other decisionmakers.
Released in January 1998 as interim guidance, RAGS Part D Revision 0 underwent field testing and
evaluation for a 3-year period. This Revision 1 guidance considers the comments received from users of the
Revision 0 guidance and provides Standard Table format changes as appropriate.
Generally, changes were made to improve useability, transparency, clarity, and/or consistency with
other risk guidance (e.g., RAGS Part E dermal guidance [U.S. EPA, 2001], adult lead exposures technical
fact sheet [U.S. EPA, 1996d], and Record of Decision guidance [U.S. EPA, 1999a]). These changes may also
increase the efficiency of the risk assessor by decreasing the number of versions of each Standard Tables
associated with certain sites.
In addition to Standard Table format changes, the Revision I guidance provides standard formats to
document radionuclide and lead risk evaluations, neither of which was addressed in the Revision 0 guidance.
The Revision 1 guidance also provides more robust and diverse examples than were included in Revision 0
These examples address comments and questions received from users of the Revision 0 guidance and are
provided as suggested approaches to address complex situations. In all cases, the EPA regional risk assessor
should be consulted to discuss the appropriate approach for a site.
This guidance does not discuss the standardization of ecological risk assessments. EPA will provide
standard tables for ecological evaluation under separate cover. This guidance does not discuss the risk
management decisions that are necessary at a CERCLA site (e g.. selection of final remediation goals).
Upon issuance, RAGS Part D Revision 1 will be effective for all new CERCLA risk assessments.
Consult the EPA risk assessor for applicability of Revision 1 to ongoing risk assessments and non-CERCLA
risk assessments. Any updates to this guidance will be posted at the RAGS Part D website at
httD-//www.eDa.gov/superrund/programs/risk/ragsd/indc\ lum.
Comments addressing usefulness, changes, and additional areas where guidance is needed
should be addressed to the RAGS Part D website or to:
Senior Process Manager for Risk (RAGS Part D)
U.S. Environmental Protection Agency
Office of Emergency and Remedial Response (5202G)
Ariel Rios Building
1200 Pennsylvania Ave. NW
Washington, DC 20460
Revision No. 1 xv September 2001
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CHAPTER 1
INTRODUCTION
This guidance has been developed by the U.S.
Environmental Protection Agency (EPA) 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 could also be a useful tool for
quantitative risk assessment for non-National
Priorities List (NPL), Base Realignment and
Closure (BRAC), and Brownfields sites.
This guidance is the fourth part (Part D) in the
five-part series Risk Assessment Guidance for
Superfund Volume I Human Health Evaluation
Mwซa/(RAGS/HHEM)(U.S.EPA, 1989c). Part
A of this guidance describes how to conduct a
site-specific baseline risk assessment: the
information in Part A is necessary background for
PartD. 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. PRGs (and final
remediation levels set in the Record of Decision
[ROD]) can be used throughout the analyses in
Part C to assist in evaluating the human health
risks of remedial alternatives. Part E provides
guidance for evaluation of dermal exposure. Part
D complements the guidance provided in Parts A,
B, C, and E 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.
Exhibit 1-1 illustrates the major correspondence of
RAGS/HHEM activities with the steps in the
CERCLA remedial process.
The remainder of this chapter:
presents an overview of Part D, including the
background and elements of the Part D
approach
describes the applicability of Part D
presents the organization of the remainder of
this document
describes where to find additional information
regarding Part D.
1.1 OVERVIEW OF PART D
1.1.1 BACKGROUND
The March 21, 1995, memorandum on Risk
Characterization Policy and Guidance from former
EPA 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 199S 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.
1.1.2 REVISION 1 CHANGES
Released in January 1998 as interim guidance,
RAGS Part D Revision 0 underwent field testing
and evaluation for a 3-year period. This Revision
1 guidance considers the comments received from
users of the Revision 0 guidance and provides
Standard Table format changes as appropriate.
Generally, changes were made to improve
useability, transparency, clarity, or consistency
with other risk guidance (e.g., RAGS Part E
dermal guidance [U.S. EPA, 2001] and ROD
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CERCLA REMEDIAL PROCESS
o
D
Scoping
Remedial
Investigation
Feasibility
Study
Remedy
Selection and
Record of
Decision
Remedial
Design/
Remedial
Action
Deletion/
Five-Year
Review
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HUMAN HEALTH EVALUATION MANUAL - VOLUME I
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PART A
Baseline Risk Assessment
PARTB
Development of Risk-based
Preliminary Remediation Goals
PARTC
Risk Evaluation of Remedial Alternatives
PARTD
Standardized Planning, Reporting, and Review
PARTE
Dermal Risk Assessment
o
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-------
guidance [U.S. EPA, 1999a]). These changes may
also increase the efficiency of the risk assessor by
decreasing the number of versions of each
Standard Table associated with certain sites.
In addition to Standard Table format changes,
the Revision 1 guidance provides standard formats
to document radionuclide and lead risk
evaluations, neither of which was addressed in the
Revision 0 guidance. The Revision 1 guidance
also provides more robust and diverse examples
than were included in Revision 0. These examples
address comments and questions received from
users of the Revision 0 guidance and are provided
as suggested approaches to address complex
situations. In all cases, the EPA risk assessor and
the RPM (when appropriate) should be consulted
to discuss the appropriate approach for a site.
Revisions associated with each Standard Table
may be found in Exhibit 3-3.
1.1.3 ELEMENTS OF PART D APPROACH
The Risk Assessment Guidance for Superfund
(RAGS) Part D approach consists of three basic
elements: Use of Standard Tools, Continuous
Involvement of EPA Risk Assessors, and
Information Transfer to a National Superfund Risk
Data Repository. Brief descriptions of the three
components follow:
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 or TARA, Standard Tables, and
Instructions for the Standard 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.
Chapters 2 through 5 of this guidance
document present the TARA m the four
CERCLA remedial process phases
During Scoping, During the Remedial
Investigation, During the Feasibility
Study, and After the Feasibility Study It
is recommended that the requirements
identified in the TARA m Chapters 2
through 5 be customized for each site-
specific human health risk assessment, as
appropriate. These requirements should
be included in project workplans so that
risk assessment requirements are clearly
defined and standardized planning will
occur. A worksheet that can be used to
summarize the TARA for a particular site
(the TARA Schedule Worksheet) is found
with the other Worksheets in Appendix C.
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 have been developed in Lotusฎ
and Excelฎ for ease of use by risk
assessors. For each site-specific risk
assessment, the Standard Tables, related
Worksheets, and Supporting Information
should first be prepared as Interim
Deliverables for EPA risk assessor
review, and should later be included m
the Draft and Final Baseline Risk
Assessment Reports. The Standard
Tables, both a blank set and a fully
completed example set, may be found in
Appendix A. Additional example
scenarios and selected Standard Tables
are provided in Appendix D. Use of the
Standard Tables will standardize the
reporting of human health risk
assessments.
Instructions for the Standard Tables have
been prepared corresponding to each TOM
and column on each Standard 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
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used to complete and/or review Standard
Tables foreach site-specific human health
risk assessment. 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 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.
Information Transfer to a Superfund Risk
Data Collection - Summary-level site-specific
risk information will be contained in a
Superfund Risk Data Repository to provide
information access and evaluation capabilities
to EPA staff.
1.2 APPLICABILITY OF PART D
APPROACH
The approach contained in RAGS Part D is
strongly recommended for all CERCLA human
health risk assessments.
Exhibit 1-2 provides guidelines regarding
RAGS Part D applicability as a function of site
lead and site type, so that site-specific
applicability may be defined by each region.
1.3 PROCESS IMPROVEMENTS
RESULTING FROM PART D
APPROACH
The RAGS Part D approach provides
advantages over previous practices in the
Superfund program at both the site level and the
overall Superfund program level.
A brief discussion of the process
improvements associated with each RAGS Part D
element follows:
Use of Standard Tools - Standard Tools
facilitate planning with TARA, reporting with
Standard Table formats, and reviewing with
Interim Deliverables. The Standard Tools
provide consistent content and clarity of data,
parameters, and assumptions. Transparency
for the public and others to understand the risk
assessment is improved by the Standard
Tables, and review is facilitated because the
basis for conclusions is clear. Because
Interim Deliverables are integral parts of the
baseline risk assessment, their early review
and resolution by EPA risk assessors
minimize rework and may reduce project
schedules and budgets, while improving
consistency.
Continuous Involvement of EPA Risk
Assessor - Involvement of the EPA risk
assessor throughout the CERCLA remedial
process results in holistic consideration of risk
issues during scoping and ensures that
appropriate and adequate data are collected.
Planning for special evaluations can also be
conducted efficiently at project inception
rather than at a later point with associated
schedule delays and additional costs
Ongoing review of Interim Deliverables by
the EPA risk assessor provides direction
regarding reasonable assumptions and
eliminates rework requirements, particularly
for those deliverables that build on previous
analyses (e.g., the Baseline Risk Assessment
Report).
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EXHIBIT 1- 2
GUIDELINES FOR PART D APPLICABILITY
SITE LEAD
Fund Lead
Federal Facility Lead
PRP Lead
State Lead
PART D APPLICABLE
/
/
/
/
SITE TYPE1
Remedial
Scoping, RI/FS, Risk Assessment, Proposed Plan, ROD,
RD/RA, Presumptive Remedy
Post-Remedial.
ESD, Amended ROD,
Five- Year Review
Removal:
Non-time Critical, Tune-Critical, Streamlined
SACMJ
RCRA Corrective Action4
/
/
_2
/
_1
Notes
1 The RAGS Part D Workgroup also suggests that RAGS Part D could be a useful loot for quantitative risk assessment Tor non-NPL, BRAG, and
Brovsnfields sites and encourages its use
2 RAGS Part D use is encouraged as appropriate
3 Superfund Accelerated Cleanup Model
4 As described in the September 1996 EPA memorandum on Coordination Between Resource Conservation and Recovery Act (RCRA)
Corrective Action and Closure and CERCLA Site Activities, EPA is " committed to the principle of parity between the RCRA corrective
action and CERCLA programs "
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At later stages of the project (e.g., after the
feasibility study), continuous involvement of
the EPA risk assessor promotes
reasonableness and consistency in risk
management decision-making by clearly
providing risk managers with the information
they need. Preparation of draft ROD risk
information as an interim deliverable in the
format specified in Guide to Preparing
Superfund Proposed Plans, Records of
Decision, and Other Remedy Selection
Decision Documents (U.S. EPA, 1999a) will
further support risk managers' efficiency. The
ROD Risk Worksheets found in Appendix C
match the ROD guidance formats.
Information Transfer to Superfund Risk
Data Collection - Submission of the
electronic Standard Tables and Worksheets to
the Superfund Risk Data Collection fulfills the
review objectives of Superfund
Administrative Reform #6A. Use of the
information by EPA risk assessors will help
improve consistency in future risk
assessments.
1.4 ORGANIZATION OF
DOCUMENT
The remainder of this guidance is organized
into four additional chapters, references, and four
appendices as follows:
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;
References
Appendix A: Standard Tables
Appendix B: Instructions for Completion of
Standard Tables
Appendix C: Worksheets
Appendix D: Example Scenarios.
In addition, other useful information has been
presented in highlight boxes placed throughout the
document.
Exhibit 1-3 depicts the continuous
involvement of the EPA risk assessor during
scoping, during the remedial investigation, and
during and after the feasibility study. The various
activities the risk assessor conducts are listed, as
well as the Part D chapter that addresses that
phase.
1.5 ADDITIONAL INFORMATION
This guidance will be updated periodically in
response to user comments and suggestions and to
address new human health risk assessment
guidance as appropriate.
The Part D guidance and corresponding
information may be accessed electronically on the
RAGS Part D website, at
httpV/www epa gov/superfiind/programs/risk/
rausd/index.htm . 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 for a particular risk assessment should be
directed to your EPA risk assessor. General Part
D questions or comments should be directed to
the RAGS Part D website. Questions or
comments received through the website will be
considered and a response will be developed and
forwarded via telephone or email as appropriate.
Frequently asked questions will be assembled and
displayed on the website with corresponding
responses to provide Part D user support.
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n
5'
3
z
o
CERCLA REMEDIAL PROCESS
2
w
o
*1
CONTINUOUS INVOLVEMENT
(RAGS Part D -
I
During Scoping
Planning
Workplans
(RAGS D - Chapter 2)
CO
n>
cr
n
o
o
OF EPA RISK
Chapter 1)
ASSESSOR
1
During Remedial Investigation
Interim Dcliverables
- Standard Tables
(Appendices A and 13)
- Worksheets
- Supporting Information
- Confidence and Uncertainty
- Probabilistic Analysis
Draft Baseline Risk Assessment Report
Final Baseline Risk Assessment Report
Information Transfer to Superfund Risk
Data Collection
Record of Decision (ROD) Risk
Worksheets
(RAGS I)-Chapter3)
I
During Feasibility Study
i Remedial Action Objectives
> Remedial Action Goals
> Risks/Hazards of Preliminary
Remediation Goals (PRGs)
1 Risks of Remedial Technologies
and Alternatives
(RAGS D-Chapter4)
I
After Feasibility Study
Remediation Goals
Proposed Plan
ROD
Explanations of Significant
Differences (ESUs)
Remedial Design/ Remedial
Action (RD/RA)
Amended RODs
Five-Year Reviews
(RAGS I) - Chapter 5)
C/5
C/5
O
m
2
pi
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o
-------
CHAPTER 2
RISK CONSIDERATIONS
DURING PROJECT SCOPING
The project scoping stage of the remedial
investigation (RI) and baseline risk assessment is
critical to the success of a Superfund project. The
EPA risk assessor should be involved in the
project scoping discussions and meetings to ensure
that the planning and workplan development tasks
incorporate risk assessment data needs and
achieve standardization in risk assessment
planning.
2.1 PLANNING
The following planning activities should be
performed at the beginning of the project. These
activities should involve the EPA RPM and EPA
risk assessor, as decisionmakers, and the risk
assessment author and other resources tasked with
preparing the Remedial Investigation Report, to
support planning. Pertinent information should be
incorporated, as appropriate, into the Remedial
Investigation Report or Site Characterization
Report and the Baseline Risk Assessment Report:
Provide site background information, site
maps, sample location map; discuss historical
site activity and chronology of land use.
