UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
DEC / I JC
OSWER 9235.7-01D-1
MEMORANDUM
SUBJECT: Implementation of Risk Assessment Guidance for Superfund (RAGS) Volume 1 -
Human Health Evaluation Manual (Part D, Standardized Planning,
Reporting,and Review of Superfund Risk Assessments) (Interim)
t-/V
onse ' \J
FROM:
Stephen D. Luftig, Director
Office of Emergency and Remedial
Barry Breen, Director
Office of Site Remediation
TO:
PURPOSE
^/x__
sment, OECA
Superfund National Managers, Regions 1-10
The purpose of this memorandum is to:
o convey Part D of Risk Assessment Guidance for Superfund (RAGS) Volume 1
Human Health Evaluation Manual
o request that you assure its implementation in all risk assessment planning and
development, effective January 1, 1998,
BACKGROUND
The March 21, 1995 memorandum on Risk Characterization Policy and Guidance from
Administrator Browner directed improvement in the transparency, clarity, consistency, and
reasonableness of risk assessments at EPA. We, over the years, have looked for opportunities for
improving Superfund risk assessments and also have received criticisms from the General
Accounting Office (GAO), members of Congress, and others. Most of these criticisms
questioned the transparency or consistency of our risk assessments at sites across the country.
The October 1995 Superfund Reform #6 A directed EPA to establish national criteria to plan,
report, and review Superfund risk assessments. RAGS Part D responds to these challenges and
fulfills the Reform #6A mandate.
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An Agency workgroup of regional and headquarters risk assessors (the RAGS Part D
Workgroup) has been active since the second quarter of FY 96 developing Standard Tools and
other approaches to support standardization. Preliminary draft Standard Tools developed by the
Workgroup in 1996 were tested and subjected to regional and state review in the fourth quarter of
FY 96. Additional development and testing were performed by the Workgroup in FY 97, and a
second regional review occurred in fourth quarter of FY 97. The Workgroup also coordinated
extensively with the development team for the National Superfund Database (CERCLIS 3)
during FY 97, concurrent with CERCLIS 3 development and testing efforts. The Standard Tools
in RAGS Part D (Technical Approach for Risk Assessment, Standard Tables, and Instructions
for the Standard Tables') reflect the results of continued development, testing, and CERCLIS 3
interaction, and are now available for use immediately.
Elements of the RAGS Part D Approach
The RAGS Part D approach consists of three basic elements: Use of Standard Tools,
Continuous Involvement of EPA Risk Assessors, and Electronic Data Transfer to a National
Superfund Database. Brief descriptions of the three components follow:
Use of Standard Tools - The Standard Tools developed by the 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. The TARA should be customized for each site-specific
human health risk assessment as appropriate.
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 site-specific risk
assessments, 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.
j>
Instructions for the Standard Tables have been prepared corresponding to
each row 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 used to complete
and/or review Standard Tables for each site-specific: human health risk
assessment.
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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 (Standard Tables, Worksheets, and Supporting Information) and
identify corrections needed prior to preparation of the Draft and Final Baseline
Risk Assessment Reports. This will help assure high quality risk assessments and
greatly reduce the potential need for rework of contractor-prepared risk
assessments. Participation of the EPA risk assessors in other stages of the
CERCLA remedial process will ensure human health risk issues are appropriately
incorporated in the remedy selection and implementation processes.
Electronic Data Transfer to a National Superfund Database - Summary-level
site-specific risk information will be stored in a National Superfund Database
(CERCLIS 3) to provide data access and data management capabilities to all EPA
staff. These risk-related summary data represent a subset of the data presented in
the Standard Tables. The electronic versions of the Standard Tables (LOTUSฎ
and EXCELฎ) are structured to be compatible with CERCLIS 3. Translation
software is under development to transfer data from the Standard Tables to
CERCLIS 3, and no additional data entry should be required in the regions to
fulfill the CERCLIS 3 risk data requirements.
OBJECTIVE
The three elements of the RAGS Part D approach described previously achieve both the
objectives of Superfund Reform #6A (i.e., establish national criteria to plan, report, and review
Superfund risk assessments) and the goals of the memorandum on Risk Characterization Policy
and Guidance (i.e., improved transparency, clarity, consistency and reasonableness of EPA risk
assessments). The elements of the RAGS Part D approach provide a methodology that will
improve the quality and consistency of human health risk assessment development and risk-based
decision making through the following:
Standard Tools will be used to document the planning, reporting, and review of
human health risk assessments in a consistent format, to clarify the assumptions
made, and to increase a reader's ability to understand the approach followed
(transparency).
Continuous Involvement of EPA Risk Assessors in the planning and review of
human health risk assessments, throughout all phases of the CERCLA remedial
process, will improve the reasonableness and consistency of risk assessment
assumptions and conclusions as well as ensure that these conclusions are
appropriately understood and applied to risk management decisions.
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Electronic Data Transfer to a National Superfund Database (CERCLIS 3) from the
Standard Tables will efficiently accomplish reporting requirements, support
program-level data consistency reviews, and make data available for other readers
to review easily (transparency).
IMPLEMENTATION
Applicability of the RAGS Part D Approach
The approach contained in RAGS Part D is recommended for all risk assessments
commencing after the issuance of Part D. Its use is also encouraged in on-going risk
assessments to the extent it can efficiently be incorporated into the risk assessment process.
RAGS Part D is not applicable to completed risk assessments.
Exhibit 1 provides guidelines regarding RAGS Part D applicability as a function of site
lead and site type, so that site-specific applicability may be determined by each region.
EXHIBIT 1: GUIDELINES FOR/2AGS PARTD APPLICABILITY
SITE LEAD
Fund Lead
Federal Facility Lead
PRPLead
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, Time-Critical, Streamlined
SACM
RCRA Corrective Action3
/
/
_2
/
__?.
Notes:
1 The RAGS Part D Workgroup also suggests that RAGS Part D could be a useful tool for quantitative risk assessment for non-NPL, BRAC, and
Brownfields sites and encourages its use.
2 RAGS Part D use is encouraged as appropriate.
3 As described in the September 1996 EPA memorandum on Coordination Between 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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Implementation jf the RAGS Part D Approach
1
In FY 98, each region will identify RAGS Part D phase-in schedules on a site-by-site
basis using the guidelines presented above. The Standard Tools (TARA, Standard Tables, and
Instructions for the Standard Tables) are for immediate use. Field testing and evaluation of
RAGS Part D will take place during the remainder of FY 98 in all regions. Modifications to
RAGS Part D will be made as necessary during FY 98 and in FY 99 in response to evaluation
results and to address new human health risk assessment guidance, as appropriate.
We are attaching the list of RAGS Part D Workgroup members and a Quick Reference
Fact Sheet, Frequently Asked Questions: RAGS Part D, to aid you and your staff in
implementation of this directive. The Workgroup member in your region has multiple copies of
RAGS Part D, including all Standard Tools and diskettes. These are also available to you on the
Intranet, and to the public on the Internet at the following location:
http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html
Training on RAGS Part D will be provided in each region in FY 98. Additional
information will be forthcoming regarding training schedules.
If you have questions about RAGS Part D or its implementation, please contact Jirn Konz,
leader of the RAGS Part D Workgroup, at 703-603-8841, or David Bennett, Senior Process
Manager for Risk, at 703-603-8759.
Attachments
cc: Members of RAGS Part D Workgroup
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RAGS PART D WORKGROUP MEMBERS
Contact
Jim Konz
Ann-Marie Burke
Marian Olsen
Jennifer Hubbard
Glenn Adams
Andrew Podowski
Ghassan Khoury
Dave Crawford
Chris Weis
Stan Smucker
Dana Davoli
Location
EPA Headquarters,
Washington,. DC
Region I
Boston, MA
Region II
New York, NY
Region HI
Philadelphia, PA
Region IV
Atlanta, GA
Region V
Chicago, JJL
Region VI
Dallas, TX
Region VII
Kansas City, MO
Region VUI
Denver, CO
Region IX
San Francisco, CA
Region X
Seattle, WA
Phone Number
(703) 603-8841
(617) 223-5528
(212)637-4313
(215) 566-3328
(404) 562-8667
(312) 886-7573
(214)665-8515
(913) 551-7702
(303) 312-6671
(415)744-2311
(206)553-2135
E-Mail Address
konz.james@epamail.epa.gov
burke.annmarie@epamail.epa.gov
olsen.marian@epamail.epa.gov
hubbard.jennifer@epamail.epa.gov
adams.glenn @ epamail.epa.gov
podowski.andrew@epamail.epa.gov
khoury.ghaijsan@epamail.epa.gov
crawford.david@epamail.epa.gov
weis.chris@epamail.epa.gov
srnucker.stan@epamail.epa.gov
davoli.dana@epamail.epa.gov
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If you are interested in being on a mailing list for notification of revisions and updates to the
RAGS Part D guidance document, please complete the following information, and indicate
whether you want to be notified by surface mail or by e-mail. Alternatively, you can go to the
RAGS, Part D website at http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html.
The notifications will contain information on how to access the document revisions and updates.
I want to receive e-mail notification
Name
_I want to receive surface mail notification
Organization,
Address
City State Postal Code.
Country
E-mail Address
Please provide any comments you may have in the space below, or via the Internet at the RAGS
Part D website at http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html.
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(Fold this page in half and seal shut before mailing)
Senior Process Manager for Risk
RAGS Part D
U.S. Environmental Protection Agency (5202G)
401 M Street, SW
Washington, DC 20460
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xvEPA
United States
Environmental Protection
Agency
Solid Waste and
Emergency Response
EPA 540-R-97-033
OSWER 9285.7-01 D
PB97-963305
http://www.epa.gov
January 1998
Superfund
Risk Assessment Guidance
for Superfund:
Volume 1 -
Human Health Evaluation Manual
(Part D, Standardized Planning,
Reporting, and Review of
Superfund Risk Assessments)
Interim
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Publication 9285.7-01D
January 1998
Risk Assessment Guidance
for Superfund:
Volume!
Human Health Evaluation Manual
(Part D, Standardized Planning,
Reporting, and Review of Superfund
Risk Assessments)
Interim
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 staff. The guidance is designed to communicate National
policy on the planning, reporting and review of Superfund risk assessments. The document does not, however,
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. 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.
Revision No. 0 ii January 1998
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CONTENTS
Page
NOTICE ii
EXHIBITS ...' vi
DEFINITIONS vii
ACRONYMS/ABBREVIATIONS xii
ACKNOWLEDGMENTS xiv
PREFACE xv
1.0 INTRODUCTION ; l-l
1.1 OVERVIEW OF PART D 1-1
1.1.1 Background 1-1
1.1.2 Elements of Part D Approach 1-1
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 1-4
1.5 ADDITIONAL INFORMATION .. 1-7
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 SAP and QAPP 2-3
3.0 RISK ASSESSMENT DATA NEEDS AND TASKS DURING
THE REMEDIAL INVESTIGATION 3-1
3.1 INTERIM DELIVERABLES 3-1
Revision No. 0 iii January 1998
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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 3-10
3.1.3 Probabilistic Analysis Information 3-10
3.2 DRAFT BASELINE RISK ASSESSMENT REPORT 3-11
3.3 FINAL BASELINE RISK ASSESSMENT REPORT 3-11
3.4 DATA TRANSFER TO CERCLIS 3 3-11
4.0 MSK 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 4-4
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 .... 7 . 7. . .. .. .'.'7.... -".".. . 5-1
5.2 DOCUMENTATION OF RISKS IN THE RECORD
OF DECISION 5-1
5.3 RISK EVALUATION DURING REMEDIAL DESIGN AND
REMEDIAL ACTION 5-2
Revision No. 0 iv January 1998
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CONTENTS (Continued)
Page
5.4 RISK EVALUATION ASSOCIATED WITH
EXPLANATIONS OF SIGNIFICANT DIFFERENCES
(ESDs) AND AMENDED RODs 5-2
5.5 RISK EVALUATION DURING
FIVE-YEAR REVIEWS , 5-2
REFERENCES R-l
APPENDIX A STANDARD TABLES
APPENDIX B INSTRUCTIONS FOR COMPLETION OF THE STANDARD TABLES
APPENDIX C DATA USEABILITY WORKSHEET
ELECTRONIC MEDIA
Revision No. 0 v January 1998
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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 PROCESS IMPROVEMENTS EXPECTED WITH PART D APPROACH 1-6
1-4 ROLE OF RISK ASSESSOR IN THE CERCLA REMEDIAL PROCESS 1-8
3-1 INTERIM DELIVERABLES FOREACH SITE 3-12
3-2 STANDARDIZED RISK ASSESSMENT REPORTING 3-14
3-3 DATA USEABEJTY WORKSHEET 3-15
4-1 EXAMPLE TABLES TO STANDARDIZE REPORTING OF
FS RISK EVALUATIONS ,. 4-6
Revision No. 0 vi January 1998
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DEFINITIONS
Term
Definition
Applicable or Relevant and
. Appropriate Requirements (ARARs)
CERCLIS 3
Conceptual Site Model
Deterministic Analysis
EPA Risk Assessor
"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.
The newest version of the Comprehensive Environmental
Response, Compensation, and Liability Information System,
EPA's primary Superfund database. CERCLIS 3 enables
Superfund staff nationwide to share comprehensive and reliable
data across EPA and eventually with other federal partners and
the public.
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.
Revision No. 0
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January 1998
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DEFINITIONS (Continued)
Term
Definition
Exposure Medium
Exposure Pathway
Exposure Point
Exposure Point Concentration
Exposure Route
Interim Deliverables
Medium
Medium EPC
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
The course a chemical 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.
An exact location of potential contact between a person and a
chemical within an exposure medium.
The value that represents a conservative estimate of the
chemical concentration available from a particular medium or
route of exposure. See definitions for Medium EPC and Route
EPC, which follow.
The way a chemical 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) originally
contaminated.
The EPC, based on either a statistical derivation of measured
data or modeled data. The Medium EPC differs from the Route
EPC in that the Medium EPC does not consider the transfer of
contaminants from one medium to another.
Revision No. 0
Vlll
January 1998
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DEFINITIONS (Continued)
Term
Definition
Preliminary Remediation Goals
(PRGs)
Probabilistic Analysis
Risk Assessment Author
Receptor Age
Receptor Population
Route EPC
Scenario Timeframe
Initial clean-up 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).
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 is presented
as a frequenc)^ 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 EPC, based on either a statistical derivation of measured
data or based on modeled data, that was selected to represent the
route-specific concentration for the exposure calculations. The
Route EPC differs from the Medium EPC in that the Route EPC
may consider the transfer of contaminants from one medium to
another, where applicable for a particular exposure route.
The time period (current and/or future) being considered for the
exposure pathway.
Revision No. 0
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January 1998
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DEFINITIONS (Continued)
Term
Definition
Standard Tables
Standard Tools
Supporting Information
One of the Standard Tools under the RAGS 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 and on the
electronic media provided with this guidance document. Use of
the Standard Tables will standardize the reporting of human
health risk assessments. The Standard Table formats can not be
altered (i.e., columns can not be added, deleted, or changed);
however, rows and footnotes can be added as appropriate.
Standardization of the Tables is needed to achieve Superfund
program-wide reporting consistency and to accomplish
electronic data transfer to the Superfund database.
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.
Revision No. 0
January 1998
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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 CERCLA
remedial process. 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. The TARA should be customized
for each site and the requirements identified should be included
in project woirkplans so that risk assessment requirements and
approaches are clearly defined. Chapters 2 through 5 of Part D
present the TARA.
Formats for documenting assumptions, input parameters, and
conclusions regarding complex risk assessment issues. The
Data Useability Worksheet (found in Exhibit 3-3) should be an
Interim Deliverable for all sites. Worksheets addressing Lead
and Radionuclides are under development and will be provided
in a revision to RAGS Part D.
Revision No. 0
XI
January 1998
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ACRONYMS/ABBREVIATIONS
Acronym/
Abbreviation
Definition
ARARs
BRAC
CERCLA
CERCLIS 3
COPCs
CSF
CT
CWA
DQOs
EPA
EPC
ESD
FS
FY
GAO
HEAST
HI
HQ
IEUBK
mis
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
Version 3 of Comprehensive Environmental Response
Compensation and Liability Information System
(CERCLIS)
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 Priority 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
Revision No. 0
xu
January 1998
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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
UTL Upper Tolerance Limit
Revision No. 0 xiii January 1998
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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
approach presented in this manual.
CDM Federal Programs Corporation provided technical assistance to EPA in the development of this
manual, under contract No. 68-W9-0056.
RAGS PART D WORKGROUP
EPA HEADQUARTERS
Office of Emergency and Remedial Response:
James Konz
David Bennett
EPA REGIONAL OFFICES
Region 1:
Region 2:
Region 3:
Region 4:
Region 5:
Region 6:
Region 7:
Region 8:
Region 9:
Region 10:
Ann-Marie Burke
Marian Olsen
Jennifer Hubbard
Glenn Adams
Andrew Podowski
Ghassan Khoury
David Crawford
Chris Weis
Stan Smucker
Dana Davoli
Revision No. 0
xiv
January 1998
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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 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
preh'minary remediation goals; and Part C addresses the human health risk evaluations of remedial alternatives.
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, and C, and in supplemental Office of Solid Waste and Emergency
Response (OSWER) directives. The potential users of Part D are persons involved in the risk evaluation,
remedy selection, and implementation process, including risk assessors, risk assessment reviewers, remedial
project managers, and other decision-makers.
This guidance does not discuss the standardization of ecological risk assessments, nor does it discuss
the risk management decisions that are necessary at a CERCLA site (e.g., selection of final remediation goals).
This manual is being distributed as an interim document to allow for a period of field testing and
evaluation. In addition, EPA is developing standardized approaches to plan, report and review:
lead risks;
radionuclide risks;- and
probabilistic analyses.
These will be issued as future revisions of RAGS Part D. In addition, EPA will provide standard tables for
ecological evaluation.
RAGS/HHEM will be revised in the future, and new documents in appropriate print and electronic
format will be issued.
Comments addressing usefulness, changes, and additional areas where guidance is needed should be
addressed to the RAGS Part D website at http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html, or to:
Senior Process Manager for Risk
RAGS Part D
U.S. Environmental Protection Agency
Office of Emergency and Remedial Response (5202G)
401 M Street, SW
Washington, DC 20460
Revision No. 0 xv January 1998
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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-NPL, BRAC,
and Brownfields sites.
This guidance is the fourth part (Part D) in the
series Risk Assessment Guidance for Superfund:
Volume I -- Human Health Evaluation Manual
(RAGS/HHEM). Part A of this guidance describes
how to conduct a site-specific baseline risk
assessment: the information in Part A is necessary
background for Part D. Part B provides guidance
for calculating risk-based concentrations that may
be used, along with applicable or relevant and
appropriate requirements (ARARs) and other
information, to develop preliminary remediation
goals (PRGs) during project scoping. 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 D
complements the guidance provided in Parts A, B,
and C and presents approaches to standardize risk
assessment planning, reporting, and review. Part
D guidance spans the CERCLA remedial process
from project scoping to periodic review of the
implemented remedial action. 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;
discusses process improvements expected as a
result of Part D;
presents the organization of the remainder of
this document; and
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 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 1995 Superfund
Administrative Reform #6A directed EPA to:
Establish National Criteria to Plan, Report, and
Review Superfund Risk Assessments. EPA has
developed an approach to respond to these
challenges, which is presented in RAGS Part D.
1.1.2 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
Electronic Data Transfer to a National Superfund
Database. 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.
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EXHIBIT 1-1
RELATIONSHIP OF THE HUMAN HEALTH EVALUATION TO THE CERCLA PROCESS
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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 in 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 in 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.
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 and on electronic
media provided with this guidance
document. 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 row
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 used
to complete and/or review Standard
Tables for each site-specific human health
risk assessment. The Instructions may be
found in Appendix B and on electronic
media provided with this document.
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.
Electronic Data Transfer to a National
Superfund Database - Summary-level site-
specific risk information will be stored in a
National Superfund database (i.e., CERCLIS
3) to provide data access and data management
capabilities to all EPA staff. The CERCLIS
3 risk-related summary data represent a subset
of the data presented in the Standard Tables.
The electronic versions of the Standard Tables
(LOTUSฎ and EXCELฎ) are structured to be
compatible with CERCLIS 3. Translation
software is under development to transfer data
from the Standard Tables to CERCLIS 3, and
no additional data entry should be required in
the regions to fulfill the CERCLIS 3 risk data
requirements.
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1.2 APPLICABILITY OF PART D
APPROACH
The approach contained in RAGS Part D is
recommended for all risk assessments commencing
after the issuance of Part D. The use of Part D is
also encouraged in on-going risk assessments to
the extent it can efficiently be incorporated into the
risk assessment process. Part D is not applicable to
completed risk assessments.
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.
13 PROCESS IMPROVEMENTS
RESULTING FROM PART D
APPROACH
The RAGS Part D approach provides
numerous advantages over current practices in the
Superfund program at both the site level and the
overall Superfund program level. Several of these
advantages are discussed in Exhibit 1-3.
A brief discussion of the process
improvements associated with each RAGS Part D
element follows:
ป Use of Standard Tools - Standard Tools will
facilitate planning with TARA, reporting with
Standard Table formats, and reviewing with
Interim Deliverables. The Standard Tools will
provide consistent content and clarity of data,
parameters, and assumptions. Transparency
for the public and others to understand the risk
assessment will be improved by the Standard
Tables, and review will be facilitated because
the basis for conclusions will be clear.
Because Interim Deliverables are integral parts
of the baseline risk assessment, their early
review and resolution by EPA risk assessors
will minimize rework and may reduce project
schedules and budgets, while improving
consistency.
Continuous Involvement of EPA Risk
Assessor - Involvement of the EPA risk
assessor throughout the CERCLA remedial
process will result in holistic consideration of
risk issues during scoping and will ensure that
appropriate and adequate data are collected.
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 will provide direction regarding
reasonable assumptions and eliminate rework
requirements, particularly for those
deliverables that build on previous analyses
(e.g., the Baseline Risk Assessment Report).
At later stages of the project (e.g., after the
feasibility study), continuous involvement of
the EPA risk assessor will promote
reasonableness and consistency in risk
management decision-making by clearly
providing risk managers with the information
they need.
Electronic Data Transfer to National
Superfund Database - Through submission
of electronic Standard Tables, CERCLIS 3 risk
data reporting requirements will be met
electronically. Additional data entry should
not be required by EPA or contractor risk
assessors. Submission of the risk data to
CERCLIS 3 will also fulfill the review
objectives of Superfund Administrative
Reform #6A by providing risk data access to
EPA and the public. Use of the data by EPA
risk assessors will improve consistency in
future risk assessments.
1.4 ORGANIZATION OF
DOCUMENT
The remainder of this guidance is organized
into four additional chapters and three appendices
as follows:
Chapter 2: Risk Considerations During Project
Scoping;
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EXHIBIT 1- 2
GUIDELINES FOR PART D APPLICABILITY
SITE LEAD
Fund Lead
Federal Facility Lead
TRPLead
State Lead
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, Time-Critical, Streamlined
SACM
RCRA Corrective Action3
PART D APPLICABLE
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Notes:
1 The RAGS Part D Workgroup also suggests that RAGS Part D could be a useful tool for quantitative risk assessment for non-NPL, BRAC, and
Brownfields sites and encourages its use.
2 RAGS Part D use is encouraged as appropriate.
3 As described in the September 1996 EPA memorandum on Coordination Between 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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EXHIBIT 1-3
PROCESS IMPROVEMENTS EXPECTED
WITH PART D APPROACH
PROCESS IMPROVEMENTS
RAGS PART D APPROACH
CURRENT PRACTICES
SITE LEVEL
1Interim Deliverables
increase the likelihood that risk
assessments are reasonable,
transparent, and acceptable.
2-Continuous Involvement of
EPA risk assessors improves
consistency between project
phases, and provides real-time
review of risk assessment
deliverables.
3-Clarify of Standard Tables
presentation promotes easy use
in risk management decisions.
4Electronic data transfer
simplifies CERCLIS 3 data
entry.
Planning, submission, and EPA review
of Interim Deliverables will clarify
requirements and assumptions, promote
reasonableness, and minimize rework.
Continuous involvement of EPA risk
assessors beyond the Rl/risk
assessment will improve and document
consistency between the risk
assessment and subsequent phases (FS,
Proposed Plan, ROD, RD, RA, BSD,
and Five-Year Reviews).
Easy to follow (transparent and clear)
standardized risk assessments will
maximize understanding and minimize
misinterpretation by risk managers and
other non-risk assessors.
Data transfer from Standard Tables to
CERCLIS 3 will be electronic and QC
will require less time.
For some sites, only the end
product is now reviewed. This
often results in longer schedules
and higher costs due to rework
requirements.
Current EPA risk assessor
involvement is often limited after
the Rl/risk assessment and may
result in inconsistent approaches
in different project phases, a
highly criticized aspect of the
Superfund program.
The current use of non-
standardized risk assessments by
risk managers and other non-risk
assessors may lead to
misunderstanding and
misinterpretation of information.
Entry of risk data into CERCLIS
3 (through screens) will be time
consuming and will require
skilled risk assessors to enter and
QC data.
PROGRAM LEVEL
5--Easy risk information access
promotes Superfund program
consistency.
6-More efficient EPA risk
assessor review improves
Superfund program qualify.
7Transparency of risk
information facilitates
Superfund program-level risk
management evaluations.
Data presentation in Standard Table
format will provide efficient access to
assumptions and information from
other risk assessments, promoting
consistency.
EPA staff will be able to conduct better
reviews of risk assessment deliverables
with less time and effort, due to clear
standard presentation of Interim
Deliverables.
Data availability for program
management use will be simplified
because all assumptions and results will
be clearly documented.
Tedious research into
individualized text-based risk
assessments is currently required
to access site-specific
assumptions and other
information.
EPA staff currently selectively
review risk assessment
deliverables due to extensive
volume, complexity, and
variability of non-standard risk
assessments.
Program management requests
currently require extensive
research by regional staff, often
conflicting with other priorities.
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Chapter 3: Risk Assessment Data Needs and
Tasks During the Remedial Investigation;
Chapter 4 Risk Evaluations During the
Feasibility Study;
Chapter 5: Risk Evaluations After the
Feasibility Study;
Appendix A: Standard Tables
Appendix B: Instructions for Completion of
Standard Tables
Appendix C: Data Useability Worksheet.
In addition, other useful information has been
presented in highlight boxes placed throughout the
document.
Exhibit 1-4 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 loose-leaf format of
the document has been specifically designed to
conveniently accommodate revisions.
A RAGS Part D mailing list will be compiled
for all interested users. Please complete and mail
the card at the back of the Part D package to
register for the Part D mailing list for automatic
notification of availability of future updates.
In addition to the guidance document, the Part
D guidance and corresponding information may be
accessed electronically on the RAGS Part D
website, at http://www.epa.gov/superfund/oerr/
techres/ragsd/ragsd.html. Updates to Part D will
also appear on the website along with an index of
the current version of each Chapter or Appendix.
Questions or comments regarding Part D usage
should be directed to your EPA regional risk
assessor or to the EPA RAGS Part D Workgroup
through the RAGS Part D website. Questions or
comments received through the website will be
considered by the Workgroup and a response will
be developed and forwarded via telephone or 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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ง
CERCLA REMEDIAL PROCESS
CONTINUOUS INVOLVEMENT OF EPA RISK ASSESSOR
(RAGS D-Chapter 1)
oo
During Scoping
! Planning
i Workplans
(RAGS D - Chapter 2)
During Remedial Investigation
I Interim Deliverables
- Standard Tables
(Appendices A and B)
- Worksheets
- Supporting Information
- Confidence and Uncertainty
- Probabilistic Analysis
Draft Baseline Risk Assessment Report
Final Baseline Risk Assessment Report
Data Transfer to CERCLIS 3
(RAGS D-Chapter 3)
During Feasibility Study
Remedial Action Objectives
Remedial Action Goals
Risks/Hazards of PRGs
Risks of Remedial Technologies
and Alternatives
(RAGS D-Chapter 4)
After Feasibility Study
Proposed Plan
ROD
RD/RA
ESDs/Amended RODs
Five- Year Reviews
(RAGS D-Chapter 5)
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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 involvedin 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 remedial project
manager and EPA risk assessor, as decision-
makers, 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
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 biomagnification 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 species.
