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United States
Environmental Protection
Agency
Office of
Solid Waste and
Emergency Response
OSWER 9360.4-22FS
EPA 540-F-05-006
July 2006
&EPA Systematic Planning Processes
for the Removal Program
Office of Emergency Management
Office of Superfund Remediation and Technology Innovation
Quality Assurance Technical Information Bulletin
No. 3 of 3
The Office of Solid Waste and Emergency Response (OSWER) is revising its 1990 QualityAssurance/Quality Control
Guidance for Removal Activities to address changes in Agency-wide quality assurance policies and guidance documents.
Environmental data collection operations should be designed using a systematic planning process that is based on the
scientific method. The planning process should be based on a common sense, graded approach to ensure that the level
of detail in planning is commensurate with the importance and intended use of the results and the available resources.
EPA has developed a systematic planning process called the Data Quality Objectives (DQO) Process. While not
mandatory, this process is the recommended planning approach for many EPA data collection activities, such as when
environmental data are used to select between two opposing conditions. Other Federal agencies have tailored the DQO
process or have developed their own systematic planning and decision support processes. Many of them are directly
related to environmental operations, and may be useful to EPA decision makers (e.g. On-Scene Coordinators) when planning
and implementing removal operations.
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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SYSTEMATIC PROJECT PLANNING
Environmental data operations should be designed
using a systematic planning process that is based on the
scientific method. The concept of the scientific method
is to make an observation, create a hypothesis based on
what was observed, use the hypothesis to make a
prediction, and test the hypothesis. One should
continue to test until there are no discrepancies between
the hypothesis and the results.
One example of the scientific method being used in an
environmental data collection operation is the
following. An On-Scene Coordinator (OSC) observes
there has been a fire at a warehouse, firefighters have
responded, and water run-off from the warehouse has
flowed into a storm drain. The OSC hypothesizes there
has been a release of hazardous chemicals from the
warehouse wApredicts that the release has entered into
the storm drain extending 100 feet from the point of
entry. The OSC tests this hypothesis by sampling the
storm sewer at points both less than and greater than
100 feet through the sewer line. Based on the results of
these tests, the OSC obtains a definitive answer (the
presence and extent of contamination) or refines the
hypothesis and tests again.
Practical Considerations in Systematic Planning
The planning process should be based on a common
sense, graded approach to ensure that the level of detail
in planning is aligned with the importance and intended
use of the results and the available resources. The EPA
Quality Manual, amended May 2000, identifies
elements of a systematic planning approach, consisting
of the following:
Identification and involvement of the project
manager, sponsoring organization and responsible
official, project personnel, stakeholders, scientific
experts, etc. (i.e., all customers and suppliers);
Description of the project goal, objectives, and
questions and issues to be addressed;
Identification of project schedule, resources
(including budget), milestones, and any applicable
requirements (e.g., regulatory requirements,
contractual requirements);
Identification of the type of data needed and how
the data will be used to support the project's
objectives;
Determination of the quantity of data needed and
specification of performance criteria for measuring
quality;
Description of how, when, and where the data will
be obtained (including existing data) and
identification of any constraints on data collection;
Specification of needed QA/QC activities to assess
the quality performance criteria (e.g., QC samples
for both the field and laboratory, audits, technical
assessments, performance evaluations, etc.); and
Description of how the acquired data will be
analyzed (either in the field or the laboratory),
evaluated (i.e., QA review, validation,
verification), and assessed against its intended use
and the quality performance criteria.
A systematic planning process ensures that all
organizations and/or parties who contribute to the
quality of the environmental program or use the results
are identified and that they participate in this process.
The planning process also provides for direct
communication between the customer and the supplier
to ensure that there is a clear understanding by all
participants of the needs and expectations of the
customer and the product or results to be provided by
the supplier.
OPTIONAL PROCESSES
Although there should be a systematic planning
process, no single process is required or is best in all
cases. There are several processes that a project
manager can choose from. Some of these are
summarized below.
EPA 'sData Quality Objectives (DQO) Process - EPA
has developed a systematic planning process called the
DQO Process. While not mandatory, this seven-step
process is the recommended planning approach for
many EPA data collection activities, such as when
environmental data are used to select between two
opposing conditions. The steps are as follows:
Step 1. State the problem;
Step 2. Identify the goals of the study;
Step 3. Identify information inputs;
Step 4. Define the boundaries of the study;
Step 5. Develop the analytic approach;
Step 6. Specify performance or acceptance
criteria; and
Step 7. Develop the plan for obtaining data.