Discuss historical data and data useability,
previous studies and actions, and an overview
of the nature and extent of contamination.
Discuss the purpose of the investigation.
Prepare the preliminary site conceptual model
which clearly identifies all potential sources
of contamination (soil, groundwater, surface
water, leachate, air, etc.), release
mechanisms, and receptor routes and
identifies all potential exposure pathways
(including secondary pathways) and the media
and receptors associated with each.
Discuss PRGs and ARARs for the site.
WHEN PREPARING THE SITE
CONCEPTUAL MODEL, CONSIDER THE
FOLLOWING
Sensitive populations, including but not limited
to the elderly, pregnant or nursing women,
infants and children, and people suffering from
chronic illnesses
People exposed to particularly high levels of
contaminants
Circumstances where a disadvantaged
population is exposed to hazardous materials
(i.e., Environmental Justice situations)
Significant contamination sources
Potential contaminant release mechanisms (e g ,
volatilization, fugitive dust emission, surface
runoff/overland flow, leaching to groundwater,
tracking by humans/animals, soil gas
generation, biodegradation and radioactive
decay)
Contaminant transport pathways such as direct
air transport downwind, diffusion in surface
water, surface water flow, groundwater flow.
soil gas migration, and biomagmfication in the
food chain
Cross media transfer effects, such as
volatilization to air; wet deposition, dry
deposition, groundwater discharge to surface
water, groundwater recharge from surface
water, and bioaccumulation by aquatic specie*
Involve the risk assessor in discussions
the stakeholders concerning land use,
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groundwater use, and exposure pathways and
variables. If possible, the risk assessor should
also visit the site.
Identify interim deliverables for the risk
assessment.
INTERIM DELIVERABLES SHOULD
INCLUDE THE FOLLOWING:
Standard Tables 0 through 10
Worksheets on Data Useability, TARA
Schedule, Dermal, Radiation Dose Assessment,
and Lead (as applicable)
Supporting Information (Section 3.1.1)
Assessment of Confidence and Uncertainty
(Section 3.1.2) and Probabilistic Analysis
information, as applicable (Section 3.1 3).
Identify Draft and Final deliverables for the risk
assessment. Draft and Final deliverables
include the Draft and Final Baseline Risk
Assessment Reports, which also incorporate the
Interim Deliverables.
Prepare a preliminary version of Standard Table
1.
During project scoping, the EPA RPM and EPA
risk assessor may also meet to discuss the
potential need for including a Probabilistic
Analysis (Monte Carlo) in the RI and the need
for a separate Workplan. This preliminary
discussion is necessary to determine whether
funds need to be allocated to carry out a
Probabilistic Analysis. This decision should be
revisited throughout Workplan development and
the risk assessment process.
2.2 WORKPLAN DEVELOPMENT
Tasks to be conducted during the remedial
investigation/feasibility study (RI/FS) are identified
and documented in several workplans. These
usually include the RI/FS Workplan, a Sampling and
Analysis Plan (SAP), and a Quality Assurance
Project Plan (QAPP). Tasks related to development
of the baseline risk assessment are sometimes
presented in a separate Risk Assessment Workplan
or incorporated into the RI/FS Workplan.
WHEN EVALUATING WHETHER TO
CONDUCT PROBABILISTIC ANALYSIS.
CONSIDER THE FOLLOWING
Extent of site remediation
Potential costs of remediation
Degree of uncertainty associated with the
exposure information available Tor each portion
of the site conceptual model
Risk assessment needs should be considered
not only in tasks related to development of the
baseline risk assessment but also in tasks related to
sampling and analysis (i.e., those in the SAP and
the QAPP) in the RI and tasks needing risk
assessment input in the feasibility study (FS) (e.g.,
development of remedial goals and estimates of
potential risk from remediation options).
2.2.1 RI/FS WORKPLAN/BASELINE
RISK ASSESSMENT WORKPLAN
The RI/FS Workplan summarizes site
background, the current and potential problems
posed by site contaminants, and the objectives and
scope of the RI/FS. It also includes a description of
the tasks to be performed and the information and
work products that will be produced from each
task. Deliverables for specific tasks are included.
Tasks and deliverables for the baseline risk
assessment may be included as a part of the RI/FS
Workplan or in a separate Risk Assessment
Workplan.
Within these Workplans, it should be clear that
risk assessment needs are being considered in the
RI/FS objectives. The site-specific objectives and
scope of the risk assessment should be included in
the Workplan. This includes information needed to
complete the baseline risk assessment in the RI as
well as information needed for the FS, such as that
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needed to develop risk-based remedial goals (e.g ,
PRGs), and to assess risks from remediation (e.g.,
incineration).
These Workplans should also reference the
methods (e.g., National guidance such as
RAGS/HHEM [U.S. EPA, 1989c]; RAGS
Probabilistic Guidance [U.S. EPA, 1997e and g and
200Id.]), that will be used to prepare the Interim,
Draft, and Final risk assessment deliverables and
define the schedule for submission. These
deliverables are described in more detail in Chapter
3. Deliverables related to development of risk-based
remedial goals and assessment of risk from
remediation should also be included in the Workplan
(see Chapter 4).
The EPA risk assessor and EPA RPM may
revisit the question of the potential value added by
using Probabilistic Analyses in the risk assessment.
If these analyses are to be used, the issues
concerning the time, expense, and possible benefit
associated with the collection of additional exposure
information or sampling data should be considered
to identify those exposure parameters with the
greatest uncertainty, where collection of additional
data and/or information may be warranted. A
separate Probabilistic Analysis Workplan identifying
associated deliverables should be prepared and
approved by the EPA RPM and risk assessor.
2.2.2 SAP AND QAPP
Sampling and analysis activities undertaken
during the RI should provide adequate data to
evaluate all appropriate exposure pathways.
Therefore, risk assessors should be involved in the
development of the data quality objectives (DQOs)
for sampling and analysis and in selecting the types
of sampling and analyses that will be done. The
DQOs should address the qualitative and
quantitative nature of the sampling data in terms of
relative quality and intent for use, to ensure that the
data collected will be appropriate for the intended
objectives. Note that the data quality evaluation
should be recorded in the Data Useabiiity Worksheet
in Appendix C.
Sampling. The SAP should discuss how the
types, numbers, and locations of samples to be
collected will be adequate to evaluate each exposure
pathway (both current and future) and medium.
The SAP should be accompanied by detailed
sampling maps showing the location and t>pe of
samples (e.g., grab, composite, or duplicate) It is
important to consider how sample results will be
used to estimate exposure point concentrations
Background samples should be collected from
appropriate areas (e.g., areas proximate to the site.
free of potential contamination by site chemicals
and similar to the site m topography, geology,
meteorology, and other characteristics)
If models will be used to evaluate exposure
pathways and estimate exposure point
concentrations, these models should be identified in
the Workplan. Site-specific data collection needed
for these models should also be discussed.
WHEN DEVELOPING THE SAP, CONSIDER
THE FOLLOWING
How will data from multiple groundwater wells
collected over tune be used to calculate
exposure?
At what depths will soil samples be taken and
how will they be combined to describe
exposures for different scenarios (e g,
industrial versus residential) or to characterize
hotspots?
What type of sampling design (e.g , random
versus purposive) will be used?
Are SAPs adequate to distinguish sue
contamination from background contamination
for each medium and for organic and inorganic
parameters9
Analysis. Development of the DQOs for
anal)sis should not be limited to concern for the
precision, accuracy, representativeness.
completeness, and comparability of the data.
DQOs that are important for risk assessment should
consider* types of laboratory analyses used.
sensitivity of detection limits of the analytical
techniques (especially for non-Target Compound
List (non-TCL] chemicals and non-standard
matrices), resulting data quality, and the
employment of adequate quality assurance/quality
control (QA/QC) measures.
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In some cases, risk assessment data needs may
be best supported by additional chemicals, different
analytical methods, and/or lower detection limits
than are being used for the RI. Based upon the
values of the risk-based PRGs calculated during
scoping, detection limits may need to be lower than
those obtained by the standard Superfund methods.
The adequacy of detection limits for conducting the
baseline risk assessment and for comparing to PRGs
should be evaluated in the Workplan (QAPP). For
example, a table listing expected contaminants and
comparing the method detection 1 im it or quant i tat ion
limit for each compound with the appropriate risk-
based goal for that chemical could be presented.
This information along with issues of cost and other
data uses should affect the methods and detection
limits finally selected.
Analytical data should be evaluated and
reviewed in accordance with the criteria to evaluate
data (e.g., the National Functional Guidelines)
Also refer to your regional Agency office for
guidance on data validation and/or chemical-
specific other guidance, as applicable.
The Workplan should also discuss how split
samples, duplicates, blanks (trip, field, and
laboratory), and qualified and rejected data will be
used in assessing site risks. The Workplan should
describe the analysis for each medium and how the
types of analyses were selected based on site
history.
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CHAPTER 3
RISK ASSESSMENT
DATA NEEDS AND TASKS
DURING THE REMEDIAL INVESTIGATION
Project Management Guidelines. Remedial
project managers will establish the schedule of
submission for the deliverables for the RI Reports
and Baseline Risk Assessment Reports. The
schedule may vary from site to site, as appropriate.
Interested parties (States, Commonwealths, tribes
and other stakeholders) may be involved in the
scheduling and review process, as appropriate.
Refer to your regional office for guidance
regarding the order of the deliverables. These
deliverables should also be defined in the
Workplan.
General RI Guidelines. RI guidance should
be followed in performing the remedial
investigation. The following items are of
particular importance to risk assessments. If the
risk assessment is being prepared as a stand-alone
document, the following items should be included.
If, instead, the risk assessment is a section of the
RI Report, the items which follow should be
addressed in the RI Report and clearly referenced
in the Baseline Risk Assessment Report.
Present a general map of the site depicting
boundaries and surface topography, which
illustrates site features, such as fences, ponds,
structures, as well as geographical
relationships between potential receptors and
the site.
Discuss historical site activity.
Discuss chronology of land use (specify
agriculture, industry, recreation, waste
deposition, and residential development at the
site).
Present an overview of the nature and extent
of contamination, including when samples
were collected and the kinds of contaminants
and media potentially contaminated.
Describe the analytical and data validation
methods used.
If modeling was used to estimate exposure
point concentrations, document the parameters
related to soil/sediment, hydrogeology,
hydrology, and meteorology either in the risk
assessment or the RI Report.
Risk Assessment Guidelines. The risk
assessment should be conducted in accordance
with all appropriate guidance and policies.
Consult with your EPA risk assessor regarding the
most appropriate guidance.
Interim Deliverables should be prepared as
described in Section 3.1.1 and should ultimately
be incorporated into the Baseline Risk Assessment
Report. The Interim Deliverables prepared by the
risk assessment author should be reviewed by the
EPA risk assessor prior to submission of the
Baseline Risk Assessment Report. Hazard
identification and exposure parameters, among
others, may require discussion, refinement, and
revision. Review and modification of Interim
Deliverables will greatly reduce the Baseline Risk
Assessment Report preparation and review time.
Discussions of the three categories of risk
assessment deliverables (Interim Deliverables,
Draft Baseline Risk Assessment Report, and Final
Baseline Risk Assessment Report) follow
3.1 INTERIM DELIVERABLES
This section presents an outline of the
Standard Tables, Worksheets, and Supporting
Information that should be prepared as Interim
Deliverables for each site. The Workplan
discussed in Section 2.2.1 should also describe the
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Standard Tables, Worksheets, and Supporting
Information for a particular site. Exhibit 3-1
presents a list of the Interim Deliverables. Use of
these deliverables for each site should improve
standardization in risk assessment reporting by
improving the transparency, clarity, consistency,
and reasonableness of risk assessments.
3.1.1 STANDARD TABLES,
WORKSHEETS, AND SUPPORTING
INFORMATION
Standardized reporting of Superfund human
health risk assessments will be achieved through
the preparation of Standard Tables, Worksheets,
and Supporting Information. These documents
should be prepared as Interim Deliverables and
reviewed by the EPA risk assessor prior to
preparation of the Baseline Risk Assessment
Report. After review and revision, as necessary,
these documents should be included in the
Baseline Risk Assessment Report.
This section describes the Standard Table
formats for use in all future risk assessments. The
Standard Table formats should not be altered (i.e.,
columns should not be added, deleted, or
changed); however, rows and footnotes should be
added as appropriate. Standardization of the
Tables is needed to achieve Superfund program-
wide reporting consistency. Note that multiple
versions of some Standard Tables may be needed
to address different Media, different Exposure
Pathways, or different Exposures (i.e., reasonable
maximum exposure [RME] versus central
tendency [CT]). Exhibit 3-2 summarizes the
relationship between five traditional risk
assessment activities and the corresponding
Standard Tables that standardize risk assessment
reporting. The five risk assessment activities
follow:
Data collection
Data evaluation
Exposure assessment
Toxicity assessment
Risk characterization.
Copies of the blank Standard Tables are
provided in both Lotusฎ and Excelฎ spreadsheet
formats associated with the Part D guidance.
Blank Standard Table templates and completed
examples of typical Standard Tables are provided
in Appendix A. Detailed Instructions for the
completion of the Standard Tables are provided in
Appendix B. Additional example scenarios and
selected Standard Tables are provided in
Appendix D.
In addition to the Standard Tables, six
Standard Worksheets are provided in Appendix C
These include Worksheets for Data Useability,
TARA Schedule, Dermal, Radiation Dose
Assessment, Lead, and ROD Risk. Use of the
Worksheets is strongly encouraged to improve
transparency, clarity, consistency, and
reasonableness.
The Standard Tables and Worksheets
document the majority of the data and
assumptions used to evaluate risk, as well as the
risks and hazards calculated. In most cases, other
data and rationale are used to support the
information presented in the Standard Tables.
This additional Supporting Information should
also be provided to the EPA risk assessor as an
Interim Deliverable and later incorporated in the
Baseline Risk Assessment Report.