Involve the risk assessor in discussions with
the stakeholders concerning land use,
groundwater use, and exposure pathways and
variables. If possible, the risk assessor should
also visit the site.
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Identify deliverables (Interim, Draft, and
Final) for the risk assessment. Interim
Deliverables should include: Standard Tables
1 through 10; Worksheets on Data Useability,
Lead, and Radionuclides (as applicable);
Supporting Information as described in
Chapter 3.1.1, the Assessment of Confidence
and Uncertainty, and Probabilistic Analysis
information. 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 remedial
project manager and EPA risk assessor should
also meet to discuss the potential need for
including a Probabilistic Analysis in the RI.
Consider the following: extent of site
remediation, potential costs of remediation,
degree of uncertainty associated with the
exposure information available for each
portion of the site conceptual model, value
added in the decision-making process, etc.
This preliminary discussion is necessary to
determine whether funds should 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 (Rl/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.
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 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), 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 remedial
project manager should 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
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those exposure parameters with the greatest
uncertainty where collection of additional data
and/or information may be warranted.
2.1.2 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.
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
type 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 in 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.
Analysis. Development of the DQOs for
analysis 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.
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 limit or
quantitation 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 (i.e., the National Functional Guidelines).
Also refer to your regional office for guidance on
data validation and/or chemical-specific guidance,
as applicable.
WHEN DEVELOPING THE SAP, CONSIDER
THE FOLLOWING:
How will data from multiple groundwater wells
collected over time 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 site
contamination from background contamination
for each medium and for organic and inorganic
parameters?
The Workplan should also discuss how split
samples, duplicates, blanks (trip, field, and
laboratory), and qualified and rejected data will be
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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.
Revision No. 0 2-4 January 1998
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CHAPTERS
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 regional risk assessor
regarding the most appropriate guidance.
Interim Deliverables should be prepared as
described in Chapter 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.
Transfer of risk assessment data to the CERCLIS
3 database is also addressed.
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 Chapter 2.2.1 should also describe the
Standard Tables, Worksheets, and Supporting
Information for a particular site. Exhibit 3-1
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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 ten Standard Table
formats for use in all future risk assessments. The
Standard Table formats can not be altered (i.e.,
columns can not be added, deleted, or changed);
however, rows and footnotes can be added as
appropriate. Standardization of the Tables is
needed to achieve Superfund program-wide
reporting consistency and to accomplish electronic
data transfer to the Superfund database. 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 on the electronic media
enclosed with 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.
In addition to the Standard Tables, a Data
Useability Worksheet is provided in Exhibit 3-3 in
this chapter, as well as in Appendix C and on the
electronic media Worksheets to document Lead
and Radionuclide risk calculations are under
development and will be provided in a future
update to Part D. 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.
Descriptions of the Standard Tables,
Worksheets, and Supporting Information follow:
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.
The information documented in Standard
Table 1 includes:
Exposure Pathways that were examined and
excluded from analysis
Exposure Pathways that will be evaluated
qualitatively or quantitatively in the risk
assessment.
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The data elements presented in Standard
Table 1 are listed in the Standard Table 1 highlight
box.
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 ELEMENTS IN
STANDARD TABLE 1
Provide the following information: Scenario
Timeframe, Medium, Exposure Medium, Exposure
Point, Receptor Population, Receptor Age,
Exposure Route, On-site/Off-site, Type of Analysis,
Rationale for Selection or Exclusion of Exposure
Pathway.
DATA USEABBLITY 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 in Risk Assessment
(Pan A, EPA 1990a), should be consulted before
completing the Data Useability Worksheet. This
Worksheet should be prepared as soon as all data
validation reports have been completed for each
medium. A media-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.
Complete the Data Useability Worksheet
for each Medium prior to screening of
chemicals of potential concern (COPCs).
The Data Useability Worksheet should later
be incorporated in the Baseline Risk
Assessment Report.
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 detected
To provide adequate information so the
user/reviewer gets a sense of the chemicals
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
detected in each Medium
The detection limits of chemicals analyzed
The toxicity screening values for COPC
selection
The chemicals selected and deleted as COPCs.
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, Exposure Medium, and
Exposure Point, provide the following information:
CAS Number, Chemical, Minimum Concentration,
Minimum Qualifier, Maximum Concentration,
Maximum Qualifier, Units, Location of Maximum
Concentration, Detection Frequency, Range of
Detection Limits, Concentration Used for
Screening, Background Value, Screening Toxicity
Value, Potential ARAR/TBC Value, Potential
ARAR/TBC Source, COPC Flag, Rationale for
Contaminant Deletion or Selection.
1. Discuss selection criteria for COPCs;
including toxicity screening values, frequency
of detection, and background comparison.
2. Perform screening; select COPCs that will be
carried into the risk assessment (include
comparison to regulatory standards and criteria
where appropriate).
3. Use background information to determine
COPCs, as appropriate.
4. 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, upper tolerance limit (UTL) derivation,
and other information that may be required to
fully describe the background selection
process.
5. The Background Supporting Information
should later be incorporated in the Baseline
Risk Assessment Report.
6, Complete Standard Table 2 for each
combination of Scenario Timeframe, Medium,
Exposure Medium, and Exposure Point.
7. Standard Table 2 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 3: Medium-Specific
Exposure Point Concentration (EPC)
Summary. The purposes of Standard Table 3
are:
To provide the reasonable maximum and
central tendency medium-specific 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 Medium EPCs for chemicals
detected in each medium
The RME Medium EPC and the CT Medium
EPC selected
The statistics which were used to make the
determinations as well as; the rationale for the
selection of the statistics for each chemical
(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, Exposure Medium, and
Exposure Point, provide the following information:
Chemical of Potential Concern, Units, Arithmetic
Mean, 95% upper confidence level (UCL) of
Normal Data, Maximum Detected Concentration,
Maximum Qualifier, EPC Units, Reasonable
Maximum Exposure (Medium EPC Value, Medium
EPC Statistic, and Medium EPC Rationale), and
Central Tendency (Medium EPC Value, Medium
EPC Statistic, and Medium EPC Rationale).
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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).
2. Discuss approach to determine how data are
normally or log-normally distributed.
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
media-specific 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 route-specific EPCs,
including derivation of modeled values,
assumptions and values used, statistical
derivation of measured values and associated
calculations, and other protocols as required.
These route-specific EPCs should be presented
in Standard Table 7.
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.
7. Standard Table 3 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLE 4:
Daily Intake Calculations.
Standard Table 4 are:
Values Used for
The purposes of
To provide the exposure parameters used for
RME and CT 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, Exposure Medium, Exposure
Point, Receptor Population, and Receptor Age,
provide the following information: Exposure Route,
Parameter Code, Parameter Definition, Units, RME
Value, RME Rationale/Reference, CT Value, CT
Rationale/Reference, and Intake Equation/Model
Name.
Perform the following steps associated with the
preparation of Standard Table 4.
1. 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.
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3.
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.
The Modeled Intake Supporting
Information should later be incorporated in
the Baseline Risk Assessment Report.
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^., K^, 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,
Exposure Medium, Exposure Point, Receptor
Population, and Receptor Age.
7. Standard Table 4 should later be
incorporated into the Baseline Risk
Assessment Report.
STANDARD TABLES 5 AND 6: Non-
Cancer and Cancer Toxicity Data. The purposes
of Standard Tables 5.1,5.2, and 5.3 are:
* To provide information on reference doses
(RfDs) target organs, and adjustment factors
for chemicals
To provide oral to dermal adjustment factors
To verify references for non-cancer toxicity
data
To provide non-cancer toxicity information for
"special-case" chemicals.
The information documented in Standard
Tables 5.1,5.2, and 5.3 includes:
The RfDs for each of the COPCs, as well as
modifying factors and reference concentration
(RfC) to RfD adjustments
The organ effects of each of the COPCs
References for RfCs and organ effects.
The data elements presiented in Standard
Tables 5.1,5.2, and 5.3 are listed in the Standard
Tables 5.1, 5.2, and 5.3 highlight box.
DATA ELEMENTS IN
STANDARD TABLE 5.1
Provide the following information: Chemical of
Potential Concern, Chronic/Subchronic, Oral
RfD Value, Oral RfD Unite, Oral to Dermal
Adjustment Factor, Adjusted Dermal RfD, Units,
Primary Target Organ, Combined
Uncertainty/Modifying Factors, Sources of
RfD:Target Organ, and Dates of RfD:Target Organ.
DATA ELEMENTS IN-
STANDARD TABLE 5.2
Provide the following information: Chemical of
Potential Concern, Chronic/Subchronic, Value
Inhalation RfC, Units, Adjusted Inhalation RfD,
Units, Primary Target Organ, Combined
Uncertainty/Modifying Factors, Sources of
RfC:RfD:Target Organ, and Dates.
DATA ELEMENTS IN
STANDARD TABLE 5.3
Provide the following information: Chemical of
Potential Concern, Chronic/Subchronic, Value,
Units, Primary Target Organ, Combined
Uncertainty/Modifying Factors, Sources of
Toxicity:Primary Target Organ, and Date.
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The purposes of Standard Tables 6.1, 6.2,
and 6.3 are:
To provide the oral, dermal, and inhalation
cancer toxicity information (values and
sources of information) for chemicals 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 of
potential concern
To provide cancer toxicity information for
"special case" chemicals.
The information documented in Standard
Tables 6.1,6.2, and 6.3 includes:
Oral, dermal, and inhalation toxicity values for
chemicals 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, and 6.3 are listed in the Standard
Tables 6.1, 6.2, and 6.3 highlight box.
Perform the following steps associated with the
preparation of Standard Tables 5 and 6.
1. 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.
2. 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
DATA ELEMENTS IN
STANDARD TABLE 6.1
Provide the following information: Chemical of
Potential Concern, Oral Cancer Slope Factor, Oral
to Dermal Adjustment Factor, Adjusted Dermal
Cancer Slope Factor, Units, Weight of
Evidence/Cancer Guideline Description, Source,
and Date.
DATA ELEMENTS IN
STANDARD TABLE 6.2
Provide the following information: Chemical of
Potential Concern, Unit Risk, Units, Adjustment,
Inhalation Cancer Slope Factor, Units, Weight of
Evidence/Cancer Guideline Description, Source,
and Date.
DATA ELEMENTS IN
STANDARD TABLE 6.3
Provide the following information: Chemical of
Potential Concern, Value, Units, Source, and Dates.
3.
4.
5.
EPA. Examples 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.
The Special Case Chemicals Supporting
Information should later be incorporated in
the Baseline Risk Assessment Report.
Refer to the end of Chapter 3.1.1
instructions for lead and radionuclides.
for
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
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6.
Standard Table 6.1: Cancer Toxicity
Data - Oral/Dermal
Standard Table 6.2: Cancer Toxicity
Data - Inhalation
Standard Table 63: Cancer Toxicity
Data - Special Case Chemicals.
Standard Tables 5 and 6 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLES 7 AND 8:
Calculation of Non-Cancer Hazards and
Cancer Risks. The purposes of Standard Tables
7 and 8 are:
To provide a summary of the variables used to
calculate non-cancer hazards and cancer risks
* To show the EPC (medium-specific or route-
specific) 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, Exposure Medium, and
Receptor presented in this table.
The information documented in Standard
Tables 7 and 8 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 factor for
each COPC for each Exposure Route.
The data elements presented in Standard
Tables 7 and 8 are listed in the Standard Tables 7
and 8 highlight boxes.
Perform the following steps associated with the
preparation of Standard Tables 7 and 8.
1. Address non-cancer hazards and cancer risks
including the calculations and supporting
information by Exposure Route.
DATA ELEMENTS IN
STANDARD TABLE 7
For each unique combination of Scenario
Timeframe, Medium, Exposure Medium, Exposure
Point, Receptor Population, and Receptor Age,
provide the following information: Exposure Route,
Chemical of Potential Concern, Medium EPC
Value, Medium EPC Units, Route EPC Value,
Route EPC Units, EPC Selected for Hazard
Calculation, Intake (Non-Cancer), Intake (Non-
Cancer) Units, Reference Dose, Reference Dose
Units, Reference Concentration, Reference
Concentration Units, and Hazard Quotient.
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 7.EI.RME: Calculation
of Non-Cancer Hazards (RME)
Standard Table 7.H.CT: Calculation of
Non-Cancer Hazards (CT)
Standard Table S.n.RME: Calculation of
Cancer Risks (RME)
Standard Table 8.H.CT: Calculation of
Cancer Risks (CT)
DATA ELEMENTS IN
STANDARD TABLE 8
For each unique combination of Scenario
Timeframe, Medium, Exposure Medium, Exposure
Point, Receptor Population, and Receptor Age,
provide the following information: Exposure Route,
Chemical of Potential Concern, Medium EPC
Value, Medium EPC Units, Route EPC Value,
Route EPC Units, EPC Selected for Risk
Calculation, Intake (Cancer), Intake (Cancer) Units,
Cancer Slope Factor, Cancer Slope Factor Units,
and Cancer Risk.
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4. 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.
5. The Special Chemical Risk and Hazard
Calculations Supporting Information
should later be incorporated in the Baseline
Risk Assessment Report.
6. Complete Standard Tables 7 and 8 for each
combination of Scenario Timeframe, Medium,
Exposure Medium, Exposure Point, Receptor
Population, and Receptor Age.
7. Standard Tables 7 and 8 should later be
incorporated in the Baseline Risk Assessment
Report.
STANDARD TABLES 9 AND 10: Risks
aid Hazards. The purpose of Standard Table 9
To provide a summary for each Receptor, by
Medium, Exposure Route, and Exposure
Point, of cancer risks and non-cancer hazards.
The purpose of Standard Table 10 is:
To provide a summary for each Receptor, by
Medium, Exposure Route, and Exposure
Point, of cancer risks and non-cancer hazards
that may trigger the need for remedial action.
The information documented in Standard
Tables 9 and 10 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 Pathway
The total cancer risk and non-cancer hazard
for each Medium across all Exposure Routes
The primary target organs for non-
carcinogenic hazard effects.
. The data elements presented in Standard
Tables 9 and 10 are listed in the Standard Tables
9 and 10 highlight boxes.
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,
Carcinogenic Risk (Ingestion, Inhalation, Dermal,
and Exposure Routes Total), Chemical, and Non-
Carcinogenic Hazard Quotient (Primary Target
Organ, Ingestion, Inhalation, Dermal, and Exposure
Routes Total).
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 (Ingestion, Inhalation, Dermal,
and Exposure Routes Total), Chemical, and Non-
Carcinogenic Hazard Quotient (Primary Target
Organ, Ingestion, Inhalation, Dermal, and Exposure
Routes Total).
Perform the following steps associated with the
preparation of Standard Tables 9 and 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.
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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)
Standard Table 10.n.RME: Risk
Assessment Summary (RME)
Standard Table 10.n.CT: Risk
Assessment Summary (CT)
4. Complete Standard Tables 9 and 10 for
each combination of Scenario Timeframe,
Receptor Population, and Receptor Age.
5. Standard Tables 9 and 10 should later be
incorporated in the Baseline Risk Assessment
Report.
LEAD AND RADIONUCLBDES WORK-
SHEETS. Perform the following steps associated
with the preparation of Lead and Radionuclides
Worksheets:
1. For lead, complete the Lead Worksheets for
Screening Analysis, Child, and Adult (to be
developed). Also attach the appropriate
graphs and results from the Integrated
Exposure Uptake Biokinetic Model (IEUBK)
model to the Child Worksheet.
2. For radionuclides, complete the
Radionuclide Worksheet (to be developed).
3. The Lead and Radionuclide Worksheets
should later be incorporated in the Baseline
Risk Assessment Report.
3.12 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.
Summarize the Assessment of Confidence
and Uncertainty. 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 Tables
7 and 8), 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. If Probabilistic
Analysis is performed, the information which
follows should be addressed:
The results from the initial evaluations
(deterministic and sensitivity analyses) should
be evaluated along with any additional
exposure information to determine whether a
Probabilistic Analysis is feasible.
For those parameters determined in the initial
evaluations to have the most uncertainty
(described in Chapter 3.1.2) proceed to the
Probabilistic Analysis. For this analysis,
provide the exposure parameter distributions,
their source and rationale for selection, and
indicate which parameters are correlated.
Indicate pertinent information such as the
model to be used for the analysis, type of
software, exposure equations, number of
iterations, etc. The results of the Probabilistic
Analysis should be presented as either a
chapter in the Baseline Risk Assessment
Report or as an appendix in accordance with
regional preferences.
As part of the Risk Characterization portion of
the Baseline Risk Assessment Report, present
a summary of the Probabilistic Analysis results
including graphic displays, the CT and RME
values, and a qualitative discussion of the
results of the analysis and the
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representativeness of distribution data for the
population of concern.
The uncertainty associated with the CT and
RME values, population risks, if appropriate,
and the uncertainty associated with the
Probabilistic Analysis should be summarized
in the Risk Characterization section of the
Baseline Risk Assessment Report.
Summarize the Probabilistic 'Analysis (if
performed).
The Probabilistic Analysis summary should
will 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 1 through 10
Worksheets on Data Useability, Lead and
Radionuclides, as applicable
Supporting Information
The Assessment of Confidence and
Uncertainty
Probabilistic Analysis information.
However, the report should not consist exclusively
of the Interim Deliverables, since 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,
Toxicological Profiles for COPCs, and other
information indicated by risk assessment guidance
should be incorporated.
Risk assessments submitted to the Agency or
performed by the Agency should incorporate any
current Agency guidance applicable on Risk
Characterization.
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.
3.4 DATA TRANSFER TO
CERCLIS 3
Upon the completion of the Final Baseline
Risk Assessment Report, use the LOTUSฎ or
EXCELฎ version of the Standard Tables to
transfer summary level risk data to the
CERCLIS 3 database.
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EXHIBIT 3-1
INTERIM DELIVERABLES FOR EACH SITE
Interim Deliverable
Scope of Deliverable
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 UseabUity 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 in Standard Table
2.
One Standard Table for each unique combination of
Scenario Timeframe, Medium, Exposure Medium, and
Exposure Point.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 3
Supporting Information on EPCs
Standard Table 3 - Medium-Specific 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, Exposure Medium, and
Exposure Point.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLE 4
Supporting Information on Modeled Intake
Methodology and Parameters
Supporting Information on Chemical-Specific
Parameters
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.
One Standard Table for each uniqine combination of
Scenario Timeframe, Medium, Exposure Medium,
Exposure Point, Receptor Population and Receptor
Age.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 5 AND 6
Supporting Information on Toxicity Data for
Special Case Chemicals
Standard Table 5 - Non-Cancer Toxicity Data
Standard Table 6 - 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.
Three Standard Tables - 6.1 for Oral/Dermal, 6.2 for
Inhalation, and 6.3 for Special Case Chemicals.
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EXHIBIT 3-1
INTERIM DELIVERABLES FOR EACH SITE (continued)
Interim Deliverable
Scope of Deliverable
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 7 AND 8
Supporting Information on Special Chemical Risk
and Hazard Calculations
Standard Table 7 - Calculation of Non-Cancer
Hazards
Standard Table 8 - Calculation of Cancer Risks
Information for each Special Case Chemical.
One Standard Table for each unique combination of
Scenario Timeframe, Medium, Exposure Medium,
Exposure Point, Receptor Population, and Receptor
Age, for RME and for CT.
INTERIM DELIVERABLES ASSOCIATED WITH STANDARD TABLES 9 AND 10
Standard Table 9 - Summary of Receptor Risks and
Hazards for COPCs
Standard Table 10 - Risk Assessment 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 AND RADIONUCLEDES
Lead Worksheets (if applicable)
TO BE DEVELOPED
Radionuclide Worksheets (if applicable)
TO BE DEVELOPED
Separate Worksheets for Screening Analysis, and Child
and Adult Exposures for each Medium.
One Worksheet for each Medium.
INTERIM DELIVERABLES ASSOCIATED \VTTH UNCERTAINTY ASSESSMENT
Assessment of Confidence and Uncertainty
One Assessment for each Risk Assessment.
INTERIM DELIVERABLES ASSOCIATED WITH PROBABILISTIC ANALYSIS
Summary of Probabilistic Analysis
One Summary for each Risk Assessment.
Notes:
1. Each Interim Deliverable will 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.
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EXHIBIT 3-2
STANDARDIZED RISK ASSESSMENT REPORTING
Risk Assessment Activity
Corresponding Standard Table/Worksheet
Data Collection
Develop a conceptual site model
Gather and report appropriate data
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 Concern
Standard Table 2 - Occurrence, Distribution, and
Selection of Chemicals of 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
Standard Table 3 - Medium-Specific Exposure Point
Concentration Summary
Standard Table 7 - Calculation of Non-Cancer Hazards
Standard Table 8 - Calculation of 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
Risk Characterization
Quantify cancer and non-cancer risk by pathway
Combine risks by media for different receptors
Summarize risk drivers for different receptors
Standard Table 7 - Calculation of Non-Cancer Hazards
Standard Table 8 - Calculation of Cancer Risks
Standard Table 9 - Summary of Receptor Risks and
Hazards for COPCs
Standard Table 10 - Risk Assessment Summary
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EXHIBIT 3-3
DATA USEABILITY WORKSHEET
Site:
Medium:
Activity
Comment
Field Sampling
Discuss sampling problems and field conditions that
affect data useability.
Are samples representative of receptor exposure for
this medium (e.g. sample depth, grab vs composite,
filtered vs unfiltered, low flow, etc.)?
Assess the effect of field QC results on data useability.
Summarize the effect of field sampling issues on the
risk assessment, if applicable.
Analytical Techniques
Were the analytical methods appropriate for
quantitative risk assessment?
Were detection limits adequate?
Summarize the effect of analytical technique issues on
the risk assessment, if applicable.
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EXHIBIT 3-3
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Activity
Comment
Data Quality Objectives
Precision - How were duplicates handled?
Accuracy - How were split samples handled?
Representativeness - Indicate any problems associated
with data representativeness (e.g., trip blank or rinsate
blank contamination, chain of custody problems, etc.).
Completeness - Indicate any problems associated with
data completeness (e.g., incorrect sample analysis,
incomplete sample records, problems with field
procedures, etc.).
Comparability - Indicate any problems associated with
data comparability.
Were the DQOs specified in the QAPP satisfied?
Summarize the effect of DQO issues on the risk
assessment, if applicable.
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EXHIBIT 3-3
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Activity
Comment
Data Validation and Interpretation
What are the data validation requirements?
What method or guidance was used to validate the
data?
Was the data validation method consistent with
guidance? Discuss any discrepancies.
Were all data qualifiers defined? Discuss those which
were not.
Which qualifiers represent useable data?
Which qualifiers represent unuseable data?
How are tentatively identified compounds handled?
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EXHIBIT 3-3
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Activity
Summarize the effect of data validation and
interpretation issues on the risk assessment, if
applicable.
Additional notes:
Comment
Note: The purpose of this Worksheet is to succinctly summarize the data useability analysis and conclusions. Reference
specific pages in the Risk Assessment text to further expand on the information presented here.
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CHAPTER 4
RISK EVALUATIONS
DURING THE FEASIBILITY STUDY
4.1 INTRODUCTION
The following are FS activities, which during
development, should involve EPA risk assessor
input. 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, and 2) supporting
comparison of risks associated with various
remedial alternatives. For these reasons, EPA risk
assessor involvement in FS preparation and review
is strongly encouraged.
The purpose of the FS is to evaluate waste
management remedial alternatives. The National
Oil and Hazardous Substance Pollution
Contingency Plan (NCP) (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 remedy implementation include
people who li ve and work 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.
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.
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SELECTION OF REMEDIATION GOALS
The NCP [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 part 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 for all chemicals 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 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 [EPA
1990c, Section 300.430(e)(2)(I)(D)]. A concen-
tration equivalent to a lifetime cancer risk of IxlO"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 IxlO"4 to IxKX6. EPA has further clar-
ified the extent of the acceptable risk range by
stating that the upper boundary is not a discrete
line at 1x10"4. 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
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risks. [See Role of the Baseline Risk Assessment in
Superfund Remedy Selection Decisions (EPA
1991d)]
For non-cancer effects, the NCP states that an
acceptable exposure level must be defined (using
reliable toxicity information such as EPA's RfD).
According to EPA guidance, (RAGS Part A, 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 (EPA 1991d].
Therefore, in calculating remediation goals at a site
to protect for non-cancer effects, remediation goals
are generally set a at a Hazard Index at or below 1.
4.1.3 PRELIMINARY REMEDIATION
GOALS
As discussed in the NCP, final remediation
goals are not determined until a final remedy for
the site is selected in the ROD. However, 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.
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). Such balancing
among alternatives and consideration 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 (EPA 1988). RAGS PartB (EPA
199la) also presents guidance for the role of risk
assessment in the FS. The EPA RPM should
follow appropriate National and regional 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 exceeding the risk range
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 in 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
Identify ARAR-based PRGs and associated
risks/hazards.
If ARAR-based PRGs are not protective,
calculate risk-based PRGs using EPA
methods.
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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.
4.32 SELECT PRELIMINARY
REMEDIATION GOALS
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
PRO should be ARAR-based unless there is
no ARAR available or the ARAR is not
protective.
ป Provide the rationale for the selected PRO.
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.
Identify the chemical 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.
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
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qualitative, based on simplifying assumptions and
professional judgement 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. 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
judgement 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.
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).
The detailed analysis of long-term risks
includes the following components for each
alternative.
Evaluate residual risk.
Evaluate protectiveness over time.
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EXHIBIT 4-1
EXAMPLE TABLES TO STANDARDIZE
REPORTING OF FS RISK EVALUATIONS
Example Table 1
REMEDIAL ACTION OBJECTIVES
Medium:
Exposure Point
Chemicals of Concern
Exposure Route
Receptor Population
Remedial Action
Objectives
Example Table 2
VALUES CONSIDERED AS PRGs
Medium:
Receptor Population:
Chemical
of Concern
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)
Example Table 3
RISKS AND HAZARDS ASSOCIATED WITH PRGs
Medium:
Receptor Population:
Chemical of Concern
Maximum
Concentration
PRO
Basis for
PRG*
Totals
Risk at PRG:
Cancer
Hazard at PRG: Non-
Cancer
*TBC (Federal ARARs, State ARARs). Risk-based.
Background Concentrations, method detection limits
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CHAPTERS
RISK EVALUATIONS
AFTER THE FEASIBILITY STUDY
EPA risk assessor involvement in risk
evaluations, after completion of the FS, 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 DOCUMENTATION OF RISKS
IN THE RECORD OF
DECISION
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 Assessment
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.
The Risk Assessment Summary prepared for
the ROD should include, at a minimum, a
summary table completed for those exposure
scenarios and chemicals that trigger the need for
cleanup. Other risk information may also be
included in the ROD depending upon the level of
detail preferred. Information related to values used
for intake calculations and non-cancer and cancer
toxicity 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.
m 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 Interim Final Guidance on Preparing
Superfund Decision Documents (EPA 1989b) for
a recommended format for summarizing human
health risk assessment information in the ROD.
Also refer to the upcoming Guidance on Preparing
Superfund Decision Documents, which will be
available by the end of fiscal year 1998.
Revision No. 0
5-1
January 1998
-------
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 remediation 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 site change
following the signing of a ROD, it is sometimes
necessary to prepare an BSD 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 clean-up standards are still
protective when considering new ARARs, new
parameters for risk and hazsird 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
two goals:
Confirm that the remedy remains protective
(including any engineering or institutional
controls).
Evaluate whether clean-up standards are still
protective by considering new ARARs, new
parameters for risk and hazard calculations,
and other new information.
Revision No. 0
5-2
January 1998
-------
REFERENCES*
U.S. EPA. 1986. "Risk Assessment Guidelines for Mutagenicity Risk Assessment." 51 Federal Register,
Page 34006, September 24, 1986.