The DQO Process is described in several guidance
documents:
EPA QA/G-4, Guidance for the Data Quality
Objectives Process, EPA/240/B-06/001, February
2006;
EPA QA/CS-1, Systematic Planning: A Case Study
for Hazardous Waste Site Investigations,
EPA/240/B-06/004, February 2006; and
• OSWER Directive 9355.9-01, Data Quality
Objectives Process for Superfund, EPA/540/R-
93/071, September 1993.
As stated above, the DQO Process is not mandatory.
However, it is the only Agency-wide systematic
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planning process described to date.} Other Federal
agencies have tailored the DQO process or have
developed their own systematic planning and decision
support processes. Many of them are directly related to
environmental operations, and may be useful to EPA
decision makers (e.g., OSCs) when planning and
implementing removal operations.
Some example processes include the following:
UFP-QAPP Systematic Planning Process - This
process was designed to ensure conformance to the
American National Standard adopted by EPA through
its Quality Order. (The standard is ANSI/ASQC E4-
1994, Specifications and Guidelines for Quality
Systems for Environmental Data Collection and
Environmental Technology Programs.) Part 1 of the
UFP-QAPP document series describes planning
elements that are similar to the DQO process. These
elements include the following:
Establishment of a team-based approach to
planning;
Description of the project goal, objectives, and
questions and issues to be addressed;
Identification of project schedule, resources
(including budget) milestones, and any applicable
requirements;
Matching of the data collection and analysis
process to project objectives;
Identification of collection and analysis
requirements; and
Description of the generation, evaluation, and
assessment of collected data.
Each element has at least one specific planning step
associated with it. For more information, see Table 1
and companion text in IDQTF's Uniform Federal
Policy for Quality Assurance Project Plans, Part 1:
UFP-QAPP Manual, EPA-505-B-04-900A, Version 1,
March 2005 [Contact: Mike Carter, (703) 603-0046].
U.S. Army Corps of Engineers' Technical Project
Planning (TPP) Process - The US ACE's TPP process
was also designed to ensure conformance to
ANSI/ASQC E4-1994 and simplify EPA's planning
requirements. The TPP process consolidates the DQO
Process into the following four phases:
Phase I: Identify Current Project;
Phase II: Determine Data Needs;
Phase III: Develop Data Collection Options; and
• Phase IV: Finalize Data Collection Program.
Compared to the DQO Process, the TPP process
activities, guidance, and tools provide more explicit
guidance in designing a data collection program for a
site. TPP can be used when planning any activities at
a site (i.e., site investigation; design; construction,
operation and maintenance; or long-term monitoring).
This process is described in Technical Project Planning
(TPP) Process, EM 200-1-2, U.S. Army Corps of
Engineers, August 31, 1998 [Contact: Larry Becker,
(202)761-8882].
U.S. Department of Energy (DOE) Streamlined
Approach for Environmental Restoration (SAFER) -
DOE developed SAFER as a methodology tailored to
the challenges of conducting environmental restoration
efforts under conditions of significant uncertainty.
SAFER was developed primarily by integrating the
DQO Process with the Observational Approach (OA),
or "learn-as-you-go." SAFER does not use the "seven
step" format explicitly, but implicitly incorporates the
process in describing the steps in Remedial
Investigation/Feasibility Study (RI/FS) planning
through to the Remedial Design/Remedial Action
(RD/RA) phase of environmental restoration. SAFER
was developed for use in streamlining the iterative
process between determining the type and extent of
contamination at a site and identifying and evaluating
cleanup alternatives. It is a corollary to EPA's
Superfund Accelerated Cleanup Model (SACM). This
process is described in "Streamlined Approach for
Environmental Restoration (SAFER)" in Remedial
Investigation/Feasibility Study (RI/FS) Process,
Elements and Technical Guidance (EH 94007658),
Environmental Management, December 1993 [Contact:
Analytical Services Division, (301) 427-1677].
Bureau of Reclamation's Decision Process - The U.S.
