QUALITY ASSURANCE PROGRAM P LAM
FOR
REGION III
PART 1
QUALITY ASSURANCE POLICIES, PROCEDURES
AND MANAGEMENT SYSTEMS
DOCUMENT CONTROL NUMBER
R3 - QA001
NVIRONMENTAL PROTECTION AGENCY - REGION I
ENVIRONMENTAL SERVICES DIVISION.
84.1 CHESTNUT BUILDING
PHILADELPHIA, PENNSYLVANIA 19107
NOVEMBER, 1986
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TABLE OF CONTENTS
Section Section/Subsection Heading Revi sion
1.0 QA PROGRAM PLAN IDENTIFICATION 0
1.1 Program Divisions Ouality
Assurance Contacts
2.0 INTRODUCTION 0
3.0 REGIONAL QUALITY ASSURANCE POLICY 0
4.0 OUALITY ASSURANCE MANAGEMENT 0
4.1 Regional Program Identification 0
4.2 Assignment of Responsibilities 0
4.3 Communication/Reporting/Work Plan 0
4.4 OA Program Operation and QA Program/ 0
Project Plan Approval Procedures
4.5 Program Evaluation/Audits 0
4.6 Resources 0
5.0 CONCEPTS AND CONSIDERATIONS OF QA PROJECT PLAN 0
5.1 Quality Assurance Project Plans Contents 0
5.2 Standard Operating Procedures 0
5.3 Data Quality Objectives 0
5.4 Data Processing and Verification 0
5.5 Data Quality Assessment 0
5.6 Corrective Action 0
6.0 TRAINING 0
7.0 IMPLEMENTATION REQUIREMENTS AND SCHEDULE 0
Date
Page
1
1
L
i
1
5
5
7
8
15
19
1
1
2
4
6
7
9
1
1
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TABLE OF CONTENTS
Section
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Appendix F
Appendix G
Appendix H
Section/Subsection Heading Revision Date Page
1 - 7
EPA QA Policy Statement and 0
EPA Order 536.01 for QA
Water Management Division 0 1-14
Organizational Components
and Program Specific OA
Program Plans
Air Management Division 0 1-5
Organizational Components
and Program Specific QA
Program Plans
Hazardous Waste Management 0 1-22
Division Organizational
Components and Program
Specific OA Program Plans
Environmental Services 0 1-16
Division Organizational
Components and Program
Specific OA Program Plans
Interim Guidelines and 0
Specifications for
Preparing Quality
Assurance Projects
Plans (QAMS-005/80)
Headquarters Program - 0
Specific Quality Assurance
Project Plan
Guidance Documents
General Regulation for 0
Assistance Program
(Federal Register)
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Regional QA Plan
Part 1, Section: 1.0
Revision No. 0
Date: 11-28-8*
Page: 1 o E 4
1.0 QUALITY ASSURANCE PROGRAM PLAN IDENTIFICATION FORM
Document Title Quality Assurance Program Plan for Region III
Document Control Number R3 - QA001
Organization Title EPA Region III
Address 841 Chestnut Building
Philadelphia, Penna. 19107
Regional Administrator James M. Seif
Quality Assurance Officer Charles Jones, Jr.
Address EPA Region III
841 Chestnut Building
Philadelphia, Penna. 19107
Plan Coverage This plan covers all monitoring and measurement activities
mandated through EPA regulations and memoranda. This includes all
internal and external environmental data generated by activities
conducted through Regional monitoring programs, grants, contracts,
interagency, and cooperative agreements.
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Regional QA Plan
Part 1, Section: 1.0
Revision No. 0
Date: 11-28-86
Page: 2 of 4
Concurrences:
(1) Name
Greene A. Jones
Title
(Director, Environmental Services Division)
Signature
Date
(2) Name
Stephen R. Wassersug
Title
(Director, Hazarodous Waste Management Division)
Signature
Date
(3) Name
W. Ray Cunningham
Title
(Director, Air Management Division)
Signature
Date
(4) Name
Alvin R. Morris
Title
(Director, Water Management Division)
Signature
Date
(5) Name
William T. Wisniewski
Title
(Assistant RA for Policy and Management)
Signature
Date
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Regional QA Plan
Part 1, Section: 1.0
Revision No. 0
Date: 11-28-86
Page: 3 of 4
(6) Name Bruce M. Diamond
Title (Regional Counsel)
Signature Date
(7) Name Charles Jones, Jr.
Title (Quality Assurance Officer)
Signature Date
Approval for Implementation
Name Stanley L. Laskowski
Title (Deputy Regional Administrator)
Signature Date
Name James M. Seif
Title (Regional Administrator)
Signature Date
Approval for Agency
Name Stanley Blacker
Title (Director, QAMS)
Signature Date
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Regional OA Plan
Part 1, Section: 1.0
Revision No. 0
Date: 11-28-86
Page: 4 of 4
1.1 Program Division Quality Assurance Contacts
Water Management Division
Victoria P. Binetti, Chesapeake Bay Program
Mary Ann Daly, Water Supply Branch (PA Implementation Section)
Joseph Davis, Water Permits Branch
Robert Lange, Water Supply Branch (State Programs Section.)
Tom Merski, Office of Groundwater
Air Management Division
Mike Giuranna, Air Programs Branch
Jack Reynolds, Air Enforcement Branch
Hazardous Waste Management Division
Walter Graham, Hazardous Waste Enforcement Branch (CERCLA Removal/Remedial)
Joel Karmazyn, Waste Management Branch
Ken McGill, Hazardous Waste Enforcement Branch (RCRA Enforcement)
Lisa Nichols, Toxics and Pesticides Branch
Edward Shoener, Superfund Branch
Environmental Services Division
Barbara D'Angelo, Environmental Impact and Marine Policy Branch
Bettina Fletcher, Central Regional Laboratory
Kim Hummel, Environmental Management Branch (Environmental Programs
Section)
David O'Brien, Environmental Management Branch (Environmental Monitoring
Section)
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Regional QA Plan
Part 1, Section: 2.0
Revision No. 0
Date: 11-28-86
Page: 1 of 2
2.0 INTRODUCTION
The primary goal of EPA's Quality Assurance (QA) Program is to ensure
that all environmentally related measurements, whether funded by EPA
under State grants or private contracts or generated by EPA itself, are
scientifically valid, defensible and of known precision and accuracy.
The. quality of the data is known when all components associated with its
collection derivation (such as project planning, field work sample analysis
and data validation/reporting) are throughly documented.
Quality Assurance and Quality Control are often used interchangeably
which is incorrect. Quality Assurance and Quality Control are defined as
follows:
Quality Control (QC)
- activities performed during data collection to document the
quality of the collected data (e.g., spikes, blanks, reference
materials, calibrations).
- the routine application of procedures for obtaining prescribed
standards of performance in the monitoring and measurement
process .
Quality Assurance (QA)
- The total integrated program for assuring reliability of
environmental monitoring and measurement data. Management
review and oversight at the planning, implementation, and
completion stages of data collection to assure that the data
provided are of the quality needed and claimed. A QA Program
Plan is a document presenting the policies, objectives,
management structure, and general procedures which comprise
this total program.
EPA Policy Memoranda issued May 30 and June 14, 1979 and EPA Order
5360.1 issued April 3, 1984, require a centrally managed QA program for
all EPA Regional Offices, Program Offices, Laboratories, and State grant
agencies. This also includes those monitoring and measurement efforts
mandated or supported by EPA through regulations, grants, contracts or
other formalized agreements. (See Appendix A.)
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Regional QA Plan
Part 1, Section: 2.0
Revision No. 0
Date: 11-28-86
Page: 2 of 2
EPA Order 5360.1 "Policy and Program Requirements to Implement
the QA Program, "incorporates the QA program into EPA operational
procedures. It defines the elements that will be required to
implement the QA program and it establishes the policy goals and
responsibilities of each program area. EPA Order 5360. L also
specifies that the Office of Research and Development (ORD) has been
given the responsibility for developing, coordinating, and directing
the implementation of the Agency Quality Assurance Program. ORD
established the Quality Assurance Management Staff (QAMS) to serve
as the central management authority for this program. The other
Agency organizations involved in the management of the mandatory QA
programs are National Program Offices and Regional Offices. Each
regional office has assigned QA representatives to assist QAMS in
the implementation of the QA program at the regional, State and
Local agency levels. The Regional Administrator has the overall
responsibility for implementation at these levels. The Environmental
Services Division has the responsibility to coordinate the Agency's
QA program.on a day-to-day basis within Region III. Implementation
of program specific QA requirements is the responsibility of the
operating programs in the various Region III Branch Offices.
To implement Agency policy, EPA laboratories, Program Offices
and Regional Offices are required to prepare a QA Program Plan
covering all intramural and extramural monitoring and measurement
activities (i.e., environmental monitoring) which generate and process
environmental data for Agency use. This includes those activities
that affect the generation, handling and use of environmental data
for planning, control strategies and enforcement actions. This
document describes the QA Program Plan for Region III. The approach
used in this QA Program Plan is to have each program division
(branch/section) identify the QA elements in its respective monitoring
program. Staff QA responsibilities (QA Project Plan development,
review of external QA Program and Project Plans, data review, etc.)
and the resources allocated for their performance are described in
the their respective sections of this QA Program Plan. (See Appendices
B to E). Internal and external audits will be used to monitor this
approach. The purpose of this QA Program Plan is to develop and
implement a QA program so that all environmental data generated
within or used by Region III will be of acceptable quality. This
will be done in cooperation with QAMS and will be consistent with
Agency policy, regulations and guidelines to maintain national
uniformity in QA activities.
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Regional QA Plan
Part 1, Sect ion: 3.0
Revision No. 0
Date: L1-28-86
Page: 1 of 2
3.0 REGIONAL QUALITY ASSURANCE POLICY
It is the policy of Region III that there shall be sufficient QA
activities conducted within the Region to ensure that all environmental
data generated and processed will be scientifically valid, of adequate
statistical quantity, of known precision and accuracy, of acceptable
completeness, representativeness, and comparability and where appropriate,
legally defensible. This goal can be achieved by ensuring that adequate
QA procedures are used throughout the entire monitoring process (from
initial study planning through data usage).
A. Specifically it is the policy of Region III that:
- Each program that generates environmental data will develop and
implement a QA Project Plan addressing the elements contained in
EPA's guidance documents QAMS-005/80, "Interim Guidelines and
Specifications for Preparing Quality Assurance Project Plans" and/or
"Guidance for Preparation of Combined Work/Quality Assurance Project
Plans for Water Monitoring", (OWRS QA-1). Each program will ensure
that adequate resources (both monetary and staff) are provided to
support the QA effort. The Project Plan will specify the detailed
procedures required to assure quality data. QA Project Plans must
be approved through the procedure described in Section 4.4, prior
to data collection.
- All environmental data generated will be of known and acceptable
quality. The data quality information developed with all environ-
mental data will be documented and available.
- All regional programs that generate environmental data will ensure
that acceptable QA requirements are included and implemented in all
applicable external monitoring activities funded by EPA.
- The intended use(s) of data will be defined before the data collection
effort begins, so that appropriate QA measures may be applied to
ensure a level of data quality commensurate with the monitoring
objectives. The determination of this level of data quality shall
also consider the prospective data needs of secondary users where
possible. Data quality objectives (DQOs) will be established to
ensure the utility of monitoring data for its intended use and as
guidance for preparation of QA Project Plans. The intended data
uses, level of quality, specific QA activities, and data acceptance
criteria necessary to meet the data quality needs of these uses will
be described in each monitoring activity's QA Project Plan.
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Regional QA Plan
Part 1, Section: 3.0
Revision No. 0
Date: 11-28-8')
Page: 2 of 2
- Data Quality Objectives (DQOs) must be established before each
monitoring activity is initiated. The key aspects of data
quality that must be addressed by these objectives are precision,
accuracy, representativeness, comparability and completeness. A
complete description of the data quality objectives should be
included in the QA Project Plan.
- Quality assurance activities will be designed in the most cost-
effective fashion possible without compromising data quality
obj ectives.
- The development and maintenance of acceptable State QA programs
will be integrated, as appropriate, into the overall State-EPA
Agreement ("SEA") process.
- Region III Project Officers will inform the Regional QA Officer
of- activities relating to QA within their specific monitoring
programs and facilitate development and implementation of QA
Project Plans.
- Facilities, equipment and services which, directly or indirectly,
impact data quality or integrity shall be routinely inspected and
maintained where appropriate.
- Data processing will be documented, reviewed, and revised as
required by the Regional Quality Assurance Program Plan or Agency
mandates and quidelines. Data will be validated according to
specific criteria which will follow EPA guidelines and regulations.