Refer to Exhibit 3-3 for a brief summary of
the Revision I improvements to the Standard
Tables and Worksheets as compared to Revision
0. Descriptions of the RAGS Part D Revision 1
Standard Tables, Worksheets, and Supporting
Information follow:
STANDARD TABLE 0: Site Risk
Assessment Identification Information. The
purposes of Standard Table 0 are:
To uniquely identify the risk assessment
To identify the relevant contacts for the risk
assessment.
The information documented in Standard
Table 0 includes:
Site Information
Contact information
Risk assessment document information.
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The data elements presented in Standard
Table 0 are listed in the Standard Table 0
highlight box.
DATA ELEMENTS IN
STANDARD TABLED
Provide the following information1 Site Name/OU,
Region, EPA ID Number, State, Status, Federal
Facility (Y/N), EPA Project Manager, EPA Risk
Assessor, Prepared by, Prepared for, Document
Title, Document Date, Probabilistic Risk
Assessment (Y/N), and Comments.
Perform the following steps associated with
the preparation of Standard Table 0:
1. Provide the identification information for the
risk assessment.
2. Include Standard Table 0 with the other
Standard Tables, Worksheets, and Supporting
Information to facilitate tracking of the
relevant contacts.
TARA SCHEDULE WORKSHEET. The
TARA Schedule of Risk-Related Activities
Worksheet (TARA Schedule Worksheet) is the
first Worksheet that should be developed for each
risk assessment to document the applicability,
responsibility, and schedule for each risk-related
activity. As the first interim deliverable, the
Worksheet documents the plan for a particular
site, identifying which Standard Tables,
Worksheets, and Supporting Information will be
provided as interim deliverables for EPA risk
assessor review, and when they are expected to be
available. The TARA Schedule Worksheet should
be prepared in consultation with the EPA risk
assessor assigned to the site.
Perform the following steps associated with
the preparation of the TARA Schedule Worksheet:
1. Complete the TARA Schedule Worksheet
prior to initiation of any other Standard
Tables, Worksheets, or Supporting
Information.
2. Obtain EPA risk assessor consensus
regarding which interim deliverables will be
submitted and the schedules for each.
The blank TARA Schedule Worksheet may be
found in Appendix C. An example TARA
Schedule Worksheet accompanies the Dean
Company example in Appendix A
STANDARD TABLE 1: Selection of
Exposure Pathways. The purposes of Standard
Table 1 are:
To assist in project planning
To accompany the site conceptual model
To present possible Receptors, Exposure
Routes, and Exposure Pathways
To present the rationale for selection or
exclusion of each Exposure Pathway
To communicate risk information to interested
parties outside EPA
To establish a framework for the generation of
subsequent Standard Tables. All subsequent
tables should be built from the information
contained in Standard Table 1.
The information documented in Standard
Table 1 includes:
Exposure Pathways that were examined and
excluded from analysis
Exposure Pathways that will be qualitatively
or quantitatively evaluated in the risk
assessment.
The data elements presented in Standard
Table 1 are listed in the Standard Table 1
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 1
Provide the following information: Scenario
Timeframe, Medium, Exposure Medium, Exposure
Point, Receptor Population, Receptor Age,
Exposure Route, Type of Analysis, Rationale for
Selection or Exclusion of Exposure Pathway
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Perform the following steps associated with
the preparation of Standard Table 1:
1. Refine site conceptual model which identifies
all potential sources of contamination, all
potential Exposure Pathways, the Medium
associated with each, and the potentially
exposed populations (Receptors).
2. Select realistic Exposure Pathways for
detailed analyses.
3. Include rationale for exclusion of potential
Exposure Pathways.
4. Modify Standard Table 1, if necessary.
5. Standard Table 1 should later be
incorporated in the Baseline Risk Assessment
Report.
DATA USEABILITY WORKSHEET.
Data quality is an important component of the risk
assessment and the evaluation of data quality
should be documented. The Data Useability
Worksheet is included to address this need.
The EPA risk assessor and the EPA document
Guidance for Data Useability m Risk Assessment
(Part A, U.S. EPA 1990a,l, should be consulted
before completing the Data Useability Worksheet
to define the appropriate level of detail to be
reflected in the comment fields in the Worksheet.
This Worksheet should be prepared as soon as all
data validation reports have been completed for
each medium. A medium-specific Data Useability
Worksheet should be completed only after the
project team (i.e., lead chemist, lead
hydrogeologist, risk assessor, etc.) has collectively
discussed the data useability criteria. The
Worksheet should be used to record and identify
the impact of data quality issues as they relate to
data useability. For example, deviations from
approved site Workplans which occurred during
sample collection, laboratory analysis, or data
review should be assessed. Also refer to your
regional office for guidance on data validation
when preparing the Worksheet.
Perform the following steps associated with
the preparation of the Data Useability
Worksheet:
1 Complete the Data Useability Worksheet for
each Medium prior to screening of chemicals
of potential concern (COPCs).
2. The Data Useability Worksheet should later
be incorporated in the Baseline Risk
Assessment Report.
The blank Data Useability Worksheet may be
found in Appendix C. An example Data
Useability Worksheet accompanies the Dean
Company example in Appendix A.
STANDARD TABLE 2: Occurrence,
Distribution, and Selection of COPCs. The
purposes of Standard Table 2 are:
To provide information useful for data
evaluation of chemicals and radionuclides
detected
To provide adequate information so the
user/reviewer gets a sense of the chemicals
and radionuclides detected at the site and the
potential magnitude of the potential problems
at the site
To provide chemical screening data and
rationale for selection of COPCs.
The information documented in Standard
Table 2 includes:
Statistical information about chemicals and
radionuclides detected in each Medium
The detection limits of chemicals and
radionuclides analyzed
The toxiciry screening values for COPC
selection
The chemicals and radionuclides selected and
deleted as CO PCs.
The data elements presented in Standard
Table 2 are listed in the Standard Table 2
highlight box.
Perform the following steps associated with
the preparation of Standard Table 2. Refer to the
regional office for guidance when performing
these steps.
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DATA ELEMENTS IN
STANDARD TABLE 2
For each unique combination of Scenario
Timeframe, Medium, and Exposure Medium,
provide the following information: Exposure Point,
CAS Number, Chemical, Minimum Concentration
(Qualifier), Maximum Concentration (Qualifier),
Units, Location of Maximum Concentration,
Detection Frequency, Range of Detection Limits,
Concentration Used for Screening, Background
Value, Screening Toxicity Value (N/C), Potential
ARAR/TBC Value, Potential ARAR/TBC Source,
COPC Flag (Y/N), and Rationale for Selection or
Deletion.
1. Discuss selection criteria for COPCs;
including toxicity screening values, frequency
of detection, and background comparison, as
appropriate.
2. Perform screening; select COPCs that will be
carried into the risk assessment (include
comparison to regulatory standards and
criteria where appropriate).
3. Submit Supporting Information to
substantiate the available Background
Value shown for each chemical in Standard
Table 2 and to enable verification of those
values by EPA. The format of the summary
will be determined by each region. The
Supporting Information should provide
relevant information for each chemical used to
determine the background concentration,
including (but not limited to) average,
maximum, hypothesis testing of equality of
the mean, and other information that may be
required to fully describe the background
selection process.
4. The Background Supporting Information
should later be incorporated in the Baseline
Risk Assessment Report.
5. Complete Standard Table 2 for each
combination of Scenario Timeframe, Medium,
and Exposure Medium.
6. Standard Table 2 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 3: Exposure Point
Concentration Summary. The purposes of
Standard Table 3 are:
To provide the EPCs for measured and
modeled values
To provide statistical information on the
derivation of the EPCs.
The information documented in Standard
Table 3 includes:
Statistical information which was used to
calculate the EPCs for chemicals and
radionuclides detected in each Medium
EPCs (RME and/or CT)
The statistics which were used to make the
determinations as well as the rationale for the
selection of the statistics for each chemical or
radionuclide (i.e., discuss statistical derivation
of measured data or approach for modeled
data).
The data elements presented in Standard
Table 3 are listed in the Standard Table 3
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 3
For each unique combination of Scenario
Timeframe, Medium, and Exposure Medium,
provide the following information: Exposure Point,
Chemical of Potential Concern, Units, Arithmetic
Mean, 95% upper confidence level (UCL),
Maximum Concentration (Qualifier), EPC Value,
EPC Units, EPC Statistic, and EPC Rationale
Perform the following steps associated with
the preparation of Standard Table 3.
1. Discuss how samples will be grouped (e.g.,
how hot spots in soil will be considered; how
groundwater data will be combined; how
temporal and chemical phases will be
addressed; how upgradient, downgradient,
and cross gradient samples will be addressed).
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2. Discuss approach to determine how data are
distributed (e.g., normal, log-normal).
3. Discuss evaluation of lead, total chromium
and any other special chemicals.
4. Submit Supporting Information to
document the EPC summary presented in
Standard Table 3 and to enable verification
of those values by. EPA. The format of the
summary will be determined by each region.
The Supporting Information should discuss
EPCs statistically derived from measured data,
including identification of the samples used in
each calculation, results of distribution testing
(Wilk-Shapiro, D'Agostino), mean
(transformed if appropriate), maximum
(transformed if appropriate), standard
deviation (transformed if appropriate), t- or H-
statistic, 95% UCL (including non-parametric
methods, where applicable), and other
protocols as required. The Supporting
Information should also present information
for EPCs, including derivation of modeled
values, assumptions and values used,
statistical derivation of measured values and
associated calculations, and other protocols as
required.
5. The EPC Supporting Information should
later be incorporated in the Baseline Risk
Assessment Report.
6. Complete Standard Table 3 for each
combination of Scenario Timeframe, Medium,
Exposure Medium, and Exposure Point.
Create separate sets of Standard Table 3 for
RME and CT, when appropriate.
7. Standard Table 3 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 4: Values Used for
Daily Intake Calculations. The purposes of
Standard Table 4 are:
To provide the exposure parameters used for
intake calculations for each Exposure Pathway
(Scenario Timeframe, Medium, Exposure
Medium, Exposure Point, Receptor
Population, Receptor Age, and Exposure
Route)
To provide the intake equations or models
used for each Exposure Route/Pathway.
The information documented in Standard
Table 4 includes
Values used for each intake equation for each
Exposure Pathway and the reference/rationale
for each
Intake equation or model used to calculate the
intake for each Exposure Pathway
The data elements presented in Standard
Table 4 are listed in the Standard Table 4
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 4
For each unique combination of Scenario
Timeframe, Medium, and Exposure Medium,
provide the following information Exposure Route,
Receptor Population, Receptor Age, Exposure
Point, Parameter Code, Parameter (Definition,
Value, and Units), Rationale/Reference, and Intake
Equation/Model Name.
Perform the following steps associated with
the preparation of Standard Table 4.
I. Provide references for all exposure
parameters.
2. Submit Supporting Information to
summarize the Modeled Intake
Methodology and Parameters used to
calculate modeled intake values and to
enable verification of those values by EPA.
The Supporting Information should be limited
to summary level information. The format of
the summary should be structured to
accommodate the variability and complexity
associated with different models.
3. The Modeled Intake Supporting
Information should later be incorporated in
the Baseline Risk Assessment Report.
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4. Submit Supporting Information on
Chemical-Specific Parameters, which apply
to all Standard Tables to be completed for the
risk assessment and to enable verification of
those values by EPA. The summary should
identify and display chemical parameters and
constants that are used to calculate risks and
hazards, but are not included on Standard
Tables. The format of the summary will be
determined by each region. The values and
constants that are used to calculate risk and
hazards, including molecular weight, vapor
pressure, K^., Kow, dermal permeability con-
stant, Henry's Law constant, and other
information that the reader would find useful
for understanding the risk assessment
discussion should be included.
5. The Chemical-Specific Parameter
Supporting Information summary should
later be incorporated into the Baseline Risk
Assessment Report.
6. Complete Standard Table 4 for each
combination of Scenario Timeframe, Medium,
and Exposure Medium. Create separate sets of
Standard Table 4 for RME and CT, where
appropriate.
7. Standard Table 4 should later be
incorporated into the Baseline Risk
Assessment Report.
DERMAL WORKSHEET. The Dermal
Worksheet presents intermediate variables for
calculating absorbed dose per event DA (event).
A version of this Worksheet should be developed
for each medium for which the dermal exposure
route will be quantitatively assessed. Available
data should be provided for each COPC under
evaluation.
Perform the following steps associated with
preparation of the Dermal Worksheet:
1. Complete the Dermal Worksheet prior to
calculation of risks and hazards.
2. Provide interim deliverables to the EPA risk
assessor, as appropriate
3. The Dermal Worksheet should later be
incorporated in the Baseline Risk Assessment
Report.
The blank Dermal Worksheet may be found in
Appendix C. An example Dermal Worksheet
accompanies the Dean Company example in
Appendix A.
STANDARD TABLES 5 AND 6: Non-
Cancer and Cancer Toxicity Data. The
purposes of Standard Tables 5.1, 5.2, and 5.J
are:
To provide information on reference doses
(RfDs), reference concentrations (RfCs),
Target organs, and adjustment factors for
chemicals
To provide oral to dermal adjustment factors
To provide RfC to RfD adjustment factors
To verify references for non-cancer toxicity
data
To provide non-cancer toxicity information
for "special-case" chemicals.
DATA ELEMENTS IN
STANDARD TABLE 5.1
Provide the following information. Chemical of
Potential Concern, Chronic/Subchromc, Oral
RfD Value and Units, Oral Absorption Efficiency
for Dermal, Absorbed RfD for Dermal Value and
Units, Primary Target Organ(s), Combined
Uncertainty/Modifying Factors, Source(s)
RfDTarget Organ(s), and Dates of RfD Target
Organ(s).
The information documented in Standard
Tables 5.1, 5.2, and 5.3 includes:
The RfDs for each of the COPCs, as well a*
modifying factors and reference concentration
(RfC) to RfD adjustments
The organ effects of each of the COPCs
References for RfCs and organ effects.
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The data elements presented in Standard
Tables 5.1,5.2, and 5.3 are listed in the Standard
Tables S.I, 5.2, and 5.3 highlight boxes.