U.S. EPA. 1988. Guidance for Conducting Remedial Investigations and Feasibility Studies Under
CERCLA, Interim Final. Office of Solid Waste and Emergency Response, Washington, DC. EPA/540/G-
89/004. OSWER Directive 9355.3-01.
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 Superfand Decision Documents. Office of
Emergency and Remedial Response, Washington, DC. OSWER Directive 9355.3-02.
U.S. EPA. 1989c. Risk Assessment Guidance for Superfimd (RAGS): Volume I - Human Health
Evaluation Manual (HHEM) (Part A, Baseline Risk Assessment). Interim Final. Office of Emergency and
Remedial Response, Washington, DC. EPA/540/1-89/002. NTISPB90-155581.
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 Substance Pollution Contingency Plan." 40 CFR 300:
55 Federal Register, Page 8666, Thursday, March 8.
U.S. EPA. 1991a. Risk Assessment Guidance for Superfimd (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/540/R-92/004. OSWER Directive 9285.7-
01C. NTIS PB92-963334.
U.S. EPA. 1991c. Risk Assessment Guidance for Superfund (RAGS): 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. 1991d. 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. 0 R-l January 1998
-------
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 Risk
Assessment Guidance. OSWER Directive 9285.7-10.
i I
U.S. EPA. 1992d. Final Guidance on Data Useability in 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 of Polycydic 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. 19955. 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 5407R-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. 1997a. EPA Guidance for Data Assessment. Office of Research and Development,
Washington, DC. EPA/600/R-96/084.
U.S. EPA. 1997b. Exposure Factors Handbook, Volume 1. Office of Research and Development,
Washington, DC. EPA/600/P-95/002Fa.
Revision No. 0 R-2 January 1998
-------
REFERENCES* (Continued)
U.S. EPA. 1997c. 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.
* This Reference Section is designed to not only give bibliographic information for documents referred to in 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. 0 R-3 January 1998
-------
-------
APPENDIX A
STANDARD TABLES
-Blank Standard Tables
-Example Standard Tables
Revision No. 0 January 1998
-------
-------
Blank Standard Tables
The Standard Table formats can not be altered (i.e.,
columns can not be added, deleted, or changed); however,
rows and footnotes can be added as appropriate.
Revision No. 0 January 1998
-------
-------
/mm
TAl
SELECTION OF EXPOSURE PATHWAYS
SITE NAME
Scenario
Timeframe
Medium
Exposure
Medium
Exposure
Point
Receptor
Population
Receptor
Age
Exposure
Route
On-Site/
Off-Site
Type of
Analysis
Rationale for Selection or Exclusion
of Exposure Pathway
01/28/98
-------
TASIE21
CAS
Numbtr
Sce
-------
TABLE 3.1
MEDIUM-SPECIFIC EXPOSURE POINT CONCENTRATION SUMMARY
SITE NAME
Scenario Timeframe:
Medium:
Exposure Medium:
Exposure Point:
Chemical
of
Potential
Concern
Units
Arithmetic
Mean
95% UCL of
Normal
Data
Maximum
Detected
Concentration
Maximum
Qualifier
EPC
Units
Reasonable Maximum Exposure
Medium
EPC
Value
Medium
EPC
Statistic
Medium
EPC
Rationale
Central Tendency
Medium
EPC
Value
Medium
EPC
Statistic
Medium
EPC
Rationale
Statistics: Maximum Detected Value (Max); 95% UCL of Normal Data (95% UCL-N); 95% UCL of Log-transformed Data (95% UCL-T); Mean of Log-transformed Data (Mean-T);
Mean of Normal Data (Mean-N).
01/28/98
-------
TABLE 4.1
VALUES USED FOR DAILY INTAKE CALCULATIONS
SITE NAME
Exposure Route
Scenario Tlmeframe:
Medium:
Exposure Medium:
Exposure Point:
Receptor Population:
Receptor Age:
Parameter
Code
Parameter Definition
Units
RME
Value
RME
Rationale/
Reference
CT
Value
CT
Rationale/
Reference
Intake Equation/
Model Name
01/28/98
-------
TABLE 5.1
NON-CANCER TOXICITY DATA -- ORAL/DERMAL
SITE NAME
Chemical
of Potential
Concern
Chronic/
Subchronic
OralRfD
Value
Oral RfD
Units
Oral to Dermal
Adjustment Factor (1)
Adjusted
Dermal
RfD (2)
Units
Primary
Target
Organ
Combined
Uncertainty/Modifying
Factors
Sources of RfD:
Target Organ
Dates of RfD: (3)
Target Organ
(MM/DD/YY)
N/A = Not Applicable
(1) Refer to RAGS, Part A
(2) Provide equation used for derivation.
(3) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
01/28/98
-------
TABLE 5,2
NON-CANCER TOXIC1TY DATA - INHALATION
SITE NAME
Chemical
of Potential
Concern
Chronic/
Subchronlc
Value
Inhalation
RfC
Units
Adjusted
Inhalation
RID (1)
Units
Primary
Target
Organ
Combined
Uncertainty/Modifying
Factors
Sources of
RfC:RfD:
Target Organ
Dates (2)
(MM/DD/YY)
N/A = Not Applicable
(1) Provide equation used for derivation in text.
(2) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
1/28/98
-------
TABLE 5.3
NON-CANCER TOXICITY DATA ~ SPECIAL CASE CHEMICALS
SITE NAME
Chemical
of Potential
Concern
Chronic/
Subchronic
Value
Units
Primary
Target
Organ
Combined
Uncertainty/Modifying
Factors
Sources of Toxicity:
Primary Target
Organ
Date
(MM/DD/YY)
01/28/98
-------
TABLE 6,1
CANCER TOXICITY DATA - ORAL/DERMAL
SITE NAME
Chemical
of Potential
Concern
Oral Cancer Slope Factor
Oral to Dermal
Adjustment
Factor
Adjusted Dermal
Cancer Slope Factor (1)
Units
Weight of Evidence/
Cancer Guideline
Description
Source
Date (2)
(fvMDD/YY)
IRIS = Integrated Risk Information System
HEAST= Health Effects Assessment Summary Tables
(1) Provide equation for derivation in text.
(2) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of article provided by NCEA.
EPA Group:
A - Human carcinogen
B1 - Probable human carcinogen indicates that limited human data are available
B2 - Probable human carcinogen - indicates sufficient evidence In animals and
inadequate or no evidence in humans
C - Possible human carcinogen
D - Not classifiable as a human carcinogen
E - Evidence of noncarcinogenicity
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
1/28/98
-------
TABLE 6.2
CANCER TOXICITY DATA -- INHALATION
SITE NAME
Chemical
of Potential
Concern
Unit Risk
Units
Adjustment
Inhalation Cancer
Slope Factor
Units
Weight of Evidence/
Cancer Guideline
Description
Source
Date (1)
(MM/DD/YY)
IRIS = Integrated Risk Information System
HEAST= Health Effects Assessment Summary Tables
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
, (1) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
EPA Group:
A - Human carcinogen
B1 - Probable human carcinogen - Indicates that limited human data are available
B2 - Probable human carcinogen indicates sufficient evidence in animals and
inadequate or no evidence in humans
C - Possible human carcinogen
D - Not classifiable as a human carcinogen
E - Evidence of noncarcinogenicity
01/28/98
-------
TABLE 6.3
CANCER TOXICITY DATA - SPECIAL CASE CHEMICALS
SITE NAME
Chemical
of Potential
Concern
Value
Units
Source
Date (1)
MM/DD/YY
(1) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
1/28/98
-------
TABLE 7.1. RME
CALCULATION OF NON-CANCER HAZARDS
REASONABLE MAXIMUM EXPOSURE
SITE NAME
Scenario Timeframe:
Medium:
Exposure Medium:
Exposure Point:
Receptor Population:
Receptor Age:
Exposure
Route
Chemical
of Potential
Concern
Medium
EPC
Value
Medium
EPC
Units
Route
EPC
Value
Route
EPC
Units
EPC
Selected
for Hazard
Calculation (1)
Intake
(Non-Cancer)
Intake
(Non-Cancer)
Units
Reference
Dose (2)
Reference
Dose Units
Reference
Concentration
Reference
Concentration
Units
Hazard
Quotient
Total Hazard Index Across All Exposure Routes/Pathways
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for hazard calculation.
(2) Specify if subchronic.
-------
CALCULATION OF CANCER RISKS
REASONABLE MAXIMUM EXPOSURE
SITE NAME
Exposure
Route
Scenario Tlmeframe:
Medium:
Exposure Medium:
Exposure Point:
Receptor Population:
Receptor Age:
Chemical
of Potential
Concern
Medium
EPC
Value
Medium
EPC
Units
Route
EPC
Value
Route
EPC
Units
EPC
Selected
for Hazard
Calculation (1)
Intake
(Cancer)
Intake
(Cancer)
Units
Cancer Slope
Factor
Cancer Slope
Factor Units
Cancer
Risk
Total Risk Across All Exposure Routes/Pathways
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for risk calculation.
-------
TABLE 9.1 .RME
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs
REASONABLE MAXIMUM EXPOSURE
SITE NAME
Scenario Timeframe:
Receptor Population:
Receptor Age:
Medium
Exposure
Medium
Exposure
Point
Chemical
Carcinogenic Risk
Ingestion
Inhalation
Dermal
Total Risk Across[Medium)
Total Risk Across All Media and All Exposure Routes
Exposure
Routes Total
Chemical
Non-Carcinogenic Hazard Quotient
Primary
Target Organ
Ingestion
Inhalation
Dermal
Total Hazard Index Across All Media and All Exposure Routes
Total [Organ] HI =
Total (Organ) HI =
Total [Organ] HI =
Exposure
Routes Total
01/28/98
-------
TABLE 10.1.RME
BISK ASSESSMENT SUMMARY
REASONABLE MAXIMUM EXPOSURE
SITE NAME
Medium
Scenatk) Tlmolrame:
Receplor Population:
Receptor Age:
Exposure
Medium
Exposure
Polnl
Chemical
Carcinogenic Risk
Ingesllon
Inhalation
Dermal
Total Risk Across [Medium]
Total Risk Across All Media and All Exposure Routes
Exposure
Routes Total
Chemical
Non-Carcinogenic Hazard Quotient
Primary
Target Organ
Ingesllon
Inhalation
Dermal
Total Hazard Index Across All Media and All Exposure Routes
Total [Organ] HI =
Total [Organ] HI =
Exposure
Routes Total
I
I
01/28/98
-------
Example Standard Tables
Revision No. 0 January 1998
-------
-------
SELECTION OF EXPOSURE PATHWAYS
Dean's Creek Development Company
Scenario
Timeframe
Current
Future
Medium
Groundwater
Sediment
Groundwater
Sediment
Exposure
Medium
Groundwater
Air
Sediment
Animal Tissue
Groundwater
Air
Sediment
Animal Tissue
Exposure
Point
Aquifer 1--Tap Water
Aquifer 1 -Water vapors
at Showerhead
Dean's Creek
Trout from Dean's Creek
Aquifer 1 --Tap Water
Aquifer 1 -water vapors
at Showerhead
Dean's Creek
Trout from Dean's Creek
Receptor
Population
Resident
Trespasser/Visitor
Resident
Trespasser/Visitor
Fisher
Resident
Trespasser/Visitor
Resident
Trespasser/Visitor
Fisher
Receptor
Age
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Adult
Child
Exposure
Route
Dermal
Ingestlon
Dermal
Ingestlon
Dermal
Ingestlon
Dermal
Ingestlon
Inhalation
Inhalation
Dermal
Ingestion
Dermal
Ingestion
Dermal
Ingestlon
Dermal
Ingestion
Dermal
Ingestlon
Dermal
Ingestion
Dermal
Ingestlon
Dermal
Ingestion
Inhalation
Inhalation
Dermal
Ingestlon
Dermal
Ingestion
Dermal
Ingestlon
Dermal
Ingestlon
On-Site/
Off-Site
Off-Site
Off-site
Off-site
Off-site
On-site
On-site
On-site
On-site
Off-site
Off-site
On-slte
On-site
On-Site
On-Site
Off-site
Off-site
Off-site
Off-site
Off-site
Off-site
Off-site
Off-site
On-slte
On-site
On-site
On-site
Off-site
Off-site
On-site
On-site
On-slte
On-site
Off-site
Off-site
Off-site
Off-site
Type of
Analysis
Quant
Quant
Quant
Quant
None
None
None
None
Quant
None
None
None
None
None
None
Quant
None
Quant
None
None
None
None
None
None
None
None
None
None
None
None
None
None
None
Quant
None
Quant
Rationale for Selection or Exclusion
of Exposure Pathway
Residents currently live next to the site, and their wells draw from Aquifer 1 .
Residents currently live next to the site, and their wells draw from Aquifer 1 .
Residents currently live next to the site, and their wells draw from Aquifer 1 .
Residents currently live next to the site, and their wells draw from Aquifer 1 .
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
Residents currently live next to the site, and their wells draw from Aquifer 1 .
Children are assumed not to shower.
Interim action was conducted to remove source and contaminated sediment.
Interim action was conducted to remove source and contaminated sediment.
Interim action was conducted to remove source and contaminated sediement.
Interim action was conducted to remove source and contaminated sediment.
Exposure to contaminants In fish unlikely through dermal pathway.
Possibility of contaminants in downstream fish previously exposed to
contaminated sediments.
Exposure to contaminants in fish unlikely through dermal pathway.
Possibility of contaminants in downstream fish previously exposed to
contaminated sediments.
Community will be serviced by public water within 2 years.
Community will be serviced by public water within 2 years.
Community will be serviced by public water within 2 years.
Community will be serviced by public water within 2 years.
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
No groundwater seeps or wells on site.
Community will be serviced by public water within 2 years.
Children are assumed not to shower.
Interim action was conducted to remove source and contaminated sediment.
Interim action was conducted to remove source and contaminated sediment.
Interim action was conducted to remove source and contaminated sediment.
Interim action was conducted to remove source and contaminated sediment.
Exposure to contaminants in fish unlikely through dermal pathway.
Possibility of contaminants in downstream fish previously exposed to
contaminated sediments.
Exposure to contaminants in fish unlikely through dermal pathway.
Possibility of contaminants in downstream fish previously exposed to
rnntnmlnntoH snrilmonta
-------
TA81E2.1
OCCURRENCE, DISTRIBUTION AND SELECTION OF CHEMICALS OF POTENTIAL CONCEHN
Doan't Crook Devetopmซot Company
Scenario Timeframo; Cunenl
Modtum: Groundwattr
Exposure Medium: Groimdwaler
Exposure Point: Aquifer 1-Tap Water
CAS
Number
7429-90-5
7440-38-2
7440-39-3
7440-41-7
7440-70-2
75-35-4
127-18-4
75-01-4
Chemical
Aluminum
Arsenic
Barium
Beryllium
Calcium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
Minimum <1>
Concentration
246
3.2
53.2
1.2
16,800
3
14
1
Minimum
Qualilier
J
Maximum <'>
Concenlrallon
3,200
42
173
2.1
30,700
75.5
560
5
Maximum
QualMer
J
Units
pgfl
ug/l
ug/i
ug/i
van
ug/i
pg/i
ug/i
Location
of Maximum
Concentration
MW-3
MW-4
MW-11
MW-9
MW-3
MW-5
MW-11
MW-5
Detection
Frequency
9/9
3/9
9/9
2/9
9/9
9/9
6/9
5/9
Range ol
Detection
Limits
1.0-10.0
1.0-1.0
2.0-2.0
.3-1.0
5000
1.0-1.0
1.0-1.0
1.0-1.0
Concentration <2>
Used for
Screening
3,200
42
173
2.1
30,700
75.5
560
5
Background W
Value
3,100
4.9
70
0.6
2,162
N/A
N/A
N/A
Screening '4'
ToxIcilyValua
N/A
0.046 C
260 N
0.019 C
N/A
0.054 C
1.3 C
0.023 C
Potential
ARAR/TBC
Value
50
50 '
2,000
4
N/A
7
5
2
Potential
ARAR/TBC
Source
SMCL
MCL
MCL
MCL
N/A
MCL
MCL
. MCL
COPC
Flag
NO
YES
NO
YES
NO
YES
YES
YES
Rationale for Is
Contaminant
Deletion
BSL
ASL
BSL
ASL
NUT
ASL, FD
ASL
ASL
(1) Minimum/maximum detected concentration.
(2) Maximum concentration used as screening value.
(3) N/A - Refer to supporting information for background discussion.
Background values derived from stalisiicai analysis. Follow Regional guldance-and provide supporting information.
(4) Risk-Based Concentration Table, Third Quarter 1993, U.S. EPA Region III, Roy L. Smith, Ph.D,
March 1997. (Cancer benchmark value = 1E-06, HQ = 0.1)
(5) Rationale Codes Selection Reason: Infrequent Detection but Associated Historically (HIST)
Frequent Detection (FD)
Toxicity Information Available (TX)
Above Screening Levels (ASL)
Deletion Reason: Infrequent Detection (IFD)
Background Levels (BKG)
No Toxicity Information (NTX)
Essential Nutrient (NUT)
Below Screening Level (BSL)
Definitions: N/A = Not Applicable
SQL = Sample Quantitatlon Limit
COPC = Chemical of Potential Concern
ARAR/TBC = Applicable or Relevant and Appropriate Requirement/To Be Considered
MCL = Federal Maximum Contaminant Level
SMCL = Secondary Maximum Contaminant Level
J = Estimated Value
C = Carcinogenic
N = Non-Carcinogenic
-------
TABLE 3.1
MEDIUM-SPECIFIC EXPOSURE POINT CONCENTRATION SUMMARY
Dean's Creek Development Company
Scenario Timeframe: Current
Medium: Groundwater
Exposure Medium: Groundwater
Exposure Point: Aquifer 1-Tap Water
Chemical
of
Potential
Concern
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
Units
MB"'
H9/I
H9/I
H9/I
M9/i
Arithmetic
Mean
2.61 E+01
1.40E+00
4.20E-f01
1.90E+02
1.20E+00
95% UCLof
Normal
Data
N/A
N/A
8.2E+001
N/A
2.0E+00
Maximum
Detected
Concentration
4.2E+001
2.1E+000
7.6E+001
5.6E+002
5.0E+000
Maximum
Qualifier
J
EPC
Units
M9/I
M9/I
M9/I
M9/I
ug/l
Reasonable Maximum Exposure
Medium
EPC
Value
3.51 E+01
1.13E+00
7.55E+01
5.12E+02
2.00E+00
Medium
EPC
Statistic
95% UCL-T
95% UCL-T
Max
95% UCL-T
95% UCL-N
Medium
EPC
Rationale
W-Test(1)
W - Test (1)
W - Test (2)
W-Test(1)
W - Test (3)
Central Tendency
Medium
EPC
Value
3.31 E+01
1.08E+00
4.20E+01
1.83E+02
1.20E+00
Medium
EPC
Statistic
Mean-T
Mean-T
Mean-N
Mean-T
Mean-N
Medium
EPC
Rationale
W-Test(1)
W-Test(1)
W- Test (3)
W-Test(1)
W - Test (3)
ooncentration; for duplicate sample results, the average value was used in the calculation.
.nee to RAGS: Calculating the Concentration Term, OSWER Directive 9285.7-081, May 1992.
JCL-N); 95% UCL of Log-transformed Data (95% UCL-T); Mean of Log-transformed Data (Mean-T);
Mean of Normal Data (Mean-N).
(1) Shapiro-Wilk W Test Indicates data are log-normally distributed.
(2) 95% UCL exceeds maximum detected concentration. Therefore, maximum concentration used for EPC.
(3) Shapiro-Wilks W Test indicates data are normally distributed.
-------
TABLE 4,1
VALUES USED FOR DAILY INTAKE CALCULATIONS
Dean's Creek Development Company
Scenario Tlmeframs: Current
Medium: Groundwater
Exposure Medium: Groundwater
Exposure Point: Aquifer 1-Tap Water
Receptor Population: Resident
Receptor Age: Adult
Exposure Route
Ingestion
Dermal
Parameter
Code
CW
IR-W
EF
ED
CF1
BW
AT-C
AT-N
CW
CF1
PC
ET
CF2
SA
EF
ED
BW
AT-C
AT-N
Parameter Definition
Chemical Concentration In Water
Ingestion Rate of Water
Exposure Frequency
Exposure Duration
Conversion Factor 1
Body Weight
Averaging Time (Cancer)
Averaging Time (Non-Cancer)
Chemical Concentration in Water
Conversion Factor 1
Permeability Constant
Exposure Time
Conversion Factor 2
Skin Surface Area Available for Contact
Exposure Frequency
Exposure Duration
Body Weight
Averaging Time (Cancer)
Averaging Time (Non-Cancer)
Units
ug/1
liters/day
days/year
years
mg/ug
kg
days
days
ug/i
mg/ug
cm/hr
hr/day
Vcm3
cm2
days/years
years
kg
days
days
RME
Value
See Table 3
2
350
24
0.001
70
25,550
8,760
See Table 3
0.001
See Text
0.33
0.001
18,000
350
24
70
25,550
8,760
RME
Rationale/
Reference
See Table 3
EPA, 1991
EPA, 1991
EPA, 1991
--
EPA, 1991
EPA, 1989
EPA, 1989
See Table 3
--
(1)
(2)
EPA, 1989
EPA, 1989
EPA, 1991
EPA, 1991
EPA, 1991
EPA, 1989
EPA, 1989
CT
Value
--
--
--
--
--
--
--
--
--
--
--
--
... --
--
--
--
- -
--
--
CT
Rationale/
Reference
--
--
--
--
-
--
--
--
--
--
--
--
--
..
--
--
--
--
--
Intake Equation/
Model Name
Chronic Dally Intake (GDI) (mg/kg-day) =
CW x IR X EF x ED x CF1 x 1/BW x 1/AT
CDI (mg/kg-day) = .
CWxSAxCFIxPCxETxEFx
ED x CF2 x 1/BW x 1/AT
(1) Refer to Supporting Information.
(2) Professional Judgement.
Sources:
EPA, 1989: Risk Assessment Guidance for Superfund. Vol.1: Human Health Evaluation Manual, Part A. OERR. EPA/540/1-89/002.
EPA, 1991: Risk Assessment Guidance for Superfund. Vol.1: Human Health Evaluation Manual - Supplemental Guidance, Standard Default Exposure Factors. Interim Final. OSWER Directive 9285.6-03.
01/28/98
-------
TABLE 4.3
VALUES USED FOR DAILY INTAKE CALCULATIONS
Dean's Creek Development Company
Scenario Timeframe: Current
Medium: Groundwater
Exposure Medium: Air
Exposure Point: Aquifer 1 -Water Vapors at Showerhead
Receptor Population: Resident
Receptor Age: Adult
Exposure Route
Inhalation
Parameter
Code
(D
Parameter Definition
(D
Units
(1)
RME
Value
(D
RME
Rationale/
Reference
(1)
CT
Value
CT
Rationale/
Reference
Intake Equation/
Model Name
ru&iei a uniuaiuw&iM OHUWOI iitiictictuuii
Model
(1) See Route-Specific EPC and Modeled Intake Supporting Information.
01/28/98
-------
TABLE 5.1
NON-CANCER TOXICITY DATA - ORAL/DERMAL
Dean's Creek Development Company
Chemical
of Potential
Concern
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
Chronic/
Subchronic
Chronic
Subchronic
Chronic
Subchronic
Chronic
Chronic
N/A
Oral RfD
Value
3.0E-04
3.0E-03
5.0E-03
5.0E-02
9.0E-03
1.0E-02
N/A '
Oral RfD
Units
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/ka-day
mg/kg-day
N/A
Oral to Dermal
Adjustment Factor (1)
95%
N/A
1%
N/A
100%
100%
N/A
Adjusted
Dermal
RfD (2)
2.9E-04
N/A
5.0E-05
N/A
9.0E-03
1.0E-02
N/A
Units
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
N/A
Primary
Target
Organ
Skin
Skin
NOEL
NOEL
Liver
Liver
N/A
Combined
Uncertainty/Modifying
Factors
3
30
100
1000
1000
1000
N/A
Sources of RfD;
Target Organ
IRISiNCEA
IRIS
IRISiNCEA
IRIS
IRIS
IRISiNCEA
N/A
Dates of RfD:
Target Organ
(MM/DD/YY) (3)
12/01/96
12/01/96
12/01/96
12/01/96
12/01/96
12/01/96
N/A
N/A = Not Applicable
(1) Refer to RAGS, Part A
(2) Provide equation used for derivation.
(3) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
1/28/98
-------
TABLE 5.2
NON-CANCER TOXICITY DATA -- INHALATION
Dean's Creek Development Company
Chemical
of Potential
Concern
1,1-Dichloroethylene
Tetrachloroethylene
Vinyl Chloride
Chronic/
Subchronic
N/A
N/A
N/A
Value
Inhalation
RfC
N/A
N/A
N/A
Units
N/A
N/A
N/A
Adjusted
Inhalation
RfD (1)
N/A
N/A
N/A
Units
N/A
N/A
N/A
Primary
Target
Organ
N/A
N/A
N/A
Combined
Uncertainty/Modifying
Factors
N/A
N/A
N/A
Sources of
RfC:RfD:
Target Organ
N/A
N/A
N/A
Dates
(MM/DD/YY) (2)
N/A
N/A
N/A
N/A = Not Applicable
(1) Provide equation used for derivation in text.
(2) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
01/28/98
-------
TABLE 5.3
NON-CANCER TOXICITY DATA - SPECIAL CASE CHEMICALS
Dean's Creek Development Company
Chemical
of Potential
Concern
Chronic/
Subchronlc
Value
Units
Primary Target
Organ
Combined
Uncertainty/Modifying
Factors
Sources of Toxiclty:
Primary Target Organ
Date
(MM/DD/YY)
1/28/98
-------
TABLE 6.1
CANCER TOXICITY DATA -- ORAL/DERMAL
Dean's Creek Development Company
Chemical
of Potential
Concern
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
Oral Cancer Slope Factor
1.75
4.3
6.0E-001
5.0E-002
1.9
Oral to Dermal
Adjustment
Factor
95%
1%
100%
100%
100%
Adjusted Dermal
Cancer Slope Factor (1)
1.84E+00
4.30E+02
6.00E-01
5.20E-02
1.90E-fOO
Units
(mg/kg-day)
(mg/kg-day)
(mg/kg-day)
(mg/kg-day)
(mg/kg-day)
Weight of Evidence/
Cancer Guideline
Description
A
B2
C
B2
A
Source
IRIS
IRIS
IRIS
IRIS
HEAST
Date (2)
(MM/DD/YY)
10/01/94
12/01/96
12/01/96
12/01/96
05/95
IRIS = Integrated Risk Information System
HEAST= Health Effects Assessment Summary Tables
(1) Provide equation for derivation in text.
(2) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of article provided by NCEA.
EPA Group:
A - Human carcinogen
B1 - Probable human carcinogen - indicates that limited human data are available
B2 - Probable human carcinogen - indicates sufficient evidence in animals and
Inadequate or no evidence in humans
C - Possible human carcinogen
D - Not classifiable as a human carcinogen
E - Evidence of noncarcinogenicity
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
01/28/98
-------
TABLE 6.2
CANCER TOXICITY DATA - INHALATION
Dean's Creek Development Company
Chemical
of Potential
Concern
1,1-Dichloroethylene
Tetrachloroethylene
Vinyl Chloride
Unit Risk
5.0E-005
5.8E-007
8.4E-005
Units
(ug/m3) -1
(ug/m3) "1
(ug/m3) '1
Adjustment (1)
3,500
3,500
3,500
Inhalation Cancer
Slope Factor
1.75E-001
2.03E-003
3.00E-001
Units
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day) "1
Weight of Evidence/
Cancer Guideline
Description
C
B2
A
Source
IRIS
NCEA
HEAST
Date
(MM/DD/YY)
12/01/96
12/01/96
5/95
IRIS = Integrated Risk Information System
HEAST= Health Effects Assessment Summary Tables
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
(1) Adjustment Factor applied to unit Risk to calculate inhalation Slope Factor =
70kg x 1/20m3/day x 1000ug/mg
(2) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
EPA Group:
A - Human carcinogen
B1 - Probable human carcinogen - indicates that limited human data are available
B2 - Probable human carcinogen - indicates sufficient evidence in animals and
inadequate or no evidence in humans
C - Possible human carcinogen
D - Not classifiable as a human carcinogen
E Evidence of noncarcinogenicity
1/28/98
-------
TABLE 6.3
CANCER TOXICITY DATA -- SPECIAL CASE CHEMICALS
Dean's Creek Development Company
Chemical
of Potential
Concern
Value
Units
Source
Date (1)
MM/DD/YY
(1) For IRIS values, provide the date IRIS was searched.