- The Regional QA Officer will submit annual QA Reports, Work/Audit
Plans to the Director of QAMS for approval. The report will become
part of the annual QA Report to the Administrator prepared by QAMS.
- The QA Program Plan will be reviewed at least annually by the
Regional QA Officer and updated as required. Significant revisions
will be submitted to QAMS for approval.
The Regional Administrator has the overall responsibility for imple-
mentation of the Agency's QA Program in Region III. These responsibilities
are specified in EPA Order 5360.1, Section 4.C. "Policy and Program
Requirements to Implement the Mandatory Quality Assurance Program". The
Director of the Environmental Services Division (ESD), through the Regional
Quality Assurance Officer (RQAO) assures that the QA responsibilities
specified in EPA Order 5360.1, Section 4.C are met for the Region. This
responsibility also includes external monitoring activities of States,
Interagency Agreements, Local Agencies, Contractors and others covered
by the Agency QA mandate.
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 1 of 19
4.0 QUALITY ASSURANCE MANAGEMENT
4.1 Regional Program Identification
The organizational structure of Region III that relates to data
collection and decision making based on results of data collecting
activity is shown in Figure 1. Regional program elements covered by
the Agency's OA requirements are described below:
4.1.1 Immediate Office of the Regional Administrator
.The Regional Administrator is responsible to the Administrator,
within the boundaries of Region III, for the execution of the Regional
programs of the Agency and such other responsibilities as may be
assigned. He serves as the Administrator's principal representative
in the Region for contracts and relationships with Federal, State,
Interstate and Local Agencies, industry, academic institutions, and
other public and private groups. He is responsible for accomplishing
national program objectives within his Region as established by the
Administrator, Deputy Administrator, Assistant Administrators and
Heads of Headquarters Staff Offices. He develops, proposes and
implements an approved Regional program for comprehensive and
integrated environmental protection activities. He is responsible
for total resource management in the Region within guidelines provided
by Headquarters. He is responsible for translating technical program
direction and evaluation provided by the various Assistant Administrators
and Heads of Headquarters Staff Offices into effective operating
programs at the Regional level, and assuring that such programs are
executed efficiently. He exercises approval authority for proposed
State standards and implementation plans provides for overall and
specific evaluations of Regional programs.
4.1.1.1 Deputy Regional Administrator
The Deputy Regional Administrator assists the Regional Administrator
in the discharge of his duties and responsibilities and serves as Acting
Regional Administrator in the absence of the Regional Administrator.
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» H. Self
AJainist rat or
)a
Reg 1011a
(October 1986
U. S. LNVIdOMHItHT/kL PROTfcLrl'W Atif.HL'Y • * EG I UK III
REGIONAL ADMINISTRATOR
Jihi H Scif
7-9SH J(«nu
Regional OA PI
Part I, Section:4.0
Revision Mo. 0
Date: 11-28-86
Vase: 2 of 19
OFFICE OF
REGIONAL COUNSEL
Bruce M. Diaaond
7-9SJ2 JBCOO
Michael Vaccaro, Oeputy
7-2671 JRCOO
AIR AND TOXtCS
BRANCH
Hareia E. Mulkey
7-0995 3RCIO
HAZARDOUS HASTE
BRANCH
Nc 11 Mi»e
7-9*79 3RC20
HATER I MANAGEMENT
BRANCH
Benjaaln Ktlkiicin
7-9477 JRCJO
CHESAPEAKE BAY
PROGRAM
Charles Spooner
922-2285 3CBOO
MATfcR MANAGEMENT
DIVISION
Alva n R. Mo r r11
7-9410 3MH00
Robert Mitkus, Deputy
7-3420 3MH00
MATES PROGRAM
MANAGEMENT
AND SUPPORT BAANCH
Joseph T. Ptctrowski
?-3927 IWHIO
MATER SUPPLY
BRANCH
Jon H.
7-8227
Capa
JMM40
DEPUTY REGIONAL A.tMl Nl STRATOR
Stanley L. la ikon il. *
1 -9812 30*00
OFFlCe OF
PUBLIC AFFAIRS
Janet Vlnliki
7-9J70 JPAOO
£EO MANAGER
Betty M.
Inge
7-3601
1PM00
CENTER
FOR
ENVIRONMENTAL
LEARNING
Hsrgot Hunt,
Director
iPHOO
OFFICE OF ASSISTANT REGIONAL
ADMINISTRATOR FOA
POLICY AND MANAGEMENT
HlUiia T. Mi»nla«>kl
7-3654 JPMOO
Elaine B. Mrlght, Deputy
7-9SJ0 3PS400
ADMINISTRATIVE
MANAGEMENT BRANCH
Mary A. Sarno
7-1180 3PM20
HUMAN RESOURCES
MANAGEMENT BRANCH
Andrew P. Carl in
7-937? 3PH40
OFFICE OF
CONGRESSIONAL |
INTERGOVERNMENTAL
LIAISON
ftlchtrd J. Pastor
7-9072 1CI00
OFFICE OF
COMPTROLLER
Robert C. Reed
JLJMi jphio
INFORMATION RESOURCES
MANAGEMENT BRANCH
A. J. NiaiIto
7-781?
JPhiQ.
PLANNING AND ANALYSIS
BRANCH
Henry J. Sololoirtkl
7-4 149 3PM60
CONSTRUCTION GRANTS
BRANCH
Mills*
7-9460
¦ M. Buia
AIR MANAGEMENT
DIVISION
¦ Ray Cunninghaa, Director
7-9390 IAH0U
Thoaas J. Maslany, Deputy
7-9342 lAMOO
X
HAZARDOUS HASTE
MANAGEMENT DIVISION
Stephen R. Nassersug
7-6131 1HM0U
Roland Schrecongosl, Deputy
7-9492 3IIM00
AIR PROGRAMS
BRANCH
Joseph M. *un«
(Acllog)
-907S )AMIQ
MATER PERMITS
BRANCH
Joseph A. CaIda
Nei I R Swanson, Uepul)
7-9U?8 5MMS0
AIR ENFORCEHENI
BRANCH
Cher*I Mas serpen
I Acting)
1 - 1989 1A>L">
HAZARDOUS MASTE
ENFORCEMENT BRANCH
Bruce P. Saith
Patrick R. Anderson
(Deputy)
imtifl
WASIf MANAGEMENT
BRANCH
Robe rt L. Allen
Maund J. Skernolis
iDeputy)
7-0980 3IIM10
ENVIRONMENTAL SERVICES
D1VI
S1 ON
Greene
A. Jones
7-4532
3ESC0
Leonard Manglaracins, Deputy
7-8173
1ES00
SUPERFUND
BAANCH
Thoaas C. Valtaggto
Charles L. Heeaan
(Deputy)
7-8132 3HH20
ENVIRONMENTAL
MANAGEMFNT
BRANCH
Jaaea M.
7-9375
Newsoa
TOIICS k PCSTICIOES
BRANCH
Iarry S Mi Iler
7-8S98 3HW4Q
MllfcELING
OFFICE
H. Rona Id Preston
IQ4-232-4DS5 3ES30
ANNAPOLIS
OFFICE
Orterio Villa. Jr.
92237S2 3ES20
LNVIHONMtNlAL IHPAC1
AND MAHINI POLICY
BRANCH
John R. Pompon to
7 1 I B1 W S40
FICURE I
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 3 of 19
4.1.2 Office of Regional Counsel
The Office of Regional Counsel under the supervision of the Regional
Counsel and Deputy Regional Counsel is responsible for providing legal
advice and services to the Regional Administrator, the Region's programs
and administrative staffs, as well as legal enforcement-related matters.
The Office of Regional Counsel is a component of the Office of
General Counsel at Headquarters. It acts as a liaison with other Offices
of Regional Counsel, other federal and state law offices with common
interests and concerns.
4.1.3 Office of Assistant Regional Administrator for Policy and Management
The Office of the Assistant Regional Administrator (ARA) for Policy
and Management is responsible for planning, reviewing, organizing, directing,
controlling, coordinating, and supporting the regional programs involving
personnel, administrative and financial management, regional planning
and policy formulation, development of state relations and oversight
policy and procedures, regulatory reform, regional participation in
regulation development, and advising on the management process. The
Office of ARA for Policy and Management ensures that grants, interagency
agreements and contracts that are subject to the provisions of Section
30.503 (Regulations for Assistance Grants), contain the required policies,
procedures, specification standards and documentation prior to award.
ARA will also confer with the Regional OA Officer on pending grant,
interagency agreement and contractual actions for QA Program implications
prior to award.
4.1.4 Water Management Division
The Water Management Division (WMD) is responsible for the manage-
ment and implementation of programs authorized under the Clean Water
Act and Safe Drinking Water Act. These programs include Water Ouality
Planning and Standards, Water Quality Compliance and Enforcement,
Municipal Facilities Construction, Public Water Supply, and Ground
Water Protection. In addition to those programs authorized by statute,
the Division Director is responsible for the Chesapeake Bay Program.
WMD assists States and localities in developing comprehensive environ-
mental programs for achievement of environmental goals and standards.
Each WMD Branch that is responsible for monitoring activities has
developed a QA Program Plan that covers its activities. The WMD OA
Program Plans are described in Appendix B of this document.
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 4 of 19
4.1.5 Air Management Division
The Air Management Division (AMD) is responsible for Regional
implementation of the Clean Air Act and for radiation programs. In
part, AMD recommends to the Regional Administrator the goals, priorities
and objectives of the Regional Air Quality and Compliance Program. AMD
serves as the technical/program authority for all air environmental
monitoring activities within Region III. AMD manages a portion of the
Regional Federal grants and contracts funding processes while overviewing
State/Local air monitoring programs. AMD QA Program Plans, developed
by its Branches, are described in Anpendix C.
4.1.6 Hazardous Waste Management Division
The Hazardous Waste Management Division (HWMD) is responsible for
all Regional activities regarding the following programs - Resource
Conservation and Recovery Act (RCRA); Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) or Superfund; Federal
Insecticide, Fungicide and Rodenticide Act as amended (FIFRA); the
Toxics Substances Act (TSCA) and the Emergency Response. HWMD is
responsible for permitting and compliance as well as enforcement for
facilities storing hazardous waste. HWMD is also responsible for
TSCA and FIFRA enforcement. HWMD serves as the technical and program
authority for all hazardous waste environmental monitoring activities
within the Region. Where applicable, each HWMD Branch has developed a
QA Program Plan describing its monitoring activities. The HWMD QA
Program Plans are described in Appendix D.
4.1.7 Environmental Services Division
The Environmental Services Division (ESD) collects, analyzes and
evaluates environmental quality data in support of Regional and National
programs, including air, water and hazardous waste programs. ESD directs
and coordinates surveillance and monitoring services within the Region
and provides necessary laboratory analytical services in support of
various Regional and National environmental monitoring activities. ESD
also provides advice and assistance to State and Local Agencies concerning
laboratory and field techniques, methodology and quality control as well
as laboratory analysis when required. ESD has management responsibilities
for the Regional Quality Assurace Program. ESD is also responsible for
Managing for Environmental Results and integrating the environmental
management programs, providing technical assistance and the transfer of
technology, and for overseeing the environmental management of Federal
Facilities. Each ESD Branch, that is responsible for monitoring activities,
has developed a QA Program Plan that covers its activities. The ESD QA
Program Plans are described in Appendix E.
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Regional QA Plan
Part 1, Section:
Revision No. 0
Date: 11-28-86
Page: 5 of 19
4.2 Assignment of Responsibilities
The Regional Administrator has the overall responsibility for the
development and implementation of the Regional QA Program. The Director
of the Environmental Services Division, through the Regional OA Program
Plan, is responsible for continued operation of Regional QA activities.
The authority and responsibility for managing the Regional OA program was
assigned to the Regional QA Officer. To ensure that the Region's OA
policy is uniformly applied throughout the Regional, a Regional Quality
Assurance Management Office (RQAMO) was established (January 10, 1982).
The Regional QA Officer (under the administrative management direction
and support of the Environmental Services Division Director) shall serve
as Chief of this office (RQAMO). The RQAMO shall function as a central
QA management authority organizationally independent of the programs
supported, i.e., environmental data generators and users.
A. Regional Quality Assurance Management Office Responsibilities
The RQAMO located in the Environmental Services Division has the
responsibility for managing the Region III QA Program. The Regional
OA Officer shall serve as the Chief of the RQAMO. The following
list enumerates the responsibilities of the Regional OA Officer:
1. The official Regional contact for QA matters of the Region.
2. Respond to QA needs, resolve problems, and answer requests
for quidance or assistance.