DATA ELEMENTS IN
STANDARD TABLE 5.2
Provide the following information: Chemical of
Potential Concern, Chromc/Subchronic, Inhalation
RfC Value and Units, Extrapolated RfD Value and
Units, Primary Target Organ(s), Combined
Uncertainty/Modifying Factors, Source(s) of RfC.
Target Organ(s), and Date(s) of RfC: Target
Organ(s).
DATA ELEMENTS IN
STANDARD TABLE 5.3
Provide the following information: Chemical of
Potential Concern, Chronic/Subchronic, Parameter
Name, Value, and Units), Primary Target Organ(s),
Combined Uncertainty/Modifying Factors,
Source(s) of Parameter: Target Organ(s), and
Date(s) of Parameter: Target Organ(s).
The purposes of Standard Tables 6.1, 6.2,
6.3, and 6.4 are:
To provide the oral, dermal, and inhalation
cancer toxicity information (values and
sources of information) for chemicals and
radionuclides of potential concern
To provide the methodology and adjustment
factors used to convert oral cancer toxicity
values to dermal toxicity values and to convert
inhalation unit risks to inhalation cancer slope
factors
To provide weight of evidence/cancer
guideline descriptions for each chemical and
radionuclide of potential concern
To provide cancer toxicity information for
"special case" chemicals.
The information documented in Standard
Tables 6.1,6.2, 6.3, and 6.4 includes:
Oral, dermal, and inhalation toxicity values
for chemicals and radionuclides of potential
concern
Weight of evidence/cancer guidelines
descriptions for chemicals of potential
concern
The source/reference for each toxicity value.
The data elements presented in Standard
Tables 6.1, 6.2, 6.3, and 6.4 are listed in the
Standard Tables 6.1, 6 2, 6.3, and 6 4 highlight
box.
DATA ELEMENTS IN
STANDARD TABLE 6 1
Provide the following information- Chemical of
Potential Concern, Oral Cancer Slope Factor Value
and Units, Oral Absorption Efficiency for Dermal,
Absorbed Cancer Slope Factor for Dermal Value
and Units, Weight of Evidence/Cancer Guideline
Descnption, Source(s) and Date(s) of Oral CSF
DATA ELEMENTS IN
STANDARD TABLE 6 2
Provide the following information: Chemical of
Potential Concern, Unit Risk Value and Units,
Inhalation Cancer Slope Factor Value and Units,
Weight of Evidence/Cancer Guideline Description,
Source(s) and Date(s) of Unit Risk: Inhalation CSF
DATA ELEMENTS IN
STANDARD TABLE 6 3
Provide the following information: Chemical of
Potential Concern, Parameter (Name, Value, and
Units), Source(s), and Dates(s).
DATA ELEMENTS IN
STANDARD TABLE 6 4
Provide the following information: Chemical of
Potential Concern, Cancer Slope Factor Value and
Units, Source(s), and Dates(s).
Perform the following steps associated with
the preparation of Standard Tables 5 and 6.
1. Refer to the end of Section 3.1.1 for Lead
Worksheets.
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2. Ensure that chronic and subchronic toxicity
values are applied correctly based on the
duration of exposure. Provide rationale for
selection of surrogate toxicity values not in
IRIS or HEAST, or provided by NCEA.
(EPA may require additional review.)
3. Submit Supporting Information regarding
Toxicity Data for Special Case Chemicals
(i.e., those chemicals with cancer risks and
non-cancer hazards calculated using methods
or toxicity parameters different from those
presented on Standard Tables 5.1, 5.2, 6.1, or
6.2). The Supporting Information will be
used to enable verification of those values by
EPA. Examples may include selection of
potency factors for polychlorinated biphenyls
(PCBs), use of relative potencies for
polynuclear aromatic hydrocarbons (PAHs)
and chlorinated dioxins and furans, and
valence species assumptions for metals.
Consult the EPA risk assessor regarding the
use of these tables.
4. The Special Case Chemicals Supporting
Information should later be incorporated in
the Baseline Risk Assessment Report.
5. Complete Standard Tables 5 and 6 for the
exposure routes and chemicals under
evaluation.
Standard Table 5.1: Non-Cancer
Toxicity Data - Oral/Dermal
Standard Table 5.2: Non-Cancer
Toxicity Data - Inhalation
Standard Table 5.3: Non-Cancer
Toxicity Data - Special Case Chemicals
Standard Table 6.1: Cancer Toxicity
Data - Oral/Dermal
Standard Table 6.2: Cancer Toxicity
Data - Inhalation
Standard Table 6.3: Cancer Toxicity
Data - Special Case Chemicals
Standard Table 6.4: Cancer Toxicity
Data -External (Radiation).
6. Standard Tables 5 and 6 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 7: Calculation of
Chemical Cancer Risks and Non-Cancer
Hazards. The purposes of Standard Table 7
are:
To provide a summary of the variables used to
calculate chemical cancer risks and non-
cancer hazards
To show the EPC and intake used in the non-
cancer hazard and cancer risk calculations
To present the result of the calculation for
each Exposure Route/Pathway for each COPC
To provide the total hazard index and cancer
risks for all Exposure Routes/Pathways for the
Scenario Timeframe and Receptor presented
in this table.
The information documented in Standard
Table 7 includes:
The non-cancer hazard quotient (HQ) and
cancer risk value for each COPC for each
Exposure Route/Pathway
The values used for EPC, non-cancer intake,
cancer intake, reference doses and
concentrations, and cancer slope factors for
each COPC for each Exposure Route.
The data elements presented in Standard
Table 7 are listed in the Standard Table 7
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 7
For each unique combination of Scenario
Timeframe, Receptor Population, and Receptor
Age. provide the following information: Medium,
Exposure Medium, Exposure Point, Exposure
Route. Chemical of Potential Concern, EPC Value
and Units, Cancer Risk Calculations
(Intake Exposure Concentration Value and Units,
CSF Unit Risk Value and Units, and Cancer Risk),
and Non-Cancer Hazard Calculations
(Intake/Exposure Concentration Value and Units,
KfD'RfC Value and Units, and Hazard Quotient)
Perform the following steps associated with the
preparation of Standard Table 7.
!. Address non-cancer hazards and cancer risks
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including the calculations and supporting
information by Exposure Route.
2. Include RME and CT results in separate
tables. Ensure that risks and hazards from
multiple chemicals are combined
appropriately across Pathways that affect the
same individual or population subgroup, for
all site-related chemicals.
3. Definitions of Standard Tables
Standard Table T.n.RME: Calculation
of Chemical Cancer Risks and Non-
Cancer Hazards (RME)
Standard Table T.n.CT: Calculation of
Chemical Cancer Risks and Non-Cancer
Hazards (CT)
4. If it is preferred to segregate cancer and non-
cancer evaluations, see the blank Standard
Tables 7.a. 1 and 7.b. 1 shown in Appendix A
as well as Example Scenario 7 in Appendix D.
5. Submit Supporting Information that
summarizes the approach used to perform
Special Chemical Risk and Hazard
Calculations and to enable verification of
those values by EPA. This summary should
address the calculation of non-cancer hazards
and cancer risks for chemicals that do not use
RfD or cancer slope factor (CSF) values,
respectively. The format of the summary will
be determined by each region.
6. The Special Chemical Risk and Hazard
Calculations Supporting Information
should later be incorporated in the Baseline
Risk Assessment Report.
7. Complete Standard Table 7 for each
combination of Scenario Timeframe, Receptor
Population, and Receptor Age.
8. Standard Table 7 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 8: Calculation of
Radiation Cancer Risks. The purposes of
Standard Table 8 are:
To provide a summary of the variables used to
calculate radiation cancer risks
To show the EPC used in the radiation cancer
risk calculations
To show, based on the documented risk
calculation approach, the intake and cancer
slope factors
To present the result of the calculation for
each Exposure Route/Pathway for each COPC
To provide the radiation cancer risks for all
Exposure Routes/Pathways for the Scenario
Timeframe and Receptor presented in this
table.
The information documented in Standard
Table 8 includes:
The approach for calculating the radiation
cancer risk for each COPC for each Exposure
Route/Pathway
The values used for EPC, intake, and cancer
slope factor for each COPC for each Exposure
Route
The Cancer risk value for each COPC for each
Exposure Route/Pathway
Total cancer risk values by Exposure Route,
Exposure Point, and across all media for the
Scenario Timeframe and Receptor presented
in this table.
The data elements presented in Standard
Table 8 are listed in the Standard Table 8
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 8
For each unique combination of Scenario
Timeframe, Receptor Population, and Receptor
Age, provide the following information: Medium,
Exposure Medium, Exposure Point, Exposure
Route, Radionuclide of Potential Concern, EPC
Value and Units, Risk Calculation Approach, and
Cancer Risk Calculations (Intake/Activity Value
and Units, CSF Value and Units, and Cancer Risk).
Perform the following steps associated with
the preparation of Standard Table 8.
1. Address radiation cancer risks including the
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calculations and supporting information by
Exposure Route.
2. Include RME and CT results in separate
tables. Ensure that risks from multiple
radionuclides are combined appropriately
across Pathways that affect the same
individual or population subgroup, for all site-
related radionuclides.
3. Definitions of Standard Tables
Standard Table S.n.RME: Calculation
of Cancer Radiation Risks (RME)
Standard Table S.n.CT: Calculation of
Cancer Radiation Risks (CT)
4. Complete Standard Table 8 for each
combination of Scenario Timeframe, Receptor
Population, and Receptor Age.
5. Standard Table 8 should later be
incorporated in the Baseline Risk Assessment
Report.
RADIATION DOSE ASSESSMENT
WORKSHEET. The Radiation Dose Assessment
Worksheet has been provided to document
alternate radionuclide cancer risk calculations,
performed using a dose approach rather than the
standard CERCLA risk calculation method.
Perform the following steps associated with
preparation of the Radiation Dose Assessment
Worksheet, if applicable to the risk assessment:
1. Complete the Radiation Dose Assessment
Worksheet for each Receptor.
2. Provide interim deliverables to the EPA risk
assessor, as appropriate.
3. The Radiation Dose Assessment Worksheet
should later be incorporated in the Baseline
Risk Assessment Report.
The blank Radiation Dose Assessment
Worksheet may be found in Appendix C. An
example Radiation Dose Assessment Worksheet is
presented in Appendix D, Example Scenario 11.
STANDARD TABLE 9: Summary of
Receptor Risk and Hazards for COPCs.
The purpose of Standard Table 9 is
To provide a summary of cancer risks and
non-cancer hazards for each Receptor, by
Medium, Exposure Medium. Exposure Route.
and Exposure Point.
The information documented in Standard
Table 9 includes:
The cancer risk and non-cancer hazard to each
Receptor for each COPC by Exposure Route
and Exposure Point
The total cancer risk and non-cancer hazard
for each Exposure Point, Exposure Medium
and Medium across all Exposure Routes
The total cancer risk and non-cancer hazard
for a Receptor across all media
The primary target organs for non-
carcinogenic hazard effects.
The data elements presented in Standard
Table 9 are listed in the Standard Table 9
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 9
For each unique combination of Scenario
Timeframe, Receptor Population, and Receptor
Age, provide the following information: Medium,
Exposure Medium, Exposure Point, Chemical of
Potential Concern, Carcinogenic Risk (Ingestion,
Inhalation, Dermal, External (Radiation) and
Exposure Routes Total), and Non-Carcinogenic
Hazard Quotient (Primary Target Organ(s),
Ingestion, Inhalation, Dermal, and Exposure Routes
Total).
Perform the following steps associated with the
preparation of Standard Table 9.
I. Address non-cancer hazards and cancer risks
including the calculations and supporting
information by Exposure Route.
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2. Include RME and CT results. Ensure that
risks and hazards from multiple chemicals are
combined appropriately across Pathways that
affect the same individual or population
subgroup, for all site-related chemicals.
3. Definitions of Standard Tables
Standard Table 9.n.RME: Summary
of Receptor Risks and Hazards for
COPCs (RME)
Standard Table 9.n.CT: Summary of
Receptor Risks and Hazards for COPCs
(CT)
4. Complete Standard Table 9 for each
combination of Scenario Timeframe, Receptor
Population, and Receptor Age.
5. Standard Table 9 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 10: Risk Summary. The
purpose of Standard Table 10 is:
To provide a summary of cancer risks and
non-cancer hazards for each Receptor, by
Medium, Exposure Medium, Exposure Route,
and Exposure Point, that may trigger the need
for remedial action.
The information documented in Standard
Table 10 includes:
The cancer risk and non-cancer hazard to each
Receptor for each chemical or radionuclide by
Exposure Route and Exposure Point for risk
drivers
The total cancer risk and non-cancer hazard
for each Exposure Point, Exposure Medium,
and Medium across all Exposure Routes for
risk drivers
The total cancer risk and non-cancer hazard
for a Receptor across all media for risk drivers
The primary target organs for non-
carcinogenic hazard effects for risk drivers.
The data elements presented in Standard
Table 10 are listed in the Standard Table 10
highlight box.
DATA ELEMENTS IN
STANDARD TABLE 10
For each unique combination of Scenario
Timeframe, Receptor Population, and Receptor
Age, provide the following information Medium.
Exposure Medium, Exposure Point, Chemical,
Carcinogenic Risk (Ingesnon, Inhalation. Dermal,
External (Radiation) and Exposure Routes Total),
and Non-Carcinogenic Hazard Quotient (Primary
Target Organ(s), Ingestion, Inhalation. Dermal.
and Exposure Routes Total).
Perform the following steps associated with
the preparation of Standard Table 10.
1. Address non-cancer hazards and cancer risks
including the calculations and supporting
information by Exposure Route.
2. Include RME and CT results. Ensure that
risks and hazards from multiple chemicals are
combined appropriately across Pathways that
affect the same individual or population
subgroup, for all site-related chemicals.
3. Definitions of Standard Tables
Standard Table lO.n.RME: Risk
Summary (RME)
Standard Table lO.n.CT: Risk Summary
(CT)
4. Complete Standard Table 10 for each
combination of Scenario Timeframe, Receptor
Population, and Receptor Age.
5. Standard Table 10 should later be
incorporated in the Baseline Risk Assessment
Report.