For HEAST values, provide the date of HEAST.
For NCEA values, provide the date of the article provided by NCEA.
01/28/98
-------
TABiE7.1.BME
CALCULATION OF NON-CANCER HAZARDS
REASONABLE MAXIMUM EXPOSURE
Dean's Creek Development Company
Scenario Tlmolramo: Current
Medium: Groundwator
Exposure Medium: Groundwaler
Exposure Poll* Aquifer 1--Tap Water
Receptor Population; Resident
Receptor Age: Adult
Exposure
Route
Ingestion
Dermal
Chemical
of Potential
Concern
Arsenic
Beryllium
1,1-Dlchloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Medium
EPC
Value
3.SE+01
1.1E+00
7.6E+01
5.1E+02
2.0E+00
3.5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+00
Medium
EPC
Units
MS/I
Mg/i
MS/I
MS/1
van
M9/I
MS/I
MS/I
MS/I
van
Route
EPC
Value
a5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+00
3.5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+00
Route
EPC
Units
M9/I
ug/1
M9/I
MS"
MS/1
MS/1
MS/1
MS/1
MS/1
MS/I
EPC
Selected
for Hazard
Calculation (1)
M
M
M
M
M
M
M
M
M
M
Intake
(Non-Cancer)
9.6E-004
3.0E-005
2.1E-003
1.4E-002
5.5E-005
4.6E-007
1.4E-008
9.9E-005
2.0E-003
1.2E-006
Intake
(Non-Cancer)
Units
ms/kg-day
mg/kg-day
mg/kg-day
rag/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
Reference
Dose (2)
3.0E-004
5.0E-003
9.0E-003
1.0E-002
--
2.9E-004
S.OE-005
9.0E-003
1.0E-002
--
Reference
Dose Units
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
Reference
Concentration
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Reference
Concentration
Units
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Hazard
Quotient
3.2E+000
6.0E-003
2.3E-001
1.4E+000
--
4.8E+000
1.60E-003
2.90E-004
1.10E-002
2.00E-001
..
2.1E-001
: Total Hazard Index Across All Exposure Routes/Pathways || S.OE+OOO
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for hazard calculation.
(2) Specify if subchronic.
-------
TABLE 7.3.RME
CALCULATION OF NON-CANCER HAZARDS
REASONABLE MAXIMUM EXPOSURE
Dean's Creek Development Company
Scenario Timeframe: Current
Medium: Groundwater
Exposure Medium: Air
Exposure Point: Aquifer 1-Water Vapors at Showerhead
Receptor Population: Resident
Receptor Age: Adult
Exposure
Route
Inhalation
Chemical
of Potential
Concern
1,1-Dlchloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Medium
EPC
Value
7.6E+01
5.1E+02
2.0E+00
Medium
EPC
Units
ug/i
ug/l
ug/i
Route
EPC
Value
3.5E+001
1.9E+002
1.0E+000
Route
EPC
Units
ug/i
ug/l
ug/l
EPC
Selected
for Hazard
Calculation (1)
R
R
R
Intake
(Non-Cancer)
3.3E-003
1.8E-002
1.0E-004
Intake
(Non-Cancer)
Units
mg/kg-day
mg/kg-day
mg/kg-day
Reference
Dose (2)
--
Reference Dose
Units
mg/kg-day
mg/kg-day
mg/kg-day
Reference
Concentration
N/A
N/A
N/A
Reference
Concentration
Units
N/A
N/A
N/A
Hazard
Quotient
..
--
--
Total Hazard Index Across All Exposure Routes/Pathways ||
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for hazard calculation.
(2) Specify if subchronic.
-------
Scenario Ttmetome: Current
Medium: Groundwater
Exposure Medium: Groundwater
Exposure Point: Aquifer 1--Tap Water
Receptor Population: Resident
Receptor Age: Adult l_
TABLE 8.1.RME
CALCULATION OF CANCER RISKS
REASONABLE MAXIMUM EXPOSURE
Dean's Creek Development Company
Exposure
Route
Ingestion
Dermal
Chemical
of Potential
Concern
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Arsenic .
Beryllium
1 , 1 -Dichloroethylene
Tetrachloroethene
Vinvl Chloride
(Total)
Medium
EPC
Value
3.5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+000
3.5E+01
. 1.1E+00
' 7.6E+01
5.1E+02
2.0E+000
Medium
EPC
Units
M9/I
M9/I
M9/I
M9/I
M9/I
ug"
ug/l
M9/I
Mg/i
ua/l
Route
EPC
Value
3.5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+000
3.5E+01
1.1E+00
7.6E+01
5.1E+02
2.0E+000
Route
EPC
Units
ug/i
ug/i
ug/i
M9/I
Mg/i
Mg/i
Mg/i
pg/i
M9/I
ug/i
EPC Selected
for Risk
Calculation (1)
M
M
M
M
M
M
M
M
M
M
Intake
(Cancer)
3.3E-04
1.1E-05
7.1E-04
4.8E-03
1.9E-005
1.6E-007
4.9E-009
3.4E-005
6.8E-004
4.1E-007
Intake
(Cancer)
Units
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
mg/kg-day
.
Cancer Slope
Factor
1.75E+00
. 4.30E+00
6.00E-01
5.20E-02
1.90E+00
1.84E+00
4.30E+02
6.00E-01
5.20E-02
1.90E+00
Cancer Slope
Factor Units
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day)
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day)
(mg/kg-day) "1
(mg/kg-day) "1
Total Risk Across All Exposure Routes/Pathways
Cancer
Risk
5.8E-04
4.5E-05
4.3E-04
2.5E-04
3.6E-005
1.3E-003
2.9E-007
2.1E-006
2.0E-005
3.6E-005
7.7E-007
5.9E-005
1.4E-003
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for risk calculation.
-------
Scenario Timeframe: Current
Medium: Groundwater
Exposure Medium: Air
Exposure Point: Aquifer 1--Water Vapors at Showerhead
Receptor Population: Resident
Receptor Age: Adult
TABLE 8.3.RME
CALCULATION OF CANCER RISKS
REASONABLE MAXIMUM EXPOSURE
Dean's Creek Development Company
Exposure
Route
Inhalation
Chemical
of Potential
Concern
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
Medium
EPC
Value
7.6E+001
5.1E+002
2.0E+000
Medium
EPC
Units
M9/I
M9/I
ug/i
Route
EPC
Value
3.4E-003
1.9E-002
. 1.0E-004
Route
EPC
Units
ug/i
M9/I
ug/i
EPC Selected
for Risk
Calculation (1)
R
R
R
Intake
(Cancer)
1.1E-003
6.1E-003
3.4E-005
Intake
(Cancer)
Units
mg/kg-day
mg/kg-day
mg/kg-day
Cancer Slope
Factor
1.75E-01
2.03E-03
3.00E-01
Cancer Slope
Factor Units
(mg/kg-day) "1
(mg/kg-day) "1
(mg/kg-day) "1
Cancer
Risk
2.0E-004
1.2E-05
1.0E-005
2.2E-004
Total Risk Across All Exposure Routes/Pathways || 2.2E-004
(1) Specify Medium-Specific (M) or Route-Specific (R) EPC selected for risk calculation.
-------
TABLE 9.1.RME
SUMMARY OF BECEPTOR RISKS AND HAZARDS FOR COPCs
REASONABLE MAXIMUM EXPOSURE
Dew's Creek Development Company
Scenario Timeframe: Current
Receptor Population: Resident
Receptor Age; Adult
Medium
Groundwater
Exposure
Medium
Groundwater
Air
Exposure
Point
Aquifer 1 -Tap Water
Aquifer 1 -Water Vapors
at Showerhead
Chemical
Arsenic
Beryllium
1,1-Dlchloroelhylene
Tetrachloroethene
Vinyl Chloride
(Total)
1,1-Dlchloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Carcinogenic Risk
Ingastlon
5.8E-04
4.5E-05
4.3E-04
2.5E-04
3.6E-005
1.3E-003
--
--
-
--
Inhalation
--
-
--
--
--
-
2.0E-04
1.2E-05
1.0E-05
2.2E-004
Dermal
2.9E-007
2.1E-006
2.0E-005
3.6E-005
7.7E-007
5.9E-005
-
-
--
Total Risk Across Groundwater
Total Risk Across All Media and All Exposure Routes
Exposure
Routes Total
5.8E-04
4.7E-05
4.5E-004
2.9E-004
3.7E-005
1.4E-003
2.0E-04
1.2E-05
1.0E-05
2.2E-004
1.6E-03
1.6E-03
Chemical
Arsenic
Beryllium
1,1-Dlchloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Non-Carcinogenic Hazard Quotient
Primary
Target Organ
skin
NOEL
liver
liver
NOEL
NOEL
protelnuria*
NOEL
Ingestton
3.2
0.006
0.2
1.4
-
4.8
--
-
-
--
Inhalation
~
--
-
-
--
-.
--
--
..
Dermal
0.002
0.0003
0.01
0.2
-
0.2
--
-
-
..
Total Hazard Index Across All Media and All Exposure Routes
Exposure
Routes Total
3.2
0.006
0.2
1.6
..
5
-
--
..
5
Total Liver HI =
Total Skin HI =
Total Proteinuria HI =
1.8
3.2
-
;01/28/98
-------
TABLE 10.1.RME
RISK ASSESSMENT SUMMARY
REASONABLE MAXIMUM EXPOSURE
Dean's Creek Development Company
Scenario Timeframe: Current
Receptor Population: Resident
Receptor Age: Adult
Medium
Groundwater
Exposure
Medium
Groundwater
Air
Exposure
Point
Aquifer 1 -Tap Water
Aquifer 1 -Water Vapors
at Showerhead
Chemical
Arsenic
Beryllium
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
1,1-Dichloroethylene
Tetrachloroethene
Vinyl Chloride
(Total)
Carcinogenic Risk
Ingestion
5.8E-04
4.5E-05
4.3E-04
2.5E-04
3.6E-005
1.3E-003
..
..
Inhalation
--
--
--
-
-
--
2.0E-04
1.2E-05
1.0E-OS
2.2E-004
Dermal
2.9E-007
2.1E-006
2.0E-005
3.6E-005
7.7E-007
5.9E-005
--
-
--
-.
Total Risk Across Groundwater
Total Risk Across All Media and All Exposure Routes
Exposure
Routes Total
5.8E-04
4.7E-05
4.5E-004
2.9E-004
3.7E-005
. 1.4E-003
2.0E-04
1.2E-05
1.0E-05
2.2E-004
1.6E-03
1.6E-03
Chemical
Arsenic
Tetrachloroethene
(Total)
(Total)
Non-Carcinogenic Hazard Quotient
Primary
Target Organ
skin
liver
Ingestion
3.2
1.4
4.6
--
-
-
--
Inhalation
--
-
-
--
--
Dermal
0.002
0.2
0.2
-
--
Exposure
Routes Total
3.2
1.6
4.8
-
-
--
-
Total Hazard Index Across All Media and All Exposure Routes 1 1 4:8
Total Liver HI =
Total Skin HI =
1.6
3.2
01/28/98
-------
-------
APPENDIX B
INSTRUCTIONS FOR COMPLETION OF
THE STANDARD TABLES
Revision No. 0 January 1998
-------
INSTRUCTIONS FOR TABLE 1
SELECTION OF EXPOSURE PATHWAYS
PURPOSE OF THE TABLE:
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.
INFORMATION DOCUMENTED:
Exposure pathways that were examined and excluded from
analysis
Exposure pathways that will be qualitatively and
quantitatively evaluated in the risk assessment.
TABLE NUMBERING INSTRUCTIONS
Complete one copy of this table only.
Number it Table 1.
The table should contain a row for each Exposure Pathway
considered.
An Exposure Pathway is
defined as each unique
combination of Scenario
Timeframe, Medium,
Exposure Medium,
Exposure Point, Receptor
Population, Receptor Age,
and Exposure Route.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
1-1
-------
INSTRUCTIONS FOR TABLE 1
SELECTION OF EXPOSURE PATHWAYS (continued)
Column 2 - Medium
Definition:
The environmental substance (e.g., air, water, soil)
originally contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Other
Column 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Groundwater (the Exposure
Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the Exposure
Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and are available for exposure to receptors.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Other
1-2
-------
INSTRUCTIONS FOR TABLE 1
SELECTION OF EXPOSURE PATHWAYS (continued)
Column 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer I - Tap Water (the Exposure Point) is evaluated.
2 Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead (the
Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and Trout from Dean's Creek (the Exposure Point) is evaluated.
Instructions:
Describe the exposure point as text in the Table (not to
exceed 80 characters).
Column 5 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
Instructions:
Choose from the picklist to the right.
The text in the Table can not
exceed 80 characters.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at SchooVDaycare/
Playground
Trespasser/Visitor
Farmer
Gardener
Other
1-3
-------
INSTRUCTIONS FOR TABLE 1
SELECTION OF EXPOSURE PATHWAYS (continued)
Column 6 - Receptor Age
Definition:
The description of the exposed individual
EPA Region or dictated by the site.
Instructions:
Choose from the picklist to the right.
For example, an adult
(receptor age) resident
35 defined by the (receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
Column 7 - Exposure Route
Definition:
The way a chemical comes in contact with a person (e.g., by
ingestion, inhalation, dermal contact).
Instructions:
Choose from the picklist to the right.
Inhalation
Ingestion
Combined (Inhalation and
Ingestion)
Dermal Absorption
Not Documented
External (Radiation)
Column 8 - On-Site/Off-Site
Definition:
The location of potential contact between
chemical (contaminant) as it relates to the
Instructions:
Choose from the picklist to the right.
a person and a
site boundary.
On-site
Off-site
On-site/Qff-site
Not Documented
1-4
-------
INSTRUCTIONS FOR TABLE 1
SELECTION OF EXPOSURE PATHWAYS (continued)
Column 9 - Type of Analysis
Definition:
The level of evaluation (quantitative or qualitative) to be
performed for the exposure pathway based on site-specific
analysis.
Instructions:
Choose from the picklist to the right.
Quant (Quantitative)
Qual (Qualitative)
None
Column 10 - Rationale for Selection or Exclusion of Exposure Pathway
Definition:
The reason the exposure pathway was selected or not
selected for quantitative or qualitative analysis.
Instructions:
Document the reason for selecting or excluding a pathway
for analysis. Provide a narrative rationale for each exposure
route.
Follow Regional guidance
for the rationale codes. The
narrative in the Table cannot
exceed 200 characters.
1-5
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN
PURPOSE OF THE TABLE:
To provide information useful for data evaluation of
chemicals detected
To provide adequate information so the user/reviewer gets a
sense of the chemicals 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.
INFORMATION DOCUMENTED:
Statistical information about chemicals detected in each
medium
The detection limits of chemicals analyzed
The toxicity screening values for COPC selection
Which chemicals were selected or deleted as COPCs.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 2 for each unique combination
of the following four fields that will be quantitatively
evaluated in the risk assessment (Scenario Timeframe,
Medium, Exposure Medium, and Exposure Point).
Enter each combination of these four fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely, beginning with 2.1 and ending
with 2.n, where "n" represents the total number of
combinations of the four key fields.
For the example table provided, there should be four copies of Table 2, numbered 2.1,2.2,2.3,
and 2.4.
Table
Number
2.1
2.2
2.3
2.4
Scenario
Timeframe
Current
Current
Current
Future
Medium
Groundwater
Groundwater
Sediment
Sediment
Exposure
Medium
Exposure
Point
Groundwater Aquifer 1 - Tap Water
Air Aquifer 1 - Water Vapors at
Showerhead
Animal Tissue Trout from Dean's Creek
Animal Tissue Trout from Dean's Creek
It is possible that some
Standard Tables may contain
the same data associated
with different descriptions in
the Summary Box in the
upper left corner.
In the example Standard
Tables, the sediment data in
Tables 2.3 and 2.4 will be the
same even though the
Scenario Timeframes
(current and future) are
different.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCUS 3 for
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
2-1
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Medium
Definition:
The environmental substance (e.g., air, water, soil)
originally contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Other
Row 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Groundwater (the Exposure
Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the Exposure
Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and are available for exposure to receptors.
2-2
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Instructions:
Choose from the picklist to the right.
Groundwater
Leackate
Sediment
Sludge
Soil
Surface Water
Debris
liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Other
Row 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer I - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the Exposure
Medium) and exposure to Aquifer I - Water Vapors at Showerhead (the Exposure
Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and Trout from Dean's Creek (the Exposure Point) is evaluated.
Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
BODY OF THE TABLE
Column 1 - CAS Number
Definition:
The Chemical Abstract Registry Number, a unique
standardized number which is assigned to chemicals.
2-3
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Instructions:
Provide the CAS Number for each chemical detected in the
samples for the medium.
Include dashes in the CAS
number. CAS numbers can
be arranged in the order that
the risk assessor prefers.
Column 2 - Chemical
Definition:
The name of the compound detected in samples for the
medium.
Instructions:
Provide the names of the chemicals which were detected in
the sample for the medium.
Chemicals can be grouped in
the order that the risk
assessor prefers.
Column 3 - Minimum Concentration
Definition:
The lowest detected concentration of the chemical in the
medium.
Instructions:
Enter the minimum detected concentration for the medium.
Footnote the heading and provide an explanation of the
method used to determine the minimum concentration.
Column 4 - Minimum Qualifier
Definition:
The alpha-numeric code assigned to the concentration value
by the analytical chemist during data validation for the
minimum concentration value.
Instructions:
Enter the qualifier associated with the minimum
concentration for each chemical. !
Provide the definition of
each qualifier in the table
footnotes or in separate
documentation.
2-4
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Column 5 - Maximum Concentration
Definition:
The highest detected concentration of the chemical in the
medium.
Instructions:
Enter the maximum detected concentration for the medium.
Footnote the heading and provide an explanation of the
method used to determine the maximum concentration.
Column 6 - Maximum Qualifier
Definition:
The alpha-numeric code assigned to the concentration value
by the analytical chemist during data validation for the
maximum concentration value.
Instructions:
Enter the qualifier associated with the maximum
concentration for each chemical.
Provide the definition of
each qualifier in the table
footnotes or in separate
documentation.
Column 7 - Units
Definition:
The concentration units for each chemical detected.
Instructions:
Enter the units for each chemical. Units may vary among
matrices/media.
Refer to Regional guidance
to determine if there is a
preference regarding the
units used for different
matrices (e.g., mg/kg for soil,
ug/Lfor groundwater).
Refer to Glossary for Units
pickKst
Column 8 - Location of Maximum Concentration
Definition:
The sample number which identifies the location where the
sample was taken.
2-5
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Instructions:
Enter the sample identifier which corresponds to the
location where the sample was taken.
Column 9 - Detection Frequency
Definition:
The number of times the chemical was detected versus the
number of times it was analyzed, expressed as the "fraction"
X/Y.
Instructions:
Indicate the number of times a chemical was detected versus
the number of times it was analyzed as the "fraction" X/Y.
Refer to Regional guidance
for an explanation of how
detection frequency should
be interpreted and applied.
For example, 519 indicates
that a chemical was detected
in 5 out of 9 samples.
Column 10 - Range of Detection Limits
Definition:
The lowest and highest detection limits.
Instructions:
Enter the lowest and highest detection limit for the chemical
in the medium.
Column 11 - Concentration Used for Screening
Definition:
The detected concentration which was used to compare to
the screening value.
Instructions:
Enter a concentration for each chemical being evaluated for
the medium.
Footnote the heading and provide a reference/explanation of
'the concentration value.
Refer to Regional guidance
in determining this value.
For example, maximum or
average.
2-6
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Column 12 - Background Value
Definition:
The background value for the chemical in that medium as
defined by Regional guidance.
If Regional guidance requires a "t-test" or other test -which requires backup
information, this supporting information should be provided separately.
Instructions:
Enter the numerical value in the column, consistent with
Regional guidance.
Footnote the heading and provide a reference/explanation
for the derivation of the background value.
Refer to Regional guidance
for how background values
are determined and whether
and how background values
are considered for COPC
screening.
For example, literature
value, data from a nearby
site, statistical tool
Column 13- Screening Toxicity Value
Definition:
The screening level used to compare detected concentrations
of chemicals.
Instructions:
Enter the screening toxicity value, in accordance with
Regional guidance.
If no toxicity value is available for the chemical, enter
"N/A."
Also indicate, with an "N" or "C" whether the value is
based on non-cancer or cancer effects, respectively.
Footnote the heading and provide a reference/explanation
for the source of the screening values used.
Refer to Regional guidance
for the source of the
screening value and for
guidance on comparing the
screening value to detected
concentrations.
N (non-cancer)
C (cancer)
Column 14 - Potential ARAR/TBC Value
Definition:
Applicable or relevant and appropriate requirements
(ARAR) and to be considered (TBC) values.
Refer to Regional guidance
regarding the requirements
for this column. For
example, MCL values, soil
cleanup level values, or other
values to be considered.
2-7
-------
INSTRUCTIONS FOR TABLE 2
OCCURRENCE, DISTRIBUTION AND SELECTION OF
CHEMICALS OF POTENTIAL CONCERN (continued)
Instructions:
Enter appropriate values, consistent with Regional guidance.
If no value is available or appropriate, enter "N/A".
Column 15 - Potential ARAR/TBC Source
Definition:
The type or source of the ARAR/TBC value entered into
Column 14.
Instructions:
Enter the type or source of ARAR/TBC value which
corresponds to the value in Column 14.
For example, MCL or
SMCL.
Column 16 - COPC Flag
Definition:
A code which identifies whether the chemical has been
selected as a COPC, based on Regional screening guidance.
Instructions:
Enter "Yes" or "No" to indicate whether the chemical has
been retained as a COPC.
Yes
No
Column 17 - Rationale for Contaminant Deletion or Selection
Definition:
The reason that the chemical was selected or not selected for
quantitative or qualitative analysis.
Instructions:
Enter the rationale codes in accordance with Regional
guidance for selection/deletion of chemicals of potential
concern.
Footnote the heading and define the rationale codes in the
footnotes.
Follow Regional guidance
for the rationale codes.
The example data table
provides rationale codes for
example purposes only.
Regional guidance may
suggest additional/different
codes.
2-8
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY
PURPOSE OF THE TABLE:
To provide the reasonable maximum and central tendency
medium-specific exposure point concentrations (EPCs) for
measured and modeled values
To provide statistical information on the derivation of the
EPCs.
INFORMATION DOCUMENTED:
Statistical information which was used to calculate the
Medium EPCs for chemicals detected in each medium
The reasonable maximum exposure (RME) Medium EPC
and the central tendency (CT) Medium EPC selected
The statistics which were used to make the determinations
as well as the rationale for the selection of the statistics for
each chemical (i.e., discuss statistical derivation of
measured data or approach for modeled data).
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 3 for each unique combination
of the following four fields that will be quantitatively
evaluated (Scenario Timeframe, Medium, Exposure
Medium, and Exposure Point).
Enter each combination of these four fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely, beginning with 3.1 and ending
with 3.n, where "n" represents the total number of
combinations of the four key fields.
For the example data provided, there should be four copies of Table.3, numbered 3.1,3.2,3.3
and 3.4.
Table
Number
3.1
3.2
3.3
3.4
Scenario
Timeframe
Current
Current
Current
Future
Medium
Groundwater
Groundwater
Sediment
Sediment
Exposure
Medium
Exposure
Groundwater Aquifer 1 - Tap Water
Air Aquifer 1 - Water Vapors at
Showerhead
Animal Tissue Trout from Dean's Creek
Animal Tissue Trout from Dean's Creek.
The medium-specific or
Medium EPC is the same for
a particular medium
regardless of exposure route.
The Medium EPC does not
consider the transfer of
contaminants from one
medium to another, unlike
the Route EPC presented on
Tables 7 and 8. See Tables 7
and 8 for additional
information on Medium
EPC and Route EPC.
It is possible that some tables
may contain the same data
associated with different
descriptions in the Summary
Box in the upper left corner.
In the example Standard
Tables, the sediment data in
Tables 3.3 and 3.4 may be
the same even though the
Scenario Timeframes
(current and future) are
different.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCLIS 3 for
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
3-1
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Attach supporting documentation regarding how the EPC
was calculated.
Attach an example calculation so the methodology used to
develop EPCs is clear to a reviewer.
Attach supporting information regarding how the
concentration term was selected.
Refer to Regional guidance concerning use of decimals or
scientific notation for data.
For certain media, all columns will not be completed.
This information should be
of sufficient detail that a
reviewer can check and
verify the calculations which
were performed and obtain
the same results as listed in
this table.
It is possible that the highest
detected value is the RME, so
the 95% UCL may not need
to be calculated, particularly,
if only one data point is
being considered.
For example, in some
regions, the arithmetic
average of concentrations
measured from the center of
the plume is used as the
RME. In this case, the 95%
UCL column does not need
to be completed.
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Medium
Definition:
The environmental substance (e.g., air, water, soil)
originally contaminated.
3-2
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Row 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and are available for exposure to receptors.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
3-3
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Row 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead (the
Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and Trout from Dean's Creek (the Exposure Point) is
evaluated.
Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
BODY OF THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals which were selected as
COPCs from Table 2.
Chemicals can be grouped in
the order that the risk
assessor prefers.
Column 2 - Units
Definition:
The concentration units for each chemical detected.
Instructions:
Enter units for each chemical. Units may vary among
matrices/media.
Refer to Regional guidance
to determine if there is a
preference regarding the
units used for different
matrices (e.g., mg/kg for soil,
ug/Lfor groundwater).
3-4
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Column 3 - Arithmetic Mean
Definition:
The arithmetic average of detected concentrations.
Instructions:
Enter the arithmetic average of detected concentrations.
Footnote the heading and provide an explanation of the
method used to determine the arithmetic mean.
For duplicate samples,
multiple rounds of sampling,
and other data evaluation
questions, refer to Regional
guidance.
Column 4-95% UCL of Normal Data
Definition:
The statistic for the 95% Upper Confidence Limit on the
arithmetic mean of measured data.
Instructions:
Enter the 95% UCL for each COPC.
Footnote the heading and indicate any assumptions made in
calculating the term.
Supporting information should be provided.
Refer to National guidance
(Supplemental Guidance to
RAGS: Calculating the
Concentration Term,
OSWER Directive: 9285.7-
081, May 1992) and Regional
guidance for calculating this
term.
For example, for non-
detects, '/2 the sample
quantitation limit is
sometimes used as a proxy
concentration. For duplicate
sample results, the average
value is sometimes used in
the calculation.
Column 5 - Maximum Detected Concentration
Definition:
The highest detected concentration of the chemical in the
medium at the exposure point which is above the sample
quantitation limit.
Instructions:
Enter the maximum concentration value.
Column 6 - Maximum Qualifier
Definition:
The alpha-numeric code assigned to the concentration value
by the analytical chemist during data validation for the
maximum concentration value.
3-5
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Instructions:
Enter the qualifier associated with the maximum
concentration.
Provide the definitions of
each qualifier in the table
footnotes or in supporting
information.
Column 7 - EPC Units
Definition:
The units of the data being used to calculate the EPC.
Instructions:
Enter the units for the data being used to calculate the EPC.
Follow Regional guidance
for preferences for different
media (e.g., ug/Lfor
groundwater; mg/kgfor
soil).
Column 8 - Medium EPC Value (for RME)
Definition:
The EPC, based on either a statistical derivation of
measured data or modeled data, that was selected to
represent the medium-specific concentration for the RME
exposure calculations. The Medium EPC differs from the
Route EPC in that the Medium EPC does not consider the
transfer of contaminants from one medium to another.