3. Assist program offices with management aspects of QA program
and project plans development for States, Contractors, and
regional program offices.
4. Review and approve/disapprove all Regional OA program plans.
Review and approve selected QA plans.
5. Assure that QA Program requirements are integrated into the
overall State/EPA Agreement Process and grants.
6. Assist States in the development and implementation of QA
Program and Project Plans.
7. Coordinate and/or conduct System and Performance audits
of selected environmental monitoring programs.
8. Submit annual OA Status Report and Work Plan to Regional
management and QAMS.
9.
Participate in QAMS' QA review of Region III QA.
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Regional OA Plan
Part 1, Section:
Revision No. 0
Date: 11-28-86
Page: 6 of 19
B. Technical Specialists Responsibilities
To ensure that a satisfactory level of QA capability is maintained
in Region III, the RQAO will be able to request technical assistance
from technical specialists primarily from the ESD. These personnel
have expertise in specific areas such as air, water, drinking water
laboratory certification, compliance monitoring, field operations,
chemistry, microbiology, biology, and data processing.
C. Regional Programs Managers Responsibilities
Regional Program Managers are responsible for ensuring that their
internal and external monitoring projects are in accordance with their
division write-up in Section 4.1 and/or Agency QA policy.
Some of the key responsibilities of Program Managers are:
1. Establish planning polices to ensure that OA matters are
reflected in monitoring budgets, program plans, and operating
plans.
2. Participates in the development of Data Quality Objectives
for monitoring activities.
3. Review and approve OA plans where applicable.
4. Review and evaluate internal/external monitoring QA
implementation and progress.
5. Review and evaluate the quality of data generated by
monitoring projects.
6. Take corrective action that may be required by audit findings.
7. Spot check Project Officers QA activities.
8. Report QA problems to RQAMO.
D. Regional Project Officers Responsibilities
Regional Project Officers, responsible for specific monitoring projects,
will be held accountable for the management of the project and its ultimate
product. Therefore, the Project Officer has the principal responsibli 1 ity
for ensuring that project Data Quality Objectives are met.
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Regional QA Plan
Part 1, Section:
Revision Mo. 0
Date: 11-28-86
Page: 7 of 19
Some of the key responsibilities of the Project Officer are:
1. Prepare OA Project Plan for every applicable project.
2. Prepares Data Quality Objectives, specifications, and
acceptance criteria for the projects.
3. Review/evaluate data quality generated from projects.
4. Participate in conducting QA system/performance audits of
internal projects.
5. Approve external QA Program/Project Plans where applicable.
6. Review/evaluate data quality generated from external
proj ects.
7. Participate in conducting QA system/performance audits of
external projects QA activities.
8. Take corrective action that may be required by audit findings.
9. Report OA problems to Regional QA Officer (RQAO).
E. Specific Staff Responsibilities
Specific QA responsibilities are assigned to individuals located in
the monitoring program offices. Detailed duties are described in the
various Program Office QA Program Plans in the Appendices.
4.3 Communication/Reporting/Work Plan
The purpose of communications is to ensure that staff personnel in
different monitoring programs can effectively develop and implement
programs, perform activities, and resolve problems. One responsibility
of the QA Program is to facilitate communications through the establish-
ment of guidance documents and the issuance of procedures. OAMS shall
be considered by the Region as the Agency's environmental monitoring QA
clearinghouse. As such, QA guidance/protocols of interest or need to
the Region shall be provided by the QAMS to the Regional OA Officer
(RQAO). Regional QA needs will be forwarded by the RQAO to QAMS for
review and action. The'RQAO shall exchange QA information with the QA
Officers of EMSLs, EPA Laboratories, and Headquarter's Program Offices.
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Regional OA Plan
Revision No. 0
Part 1, Section: £.0
Date: 11-28-86
Page: 8 of 19
The ROAO shall exchange OA information with Regional Programs Managers,
Project Officers, appropriate ESD ..staff, and State OA Officers. The
State QA Officers shall communicate with appropriate State environmental
monitoring personnel, the Local Agencies' OA Officers, and the industries'
QA Officers.
By October 1 of each year, the RQAO shall prepare and submit a OA
Status Report and Work/Audit plan to Regional Management and to the
Director of OAMS. This report shall reflect the implementation status
of the Region III OA Program. The Work. Plan will describe all planned
OA activities for the fiscal year beginning in October. The Audit Plan
will describe specific audits and audit responsibilities.
The OA Report/Work Plan shall contain at least the following types of
information:
1. Implementation Status of Regional OA Program.
2. Revisions to Regional OA Program Plan.
3. Significant OA-related needs i.e., new policies, changes to
existing policies, guidance documents, audit protocols, etc.
4. Audits - number and types to be conducted annually.
5. . Resources - allocated to the Regional OA Program.
6. Training - internal, external, given and taken.
The OA Status report shall also contain the OA status report developed
by the State Program Offices.
4.4 OA Program Operation and OA Program/Project Plan Approval Procedures
Effective management of a data collection program requires periodic
assessment of the quality of data being obtained to establish a basis
for corrective action which may be needed. To ensure that this assess-
ment occurs, all environmental monitoring planned or conducted within
the Region shall have an approved OA Project Plan prior to initiating
sample collection.
Each QA Project Plan shall ensure that:
- The level of needed data quality will be determined by the
users and stated before the data collection effort begins.
- All environmental data generated and processed will be of the
quality and integrity established by each OA Project Plan.
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-23-36
Page: 9 of 19
Oversight of the data generation activities in Region III will be
tailored to the nature of the activity and the associated management
and administrative system. Within the Region, OA operations and overview
fall into th'-ee categories: 1) internal (data generation programs designet
and operated by Regional staff), 2) grants and cooperative agreements
(data generation under program grants, etc.), and 3) contracts and inter-
agency and other formal agreements (special contract studies, etc).
Program managers/project officers will be responsible for preparing
QA Project Plans. Appropriate ESD staff will be available to assist in
the development of QA Project Plans. The OA Program/Project Plans
shall be reviewed and as appropriate, approved by the ESD. The program
manager/project officer shall review and evaluate the use of these Plans.
Upon completion of the monitoring activities, the program manager/project
officer shall assess the actual performance of the planned activity and
subsequent results.
A. OA Program Interactions
The EPA OA Program interactions are identified under the following
Flow Chart entitled "EPA Quality Assurance Program Linkages", Figure 2.
As depicted in the chart, EPA identifies Agency QA requirements
which are promulgated into regulations for assistance grants (40 CFR
Part 30, Section 30.503). The Office of Research and Development
(ORD) also formulates these requirements into Guidance to the Regional
Administrators (RAs) and the National Program Managers (NPMs). The
NPMs thereupon develop their respective National Program Specific OA
Plans and Data Ouality Objectives (DOOs). The OA Program Plans and
DQOs are then issued by the NPMs to the Regions' respective Program
Division Directors.
In Region III, the Environmental Services Division (ESD) acts as
the RA's OA Program agent by advising the division directors of the
ORD Guidance for developing OA Plans. The division directors submit
Regional Program Specific OA Plans (or Annual OA Program Plan updates
thereto) to ESD. In part, these plans include Standard Operating
Procedures (SOPs), QA Project Plans and output commitments. The
various ESD branches and laboratories also prepare these documents.
ESD consolidates these into the Regional QA Program Plan and subsequent
Annual OA Program Plan updates. Upon RA approval, the Regional OA
Program Plan is submitted to ORD for final approval. ESD issues the
ORD approved Plan to the Region III Divisions for implementation
(see Chart A: Regional OA Program Plan Development & Approval Process),
Figure 3.
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 10 of 19
B. QA Program Plan Approval Procedure
At about the same time that the Divisions prepare their OA documents
for submission to ESD, they also are preparing Annual Grant Guidance to
the States. Included in the Grant Guidance are Program Specific OA
Guidance and output commitments for the States. Based upon the preceding
OA guidance, the States prepare State OA Program Plans (or Annual OA
Program Plan updates thereto) to meet the requirements of 40 CFR Part
30, Section 30.503. In part, these OA Plans include SOPs and Project
Plans. The State OA Program Plans (or subsequent Annual OA Program Plan
updates) are submitted to the appropriate Region III Division for review.
The Division concurs/nonconcurs with the OA Program Plan(s) and submits
the Program Plan(s) with comments to ESD. ESD approves/disapproves the
OA Program Plan(s) based upon adherence to 40 CFR Part 30, Section 30.503
and other Agency QA requirements. ESD approved OA Program Plans are
returned to the appropriate Division for issuance to the State (see
Chart B: State QA Program Plan Development & Approval Process). Figure 4.
C. OA Project Plan Approval Procedure
Subsequent to approval and implementation of Regional and State OA
Program Plans, respectively, additional tasks may be initiated which are
subject to QA and may require OA Project Plans. Figure 5 depicts the
subsequent State OA Project Plan Approval Process. State Assistance
Grant Program Offices develop OA Project Plans which are reviewed and
approved by the responsible State officials. These State OA Project
Plans are then submitted to the lead Regional Program Division for review
and approval. If the OA Project Plan(s) is approved it is returned to
the State for implementation; if it is not approved, it is returned to
the State for additional development. ESD will also review select OA
Project Plans upon request. The number of OA Project Plans that will be
reviewed for each program office is determined during the Decision Unit
(DU) resource allocation process. The Program Manager and/or Project
Officer for the respective program office, determines the specific OA
Project Plans that will be reviewed by ESD.
Figure 5 also depicts the subsequent EPA or Contractor OA Project
Plan Approval Process. Under both processes, OA Project Plans not
previously approved as part of a Regional or State QA Program Plan must
be submitted to the appropriate Region III Division which will exercise
review and approval authority for the proposed QA Project Plans. Approved
QA Project Plans will then be returned to the requester for implementation.
-------
EPA QUALITY ASSURANCE PROGRAM LINKAGES
START
AGENCY QA
REQUIREMENTS
ESTABLISHED
ORD (QAMS)
GUIDANCE
PREPARED
RA (ESD) REG'L
QA PROGRAM
PLAN GUIDANCE
PREPARED
ANNUAL QA
PROGRAM PLAN
AND OUTPUT
COMMITMENTS
OUTPUT
COMMITMENTS
(GRANTS)
QA REGULATIONS
FOR ASSISTANCE
GRANTS
AO CFR 30.503
EPA QA
PROJECT PLANS
AND SOPs
STATE QA
PROJECT
PLANS & SOPs
AA's (NPMs)
PREPARE
a) NAT'L PROG.
SPEC. QA PLAN
b) DATA QUAL. OBJ.
STATE PREPARE
STATE QA PROGRAM
PLANS AND SOPs
* DD1s(PROG. MGRS)
PREPARE
a) PROG. SPECIFIC
QA PLANS & SOPb
b) STATE QA GUID.
Footnotes: * Includes ESD Laboratories
(a) Program Specific QA Plan Flowline
(b) State QA Guidance Flowline
Regional OA Plan
Part 1 , Section:
Revision No. 0
Date: 11-28-86
Page: 11 oE 19
A .0
FIGURE 2
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CHART A
REGIONAL QA PROGRAM PLAN DEVELOPMENT & APPROVAL PROCESS
Regional QA
Ptogru Plan 4
SOP* a ESD
Lead
AA'a National
Prograa Qa Plan
4 Data Quailty
Objective*
DD'a Program
Specific QA Plans
4 SOP'a
ORD Guidance to
AA*e & National
Program Managera
Mo
No
ESD Guidance to
DD'a & Regional
Progrea Manager*
ORD Guidance to
RA'a 4 ESD'a
Regional Overalght Evaluation
of QA Pcogrea Effectiveness
ESD Review &
Recoaaaendatlona
for RA'•
Approval
o
Required prograa Qa Plana
AMD
-Air Enforcement
ESD
-Air Monitoring
-Water Monitoring
-Wetlanda/HEPA
-Regional Laboratory
HVHO
-CERCLA
-RCRA
-TSCa
-fifra
WWD
-U1C
"Public Water Supply
-NPDES
-Water Quality Stds.
