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United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
OSWER 9360.4-20FS
EPA 540-F-05-004
July 2006
&EPA Changes in Quality Assurance Policies
for the Removal Program
Office of Emergency Management
Office of Superfund Remediation and Technology Innovation
Quality Assurance Technical Information Bulletin
No. 1 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.
Removal Program quality assurance (QA) elements are contained in the National Contingency Plan (40 CFR Part 300)
as well as Agency-wide documents. For each non-time-critical and time-critical response action, Regional Removal
Program personnel should perform systematic, project-specific planning and document the results of that planning in
QA Sampling Plans. These plans should be approved prior to any data collection. Response-specific QA Sampling
Plans can refer to standard language in a programmatic Regional Removal Program QA Project Plan. QA Sampling
Plans for emergency responses are encouraged, but do not require approval prior to implementation. Following an
emergency response, a report of the sampling protocols and QA specifications implemented is recommended.
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 Guidance for
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
Requirements for 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 Policy for 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 (OSRTI) are issuing three QA
Technical Information Bulletins focusing on some of
the more significant QA changes now impacting the
Removal Program, f
* 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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ORIGINS OF QUALITY POLICY
QA policies for the Removal Program come from a
variety of sources, including Agency-wide policies and
the National Contingency Plan (NCP). Ideally,
information from these different sources is integrated
by OSWER, and issued to the Regional offices
implementing the Removal Program activities.
This bulletin was written to provide detailed practical
guidance and clarification to the Removal Program in
implementing QA policies.
As stated in the revised Quality Order, it is Agency
policy that all environmental programs performed by or
directly for EPA through EPA-funded extramural
agreements be supported by quality systems based on a
uniform standard.
In July 1998, EPA issued a revised Quality Order (EPA
Order 5360.1 CHG 1), which re-affirmed the policy
defined by EPA Order 5360.1 (April 1984), and
expanded the policy to accommodate the current and
evolving needs of the Agency. Subsequently, EPA
issued EPA Order 5360.1 A2 (May 5, 2000), which
addressed QA administrative reporting changes within
the Agency, but made no additional substantive changes
to the Quality Order revised in 1998.
The revised Quality Order defines the minimum quality
systems supporting EPA environmental programs that
encompass the following:
• The collection, evaluation, and use of environmental
data by or for EPA; and
• The design, construction, and operation of
environmental technology by EPA.
This revised Quality Order also applies to any
collection and use of environmental data pertaining to
the occupational health and safety of personnel in the
field.
According to the revised Quality Order, "[a] consistent,
Agency-wide Quality System will provide, when
implemented, the needed management and technical
practices to assure that environmental data used to
support Agency decisions are of adequate quality and
usability for their intended purpose." Data quality and
usability are directly related to planning and
performing a sufficient level ofQA and quality control
(QC) activities.
PROGRAM-LEVEL QUALITY PLANNING
As part of their participation in the Agency-wide
quality system, National Program Offices such as
OSWER established their own Quality Management
Plans (QMPs). A QMP is an evolution of the QA
Program Plan, and should be prepared and updated at
least every five years. A QMP should specify the
organizational structure, policy and procedures,
functional responsibilities of management and staff,
lines of authority, and interfaces for those planning,
implementing, documenting, and assessing all activities
performed by or overseen by the organization.
The QMP is established at the EPA Headquarters level.
For the Removal Program, the initial responsibility for
the QMP lies within OSWER. In addition to OS WER' s
QMP, each Region should develop a QMP. These
plans are tailored to the specific operational needs of
the Regional office. The OSWER QMP, in conjunction
with the OEM Quality Management Implementation
Plan, issues Removal Program QA parameters to the
Regions; the Regional QMPs then address them.
NEW POLICIES FOR PROJECT-SPECIFIC
PLANNING
The revised Quality Order sets forth the use of a
systematic planning process to design an effective data
collection and evaluation program. One such planning
process is the Agency' s Data Quality Objectives (DQO)
Process. The results of systematic planning, including
the data use objectives and the collection strategies
decided upon, should be documented in a QA project
plan. A separate QA Technical Information Bulletin,
Systematic Planning Processes for the Removal
Program, describes the purposes and components of
systematic planning in more detail.
PROJECT-SPECIFIC PLANS
This revised Quality Order also calls for QA Project
Plans (Q APPs), or equivalent documents defined by the
prevailing QMP, to be developed for all applicable
projects and tasks involving environmental data.