For example,
the Medium EPC value may be statistically derived by calculating the 95% UCL of
measured ground-water contaminant concentrations from multiple residential wells.
Alternatively, the Medium EPC value may be selected as a single measured value, if one
data point is used to calculate the risk for each residential wett individually. In some
cases, the Medium EPC value may be a modeled value (e.g., ifupgradient groundwater
contaminant concentrations are used to model a downgradient exposure point.) Note
that none of these examples consider the transfer of contaminants from one medium to
another, as is evaluated by Route EPC.
Instructions:
Enter the value in the column.
Footnote the heading and explain how the value was
derived.
The Medium EPC Value
may be developed from a
statistical derivation of
measured data or from
modeled data.
Refer to Regional guidance
concerning how to determine
this value.
3-6
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Column 9 - Medium EPC Statistic (for RME)
Definition:
The statistic selected to represent the Medium EPC Value
(for RME), based on Regional guidance, the distribution of
the data, number of data points, etc.
Instructions:
Enter the statistic used by choosing from the picklist to the
right.
If the statistic used is not on the picklist, enter an
abbreviation in Column 9 and provide a description of the
statistic in the footnotes of the table.
Often this is 95% UCL of the
log-transformed data.
Max (Maximum)
95% UCL - N (95% UCL of
Normal Data)
95% UCL- T (95% UCL of
Log-transformed Data)
Mean - N (Mean of Normal
Data)
Mean - T (Mean of Log-
transformed Data)
Column 10 - Medium EPC Rationale (for RME)
Definition:
The reason the cited statistic was used to represent the EPC
for RME.
Instructions:
Enter the rationale for the selection.
Column 11 - Medium EPC Value (for CT)
Definition:
The EPC, based on either a statistical derivation of
measured data or modeled data, that was selected to
represent the medium-specific concentration for the CT
exposure calculations. The Medium EPC differs from the
Route EPC in that the Medium EPC does not consider the
transfer of contaminants from one medium to another.
For example,
the Medium EPC value may be statistically derived by calculating the 95% UCL of
measured groundwater contaminant concentrations from multiple residential wells.
Alternatively, the Medium EPC value may be selected as a single measured value, if one
data point is used to calculate the risk for each residential well individually. In some
cases, the Medium EPC value may be a modeled value (e.g., if upgradient groundwater
contaminant concentrations are used to model a downgradient exposure point.) Note
that none of these examples consider the transfer of contaminants from one medium to
another, as is evaluated by Route EPC.
Instructions:
Enter the value in the column.
The Medium EPC Value
may be developed from a
statistical derivation of
measured data or from
modeled data.
Refer to Regional guidance
concerning how to determine
this value.
3-7
-------
INSTRUCTIONS FOR TABLE 3
MEDIUM-SPECIFIC EXPOSURE POINT
CONCENTRATION SUMMARY (continued)
Column 12 - Medium EPC Statistic (for CT)
Definition:
The statistic selected to represent the Medium EPC Value
(for CT), based on Regional guidance, the distribution of the
data, number of data points, etc.
Instructions:
Enter the statistic used by choosing from the picklist to the
right.
If the statistic used is not on the picklist, enter an
abbreviation in Column 12, and provide a description of the
statistic in the footnotes of the table.
Often this is a Mean for a
normally distributed data set.
Max (Maximum)
95% VCL - N (95% UCL of
Normal Data)
95% VCL- T (95% UCL of
Log-transformed Data)
Mean - N (Mean of Normal
Data)
Mean - T(Mean of Log-
transformed Data)
Column 13 - Medium EPC Rationale (for CT)
Definition:
The reason the cited statistic was used to represent the EPC
for CT.
Instructions:
Enter the rationale for the selection.
3-8
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS
PURPOSE OF THE TABLE:
To provide the exposure parameters used for RME and CT
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.
INFORMATION DOCUMENTED:
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.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 4 for each unique combination
of the following six fields that will be quantitatively
evaluated (Scenario Timeframe, Medium, Exposure
Medium, Exposure Point, Receptor Population, and
Receptor Age).
Enter each combination of these six fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely, beginning with 4.1 and ending
with 4.n, where "n" represents the total number of
combinations of the six key fields.
For the example data provided, there should be seven copies of Table 4, numbered 4.1 through
4.7
Table Scenario
Number Timeframe Medium
Exposure
Medium
Exposure
Point
4.1
4.2
4.3
4.4
4.5
4.6
4.7
Current
Current
Current
Current
Current
Future
Future
Groundwater
Groundwater
Groundwater
Sediment
Sediment
Sediment
Sediment
Groundwater Aquifer 1
Tap Water
Groundwater Aquifer 1
Tap Water
Air Aquifer 1~
Water Vapors
atShowerhead
Animal Tissue Trout from
Dean's Creek
Animal Tissue Trout from
Dean's Creek
Animal Tissue Trout from
Dean's Creek
Animal Tissue Trout from
Dean's Creek
Receptor
Population
Resident
Resident
Resident
Fisher
Fisher
Fisher
Fisher
Adult
Child
Adult
Child
It is possible that some tables
may contain the same data
associated with different
descriptions in the Summary
Box in the upper left corner.
In the example Standard
Tables, the sediment data in
Tables 4.4 through 4.7 may
be the same, even though the
Scenario Timeframes and
Receptor Ages are different
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCLIS 3 for
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
4-1
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Medium
Definition:
The environmental substance (e.g, air, water, soil) which
has been contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Row 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and are available for exposure to receptors.
4-2
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Row 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead
(the Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and Trout in Dean's Creek (the Exposure Point) is
evaluated.
Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
The field can not exceed 80
characters.
Row 5 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
4-3
-------
INSTRUCTIONS FOR TABLE 4
-
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
Instructions:
Choose from the picklist to the
right.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at SchooVDaycare/
Playground
Trespasser/Visitor
Farmer
Gardener
Other
Row 6 - Receptor Age
Definition:
The description of the exposed
EPA Region or dictated by the
Instructions:
Choose from the picklist to the
individual as defined by the
site.
right.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
BODY OF THE TABLE
Column 1 - Exposure Route
Definition:
The way a chemical comes in contact with a person (e.g., by
ingestion, inhalation, dermal contact).
Instructions:
Choose from the picklist to the
right.
Inhalation
Ingestion (i.e., Inhalation
and Ingestion)
Combined
Dermal Absorption
Not Documented
External (Radiation)
4-4
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
Column 2 - Parameter Code
Definition:
The code used for parameters in the intake equation.
Instructions:
. Enter the appropriate code for the intake parameter from the
picklist below.
Develop additional intake parameter codes as necessary.
Parameter
Code Parameter Definition Units
CS Chemical Concentration in Soil mg/kg
CW Chemical Concentration in Water ug/l
IR-W Ingestion Rate of Water liters/day
EF Exposure Frequency days/year
ED Exposure Duration years
CF1 Conversion Factor 1 mg/ug
BW Body Weight kg
AT-C Averaging Time (Cancer) days
AT-N Averaging Time (Non-Cancer) days
KP Permeability Constant (Dermal for Liquids) cm/hr
ET Exposure Time hr/day
CF2 Conversion Factor 2 Vcm3
SA Skin Surface Area Available for Contact cm2
IN Inhalation Rate nflhr
IR-SM Ingestion Rate (Swimming) l/hr
IR-S . Ingestion Rate of Soil mg/day
DABS Dermal Absorption Factor (Solid) -
SSAF Soil to Skin Adherence Factor mg/cm2/event
IR-F Ingestion Rate of Food kg/meal
EF-F Exposure Freqeuncy (Food) meals/year
Do not provide detailed
information regarding
modeled intakes in this table.
This information should be
provided separately. The
table should list the name of
the model used or the
equation with a footnote
providing a reference to the
supporting information
regarding route-specific
EPCs and modeled intake
development.
Column 3 - Parameter Definition
Definition:
The parameter used in the intake equation.
Instructions:
Enter the parameter definition, consistent with the picklist
defined under Column 2.
Develop additional intake parameter definitions as
necessary.
Do not provide detailed
information regarding
modeled intakes in this table.
This information should be
provided separately. The
table should list the name of
the model used or the
equation with a footnote
providing a reference to the
supporting information
regarding route-specific
EPCs and modeled intake
development.
4-5
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
Column 4 - Units
Definition:
The units for the parameter code used in the intake equation.
Instructions:
Enter the units for each parameter code consistent with the
picklist defined under Column 2.
Develop additional intake parameter units as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units used for different
matrices (e.g., mg/kg for soil,
ug/Lfor groundwater).
Refer to Glossary for Units
picklist
Column 5 - RME Value
Definition:
The parameter value used for the RME intake calculation.
Instructions:
Enter the values used for RME calculations.
For the CS and CW (chemical concentrations in soil and
water, respectively) parameters, refer to Table 3.n or
supporting documentation, as appropriate.
Refer to Regional guidance
for intake parameter values
appropriate for each
exposure pathway.
Column 6 - RME Rationale/Reference
Definition:
The reason and reference for the parameter value used.
Instructions:
Enter the rationale and reference for the value.
If the value used is inconsistent with guidance values,
provide a detailed explanation of the rationale and a
complete reference for the value used.
This rationale may be based
upon Regional or National
guidance.
Provide sufficient detail that
the reviewer can easily
substantiate the value.
Column 7 - CT Value
Definition:
The parameter value used for the CT exposure intake
calculation.
4-6
-------
INSTRUCTIONS FOR TABLE 4
VALUES USED FOR DAILY INTAKE CALCULATIONS (CONTINUED)
Instructions:
Enter the values used for CT exposure calculations.
For the CS and CW (chemical concentrations in soil and
water, respectively) parameters, refer to Table 3.n or
supporting documentation, as appropriate.
Refer to Regional guidance
for intake parameter values
appropriate for each
exposure pathway.
Column 8 - CT Rationale/Reference
Definition:
The reason and reference for the parameter value used.
Instructions:
Enter the rationale and reference for the value.
If the value used is inconsistent with guidance values,
provide a detailed explanation of the rationale and a
complete reference for the value used.
This rationale may be based
on Regional or National
guidance.
Provide sufficient detail that
the reviewer can easily
substantiate the value.
Column 9 - Intake Equation/Model Name
Definition:
The calculation, equation, or model used for intake
estimates for each exposure route.
Instructions:
Enter the National and/or Regional guidance for intake
calculations, equations, and/or models.
Do not provide detailed
information regarding
modeled intakes in this table.
This information should be
provided separately. The
table should list the name of
the model used or the
equation footnote providing
a reference to the supporting
information regarding route-
specific EPCs and modeled
intake development.
4-7
-------
-------
INSTRUCTIONS FOR TABLE 5.1
NON-CANCER TOXICITY DATA - ORAL/DERMAL
PURPOSE OF THE TABLE:
To provide information on RfDs, target organs, and
adjustment factors for chemicals
To provide oral to dermal adjustment factors
To verify references for non-cancer toxicity data.
INFORMATION DOCUMENTED:
The RfDs for each of the COPCs, as well as modifying
factors and oral to dermal adjustments
The organ effects of each of the COPCs
References for RfDs and organ effects.
TABLE NUMBERING INSTRUCTIONS:
Complete one copy of this table only.
Number it Table 5.1.
The table should contain a row for each COPC considered.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 5. 1 does not replace the toxicological profiles for the
individual chemicals that will be presented in the risk
assessment.
If chronic and subchronic
effects are listed for the same
COPC, two rows Witt be
required.
It may be necessary to refer
to RAGS, the risk assessment
technical approach, and
EPA Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals can be grouped in
the order that the risk
assessor prefers.
5.1-1
-------
INSTRUCTIONS FOR TABLE 5.1
NON-CANCER TOXICITY DATA - ORAL/DERMAL (continued)
Column 2 - Chronic/Subchronic
Definition:
Identifies whether the RfD for a particular chemical is for
chronic (long-term) and/or subchronic (short-term)
exposure.
Instructions:
Enter either "Chronic" or "Subchronic" in the field. Both
values may be available for an individual COPC.
Subchronic values may not be available or necessary for an
individual COPC. If that is the case, enter only "Chronic"
hi Column 2.
The risk assessor should use
professional judgement
when extrapolating to time-
frames shorter or longer
than those employed in any
crticial study referenced. As
a Superfund program guide-
line, chronic is seven years
to a lifetime; subchronic is
two weeks to seven years
(RAGS Part A, Sections 6
and 8).
Chronic
Subchronic
Column 3 - Oral RfD Value
Definition:
The oral RfD value for each of the COPCs.
Instructions:
Enter the value for the chronic and/or subchronic oral RfD
(as appropriate).
Column 4 - Oral RfD Units
Definition:
The oral RfD units for each COPC.
Instructions:
Enter units for each oral RfD as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
5.1-2
-------
INSTRUCTIONS FOR TABLE 5.1
NON-CANCER TOXICITY DATA - ORAL/DERMAL (continued)
Column 5 - Oral to Dermal Adjustment Factor
Definition:
The adjustment factor used to convert oral RfD values to
dermal RfD values.
Instructions:
Enter the adjustment factor in this column.
Column 6 - Adjusted Dermal RfD
Definition:
The adjusted RfD for each COPC detected that is derived
from the oral RfD.
Instructions:
Enter the value that was derived from the adjustment factor
in Column 5.
Derivations of the adjusted
dermal RfD should be
performed in accordance
with Regional guidance.
Column 7 - Units (for Adjusted Dermal RfD)
Definition:
The adjusted dermal RfD units for each COPC.
Instructions:
Enter units for each adjusted RfD as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
Column 8 - Primary Target Organ
Definition:
The organ that is affected most (i.e., experiences critical
effects) by chronic or subchronic exposure to the specific
COPC, and upon which the RfD is based.
Instructions:
Enter the name of the most affected organ or organ system
in the column.
If there are two organs that
are equally affected, enter
the names of both, separated
by a'/'.
5.1-3
-------
INSTRUCTIONS FOR TABLE 5.1
NON-CANCER TOXICITY DATA - ORAL/DERMAL (continued)
Column 9 - Combined Uncertainty/Modifying Factors
Definition:
The factors applied to the critical effect level to account for
areas of uncertainty inherent in extrapolation from available
data.
Instructions:
Enter number obtained from IRIS/HEAST.
Refer to IRIS/HEAST for
these values. Examples of
uncertainty to be addressed
include:
- variations in the general
population
- interspecies variability
between humans and
animals
- use ofsubchronic data for
chronic evaluation
- extrapolation from
LOAELs to NOAELs.
Refer to IRIS/HEAST for
these values.
Column 10 - Sources of RfD/Target Organ (Information)
Definition:
The source of the RfD and target organ information.
Instructions:
Enter the source of the RfD and target organ information.
Use a colon to delineate between the two information
sources if the sources of information are different for RfD
and target organ.
IRIS
HEAST
NCEA
Column 11 - Dates (MM/DD/YY)
Definition:
The date of the document that was consulted for the RfD
information and the target organ information in
MM/DD/YY format.
Instructions:
Enter the date, in MM/DD/YY format, for both RfD and
target organ information. Use a colon to delineate between
the two dates, if the sources of information are different for
RfD and target organ.
For IRIS references, provide the date IRIS was searched.
For HEAST references, provide the date of the HEAST reference.
For NCEA references, provide the date of the article provided by NCSA.
The MMJDD/YY format
refers to month/day/year.
For example, the
MM/DD/YY version of the
date March 30, 1995 is
03/30/95.
5.1-4
-------
INSTRUCTIONS FOR TABLE 5.2
NON-CANCER TOXICITY DATA - INHALATION
PURPOSE OF THE TABLE:
To provide information on RfCs, RfDs, target organs, and
adjustment factors for chemicals
To provide RfC to RfD adjustment factors
To verify references for non-cancer toxicity data.
INFORMATION DOCUMENTED:
The RfDs for each of the COPCs, as well as modifying
factors and RfC to RfD adjustments
The organ effects of each of the COPCs
References for RfCs and organ effects.
TABLE NUMBERING INSTRUCTIONS:
Complete one copy of this table only.
Number it Table 5.2.
The table should contain a row for each COPC considered.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 5.2 does not replace the toxicological profiles for the
individual chemicals that will be presented in the risk
assessment.
If chronic and subchronic
effects are listed for (he same
COPC, two rows will be
required.
It may be necessary to refer
to RAGS, the risk assessment
technical approach, and
EPA Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE:
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals can be grouped in
the order that the risk
assessor prefers.
5.2-1
-------
INSTRUCTIONS FOR TABLE 5.2
NON-CANCER TOXICITY DATA - INHALATION (continued)
Column 2 - Chronic/Subchronic
Definition:
Identifies whether the RfC or RfD for a particular chemical
is for chronic (long-term) and/or subchronic (short-term)
exposure.
Instructions:
Enter either "Chronic" or "Subchronic" in the field. Both
values may be available for an individual chemical.
"Subchronic" values may not be available or necessary for
an individual COPC. If that is the case, enter "Chronic" in
Column 2.
The risk assessor should use
professional judgement
when extrapolating to time-
frames shorter or longer
than those employed in any
crticial study referenced. As
a Superfund program guide-
line, chronic is seven years
to a lifetime; subchronic is
two weeks to seven years
(RAGS Part A, Sections 6
and 8).
Chronic
Subchronic
Column 3 - Inhalation RfC Value
Definition:
The RfC value for each of the COPCs.
Instructions:
Enter the value for the chronic and/or subchronic oral RfC
(as appropriate).
Column 4 - Units for Inhalation RfC
Definition:
The RfC units for each chemical detected.
Instructions:
Enter units for each RfC as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
5.2-2
-------
INSTRUCTIONS FOR TABLE 5.2
NON-CANCER TOXICITY DATA - INHALATION (continued)
Column 5 - Adjusted Inhalation RfD
Definition:
The inhalation RfD for each COPC that is derived from the
RfC value.
Instructions:
Enter the derived RfD factor in this column.
The derivation of the RfD
from an RfC should be
performed in accordance
with Regional guidance.
The equation to derive the
RfD from the RfC is to be
included as a footnote in the
table.
Column 6 - Units (for Adjusted Inhalation RfD)
Definition:
The adjusted RfD units for each COPC.
Instructions:
Enter units for each adjusted RfD as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
Column 7 - Primary Target Organ
Definition:
The organ that is affected most (i.e., experiences critical
effects) by chronic or subchronic exposure to the specific
COPC, and upon which the RfD is based.
Instructions:
Enter the name of the most affected organ or organ system
in the column.
Column 8 - Combined Uncertainty/Modifying Factors
Definition:
The factors applied to the critical effect level to account for
areas of uncertainty inherent in extrapolation from available
data.
Instructions:
Enter number obtained from IRIS/HEAST.
If there are two organs that
are equally affected, enter
the names of both, separated
by a'/'.
Refer to IRIS/HEAST for
these values. Examples of
uncertainty to be addressed
include:
- variations in the general
population
- interspecies variability
between humans and
animals
- use of subchronic data for
chronic evaluation
- extrapolation from
LOAELs to NOAELs.
Refer to IRIS/HEAST for
these values.
5.2-3
-------
INSTRUCTIONS FOR TABLE 5.2
NON-CANCER TOXICITY DATA - INHALATION (continued)
Column 9 - Sources of RfC:RfD:Target Organ (Information)
Definition:
The sources of the RfC, RfD, and target organ information.
Instructions:
Enter the sources of the RfC, RfD, and target organ
information. Use a colon to delineate between the
information sources if the sources of information are
different for RfC, RfD, and target organ.
IRIS
HEAST
NCEA
Column 10 - Date (MM/DD/YY)
Definition:
The dates of the documents that were consulted for the
RfC/RfD information and the target organ information in
MM/DD/YY format.
Instructions:
Enter the dates, in MM/DD/YY format, for RfC, RfD and
target organ information. Use a colon to delineate between
the dates, if the sources of information are different for RfC,
RfD, and target organ.
For IRIS references, provide the date IRIS was searched.
For HEAST references, provide the date of the HEAST reference.
* For NCEA references, provide the date of the article provided by NCEA.
The MM/DD/YY format
refers to month/day/year.
For example, the
MM/DD/YY version of the
date March 30,1995 is
03/30/95.
5.2-4
-------
INSTRUCTIONS FOR TABLE 5.3
NON-CANCER TOXICITY DATA - SPECIAL CASE CHEMICALS
PURPOSE OF THE TABLE:
To provide information on toxicity values, target organs,
and adjustment factors for unusual chemicals or
circumstances that are not covered by Tables 5. 1 or 5.2
To verify references for non-cancer toxicity data.
INFORMATION DOCUMENTED:
The toxicity values for each of the COPCs, as well as
modifying factors
The organ effects of each of the COPCs
References for toxicity values and organ effects.
TABLE NUMBERING INSTRUCTIONS:
Complete one copy of this table only.
Number it Table 5.3.
The table should contain a row for each COPC considered.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 5.3 does not replace the toxicological profiles for the
individual chemicals that will be presented in the risk
assessment.
For example, a toxicity
factor derived specifically for
an individual risk assessment
should be documented in
Table 5.3.
If chronic and subchronic
effects are listed for the same
COPC, two rows witt be
required.
Refer to RAGS, the risk
assessment technical
approach, and EPA
Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals can be grouped in
the order that the risk
assessor prefers.
5.3-1
-------
INSTRUCTIONS FOR TABLE 5.3
i '
NON-CANCER TOXICITY DATA -SPECIAL CASE CHEMICALS (continued)
Column 2 - Chronic/Subchronic
Definition:
Identifies whether the toxicity value for a particular
chemical is for chronic (long-term) and/or subchronic
(short-term) exposure.
Instructions:
Enter either "Chronic" or "Subchronic" in the field. Both
values may be available for an individual COPC.
"Subchronic" values may not be available or necessary for
an individual chemical. If that is the case, enter only
"Chronic" in the column.
The risk assessor should use
professional judgement
when extrapolating to time-
frames shorter or longer
than those employed in any
crticial study referenced. As
a Superfund program guide-
line, chronic is seven years
to a lifetime; subchronic is
two weeks to seven years
(RAGS Part A, Sections 6
and 8).
Chronic
Subchronic
Column 3 - Toxicity Value
Definition:
The toxicity value for each COPC.
Instructions:
Enter the value for the chronic and/or subchronic toxicity
values (as appropriate).
Column 4 - Toxicity Units
Definition:
The units associated with the toxicity value for each COPC.
Instructions:
* Enter units for each reference as necessary.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
5.3-2
-------
INSTRUCTIONS FOR TABLE 5.3
NON-CANCER TOXICITY DATA -SPECIAL CASE CHEMICALS (continued)
Column 5 - Primary Target Organ
Definition:
The organ that is affected most (i.e., experiences critical
effects) by chronic or subchronic exposure to the specific
COPC, and upon which the RfD is based.
Instructions:
Enter the name of the most affected organ or organ system
in the column.
If there are two organs that
are equally affected, enter
the names of both, separated
by a'/'.
Column 6 - Combined Uncertainty/Modifying Factors
Definition:
The factors applied to the critical effect level to account for
areas of uncertainty inherent in extrapolation from available
data.
Instructions:
Enter number obtained from IRIS/HEAST.
Refer to IRIS/HEAST for
these values. Examples of
uncertainty to be addressed
include:
- variations in the general
population
- interspecies variability
between humans and
animals
- use of subchronic data for
chronic evaluation
- extrapolation from
LOAELs to NOAELs.
Refer to IRIS/HEAST for
these values.
Column 7 - Sources of Toxicity/Primary Target Organ Information
Definition:
The sources of the toxicity and target organ information.
Instructions:
Enter the sources of the toxicity and target organ
information.
IRIS
HEAST
NCEA
Column 8 - Date (MM/DD/YY)
Definition:
The dates of the document that were consulted for the
toxicity information and the target organ information in
MM/DD/YY format.
The MM/DD/YY format
refers to month/day/year.
5.3-3
-------
INSTRUCTIONS FOR TABLE 5.3
NON-CANCER TOXICITY DATA -SPECIAL CASE CHEMICALS (continued)
Instructions:
Enter the dates, in MQV1/DD/YY format, for the toxicity and
target organ information. Use a colon to delineate between
the dates, if the sources of information are different for
toxicity and target organ.
For IRIS references, provide the date IRIS was searched.
For HEAST references, provide the date of the HEAST reference.
For NCEA references, provide the date of the article provided by NCEA.
For example, the
MM/DD/YY version of the
date March 30,1995 is
03/30/95.
5.3-4
-------
INSTRUCTIONS FOR TABLE 6.1
CANCER TOXICITY DATA - ORAL/DERMAL
PURPOSE OF THE TABLE:
To provide the oral and dermal cancer toxlcity information
(values and sources of information) for chemicals of
potential concern
To provide the methodology and adjustment factors used to
convert oral cancer toxicity values to dermal toxicity values
To provide weight of evidence/cancer guideline descriptions
for each chemical of potential concern.
INFORMATION DOCUMENTED:
Oral and dermal toxicity values for chemicals of potential
concern
Weight of evidence/cancer guidelines descriptions for
chemicals of potential concern
The source/reference for each toxicity value.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 6. 1 does not replace toxicological profiles for the
individual chemicals that will be presented in the risk
assessment.
It may be necessary to refer
to RAGS, the risk assessment
technical approach, and
EPA Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals may be grouped
in the order that the risk
assessor chooses.
6.1-1
-------
INSTRUCTIONS FOR TABLE 6.1
CANCER TOXICITY DATA - ORAL/DERMAL (continued)
Column 2 - Oral Cancer Slope Factor
Definition:
Cancer slope factor for ingestion.
Instructions:
Enter the oral cancer slope factor.
Refer to IRIS and HEAST.
Iftoxicity information is not
available, contact EPA's
National Center for
Environmental Assessment
(NCSA) office.
Column 3 - Oral to Dermal Adjustment Factor
Definition:
The adjustment factor used to convert the oral RfD values to
dermal RfD values.
Instructions:
Enter the oral to dermal adjustment factor.
Refer to RAGS and Regional
guidance.
Column 4 - Adjusted Dermal Cancer Slope Factor
Definition:
The adjusted dermal cancer slope factor for each chemical
of potential concern which typically is derived from the oral
cancer slope factor.
Instructions:
Enter the derived dermal cancer slope factor.
Derivation of the dermal
cancer slope factor should be
performed in accordance
with Regional guidance.
Provide the
equation/adjustment used for
derivation.
Column 5 - Units
Definition:
The concentration units for each chemical detected.
Instructions:
Enter the units for the cancer slope factors.
Typically (mg/kg-day)''
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
6.1-2
-------
INSTRUCTIONS FOR TABLE 6.1
CANCER TOXICITY DATA - ORAL/DERMAL (continued)
Column 6 - Weight of Evidence/Cancer Guideline Description
Definition:
An EPA classification system for characterizing the extent to
which the available data indicate that an agent is a human
carcinogen.
Instructions:
Provide the weight of evidence/cancer guideline description.
Choose from the categories to the right.
EPA Group:
A - Human carcinogen
Bl - Probable human
carcinogen - indicates that
limited human data are
available.
B2 - Probable human
carcinogen - indicates
sufficient evidence in
animals and inadequate or
no evidence in humans.
C - Possible human
carcinogen
D - Not classifiable as a
human carcinogen
E - Evidence of
noncarcinogenicuy
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
Column 7 - Source
Definition:
A reference for the weight of evidence/cancer guideline
description entry.
Instructions:
Enter the reference for toxicity information.
For example:
IRIS
HEAST
NCEA
Column 8 - Date (MM/DD/YY)
Definition:
The date of the document that was consulted for the cancer
toxicity data in MM/DD/YY format.
Instructions:
Enter the date in MM/DD/YY format. Use a comma to delineate
between multiple dates, if multiple sources of data were used.
For IRIS references, provide the date IRIS was selected.
For HEAST references, provide the date of the HEAST reference.
For NCSA references, provide the date of the article provided by NCEA.
The MM/DD/YY format
refers to month/day/year.
For example, the
MM/DD/YY version of the
date March 30, 1995 is
03/30/95.