-Cround Water
-Chesapeake Bay
o
Major Elemeota of Qa Porgraa Plana
-QA Prograa Coordinator
-Prograa Policy on Qa
-Internal QA Manageaent Plan
-Personnel QualIfIcatloaa
-Facilities, e«julp*ent, service*
-Data generation and QA requlreoenta
-Data proceaaing, validation, reporting
-Data quality aaaessnent
-Action plan for dtf(tclency aituatlous
-Project plan development
-SOP'b
-Approval of State/granteo QA prograa plant
-Approval of Siata/graoteo/contractox QA
project plana
©
©
CSD Revley Proceaa
-Conformity wlLb ORD, AA & ESD guidance#
-QA PrograaPlao Kay Eleaanta
-Staffing
Major Elcicpta of
QA Pla
UlC QA
-Regional laboratory QA plan 4 SOP'a
-State laboratory cartlflcatloo prograa
-QA aanagoenet ayateaa audita of
Regional prograaa 4 State*
FIGURE 3
Regional QA Plan
Part 1, Section: 4.0
Revision Mo. 0
Da te: J 1-28-86
Page: 12 oC 19
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CHAr B
STATE QA PROGRAM PLAN DEVELOPMENT & APPROVAL PROCESS
AA'a National
Prograe Qa Plan
6 Da La Quality
Objectlve*
DD'a Prograa
Specific Qa Plans
k SOP'a
ORD Guidance To
RA'a fc ESD's
ESD Culdance To
DD'a 1 Regional
Program Manager*
QA Regulation*
for A**l*taacc
Graot* 40CFR30.503
Prograa Spec 11 lc
QA Culdance to
Stales - Prepared
by Lead DlvIsI on
Review of Stale
Prograa Plan by
Lead Olvlilona
State QA Progtan
Plan & SOP
& QAPjP
CSD Review fc
Ajs l*tance
Approvad
Stat* QA
antAtlon
Prograa
EPA Audit of State QA Program
0* quired ProRraa QA Plans Q riajor Eleacnt* of QA Progra» Plans
A/lD
-Air Enforcement
ESD
-Air Monitoring
-Water Honltorlog
-Wetl*nda/NEPA
-Regional Laboratory
HWflO
-CCRCtA
-RCRA
-TSCa
-FIFRa
UttD
-U1C
-Public Water Supply
-hPDES
-Water Quality Std6.
-Ground Water
-Chesapeake toy
-Qa Prograa Coordinator
-Prograa policy oo QA
-Internal QA aanageftem plan
-Personnel Qual11 lea11oca
-Faclllilea, equlpaeat., aervlces
-Data general loo and Qa requlrcaents
-Data processing, validation, reporting
-Data quality aesrss&ent
-Action plan (or defflclency altuallona
-Project plan development
©
0
Review Process
Lead Divisions
-Conformity with prograa specific
guidance
-Implementation schedules
-Hey elements aa follow*:
.QA Prograa Coordinator
•Prograo Policy on Qa
•Internal Qa Ban«ge*ent pies
.Personnel qual1f Icatloo*
.Facilities, equlpsent, aervlcea
.Action plan for deficiency altuatlooa
.Project plan developseni
CSD
-Technical assistance
-Key elenenta aa follow*;
.Peraonnel quallficatlooa
.Facilities, equipment, service*
.Data generation and QA requlrcaeota
.Data processing, validation, reporting
.Data quality asses:»oent
.Correctlv« act ion
Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
FIGURE 4 Page: 13 of 19
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CHARi C
STATE QA PROJECT PLAN APPROVAL PROCESS
Yes, only
or ici LPA approved Program Plan or Grant Condition
Annua] Stale
Cr.int Program
Plon & Output
Coaatl Inert for
I'roj cc lb
Djta Qual1iy
Objec11ves I or
Project Proposed
by Sutti Program
ngr.
fPA Approved
Slate Qa Prograo
EPA Guidance for
Preparing Qa
Project Plans
Slutf Qa Project
Plan by Statu
Project Officer
uvlded
mpleoent
Approved
EPA Qa
Project
HI
evicw by
Lead Dlvlsl
Ln EPA
Approve
by SesponyIblc
late Off ic lu
DD Approvs
Hay be
elega te
ESD Kevleu
and
Assistance by
Request Only
EPA OR CONTRACTOR PROJECT PLAN APPROVAL PROCESS
Annual Program
Plan and Output
{Jouml cmonts for
t'rujuc t s
Data Qua 1 i ty
Objectives for
Project Prepared
by Program Hgr.
DO1s> Prograo
Speciflc Qa
Plan* I SOP's
CPA Culdance
for Preparing
QA project Plans
Q
-»¦
ftajor Elements ol QA Project Plant
-Principle Investlgatlon( a)
-Project description
-Project organisation and
responsibilities
-Qa objectives
'Precision, accuracy, cospleteneae
and representstlveoesa
-Saopllng procedures fc custody
-Calibration procedures & standards
-Analytical procedures
-<]C checks
-Perforoance & systeas audits
-Laboratory SOP's
-Corrective acton for deficiency
s1tuationa
-Qa reporting procedures
QA Project Plan
Prepared by EPA
Project Officer
or Contractor
loplepent
Approved
State QA
Project
Plan
Review by
Lead Division
Ln EPA
Appr
Review Process
Lead Divisions
ESO Review &
Assistance by
Request Only
-Conforolty with Annual Pcogrsa Plan
and Output Cosaltaents for projecta
-Conforolty with data quality objectives
-Conforelty with EPA guidance for
preparlog Qa project plana
-Conforolty with Key Eleoents of QA
project plans
-Technical capability 6 staffing to
perfora work
©ESO
-ftevlew and provide technical assistance
for ony review functions on a request
only basis
Regional QA Plan
P/irC 1, Sect "ion: 4.0
Revision No. 0
FICURE 5 Date: ,i-28"86
Page: 14 of 19
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 15 of 19
4.5 Program Evaluation
The Agency's OA Program requires that an adequate level of auditing
be performed in all EPA programs involving the collection of environmental
data. To be effective, the Regional OA Program must have a mechanism
to routinely monitor and evaluate the adequacy of procedures implemented
throughout the Regional programs. The audit system is designed to provide
this critical means for overviewing and assessing the procedures to ensure
they have bPran implemented uniformly and are functioning effectively;
i.e., they meet the objectives and goals of the Regional Quality Assurance
Program Plan. The four types of audits - Management Systems, Technical
Systems, Data Quality and Performance - are described in detail in the
subequent subsections. They are intended to provide essential information
needed to assess various aspects of the OA Program in the Region on a
continuing basis. Overall, the audit system is expected to identify
strengths and weaknesses; cause corrective actions to be taken, as
necessary, to alleviate problems; facilitate the initiation of changes
aimed at enhancing the OA Program; serve as a vehicle for providing
technical assistance, as appropriate; enhance awareness and understanding
of QA and 0C policies and procedures; and provide a measurement of the
effectiveness of QC in assuring the quality of data.
As an essential element of the OA Program, an adequate level of
auditing will be performed in all programs involved in environmental
data collection. Toward this end, audits will be scheduled and performed
throughout the Region as needed to provide an overview of the effectiveness
of the implemented procedures under the OA Program. Dependent upon the
availability of resources, program guidance, regulatory requirements and
regional needs, the number and type of audit to be performed in the Region
will be projected and outlined in the workplan portion of Part 3 of the
Regional OA Program Plan (QAPP) on an annual [Fiscal Year (FY)] basis.
The number and types of audits completed during the previous FY will be
summarized in the status report portion of Part 4 of the Regional OAPP.
The results of System and Performance audits will be documented
by the audir^r(s) for presenting a visual picture of the performance of
the program to see if the minimum requirements of the Agency's OA program
are being met. If not, deviations will be identified and recommendations
made for corrections. If corrections are not made, recommendations will
be made to the appropriate Program Manager for action (i.e., withholding
grants or contract funds, etc).
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 1L-28-86
Page: 16 of 19
4.5.1 Management Systems Audit
The Management Systems Audit (MSA) is designed to evaluate the manage-
ment aspects of the OA Program. Based on guidance from OAMS and developed
within the Region, MSAs will be performed on the Regional organizational
units having the responsibility for managing specific programs that involve
data collection activities. The MSA will also be utilized to evaluate a
State or Local Agency to which a specific program has been delegated.
This type of audit will be used to examine and evaluate the procedures
integrated into the management of a program to ensure they are consistent
with and adequate to meet the policies and objectives of the approved
Regional QAPP. Through the MSA, strengths and weaknesses are identified
in the implementation and management of program-specific OC procedures
and corrective actions are recommended to rectify problems.
MSAs are scheduled and conducted at the discretion of the Regional
Administrator, or his authorized designee, for Regional organizational
units and at the discretion of the Regional program manager for State or
Local Agencies responsible for delegated programs. An MSA will normally
be conducted as part of the overall systems audit of a specific program
and in conjunction with a Technical Systems Audit (TSA), but may be
performed independently, as appropriate.
The MSAs of Regional organizational units will be accomplished by the
Environmental Services Division (ESD) at the discretion and direction of
the Regional Administrator, or his authorized designee. The ESD Division
Director is the designated Audit Director and will provide management
support and guidance for the audit. The Regional OA Officer is the
designated Lead Auditor and will coordinate the conduct of the audit.
The size and composition of the audit team will be determined by the
Audit Directur and Lead Auditor based on the scope of the audit and size
of the organizational unit being audited. The specific procedures for
these audits will be established by the ROAO based on guidance from
OAMS, the RA and Director, ESD.
The MSAs of State and Local Agencies., to which specific programs
have been delegated, are the OA portion of the overall audit of the
program and/or grant performed by the Regional Program Manager. These
audits may be conducted in conjunction with or independently of the
program or grant audit. These audits serve a dual function, because
they are intended to evaluate the State or Local Agencies' OA programs
and they provide input for the evaluation of the Regional organizational
units responsible for managing the specific programs. These MSAs are
scheduled, coordinated and performed in the same manner as the MSAs of
Regional organizational units.
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Regional OA Plan
Part 1, Section: U
Revision No. 0
Date: 11-28-86
Page: 17 of 19
A report resulting from an MSA will be prepared to include when, ho
and by whom the audit was conducted, what specific items were reviewed,
a summary of the findings of the audit (identification of deficiencies,
assessment of specific items, etc.) and recommendations for corrective
actions, as necessary. The audit report will be transmitted by the
Audit Director to the audited organization and the Program's Division
Director, as appropriate.
4.5.2 Technical Systems Audit
The Technical Systems Audit (TSA) is designed to evaluate the
actual data collection aspects of the OA Program. Based on guidance
from QAMS and developed within the Region, TSAs will be performed on
organizational units, both internally (within the Regional Office)
and externally (State and Local Agencies and contract entities),
that are involved directly in the collection and generation of
environmentally-related data. This type of audit will be used to
evaluate the data collection and generation procedures (i.e., field,
analytical and associated procedures) in order to ensure that data
collection activities are performed in accordance with approved OA
Project Plans or accepted practices, as appropriate, and include
adequate quality control provisions to assess and assure data quality.
A TSA will normally be conducted as part of the overall system
audit of a specific program and in conjunction with an MSA, but may
be performed independently, as appropriate. TSAs are scheduled and
conducted at the discretion of the RA, or his authorized designee,
for Regional organizational units, as appropriate, and at the
discretion of the Regional Program Manager for State and Local
Agencies responsible for delegated programs and for contractors
responsible for specific projects.
The TSAs will usually be conducted by ESD personnel. Due to the
nature of this type of audit, the individuals who actually perform
an audit must be technically competent regarding the data collection
activities being audited. The audit team leader, will coordinate and
provide guidance for the audit based on the needs of the RA, or
requesting Program Manager or Project Officer, as appropriate. The
ESD Director will provide management support for the audit; i.e.,
allocation of personnel and resources. The size and composition of
the audit team will be dependent upon the scope of the audit and
size/complexity of the activity being audited.
A report resulting from a TSA will be prepared to include when,
how and by whom the audit was conducted, what specific procedures
were reviewed, a summary of the findings of the audits (identification
of deficiencies, assessment of specific procedures, etc.) and recommen-
dations for corrective actions, as necessary. The audit report will
be transmitted to the audited activity, the Program Manager and
Project Officer, as appropriate.
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Regional OA Plan
Part 1, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 18 of 19
4.5.3 Audit of Data Quality
An Audit of Data Quality (ADQ) is used to evaluate the documentation
of the quality of data generated. Based on guidance from OAMS, National
Programs and.Regional Offices, ADQs may be performed on all or selected
projects involving data collection. The primary purpose of this type
of audit is to determine if the data collected is acceptable for its
intended use based on the documentation associated with data quality
indicators of the data generated. The audit will consist of an evaluation
of the completeness of the documentation of field and analytical procedures
and quality control results; and a comparison of the data quality of the
collected data with the Data Quality Objectives (DQOs) for the project
to determine if the data meets the DQOs. This evaluation and comparison
will result in the determination that the data met the objectives (DOOs)
of the project or the data should be used with caution or not at all; i.e.,
there are quantitative limitations on the quality of the data generated.
