The U.S. Environmental Protection Agency (EPA) is establishing national guidance for data quality requirements to optimize the
useahility of data collected under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCI.A).
"I Jseable" data ;ire data of sufficient quality to meet their intended use. The Guidance for Data Useability in Risk Assessment (Pari A)
(9285.7-09 A) provides risk assessors and RPMs with nationally-consistent procedures to plan and assess sampling and analysis of useable
environmental da la for baseline human health risk assessments. Although the guidance addresses the baseline risk assessment within the
remedkd investigation (RI), it is appropriate for use in the new Superfund Accelerated Cleanup Model (S ACM) where data needs for risk
assessment ;ue considered at Hie onset of site evaluation. The guidance is useful to all parties involved in a site evaluation. This final
version supersedes the "interim final" Guidance for Data Useability in Risk Assessment (EPA/540/G-90/008).
This fact sheet provides an overview of Part A and Part R of the Guidance for Data Useability in Risk Assessment. It highlights key
points of (lie documents and stales where additional information can be found. Copies of the guidances can be obtained from the National
Technical Information Service at 703-487-4650. Part B of the guidance specifically addresses the useability of radioanalytical data tor
baseline human health risk assessment.
United States	Office of	Publication 9285.7-09FS
Environmental Protection Solid Waste and	June 1992
Agency	Emergency Response
Guidance For
Data Useability In
Risk Assessment
Office of Emergency and Remedial Response	Quick Reference Fact Sheet
Hazardous Site Evaluation"Division^ 6S-230
Who is This Guidance for?
Remedial project managers (RPMs), who have the principal
responsibility lor leading data collection and assessment activi-
ties, and risk assessors, who support human health risk assess-
ments, will benefit the most from the guidance. RPMs oversee the
preparation of work plans and s;unpling and analysis plans forRI
data collection. It is important for them to understand the types,
quality, and quantity of data needed by risk assessors, and the
impact that their data collection and analysis decisions have on the
level of ceruiinty of baseline risk assessment for human health.
The guidance will help risk assessors to be an integral part of
the RI planning process, to ensure that the environmental data
collected during the RI meet their needs. Data collected only to
identify the "nature and extent" of contamination at a site may not
necessarily satisfy the data needs for baseline risk assessments,
l or exiunple, a sampling strategy designed to determine the
spatial boundaries of a contaminated area may not provide ad-
equate data to quantitate concentrations within an exposure area.
The risk assessor should work closely with the RPM to identify
and recommend sampling designs and analytical methods that
will optimize thequality of the data collected for a baseline human
health risk assessment within the site-related and budgetary con-
straints of the RI. Chemists, quality assurance specialists,
hydrogeologists, statisticians and other technical personnel in-
volved in die RI process will also find this guidance useful.
Part B of the Guidance for Data Useahility in Risk Assess-
ment is addressed primarily to RPMs and risk assessors who share
the responsibility of ensuring that the data collected during the RI
lor a radiation site are of sufficient quality and quantity to be
useable in developing a baseline human health risk assessment. It
is also directed to radiation protection specialists, health physi-
cists and radiochemists who are called upon by RPMs and risk
assessors to assist in the identification and evaluation of radiation
hazards, to recommend specific radionuclide sampling and analy-
sis procedures, and to interpret and comment on the useability of
resultant radioanalytical data.
What is the Guidance?
The guidance is a tool for obtaining and assessing analylic;il
data for baseline human health risk assessments that are conducted
as part of an RI. The guidance:
•	Defines six criteria which determine data useability and
describes how they ;ire applied through the planning and
assessment phascsof baseline risk assessment (see 11 i
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HIGHLCgKT 1. DATA USEABILITY CRITERIA TO PLAN SAMPLING,
ANALYSIS AND ASSESSMENT EFFORTS
IN BASELINE RISK ASSESSMENT
DEFINING
PLANNING
ASSESSING
DETERMINING
Tips that draw attention to key is-
sues in the text. For example:
All data can be used in
baseline risk assessment
as long as their uncer-
tainties are clearly de-
scribed.