Additionally, the QAPPs or QAPP-equivalents should
be reviewed and approved by the EPA Q A Manager (or
an authorized representative defined in the QMP).
QAPPs or QAPP-equivalents should be approved prior
to any data gathering work or use, except under
circumstances requiring immediate action to protect
human health and the environment or operations
conducted under police powers.
Importance of the QAPP
According to the Agency Quality Manual (also updated
in May 2000), the QAPP is a critical planning
document for any environmental data operation. The
QAPP documents how environmental data operations
are planned, implemented, documented, and assessed
during the life cycle of a program, proj ect, or task. The
ultimate success of an environmental program or
project depends on the adequacy and sufficiency of the
quality of the environmental data collected and used in
decision making. This may depend significantly on the
adequacy of the QAPP and its effective
implementation.
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Removal Program Support for QAPPs
The NCP states the following in 40 CFR
300.415(b)(4)(ii):
If environmental samples are to be collected, the
lead agency shall develop sampling and analysis
plans that shall provide a process for obtaining
data of sufficient quality and quantity to satisfy
data needs. Sampling and analysis plans shall
be reviewed and approved by EPA. The
sampling and analysis plans shall consist of two
parts:
(A) The field sampling plan, which describes
the number, type, and location of samples
and the type of analyses; and
(B) The quality assurance project plan,
which describes policy, organization, and
functional activities and the data quality
objectives and measures necessary to
achieve adequate data for use in planning
and documenting the removal action.
This language was included in an NCP revision on
March 8, 1990. The Preamble to this regulation
published in the Federal Register (55 FR 8694)
included more explanatory language for 40 CFR
300.415, Removal Action, as follows:
. . .EPA believes that, when samples will be
taken, it is appropriate to describe sampling
requirements for non-time-critical removal
actions to ensure that data of sufficient quality
and quantity will be collected for this type of
action.
EPA also notes that portions of the QAPP
may incorporate by reference non-site-specific
standardized portions of already-approved
QAPPs, especially those portions addressing
policy and organization, or describing general
functional activities to be conducted at a site to
ensure adequate data. This eliminates the
necessity to reproduce non-site-specific Quality
assurance procedures for every site, [emphasis
added]
The Elements of the QAPP
To meet the need for a QAPP in the Removal Program,
the QAPP should be divided into two functional
documents: a generic "Branch QAPP," and a response-
specific QA Sampling Plan. When combined, both
documents address the 24 elements described in the
EPA Quality Manual, Chapter 5 (Table 1), as well as
the content of the NCP, 40 CFR 300.415. The
worksheets in the UFP-QAPP Part 2A (UFP-QAPP
Workbook) can assist in the development of each
document.
Table 1: General QAPP Content
Group A, Project Management
A1 Title and Approval Sheet
A2 Table of Contents
A3 Distribution List
A4 Project/Task Organization
A5 Problem Definition/Background
A6 Project/Task Description
A7 Quality Objectives and Criteria for
Measurement Data
A8 Special Training/Certification
A9 Documentation and Records
Group B, Measurement/Data Acquisition
B1 Sampling Process Design (Experimental
Design)
B2 Sampling Methods
B3 Sample Handling and Custody
B4 Analytical Methods
B5 Quality Control
B6 Instrument/Equipment Testing, Inspection,
and Maintenance
B7 Instrument Calibration and Frequency
B8 Inspection/Acceptance for Supplies and
Consumables
B9 Data Acquisition (Non-direct
Measurements)
B10 Data Management
Group C, Assessment/Oversight
C1 Assessments and Response Actions
C2 Reports to Management
Group D, Data Validation and Usability
D1 Data Review, Validation, and Verification
D2 Validation and Verification Methods
D3 Reconciliation with User Needs
Source: Adapted from Chapter 5, Quality Manual,
May 2000
Responsibilities for Branch-level QAPPs
The Branch QA Project Plan should be prepared by
each Regional Removal branch and addresses only
those elements generic to all Removal activities
occurring within the Region. These might include
calibration procedures for each instrument (in
accordance with the manufacturer's specifications),
decontamination procedures for each analyte class, and
the generic corrective action process. The Branch
QAPP should be reviewed annually and updated
periodically to reflect any operational changes in the
Region.
Elements of the Response-specific QAPP
The response-specific QA Sampling Plan should be
prepared for each site where sampling will be
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performed. The plan also addresses those elements
specific to the site, such as sample collection and
analysis. The response-specific QA Sampling Plan
should be prepared for each response and amended
when the scope of work changes significantly from the
scope of work described in any previous plan.