ADQs are routinely performed on all data generated for projects
accomplished by or through the ESD. The Project Officer for each project
is ultimately responsible for ensuring that an ADO is accomplished on
all data generated for a project and that a determination on the usefulness
.of the data is performed prior to release of the data. In addition to
the routine ADQs performed by the ESD, special ADOs may be performed for
projects accomplished external to the ESD or the Region; e.g., State and
Local Agencies or contract entities.
The analysis of ADQ results may be used to determine the need for
changes in the design and performance of data collection efforts and in
the use and documentation of QC procedures. Problems identified through
ADOs may trigger the need for an MSA to determine management deficiencies.
4.5.4 Performance Audit
The Performance Audit (PA) is utilized for evaluating the ability
of an analytical system to obtain reliable data. Based on guidance from
QAMS, regulatory requirements of specific programs and procedures developed
within the Region, PAs will be accomplished at laboratories performing
analytical services directly or indirectly for the Region. This audit
consists of providing a reference or performance evaluation (PE) sample,
or samples, to the laboratory for analysis. The PE sample contains
fixed concentrations of chemical or microbiological constituents, of
concern and will normally be in the appropriate media (e.g., soil, water).
The analytical results obtained by the laboratory audited are compared
to the known concentrations of the specific parameters contained in the
PE sample(s) as a means of determining if the laboratory demonstrated
its ability to properly identify and quantify pollutants within established
or calculated control limits.
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Regional OA Plan
Part L, Section: 4.0
Revision No. 0
Date: 11-28-86
Page: 19 of 19
PAs may be accomplished on a regular basis or on an as-needed
basis depending on the laboratory and program involved. Some National
Programs, such as Public Water Supply, National Pollutant Discharge
Elimination System (NPDES) and Air National Performance Audit (EMSL-RTP)
have regularly-scheduled audits in which participation is mandatory for
designated laboratories. Other National Programs, such as Ambient Water,
have regularly-scheduled audits, but participation is optional. In
addition, audit samples for specific parameters may be obtained from
appropriate oPA ORD laboratories on an as-needed request basis.
All PAs, either required on a regular basis or a one time basis, in
the Region, will be coordinated through or requested from the ESD. The
Director, ESD, in conjunction with the RQAO, will designate an appropriate
representative to coordinate and arrange for PAs as requested by Regional
or National Program Managers. The ESD representative, or representatives,
will track and monitor the conduct of PAs and upon completion, will provide
the results to the requestor and the audited facility, as appropriate.
The results of specific studies, such as under the Safe Drinking Water Act,
and other PAs will be summarized upon completion and provided to the RQAO
as input for Part 3 of the Regional QAPP on an annual' basis. In addition
to providing a means for assessing data integrity, the results of PAs
may be used as the criteria for selecting candidates for on-site TSAs.
4.6 Resources
Through the workload models, Headquarters recommends funding levels
for OA activities in each of the Monitoring Programs. The ESD Director,
and the individual Program Managers jointly determine the level of resources
that need to be allocated to ESD to ensure program compliance with OA
objectives. Region III Program Managers allocate the enabling OA resources
to their Program Offices and to the ESD Director. The ESD Director in
turn distributes these OA resources within ESD. The amount and distribution
of OA resources in the Region is not static, bat a dynamic function of
the changing emphases of Agency Monitoring Programs.
The quality of monitoring data will be affected directly by the level
of resources allocated to OA activities. While -managers understand the
importance of OA, they are also held accountable for quantitative program
outputs. Line performance must be judged on the basis of both quantitative
and qualitative criteria. Therefore, resources allocated- to the OA Program
for each fiscal year will be identified in the annual OA Work Plan.
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Regional QA Plan
Part 1, Section: 5.0
Revision No. 0
Date: 11-28-56
Page: 1 of 9
5.0 Concepts and Considerations of Quality Assurance Project Plans
Environmental-related measurement activities include all field and
laboratory investigations which generate data and the data processing
functions which include the data storage, retrieval, and analysis. QA
Project Plans shall be developed and implemented for all environmental
monitoring activities so that all data generated and processed will be
of acceptable and documented quality.
5.1 Quality Assurance Project Plan Contents
The QA Project Plan (QAPjP) documents the Data Quality Objectives
(DQOs) (acceptance criteria) for a project, identifies the critical
measurements to be performed, and discusses the QA activities to be
conducted during the sampling, analytical, and validation phases of
the project. The QA Project Plan shall describe the specific details
of each environmental study not normally included in the Standard
Operating Procedures to ensure that data of known quality and integrity
are generated and processed. Standard Operating Procedures shall be
prepared or referenced for all routine tasks but are not required to
be contained in the QA Project Plan. However, they should be on
file in the appropriate office and available for review.
Region III QA policy requires QA Project Plans to be developed by
the monitoring programs. QA Project Plans must also be approved prior
to the start of any Regional monitoring project which is to generate
environmental data. (See Federal Grants and Cooperative Agreement Act,
40 CFR Part 30, Appendix H). If a manager proceeds with a monitoring
activity without an approved QA Project Plan, he or she is fully aware
of the risk and assumes all responsibility. Also, it is the Project
Officers' responsibility to provide copies of the approved QA Project
Plan to each individual who has a major responsibility in the monitoring
project. All QA Project Plans shall adhere to QAMS-005/80 (Appendix F)
and/or Headquarter's QA Project Plan guidance Documents (Appendix G)
The QA Project Plan will contain the information (as stipulated in
40 CFR 30.503, Appendix H and QAHS-005/80, Appendix F), summarized below:
1. Title Page, with provision for approval signatures
2. Table of Contents (for plans of more than 5 pages)
3. Project Description
4. Project Organization and Responsibilites
5.
Objectives for Measurement Data
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6. Sampling Procedures
7. Sample Custody and Documentation
8. Calibration Procedures and Frequency
9. Analytical Procedures
10. Data Reduction, Validation and Reporting
11. Internal Quality Control Checks
12. Performance and System Audits
L3. Preventative Maintenance
14. Specific Routine Procedures Used to Assess Data Precision, Accuracy,
and Completeness, Representativeness, and Comparability
15. Corrective Action
L6. Quality Assurance Reports to Management
17. Safety (if applicable)
Upon request, appropriate ESD staff shall peer review all QA Project
Plans with regard to their area of expertise. The Regional QA Officer
(RQAO) shall maintain a current file of all approved QA Program Plans,
Project Plans and SOPs for all environmental monitoring programs within
Region III. This file will be utilized by the RQAO for selection of
specific projects to audit, as appropriate or necessary to overview the
implementation of approved QA Project Plans. QA activities are tracked
by the appropriate Project Officer. The QAMS and the National Program
Offices are expected to provide guidance and assistance to the RQAO on
DQOs, preparation of QA Project Plans either through written documentation,
workshops, or on an individual consultation basis.
5.2 Standard Operating Procedures
Standard Operating Procedures (SOPs) are documented methods for
performing certain routine or repetitive tasks. These tasks frequently
involve such operations as sampling, sample tracking, analysis, instrument
or method calibrations, preventative and corrective maintenance, internal
quality control, and data reduction and analysis. The SOPs shall be
prepared in Document Control Format by the user as required. To avoid
duplication of effort, an SOP prepared by one Branch may be utilized by
another Branch, as appropriate and pertinent. SOPs may be utilized
throughout the Region for incorporation into program operations and
included by reference in QA Project Plans, as appropriate and applicable.
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The originals of all SOPs prepared by a particular Branch should be
maintained in a permanent file in the Branch. The following are
considerations involved in the development and utilization of Standard
Operating Procedures.
A. Standard Operating Procedures Objectives
1. Adequate to establish traceability or standards, instrumentation,
samples, and environmental data.
2. Simple, so a user with basic education, experience and/or training
can properly use them.
3. Complete enough so the user/reader follows the directions in a
stepwise manner through the sampling, analysis, and data-handling
process.
4. Consistent with sound scientific/engineering principles.
5. Consistent with current EPA regulations and guidelines.
6. Consistent with the instrument manufacturers' specific instruction
manuals.
B. Benefits of Standard Operating Procedures
1. Record the performance of all tasks and their results.
2. Explain the cause for missing data.
3. Demonstrate the validation of data each time they are recorded,
calculated, or transcribed.
C. Items to be addressed in Standard Operating Procedures
1. General network design.
2. Specific sampling-site selection.
3. Sampling and analytical methodology.
4. Probes, collection devices, storage containers, and sample
additives such as preservatives.
5. Special precautions, such as holding times and protection from
heat, light, reactivity, and combustability.
6.
Federal reference, equivalent, and Alternate Test Procedures.
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7. Instrumentation selection and use.
8. Calibration and standardization.
9. Preventative and remedial maintenance
10. Duplicate, spiked, blank samples and analysis.
11. Quality control procedures such as inter- and intra field
laboratory activities.
12. Documentation, sample custody, transportation, and handling
procedures.
13. Safety.
14. Data handling assessment procedures.
15. Precision, accuracy, completeness, representativeness, and
comparability.
16. Service contracts.
17. Document control.
All environmental monitoring shall meet established EPA regulations
and Region III SOPs. Deviations shall be justified and documented. The
degree of adherence to the approved SOPs shall be determined during the
Technical Systems Audits. SOPs shall be revised by the user and approved
by the user's supervisor. As appropriate, these SOPs may be reviewed by
the RQAO.
5.3 Data Quality Objectives
Data Quality Objectives (DQOs), as defined in QAMS guidance
documents, are qualitative and quantitative statements of the quality
of data needed to suport specific decisions or regulatory actions. The
requirements for DQOs is not intended to place additional requirements
on program managers or project officers, but is meant to be integrated
into the normal thought process of planning, designing and carrying out
environment monitoring projects. The development of Data Quality
Objectives is the first step in a process that leads to the preparation
of detailed technical guidance to data collectors and the use of such
technical guidance for the preparation of QA Project Plans. QA Project
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Plans document the procedures that" will be used to characterize and
control the quality of data resulting from data collection efforts.
Data Quality Objectives are qualitative and quantitative statements
development by data user to specify the quality of data needed from
a particular data collection activity. The specific Data Quality
Goals or Objectives which are expressed in terras of precision,
accuracy (or bias), representativeness, completeness, and comparability,
are used for this purpose.
DQOs are developed in three general stages. First, the decision
maker and the technical staff discuss the problem being addressed,
the resource and time constraints for addressing the problem, and the
information needed. Second, the decision maker and the technical
staff discuss specific questions developed by the staff to clarify
what information is needed, how the information will be used, and
what limitations of the information will be acceptable. Third, the
technical staff develops possible approaches for collecting the
necessary data and determines the quality of the data that can be
expected from each approach. The approaches are summarized and
presented to the decision maker with information on the limitations
of each. During the discussions, it may be necessary to reconsider
the time and resource constraints or to modify the objectives of the
study. The outcome of the third stage is the decision maker's selection
of the specific approach that will be used and the statement of the
DQOs for that approach.
While the process for developing DQOs is presented in three
discrete stages, it actually involves a complex series of discussions
and interactions between the decision maker and the technical staff.
The stages described show an evolution of the concepts guiding data
collection, from an initial impression of needs, through a clearer
understanding of the problem, to the eventual selection of an approach
based on the expected quality and utility of the data. It may not
always be possible to address the topics discussed in exactly the
order presented. However, the decision maker and the technical
staff can always use an interactive process containing the essential
elements identified in this section in order to reach a detailed
understanding of the problems being addressed, the data quality
needed, and the limitations and applicability of the data that will
be collected within the time and resource constraints of the effort.
The involvement of decision makers in the development of DQOs
is critical for two reasons. First, they have a larger perspective
of the Agency's needs and the regulatory process than technical
staff. Second, they are responsible for making sound and supportable
regulatory decisions. Their decisions are based, at least in part,
on environmental data. To ensure that the right data are collected
and that the data are of sufficient quality to be useful to the
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Agency, it is within the decision maker's and associated data users' own
interests to participate in the careful consideration of what information
is needed, why it is important, and how the information will be used to
accomplish the intended purpose.
For many of the routine monitoring programs, the National Program
Offices in Headquarters, EPA, are iii the process of developing DOOs. In
the absence of DOOs development by the National Program Offices, specific
DQOs for data collection activities initiated by the Region will be
developed. DQOs for the Regional Program Offices are addressed in Section
4.1 of Appendices B to E. The Program Manager who identifies the need
for a specific data collection activity will be responsible for initiating
the DQOs development process as part of the normal planning process.