Bureau of Reclamation's DecisionProcess is broader in
scope and designed to be used for a variety of
operations, environmental or otherwise. It integrates
the spirit of the DQO Process (using eight steps for
planning) and continues the process through
implementation and follow-up. Case studies available
include a National Environmental Policy Act
compliance study and a study on environmental
indicators, demonstrating its flexibility. This process is
described in Decision Process Guidebook (How to Get
Things Done in Government), Bureau of Reclamation
[Contact: Thayne Coulter, (303) 445-2706].
The Triad Approach/Framework - Like the U.S.
Bureau of Reclamation's Decision Process, the
systematic planning performed for Triad projects is
broader in scope than data collection, and is heavily
focused on site remedial or closeout decision-making.
Triad encourages the use of conceptual site
models(CSMs) to aid understanding of contaminated
sites.§ Information on Triad's systematic project
J EPA Quality Staff had made available for peer review a draft guidance document describing the "Performance and Acceptance Criteria (PAC)
Process" in Guidance on Systematic Planning for Environmental Data Collection Using Performance and Acceptance Criteria (EPA QA/G-4A),
Peer Review Draft, October 2002. By April 2003, however, this peer review draft was removed from Quality Staffs public Web site due to
extensive revisions needed. By March 2004, EPA Quality Staff had decided not to revise and reissue EPA QA/G-4A as a separate document but
to incorporate its information into the next revision of EPA QA/G-4, which was issued in February 2006.
§ CSM is a depiction of the contaminated site of interest and addresses contaminant release, migration, and potential exposure receptors.
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planning and Triad case studies are available through
the Triad Resource Center Web site at
www.triadcentral.org [Contact: Deana Crumbling,
(703)603-0643].
Each of these five processes meets the eight elements of
systematic planning described in the Quality Manual
and included above. This is not intended to be an
exhaustive list. Other processes may be more suitable
to Removal Program staff in the Regions.
IDENTIFICATION OF SUPERFUND DATA
CATEGORIES
Regardless of the process selected, completion of one
of the planning process elements should include the
identification of the Superfund data category or
categories applicable to data to be generated during the
removal event and the subsequent decisions. (That
element is "identification of the type of data needed and
how the data will be used to support the project's
objectives.") A separate QA Technical Information
Bulletin, Applicability of Superfund Data Categories to
the Removal Program, discusses these Superfund data
categories more thoroughly.
REGIONAL POLICIES ON SYSTEMATIC
PLANNING
It is important that the Regional Quality Management
Plan describe the process for project planning in the
Removal Program. This should include identification
of who is responsible and how project planning will be
documented.
The results of systematic planning are typically
documented in a QA Project Plan. A separate QA
Technical Information Bulletin, Changes in Quality
Assurance Policies for the Removal Program, describes
the contents and QA Project Plan documentation for
removals in more detail.
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. U.S. Department of Army, Technical Project
Planning (TPP) Process, EM 200-1-2, U.S. Army
Corps of Engineers, August 31, 1998.
4. U.S. Department of Energy, "Streamlined
Approach for Environmental Restoration
(SAFER)" in Remedial Investigation/Feasibility
Study (RI/FS) Process, Elements and Technical
Guidance (EH 94007658), Environmental
Management, December 1993.
5. U.S. Department of Interior, Decision Process
Guidebook (How to Get Things Done in
Government), Bureau of Reclamation,
http://www.usbr.gov/pmts/guide/.
6. U.S. Environmental Protection Agency, Data
Quality Objectives Process for Superfund (Interim
Final Guidance), (EPA 540/R-93-071), Office of
Emergency and Remedial Response, September
1993.
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,
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.
10. U.S. Environmental Protection Agency, Guidance
For The Data Quality Objectives Process, EPA
QA/G-4 (EPA/240/B-06/001). Office of
Environmental Information, February 2006.
11. U.S. Environmental Protection Agency, Systematic
Planning: A Case Study for Hazardous Waste Site
Investigations, EPA QA/CS-1 (EPA/240/B-
06/004), Office of Environmental Information,
February 2006.
12. U.S. Environmental Protection Agency, Triad
Resource Center, http://www.triadcentral.org/
13. U.S. Environmental Protection Agency,
Applicability of Superfund Data Categories to the
Removal Program, Quality Assurance Technical
Information Bulletin, July 2006.
14. U.S. Environmental Protection Agency, Changes
in Quality Assurance Policies for the Removal
Program, Quality Assurance Technical
Information Bulletin, July 2006.
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