Appendices requested by risk as-
sessors and RPMs, including a
model for data review packages, a
list of common pollutants gener-
ated by seven industries, a list of
laboratory contaminants, and sta-
tistical calculations.
An "interim final" version of this guidance
was issued in October 1990, to obtain and incorporate
communis and criticisms following a period of use at
Superfund sites. Based on input from users of the
"interim final," the "final" guidance provides a more
dcUiiled discussion of sampling and background sam-
pling strategies and addresses soil depth sampling
issues. The use and validation of fixed laboratory
analyses, field analyses, tentatively identified com-
pound data, and non-CLP analyses are also discussed
in greater detail.
Attention to ecological data needs is included.
The guidance does not directly address the use of
ecological data for purposes other than baseline risk
assessments for human health. However, the chemi-
cal data obtained from site characterization are use-
able in the ecological assessment. Biota sampling and
analytical issues are discussed, as well as ways to
differentiate chemicals of potential concern to eco-
logical risk assessments from those of concern to
human health risk assessments.
Highlight 2 outlines the content of each chapter of
Part A of the guidance. Various tools to assist RPMs
and risk assessors to plan and assess sampling and
analysis complement the text of the chapter.
•	Worksheets to organize sampling or analyti-
cal planning strategies, and to clarify depth
of sampling requirements in soil investiga-
tions.
•	Checklists for workplans and sampling and
analysis plans.
•	Available software U> assist in planning and
assessment.
HIGHLIGHT 2.
Part B provides supplemental guidance on
data collection and evaluation issues that
affect the quality and useability of
radioanalytical data required for perform-
ing baseline risk assessments at sites con-
taminated with radioactive substances. The
guidance:
ORGANIZATION OF PART A OF THE GUIDANCE
Chapter 1
Introduction and Ba
Aground
Presents critical data useabiMy Issues.
Specifies audience to be primarily RPMs and risk assessors.
Defines scope and specifies organization of the guidance.
Chapter 2
The Rtok Assessment Process
*	Explains the elements of a risk assessment and the impact of analytical data quality on each
element
*	Defines the uncertainties In the risk assessment process.
» Describes the roles of the risk assessor, RPM and others involved wrth the risk assessment
planning and assessment process.
Chapter 3
Useability Criteria lor Baeeline Risk Assessments
•	Defines six criteria for assessing data useability: data sources, documentation, analytical
methods/detection limits, data quality indicators, data review, and reports to the risk assessor
•	Applies criteria to sampling and analytical issues.
ChepteM
Steps for Planning for the Acquisition of Useable Environmental Data In Baeeline Risk
Assessments
*	Provides guidelines for designing sampling plans and selecting analytical methods.
*	Provides worksheets to support sampling design selection, soil depth sampling,
and analytical method selection.
Chapters
Assessment of Environmental Data for Useability In Baseline Risk Assessments
•	Describes minimum requirements tor useable data.
•	Explains how to determine actual performance compared to objectives,
•	Recommends corrective actions for critical data not meeting objectives.
•	Describes options for combining data from different sources and of varying quality into the risk
assessment
Chapter •
Application of Data to Risk Assessments
*	Provides procedures to determine the uncertakrty of the analytical data.
*	Explains how to distinguish site from background levels of contamination and determine the
presence (absence) of chemicals of potential concern.
*	Discusses how to characterize contaminant concentrations within exposure areas.
Appendices
Provide technical reference materials for sampffng and analysis.
Descrfee data review packages and meanings of selected data quarters.
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Provides an overview of the similarities and key differ-
ences between chemical and radionuclide risk assess-
ments with respect to data collection and evaluation,
exposure assessment, and risk characterization.
Discusses data useability criteria and preliminary sam-
pling and analysis issues for baseline radiation risk
assessments,
•	Oudines steps involved in planning for the acquisition of
useable environmental radiation data, including strate-
gies for designing sampling plans and considerations for
selecting radioanalytical methods and laboratories.
Describes how to assess and interpret environmental
radioanalytical data, and
•	Discusses how to apply the radioanalytical data to the
baseline human health risk assessment.