LEAD WORKSHEETS. Two Lead
Worksheets have been provided to document lead
risk evaluations performed for young children and
adult receptors at a site.
Perform the following steps associated with
the preparation of Lead Worksheets:
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1. Complete the Lead Worksheets for Child
and Adult. Also attach the appropriate graphs
and results from the Integrated Exposure
Uptake Biokinetic Model (IEUBK) model (if
used) to the Child Worksheet. Also attach
results from the adult lead spreadsheet to the
Adult Worksheet.
2. The Lead Worksheets should later be
incorporated in the Baseline Risk Assessment
Report.
Blank Lead Worksheets may be found in
Appendix C. Example Lead Worksheets are
presented in Appendix D Example Scenario 10.
3.1.2 ASSESSMENT OF CONFIDENCE
AND UNCERTAINTY
Uncertainty assessment is important in risk
assessment. Although the risk assessment should
indicate sources of variability and uncertainty
throughout the process, it will generally be
appropriate to include a separate section of the
Baseline Risk Assessment Report that also focuses
on the uncertainties associated with data
evaluation, toxicity assessment, exposure assess-
ment, and risk characterization, as well as overall
uncertainty of the final risk numbers. The region
may choose to defer presentation of this specific
section to the Draft Baseline Risk Assessment
Report.
Perform the following steps associated with
the Assessment of Confidence and Uncertainty:
1. Summarize the Assessment of Confidence
and Uncertainty.
2. The Assessment of Confidence and
Uncertainty should later be incorporated in
the Baseline Risk Assessment Report.
3.1.3 PROBABILISTIC ANALYSIS
INFORMATION
Based upon the results from a deterministic
risk characterization calculation (Standard Table
7) a decision should be made if a Probabilistic
Analysis will be performed to calculate cancer
risks and non-cancer hazards in accordance with
Agency policy.
Perform the following steps associated with
the Probabilistic Analysis:
1 Summarize the Probabilistic Analysis (if
performed) in a non-standard format.
(Standard formats have not been developed to
document probalistic analysis) Refer to
probabilistic analysis guidance (U S EPA
1997e, 1997g and 200Id) to determine the
information to be documented.
2. The Probabilistic Analysis summary should
later be incorporated in the Baseline Risk
Assessment Report.
3.2 DRAFT BASELINE RISK
ASSESSMENT REPORT
Submit the Draft Baseline Risk Assessment
Report after the completion and acceptance of the
Interim Deliverables described above. EPA
guidance should be consulted in preparing the
Draft Baseline Risk Assessment Report EPA
anticipates that this report preparation will be
greatly expedited, since it should incorporate the
following Interim Deliverables:
Standard Tables 0 through 10
Worksheets on Data Useability, Dermal,
Radiation Dose Assessments, and Lead, as
applicable
Supporting Information
The Assessment of Confidence and
Uncertainty
Probabilistic Analysis information (if
applicable).
However, the report should not consist exclusively
of the Interim Deliverables, because additional
narrative will be necessary for a clear and
comprehensible Baseline Risk Assessment Report.
For example, information such as definition of
hazard indices and cancer slope factors,
lexicological profiles for COPCs, and other
information indicated by risk assessment guidance
should be incorporated.
Every risk assessment should contain a Risk
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Characterization appropriate to the assessment.
Risk assessments submitted to the Agency or
performed by the Agency should incorporate any
current Agency guidance applicable on Risk
Characterization (e.g., RAGS/HHEM, EPA 1989c;
Memorandum from Carol Browner on Risk
Characterization, EPA 1995b).
3.3 FINAL BASELINE RISK
ASSESSMENT REPORT
Submit the Final Baseline Risk Assessment
Report as a revision of the draft, incorporating
review comments as necessary and appropriate.
Prepare Draft ROD Risk Worksheet (ROD
Risk Highlights) as directed by the EPA RPM
and EPA risk assessor, upon completion of the
Final Baseline Risk Assessment Report. Refer to
the ROD guidance (U.S. EPA, 1999a) for human
health risk data needs. The draft ROD Risk
Worksheets present the Exposure Pathways and
Chemicals that justify the need for remedial
action Preparation of these Worksheets is
recommended when the Final Baseline Risk
Assessment Report is completed, in order to
facilitate the EPA risk manager's preparation of
the ROD at a later date.
Exhibit 3-4 identifies the RAGS Part D
information sources (Standard Table and column)
for ROD Risk Worksheets (Highlights) 6-15, 6-
16A, 6-16B, 6-18A, and 6-1 SB Blank templates
for the five ROD Risk Worksheets (Highlights)
may be found in Appendix C.
3.4 INFORMATION TRANSFER
TO SUPERFUND RISK DATA
COLLECTION
Upon the completion of the Final Baseline
Risk Assessment Report, provide the Lotusฎ or
Excelฎ version of the Standard Tables and
Worksheets to the EPA risk assessor, who will
submit them to the EPA Headquarters Risk
Information Manager responsible for the
Superfund Risk Data Collection.
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EXHIBIT 3-1
INTERIM DELIVERABLES FOR EACH SITE
Interim Deliverable
Scope of Deliverable
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 0
TARA Schedule Worksheet
Standard Table 0 - Site Risk Assessment
Identification Information
One Worksheet for each Risk Assessment
One Standard Table for each Risk Assessment
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 1
Standard Table 1 - Selection of Exposure Pathways
One Standard Table for each Risk Assessment.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 2
Data Useability Worksheet
Supporting Information on Background Values
Standard Table 2 Occurrence, Distribution, and
Selection of Chemicals of Potential Concern (COPCs)
One Worksheet for each Medium.
Information for all Chemicals listed m Standard Table
2.
One Standard Table for each unique combination of
Scenario Timeframe, Medium, and Exposure Medium
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 3
Supporting Information on EPCs
Standard Table 3 - Exposure Point Concentration
(EPC) Summary
Information for all EPCs presented in Standard Table
3.
One Standard Table for each unique combination of
Scenario Timeframe, Medium, and Exposure Medium
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 4
Supporting Information on Modeled Intake
Methodology and Parameters
Supporting Information on Chemical-Specific
Parameters
Dermal Worksheet
Standard Table 4 - Values Used for Daily Intake
Calculations
Information for all Modeled Intake calculations that are
not presented in Standard Table 4.
Information for all Chemical-Specific Parameters used
Information for calculation of DA(event)
One Standard Table for each unique combination of
Scenario Timeframe, Medium, and Exposure Medium
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 5 AND 6
Supporting Information on Tozicity Data for
Special Case Chemicals
Standard Table 5 - Non-Cancer Toxicity Data
Information for each Special Case Chemical
Three Standard Tables - 5. 1 for Oral/Dermal, 5 2 for
Inhalation, and 5 3 for Special Case Chemicals.
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EXHIBIT 3-1
INTERIM DELIVERABLES FOR EACH SITE (continued)
Interim Deliverable
Standard Table 6 - Cancer Toxicity Data
Scope of Deliverable
Four Standard Tables - 6 1 for Oral/Dermal, 6 2 for
Inhalation, 6 3 for Special Case Chemicals, and 6 4 for
External (Radiation)
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 7 AND 8
Supporting Information on Special Chemical Risk
and Hazard Calculations
Standard Table 7 - Calculation of Chemical Cancer
Risks and Non-Cancer Hazards
Radiation Dose Assessment Worksheet
Standard Table 8 - Calculation of Radiation Cancer
Risks
Information for each Special Case Chemical.
One Standard Table for each unique combination of
Scenario Timeframe, Receptor Population, and
Receptor Age, for RME and for CT.
One Worksheet for each unique combination of
Scenario Timeframe. Receptor Population, and
Receptor Age (as appropriate).
One Standard Table for each unique combination of
Scenario Timeframe, Receptor Population and
Receptor Age.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 9 AND 10
Standard Table 9 - Summary of Receptor Risks and
Hazards for COPCs
Standard Table 10 - Risk Summary
One Standard Table for each unique combination of
Scenario Timeframe, Receptor Population, and
Receptor Age, for RME and CT.
One Standard Table for each unique combination of
Scenario Timeframe, Receptor Population, and
Receptor Age, for RME and CT
INTERIM DELIVERABLES ASSOCIATED WITH LEAD
Lead Worksheets (if applicable)
Separate Worksheets for Residential and Non-
Residential Scenarios for each unique combination of
Scenario Timeframe, Receptor Population, and
Receptor Age
INTERIM DELIVERABLES ASSOCIATED WITH UNCERTAINTY ASSESSMENT
Assessment of Confidence and Uncertainty
One Assessment for each Risk Assessment.
INTERIM DELIVERABLES ASSOCIATED WITH PROBABILISTIC ANALYSIS
Summary of Probabilistic Analysis (if applicable)
One Summary for each Risk Assessment.
Revision No. 1
3-16
September 2001
-------
EXHIBIT 3-1
INTERIM DELIVERABLES FOR EACH SITE (continued)
Interim Deliverable
Scope of Deliverable
INTERIM DELIVERABLES ASSOCIATED WITH THE ROD
ROD Risk Worksheets
As appropriate to document (in draft form) the need for
remedial action.
Notes
1 Each Interim Deliverable should be reviewed and verified by EPA prior to submission of the Draft Baseline Risk Assessment Report
2 Each Interim Deliverable should later be incorporated in the Draft and Final Baseline Risk Assessment Reports
3 The Interim Deliverables are needed for each risk assessment to achieve standardization in risk assessment reporting
Revision No. 1 3-17 September 2001
-------
EXHIBIT 3-2
STANDARDIZED RISK ASSESSMENT REPORTING
Risk Assessment Activity
Corresponding Standard Table/Worksheet
Data Collection
Provide identification information for the risk
assessment
Plan the risk assessment review process
Develop a conceptual sue model
Gather and report appropriate data
Standard Table 0 - Site Risk Assessment Identification
Information
TARA Schedule Worksheet
Standard Table 1 - Selection of Exposure Pathways
Standard Table 2 - Occurrence, Distribution, and
Selection of Chemicals of Potential Concern
Data Evaluation
Evaluate detection frequency, background data, and
site data
Identify chemicals of potential concern and provide
rationale for selection and deletion
Data Useability Worksheet
Standard Table 2 - Occurrence, Distribution, and
Selection of Chemicals of Potential Concern
Standard Table 2 - Occurrence, Distribution, and
Selection of Chemicals of Potential Concern
Exposure Assessment
Characterize physical setting, identify potential
pathways and exposed population
Identify exposure assumptions
Estimate exposure point concentrations
Estimate exposure intakes
Standard Table 1 - Selection of Exposure Pathways
Standard Table 4 - Values Used for Daily Intake
Calculations
Dermal Worksheet
Standard Table 3 - Exposure Point Concentration
Summary
Standard Table 7 - Calculation of Chemical Cancer
Risks and Non-Cancer Hazards
Standard Table 8 - Calculation of Radiation Cancer
Risks
Toxicity Assessment
Determine toxicity values for carcinogenic and non-
carcinogenic effects and provide source information
Standard Table 5 - Non-Cancer Toxicity Data
Standard Table 6 - Cancer Toxicity Data
Revision No. 1
3-18
September 2001
-------
EXHIBIT 3-2
STANDARDIZED RISK ASSESSMENT REPORTING (continued)
Risk Assessment Activity
Corresponding Standard Table/Worksheet
Risk Characterization
Quantify cancer and non-cancer risk by pathway
Combine risks by media for different receptors
Summarize risk drivers for different receptors
Prepare draft risk documentation for ROD
Standard Table 7 - Calculation of Chemical Cancer
Risks and Non-Cancer Hazards
Standard Table 8 - Calculation of Radiation Cancer
Risks
Radiation Dose Assessment Worksheet
Standard Table 9 - Summary of Receptor Risks and
Hazards for COPCs
Standard Table 10 - Risk Summary
ROD Risk Worksheets
Revision No. 1
3-19
September 2001
-------
EXHIBIT 3-3
SUMMARY OF RAGS PART D
REVISION 1 CHANGES
STANDARD TABLE/WORKSHEET
REVISION 1 CHANGES
Standard Table 0
This is a new Standard Table
TARA Schedule Worksheet
This is a new Worksheet.
Standard Table 1
Revision 1 does not include the On-Site/Off-Site field from
Revision 0
Data Useability Worksheet
The Revision 1 Worksheet is the same as the Revision 0
Worksheet.
Standard Table 2
Exposure Point was moved from the last row of the Summary
Box (Revision 0) to the first column of the table (Revision 1).
This may reduce the number of versions of Standard Table 2
needed for some sites. The Qualifier information for Minimum
and Maximum Concentrations has been moved to the
corresponding Concentration fields.
Standard Table 3
In Revision 1, separate versions of this table should be prepared
for RME and CT. Exposure Point was moved from the last row
of the Summary Box (Revision 0) to the first column of the
table (Revision 1). This may reduce the number of versions of
Standard Table 3 needed for some sites. The Qualifier
information has been moved to the corresponding Maximum
Concentration field.
Standard Table 4
In Revision 1, separate versions of this table should be prepared
for RME and CT Receptor Population, Receptor Age, and
Exposure Point were moved from the Summary Box (Revision
0) to columns in Revision I. This may reduce the number of
versions of Standard Table 4 needed for some sites.
Standard Tables 5.1,5.2, and 5.3
The Revision 1 Standard Tables are essentially the same as
Revision 0. Some column headings have been slightly
reworded, but the data needs are the same
Standard Table 6.1,6.2,6.3, and 6.4
The Revision 1 Standard Tables 6.1,6.2, and 6.3 are essentially
the same as Revision 0 Some column headings have been
slightly reworded, but the data needs are the same. Revision 1
Standard Table 6.4 for radionuclides was not included in
Revision 0.
Revision No. 1
3-20
September 2001
-------
EXHIBIT 3-3
SUMMARY OF RAGS PART D
REVISION 1 CHANGES (continued)
STANDARD TABLE/WORKSHEET
Standard Table 7
Standard Table 8
Radiation Dose Assessment Worksheet
Standard Tables 9 and 10
Lead Worksheets
ROD Risk Worksheets (ROD Risk
Highlights)
REVISION I CHANGES
Medium. Exposure Medium, and Exposure Point were moved
from the Summary Box (Revision 0) to columns in the table
(Revision 1) This may reduce the number of versions of
Standard Table 7 needed for some sites Standard Table 7,
which previously contained only non-cancer information
(Revision 0), now presents cancer and non-cancer information
for chemicals.