5.A Data Processing and Verification
-Data processing includes collection, validation, storage, transfer
and reduction. Precautions shall be taken each time the data are reduced,
recorded, calculated, and transcribed to prevent the introduction of
errors and the loss of information.
The data processing requirements are detailed as follows:
A. Collection—Each QA Project Plan shall address the checks which
must be used to avoid errors in the data collection process.
B. Validation—Data validation is defined as "the process whereby
data are accepted or rejected based on a set of criteria".
Since this aspect of OA may include various forms of manual or
computerized checks, criteria for data validation shall be
specified in each QA Project Plan.
C. Storage—Each QA Project Plan shall indicate how specific types
of data will be stored.
D. Transfers—Each OA Project Plan shall describe procedures which
shall be used to ensure that data transfer is error-free, and
that no information is lost in the transfer. Data transfer
steps contained in each OA Project Plan shall be kept to a minimum.
E. Reduction—Each OA Project Plan shall contain procedures for
ensuring the correctness of data reduction processes. Data
reduction includes all processes which change either the form
of expression or quantity of data items. It is distinct from
data transfer in that it entails a reduction in the size (or
dimensionality) of the data set. The OA Project Plan must
identify the processes used to obtain the reduced data set.
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Each QA Project Plan shall describe procedures for verifying the
accuracy of the data reduction process.
5.5 Data Quality Assessment
The quality of all environmental data generated and processed shall
be assessed for accuracy, precision, completeness, comparability and
representativeness based upon the QA Project Plans. The data assessment
requirements are detailed below.
A. Accuracy
Each QA Project Plan shall contain a mechanism which will demonstrate
that the reported data are favorably comparable to the true value(s).
Examples of activities to assess accuracy are:
1. Traceability of Instrumentation - Each measurement device shall
be assigned a unique identification number. Documentation shall
identify the specific measurement device, where and when used,
maintenance performed, and the equipment and standards used for
calibration.
2. Traceability of Standards - Each standard and each measurement
device shall be compared against a standard of known and higher
accuracy (where possible). Where available, all calibration
standards shall be traceable to available National Bureau of
Standards (NBS). If NBS standards are not available, other
primary standards shall be used.
3. Traceability of Samples - Each sample shall be assigned a unique
identification number. Documentation should identify sampling
time, place, samplers name and action taken on each sample.
4. Traceablity of Data - Data shall be documented to allow complete
reconstruction, from initial field records through data storage
system retrieval.
5. Methodology - If available, Federal reference, equivalent, or
approved alternate test methods of known accuracy shall be used.
For very critical work, it is recommended, in Region III at
least, that two independent analytical methods be used to check
for accuracy.
6. Reference or Spiked Samples - Recoveries shall be within pre-
determined acceptance limits.
7. Performance Evaluation - Each environmental monitoring program
shall continually participate in the EPA National and Regional
Performance Evaluation Programs where available.
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B. Precision
Each QA Project Plan shall contain a mechanism which will demonstrate
the reproducibility of the measurement process.
Examples of activities to assess precision are:
1. Replicate Samples - Replicate sample data shall be within
predetermined acceptance limits.
2. Collocated Samples - Sample data from collocated sampling points
or monitors shall be within predetermined acceptance limits.
3. Inter/Intra Laboratory Testing - Sample data from independent
studies shall be within predetermined acceptance limits.
4. Instrumental Checks - Each measurement device shall have routine
checks performed to demonstrate that variables are within
predetermined limits.' Examples of include:
° Zero and span
0 Noise levels
° Drift
° Flow rate
° Pressure rate
0 Linearity
C. Completeness
Each QA Project Plan shall identify the quantity of data needed to
support a planning or enforcement action. Completeness shall take into
consideration the potential for environmental change with respect to
time and timing.
D. Comparability
Each QA Project Plan shall contain procedures to assure the compara-
bility of data. Examples are:
1. Consistency of reporting units.
2. Standardized siting, sampling, and analysis.
3. Standardized data format.
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E. Representativeness
Each QA Project Plan shall contain procedures to ensure that all
samples collected, are as accurate and precise as possible and represent
the media sampled.
Examples of activities to assess representativeness are:
1. Site Purpose - Each sampling site shall have a preidentified
and documented purpose.
2. Site Description - Each sampling site shall be specifically
identified by location and by suitability to meet the pre-
identified purpose.
y. Site Photo Documentation - Each sampling site should be photo-
graphed from each of the four major compass directions when
possible.
4. Sampling Conditions - The conditions under which each sample
was collected shall be described. Conditions include such
items as:
o Stream flow and homogeneity
o Wind speed and direction
o Temperature
o Barometric pressure
5.6 Corrective Action
Each QA Project Plan shall include provisions for written requirements
establishing and maintaining QA reporting or feedback channels to the
management responsible to ensure that early and effective corrective action
can be taken when data quality falls outside established Data Quality
Objectives (acceptance criteria). Each QA Project Plan shall also include
provisions to keep responsible management informed of the performance of
all data collection systems. Each QA Project Plan shall describe the
mechanism(s) to be used when corrective actions are necessary. Corrective
action shall relate to the overall QA management scheme: who is responsible
for taking corrective actions, when, are corrective actions to be taken,
and who follows-up to see that corrective actions have been taken and
that they have produced the desired results.
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6.0 Training
Each monitoring Program Manager will ensure that all personnel
performing tasks and functions related to data quality will have the
needed education, training, and experience. This includes laboratory
technicians, analysts, maintenance technicians, supervisors, principal
investigators, statisticians, project officers, and Regional QA staff.
Training needs will be identified during performance evaluations and
thru career development plans. The RQAO provides QA guidance manuals
and identifies QA training courses. Training needs are not static, but
are a dynamic function of program requirements. Various Regional Program
Divisions will provide training on identified program specific needs.
ESD will conduct a training course on QA Project Plan development for
the HWMD Superfund Branch. Therefore, training needs will be addressed
in the Region's Annual QA Report/Work Plan.
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7.0 Implementation Requirements and Schedule
Implementation of the Agency's mandatory QA Program requires that
each major milestone be identified and scheduled for accomplishment.
Major National/Regional Milestones shall be identified, scheduled, and
progress reported in the Region's Annual QA Report/Work Plan. The
Report/Work Plan shall be submitted annually to the Director of QAMS.
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APPENDIX A
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mj
%
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAY 3 0 1979
THc ACJMINISTrtAlGK
MEMORANDUM
TO:
SUBJECT:
Deputy Administrator
Director, Science Advisory Board
Director, Office of Regional and
Regional Administrators
Assistant Administrators
General Counsel
Intergovernmental Operations
Environmental Protection Agency (EPA) Quality Assurance
Policy Statement
The EPA must have a comprehensive quality assurance effort to
provide for the generation, storage, and use of environmental data which
are of known quality. Reliable data must be available to answer
questions concerning environmental quality and pollution abatement
and control measures. This can be done only through rigorous
adherence to established quality assurance techniques and practices.
Therefore, I am making participation in the quality assurance effort
mandatory for all EPA supported or required monitoring activities.
An Agency quality assurance policy statement is attached which
gives general descriptions of program responsibilities and basic
management requirements. For the purpose of this policy statement,
monitoring is defined as all environmentally related measurements
which are funded by the EPA or which generate data mandated by the EPA.
A detailed implementation plan for a total Agency quality
assurance program is being developed for issuance at a later date.
A Select Committee for Monitoring, chaired by Dr. Richard Dowd, is
coordinating this effort, and he will be contacting you directly
for your participation and support. I know that ea
my concern about the need to improve our monitoryrg' p
data; therefore, I know that you will take the/fieces
the success of this effort./
/ I
that will ensure
of you shares
ograms and
$ actions/
L
Doug,
Costle
Attachment
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zy
$ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D C 20460
APR 17 1984
o^nci O*
TMC AOMINHTR ATQH
MEMORANDUM
SUBJECT: EPA Order 5360.1, "Policy and Program Requirements to
Implement the Quality Assurance Program"
Alvin L. Aim
Deputy administrator
FROM:
TO: Addressees
One of my major goals is to ensure that all decisions by EPA can be
supported by a sound data base. An important step toward achieving this
objective is to require that quality assurance becane an integral part of
all data collection activities. Quality assurance is the total integrated
program for assuring the reliability of environmental measurements and
consists of multiple steps undertaken to ensure that all acquired data
are suitable for the user's intended purpose. Two of the major steps are:
the user must first specify the quality of data he needs; then the degree
of quality control necessary to assure that the resultant data satisfies his
specifications must be determined. Central to this process is assuring that
the data is of known quality. The quality of data is known when all compo-
nents associated with its derivation are thoroughly documented, such
documentation being verifiable and defensible.
In order to establish quality assurance solidly in all data collection
activities, the important step of issuing this order on quality assurance
is being taken. The implementation of the elements in this order will
require dedication and hard work by the Quality Assurance itenagement and
Special Studies Staff, by quality assurance officers throughout the Agency,
and by senior management. This order identifies the goals, objectives, and
general responsibilities of each program area, lb carry out the order,
specific policy -and technical guidance materials need to be prepared. I
will be following that progress.
The attached order reflects my camutnent to the Agency's QA program
and to the promotion of good science in all EPA monitoring and measurement
activities. Therefore, I expect that each of you vrork cooperatively to
ensure that the appropriate level of quality assurance is embedded in all
data collection undertaken by or for the Agency.
Attachment
A -1
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EPA ORDER 5360.1
APR 3 £34
POLICY AND PROGRAM REOUIRB4EOTS
TO IMPLEMENT THE MANDATORY QUALITY ASSURANCE PROGRAM
1. PURPOSE. This Order establishes policy and program requirements for the
conduct of quality assurance (OA) for all environmentally related measurements
performed by or for this Agency.
2. BACKGROUND. Agency policy requires participation in a centrally managed
OA program by all EPA organizational units supporting environmentally related
measurements. Under Delegation of Authority 1-41, "Mandatory Ouality Assurance
Program" (dated 4/1/81), tne Office of Research and Development (ORD) is the
focal point in the Agency for quality assurance policy and is responsible for
developing OA requirements and overseeing Agencywide implementation of the OA
program. ORD established the Quality Assurance Management and Special Studies
Staff (QAMSS) to serve as the central management authority for this program.
The QAMSS activities involve the development of policies and procedures; co-
ordination for and direction of the implementation of the Agency CA program;
and review, evaluation, and audit of program activities involving environmental
monitoring and other types of data generation.
The Agency OA progra-n embraces many functions including: establishing OA policy
and guidelines for development of program and project operational plans; establishing
criteria and guidelines for assessing data quality; serving as a OA information focal
point; auditing to ascertain effectiveness of CA iirplementation; and identifying and
developing OA training programs.
3. GOALS AND POLICY. The primary goal of the OA program is to ensure that
all environmentally related measurements supported by the EPA produce data of
known quality. The quality of data is known when all canponents associated
with its derivation are thoroughly documented, such documentation being verifi-
able and defensible. It shall be the policy of all EPA organizational units to
ensure that data representing environmentally related measurements are of known
quality. Decisions by management rest on the quality of environmental data;
therefore, program managers shall be responsible for: 1) specifying the quality
of the data required from environmentally related measurements and 2) providing
sufficient resources to assure that an adequate level of OA is performed.
All routine or planned projects or tasks involving environmentally related
measurements shall be undertaken with an adequate OA project plan that specifies
data quality goals acceptable to the data user and assigns responsibility for
achieving these goals.
In discharging its responsibility for implementing the Agency-mandated Ouality
Assurance Program, the ORD/QAMSS will strive for consensus by submitting for
review proposed policies and procedures to affected program offices and regions.
Responsibility for adjudication of unresolved issues, with respect to the above
and QAMSS conducted audits, will be at the lowest level of authority consistent
with the scope of the issues. The QAMSS will refer issues which remain un-
resolved at lower levels of authority to the AA/ORD for decision, after con-
sultation with the appropriate AA or RA.
A - 2
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EPA CREER 5360.1
^PR 3 (984
The following activities are basic to the implementation of the OA program:
a. Preparation and annual update of a V program plan based on guidelines
established by QftMSS.
j b. Development of a Oft project plan for all projects and tasks involving
environmentally related measurements in accordance with guidelines established
by tfiMSS.
c. Assuring Lrrplementation of OA for all contracts and financial assistance
involving environmentally related measurements, as specified in applicaole EPA
regulations, including subcontracts and subagreements.
d. Conducting audits (system, performance evaluations, data quality, bench,
etc.) on a scheduled basis of organizational units and projects involving environ-
mentally related measurements.
je. Developing and adopting technical guidelines for estimating data quality
in terms of precision (variability), bias (accuracy), representativeness,
ccrpleteness and ccnparability, as appropriate, and incorporating data quality
requirements in all projects and tasks involving environmentally related
measurements.
f. Establishing achievable data quality limits for methods cited in
regulations based on results of methods evaluations arising fran the methods
standardization process, e.g., ASTM Standard D2777-77.
g. Implementation of corrective actions, based on audit results, and for
incorporating this process into the management accountability system.
h. Provision for appropriate training based on perceived needs, for all
levels of Oft management, to assure that OA responsibilities and requirements are
understood at every stage of project implementation.