Elements that are not addressed in the Branch QAPP
should be included in the QA Sampling Plan.
Certain elements should be addressed in the response-
specific plan. For example, to meet element A7,
Quality Objectives and Criteria for Measurement Data,
the data use objectives during the specific effort should
be known and documented. Proper use of a systematic
planning process results in the identification of the
"data categories" appropriate to the specific response.
Refer to the QA Technical Information Bulletin,
Applicability of Superfund Data Categories to the
Removal Program, for additional discussion of data
categories selection and use.
When Should the QAPP be Prepared?
The revised Agency-wide Quality Order states:
"QAPPs must be approved prior to any data gathering
work or use, except under circumstances requiring
immediate action to protect human health and the
environment or operations conducted under police
powers." Applying this to the Removal Program, only
emergency responses would be included in this
exemption. Although the NCP specifically calls for
sampling and analysis plans (e.g., QA Sampling Plans)
for non-time-critical responses (responses with at least
6 months lead time), the revised Quality Order does not
exempt time-critical responses (responses withless than
6 months lead time). Thus, time-critical responses
should also have a QA Sampling Plan prepared.
Historically, Superfund policy for emergency
responses, where the release requires that response
activities begin on-site within hours of the Agency's
determination that a removal action is appropriate, has
been that a QA Sampling Report (or equivalent) be
submitted no later than 30 days after the response date
for documentation purposes. It is recommended that
this QA Sampling Report describe the sampling event
that occurred by containing the types of information
that would have been included in a QA Sampling Plan.
In practice, some Regions are using QA Sampling Plan
templates, filled in by hand if necessary, for real-time
emergency response sampling and QA planning.
In all other cases, as stated above, the QA Sampling
Plan should be written and approved prior to initiating
the response activities.
SUMMARY OF HIERARCHY OF QA
DOCUMENTATION
Quality assurance planning, implementation, and
assessment for the Removal Program are documented
Figure 1 : EPA Quality Assurance Documentation
Quality Management Plan (OSWER Level)
As per EPA Quality Manual, Chapter 3
Quality Management Implementation Plan
(OEM Level)
As per OSWER Quality Management Plan
Quality Management Plan (Regional Level)
As per EPA Quality Manual, Chapter 3
Regional Removal Program Quality Assurance
Project Plan (Branch Level)
As per EPA Quality Manual, Chapter 5
Quality Assurance Sampling Plan
(Site- or Response-Specific)
As per Quality Assurance/Quality Control Guidance
for Removal Data Collection
at several levels (Figure 1). Source documents at each
level are also depicted.
NOTE: the 1990 Quality Assurance/Quality Control
Guidance for Removal Activities is under revision as
Quality Assurance/Quality Control Guidance for
Removal Data Collection.
REFERENCES
1. Intergovernmental Data Quality Task Force,
Uniform Federal Policy for Implementing
Environmental Quality Systems, EPA-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. Intergovernmental Data Quality Task Force,
Uniform Federal Policy for Quality Assurance
Project Plans, Part 2A: UFP-QAPP Workbook,
EPA-505-B-04-900C, Version 1, March 2005.
4. Intergovernmental Data Quality Task Force,
Uniform Federal Policy for Quality Assurance
Project Plans, Part2B, Quality Assurance/Quality
Control Compendium: Minimum QA/QCActivities,
EPA-505-B-04-900B, Version 1, March 2005.
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5. 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.
6. U.S. Environmental Protection Agency, National
Oil and Hazardous Substances Contingency Plan,
40 CFR Part 300, as amended.
7. U.S. Environmental Protection Agency, EPA
Quality Manual For Environmental Programs,
EPA Manual 5360 Al, Office of Environmental
Information, May 2000.
8. U.S. Environmental Protection Agency, Policy And
Program Requirements For The Mandatory
Agency-wide Quality System, EPA Order 5360.1
A2, May 5, 2000.
9. U.S. Environmental Protection Agency, OSWER
Quality Management Plan, Office of Solid Waste
and Emergency Response, August 2003.
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10. 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.
11. U.S. Environmental Protection Agency, Systematic
Planning Processes for the Removal Program,
Quality Assurance Technical Information Bulletin,
July 2006.
12. U.S. Environmental Protection Agency,
Applicability of Super fund Data Categories to the
Removal Program, Quality Assurance Technical
Information Bulletin, July 2006.
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