Standard Table 8 (Revision 1) focuses exclusively on the
calculation of radiation cancer risks Standard Table 8
(Revision 0) focused on cancer risk calculations for all
chemicals Medium, Exposure Medium, and Exposure Point
were moved from the Summary Box (Revision 0) to columns in
the table (Revision 1) This may reduce the number of versions
of Standard Table 8 needed for some sites. Medium EPC and
Route EPC information (Revision 0) was replaced by EPC
information (Revision 1)
This is a new Worksheet.
A column for Exposure Route External (Radiation) has been
added to the cancer calculations in Revision 1 The second
COPC (Standard Table 9) or Chemical (Standard Table 10)
column from Revision 0 has been deleted in Revision 1
Accommodations have been made for summing risks and
hazards at the Exposure Point, Exposure Medium, Medium, and
Receptor Levels.
These are new Worksheets.
These are new Worksheets that copy the ROD Guidance (U S
EPA, 1999a) Risk Highlights.
Revision No. 1
3-21
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS
ROD RISK
HIGHLIGHT
Highlight
6-15
PURPOSE
OF ROD
RISK
HIGHLIGHT
Summary of
Chemicals of
Concern and
Medium-
Specific
Exposure Point
Concentrations
ROD FIELDS
Scenario Tuneframe
Medium
Exposure Medium
Exposure Point
Chemical of
Concern
Concentration
Detected- Min
Concentration
Detected- Max
Units
Frequency of
Detection
Exposure Point
Concentration
Exposure Point
Concentration Units
Statistical Measure
ASSOCIATED
RAGS D TABLE
Standard Tables 2 & 3
Standard Tables 2 & 3
Standard Tables 2 & 3
Standard Tables 2 & 3
Significant Chemicals
from Standard Table 2
(site specific definition)
Standard Table 2
Standard Table 2
Standard Table 2
Standard Table 2
Standard Table 3
Standard Table 3
Standard Table 3
ASSOCIATED
RAGS D FIELDS
Scenario Tuneframe
Medium
Exposure Medium
Exposure Point
Chemical
Minimum
Concentration
Maximum
Concentration
Units
Detection Frequency
Exposure Point
Concentration Value
Exposure Point
Concentration Units
Exposure Point
Concentration Statistic
Notes:
-A version of ROD Highlight 6- 1 5 is to be prepared for each combination of Scenario Tunefirame, Medium, and
Exposure Medium with "significant routes of exposure". The definition of "significant" will be site specific.
-Only Exposure Points with "Significant Routes of Exposure" are to be included.
Revision No. 1
3-22
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight
6-16A
PURPOSE
OF ROD
RISK
HIGHLIGHT
Cancer Toxicity
Data Summary
ROD FIELDS
Pathway. Ingestion,
Dermal
Chemical of
Concern
Oral Cancer Slope
Factor
Dermal Cancer
Slope Factor
Slope Factor Units
Weight of
Evidence/
Cancer Guideline
Description
Source
Date
Pathway: Inhalation
Chemical of
Concern
Unit Risk
Units
ASSOCIATED
RAGS D TABLE
Standard Table 6 1
(Cancer Toxicity Data-
Oral/Dermal)
Chemicals of Concern
from Standard Table
6. 1 (site specific
definition)
Standard Table 6 I
Standard Table 6. 1
Standard Table 6. 1
Standard Table 6. 1
Standard Table 6. 1
Standard Table 6. 1
Standard Table 6.2
(Cancer Toxicity Data -
Inhalation)
Chemicals of Concern
from Standard Table
6 2 (site specific
definition)
Standard Table 6.2
Standard Table 6.2
ASSOCIATED
RAGS D FIELDS
Chemical of Potential
Concern
Oral Cancer Slope
Factor
Absorbed Cancer
Slope Factor for
Dermal Value
Oral Cancer Slope
Factor Units and
Absorbed Cancer
Slope Factor for
Dermal Units
Weight of
Evidence/Cancer
Guideline Description
Oral CSF Source(s)
Oral CSF Date(s)
Chemical of Potential
Concern
Unit Risk Value
Unit Risk Units
Revision No. 1
3-23
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight 6- 16A
(continued)
PURPOSE
OF ROD
RISK
HIGHLIGHT
Cancer Toxicity
Data Summary
(continued)
ROD FIELDS
Inhalation Cancer
Slope Factor
Units
Weight of
Evidence/ Cancer
Guideline
Description
Source
Date
Pathway: External
(Radiation)
COC
Cancer Slope or
Conversion Factor
Exposure Route
Units
Weight of
Evidence/ Cancer
Guideline
Description
Source
Date
ASSOCIATED
RAGS D TABLE
Standard Table 6 2
Standard Table 6 2
Standard Table 6 2
Standard Table 6 2
Standard Table 6 2
Standard Table 6 4
(Cancer Toxicity Data -
Radiation)
Chemicals of Concern
from Standard Table
6 4 (site specific
definition)
Standard Table 6 4
Standard Table 1
Standard Table 6 4
Nol Available
Standard Table 6 4
Standard Table 6 4
ASSOCIATED
RAGS D FIELDS
Inhalation Cancer
Slope Factor Value
Inhalation Cancer
Slope Factor Units
Weight of
Evidence/Cancer
Guideline Description
Unit Risk Inhalation
CSF Source(s)
Unit Risk . Inhalation
CSF Date(s)
Chemical of Potential
Concern
Cancer Slope Factor
Value
Exposure Route
Cancer Slope Factor
Units
Not Available
Source(s)
Date(s)
Note:
-A version of ROD Highlight 6-16A is to be prepared for the Chemicals of Concern. This definition will be site
specific.
Revision No. 1
3-24
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight
6-16B
PURPOSE
OF ROD
RISK
HIGHLIGHT
Non-Cancer
Toxicity Data
Summary
ROD FIELDS
Pathway Ingestion,
Dermal
Chemical of
Concern
Chronic/
Subchronic
Oral RfD Value
Oral RfD Units
Dermal RfD
Dermal RfD Units
Primary Target
Organ
Combined
Uncertainty/
Modifying Factors
Sources of
RfD:Target Organ
Dates of RfD.Target
Organ
Pathway: Inhalation
Chemical of
Concern
ASSOCIATED
RAGS D TABLE
Standard Table 5 1
(Non-Cancer Toxicity
Data - Oral/Dermal)
Chemicals of Concern
fiom Standard Table
5 1 (site specific
definition)
Standard Table 5 1
Standard Table S.I
Standard Table 5.1
Standard Table 5. 1
Standard Table 5 1
Standard Table S.I
Standard Table 5 1
Standard Table 5 I
Standard Table 5. \
Standard Table 5.2
(Non-Cancer Toxicity
Data - Inhalation)
Chemicals of Concern
from Standard Table
5 2 (site specific
definition)
ASSOCIATED
RAGS D FIELDS
Chemical of Potential
Concern
Chromc/Subchromc
Oral RfD Value
Oral RfD Units
Absorbed RfD for
Dermal Value
Absorbed RfD for
Dermal Units
Primary Target
Organ(s)
Combined
Uncertainty/
Modifying Factors
RfD Target Organ(s)
Source(s)
RfD Target Organ(s)
Date(s)
Chemical of Potential
Concern
Revision No. 1
3-25
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight
6-16B
(continued)
PURPOSE
OF ROD
RISK
HIGHLIGHT
Non-Cancer
Toxicity Data
Summary
(continued)
ROD FIELDS
Chronic/
Subchronic
Inhalation RIC
Inhalation RfC
Units
Inhalation RID
Inhalation RfD
Units
Primary Target
Organ
Combined
Uncertainty/
Modifying Factors
Sources of
RfCiRfD: Target
Organ
Dates
ASSOCIATED
RAGS D TABLE
Standard Table 5 2
Standard Table 5 2
Standard Table 5 2
Standard Table 5 2
Standard Table 5.2
Standard Table 5 2
Standard Table 5 2
Standard Table 5 2
Standard Table 5 2
ASSOCIATED
RAGS D FIELDS
Chronic/ Subchronic
Inhalation RfC Value
Inhalation RfC Units
Extrapolated RfD
Value
Extrapolated RfD
Units
Primary Target
Organ(s)
Combined
Uncertainty/
Modifying Factors
RfC.Target Organ(s)
Source(s)
RfC.Target Organ(s)
Date(s)
Notes:
A version of ROD Highlight 6-16B is to be prepared for the Chemicals of Concern. This definition will be site
specific.
Revision No. 1
3-26
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight
6- ISA
PURPOSE
OF ROD
RISK
HIGHLIGHT
Risk
Characterization
Summary -
Carcinogens
ROD FIELDS
Scenario Timeframe
Receptor Population
Receptor Age
Medium
Exposure Medium
Exposure Point
Chemical of
Concern
Carcinogenic Risk-
Ingestion
Carcinogenic Risk-
Inhalation
Carcinogenic Risk-
Dermal
Carcinogenic
Risk-External
(Radiation)
Carcinogenic Risk
Exposure Routes
Total
Medium Risk Total
Total Risk
ASSOCIATED
RAGS D TABLE
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Chemicals of Concern
from Standard Table 9
or 10 (site specific
definition)
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
ASSOCIATED
RAGS D FIELDS
Scenario Timeframe
Receptor Population
Receptor Age
Medium
Exposure Medium
Exposure Point
Chemical
Carcinogenic
Risk-lngestion
Carcinogenic
Risk-Inhalation
Carcinogenic
Risk-Dermal
Carcinogenic
Risk-External
(Radiation)
Carcinogenic Risk -
Exposure Routes Total
Medium Total (Risk)
Receptor Risk Total
Notes:
-A version of Highlight 6- ISA is to be prepared for each Receptor (combination of Scenario Timeframe, Receptor
Population, and Receptor Age) with "Significant Exposure". The definition of "Significant Exposure" will be sue
specific.
Revision No. 1
3-27
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
Highlight
6-18B
PURPOSE
OF ROD
RISK
HIGHLIGHT
Risk
Characterization
Summary -
Non-
Carcinogens
ROD FIELDS
Scenario Timeframe
Receptor Population
Receptor Age
Medium
Exposure Medium
Exposure Point
Chemical of
Concern
Primary Target
Organ
Non-Carcinogenic
Hazard Quotient -
Ingestion
Non-Care inogenic
Hazard Quotient -
Inhalation
Non-Carcinogenic
Hazard Quotient -
Dermal
Non-Carcinogenic
Hazard Quotient -
Exposure Routes
Total
ASSOCIATED
RAGS D TABLE
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Chemicals of Concern
from Standard Table 9
or 10 (site specific
definition)
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
Standard Table 9 or 10
ASSOCIATED
RAGS D FIELDS
Scenario Timeframe
Receptor Population
Receptor Age
Medium
Exposure Medium
Exposure Point
Chemical
Non-Carcinogenic
Hazard Quotient -
Primary Target
Organ(s)
Non-Carcinogenic
Hazard Quotient -
Ingestion
Non-Carcinogenic
Hazard Quotient -
Inhalation
Non-Carcinogenic
Hazard Quotient -
Dermal
Non-Carcinogenic
Hazard Quotient -
Exposuse Routes
Total
Revision No. 1
3-28
September 2001
-------
EXHIBIT 3-4
RAGS PART D INFORMATION SOURCES
FOR ROD RISK GUIDANCE HIGHLIGHTS (continued)
ROD RISK
HIGHLIGHT
PURPOSE
OF ROD
RISK
HIGHLIGHT
ROD FIELDS
ASSOCIATED
RAGS D TABLE
ASSOCIATED
RAGS D FIELDS
Highlight 6-1 SB
(continued)
Risk
Characterization
Summary -
Non-
Carcinogens
(continued)
Medium Hazard
Index Total
Standard Table 9 or 10
Medium Total
(Hazard)
Receptor Hazard
Index
Standard Table 9 or 10
Receptor HI Total
Organ Hazard Index
Standard Table 9 or 10
Total Organ HI
Across All Media
Notes:
-A version of Highlight 6-1 SB is to be prepared for each Receptor (combination of Scenario Timeframe, Receptor
Population, and Receptor Age) with "Significant Exposure" The definition of "Significant Exposure" will be site
specific.
Revision No. 1
3-29
September 2001
-------
CHAPTER 4
RISK EVALUATIONS
DURING THE FEASIBILITY STUDY
Continuous involvement of the EPA risk
assessor during the FS has the benefit of. 1)
supporting the development of remedial action
objectives (RAOs) and PRGs, 2) identifying risks
and hazards associated with PRGS, and 3)
supporting comparison of risks associated with
various remedial alternatives. For these reasons,
EPA risk assessor involvement in FS preparation
and review is strongly encouraged.
4.1 INTRODUCTION
The purpose of the FS is to evaluate waste
management remedial alternatives. The National
Oil and Hazardous Substances Pollution
Contingency Plan (NCP) (U.S. EPA, 1990c)
specifies that a detailed analysis be performed that
involves nine criteria. The NCP specifies that for
screening of remedial alternatives, the long-term
and short-term aspects of three criteria -
effectiveness, implementability, and cost - should
be used to guide the development and screening of
remedial alternatives. Consideration of
effectiveness involves evaluating the long-term
and short-term human health risks. Long-term
risks associated with a remedial alternative are
those risks that will remain after the remedy is
complete; short-term risks associated with a
remedial alternative are those risks that occur
during implementation of the remedial alternative.
Evaluating long-term risks ideally includes an
assessment of the risks associated with treatment
of residuals and untreated wastes for a treatment-
based remedy, or an evaluation of the remedy's
ability to provide protectiveness over time for a
containment-based remedy. For short-term human
health risks associated with a remedial alternative,
a risk assessor may need to evaluate the risks that
occur during implementation of the remedial
alternative (e.g., risks associated with emissions
from an onsite air stripper). Because some
remedies may take many years to complete, some
'short-term" risks may actually occur over a
period of many years Populations that may be
exposed to chemicals during remedj
implementation include people who live and uork
in the vicinity of the site
The NCP also requires that RAOs and
remediation goals be developed. These serve as
objectives and goals that can be used to identify
and assess remedial alternatives at Superfund sites.