Includes a glossary of radiation terminology and con-
cepts, a discussion of potential sources, properties, and
migration pathways for naturally occurring and manmade
radionuclides in the environment, and a listing of the
names and addresses of EPA's regional, laboratory and
headquarters radiation prognuns staff.
Chemical and radiation risk assessments share many of the
same data useability issues, criteria and
objectives. To avoid redundancy in these
cases, Part B refers back to specific de-
tailed discussions, exhibits and guidance
provided in Part A of Guidance for Data
Useability in Risk Assessment. Conse-
quently, Part B is not a stand-alone docu-
ment; it must be used in conjunction
with Part A at all times.
The guidance provided in Part A and
Piirt B complements the Risk Assessment
Guidance far Superfund (RAGS) Volume
I: Human Health Evaluation Manual, Part
A. RAGS provides the framework for
making data quality assessments in base-
line risk assessments. The Guidance for
Data Useability in Risk Assessment (Part
A) supplements the RAGS framework by
providing minimum requirements for the
sampling strategies and the resulting envi-
ronmental analytical data used in baseline
risk assessments. As such, it also comple-
ments and builds upon Agency guidance
for the development and use of data qual-
ity objectives in all data collection activi-
ties, as found in the Guidance for Con-
ducting Remedial Investigations and Fea-
sibility Studies under CERCLA and the
Data Quality Objectives for Remedial
Response Activities: Development Pro-
cess.
Why Use This Guidance?
Optimizing data useability in baseline human healdi risk
assessments reduces uncertainty in environment^ data used in
risk assessment and also saves time and money. With this
guidance risk assessors and RPMs can more efficiently identify
and communicate risk assessment needs during RI planning lor
both sampling and analysis. They can also determine the useabilit -
of previously obtained data, thus minimizing requirements for
more data.
Data Useability Issues in Risk Assessment
Risk assessors and RPMs identified five basic issues that are
frequently encountered in obtaining useable data for risk assess-
ment:
Data sources. Practical tradeoffs among available sampling
the needs to locate "hot spots," to provide representative site
sampling, to provide representative background samples, and to
quantitate sampling error. Variable sampling results are often the
major determinant in the overall level of certainty in risk assess-
ment. RPMs and risk assessors should determine the sampling
strategy or combination of strategies that best serve the data
quality needs of risk assessment. A combination of statistically
based and purposive sampling can often provide samples repre-
sentative of a site and of the background. Highlight 3 summarizes
the importance of sampling issues in risk assessment.
HIGHLIGHT 3. IMPORTANCE OF SAMPLING ISSUES IN RISK ASSESSMENT
Issue
Importance
Suggested Action
Chemicals of Potential
Concern
(3.2.1)
Chemicals have different rates ot
occurrence and coefficients of variation.
This impacts the probability of lalse
negatives and reduces confidence limits for
estimates of concentralion.
Increase the number ol samples lor
chemicals with low occurrence and/or
high coefficients of variation.
Sampling and
Analytical Variability
versus Measurement
Error (3.2.5)
Sampling variability can exceed
measurement error by a factor of three to
four (EPA 1989c).
Sampling variability increases uncertainty
or variability: measurement error
increases bias.
Reduce sampling variability by taking
more samples (using less expensive
methods). This allows more sarr^les
to be analyzed.
Use QC samples to estimate and
control bias. Prepare SOPs lor
handling all field equipment.
Media Variability
(3.2.5)
Sampling problems vary widely by media as
do variability and bias.
Design media-specific sampling
approaches.
Sample Preparation
and Sample
Preservation
(3.2.6)
Contamination can be introduced during
sample preparation, producing false
positives. Filtering may remove
contaminants sorbed on particles.
Use blanks at sources of potential
contamination. Collect filtered and
unfiltered samples.
Identification of
Exposure Pathways
(32.7)
Not all samples taken in a she
characterization are uselul for risk
assessment. Often only a few samples have
been taken in the area of interest.
Specifically address exposure
pathways in sampling designs. Risk
assessors should participate in
scoping meeting.
Use of Judgmental or
Purposive Sampling
Design
(3.2.8)
Statistical sampling designs may be costly
and do not take advantage of known areas
of contamination.