4. RESPONSIBILITIES.
a. In conformity with the oversight responsibility for the nandatory OA
program, the AA/QRD shall:
(1) Establish ^ency policies and procedures for implementing the
nandatory Oft program.
(2) Provide guidance for determining precision, bias, representativeness,
catpleteness, and comparability of data.
(3) Review OA Program Plans from ^ency ccnponents involved in
environmentally related measurements.
(4) Conduct OA audits of all organizational units supporting environ-
mentally related measurements based on established audit criteria and procedures.
A - 3
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EPA CRDER 5360.1
3 i 5C-,
(5) Reconnend corrective actions, based on audit results, for inclusion
in the management accountability system.
(6) Establish achievable data quality limits for methods provided by ORD
for citation in regulations, based on results of methods evaluations arising frcm
the methods standardization process, e.g., ASTM Standard D2777-77, to help project
officers define data quality goals.
(7) Serve as the Agency OA information focal point.
(8) Develop generic training programs, based cn perceived needs, for all
levels of management to assure that QA responsibilities and requirements are
understood at every stage of project implementation.
(9) Ensure that all ORD investigations involving data collection are
covered by an acceptable QA plan with resources adequate to acccnplish program
objectives.
(10) Ensure that deficiencies highlighted in review of ORD program plans
or in .audits of ORD components are appropriately addressed.
b. In accordance with policies and procedures established by AA/ORD,
National Program Managers shall:
(1) Ensure that OA is an identifiable activity with associated resources
adequate to acconplish program goals in the developnent and execution of all pro-
jects and tasks, both intramural and extramural, involving environmentally related
measurements.
(2) Ensure that appropriate OA criteria are included in operating guidance.
(3) Establish data quality acceptance criteria for all projects and tasks
conducted by the program office.
(4) Ensure that an adequate degree of auditing is performed to determine
carpiiance with OA requirements.
(5) Ensure that deficiencies highlighted in audits are appropriately
addressed.
(6) Ensure that all projects and tasks involving environmentally related
measurements are covered by an acceptable OA project plan and that the plan is
implemented.
(7) Identify program-specific OA training needs and provide for the
required OA training.
c. In accordance with policies and procedures established by AA/ORD, Regional
Administrators shall:
A-4
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EPA ORDER 5360.1
-ft 3 !3C\
(1) Ensure that W is an identifiable activity with associated resources
adequate to acccnplish program and regional goals in the aevelcpnent and execution
of all projects and tasks involving environmentally related measurements, both
intramural and extramural.
(2) Ensure that QA guidelines are specified for estimating data quality
in terms of precision, bias, representativeness, carpleteness, and canparability,
for all environmentally related measurements which meet the operating guidance
established by the program offices.
(3) Establish data quality acceptance criteria for all projects and tasks
initiated by the Region.
(4) Ensure that all projects and tasks involving environmentally
related measurements are covered by an acceptable OA project plan and that the
plan is irrplemented.
(5) Ensure that an adequate degree of auditing is performed to determine
compliance with OA requirements.
(6) Ensure that deficiencies highlighted in audits are corrected
expeditiously.
(7) Identify program-specific OA training needs and provide for the
required OA training.
d. The AA for Administration shall establish a mechanian for incorporating
QH in the ^ency's planning and budgeting cycle.
5. DEFINITIONS. The following terms have special meanings in relation to this
Order.
(a) Documentation. The use of documentary evidence; a written record
furnishing information that a procedure has been performed. When applied to
environmentally related measurements it includes all calculations related to
sanpling design; all steps in the chain of custody, where appropriate; and
all notes and raw data generated in the sanpling, analysis, or data validation
process.
(b) Defensible. The ability to withstand any reasonable challenge related
to veracity or truthfulness.
(c) Environmentally Related Measurement. Any laboratory or field data
gathering activity or investigation involving the determination of chemical,
physical, or biological factors related to the environment.
The following are representative exanples of environmentally related
measurements. Data collection or investigation of chemical, physical, or bio-
logical factors for determination of:
A-5
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EPA OREER
5360.1
7 -
{1) pollutant concentrations frem sources, in the ambient environment,
(2) respense of organises to pollutants;
(3) the effects of pollutants on hunan health and on the environment;
(4) risk/benefit analysis;
(5) environmental or economic impact.
(6) the environmental irpact of cultural and natural processes;
(7) pollutant levels, exposure levels, etc., used in modeling.
(d) Organizational Unit. Any administrative entity (national program
office, regional office, CRD or NEIC laboratory) which engages in environmentally
related measurements.
(e) Project. An organized undertaking or specified unit of investigation
involving environmentally related measurements.
(f) Quality Assurance. The total integrated program for assuring the
reliability of monitoring and measurement data.
(g) Verifiable. The ability to prove or substantiate any claim or result
related to the documented record.
6. ADDITIONAL REFERENCE. This Order will be arplified by a detailed inplsnen-
tation plan.
or pollutant'transport and fate;
Howard M. Messner
Assistant Administrator
Office of Administration and Resources Management
A - 6
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APPENDIX B
WATER MANAGEMENT DIVISION
ORGANIZATIONAL COMPONENTS AND PROGRAM SPECIFIC
QA PROGRAM PLANS
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Regional QA Plan
Appendix B
Revision No. 0
Date: 11-28-86
Page: 1 of 14
4.1.4 Water Management Division
The Water Management Division (WMD) is responsible for administering
major surface and ground water protection programs for all water media
in the Region. These programs include the Public Water Supply, Ambient
Surface and Ground Water Protection, Underground Injection Control,
Off-shore Discharge, and Domestic and Industrial Wastewater Treatment
Programs. It is responsible for permit issuance and compliance as well
as enforcement activities for point source discharges from domestic and
industrial treatment facilities. In addition to those programs, the WMD
is responsible for the Chesapeake Bay Program (discussed in Part IV,
separate section of the Region III OA Program Plan).
The WMD manages federal grants and contract funds and ensures that
QA requirements are properly identified in budgets, OA Program Plans and
work plans. It overviews external water monitoring programs (except
ambient surface water monitoring which is overseen by ESD), and ensures
full coordination with other divisions on matters of common concern and
interest.
The Environmental Services Division (ESD) has lead responsibility
for ambient surface water monitoring and provides WMD with technical
assistance relevant to monitoring and data processing activities. This
assistance includes laboratory operations, NPDES compliance inspections,
oversight inspections, and performance audits of State water supply and
wastewater monitoring activities. ESD will prepare QA Project Plans for
all special studies and compliance monitoring/inspections it conducts.
WMD will develop QA Project Plans for data collection activities it
conducts. QA Program Plans developed by WMD and State/Local Agencies
will be reviewed and approved by ESD. ESD will review selected OA Project
Plans for State ambient monitoring projects. WMD, with technical assistance
from ESD will review selected QA Project Plans for the States' other
water monitoring activities. All QA Program/Project Plans will be prepared
according to national and regional QA requirements and specifications.
WMD will also assist with audits of its Program specific OA activities.
The administration of the programs assigned to the Water Management
Division is accomplished by the following organizational components:
Water Program Management and Support Branch, Construction Grants Branch,
Water Permits Branch, Water Supply Branch and the Chesapeake Bay Program
Office. These organizational components, along with their respective
program specific OA Program Plans (where required) are discussed herein.
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4.1.4.1 Water Program Management and Support Branch
The Branch provides management oversight of all the programs
assigned to the Water Management Division. Management activities
include program planning, review and analyses, delegation monitoring,
and policy and operating procedure development. The Branch administers
the Regional Water Ouality Management Planning Program and provides
technical assistance to Regional staff and State Agencies in such
areas as wasteload allocation, water quality modeling, effluent
limitations, water quality standards, agricultural non-point
source pollution, acid mine run-off, and project priority rating
systems. The Branch also manages the interagency Corps of Engineers
Agreement and serves as liaison with States, and EPA Headquarters,
and consulting engineers' and contractors' organizations. The Branch
manages all water quality and operation and maintenance grants
authorized under the Clean Water Act including those grants authorized
under Sections 104, 106, 109, 205(j), 208, and 314.
The Branch is composed of two sections, the Water Programs
Management Section and the Water Quality Control Section. The Basin
Commission Coordinator (BCC) is located in the Branch Office. The
BCC is responsible for the execution of grant programs for three major
interstate agencies. and for maintaining contact with commission
officials, reviewing outputs and providing program guidance.
4.1.4.2 Construction Grants Branch
The Branch is the focal point in Region III for the construction
grants program and the planning, review, analysis and management
thereof, plus a full range of technical assistance. Specific major
activities include program delegation to the States, delegated grants
program overview and evaluation, performing undelegated or non-delegable
work, and coordination with the Corps of Engineers for construction
management services. The Branch does not generate environmental
monitoring data.
4.1.4.3 Water Supply Branch
The Branch is responsible for regional management and implementation
of the Safe Drinking Water Act (PL 99-399). In administering the various
facets of the federal water supply effort, the Branch activities include
planning, technical assistance, and response to State, local, and public
inquiries. The Water Supply Branch is composed of the State Programs
Section, the Pennsylvania Implementation Section and the Office of Ground
Water.
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4.1.4.3.1 State Programs Section (SPS)
The Water Supply Branch, and more specifically, the State Programs
Section (SPS) is responsible for accomplishing the objectives of the
Public Water Systems Supervision (PWSS) Program of the Safe Drinking
Water Act.
The State Programs Section is responsible for the negotiation and
oversight of federal grants to Region III State agencies for the PWSS
Program which includes compliance monitoring by public water supplies.
SPS negotiates specific public water system compliance monitoring targets
in 5 State PWSS Program Plans in accordance with guidance and regulations
prior to grant approvals. The SPS reviews State quarterly compliance
monitoring data and participates in midyear review of work plan
implementation. The State Programs Section is also responsible for the
implementation of the PWSS Program in the District of Columbia.
A. Quality Assurance Responsibilities for State Programs Section
1. Goal
The goal of the State Programs Section is to ensure that the
public water system compliance monitoring data generated in
Region III will be scientifically valid, defensible and of
known precision and accuracy.
2. Policy
The State Programs Section QA Policy is to negotiate with
the State agencies the inclusion of QA activities in the
State PWSS Programs and to oversee these QA activities
related to public water system compliance monitoring in
accordance with the State regulations and EPA regulations
under 40 CFR Part 141. State Programs Section policy is
to conduct internal QA activities during the implementation
of EPA regulations under 40 CFR Part 141 in the District
of Columbia.
3.. Specific QA Responsibilities for State Programs Section (SPS)
The Water Programs Section's implementation of the PWSS
Program includes the following QA responsibilities:
- Participate in the review of State OA Program Plans in
conjunction with the Environmental Services Division.
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Review, with technical assistance from ESD State OA. Project
Plans.
- Develop OA Program Plan for the District of Columbia (D.C.)
since it is a non-delegated program for D.C.
- Audit public water supply compliance monitoring data base
for completeness, precision, accuracy, representativeness,
comparability and make or oversee corrections where necessary
- Review quarterly compliance monitoring data for completeness
and accuracy.
- Participate in the review of the water systems laboratory
certification.
- Review State Performance Evaluation Study results and prepare
letters to State Laboratory Directors in accordance with the
"Interim Region III Protocol for the use of Water Supply
Performance Evaluation Samples and the On-Site Laboratory
Evaluation in the Drinking Water Laboratory Certification
Program".
- Participate in the on-site laboratory evaluations of State
laboratories by evaluating field/sampling collection
activities.
Specific Staff Responsibilities
Within State Programs Section, the following individuals are
responsible for oversight of QA activities related to compliance
monitoring under the PWSS Program in States listed.
Individual OA Responsibility
WV State Program Manager West Virginia
VA State Program Manager Virginia
DE, MD & DC State Program Manager Delaware, Maryland
& District of Columbi
PA State Program Manager Pennsylvania
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5. Concepts and Considerations of Ouality Assurance Project Plans
A. Data Quality Objectives
State Programs Section is responsible for reviewing internal
and State OA Program/Project Plans. SPC is also responsible
for ensuring that Data Quality Objectives are established in
external monitoring activities by the primacy States and the
District of Columbia under the PWSS Program.