The remainder of this chapter defines and
discusses RAOs and remediation goals. As also
discussed in the NCP, final remediation goals are
not determined until a final remedy for the site is
selected in the ROD (see Chapter 5).
4.1.1 REMEDIAL ACTION OBJECTIVES
As discussed in the NCP, RAOs describe, in
general terms, what any remedial action needs to
accomplish in order to be protective of human
health and the environment. They are typically
narrative statements that specify the contaminants
and environmental media of concern, the potential
exposure pathways to be addressed by remedial
actions, the exposed populations and
environmental receptors to be protected, and the
acceptable contaminant concentrations or
concentration ranges (remediation goals) in each
environmental medium.
4.1.2 REMEDIATION GOALS
Remediation goals are a subset of the RAOs
They provide the acceptable contaminant
concentrations in each medium for remedial
actions to meet.
EPA explained in the preamble to the final
NCP that remediation goals are based on ARARs
unless ARARs are not available or are not
protective. ARARs do not always exist for all
chemicals and all environmental media
Revision No. 1
4-1
September 2001
-------
SELECTION OF REMEDIATION GOALS
The NCP [US. EPA, 1990c, Section
300.430(e) (2)(I)] states that the selection of
remediation goals should consider the following.
"...remediation goals shall establish acceptable
exposure levels that are protective of human
health and the environment and shall be
developed considering the following...
ARARs under Federal environmental or State
environmental or facility siting laws, if
available, and the following factors:
1. For systemic toxicants, acceptable
exposure levels shall represent
concentration levels to which the human
population, including sensitive subgroups,
may be exposed without adverse effect
during a lifetime or pan of a lifetime,
incorporating an adequate margin of
safety;
2. For known or suspected carcinogens,
acceptable exposure levels are generally
concentration levels that represent an
excess upper bound lifetime cancer risk to
an individual of between 10"4 and 10"6 us-
ing information on the relationship
between dose and response. The lO^risk
level shall be used as the point of
departure for determining remediation
goals for alternatives when ARARs are not
available or are not sufficiently protective
because of the presence of multiple
contaminants at a site or multiple
pathways of exposure;
3. Factors related to technical limitations
such as detection/quantification limits for
contaminants;
4. Factors related to uncertainty; and
5 Other pertinent information."
Therefore, according to the NCP, there are two
major sources for the acceptable exposure levels
used for remediation goals: a) concentrations
found in Federal and State ARARs and, if these
are not available or not protective, (b) risk-based
concentrations that are determined to be protective
of human health and the environment. These risk-
based concentrations are calculated using, at a
minimum, the criteria sited in numbers 1 and 2 in
the Remediation Goals highlight box. Other
factors mentioned in the highlight box [i e . limits
of detection (number 3). uncertainty (number 4),
and background concentration levels (number 5)]
are also considered.
Risk-based concentrations may need to be
developed even if ARARs are available to ensure
that these ARARs are protective of human health
and the environment.
ARAR-Based Remediation Goals. Potential
chemical-specific ARARs include concentration
limits set by Federal environmental regulations
such as Maximum Contaminant Levels (MCLs)
established under the Safe Drinking Water Act
(SDWA), ambient water quality criteria
established under the Clean Water Act (CWA),
and State regulations (e g , State drinking water
laws) Action-specific and location-specific
ARARs must also be complied with or waived
according to the NCP.
Risk-Based Remediation Goals. In general,
remediation goals based on risk-based calculations
are determined using cancer or non-cancer toxicity
values with specific exposure assumptions For
chemicals with carcinogenic effects, the NCP has
described the development of remediation goals,
as a practical matter, as a two-step process [U S.
EPA, 1990c, Section 300.430(e)(2)(I)(D)]. A
concentration equivalent to a lifetime cancer risk
of 10"6 is first established as a point of departure
Then, other factors are taken into account to
determine where within the acceptable range the
remediation goals for a given contaminant at a
specific site will be established.
The NCP discusses a generally acceptable
risk range of 10"4 to 10'6. EPA has further
clarified the extent of the acceptable risk range by
stating that the upper boundary is not a discrete
line at I.X10"1 Risks slightly greater than 1x10 "
may be considered to be acceptable (i.e.,
protective) if justified based on site-specific
conditions, including any uncertainties about the
nature and extent of contamination and associated
Revision No. 1
4-2
September 2001
-------
risks. [See Role of the Baseline Risk Assessment in
Superfund Remedy Selection Decisions (U.S. EPA,
199 Id)].
For non-cancer effects, the NCP states that an
acceptable exposure level must be defined. (See
"Selection of Remediation Goals" highlight box in
this section.) According to EPA guidance, (RAGS
Part A, U.S. EPA, 1989c), generally, if the Hazard
Index (HI) (Intake/RfD) is above 1 (i.e., the site
exposure is estimated to be above the RfD) there
may be a concern for potential non-cancer effects
[see Role of the Baseline Risk Assessment in
Superfund Remedy Selection Decisions (U.S. EPA,
199Id)]. Therefore, in calculating remediation
goals at a site to protect for non-cancer effects,
remediation goals are generally set at a Hazard
Index at or below 1.
4.1.3 PRELIMINARY REMEDIATION
GOALS
PRGs for a site are established as early in the
RI/FS process as possible during project scoping
(see Chapter 2). These initial PRGs can then be
modified as necessary during the FS, based on
site-specific information from the baseline risk
assessment. The PRGs will then be used to
establish the goals to be met by the remedial
alternatives in the FS. The PRGs also guide the
development of the Proposed Plan for remedial
action and the selection of remediation levels in
the Record of Decision. During the FS, both risk-
based and ARAR-based PRGs are considered.
(See Section 4.1.2 for more discussion on ARAR-
based PRGs).
Risk-based PRGs (non-ARARs) may be
modified within the acceptable risk range during
the remedy selection process based on a balancing
of the major trade-offs among the alternatives as
well as the public and Agency comments on the
Proposed Plan (RAGS Part B, U.S. EPA, 199la).
Such balancing among alternatives and consider-
ation of community and State acceptance will
establish the specific level of protection the
remedy will achieve (i.e., the final remediation
levels).
The dialogue begun during Scoping between
the EPA risk assessor and the EPA RPM should
continue during the FS and beyond to ensure that
risk assessment information is used appropriately
in the risk management decision process
The primary guidance on development of the
FS is available in "Guidance for Conducting
Remedial Investigations and Feasibility Studies
Under CERCLA (U.S EPA, 1988) RAGS Part B
(U.S EPA, 199la) also presents guidance for the
role of risk assessment m the FS Consult the
EPA RPM for guidance
4.2 DEVELOP REMEDIAL
ACTION OBJECTIVES
The risk assessor should be involved in the
preparation or review of the following
A narrative description of the Medium,
Exposure Point and Exposure Routes, and
chemicals and radionuclides that will be the
focus of the remedial action
A narrative identifying the remedial action
objectives for prevention of exposure and
restoration of each contaminated Medium
(e.g., restoring groundwater to a potable water
source)
A format such as Example Table 1 in Exhibit
4-1 may be a useful approach to present these data
for each Medium.
4.3 DEVELOP REMEDIATION
GOALS
The risk assessor should be involved m the
preparation or review of a short narrative or tables
which provide the goals of the remediation. First.
all values considered as PRGs should be
identified. Then the PRGs selected for each
chemical to be used in the FS should be presented.
4.3.1 IDENTIFY VALUES CONSIDERED
AS PRELIMINARY REMEDIATION
GOALS
The risk assessor should be involved m the
following activities:
Identify which chemicals and/or radionuclides
will have PRGs developed.
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Identify ARAR-based PRGs and associated
risks/hazards.
If ARAR-based PRGs are not protective,
calculate risk-based PRGs using EPA
methods.
Identify other values to consider as PRGs
[e.g., background, detection limits, Procedure
Quantitation Limits (PQLs)].
A format such as Example Table 2 in Exhibit
4-1 may be a useful approach to present these
values, for each Medium and Receptor Population
combination.
4.3.2 SELECT PRELIMINARY
REMEDIATION GOALS
The risk assessor should be involved in the
following activities:
Select PRG(s) for each chemical from among
the values considered (e.g., risk-based for
cancer and non-cancer, ARAR-based, other),
modifying values as appropriate. Note that
the PRG should be ARAR-based unless there
is no ARAR available or the ARAR is not
protective.
Provide the rationale for the selected PRG.
Include the source of the value.
A format such as Example Table 3 in Exhibit
4-1 may be a useful approach to present these
values for each Medium and Receptor Population
combination.
4.4 SUMMARIZE RISKS AND
HAZARDS ASSOCIATED
WITH PRELIMINARY
REMEDIATION GOALS
The risk assessor should be involved in the
preparation or review of a short narrative or tables
which summarize the risks and hazards associated
with the PRGs. The risk assessor should be
involved in the following activities:
Identify the chemical and/or radionuclide of
concern, maximum concentration. PRG, basis
of PRG, and calculated risks and hazards
associated with the PRG for each Medium and
Receptor Population.
Summarize the total risk and total hazard
among all chemicals for each Medium and
Receptor Population combination
A format such as Example Table 3 in Exhibit
4-1 may be a useful approach to present these
values for each Medium and Receptor Population
combination.
4.5 EVALUATE REMEDIAL
TECHNOLOGIES AND
ALTERNATIVES FOR RISK
CONSIDERATIONS
The risk assessor may provide input in the
process of evaluating remedial technologies and
alternatives for risk considerations beginning in
the development and screening stage of the FS and
extending into the detailed analysis stage. The
major goal for the risk evaluation during these
steps is to provide the FS team and the EPA RPM
with specific long-term and short-term human
health risk information to consider when
identifying and screening technologies and
alternatives and performing detailed analysis of
alternatives.
The long-term human health risks associated
with a remedial technology or alternative are those
risks that will remain after the remedy is complete
(i.e., residual risks). The risk issues to be
considered may include an assessment of the risks
associated with treatment residuals, untreated
wastes, or contained wastes.
The short-term human health risks associated
with a remedial technology or alternative are those
risks that occur during implementation of the
technology or alternative, which may occur over
a period of years. Populations to be considered
include people who live and work in the vicinity
of the site and workers involved in site
remediation.
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4.5.1 IDENTIFICATION AND
SCREENING OF TECHNOLOGIES
AND ALTERNATIVES
The risk assessor may contribute to the
identification and screening of technologies and
alternatives and focus on evaluating associated
short-term and long-term human health risks to
ensure that they meet RAOs and PRGs. The goal
of the risk assessor is to assist in identifying, and
eliminating from further consideration,
technologies and/or alternatives with clearly
unacceptable risks. This evaluation is typically
qualitative, based on simplifying assumptions and
professional judgment rather than detailed
analysis. The risk assessor's evaluation is
associated with the consideration of effectiveness,
one of three criteria specified by the NCP.
(Implementability and cost are the other two
criteria evaluated at this screening stage, but they
do not typically involve risk assessor
participation.)
4.5.2 DETAILED ANALYSIS OF
ALTERNATIVES
The overall objective of the risk assessor's
role in the detailed analysis of alternatives is to
support the preparation and evaluation of the risk
information needed for RPMs to select a remedial
alternative for a site. See the highlight box for the
nine remedial alternative evaluation criteria
specified by the NCP. The risk assessor
contributes to the analysis of three of the nine
criteria specified by the NCP:
Overall Protection of Human Health and the
Environment
Long-term Effectiveness and Permanence
Short-term Effectiveness.
The detailed analysis of short-term and long-
term risks may be qualitative or quantitative
depending on the "perceived risk" associated with
the alternative based on both professional
judgment and community concerns. The risk
analysis follows the same general steps as the
baseline risk assessment; however, the steps will
typically not be conducted in the same level of
detail for the FS.
NCP CRITERIA FOR REMEDIAL
ALTERNATIVE DETAILED EVALUATION
1 Overall Protection of Human Health and
Environment
2 Compliance with ARARs
3 Long-term Effectiveness and Permanence
4 Reductions in Toxicity. Mobility, and
Volume Through Treatment
5 Short-term Effectiveness
6 Implementability
7 Cost
8 State Acceptance
9 Community Acceptance
The detailed analysis of short-term risks
includes the following components for each
alternative:
Evaluate short-term exposure
Evaluate short-term toxicity
Characterize short-term risks to the
community (including people who live or
work on or near the site)
Characterize short-term risks to remediation
workers (a qualitative assessment may be
appropriate if the risks to remediation workers
are addressed adequately in the site-specific
Health and Safety Plan)
Che detailed analysis of long-term risks
includes the following components for each
alternative.
Evaluate residual risk
Ks aluate protectiveness over time.
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EXHIBIT 4-1
EXAMPLE TABLES TO STANDARDIZE
REPORTING OF FS RISK EVALUATIONS
Example Table I
REMEDIAL ACTION OBJECTIVES
Medium
Exposure Point
Chemical
Exposure Route
Receptor Population
Remedial Action
Obiectives
Example Table 2
VALUES CONSIDERED AS PRGs
Medium1
Receptor Population.
Chemical
Most
Restrictive
ARAR
Most
Restrictive
ARAR
Source
Risk/Hazard
at ARAR
Risk-Based
PRO
Cancer*
Risk-Based
PRO
Non-Cancer*
Other
Value* *
Other
Value* *
Source
'Provide the associated risk and hazard levels in the footnotes
**(e g , detection limits, background)
Exam pie Table 3
RISKS AND HAZARDS ASSOCIATED WITH PRGs
Medium.
Receptor Population
Chemical
Site
Concentration
PRO
Basis for
PRO*
Totals
Risk at PRG
Cancer
Hazard at PRG Non-
Cancer
Target Endpoint
TBC (Federal ARARs, Slate ARARs), Risk-based
Background Concentrations, method detection limits
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CHAPTER 5
RISK EVALUATIONS
AFTER THE FEASIBILITY STUDY
After completion of the FS, EPA risk assessor
involvement in risk evaluations should be
conducted as necessary to support the EPA RPM
in ensuring that the remedy is protective. While
these risk evaluations may not always require a
significant level of quantitation, continuous
involvement of EPA risk assessors is essential to
ensure consistency in risk evaluation and risk
communication. Post-FS activities benefitting
from EPA risk assessor involvement typically
include the Proposed Plan, the Record of Decision
(ROD), the Remedial Design/Remedial Action,
and Five-Year Reviews.
