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United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
OSWER 9360.4-21 FS
EPA 540-F-05-005
July 2006
Applicability of Superfund Data
Categories to the Removal Program
Office of Emergency Management
Office of Superfund Remediation and Technology Innovation
Quality Assurance Technical Information Bulletin
No. 2 of 3
The Office of Solid Waste and Emergency Response (OSWER) is revising its 1990 Quality Assurance/Quality Control
Guidance for Removal Activities to address changes in Agency-wide quality assurance policies and guidance documents.
Additionally, concepts described in the Removal Guidance have been modified by a 1993 OSWER document, Data Quality
Objectives Process for Superfund. The 1990 Removal Guidance referred to three "quality assurance objectives" (known as
QA1, QA2, and QA3). The 1993 document replaced those codes with alternative, more descriptive terms, screening data,
screening data with definitive confirmation, and definitive data, known collectively as Superfund data categories. For each data
collection activity, the Superfund data category or categories should be specified to correspond to the data use objectives.
INTRODUCTION
In April 1990, the Office of Emergency and Remedial
Response (OERR) prepared the Office of Solid Waste and
Emergency Response (OSWER) Directive 9360.4-01,
Quality Assurance/Quality Control Guidancefor Removal
Activities (the Removal Guidance), which was based on
then-current Agency-wide quality assurance (QA) policies.
Since then, the following Agency-wide quality documents
were issued in May 2000:
•	EPA Order 5360.1 A2, Policy and Program
Requirementsfor the Mandatory Agency- Wide Quality
System (the revised Quality Order); and
•	EPA 5360 Al, the EPA Quality Manual for
Environmental Programs (the Quality Manual).
In addition, beginning in 1997, OSWER spearheaded an
Intergovernmental Data Quality Task Force (IDQTF) to
address issues related to the management of environmental
data quality at Federal facilities. The IDQTF has produced
the Uniform Federal Policy for Implementing
Environmental Quality Systems and the multi-part Uniform
Federal Policyfor Quality Assurance Project Plans (UFP-
QAPP). OSWER has adopted the UFP-QAPP for federal
facility hazardous waste activities and highly recommends
that it be considered more broadly for data collection
projects conducted under Superfund. Regions are strongly
encouraged to consider the use of the UFP-QAPP for other
purposes. (See OSWER 9272.0-17.)
OSWER has recognized the need to update the Removal
Guidance in light of these Agency-wide and OSWER-
specific policy changes as well as organizational changes
within OSWER through 2004. * As part of the process of
revising the Removal Guidance, the Office of Emergency
Management (OEM) and the Office of Superfund
Remediation and Technology Innovation (OSRH) are
issuing three QA Technical InformationBulletins focusing
on some of the more significant QA changes now
impacting the Removal Program, f
DATA CATEGORIES
There are two Superfund data categories described in the
September 1993 OSWER Directive 9355.9-01, Data
Quality Objectives Process for Superfund. The data
categories are definitive data and screening data with
definitive confirmation. Although OSWER Directive
9344.9-01 used the terms "screening data with definitive
confirmation" and "screening data" essentially
* In January 2003, the Assistant Administrator of OSWER proposed an organizational structure to better meet new responsibilities related to
homeland security. The organizational change included moving the emergency response (including emergency and time-critical removals) and oil
spill programs, then in OERR, into the Chemical Emergency Preparedness and Prevention Office (CEPPO), and the Technology Innovation
Office (TIO) into OERR. The final phases of the reorganization were completed by January 2004 for the former OERR, now renamed the Office
of Superfund Remediation and Technology Innovation (OSRTI), and by September 2004 for the former CEPPO, now renamed the Office of
Emergency Management (OEM).
| The discussion in this document is intended solely as guidance. This document is not a regulation. It does not impose binding legal
requirements. EPA retains the right to adopt approaches on a case-by-case basis that differ from those described in this guidance, where
appropriate. This guidance document interprets Agency policies on QA. This guidance document may be revised without notice.