6.1-3
-------
-------
INSTRUCTIONS FOR TABLE 6.2
CANCER TOXICITY DATA - INHALATION
PURPOSE OF THE TABLE:
To provide the inhalation cancer toxicity information
(values and sources of information) for chemicals of
potential concern
To provide the methodology and adjustment factors used to
convert inhalation unit risks to inhalation cancer slope
factors
To provide weight of evidence/cancer guideline descriptions
for each chemical of potential concern.
INFORMATION DOCUMENTED:
Inhalation toxicity values for chemicals of potential concern
Weight of evidence/cancer guidelines descriptions for
chemicals of potential concern
The source/reference for each toxicity value.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 6.2 does not replace toxicological profiles for the
individual chemicals that will be presented, in the risk
assessment.
It may be necessary to refer
to RAGS, the risk assessment
technical approach, and
EPA Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals may be grouped
in the order that the risk
assessor chooses.
6.2-1
-------
INSTRUCTIONS FOR TABLE 6.2
CANCER TOXICITY DATA - INHALATION (continued)
Column 2 - Unit Risk
Definition:
Toxicity values for carcinogenic effects expressed in terms
of risk per unit concentration of the substance in the
medium where human contact occurs. These measures can
be calculated from cancer slope factors.
Instructions:
Enter the inhalation unit risk value
Refer to IRIS and HEAST; if
toxicity information is not
available, contact EPA's
National Center for
Environmental Assessment
(NCEA) office.
Column 3 - Units
Definition:
The units used for the unit risk for each chemical detected.
Instructions:
Enter the units for the unit risk values.
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
Column 4 - Adjustment
Definition:
The value used to derive the inhalation cancer slope factor
from the unit risk value.
Instructions:
Enter the adjustment factor used to convert unit risk to a
cancer slope factor.
Toxicity values for
carcinogenic effects also can
be expressed in terms of risk
per unit concentration of the
substance in the medium
where human contact
occurs. These measures are
catted unit risks and can be
calculated from cancer slope
factors.
Refer to RAGS/HEAST and
Regional guidance.
6.2-2
-------
INSTRUCTIONS FOR TABLE 6.2
CANCER TOXICITY DATA - INHALATION (continued)
Column 5 - Inhalation Cancer Slope Factor
Definition:
A plausible upper-bound estimate of the probability of a
response per unit intake of a chemical over a lifetime.
Instructions:
Enter the inhalation cancer slope factor.
Usually the cancer slope
factor is the upper 95th %
confidence limit of the dose-
response curve for
inhalation.
Column 6 - Units
Definition:
The units used for the inhalation cancer slope factor for each
chemical detected.
Instructions:
Enter the units for the cancer slope factors.
Column 7 - Weight of Evidence/Cancer Guideline Description
Definition:
An EPA classification system for characterizing the extent
to which the available data indicate that an agent is a human
carcinogen.
Instructions:
Provide the weight of evidence/cancer guideline description.
Choose from the categories to the right.
EPA Group:
A - Human carcinogen
Bl - Probable human
carcinogen - indicates that
limited human data are
available.
B2 - Probable human
carcinogen - indicates
sufficient evidence in
animals and inadequate or
no evidence in humans.
C - Possible human
carcinogen
D - Not classifiable as a
human carcinogen
E - Evidence of
noncarcinogenicity
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
6.2-3
-------
INSTRUCTIONS FOR TABLE 6.2
CANCER TOXICITY DATA - INHALATION (continued)
Column 8 - Source
Definition:
A reference for the weight of evidence/cancer guideline
description entry.
Instructions:
Enter the reference for toxicity information.
IRIS
HEAST
NCEA
Column 9 - Date (MM/DD/YY)
Definition:
The date of the document that was consulted for the cancer
toxicity data in MM/DD/YY format.
Instructions:
Enter the date in MM/DD/YY format. Use a comma to
delineate between multiple dates, if multiple sources of
information were used.
For IRIS references, provide the date IRIS was selected.
For HEAST references, provide the date of the HEAST reference.
For NCEA references, provide the date of the article provided by NCEA.
The MM/DD/YY format
refers to month/day/year.
For example, the
MM/DD/YY version of the
date March 30, 1995 is
03/30/95.
6.2-4
-------
INSTRUCTIONS FOR TABLE 6.3
CANCER TOXICITY DATA - SPECIAL CASE CHEMICALS
PURPOSE OF THE TABLE:
To provide cancer toxicity information for "special case"
chemicals.
INFORMATION DOCUMENTED:
Cancer toxicity information (values and units) for special
case chemicals
The date and source of the toxicity information.
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Table 6.3 does not replace toxicological profiles for the
individual chemicals that will be presented in the risk
assessment.
For example, a toxicity
factor derived specifically for
an individual risk assessment
should be documented in
Table 6.3.
It may be necessary to refer
to RAGS, the risk assessment
technical approach, and
EPA Regional guidance to
complete the table.
HOW TO COMPLETE/INTERPRET THE TABLE
Column 1 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the names of the chemicals that were selected as
COPCs from Table 2.
Chemicals may be grouped
in the order that the risk
assessor chooses.
Column 2 - Toxicity Value
Definition:
The toxicity value for each chemical of potential concern.
Instructions:
Enter the toxicity value for each chemical of potential
concern.
6.3-1
-------
INSTRUCTIONS FOR TABLE 6.3
CANCER TOXICITY DATA - SPECIAL CASE CHEMICALS (continued)
Column 3 - Toxicity Units
Definition:
The units associated with the toxicity value.
Instructions:
Enter the toxicity units.
Typically (mg/kg-day)''
Refer to Regional guidance
to determine if there is a
preference regarding the
units to be used.
Column 4 -Source
Definition:
A reference for the cancer toxicity information.
Instructions:
Enter the reference for toxicity information.
IRIS
HEAST
NCEA
Column 5 - Date (MM/DD/YY)
Definition:
The date of the document that was consulted for the cancer
toxicity data in the MM/DD/YY format.
Instructions:
Enter the date in MM/DD/YY format. Use a comma to
delineate between multiple dates, if multiple sources of
information were used.
For IBIS references, provide the date IRIS was selected.
For SEAST references, provide the date of the HEAST reference.
For NCEA references, provide the date of the article provided by NCEA.
The MM/DD/YY format
refers to month/day/year.
For example, the
MM/DD/YY version of the
date March 30,1995 is
03/30/95.
6.3-2
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS
PURPOSE OF THE TABLE:
To provide a summary of the variables used to calculate
non-cancer hazards
To show the EPC (medium-specific or route-specific) and
intake used in the non-cancer hazard calculations
To present the result of the calculation for each exposure
route/pathway for each COPC
To provide the total hazard index for all exposure
routes/pathways for the scenario timeframe, exposure
medium, and receptor presented in this table.
INFORMATION DOCUMENTED:
The non-cancer hazard quotient for each COPC for each
exposure route/pathway
The values used for EPC, non-cancer intake, reference
doses, and reference concentrations.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 7 for each unique combination
of the following six fields that will be quantitatively
evaluated (Scenario Timeframe, Medium, Exposure
Medium, Exposure Point, Receptor Population, and
Receptor Age).
Enter each combination of these six fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely, beginning with 7.1 and ending
with 7.n where "n" represents the total number of
combinations of the six key fields.
Different tables should be prepared to address RME and CT
non-cancer hazard calculations.
Tables 7.1 .RME through 7.n.RME should be completed for
RME non-cancer hazard calculations.
Tables 7.1 .CT through 7.n.CT should be completed for CT
non-cancer hazard calculations.
The medium-specific or
Medium EPC is the same for
a particular medium
regardless of exposure route.
The route-specific or Route
EPC differs from the
Medium EPC in that the
Route EPC may consider the
transfer of contaminants
from one medium to
another, where applicable
for a particular exposure
route.
It is possible that some tables
may contain some of the
same data associated with
different descriptions in the
Summary Box in the upper
left corner.
In the example Standard
Tables, the sediment EPC
values in Tables 7.4.RME
through 7.7.RME may be the
same. However the intakes
vary due to differences in the
Scenario Timeframes and
ReceptorAges.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCLIS 3 for
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
7-1
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS
(continued):
For the example data provided, there should be seven copies of Table 7 for the RME
calculations, numbered 7.1JIME through 7.7.RME. Seven corresponding tables should be
preparedfor CT'calculations, numbered 7.1.CTthrough 7.7.CT.
Table Scenario
Number Tbneframe Medium
7.1J&tE Current Groundwater
7.2JKME
73JIME
Current
Current
7.4JRME Current
73JRME Current
7.6JKME Future
7.7JKME Future
Groundwater
Groundwater
Sediment
Sediment
Sediment
Sediment
Exposure Exposure Receptor Receptor
Medium Point Population Aee
Groundwater Aquifer 1 Resident Adult
Tap Water
Groundwater Aquifer 1 Resident Child
Tap Water
Air Aquifer 1 Resident Adult
Water Vapors
at Showerhead
Animal Tissue Trout from Fisher Adult
Dean's Creek
Animal Tissue Trout from Fisher Child
Dean's Creek
Animal Tissue Trout from Fisher Adult
Dean's Creek
Animal Tissue Trout from Fisher Child
Dean's Creek
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
All table entries with the exception of route EPC, intake, and non-
cancer hazard are presented on tables preceding Table 7.
With the exception of modeled intakes, the intake value is the
result of calculations performed using parameters and equations
presented in Table 4 and concentrations presented in Table 3.
The total non-cancer hazard for each exposure route is to be
summed and the total non-cancer hazard for all exposure pathways
is to be presented as a sum at the end of the table.
This value represents the non-cancer hazard of the various
exposure routes/pathways combined.
Medium EPC and Route EPC Examples for Frequently Evaluated Pathways
Medium
Groundwater
Groundwater
Exposure
Medium
Groundwater
Groundwater
Groundwater Air
Soil
Soil
Soil
Soil
Soil
Air
Exposure
Route
Ingestion
Dermal
Inhalation
Ingestion
Dermal
Inhalation
Medium Route EPC Selected
EPC EPC For Calculation
Measured Measured M
Measured Modeled R
Measured Modeled R
Measured Measured M
Measured Modeled R
Measured Modeled'
R
'EPC's wiH be modeled separately for particulates and vapors.
Measured - Developed from a statistical derivation of measured data.
Modeled Developed from model based on measured data.
M-Medium EPC R-Route EPC
The medium-specific or
Medium EPC is the same for
a particular medium
regardless of exposure route.
The route-specific or Route
EPC differs from the
Medium EPC in that the
Route EPC may consider the
transfer of contaminants
from one medium to
another, where applicable
for a particular exposure
route.
7-2
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Medium
Definition:
The environmental substance (e.g., air, water, soil) which
has been contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
SoU
Surface Water
Debris
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Other
Row 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Ground-water (the
Exposure Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and are available for exposure to receptors.
7-3
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Other
Row 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Ground-water (the Medium and the Exposure Medium) and
exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead (the
Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue (the
Exposure Medium) and Trout from Dean's Creek (the Exposure Point) is
evaluated.
Instructions:
Provide the information as text in the Table not to exceed 80
characters).
The text in the Table can not
exceed 80 characters.
Row 5 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
7-4
-------
, INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Instructions:
Choose from the picklist to the
right.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at SchooUDaycare/
Playground
Trespasser/Visitor
Farmer
Gardener
Other
Row 6 - Receptor Age
Definition:
The description of the exposed
EPA Region or dictated by the
Instructions:
Choose from the picklist to the
individual, as defined by the
site.
right.
For example, an adult
(receptor age) resident
(receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
BODY OF THE TABLE
Column 1 - Exposure Route
Definition:
The way a chemical comes in contact with a person (e.g., by
ingestion, inhalation, dermal contact).
Instructions:
Enter the exposure route considered from the picklist to the
right.
Inhalation
Ingestion
Combined (i.e., Inhalation
and Ingestion)
Dermal Absorption
Not Documented
External (Radiation)
7-5
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Column 2 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the COPCs selected from the COPC screening.
Table 2 documents COPC
screening.
Column 3 - Medium EPC Value
Definition:
The EPC, based on either a statistical derivation of
measured data or modeled data, that was selected to
represent the medium-specific concentration for the
exposure calculations. The Medium EPC differs from the
Route EPC in that the Medium EPC does not consider the
transfer of contaminants from one medium to another.
For example,
the Medium EPC value may be statistically derived by calculating the 95% UCL of
measured ground-water contaminant concentrations from multiple residential wells.
Alternatively, the Medium EPC value may be selected as a single measured value, if one
data point is used to calculate the risk for each residential well individually. In some
cases, the Medium EPC value may be a modeled value (e.g., ifupgradient ground-water
contaminant concentrations are used to model a downgradient exposure point.) Note
that none of these examples consider the transfer of contaminants from one medium to
another, as is evaluated by Route EPC.
Instructions:
Enter the medium EPC value for each COPC.
The Medium EPC Value
may be developed from a
statistical derivation of
measured data or from
modeled data.
Table 3 documents medium
EPC calculations for RME
andCT.
Column 4 - Medium EPC Units
Definition:
The units associated with the medium EPC value.
Instructions:
Enter the units for medium EPC values.
The units may vary
depending on the medium.
7-6
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Column 5 - Route EPC Value
Definition:
The EPC, based on either a statistical derivation of
measured data or based on modeled data, that was selected
to represent the route-specific concentration for the
exposure calculations. The Route EPC differs from the
Medium EPC in that the Route EPC may consider the
transfer of contaminants from one medium to another,
where applicable for a particular exposure route.
For example,
for groundwater ingestion, the Medium EPC and the Route EPC will typically be the
same value. Alternatively, for groundwater inhalation, the Medium EPC will often be a
statistical derivation of measured concentrations in groundwater, while the Route EPC
will often be a modeled inhalation concentration that is based on the measured
concentrations.
Instructions:
Enter the route EPC value for each COPC.
The Route EPC may be
developed from a statistical
derivation of measured data
or from modeled data. The
Route EPC may be identical
to the Medium EPC or it ,
may be modeled based on the
Medium EPC.
Supporting information
should be provided
documenting Route EPC
calculations.
Column 6 - Route EPC Units
Definition:
The units associated with the route EPC value.
Instructions:
Enter the units for route EPC values.
The units may vary
depending on the route of
exposure.
Column 7 - EPC Selected for Hazard Calculation
Definition:
The EPC that will be used to quantify potential non-cancer
hazards.
Instructions:
Identify the type of EPC used for non-cancer hazard
calculation for each COPC for each exposure route.
Enter "M" for medium EPC.
Enter "R" for route EPC.
M (Medium EPC)
jR (Route EPC)
Follow Regional guidance
for selection of this value.
7-7
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Column 8 - Intake (Non-Cancer)
Definition:
A measure of exposure expressed as the mass of a substance
in contact with the exchange boundary per unit body weight
per unit time.
Instructions:
Enter the result of the intake calculations/modeling
performed for each COPC and exposure route.
Refers to the intake results
using the parameters and
equations, calculations
and/or models presented in
Table 4.
The intake equations,
calculations, and/or models
are documented in Table 4.
Column 9 - Intake Units (Non-Cancer)
Definition:
The units for intake for each COPC and exposure route.
Instructions:
Enter the units from the intake calculation for each COPC
which corresponds to each exposure route.
Column 10 - Reference Dose
Definition:
The preferred toxicity value for evaluating non-cancer
effects resulting from exposures.
Instructions:
Enter the reference dose for each COPC which corresponds
to each exposure route.
Enter Oral RfD values for ingestion.
Enter Adjusted Dermal RfD values for dermal.
Enter Adjusted Inhalation RfD values for inhalation.
The reference doses for each
COPC are presented in Table
5.
Column 11 - Reference Dose Units
Definition:
The units associated with the reference dose.
Instructions:
Enter the reference dose units for each COPC for each
exposure route.
Specify if the reference dose is subchronic by using a
footnote.
Typically reported in mg/kg-
day, a dose term.
7-8
-------
INSTRUCTIONS FOR TABLE 7.1
CALCULATION OF NON-CANCER HAZARDS (continued)
Column 12 - Reference Concentration
Definition:
The toxicity value for inhalation typically reported as a
concentration in air (mg/m3) which can be converted to an
inhaled dose (mg/kg-day).
Instructions:
Enter the reference concentration for each COPC which
corresponds to each exposure route.
Column 13 - Reference Concentration Units
Definition:
The units associated with the reference concentration.
Instructions:
Enter the reference concentration units for each COPC for
each exposure route.
Column 14 - Hazard Quotient
Definition:
The ratio of a single substance exposure level, over a
specified time period, to a reference dose for that substance,
derived from a similar exposure period.
Instructions:
Enter the result of the hazard quotient calculation for each
COPC.
Sum the hazard quotient for each exposure route/pathway.
Sum the hazard quotients for all exposure routes/pathways.
The Hazard Index represents
the total non-cancer hazard
for att exposure
routes/pathways presented in
this table.
7-9
-------
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS
PURPOSE OF THE TABLE:
To provide a summary of the variables used to calculate
cancer risks
To show the EPC (medium-specific or route-specific) and
intake used in the cancer risk calculations
To present the result of the calculation for each exposure
route/pathway for each COPC
To provide the total cancer risks for all exposure
routes/pathways for the scenario timeframe, exposure
medium, and receptor presented in this table.
INFORMATION DOCUMENTED:
The cancer risk value for each COPC for each exposure
route/pathway
The values used for EPC, cancer intake, and cancer slope
factor for each COPC for each exposure route.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 8 for each unique combination
of the following six fields that will be quantitatively
evaluated (Scenario Timeframe, Medium, Exposure
Medium, Exposure Point, Receptor Population, and
Receptor Age).
Enter each combination of these six fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely, beginning with 8.1 and ending
with 8.n where "n" represents the total number of
combinations of the six key fields.
Different tables should be prepared to address RME and CT
cancer risk calculations.
Tables 8.1. RME through 8.n. RME should be completed
for RME cancer risk calculations.
Tables 8.1. CT through 8.n. CT should be completed for CT
cancer risk calculations.
The medium-specific or
Medium EPC is the same for
a particular medium
regardless of exposure route.
The route-specific or Route
EPC differs from the
Medium EPC in that the
Route EPC may consider the
transfer of contaminants
from one medium to
another, where applicable
for a particular exposure
route.
It is possible that some tables
may contain the same data
associated with different
descriptions in the Summary
Box in the upper left corner.
In the example Standard
Tables, the sediment EPC
values in Tables 8.4.RME
through 8.7.RME may be the
same. However the intakes
may vary due to differences
in the Scenario Ttmeframes
and Receptor Ages.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCUSSfor
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
8-1
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS
(continued):
For the example data provided, there should be seven copies of Table 8 for the RME
calculations, numbered 8.1.BME through 8.7.RME. Seven corresponding tables should be
prepared for CT calculations, numbered 8.1.CT through 8.7.CT.
Table Scenario
Number Timeframe Medium.
SJ.RME Current Groundwater
8.2JZME
8.3JRME
Current
Current
Groundwater
Groundwater
S.4.RME Current Sediment
S3JRME Current Sediment
8.6.RME Future Sediment
8.7JRME Future Sediment
Exposure Exposure Receptor Receptor
Medium Point Population Age
Groundwater Aquifer 1 Resident Adult
Tap Water
Groundwater Aquifer 1 Resident Child
Tap Water
Air Aquifer 1 Resident Adult
Water Vapors
atShowerhead
Animal Tissue Trout from Fisher Adult
Dean's Creek
Animal Tissue Trout from Fisher Child
Dean's Creek
Animal Tissue Trout from Fisher Adult
Dean's Creek
Animal Tissue Trout from Fisher Child
Dean's Creek
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
All table entries with the exception of intake and cancer risk
are presented on tables preceding Table 8.
With the exception of modeled intakes, the intake value is
the result of calculations performed using parameters and
equations presented in Table 4 and concentrations presented
in Table 3.
The total cancer risk for each exposure route is to be
summed and the total cancer risk for all exposure pathways
is to be presented as a sum at the end of the table. This
value represents the cancer risk of the various exposure
routes/pathways combined.
Medium EPC and Route EPC Examples for Frequently Evaluated Pathways
Exposure Exposure Medium
Medium Medium Route EPC
Groundwater Groundwater Ingestion Measured
Groundwater Groundwater Dermal Measured
Groundwater Air Inhalation Measured
Soil Soil Ingestion Measured
Soil Soil Dermal Measured
Soil Air Inhalation Measured
Route EPC Selected
EPC For Calculation
Measured M
R
R
M
Modeled
Modeled
Measured
Modeled
Modeled'
R
R
'EPC's wiU be modeled separately for particutates and vapors.
Measured - Developed from a statistical derivation of measured data.
Modeled Developed from model based on measured data.
M-Medium EPC R-Route EPC
The medium-specific or
Medium EPC is the same for
a particular medium
regardless of exposure route.
The route-specific or Route
EPC differs from the
Medium EPC in that the
Route EPC may consider the
transfer of contaminants
from one medium to
another, where applicable
for a particular exposure
route.
8-2
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Medium
Definition:
ซ The environmental substance (e.g., air, water, soil) which
has been contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Row 3 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
1) Contaminants in Ground-water (the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal
Tissue (the Exposure Medium) and are available for exposure to receptors.
8-3
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Row 4 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium)
and exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead
(the Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal
Tissue (the Exposure Medium) and Trout from Dean's Creek (the Exposure
Point) is evaluated.
Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
The text in the Table can not
exceed 80 characters
Row 5 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
8-4
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Instructions:
Choose from the picklist to the right.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at SchooVDaycare/
Playground
Trespasser/Visitor
Farmer
Gardener
Other
Row 6 - Receptor Age
Definition:
The description of the exposed individual, as defined by the
EPA Region or dictated by the site.
Instructions:
Choose from the picklist to the right.
For example, an adult
(receptor age) resident
(receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
BODY OF THE TABLE
Column 1 - Exposure Route
Definition:
The way a chemical comes in contact with a person (e.g., by
ingestion, inhalation, dermal contact).
Instructions:
Enter the exposure route considered from the picklist to the
right.
Inhalation
Ingestion
Combined (i.e., Inhalation
and Ingestion)
Dermal Absorption
Not Documented
External (Radiation)
8-5
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Column 2 - Chemical of Potential Concern
Definition:
Chemicals that are potentially site-related, with data of
sufficient quality, that have been retained for quantitative
analysis as a result of the screening documented in Table 2.
Instructions:
Enter the COPCs selected from the COPC screening.
Table 2 documents COPC
screening.
Column 3 - Medium EPC Value
Definition:
The EPC, based on either a statistical derivation of
measured data or modeled data, that was selected to
represent the medium-specific concentration for the
exposure calculations. The Medium EPC differs from the
Route EPC in that the Medium EPC does not consider the
transfer of contaminants from one medium to another.
For example,
the Medium EPC value may be statistically derived by calculating the 95% UCL of measured
groundwater contaminant concentrations from multiple residential wells. Alternatively, the
MediumEPC value may be selected as a single measured value, if one data point is used to
calculate the risk for each residential well individually. In some cases, the Medium EPC value
may be a modeled value (e.g., ifupgradientgroundwater contaminant concentrations are used
to model a downgradient exposure point.) Note that none of these examples consider the
transfer of contaminants from one medium to another, as is evaluated by Route EPC.
Instructions:
Enter the medium EPC value for each COPC.
The Medium EPC Value
may be developed from a
statistical derivation of
measured data or from
modeled data.
Table 3 documents medium
EPC calculations for RME
and CT.
Column 4 - Medium EPC Units
Definition:
The units associated with the medium EPC value.
Instructions:
Enter the units for medium EPC values.
The units may vary
depending on the medium.
8-6
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Column 5 - Route EPC Value
Definition:
The EPC, based on either a statistical derivation of
measured data or based on modeled data, that was selected
to represent the route-specific concentration for the
exposure calculations. The Route EPC differs from the
Medium EPC in that the Route EPC may consider the
transfer of contaminants from one medium to another,
where applicable for a particular exposure route.
For example,
for groundwater ingestion, the Medium EPC and the Route EPC wtti typically be the
same value. Alternatively, for groundwater inhalation, the Medium EPC will often be a
statistical derivation of measured concentrations in groundwater, while the Route EPC
win often be a modeled inhalation concentration that is based on the measured
concentrations.
Instructions:
Enter the route EPC value for each COPC.
The Route EPC may be
developed from a statistical
derivation of measured data
or from modeled data. The
Route EPC may be identical
to the Medium EPC or it
may be modeled based on the
Medium EPC.
Supporting information
should be provided
documenting Route EPC
calculations.
Column 6 - Route EPC Units
Definition:
The units associated with the route EPC value.
Instructions:
Enter the units for route EPC values.
The units may vary
depending on route of
exposure.
Column 7 - EPC Selected for Risk Calculation
Definition:
The EPC that will be used to quantify potential cancer risks.
Instructions:
Identify the type of EPC used for cancer risk calculations for
each COPC for each exposure route.
Enter "M" for medium EPC.
Enter "R" for route EPC.
M (Medium EPC)
R (Route EPC)
Follow Regional guidance
for selection of this value.
8-7
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Column 8 - Intake (Cancer)
Definition:
A measure of exposure expressed as the mass of a substance
in contact with the exchange boundary per unit body weight
per unit time (e.g. mg chemical/kg body weight/day).
Instructions:
Enter the result of the intake calculations/modeling
performed for each COPC and exposure route.
Refers to the intake result
using the parameters and
equations/calculations, and
or models presented in Table
4.
The intake calculations
and/or models are
documented in Table 4.
Column 9 - Intake Units ( Cancer)
Definition:
The units for intake for each COPC and exposure route.
Instructions:
Enter the units from the intake calculation for each COPC
which corresponds to each exposure route.
Column 10 - Cancer Slope Factor
Definition: ;
A plausible upper-bound estimate of the probability of a
response per unit intake of a chemical over a lifetime.
Usually the cancer slope factor is the upper 95th %
confidence limit of the dose-response curve.
Instructions:
Enter the cancer slope factor for each COPC which
corresponds to each exposure route.
The slope factors for each
COPC are presented in Table
6.
Column 11 - Cancer Slope Factor Units
Definition:
Usually, the cancer slope factor is the upper 95th %
confidence limit of the dose-response curve and is expressed
as (mg/kg-day)"1.
Instructions:
Enter the cancer slope factor units for each COPC for each
exposure route.
8-8
-------
INSTRUCTIONS FOR TABLE 8.1
CALCULATION OF CANCER RISKS (continued)
Column 12 - Cancer Risk
Definition:
The result of the cancer risk calculation for each COPC for
each exposure route and pathway.
Instructions:
Enter the cancer risk calculation for each COPC.
Sum the cancer risk results for each exposure
route/pathway.
Sum the total cancer risk results for all exposure
routes/pathways.
The sum of ail exposure
routes represents the total
cancer risk for all exposure
routes/ 'pathways.
8-9
-------
-------
INSTRUCTIONS FOR TABLE 9
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs
PURPOSE OF THE TABLE:
To provide a summary for each receptor by medium,
exposure route, and exposure point of cancer risks and non-
cancer hazards.
Table 9 presents cancer risk
and non-cancer hazard
information for all COPCs
and media/exposure points
quantitatively evaluated.
INFORMATION DOCUMENTED:
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 pathway
The total cancer risk and non-cancer hazard for each
medium across all exposure routes
The primary target organs for non-carcinogenic hazard
effects.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 9 for each unique combination
of the following three fields that will be quantitatively
evaluated (Scenario Timeframe, Receptor Population, and
Receptor Age).
Enter each combination of these three fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely beginning with 9.1 and ending
with 9.n where "n" represents the total number of
combinations of the three key fields.
Different tables should be prepared to address RME and CT
Risk and Hazard summaries.
Tables 9.1. RME through 9.n. RME should be completed
for RME Risk and Hazard summaries.
Table 9.1 .CT through 9.n.CT should be completed for CT
Risk and Hazard Summaries.
For the example data provided, there should be six copies of Table 9 for the RME calculations,
numbered 9.1.RME through 9.6.RME. Six corresponding tables should be prepared for CT
calculations, numbered 9.1.CT through 9.6.CT.