5.1 RISK EVALUATION FOR THE
PROPOSED PLAN
The Proposed Plan should include sufficient
risk assessment information to support the basis
for the proposed remedial action. EPA risk
assessor support is recommended during the
preparation of the Proposed Plan to ensure the
consistency of risk information with the Baseline
Risk Assessment Report and the FS Report. The
level of detail in the Proposed Plan should be
appropriate to the needs of the community.
Additional EPA risk assessor support required at
this time may be qualitative or quantitative,
typically focusing on refinement of previous
analyses, based on newly developed information.
5.2 RISK EVALUATION
ASSOCIATED WITH THE
RECORD OF DECISION
EPA risk assessor involvement in preparation
of the risk evaluation in the ROD is strongly
recommended. A summary of the relevant
information from the Baseline Risk Assessment
Report should be presented in a mixture of text
format and table format. In addition, the risks
(short-term and residual) associated \vith each
alternative should be discussed
5.2.1 BASELINE RISK SUMMARY
THE RECORD OF DECISION
IN
To support the preparation of the Record of
Decision, the EPA risk assessor should prepare or
review a summary of the Baseline Risk
Assessment Report which supports the basis for
the remedial action. The primary focus should be
on those exposure pathways and chemicals of
concern found to pose actual or potential threats to
human health or the environment. Chemicals
included in the risk assessment but determined not
to contribute significantly to an unacceptable risk
need not be included in the Risk Characterization
Summary in the ROD (e.g., chemicals with risk
levels less than IxlO"6 or HQ less than 0.1) unless
they are needed to justify a No Action ROD
Refer to Interim Final Guidance on Preparing
Superfund Decision Documents (U.S EPA.
1989b) and Guide to Preparing Superfund
Proposed Plans. Records of Decision, and Other
Remedy Selection Decision Documents (U S EPA,
1999a) for a recommended format for
summarizing human health risk assessment
information in the ROD.
Other risk information may also be included m
the ROD depending upon the level of detail
preferred. Information related to values used for
intake calculations and non-cancer and cancer
tox icity data and exposure point concentrations are
summarized on Standard Tables 4, 5, 6, 7, and 8.
which could be placed in appendices to the ROD
Section 3 3 provides ROD Risk Worksheets that
correspond to ROD guidance highlights 6-15, 6-
I6A, 6-16B, 6-ISA and 6.1 SB. Preparation of
these Worksheets previously, as interim
deliverables (see Section 3.3), is strongly
recommended because it greatly facilitates risk
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evaluation in the ROD. If these Worksheets were
not previously prepared, refer to Exhibit 3-4 for
RAGS Part D Standard Table sources for this
information.
5.2.2 RISKS ASSOCIATED WITH
CLEANUP LEVELS IN THE
RECORD OF DECISION
The ROD (except for no-action RODs) should
describe how remedial alternatives will reduce
risks by achieving cleanup levels through
treatment or by eliminating exposures through
engineering controls for the contaminated media.
In addition, the risk assessor should
prepare/review the following information related
to the selected alternative:
Document short-term risks that may occur
during remedy implementation
Document risks that may remain after
completion of the remedy (including residual
risk from untreated waste remaining at the
site)
Determine the need for five-year reviews.
Refer to the ROD guidance (U.S. EPA, 1999a) for
suggestions regarding presentation of risks
associated with cleanup levels in the ROD (e.g.,
see Highlight 6-32).
5.3 RISK EVALUATION DURING
REMEDIAL DESIGN AND
REMEDIAL ACTION
The EPA risk assessor's role during remedial
design and remedial action may be qualitative or
quantitative depending on the site and phase of the
project. During the remedial design, short-term
and long-term risks may be assessed through
refinement of previous analyses and identification
of the need for engineering controls or other
measures to mitigate risk.
During the remedial action, the EPA risk
assessor is more likely to provide quantitative risk
evaluation support. Short-term risk evaluation
may address impacts to remediation workers and
neighboring communities. Long-term risk
evaluations typically focus on the following
Whether cleanup levels specified in the ROD
have been attained
Whether residual risk after completion of the
remedy ensures protectiveness.
5.4 RISK EVALUATION
ASSOCIATED WITH
EXPLANATIONS OF
SIGNIFICANT DIFFERENCES
(ESDs) AND AMENDED RODs
When conditions relevant to a sue change
following the signing of a ROD, it is sometimes
necessary to prepare an ESD or amended ROD.
Examples of conditions causing this situation may
include, but are not limited to, the following:
Toxicity values change
Additional technology performance
information becomes available
ARARs change (e.g., Land Disposal
Restrictions).
EPA risk assessor involvement with RPM
evaluations of ESDs and Amended RODs focuses
on evaluating whether cleanup levels are still
protective when considering new ARARs, new
parameters for risk and hazard calculations, new
technology information, and other new
information. Any new information and revised
risk evaluations should be thoroughly
documented.
5.5 RISK EVALUATION DURING
FIVE-YEAR REVIEWS
CERCLA provides for reviews of certain
remedies at least every five years to assure that
human health and the environment are being
protected by the remedial alternative implemented.
EPA risk assessor involvement with RPM
evaluations during Five-Year Reviews are
generally quantitative and focus on the following
three goals:
Confirm that the remedy remains protective
(including any engineering or institutional
controls)
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Evaluate whether cleanup levels are still Evaluate whether cleanup has reduced risks to
protective by considering new ARARs, new levels no longer requiring restricted site use
parameters for risk and hazard calculations, and five-year reviews (U S EPA. 2001 b)
and other new information
Revision No. 1 5-3 September 2001
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REFERENCES-
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U.S. EPA. 1988. Guidance for Conducting Remedial Investigations and Feasibility Studies Under
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U.S. EPA. 1989a. Exposure Factors Handbook. Office of Research and Development. Washington. DC
EPA/600/8-89/043.
U.S. EPA. 1989b. Interim Final Guidance on Preparing Superfund Decision Documents Office of
Emergency and Remedial Response, Washington, DC. OSWER Directive 9355 3-02.
U.S. EPA. 1989c. Risk Assessment Guidance for Superfund (RAGS). Volume I - Human Health
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and Remedial Response, Washington, DC. EPA/540/1-89/002 NTIS PB90-155581.
U.S. EPA. 1990a. Guidance for Data Useability in Risk Assessment (Part A). Final. Office of
Emergency and Remedial Response, Washington, DC OSWER Directive 9285.7-09A PB92-963356
U.S. EPA. 1990b. Guidance for Data Useability in Risk Assessment (Part B). Final. Office of
Emergency and Remedial Response, Washington, DC. OSWER Directive 9285.7-09B. PB92-963362
U.S. EPA. 1990c. "National Oil and Hazardous Substances Pollution Contingency Plan." 40CFR300
U.S. EPA. 1991a. Risk Assessment Guidance for Superfund (RAGS): Volume I - Human Health
Evaluation Manual (HHEM) (Part B, Development of Risk-Based Preliminary Remediation Goals)
Office of Emergency and Remedial Response, Washington. DC EPA/540/R-92/003 OSWER Directive
9285.7-01B. NTIS PB92-963333.
U.S. EPA. 1991b. Risk Assessment Guidance for Superfund (RAGS) Volume I Human Health
Evaluation Manual (HHEM) (Part C, Risk Evaluation of Remedial Alternatives) Interim. Office of
Emergency and Remedial Response, Washington, DC EPA/5-10/R-92/004. OSWER Directive 9285 7-
01C. NTIS PB92-963334.
U.S. EPA. 1991c. Risk Assessment Guidance for Superfund/R.UJS) Volume I - Human Health
Evaluation Manual Supplemental Guidance: "Standard Default Exposure Factors " Interim Final
Office of Emergency and Remedial Response, Washington. DC OSWER Directive 9285 6-03
U.S. EPA. 1991 d. Role of the Baseline Risk Assessment in Superfund Remedy Selection Decisions
Office of Solid Waste and Emergency Response, Washington. DC OSWER Directive 9355 0-30.
U.S. EPA. 1992a. Data Quality Objectives Process for Superfund. Interim Final Guidance. Office of
Solid Waste and Emergency Response, Washington, DC. OSWER Directive 9355 9-01. EPA/540/R-
93/071.
Revision No. 1 R-l September 2001
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REFERENCES' (Continued)
U.S. EPA. 1992b. Dermal Exposure Assessment. Principles and Applications Office of Health and
Environmental Assessment, Washington, DC. EPA/600/8-91/01 IB.
U.S. EPA. 1992c. Human Health Evaluation Manual Supplemental Guidance Interim Dermal Rn>k
Assessment Guidance. OSWER Directive 9285.7-10.
U.S. EPA. 1992d. Final Guidance on Data Useability m Risk Assessment (Part A) Office of Solid
Waste and Emergency Response, Washington, DC. OSWER Directive 9285 7-09A
U.S. EPA. 1992e. Final Guidance on Data Useability in Risk Assessment (Part B) Office of Solid
Waste and Emergency Response, Washington, DC. OSWER Directive 9285 7-09B.
U.S. EPA. 1992f. Supplemental Guidance to RAGS. Calculating the Concentration Term Office of
Solid Waste and Emergency Response, Washington, DC. OSWER Directive 9285.7-081.
U.S. EPA. 1993a. Guidance for Conducting Non-Time Critical Removal Actions Under CERCLA
Office of Solid Waste and Emergency Response, Washington, DC. EPA/540/R-93/057
U.S. EPA. 1993b. Provisional Guidance for Quantitative Risk Assessment ofPolycyclic Aromatic
Hydrocarbons. Office of Research and Development, Washington, DC. EPA/600/R-93/C89
U.S. EPA. 1993c. Revised Interim Soil Lead Guidance for CERCLA Sites and RCRA Corrective Action
Facilities. Office of Solid Waste and Emergency Response, Washington, DC. OSWER Directive 9355 4-
12.
U.S. EPA. 1995a. EPA Risk Characterization Program. Memorandum from Administrator Carol
Browner. Office of the Administrator, Washington, DC. March 21, 1995.
U.S. EPA. 1995b. Memorandum from Carol Browner on Risk Characterization Office of the
Administrator, Washington, DC. February 22, 1995.
U.S. EPA. 1995c. Soil Screening Guidance: Technical Background Document Office of Solid Waste
and Emergency Response, Washington, DC. EPA 540/R-95/126.
U.S. EPA. 1996a. Exposure Factors Handbook - SAB Review Document Office of Health and
Environmental Assessment, Washington, D.C.
U.S. EPA. 1996b. Final Soil Screening Guidance, May 17, 1996 Soil Screening Guidance User's
Guide. Office of Solid Waste and Emergency Response, Washington, DC. EPA 540/R-96/018.
U.S. EPA. 1996c. PCBs: Cancer Dose-Response Assessment and Application to Environmental
Mixtures. Office of Research and Development, Washington, DC. EPA/600/P-96/001A.
U.S. EPA. 1996d. Recommendations of the Technical Review Workgroup for Lead for an Interim
Approach to Assessing Risks Associated with Adult Exposures to Lead in Soil. Office of Solid Waste and
Emergency Response, Washington, DC.
Revision No. 1 R-2 September 2001
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REFERENCES' (Continued)
U.S. EPA. 1997a. EPA Guidance for Data Assessment Office of Research and Development,
Washington, DC. EPA/600/R-96/084.
U.S. EPA. I997b. Exposure Factors Handbook, Volume I Office of Research and Development,
Washington, DC. EPA/600/P-95/002Fa.
U.S. EPA. I997c. Exposure Factors Handbook, Volume 2 Office of Research and Development,
Washington, DC. EPA/600/P-95/002Fb.
U.S. EPA. 1997d. Exposure Factors Handbook, Volume 3 Office of Research and Development,
Washington, DC. EPA/600/P-95/002Fc.
U.S. EPA. 1997e. Guiding Principles for Monte Carlo Analysis. Office of Research and Development
Washington, DC. EPA/630/R-97/001.
U.S. EPA. 1997f. Health Effects Assessment Summary Tables (HEAST), Annual FY1997 Office of
Solid Waste and Emergency Response, Washington, DC. EPA/540/R-97/036.
U.S. EPA. 1997g. Policy for Use of Probabilistic Analysis in Risk Assessment. Office of Research and
Development, Washington, DC. EPA/630/R-97/001.
U.S. EPA. 1997h. Integrated Risk Information System (IRIS) Data Base. Office of Research and
Development/National Center for Environmental Assessment. Also see
www.epa.gov/.iris/prototype/index.htm.
U.S. EPA. 1999a. Guide to Preparing Superfund Proposed Plans, Records of Decision, and Other
Remedy Selection Decision Documents. Office of Emergency and Remedial Response, Washington, DC.
EPA/540/R-98/031.
U.S. EPA. 2001 a. Risk Assessment Guidance for Superfund (RAGS): Volume I - Human Health
Evaluation Manual (HHEM) (Part E, Supplemental Guidance for Dermal Risk Assessment) Interim
Review Draft - For Public Comment. Office of Emergency and Remedial Response, Washington, DC
EPA/540/R-99/005. OSWER Directive 9285.7-02EP.
U.S. EPA. 200Ib. Comprehensive Five-Year Review Guidance Office of Emergency and Remedial
Response, Washington, DC. OSWER Directive 9355.7-03B-P.
U.S. EPA. 200 Ic. Guidance for Characterizing Background Chemicals in Soil at Superfund Sues.
Office of Emergency and Remedial Response, Washington, DC. OSWER Directive 9285.7-41.
U.S. EPA. 200 Id. Risk Assessment Guidance for Superfund. Volume III- Part A, Process for
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* This Reference Section is designed to not only give bibliographic information for documents referred to m the
RAGS Part D text, but also to be a source of bibliographic information for documents that are relevant to risk
assessment in general.
Revision No. 1 R-3 September 2001
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