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interchangeably, there is a distinction based on the
availability of confirmation data. In addition to the two
Superfund data categories identified in OS WER Directive
9344.9-01, the Removal Program uses a third category,
"screening data without definitive confirmation";
throughout the remainder of this Quality Assurance
Technical Information Bulletin, the third category will be
referred to simply as "screening data." The UFP-QAPP
Part 1 also discusses definitive data and screening data in
a fashion consistent with OSWER Directive 9355.9-01.
For each data collection activity, the data category or
categories should be specified to correspond to the data use
objectives.
Changes in the Removal Program are structured around the
three analytical data categories (described below), which
replace the three "quality assurance objectives" (i.e., QA1,
QA2, and QA3) discussed in the April 1990 edition of the
Removal Guidance.
What are "Definitive Data"?
Definitive data are generated using rigorous analytical
methods, such as EPA reference methods. Data are
analyte-specific, with confirmation of analyte identity and
concentration Methods generating definitive data produce
tangible raw data (e.g., chromatograms, spectra, digital
values) in the form of paper printouts or computer-
generated electronic files. Data may be generated at the
site or at an off-site location, as long as the quality control
requirements are satisfied. For the data to be definitive,
Table 1: Requirements of the Data Categories
(Analytical Data)
Screening Data
Screening Data With Definitive
Confirmation
Definitive Data
Sample documentation (location, date
and time collected, batch, etc.)
Sample documentation (location, date
and time collected, batch, etc.)
Sample documentation (location, date
and time collected, batch, etc.)
Chain of custody (when appropriate)
Chain of custody (when appropriate)
Chain of custody (when appropriate)
Sampling design approach (systematic,
simple or stratified random,
judgmental, etc.)
Sampling design approach (systematic,
simple or stratified random,
judgmental, etc.)
Sampling design approach (systematic,
simple or stratified random,
judgmental, etc.)
Initial and continuing calibration
Initial and continuing calibration
Initial and continuing calibration
Determination and documentation of
detection limits
Determination and documentation of
detection limits
Determination and documentation of
detection limits
Analyte(s) identification
Analyte(s) identification
Analyte(s) identification
Analyte(s) quantitation
Analyte(s) quantitation
Analyte(s) quantitation


Quality control (QC) blanks (trip,
rinsate, method)


Matrix spike recoveries


Performance Evaluation (PE) samples
(when specified)

Analytical error determination1
Analytical error determination1

Definitive confirmation2
Total measurement error
determination3
Notes:
1. Measures the precision of the analytical method. An appropriate number of replicate aliquots, as specified in the QA Project Plan
(QAPP), are taken from at least one thoroughly homogenized sample, the replicate aliquots are analyzed, and standard laboratory QC
parameters (such as variance, mean, and coefficient of variation) are calculated and compared to method-specific performance
requirements specified in the QAPP.
2. At least 10 percent of the screening data must be confirmed with definitive data. At a minimum, at least three screening samples reported
above the action level (if any) and three screening samples reported below the action level (or as non-detects) should be randomly selected
from the appropriate group and confirmed.
3. Measures overall precision of the measurement system, from sample acquisition through analyses. An appropriate number of co-located
samples as determined by the QAPP are independently collected from the same location and analyzed following standard operating
procedures. Based on these analytical results, standard laboratory QC parameters such as variance, mean, and coefficient of variation
should be calculated and compared to established measurement error goals. This procedure may be required for each matrix under
investigation, and may be repeated for a given matrix at more than one location at the site.
Source: Adapted from OSWER Directive 9355.9-01, Data Quality Objectives Process for Superfund, September 1993.