Use judgmental sampling to examine
known contaminated areas, then use
an unbiased method to characterize
exposure.

Detection limits. Risk assessors and RPMs choose the analytical
methods to optimize detection limits; this is fundamental to the
useability of analytical data in risk assessments. The type of
detection limit used in making data quality decisions, such as
method detection limit or sample quantitation limit, also affects
the certainty of the risk assessment. Advances in analytical
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technology have lowered detection limits in field analyses. With
the appropriate quality control measures, field data can be used
more frequently in risk assessments. A combination of field
analyses and fixed laboratory analyses optimizes the amount of
available data to characterize a site.
Qualified data. Data assessment often results in qualification of
environmental data. Qualified data are almost always useable as
long as the uncertainty in the data and its impact on the certainty
of the risk assessment are documented and explained. Procedures
are provided for incorporating qualified data and data of various
analytical quality into the risk assessment.
Rackground samples. Distinguishing site contamination from
background levels in risk assessment is critical. Analytical data
reported near method detection limits and sample results qualified
during data review often complicate data use in risk assessment.
Planning for collection of a sufficient number of background
samples increases the certainty in decisions about the presence or
absence of site contamination.
Consistency in data collection. Consistency must be maintained
among all parties conducting Superfund baseline risk assess-
ments, and among different sampling and analytical events at a
given site. The guidance provided in this document and in RAGS
helps RPMs and risk assessors to ensure that baseline risk assess-
ments for human health are conducted consistently and each are
equally protective of the public health.
The Guidance for Data Vseability in Risk Assessment ad-
dresses these live issues in detail and provides procedures, mini-
mum requirements, and corrective actions to resolve the impact
the issues have on the confidence in the risk assessment.
Making Decisions with Environmental Data
The following questions guide risk assessment planning:
What contamination is
present and at what level?
When the sampling design is
representative of the site and
exposure area, then appropri-
ate analytical methods can de-
termine the presence or ab-
sence of contamination at the
site. The RPM's selection of
siunpling strategies, analyti-
cal methods, and the type and
level of data review can af-
fect the probability of false
negatives and false positives
for both site and background
samples. Selecting the ap-
propriate sampling design is
critical and is discussed at
length in ibe guidance.
'creased risk for human health on the basis of the site contamina-
tion. The guidance discusses both sampling and analytical de-
signs.
Are all exposure pathways and exposure areas identified and
examined? All exposure pathways and exposure areas must be
identified. Identifying and sampling the media of concern and the
importance of representative sampling are discussed in the guid-
ance.
Are all exposure areas fully characterized? For all exposure
areas to be fully characterized, sampling must be representative
and must satisfy performance objectives determined during the
planning process. A broad spectrum analysis must be available in
order to characterize the areas and avoid false negatives.
Uncertainty in chemical identification and quantitation is
determined based on how these questions are decided. This
analytical data uncertainty affects the level of confidence of the
final risk assessment.
Planning for Risk Assessment
RPMs and risk assessors should develop a conceptual model
of the site before planning data collection activities for risk
assessment. The model acts as a sketch which the sampling effort
completes. Highlight 4 illustrates how a conceptual site model is
developed. The guidance describes the six planning and assess-
ment criteria that follow from such a model to ensure data
useability.
Data sources must be comparable if data are combined
for quantitative use in risk assessment.
Documentation, such as sampling and analysis plans and
standard operating procedures, must be followed or
deviations must be documented.
4. DEVELOPMENT OF CONCEPTUAL
SITE MODEL
Identify Population Characteristics
•	On-site and nearby off-site
population.
•	Land use (current and future)
(e.g., residential, industrial,
recreational).
•	Receptors at risk.
HIGHLIGHT
Identify Chemicals of Potential Concern
•	Historical data on former useage of site.
•	Results from earlier analyses.
•	Potential background chemicals.
•	Mobility, toxicity and degradation
characteristics.
Identify Exposure
Pathways (e.g.. Soil
Ingestion)


Identify Chemicals of Potential Concern
•	Historical data on former useage of site.