Table
Number
9.1.RME
9.2.RME
9.3.RME
9.4.RME
9.S.RME
9.6.RME
Scenario
Timeframe
Current
Current
Current
Current
Future
Future
Receptor
Population
Resident
Resident
Fisher
Fisher
Fisher
Fisher
Receptor
Adult
Child
Adult
Child
Adult
Child
It is possible that some tables
may contain the same data
associated with different
descriptions in the Summary
Box in the upper left corner.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCLIS 3 for
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
9-1
-------
INSTRUCTIONS FOR TABLE 9
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs (continued)
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE:
Cancer risk and non-cancer hazard information for all
COPCs and media/exposure points quantitatively evaluated
is to be presented in Table 9.
All table entries are presented on Tables preceding Table 9.
Documentation of the non-cancer hazard values was
presented on Table 7.
Documentation of the carcinogenic risk values was
presented on Table 8.
Total cancer risks and non-cancer hazards associated with
each receptor are to be presented for each exposure point,
across all media and all exposure routes, and for each
individual medium.
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
Row 2 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
Instructions:
Choose from the picklist to the right.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer, Jogger, Fisher
Hunter, Fisher/Hunter
Swimmer
Other Recreational Person
Child at SchooUDaycare/
Playground
Trespasser/Visitor
Farmer, Gardener
Other
9-2
-------
INSTRUCTIONS FOR TABLE 9
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs (continued)
Row 3 - Receptor Age
Definition:
The description of the exposed individual, as defined by the
Region or dictated by the site.
Instructions:
Choose from the picklist to the right.
For example, an adult
(receptor age) resident
(receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
BODY OF THE TABLE
Column 1 - Medium
Definition:
The environmental substance (e.g., air, water, soil) which
has been contaminated.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Column 2 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of
contaminants from one medium to another.
For example:
1) Contaminants in Groundwater (the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure to receptors.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and are available for exposure to receptors.
9-3
-------
INSTRUCTIONS FOR TABLE 9
.. , . i . I
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COlPCs (continued)
Instructions:
Choose from the picklist to the right.
ฃ
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Column 3 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
I) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Skowerhead
(the Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and Trout from Dean's Creek (the Exposure Point) is
evaluated.
Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
The text in the Table can not
exceed 80 characters.
Column 4 - Chemical
Definition:
The COPCs quantitatively considered in the risk
characterization.
The last entry in this column is the term "Total" which
refers to a row of totals for the four columns.
Instructions:
Enter the COPCs from previous tables.
Enter the term "Total" at the end of the list of chemicals for
each exposure point.
9-4
-------
INSTRUCTIONS FOR TABLE 9
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs (continued)
Columns 5, 6, and 7 - Carcinogenic Risk - Ingestion, Inhalation, Dermal
Definition:
The cancer risk value calculated by receptor for each COPC
for each exposure route for each exposure point.
Instructions:
Enter the cancer risk value calculated by receptor for each
exposure route for each exposure point.
Enter the cancer risk totals for each exposure route in the
last row, corresponding to the term "Total" in Column 4.
The value at the bottom of
each column presents the
cancer risk by exposure
route for each exposure
point.
Column 8 - Carcinogenic Risk - Exposure Routes Total
Definition:
The total cancer risk for each COPC across all exposure
routes at each exposure point.
Instructions:
Enter the sum of cancer risks across the three exposure
routes for Columns 5, 6, and 7.
Enter the sum of the cancer risks across exposure routes for
each COPC.
Enter the sum of the cancer risks in this column for each
exposure point.
Enter the total cancer risk across all media and all exposure
routes.
Enter the total cancer risk for each individual medium.
Column 9 - Chemical
Definition:
The COPCs quantitatively considered in the risk
characterization.
The last entry in this column is the term "Total" which
refers to a row of Totals for Columns 11, 12, 13 and 14.
Instructions:
Enter the COPCs from previous tables.
Enter the term "Total" at the end of the list of chemicals for
each exposure point.
9-5
-------
INSTRUCTIONS FOR TABLE 9
SUMMARY OF RECEPTOR RISKS AND HAZARDS FOR COPCs (continued)
Column 10 - Non-Carcinogenic Hazard Quotient - Primary Target Organ
Definition:
The primary effect reported as a primary target organ effect
in IRIS and HEAST.
Instructions:
Enter the primary target organ effect as reported in IRIS
and/or HEAST.
Refer to Regional guidance
to determine if multiple
effects should be provided.
Columns 11, 12, and 13 - Non-Carcinogenic Hazard Quotient - Ingestion, Inhalation,
Dermal
Definition:
The non-cancer hazard calculated by receptor for each
COPC for each exposure route for each exposure point.
Instructions:
Enter the non-cancer hazard value calculated by receptor for
each COPC for each exposure route for each exposure point.
Enter the non-cancer hazard totals for each exposure route
in last row, corresponding to the term "Total" in Column 9.
The value at the bottom of
each column presents the
non-cancer hazard by
exposure route for each
exposure point, for all effects
considered together.
Refer to Regional guidance
for summing hazard
quotients.
Column 14 - Non-Carcinogenic Hazard Quotient - Exposure Routes Total
Definition:
The total non-cancer hazard calculated for each COPC
across all exposure routes at each exposure point.
Instructions:
Enter the sum of non-cancer hazards across the three
exposure routes in Columns 11, 12, and 13.
Enter the sum of the non-cancer hazards across exposure
routes for each COPC and primary target organ.
Enter the sum of the non-cancer hazards in this column for
each exposure point.
Enter the total hazard index across all media and all
exposure routes.
Enter the total hazard index for primary target organs.
Sum the hazard quotient target organ effects by target organ
and enter into the appropriate boxes.
The Totals in each column
present the total non-cancer
hazards across all exposure
routes for each exposure
point. The values at the
bottom of this column
present hazard quotients for
target organs.
Refer to Regional guidance
for specific instructions in
summing hazard quotients.
9-6
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY
PURPOSE OF THE TABLE:
To provide a summary for each receptor by medium,
exposure route, and exposure point of cancer risks and non-
cancer hazards that trigger the need for cleanup.
The Risk Assessor should consult the Project Manager to
determine what levels of risk may be actionable at the site.
The risks shown on Table 10 should be based upon the
Project Manager's recommendation. If all risks are below
actionable levels, determine with the Project Manager
which chemicals should be shown to document the
suitability of a No Action decision.
INFORMATION DOCUMENTED:
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 pathway for risk drivers
The cancer risk and non-cancer hazard for each medium
across all exposure routes for risk drivers
The primary target organs for non-carcinogenic hazard
effects.
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS:
Complete one copy of Table 10 for each unique
combination of the following three fields that will be
quantitatively evaluated (Scenario Timeframe, Receptor
Population, and Receptor Age).
Enter each combination of these three fields in the Summary
Box in the upper left corner of the table.
Number each table uniquely beginning with 10.1 and ending
with 10.n where "n" represents the total number of
combinations of the three key fields.
Different tables should be prepared to address RME and CT
Risk and Hazard summaries.
Tables 10.1. RME through lO.n. RME should be completed
for RME Risk and Hazard summaries.
Table 10.1 CT through lO.n.CT should be completed for CT
Risk and Hazard Summaries.
Table 10 presents cancer risk
and non-cancer hazard
information for those
COPCs and media/exposure
points that trigger the need
for cleanup (the risk drivers).
It is possible that some tallies
may contain the same data
associated with different
descriptions in the Summary
Box in the upper left corner.
Separate tables are necessary
to ensure transparency in
data presentation and
appropriate information
transfer to CERCLISSfor
each exposure pathway.
Replication of information is
readily accomplished using
spreadsheet software.
10-1
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
TABLE NUMBERING AND SUMMARY BOX INSTRUCTIONS
(continued):
For the example data provided, there should be six copies of Table 10 for the RME
calculations, numbered 10.1.RME through 10.6.RME. Six corresponding tables should be
prepared for CT calculations, numbered 10.1.CT through 10.6.CT.
Table Scenario Receptor Receptor
Number Timeframe Population Aee
10.1.RME Current Resident Adult
10.2JRME Current Resident Child
10.3.RME Current Fisher Adult
10.4.RME Current Fisher Child
10.5.RME Future Fisher Adult
10.6.RME Future Fisher Child
GENERAL NOTES/INSTRUCTIONS FOR THIS TABLE
Cancer risk and non-cancer hazard information for only
those COPCs and media/exposure points that trigger the
need for cleanup (the risk drivers) is to be presented in
Table 10.
All table entries are presented on Tables preceding Table
10.
Documentation of the non-cancer hazard values was
presented on Table 7.
Documentation of the carcinogenic risk values was
presented on Table 8.
Total cancer risks and non-cancer hazards associated with
each receptor are to be presented for each exposure point,
across all media and all exposure routes, and for each
individual medium.
HOW TO COMPLETE/INTERPRET THE TABLE
SUMMARY BOX IN UPPER LEFT CORNER
Row 1 - Scenario Timeframe
Definition:
The time period (current and/or future) being considered for
the exposure pathway.
Instructions:
Choose from the picklist to the right.
Current
Future
Current/Future
Not Documented
10-2
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
Row 2 - Receptor Population
Definition:
The exposed individual relative to the exposure pathway
considered.
Instructions:
Choose from the picklist to the right.
For example, a resident
(receptor population) who
drinks contaminated
groundwater.
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at
SchooUDaycare/Playground
Trespasser/Visitor
Farmer
Gardener
Other
Row 3 - Receptor Age
Definition:
The description of the exposed individual, as defined by the
Region or dictated by the site.
Instructions:
Choose from the picklist to the right.
For example, an adult
(receptor age) resident
(receptor population) who
drinks contaminated
groundwater.
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Other
Infant
Toddler
Pregnant
BODY OF THE TABLE
Column 1 - Medium
Definition:
The environmental substance (e.g., air, water, soil) which
has been contaminated.
Enter only the media that
have risks or hazards
exceeding target levels.
10-3
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Column 2 - Exposure Medium
Definition:
The contaminated environmental medium to which an
individual is exposed. Includes the transfer of contaminants
from one medium to another.
For example:
2) Contaminants in Groundwater (the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure to receptors.
2J Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure to receptors.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and are available for exposure to receptors.
Enter only the exposure
media that have risks or
hazards exceeding target
levels.
Instructions:
Choose from the picklist to the right.
Groundwater
Leachate
Sediment
Sludge, Soil
Surface Water
Debris
Other
Liquid Waste
Solid Waste
Air, Vapors
Plant Tissue
Animal Tissue
Surface Soil
Subsurface Soil
Particulates
Spring Water
Column 3 - Exposure Point
Definition:
An exact location of potential contact between a person and
a chemical within an exposure medium.
For example:
1) Contaminants are in Groundwater (the Medium and the Exposure Medium) and
exposure to Aquifer 1 - Tap Water (the Exposure Point) is evaluated.
2) Contaminants in Groundwater (the Medium) may be transferred to Air (the
Exposure Medium) and exposure to Aquifer 1 - Water Vapors at Showerhead
(the Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be transferred to Animal Tissue
(the Exposure Medium) and Trout in Dean's Creek (the Exposure Point) is
evaluated.
Enter only the exposure
points that have risks or
hazards exceeding target
levels.
10-4
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
. Instructions:
Provide the information as text in the Table (not to exceed
80 characters).
The text in the Table can not
exceed 80 characters.
Column 4 - Chemical
Definition:
The COPCs quantitatively considered in the risk
characterization.
The last entry in this column is the term "Total" which
refers to a row of totals for the four columns.
Instructions:
Enter the COPCs from previous tables that exceed target
levels.
Enter the term "Total" at the end of the list of chemicals for
each exposure point.
Enter only the chemicals that
have risks exceeding target
levels.
Columns 5, 6, and 7 - Carcinogenic Risk - Ingestiont, Inhalation, Dermal
Definition:
The cancer risk value calculated by receptor for each COPC
for each exposure route for each exposure point.
Instructions:
Enter the cancer risk value calculated by receptor for each
COPC for each exposure route for each exposure point that
exceeds target levels.
Enter the cancer risk totals for each exposure route in the
last row, corresponding to the term "Total" in Column 4.
Enter only the risks that
exceed target levels.
The value at the bottom of
each column presents the
cancer risk by exposure
route for each exposure
point.
Column 8 - Carcinogenic Risk - Exposure Routes Total
Definition:
The total cancer risk for each COPC across all exposure
routes at each exposure point.
10-5
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
Instructions:
Enter the sum of cancer risks across the three exposure
routes for Columns 5, 6, and 7.
Enter the sum of the cancer risks across exposure routes for
each COPC.
Enter the sum of the cancer risks in this column for each
exposure point.
Enter the total cancer risk across all media and all exposure
routes.
Enter the total cancer risk for each individual medium.
Column 9 - Chemical
Definition:
The COPCs quantitatively considered in the hazard
characterization.
The last entry in this column is the term "Total" which
refers to a row of Totals for Columns 11, 12, 13 and 14.
Instructions:
Enter the COPCs from previous tables with hazards
exceeding target levels.
Enter the term "Total" at the end of the list of chemicals for
each exposure point.
Enter only the chemicals
that have hazards exceeding
target levels.
Column 10 - Non-Carcinogenic Hazard Quotient - Primary Target Organ
Definition:
The primary effect reported as a primary target organ effect
in IRIS and HEAST.
Instructions:
Enter the primary target organ effect as reported in IRIS
and/or HEAST.
Enter only the target organs
that have hazards exceeding
target levels.
Refer to Regional guidance
to determine if multiple
effects should be provided.
Columns 11, 12, and 13 - Non-Carcinogenic Hazard Quotient - Ingestion, Inhalation,
Dermal
Definition:
The non-cancer hazard calculated by receptor for each
COPC for each exposure route for each exposure point.
Enter only the hazards that
exceed target levels.
The value at the bottom of
each column presents the
non-cancer hazard by
exposure route for each
exposure point, for all effects
considered together.
10-6
-------
INSTRUCTIONS FOR TABLE 10
RISK ASSESSMENT SUMMARY (continued)
Instructions:
Enter the non-cancer hazard value calculated by receptor for
each COPC for each exposure route for each exposure point
that exceeds target levels.
Enter the non-cancer hazard totals for each exposure route
in the last row, corresponding to the term "Total" in Column
9.
Refer to Regional guidance
for summing hazard
quotients.
Column 14 - Non-Carcinogenic Hazard Quotient - Exposure Routes Total
Definition:
The total non-cancer hazard calculated for each COPC
across all exposure routes at each exposure point.
Instructions:
Enter the sum of non-cancer hazards across the three
exposure routes in Columns 11, 12, and 13.
Enter the sum of the non-cancer hazards across exposure
routes for each COPC and primary target organ.
Enter the sum of the non-cancer hazards in this column for
each exposure point.
Enter the total hazard index across all media and all
exposure routes.
Enter the total hazard index for primary target organs.
Sum the hazard quotient target organ effects by target organ
and enter into the appropriate boxes.
The Totals in each column
present the total non-cancer
hazards across all exposure
routes for each exposure
point
The values at the bottom of
this column present hazard
quotients for target organs.
Refer to Regional guidance
for specific instructions in
summing hazard quotients.
10-7
-------
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
DEFINITION
ADDITIONAL
INFORMATION
Adjusted Dermal
RfD (5.1)
The adjusted reference dose (RfD)
for each cehmical of potential
concern detected which is derived
from the oral RfD.
Derivations of the adjusted dermal RfD should
be performed in accordance with Regional
guidance.
Adjusted Dermal
Cancer Slope Factor
(6.1)
The dermal cancer slope factor for
each chemical of potential
concern, which typically is derived
from the oral cancer slope factor.
Derivation of the dermal cancer slope factor
should be performed in accordance with
Regional guidance.
Adjusted Inhalation
RfD (5.2)
The inhalation RfD for each
chemical of potential concern
which is derived from the
reference concentration (RfC)
value.
The derivation of the RfD from RfC should be
performed in accordance with Regional
guidance.
Adjustment (6.2)
The value used to derive the
inhalation cancer slope factor from
the unit risk value.
Toxicity values for carcinogenic effects also can
be expressed in terms of risk per unit
concentration of the substance in the medium
where human contact occurs. These measures
are called unit risks and can be calculated from
cancer slope factors.
Arithmetic Mean (3)
The arithmetic average of detected
concentrations.
Background Value
(2)
The background value for the
chemical in that medium as
defined by Regional guidance.
Refer to Regional guidance for how background
values are determined and how background
values are considered for COPC screening. If
Regional guidance requires a "t-test" or other
test which requires backup information, this
information should be presented. A footnote
should be added to this column to clarify the
Regional method used for background. (e.g.,
literature value, data from a nearby site,
statistical tool).
Cancer Risk (8)
The result of the cancer risk
calculation for each COPC for
each exposure route and pathway.
Cancer Slope Factor
(8)
A plausible upper-bound estimate
of the probability of a response per
unit intake of a chemical over a
lifetime. Usually, the cancer slope
factor is the upper 95th %
confidence limit of the dose-
response curve.
Slope factors presented in Table 6 for each
COPC are the same as cancer slope factors
presented in Table 8.
G-l
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
Cancer Slope Factor
Units (8)
DEFINITION
Usually, the cancer slope factor is
the upper 95th % confidence limit
of the dose-response curve and is
expressed as (mg/kg-day)"1.
ADDITIONAL
INFORMATION
Carcinogenic Risk
(Lngestion,
Inhalation, Dermal)
(9,10)
The cancer risk value calculated
by receptor for each COPC for
each exposure route for each
exposure point.
The value at the bottom of each column presents
the cancer risk by exposure route for each
exposure point.
Carcinogenic Risk
(Exposure Routes
Total) (9)
The total cancer risk for each
COPC across all exposure routes
at each exposure point.
CAS Number (2)
The Chemical Abstract Registry
Number, a unique standardized
number which is assigned to
chemicals.
Provide CAS Number for chemicals detected in
the samples for the medium.
Central Tendency
(CT) (3)
Risk calculations which result
from using less conservative
methodologies, instead of
reasonable maximum
methodologies.
Refer to Regional guidance.
CT
Rationale/Reference
(4)
The reason and reference for the
parameter value used. If the
parameter used is inconsistent
with guidance values, provide a
detailed explanation of the
rationale and a complete reference
for the value used.
Refer to Regional or National guidance for
intake parameter values appropriate for each
exposure pathway.
CT Value (4)
The parameter value used for the
central tendency exposure intake
calculation.
Chemical (2)
The name of the compound
detected in samples for the
medium.
Chemicals can be arranged in the order that the
risk assessor prefers.
G-2
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATIONS))
DEFINITION
ADDITIONAL
INFORMATION
Chemicals of
Potential Concern
(COPC)
(3,5.1,5.2,5.3,6.1,6.2,
6.3,7,8)
Chemicals that are potentially site-
related, with data of sufficient
quality, that have been retained for
quantitative analysis as a result of
the screening documented in Table
2.
Provide the chemical name of the COPC based
on the results of the screening documented in
Table 2. Chemicals can be arranged in the
order that the risk assessor prefers.
COPC Flag (2)
A code which identifies whether
the chemical has been selected as
a COPC, based on Regional
screening guidance.
Yes
No
Chronic/Subchronic
(5.1,5.2,5.3)
Identifies whether the RfD for a
particular chemical is for chronic
(long-term) and/or subchronic
(short-term) exposure.
The risk assessor should use professional
judgement when extrapolating to time-frames
shorter or longer than those employed in any
crticial study referenced. AsaSuperfund
program guide-line, chronic is seven years to a
lifetime; subchronic is two weeks to seven years
(RAGS Part A, Sections 6 and 8).
Combined
Uncertainty/
Modifying Factors
(5.1,5.2,5.3)
The factors applied to the critical
effect level to account for areas of
uncertainty inherent in
extrapolation from available data.
Refer to ISIS/HEASTfor these values.
Examples of uncertainty to be addressed
include:
- variations in the general population
- interspecies variability between humans and
animals
- use of subchronic data for chronic
evaluation
- extrapolation from LOAELs to NOAELs.
Concentrations
Used For Screening
(2)
The detected concentration which
was used to compare to the
screening value.
Refer to Regional guidance in determining this
value. For example, maximum or average
values.
Date (MM/DD/YY)
(5,6)
The date of the document that was
consulted for the toxicity and
target organ information.
The MM/DD/YY format refers to
month/day/year. For example, the MMfDD/YY
version of the date March 30,1995 is 03/30/95.
Dermal (9,10)
The predicted route of chemical
exposure through the skin.
Detection
Frequency (2)
The number of times the chemical
was detected versus the number of
times it was analyzed, expressed
as the "fraction" X/Y.
Refer to Regional guidance for an explanation
of how detection frequency should be
interpreted and applied. For example, 5/9
indicates that a chemical was detected in 5 out
of 9 samples.
G-3
-------
"mil! jii'":""
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
Exposure Medium
(1,2,3,4,7,8,9,10)
Exposure Pathway
(1)
Exposure Point
(1,2,3,4,7,8,9,10)
DEFINITION
The contaminated environmental
medium to which an individual is
exposed. Includes the transfer of
contaminants from one medium to
another.
For example, 1) Contaminants in Groundwater
(the Medium) remain in Groundwater (the
Exposure Medium) and are available for exposure
to receptors. 2) Contaminants in Groundwater
(the Medium) may be transferred to Air (the
Exposure Medium) and are available for exposure
to receptors. 3) Contaminants in Sediment (the
Medium) may be transferred to Animal Tissue (the
Exposure Medium) and are available for exposure
to receptors.
The course a chemical 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.
An exact location of potential
contact between a person and a
chemical within an exposure
medium.
For example: 1) Contaminants are in
Groundwater (the Medium and the Exposure
Medium) and exposure to Aquifer I - Tap Water
(the Exposure Point) is evaluated. 2)
Contaminants in Groundwater (the Medium) may
be transferred to Air (the Exposure Medium) and
exposure to Aquifer 1 - Water Vapors at
Showerhead (the Exposure Point) is evaluated.
3) Contaminants in Sediment (the Medium) may be
transferred to Animal Tissue (the Exposure
Medium) and Trout from Dean's Creek (the
Exposure Point) is evaluated.
ADDITIONAL
INFORMATION
Choose from the following picklist:
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Liquid Waste
Solid Waste
Air
Plant Tissue
Animal Tissue
Spring Water
Surface Soil
Subsurface Soil
Particulates
Vapors
Other
Provide the information as text in the table
(not to exceed 80 characters).
G-4
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
Exposure Point
Concentration
(EPC)
(1,2,3,4,7,8,9,10)
EPC Selected for
Risk or Hazard
Calculation (7,8)
EPC Units (3)
Exposure Route
(1,4,7,8,9,10)
Exposure Routes
Total (9,10)
Hazard Quotient (7)
Ingestion (9,10)
Inhalation (9,10)
Inhalation Cancer
Slope Factor (6.2)
Inhalation RfC
Units (5.2)
DEFINITION
The value that represents a
conservative estimate of the
chemical concentration available
from a particular medium or route
of exposure.
The EPC that will be used to
quantify potential cancer risks and
non-cancer hazards.
The units of the data being used to
calculate the exposure point
concentration (EPC).
The way a chemical comes in
contact with a person (e.g., by
ingestion, inhalation., dermal
contact).
The arithmetic sum of cancer risk
and non-cancer hazards for the
COPCs for the exposure point.
The ratio of a single substance
exposure level, over a specified
time period, to a reference dose for
that substance, derived from a
similar exposure period.
The route of chemical exposure
through eating (ingestion).
The route of chemical exposure
through breathing (inhalation)..
A plausible upper-bound estimate
of the probability of a response per
unit intake of a chemical over a
lifetime.
The RfC units for each chemical
detected.
ADDITIONAL
INFORMATION
The EPC may be calculated, measured, or
modeled.
M (le., Medium-Specific EPC)
R (ie., Route-Specific EPC)
Follow Regional guidance for selection of this
value.
Units may vary depending on the environmental
medium.
Choose from the following picklist:
Inhalation
Ingestion
Combined (Le., Inhalation/Ingestion)
Dermal Absorption
Not Documented
External (Radiation)
For non-cancer totals, follow Regional
guidance.
Usually the cancer slope factor is the upper 95th
% confidence limit of the dose-response curve
for inhalation.
G-5
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
DEFINITION
ADDITIONAL
INFORMATION
Inhalation RfC
Value (5.2)
The reference concentration value
for each of the COPCs.
Intake (Cancer) (8)
A measure of exposure expressed
as the mass of a substance in
contact with the exchange
boundary per unit body weight per
unit tune (e.g., mg chemical/kg
body weight/day).
Refers to the intake result using the parameters
and equations/calculations and/or models
presented in Table 4.
Intake (Non-
Cancer) (7)
A measure of exposure expressed
as the mass of a substance in
contact with the exchange
boundary per unit body weight per
unit time (e.g., mg chemical/kg
body weight/day.
Refers to the intake result using the parameters
and equations/calculations and/or models
presented in Table 4.
Intake (Cancer)
Units (8)
The units for intake for each
COPC and exposure route.
Intake (Non-
Cancer) Units (7)
The units for intake for each
COPC and exposure route.
Intake
Equation/Model
Name (4)
The calculation, equation or model
used for intake estimates for each
exposure route.
Location of
Maximum
Concentration (2)
The sample number which
identifies the location where the
sample was taken.
Maximum
Concentration (2)
The highest detected concentration
of the chemical in the medium.
Refer to RAGS - Part A (EPA, 1989) page 5-8
for guidance on detection/quantification limits.
Maximum Detected
Concentration (3)
The highest detected concentration
of the chemical in the medium
which is above the sample
quantisation limit.
Maximum Qualifier
(2)
The alpha-numeric code assigned
to the concentration value by the
analytical chemist during data
validation for the maximum
concentration value.
G-6
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
DEFINITION
ADDITIONAL
INFORMATION
Medium (1)
The environmental substance (e.|
air, water, soil) originally
contaminated.
Choose from the fallowing picklist:
Groundwater
Leachate
Sediment
Sludge
Soil
Surface Water
Debris
Liquid Waste
Solid Waste
Air
Surface Soil
Subsurface Soil
Other
Medium EPC
Rationale (for RME
or CT) (3)
The reason the cited statistic was
used to represent the EPC for
RME or CT.
Medium EPC
Statistic (for RME
or CT) (3)
The statistic selected to represent
the Medium EPC Value (RME or
CT), based on Regional guidance,
the distribution of the data,
number of data points, etc.
Often, this is the 95% Upper Confidence Level
(UCL) of the log-transformed data.
Medium EPC Units
(7,8)
The units associated with the
Medium EPC Value.
Units may vary depending on the Medium.
Medium EPC Value
(for RME) (3,7,8)
The EPC, based on either a
statistical derivation of measured
data or modeled data, that was
selected to represent the medium-
specific concentration for the
RME exposure calculations. The
Medium EPC differs from the
Route EPC in that the Medium
EPC does not consider the transfer
of contaminants from one medium
to another.
The Medium EPC Value may be developed from
a statistical derivation of measured data or from
modeled data. For example, the Medium EPC
value may be statistically derived by calculating
the 95% UCL of measured groundwater
contaminant concentrations from multiple
residential wells. Alternatively, the Medium
EPC value may be selected as a single measured
value if one data point is used to calculate the
risk for each residential well individually. In
some cases, the Medium EPC value may be a
modeled value (e.g., if upgradient groundwater
contaminant concentrations are used to model a
downgradient exposure point.) Note that none
of these examples consider the transfer of
contaminants from one medium to another, as
is evaluated by Route EPC.
G-7
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
DEFINITION
ADDITIONAL
INFORMATION
Medium EPC Value
(for CT) (3,7,8)
The EPC, based on either a
statistical derivation of measured
data or modeled data, that was
selected to represent the medium-
specific concentration for the CT
exposure calculations. The
Medium EPC differs from the
Route EPC in that the Medium
EPC does not consider the transfer
of contaminants from one medium
to another.
The Medium EPC Value may be developed from
a statistical derivation of measured data or from
modeled data. For example, the Medium EPC
value may be statistically derived by calculating
the 95% UCL of measured groundtvater
contaminant concentrations from multiple
residential wells. Alternatively, the Medium
EPC value may be selected as a single measured
value, if one data point is used to calculate the
risk for each residential well individually. In
some cases, the Medium EPC value may be a
modeled value (e.g., if upgradient ground-water
contaminant concentrations are used to model a
downgradient exposure point) Note that none
of these examples consider the transfer of
contaminants from one medium to another, as
is evaluated by Route EPC.