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either analytical or total measurement error must be
determined. (See Table 1.) Per the UFP-QAPP Part 1,
definitive data"are analytical data that are suitable forfinal
decision-making."
What are "Screening Data"?
Screening data are generated by rapid, less precise
methods of analysis with less rigorous sample preparation
than definitive data. Screening data provide analyte (or at
least chemical class) identification and quantification,
although the quantification may be relatively imprecise.
According to the UFP-QAPP Part 1, screening data are
"analytical data that are of sufficient quality to support an
intermediate or preliminary decisionbut must eventually be
supported by definitive data before a project is complete."
For definitive confirmation, at least 10 percent of the
screening data are confirmed using analytical methods,
quality control procedures, and criteria associated with
definitive data. Screening data without associated
confirmation data are generally not considered to be data
of known quality. Screening data without confirmation
data are generally allowed only under limited
circumstances, and will be discussed later.
Requirements for the Data Categories
Each data category is associated with a list of minimum
requirements. (See Table 1.) Therefore, any method or
analytical instrument that can meet the quality
requirements can be used for each one of the data
categories.
For example, if a field portable X-ray fluorescence method
can meet all the "definitive data" quality requirements, the
resulting data are definitive. However, if a mass
spectrometer method was used, but not all "definitive data"
quality requirements were met, then the resulting data are
not definitive.
Data Category Most Relevant to the Removal Program
"Definitive data" and "screening data with definitive
confirmation" provide useful and valid data for
enforcement purposes, determination of extent of
contamination, disposal and/ortreatment, responsible party
identification, and cleanup verification.
It is anticipated that "screening data with definitive
confirmation" will satisfy most data quality requirements
for the Removal Program The "definitive data" categoiy
is expected to be used only in those cases where an error
determination is needed to identify false negative or false
positive values for critical decision level concentrations.
The "screening data" category (without confirmation) has
only limited use, specifically for the following:
•	Emergencies;
•	Health and safety screeningusing, forexample, Jerome
Mercury Vapor analyzer, Industrial Scientific multi-gas
monitor, or RAE Systems MultiRAE organic vapor
monitor (OVM), and other techniques; {
•	Real-time field data to supplement analytical data (e.g.,
"sniffing" a monitoring well with an OVM prior to
sampling or measuring pH, dissolved oxygen and/or
conductivity at the time of sampling);
•	Field sample locational decisions (i.e., collecting
screening data to determine in real time where to
collect confirmation samples for definitive data
analysis);
•	Waste profiling; and
•	Preliminary identification and quantitation of
pollutants.
Quality Control for Screening Data Collection
Operating procedures for OVMs, conductivity meters, and
other field instruments require the use of calibration gases
or solutions. The manufacturer's instructions or the
Regional standard operating procedures should specify the
method for and frequency of continuing calibration during
use of field measurement instruments. Actual frequency
during use should meet or exceed these levels.
IDENTIFICATION OF DATA CATEGORIES FOR
A PROJECT
The selected data category orcategories should be decided
upon during the project's systematic planning process. As
stated earlier, the data category or categories need to
correspond to the project's data use objectives.
Additionally, the data category or categories should be
documented in the project's Quality Assurance Project
Plan or Quality Assurance Sampling Plan. Refer to the
Quality Assurance Technical Information Bulletins titled
Systematic Planning Processes for the Removal Program
and Changes in Quality Assurance Policies for the
Removal Program for a more detailed discussion of the
planning process as well as the contents and completion of
QA plans for removals.
REFERENCES
1.	Intergovernmental Data Quality Task Force, Uniform
Federal Policy for Implementing Environmental
Quality Systems, EP A-505-F-03-001, Version 2, March
2005.
2.	Intergovernmental Data Quality Task Force, Uniform
Federal Policy for Quality Assurance Project Plans,
Part 1: UFP-QAPP Manual, EPA-505-B-04-900A,
Version 1, March 2005.
3.	U.S. Environmental Protection Agency, Quality
Assurance/Quality Control Guidance for Removal
Activities, OSWER Directive 9360.4-01, April 1990.
4.	U. S. Environmental Protection Agency, Data Quality
Objectives Process for Superfund, OSWER Directive
9355.9-01 (Interim Final Guidance), (EPA540/R-93-
071), Office of Emergency and Remedial Response,
September 1993.
5.	U.S. Environmental Protection Agency, EPA Quality
Manual For Environmental Programs, EPA Manual
{ Mention of company or product names should not be construed as an endorsement by the U.S. Environmental Protection Agency.

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5360 Al, Office of Environmental Information, May
2000.
6.	U.S. Environmental Protection Agency, Policy And
Program Requirements For The Mandatory Agency-
wide Quality System, EPA Order 5360.1 A2, May 5,
2000.
7.	U.S. Environmental Protection Agency,
Implementation of the Uniform Federal Policy for
Quality Assurance Project Plans (UFP-QAPP) at
Federal Facility Hazardous Waste Sites,
Memorandum from Thomas P. Dunne, Deputy
Assistant Administrator, Office of Solid Waste and
Emergency Response, to Regional Administrators,
Regions I-X, OSWER Directive 9272.0-17, June 7,
2005.
8.	U.S. Environmental Protection Agency, Changes in
Quality Assurance Policies for the Removal Program,
Quality Assurance Technical InformationBulletin, July
2006.
9.	U.S. Environmental Protection Agency, Systematic
Planning Processes for the Removal Program, Quality
Assurance Technical InformationBulletin, July 2006.

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