•	Results from earlier analyses.
•	Potential background chemicals.
•	Mobility, toxicity and degradation
characteristics.
Are site concentrations suf-
ficiently different from
background? Site concen-
trations must be distinguished
from background levels to
support an evaluation of in-
loeniiTy exposure
Areas
loeniay exposure
Areas
tdentvy Ej^osure
Areas
Develop Conceptual Site Model
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•	Analytical methods and detection limits must test for
the chemicals of potential concern at the concentra-
tion levels of concern.
•	Data quality indicators (such as representativeness
and completeness) must be met.
Datareview mustbeapropriatetotheuseofthedata.
•	Reports to risk assessors must be clear.
The guidance explains how to use these criteria with the
conceptual model to plan data collection efforts that maximize
the useability of environmental analytical data in baseline risk
assessments. Worksheets are provided to help select the most
appropriate sampling and analytical procedures and the ap-
propriate depth for soil sampling. Checklists and tips are also
included. Automated systems are referenced that are useful in
selecting sampling and analytical procedures. Regional Envi-
ronmental Services Divisions (ESDs) can also provide assis-
tance.
Assessing Environmental Data for
Useability
Conducting the Data Assessment. The risk assessor and
data re viewer examine the data, documentation, and reports to
determine if they meet the performance objectives required in
the RI planning. If no performance objectives have been
specified or the specification is incomplete, the minimum
acceptable requirements for thedata useability criterion should
be used. The guidance presents minimum requirements for
each data useability criterion.
The guidance describes how to evaluate each criterion.
The process is briefly outlined below:
•	Identify or determine minimum data requirements
and performance objectives,
Determine actual performance compared to objec-
tives, and
Determine and execute any corrective action required.
The guidance also provides the appropriate corrective actions
when actual performance fails to meet the objectives for data
critical to risk assessment.
Organizing the Data Assessment. The guidance helps risk
assessors to determine whether the level of certainty for the data
involved is satisfactory, questionable, or unsatisfactory for each
performance measure within an assessment phase. Guidance
tools include a worksheet to apply useability criteria to the data.
For each criterion, the worksheet requires a decision to be made:
whether to accept, accept with qualification, or reject the data for
use in the risk assessment. The justification for each decision is
also recorded on the worksheet.
Applying Data to Risk Assessment
As shown in Highlight 5, the level of certainty associated with
data determines the certainty in the answers to the four fundamen-
tal decisions that risk assessors must make. The final sections of
the guidance provide procedures for determining the level of
certainty for each decision, given the results of the assessment of
performance measures. These measures are the bases for the
estimation of the degree of confidence in the risk assessment.
HIGHLIGHT 5. UNCERTAINTY IN DATA COLLECTION AND
EVALUATION DECISIONS AFFECTS THE CERTAINTY
OF THE RISK ASSESSMENT
Need More Help?
Questions regarding site-specific Superfund risk assessment
issues should be referred to the Superfund Toxics Integration
Coordinators listed in Highlight 6. Questions regarding Superfund
radiation risk assessment issues should be directed to the EPA
Regional Radiation Program Managers or to the Office of Radia-
tion Programs (ORP) Laboratory Directors listed in Highlight 7.
The ORP Radiation Assessment Branch (RAB) can be contacted
at 202-260-9630. The Toxics Integration Branch (TIB), Office of
Emergency and Remedial Response (OERR), may also be con-
tacted at 202-260-9486 for technical information sources and
assistance with this guidance. Potential sources for technical
assistance are Regional ESDs and quality assurance officers.
