Page 1 of 5
                     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.
                                    Page 5 of 5

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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