Minimum
Concentration (2)
The lowest detected concentration
of the chemical in the medium.
Minimum Qualifier
(2)
The alpha-numeric code assigned
to the concentration value by the
analytical chemist during data
validation for the minimum
concentration value.
Non-Carcinogenic
Hazard Quotient
(Primary Target
Organ) (9,10)
The primary effect reported as a
primary target organ effect in IRIS
and HEAST.
Non-Carcinogenic
Hazard Quotient
(Digestion,
inhalation, Dermal)
(9,10)
The non-cancer hazard calculated
by receptor for each COPC for
each exposure route for each
exposure point.
The value at the bottom of each column presents
the non-cancer hazard by exposure route for
each exposure point, for all effects considered
together.
Non-Carcinogenic
Hazard Quotient
(Exposure Routes
Total) (9,10)
The total non-cancer hazard
calculated for each COPC across
all exposure routes at each
exposure point.
The totals in each column present the total non-
cancer hazards across all exposure routes for
each exposure point. The values at the bottom
of this column present hazard quotients for
specific target organs.
Not Documented
(picklist term)
The CERCLIS 3 picklist term used
when no information is available.
On-Site/Off-Site (1)
The location of potential contact
between a person and a chemical
(contaminant) as it relates to the
site boundary.
Choose from the following picklist:
On-site
Off-site
On-site/Off-site
Not Documented
G-8
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GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
Oral Cancer Slope
Factor (6.1)
Oral Reference
Dose (RfD) Units
(5-1)
Oral RfD Value
(5-1)
Oral to Dermal
Adjustment Factor
(5.1,6.1)
Parameter Code (4)
Parameter
Definition (4)
Potential Applicable
or Relevant and
Appropriate
Requirements and
To Be Considered
(ARAR/TBC)
Source (2)
Potential
ARAR/TBC Value
(2)
Primary Target
Organ
(5.1,5.2,5.3,9,10)
Range of Detection
Limits (2)
Rationale for
Contaminant
Deletion/Selection
(2)
DEFINITION
Cancer slope factor for ingestion.
The oral reference dose (RfD)
units for each COPC.
The oral RfD value for each of the
COPCs.
The adjustment factor used to
convert the oral RfD values to
dermal RfD values.
The code used for parameters in
the intake equation.
The parameters used in the intake
equation.
The type or source of ARAR/TBC
value entered into the adjacent
column.
ARAR/TBC values.
The organ that is affected most
(i.e., experiences critical effects)
by chronic or subchronic exposure
to the specific COPC, and upon
which the RfD is based.
The lowest and highest detection
limits.
The reason the chemical was
selected or not selected for
quantitative or qualitative analysis.
ADDITIONAL
INFORMATION
See the instructions for standard codes. Other
codes may be added if appropriate.
For example,
MCL
SMCL
They could be MCL values, soU cleanup level
values, or other values to be considered. Refer
to Regional guidance regarding the
requirements for this column.
Refer to Regional or National guidance for
definitions of detection limits.
Follow Regional guidance for the rationale
codes.
G-9
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GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
Rationale for
Selection or
Exclusion of
Exposure Pathway
(1)
Reasonable
Maximum Exposure
(RME)(3)
RME
Rationale/Reference
(4)
RME Value (4)
Receptor Age (1)
Receptor
Population (1)
DEFINITION
The reason the exposure pathway
was selected or not selected for
quantitative or qualitative analysis.
The highest exposure that is
reasonably expected to occur.
The reason and reference for the
parameter value used. This
rationale may be Regional or
National guidance.
The parameter value used for the
RME intake calculation.
The description of the exposed
individual as defined by the EPA
Region or dictated by the site.
For example, an adult (Receptor Age) resident
(Receptor Population) who drinks contaminated
groundwater.
The exposed individual relative to
the exposure pathway considered.
For example, a resident (Receptor Population) who
drinks contaminated groundwater.
ADDITIONAL
INFORMATION
Follow Regional guidance for the rationale
codes. The narrative in the Table can not
exceed 200 characters.
Jfthe parameter used is inconsistent with
guidance values, provide a detailed explanation
of rationale and a complete reference for the
value.
Choose from the following picklist:
Child
Adult
Adolescents (teens)
Pre-Adolescents
Not Documented
Child/Adult
Geriatric
Sensitive
Infant
Toddler
Pregnant
Other
Choose from the following pickUst:
Resident
Industrial Worker
Commercial Worker
Construction Worker
Other Worker
Golfer
Jogger
Fisher
Hunter
Fisher/Hunter
Swimmer
Other Recreational Person
Child at School/Daycare/Playground
Trespasser/Visitor
Farmer
Gardener
Other
G-10
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GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
DEFINITION
ADDITIONAL
INFORMATION
Reference
Concentration (7)
The toxicity value for inhalation
typically reported as a
concentration in air (mg/m3) which
can be converted to an inhaled
dose (mg/kg-day).
Reference
Concentration Units
(7)
The units associated with the
reference concentration.
Reference Dose
(RfD) (7)
The preferred toxicity value for
evaluating non-cancer effects
resulting from exposures.
RfD or RfC Units
(7,8)
The units associated with the RfD
or RfC for each COPC.
Typically reported in mg/kg-day, a dose term.
Route EPC Units
(7,8)
The units associated with the
Route EPC Value.
Units may vary depending on the Route of
Exposure.
Route EPC Value
(7,8)
The EPC, based on either a
statistical derivation of measured
data or based on modeled data,
that was selected to represent the
route-specific concentration for
the exposure calculations. The
Route EPC differs from the
Medium EPC in that the Route
EPC may consider the transfer of
contaminants from one medium to
another, where applicable for a
particular exposure route.
The Route EPC may be developed from a
statistical derivation of measured data or from
modeled data. The Route EPC may be identical
to the Medium EPC or it may be modeled based
on the Medium EPC. For example, for
groundwater ingestion, the Medium EPC and
the Route EPC will typically be the same value.
Alternatively, for groundwater inhalation, the
Medium EPC will often be a statistical
derivation if measured concentrations in
groundwater, while the Route EPC will often be
a modeled inhalation concentration that is based
on the measured concentrations.
Scenario Timeframe
(1)
The time period (current and/or
future) being considered for the
exposure pathway.
Choose from the fallowing picklist:
Current
Future
Current/Future
Not Documented
Screening Toxicity
Value (2)
The screening level used to
compare detected concentrations
of chemicals.
Refer to Regional guidance for the source of the
screening value and for guidance on comparing
the screening value to detected concentrations.
Source (6.1,6.2,6.3)
A reference for the weight of
evidence/cancer guideline
description entry.
For example:
IRIS
HEAST
NCSA
G-ll
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION(S))
Source of
Toxicity/Primary
Target Organ (5.3)
Source of
RfD/RfC/Primary
Target Organ
(5.1,5.2,5.3)
Sub chronic
(5.1,5.2,5.3)
Summary Box
(2,3,4,7,8,9,10)
Total Hazard Index
(9,10)
Total Risk (9,10)
Toxicity Units
(5.3,6.3)
Type of Analysis (1)
DEFINITION
The source of the toxicity value
and primary target organ
information.
The source of the RfD/RfC and
target organ information.
A short-term (two weeks to seven
years) designation.
A box in the upper left comer of a
Table containing the combination
of parameters that define a unique
exposure pathway.
A summation of non-cancer
hazards across media and
exposure routes.
A summation of cancer risk across
media and exposure routes.
The units associated with the
toxicity value.
The level of evaluation
(quantitative or qualitative) to be
performed for the exposure
pathway based on site-specific
analysis.
ADDITIONAL
INFORMATION
For example:
IRIS
HEAST
NCEA
For example:
IRIS
HEAST
NCEA
As a Superfund program guideline, chronic is
seven years to a lifetime; subchronic is two
weeks to seven years (RAGS Part A, Sections 6
and 8). The risk assessor should use
professional judgement when extrapolating to
timeframes shorter or longer than those
employed in any crticial study referenced.
The Summary Box typically specifies the unique
combination of Scenario Timeframe, Medium,
Exposure Medium, and Exposure Point. For
selected tables, the Receptor Population and
Receptor Age are presented.
Refer to Region-specific guidance on summing
toxic endpoint effects.
Choose from the following picklist:
Quant (Le., Quantitative)
Qual (Le., Qualitative)
None
G-12
-------
GLOSSARY FOR COMPLETION OF STANDARD TABLES
TERM (TABLE
LOCATION^))
DEFINITION
ADDITIONAL
INFORMATION
Units (2,3)
The concentration units for each
chemical detected.
Refer to Regional guidance to determine if there
is a preference regarding the units used for
different matrices (e.g., mg/kg for soil, ug/Lfor
groundwater). Choices include:
mg/l
Pgfl
ppb
mg/kg
fg/S
fibers/I
Ibs/day
jiRemlhr
pCVkg
fg/l
%
ppt
mg/nf
fibers/m3
ugflOOcm2
Rem/yr
pCi/m3
pCUnflsec Other
ng/l
ppm
gfkg
ng/kg
ftg/m3
fibers/kg
mg/cm2
pCi/g
pan
Not Documented
Units (for
parameter codes)
(4)
The units for the parameter code
used in the intake equation.
Unit Risk (6.2)
Toxicity values for carcinogenic
effects expressed in terms of risk
per unit concentration of the
substance in the medium where
human contact occurs. These
measures can be calculated from
cancer slope factors.
Toxicity Value
(5.3,6.3)
The toxicity value for each of the
COPCs.
Weight of
Evidence/Cancer
Guideline
Description (6.1,6.2)
An EPA classification system for
characterizing the extent to which
the available data indicate that an
agent is a human carcinogen.
EPA Group:
A - Human carcinogen
Bl - Probable human carcinogen - indicates
that limited human data are available.
B2 - Probable human carcinogen - indicates
sufficient evidence in animals and inadequate or
no evidence in humans.
C - Possible human carcinogen
D - Not classifiable as a human carcinogen
E - Evidence ofnoncarcinogenicity
Weight of Evidence:
Known/Likely
Cannot be Determined
Not Likely
95% UCL of
Normal Data (3)
The statistic for the 95% Upper
Confidence Limit (UCL) on the
arithmetic mean of measured data.
Refer to National guidance (Supplemental
Guidance to RAGS: Calculating the
Concentration Term, OSWER Directive:
9285.7-081, May 1992) and Regional guidance
for calculating this term.
Supplemental information should be provided in
the risk assessment.
G-13
-------
-------
APPENDIX C
DATA USEABILITY WORKSHEET
Revision No. 0 January 1998
-------
-------
DATA USEABILITY WORKSHEET
Site:
Medium:
Requirement
Comment
Field Sampling
Discuss sampling problems and field conditions that
affect data useability.
Are samples representative of receptor exposure for
this medium (e.g. sample depth, grab vs composite,
filtered vs unfiltered, low flow, etc.)?
Assess the effect of field QC results on data useability.
Summarize the effect of field sampling issues on the
risk assessment, if applicable.
Analytical Techniques
Were the analytical methods appropriate for
quantitative risk assessment?
Were detection limits adequate?
Summarize the effect of analytical technique issues on
the risk assessment, if applicable.
-------
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Requirement
Comment
Data Quality Objectives
Precision - How were duplicates handled?
Accuracy - How were split samples handled?
Representativeness - Indicate any problems associated
with data representativeness (e.g., trip blank or rinsate
blank contamination, COC problems, etc.).
Completeness - Indicate any problems associated with
data completeness (e.g., incorrect sample analysis,
incomplete sample records, problems with field
procedures, etc.).
Comparability - Indicate any problems associated with
data comparability.
Were the DQOs specified in the QAPP satisfied?
Summarize the effect of DQO issues on the risk
assessment, if applicable.
-------
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Requirement
Comment
Data Validation and Interpretation
What are the data validation requirements for this
region?
What method or guidance was used to validate the
data?
Was the data validation method consistent with
regional guidance? Discuss any discrepancies.
Were all data qualifiers defined? Discuss those which
were not.
Which qualifiers represent usable data?
Which qualifiers represent unusable data?
How are tentatively identified compounds handled?
-------
DATA USEABILITY WORKSHEET (continued)
Site:
Medium:
Requirement
Summarize the effect of data validation and
interpretation issues on the risk assessment, if
applicable.
Additional notes:
Comment
Note: The purpose of this Worksheet is to succinctly summarize the data useability analysis and conclusions. Reference
Specific pages in the Risk Assessment text to further expand on the information presented here.
-------
If you are interested in being on a mailing list for notification of revisions and updates to the
RAGS Part D guidance document, please complete the following information, and indicate
wnether you want to be notified by surface mail or by e-mail. Alternatively, you can go to the
RAGS Part D website at http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.html.
The notifications will contain information on how to access the document revisions and updates.
I want to receive e-mail notification
I want to receive surface mail notification
Name
Organization,
Address
City State Postal Code_
Country
E-mail Address
Please provide any comments you may have in the space below, or via the Internet at the RAGS
Part D website at http://www.epa.gov/superfund/oerr/techres/ragsd/ragsd.htnil.
-------
(Fold this page in half and seal shut before mailing)
Senior Process Manager for Risk
RAGS Part D
U.S. Environmental Protection Agency (5202G)
401 M Street, SW
Washington, DC 20460
-------
RISK ASSESSMENT GUIDANCE FOR SUPERFUND
RAGS PartO
- Blank and Example Standard Tables
- Instructions for Standard Tables
- Data Useablllty Worksheet
-------
1 II
1 1 ' ijl ll Ill i '
1 ii ". i I II i I i I ll I ; " n>i i, i : ,
ilillli I
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-------
United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
&EPA
Publication 9285.7-01 DPS
EPA/540/F-97/036
PB97-963311
January 1998
Frequently Asked Questions:
RAGS Part D
Office of Emergency and Remedial Response
Quick Reference Fact Sheet
This fact sheet summarizes frequently asked questions regarding the U.S. Environmental Protection Agency's (EPA)
Risk Assessment Guidance for Superfund Volume I - Human Health Evaluation Manual (Part D, Standardized Planning,
Reporting, and Review of Superfund Risk Assessments) Interim (RAGS Part D). The March 21, 1995 memorandum
on Risk Characterization Policy and Guidance from 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, members of Congress, and others have called for the betterment of Superfund risk assessments. The October
1995 Superfund Administrative Reform #6A directed EPA to: Establish National Criteria to Plan, Report, and Review
Superfund Risk Assessments. EPA has developed an approach to respond to these challenges, which is presented in
RAGS Part D.
RAGS Part D was developed by a Workgroup of EPA Headquarters and regional risk assessors (the RAGS Part D
Workgroup) in concert with the CERCLIS 3 database development team to help standardize and improve the risk
assessment process. The following frequently asked questions have been developed to clarify how and when RAGS Part
D should be applied to a risk assessment.
APPLICABILITY
1. To what sites will RAGS Part D apply?
RAGS Part D will apply to all Superfund risk assess-
ments starting after January 1, 1998. In addition, the
use of RAGS Part D is encouraged to the extent it can
be efficiently incorporated into ongoing risk assessments
started before that time. RAGS Part D is applicable to
Remedial, Post-Remedial and SACM sites. The use of
RAGS Part D is also encouraged for Removal and
RCRA Corrective Action sites. The RAGS Part D
Workgroup suggests that RAGS Part D could also be a
useful tool for quantitative risk assessment at non-NPL,
BRAC, and Brownfields sites, and encourages its use.
2. At what phase of investigation should the Standard
Tables be used at sites?
RAGS Part D describes the value that Interim Deliver-
ables, which include the Standard Tables, add to the
CERCLA remedial process, beginning with scoping and
extending through the completion of the Baseline Risk
Assessment.
3. Has DOD accepted RAGS Part D? Who will be
responsible for ensuring that all of the services
receive and use the Standard Tables?
We are working with DOD Headquarters as well as our
4.
5.
EPA Federal Facilities office to introduce the elements
of RAGS Part D. So far, we have received positive
feedback from the management at DOD. The individual
services will be responsible for implementation of
RAGS Part D. We are briefing various levels of Federal
Facilities (DOD and others) about RAGS Part D and are
highlighting the advantages of using it.
Some Federal department staff were involved in the
development of RAGS Part D. The Air Force, Navy,
and Army were asked to comment on the draft Standard
Table package and many of their comments were
incorporated into RAGS Part D.
Should every EPA region use RAGS Part D?
Yes
Does this guidance apply to non-NPL sites?
While the guidance is specifically targeted for NPL
sites, the use of RAGS Part D is also encouraged for
Removal and RCRA Corrective Action risk assess-
ments. The principles of continuous involvement of the
EPA risk assessor and the use of Standard .Tools to plan,
report, and review risk assessments would be helpful at
any site.
-------
6. Is RAGS Part D applicable to state agencies?
RAGS Part D is applicable to Superfiind risk assess-
ments performed under state oversight. The use of
RAGS Part D is also encouraged for Removal and
RCRA Corrective Action sites.
7. Have state agencies been involved in the develop-
ment of RAGS Part D?
Several regions have shared drafts of RAGS Part D with
states in their region, and the Workgroup considered the
state comments when preparing RAGS Part D.
IMPLEMENTATION
8. Rather than save time and money, it seems that the
use of RAGS Part D will slow down the process.
How will use of the Standard Tables save tune and
money? Adding another major review of Interim
Deliverables will cause major delays in projects.
Initially, implementation may take longer than tradi-
tional risk assessments; there is a learning curve associ-
ated with any new guidance. The road map for continu-
ous involvement of the EPA risk assessor, presented in
Chapters 2 through 5 of RAGS Part D, and the Standard
Tables, are standard tools to perform a risk assessment
that should ultimately make the process more efficient.
Specifically, review of Interim Deliverables will in-
crease the likelihood that deliverables will be right the
first time and will reduce rework because EPA's expec-
tations for the risk assessment are clear at project
initiation to both PRP and EPA contractors.
Preparation, review, and approval time will be shortened
when each risk assessment presents information in a
consistent manner using the Standard Table format.
Consistency of presentation between risk assessments
should also lead to better quality risk assessments.
Eliminating manual data entry into CERCLIS 3 will
greatly reduce time and resources spent on reporting risk
information. On the regional level, eliminating manual
data entry will save the regions from having to provide
hard copies of risk assessments to EPA Headquarters.
In addition, EPA should be able to respond more easily
to information requests, such as Congressional inquiries,
by accessing electronic databases.
Regarding Interim Deliverables, another review is not
being added; instead existing reviews are being phased
to occur at trie most critical times. Early and continuous
involvement of the EPA risk assessor will lead to fewer
data gaps and less rework associated with the Draft
Baseline Risk Assessment.
9. The risk assessors in our region are so busy now,
how can they possibly be involved in every step of
the RI, FS, and other parts of the process? We are
going to need more risk assessors if this is the case.
EPA Headquarters has canvassed the regions and
requested resource requirements to implement the
elements of RAGS Part D. EPA Headquarters is at-
tempting to supplement the staff in the regions to meet
those demands. In addition, the standard reporting
formats (Standard Tables) provided in this guidance will
make it easier for RPMs to identify risk assessment data
requirements if a regional risk assessor is not available
to review a risk assessment.
10. It seems that implementation of RAGS Part D will
cost more money, since most PRPs and contractors
already have their own standard formats for risk
assessments. Why are we reinventing the wheel?
How can we estimate the initial increase in cost of
this guidance for our contractors?
Initially, PRPs and contractors may have to amend their
spreadsheets to provide appropriate data for the Stan-
dard Tables. Regional risk assessors should be able to
estimate the initial cost for amending spreadsheets.
After this initial effort, the cost should actually decrease
because of the standardization of requirements. EPA is
implementing RAGS Part D in response to concerns by
Congress (and the public) regarding the problems with
transparency, clarity, consistency, and reasonableness of
risk assessments. Without Standard Table formats, risk
assessment information would continue to vary in
completeness and clarity, and the data would have to be
entered into CERCLIS 3 manually.
11. Why are the Standard Tables so long and redun-
dant? Why not "nest" information within columns?
The Standard Table format promotes transparency in
data presentation and facilitates subsequent electronic
data transfer to CERCLIS 3. The electronic format will
enable risk assessors to copy columns rather than retype
information, so any repetition should not be burden-
some. In addition, because of the eventual link between
the Standard Tables and CERCLIS 3, it is necessary to
segregate distinct pieces of information in order to make
electronic transfer possible.
12. How will implementation of RAGS Part D add to
consistency hi risk assessments when we say that risk
assessors should refer to regional guidance?
RAGS Part D adds to consistency of reporting of risk
information. Where there is not overarching National
guidance, regional differences exist. The risk assessor
should refer to the regional office for appropriate
guidance on topics such as variations in fish consump-
tion rates, models used for showering scenarios, and
selection of default exposure parameters.
TRANSITION
13. If I am asking my contractors to implement the use
-------
of Standard Tables, I will have to amend state-
ments of work for all my sites. This will be a lot of
work.
Sites with risk assessments already underway will be
handled on a case-by-case basis and may not need
amended SOWs. EPA Headquarters has offered assis-
tance to regions in amending SOWs for EPA contractors
performing risk assessments. For PRP lead sites,
regions will be responsible for amending consent
decrees as needed.
14. Will RPMs, contractors, etc. be trained in the use of
RAGS Part D?
There will be training in each region in FY 98 for
Federal and state risk assessors, RPMs, and contractors
regarding the elements of RAGS Part D.
15. How will the format of the Standard Tables change
in years ahead as new guidance is released?
The format of the Standard Tables is the result of an
extensive development effort, and we do not expect
major changes to the Standard Tables except for addi-
tions resulting from new guidance (e.g., lead guidance,
Monte Carlo/Probabilistic Analysis, and ecological
guidance).
16. If I have questions on how to complete one of the
Standard Tables, who do I contact?
The Instructions for the Standard Tables offer detailed
guidance for completion of these Tables. EPA is also
developing a website and telephone Helpline to assist
users in implementing RAGS Part D and as a source of
update information. In addition, the RAGS Part D
Workgroup member from your region (listed at the end
of this Fact Sheet) should be able to assist you and
answer questions about the Standard Tables.
PROCEDURES/APPLICATION
17. Are there comparable tables for ecological risk
assessment?
Standard Tables for ecological risk assessment are on a
different track than the human health Standard Tables.
EPA Headquarters representatives are working with
regional risk assessors on Standard Tables for ecological
risk assessment.
18. If ecological concerns are driving the site cleanup,
what Standard Tables should be used?
The Standard Tables for human health risk assessment
should be completed if a human health risk assessment
is being prepared. Ecological Standard Tables, once
finalized, should be used to present ecological risk
assessment information. Standard Tables for ecological
risk assessment are being developed under another
initiative.
19. EPA just released Monte Carlo guidance. How will
tins be reflected in the Standard Tables?
The current version of the Standard Tables in RAGS
Part D does not address Monte Carlo Analysis; however,
Chapters 2 and 3 discuss probabilistic analysis. Once
the Superfund program completes guidance in these
areas, Standard Tables will be developed to implement
the guidance, hi addition, there will be updates to these
tables periodically and a website and Helpline will be
available for guidance on changes.
20. What is the definition of EPA risk assessor?
This term refers to the risk assessor responsible for
reviewing the risk assessment on behalf of EPA. hi
general, the EPA risk assessor is employed by EPA.
Many EPA regions may also receive contractor, inter-
agency, or state support hi performing the role of the
EPA risk assessor. The designation is a region-specific
matter.
21. Mow is lead exposure addressed by the Standard
Tables?
A separate Standard Table documenting lead exposure,
based on the IEUBK model, is under development.
When completed, it will be made available through the
website (http://www.epa.gov/superfund/oerr/techres/
ragsd/ragsd-html) and through the RAGS Part D Work-
group member from your EPA region.
22. Will Interim Deliverables be subject to enforceable
schedules?
Enforceable schedules of Interim Deliverables will be
handled on a site-specific basis in each region.
23. Can the Standard Tables be altered?
No. The Standard Table formats can not be altered (i.e.,
columns can not be added, deleted, or changed); how-
ever, rows and footnotes can be added as appropriate.
Standardization of the Standard Tables is needed to
achieve Superfund program-wide reporting consistency
and to accomplish electronic data transfer to CERCLIS
3.
24. When, in the risk assessment process, are Interim
Deliverables due?
The schedule for Interim Deliverables will be deter-
mined on region-specific and site-specific bases.
25. Does RAGS Part D contradict the format outlined in
FLAGS Part A?
No. RAGS Part D supplements RAGS Parts A, B, and
C.
26. What happens if a chemical is not originally included
as a Chemical of Potential Concern, but is later
detected?
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The Standard Tables should reflect the information used
in the Baseline Risk Assessment to make the remedy
decision. If necessary, the Standard Tables may require
modification to reflect new data. The use of electronic
spreadsheets makes this an easy task.
CERCLIS 3
27. How will information be entered into CERCLIS 3?
The Standard Tables prepared in Lotusฎ and/or Excel8
formats will be electronically transferred to CERCLIS
3 using an upload function that is under development.
28. Who will enter information into CERCLIS 3?
Responsibility for entry of CERCLIS 3 risk data during
FY 98 has not yet been determined. Use of Standard
Tables by the risk assessor will minimize the burden of
manual entry of risk data into CERCLIS 3.
29. Who will have access to the risk data in CERCLIS 3
(e.g., public, DOD, EPA Program Managers, RPMs,
risk assessors)?
The CERCLIS 3 database managers will determine data
accessibility. It has been recommended that entities
contributing data to CERCLIS 3 be given access to it.
At the moment, it is planned for the public to have
access to non enforcement-sensitive data. The EPA
regional Information Management Coordinators will
have information on CERCLIS 3 data accessibility.
FOR FURTHER INFORMATION
The technical details (e.g., equations and assumptions)
necessary to complete a risk assessment are available in
RAGS. Additional information and guidance can be found
in the various OSWER directives that have been released on
risk assessment, for additional copies of this Frequently
Asked Questions Fact Sheet, or any of the aforementioned
risk assessment guidance documents, call the National
Technical Information Service (NTIS) at (703) 487-4650 or
1-800-553-NTIS (6847). Alternately, you can access
information on RAGS Part D via the Internet at the following
location:
http:/Avww.epa.gov/superfund/oerr/techres/ragsd/ragsd.html
The following members of the EPA RAGS Part D Work-
group may also be contacted:
EPA Headquarters: Jim Konz
(konz.james@epamail.epa.gov)
Region I: Ann-Marie Burke
(burke.annmarie@epamail.epa.gov)
Region II: Marian Olsen
(olsen.marian@epamail.epa.gov)
Region HI: Jennifer Hubbard
(hubbard.jennifer@epamail.epa.gov)
Region IV: Glenn Adams
(adams.glenn@epamail.epa.gov)
Region V: Andrew Podowski
(podowski.andrew@epamail.epa.gov)
Region VI: Ghassan Khoury
(khoury.ghassan @ epamail. epa.gov)
Region YE: Dave Crawford
(crawford.david@epamail.epa.gov)
Region Vffl: Chris Weis
C we is. chris @ epama il. epa. gov)
Region IX: StanSmucker
(smucker.stan @ epamail. epa. gov)
Region X: DanaDavoli
(davoli. dona @ epamail. epa.gov)
REFERENCES
U.S. EPA. 1989. Risk Assessment Guidance for Superfund
(RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part A, Interim Final. Office of Emergency and
Remedial Response, Washington, DC. EPA/540/1-89/002.
NTISPB90-155581.
U.S. EPA. 1991a. Risk Assessment Guidance for Super-fund
(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 Publication
9285.7-01 B. 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/540/R-92/004. Publication 9285.7-
01C. NTIS PB92-963334.
U.S. EPA. 1998. Risk Assessment Guidance for Superfund
(RAGS): Volume I: Human Health Evaluation Manual
(HHEM), Part D, Standardized Planning, Reporting, and
Review of Superfund Risk Assessments. Office of Emergency
and Remedial Response, Washington, DC. EPA/540/R-
97/033. Publication 9285.7-01D. NTIS PB97-963305.
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