EMSL/LV may be a source for assistance on sampling or statisti-
cal issues. The mailing address for EMSL/LV is:
U.S. EPA Environmental Monitoring Systems Laboratory
(EMSL)
944 E. Harmon Avenue
Box 93478
Las Vegas, NV 89119
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How to Obtain the Guidance
To order a copy of ihe guidance, call or write:
National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
Phone: 703-487-4650
HIGHLIGHT 6. REGIONAL TOXICS INTEGRATION COORDINATORS
Region Name, Address and Phone Number
I	Ann-Marie Burke
Waste Management Division (HSS-CAN-7)
EPA Region t
90 Canal Street
Boston, MA 02110
FTS 833-1528
617-223-5528
II	Peter Grevatt
Program Support Branch
ERR Division
EPA Region II
26 Federal Plaza
New York, NY 10278
FTS 597-6323
212-597-6323
III	Debra Forroan
Hazardous Waste Management Division (3HW15)
EPA Region III
841 Chestnut Street
Philadelphia, PA 19107
FTS 597-6626
215-597-6626
IV	Elmer Akin
Waste Management Division
EPA Region IV
345 Courtland Street, NE
Atlanta, GA 30365
FTS 257-1536
404-347-1586
V	Erin Moran
Technical Support Unit (SHSM-TUB12)
EPA Region V
77 West Jackson Boulevard
Chicago, IL 60604
FTS 353-1420
312-353-1420
Region Name, Address and Phone Number
VI	Jon Rauscher
EPA Region VI (6H-SR)
1445 Ross Avenue
Dallas, TX 75202-2733
FTS 255-2198
214- 655-2198
VII	David Crawford
EPA Region VII
726 Minnesota Avenue
Kansas City, KS 66101
FTS 276-7702
913-551-7702
VIII	Chris Weis
EPA Region VIII (8HWM-SRM)
999 18th Street, Suite 500
Denver, CO 80202-2405
FTS 330-7655
303-294-7655
IX	Daniel Stralka
Technical Support Section (H-8-4)
EPA Region IX
75 Hawthorne Street
San Francisco, CA 94105
FTS 484-2310
415-744-2310
X	Pat Crone
EPA Region X {ES-098}
1200 Sixth Avenue
Seattle, WA 98101
FTS 399-1597
206-553-1597
B21-007-1
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HIGHLIGHT 7. EPA REGIONAL AND LABORATORY RADIATION PROGRAM STAFF
Region Name, Address and Phone Number	Region
I	Tom D'Avanzo	VII
Radiation Program Manager
EPA Region I
John F. Kennedy Federal Building, Rm. 2311
Boston, MA 02203
617-565-4502
II	Paul A. Giardina	VIII
Radiation Program Manager
EPA Region II
Rm. 1005 (AWM-RAD)
26 Federal Plaza
New York, NY 10278
212-264-4110
III	Lewis Felleisen	IX
Radiation Program Manager
EPA Region III
Special Program Section (3AM12)
841 Chestnut Street
Philadelphia, PA 19107
215-597-8326
IV	Chuck Wakamo
Radiation Program Manager
EPA Region IV
345 Courtland Street, NE
Atlanta, GA 30365
404-347-3907
V	Gary V. Gulezian
Radiation Program Manager
(AT18J)
EPA Region V
77 West Jackson Boulevard
Chicago, IL 60604
312-353-2206
VI	Donna Ascenzi
Radiation Program Manager
EPA Region VI
Air Enforcement Branch
(6TE)
1445 Ross Avenue
Dallas, TX 75202-2733
214- 655-7223
NAREL
ORP-LV
Name, Address and Phone Number
Gale Wright
Radiation Program Manager
EPA Region VII
726 Minnesota Avenue
Kansas City, KS 66101
913-551-7600
Milton W. Lammering
Radiation Program Manager
EPA Region VIII
(8AT-RP)
999 18th Street
Denver, CO 80202-2405
303-294-1709
Michael S. Bandrowski
Radiation Program Manager
EPA Region IX
(A1-1)
75 Hawthorne Street
San Francisco, CA 94105
415-744-1048
Jerry Leitch
Radiation Program Manager
EPA Region X
(AT-082)
1200 Sixth Avenue
Seattle, WA 98101
206-553-7660
Samuel T. Windham
Director
National Air and Radiation Environmental
Laboratory (NAREL)
1504 Avenue A
Montgomery, AL 36115-2601
205-270-3400
Jed Harrison
Acting Director
Office of Radiation Programs - Las Vegas
Facility (ORP-LV)
P.O. Box 98517
Las Vegas, NV 89193-8517
206-798-2476
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