For external monitoring activities, each State agency is
responsible for the PWSS Program using the regulatory Data
Quality Objectives and for documenting their approach in the
States's QA Project Plan.
6. Resources
The Water Management Division allocates resources to the various
Branches and Sections responsible for performing QA functions.
State Programs Section receives workyear allocations to conduct
the PWSS Program activities identified above.
4.1.4.3.2 Pennsylvania Implementation Section
The Water Supply Branch, and more specifically, the Pennsylvania
Implementation Section and State Program Section are responsible for a
regulatory program to control the use of injection wells for the disposal
of waste materials, storage of hydrocarbons, recovery of oil and gas and
other purposes. Monitoring conducted for the Underground Injection
Control (UIC) Program, whether implemented by the States (Delaware,
Maryland, West Virginia) or EPA (Pennsylvania, Virginia, District of
Columbia), is intended to ensure that injection wells are being operated
properly so that contaminants do not migrate into underground sources of
drinking water. For convenience, monitoring activities pursuant to those
authorities may be grouped into five broad categories:
0 Support for standard setting
0 Evaluation of system compliance with drinking
water standards
0 Monitoring associated with contamination incidents
0 Underground Injection Control Program monitoring
0 Other monitoring activities
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Monitoring associated with contamination incidents involves the
surveillance of contaminants associated with a specific event. The goal
of this activity is to conduct special studies and to provide expert
technical assistance when incidents of contamination of drinking water
supplies occur. Ordinarily, State and local governments (frequently
supported by EPA grant funds) are the primary agencies to deal with such
cases. The Regional Offices are involved directly in non-primacy States
and in a technical assistance mode in primacy States. When contamination
is discovered, monitoring is conducted to accurately define the scope
and magnitude of the contamination, to identify the source(s) of contami-
nation and to provide an assessment of the future potential expansion,
movement, and control of the contamination plume.
The Pennsylvania UIC Direct Implementation staff is responsible for
all program management and technical functions of the program such as
compliance monitoring and surveillance, inspections, permit application
review, technical assistance, and program direction. At this time,
there are no UIC facilities in Virginia that are required to submit data
to EPA on a regular or one-time basis. The only time data are presently
required is when the EPA Level-of-Effort (LOE) Contractor, Engineering
Enterprises, Inc. is requested by the Regional Office to sample a facility.
A. QA Responsibilities for PA Implementation/State Program Sections
1. Goal
The goal of the Water Supply Branch/PA Implementation
Section is to produce data that meet user requirements in
terms of completeness, precision, accuracy, representative-
ness, and comparability.
2. Policy
The Water Supply Branch and the UIC Program Sections recognize
the critical need to maintain control of the quality of all
data submitted as a part of the permit application, routine
monitoring, or any other aspect of the UIC process which
requires the submission or analysis of data. To assure
that methods used to obtain environmental measurement data are
usable, technically valid and scientifically defensible,
all internal monitoring activities and oversight of external
monitoring activities will be conducted in accordance with
EPA regulations under 40 CFR Part 30.
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Specific OA Responsibilities for the Underground Injection
Control (UIC) Program
The UIC Program is subject to the Agency's OA policy, but
the types of monitoring it requires do not fit the conventional
QA model because of the short time required to respond to an
emergency, precludes detailed project specific quality
assurance planning. Regional, State, and local programs
will develop common mechanisms to deal with monitoring data,
locate contaminated groundwater, to increase their awareness
of the need for careful QA measures, and to protect the
health of people whose source of drinking water may be
impacted by identified contamination. In order to develop a
QA plan for the UIC program, Office of Drinking Water has
divided the required monitoring into three categories:
0 Water quality measurements. This includes measurements
of water quality parameters such as those addressed in
the NPDES Program and PWS Program.
0 Physical measurements. This includes the physical
measurements normally associated with volumes, rates
and pressures.
° Geophysical measurements. This includes measurements
such as radioactive tracer surveys.
By far the most important of the measurements in the scheme
of the UIC regulations relate to physical and geophysical
parameters, not to water quality, since the technical parts
of the regulations largely deal with the physical integrity
of the well and the movement of fluids away from the vicinity
of the injection well and into underground sources of drinking
water. Office of Drinking Water, in cooperation with the
Regional Offices and States is examining the feasibility of
developing Standard Operating Procedures and other guidance on
how to perform the required physical tests and other activities.
Specific Staff Responsibilities -
The primary purpose of OA is the documentation and the subsequent
improvement of the quality of the data generated by the States
and EPA. The QA program should be viewed as a cooperative
effort between these two parties. A OA program is necessary
to ensure effective environmental programs; EPA, the States
and the regulated community are responsible for implementing
such a program. EPA has made the collection of data of
known quality one of its highest priorities.
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Guidance on Che preparation of QA Project Plans for chemical
tests has been provided to the States. Some States, as in the
case of a Class II Program (oil and gas related) require very
few chemical analyses by the operator, and may also include
only a few chemical tests by the UIC Agency in support of
UIC. The Water Supply Branch, with assistance from ESD, will
determine the adequacy of the State QA Project Plans. For Direct
Implementation States, the QA Project Plans will be sent to the
Chief, Underground Injection Control Branch in Headquarters after
concurrence from the Regional QA Officer. The QA Project Plans
should give consideration not only to the primary use of the
data, but also to secondary uses. For example, consideration
could be given to possible applications in enforcement activities
(secondary use) for any data submitted to support a permit
application (primary use).
Within the Water Supply Branch, the following individuals are
responsible for QA oversight of monitoring activities in the
States listed:
Individual
OA Responsibility
UIC Program Manager (PA)
UIC Program Manager (VA)
UIC Program Manager for
Delegated States -
DE, MD, WV
UIC QA Program Contact and
responsible for developing a UIC
QA Project Plan for Pennsylvania,
Responsible for developing a UIC
QA Project Plan for Virginia.
Responsible for determining the
adequacy of the primacy States
UIC OA Project Plans.
5. Concepts and Considerations of Ouality Assurance Project Plans
a. Data Ouality Objectives
The Chief of the Water Supply Branch has the overall responsibility
of decision maker in the development of Data Quality Objectives
(DOOs) to specify the quality of data needed from a particular
data collection activity. DQOs are target values for data quality.
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DQOs are developed as follows:
1. The Chief of the Water Supply Branch and the UIC Technical
Staff discuss the problem being addressed, the resource
,and time constraints for addressing the problem and the
information needed.
2. The UIC Technical Staff will develop specific questions
to clarify what information is needed, how the information
will be used and what limitations of the information will
be acceptable.
3. After discussing these questions with the Water Supply
Branch Chief, the UIC Technical Staff develops possible
approaches for collecting the necessary data and determines
the quality of the data that can be expected from each
approach.
A. After reviewing the summary of approaches presented by
the UIC Technical Staff and the limitations of each,
the Water Supply Branch Chief will select the specific
approach that will be used and the statement of the
DQOs for that approach.
Qualitative (description of data representativeness, comparability
and completeness) and quantitative (specific requirements for
detection/quantitation limits, precision and accuracy) descriptors
of data quality must be considered in order to determine whether
data are appropriate for a particular application. When internal
monitoring activities are conducted through a contract, the
specific Data Quality Objectives will be included in the language
of the contract.
6. Resources
Quality Assurance is a recognized element of the Water Supply
Branch work plans of the PA Implementation/State Program
Sections. One man year will be devoted to the UIC Program QA
activities.
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4.1.4.3.3 Office of Ground Water
The Office of Ground Water is a recently formed unit in the Region
(FY'85), intended to implement the elements of the Agency's Ground Water
Protection Strategy. To date, there are no environmental laws which it
is charged to implement, but rather, it acts as focus for coordinating
and assisting existing or developing State and Agency ground water-related
activi ti es .
The Office of Ground Water is responsible however, for providing
grants to States for the purpose of developing and implementing Compre-
hensive ground water protection programs under §106 of the Clean Water
Act. As such, it is responsible for reviewing and approving any ground
water monitoring activities proposed by the States in Region III under
this grant. Hence, it is also responsible for reviewing and approving
all work plans; reviewing QA Program Plans; and where applicable,
reviewing and approving QA Project Plans under this grant program.
A. Quality Assurance Responsibilities for the Office of Ground Water
1. Goal
The OA goal for the Office of Ground Water is coincidental with that
of the Division and Region; i.e., that any and all ground water quality
data generated by the States or by EPA in Region III will be sampled and
analyzed in a scientifically valid manner, and will be consistent with
acceptable levels of precision and accuracy.
2. Policy
The QA Policy for the Office of Ground Water is to provide sufficient
programmatic oversight to the Region III States' ground water monitoring
activities via semi-annual program reviews to assure that these activities
are being conducted in accordance with 40 CFR Part 30.
3. Specific Quality Assurance Responsibilities
a. The oversight of any State's ground water monitoring QA
Project Plan is handled by the State Ground Water Programs Manager. His
specific tasks include:
(1) Provide all applicable technical and administrative guidance
necessary to fulfill all Agency QA Program and Project Plan
requirements.
(2) Review all Regional States' and any applicable basin commissions'
(i.e., those who receive a grant) ground water monitoring
QA Project Plans prior to grant approval (should the States
or basin commissions propose to conduct any monitoring
which would be subject to OA requirements).
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(3) Conduct a review of- States' ground water monitoring activities
(if any) no less than seai-annually to assure that Quality
Assurance procedures are understood and implemented.
4. Specific Staff Responsibilities
Within the Office of Ground Water, the State Ground Water Programs
Manager is responsible for all QA aspects related to
ground water monitoring activities associated with all Regional
States-and basin commissions receiving grants under the ground water
supplement of §106 of the Clean Water Act. Review of the Program
Manager's QA oversight is provided by the Regional QA Officer.
5. Concepts and Considerations of Quality Assurance Project Plans
a. Data Quality Objectives
Currently, the Ground Water Program is in a developmental mode
and has no need to gather any type of environmental data. As the program
matures to the implementation stage, Data Quality Objectives will need
to be developed. Although the Water Supply Branch Chief will have ultimate
responsibility for this program and its ultimate data collection activities,
the Ground Water Coordinator and State Ground Water Programs Manager
will assist in developing the Data Quality Objectives (DQOs). DQOs will
be developed as follows:
(1) The WSB Chief and the Office of Ground Water staff will
review the type of problem being addressed, and identify
the type of information which needs to be gathered and
what constraints exist for addressing the problem.
(2) The Office of Ground Water Staff will clarify informtion
needs, uses, and acceptable limits of information.
(3) Alternative approaches for collecting data and data quality
expections will be discussed with the WSB Chief.
(4) The WSB Chief will review the approaches and will select the
methodologies that will be used, and the statement of the
DQOs which will be utilized.
b. Resources
Due to the evolving posture of the Office of Ground Water, no
separate resources have been designated for QA activities in the Ground
Water Program. All QA activities will be integrated into the regular
workload.
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4.1.4.4 Water Permits Branch (WPB)
The Water Permits Branch is responsible for meeting the Water
Management Division's objectives as they relate to the National
Pollutant Discharge Elimination System (NPDES) and assists other
Divisions in water related enforcement activities as appropriate.
WPB is responsible for the overview of Delegated State NPDES permitting
and enforcement programs in accordance with guidances and regulations.
WPB also implements the NPDES Program in the District of Columbia in
accordance with guidances and regulations. The Water Permits Branch
is divided into three geographic sections. The responsibilities of
these sections are divided along State boundaries. Maryland/Virginia/DC
Section is responsible for all Branch activities in Maryland, Virginia
and the District of Columbia. The Pennsylvania Section is responsible
for all Branch activities in Pennsylvania. While the West Virginia/
Delaware Section is responsible for all Branch activities in West
Virginia and Delaware.
A. Quality Assurance Responsibilities for Water Permits Branch
1. Goal
The goal of the WPB is to provide enforcement support as
needed to ensure that the discharge monitoring data generated
by Region III dischargers are scientifically valid, and of
acceptable precision and accuracy.
Policy
2. The WPB QA policy assumes, under the policy of strict liability,
that all Discharge Monitoring Report (DMR) data supplied are
absolute. At the same time several ESD programs, such as
the Discharge Monitoring Report - Quality Assurance (DMR-QA)
Studies and the various on-site inspections, provide the
means of assessing the reliability of that data. Review
and/or computerization of the DMR data is a function of WPB.
3. Specific QA Responsibilities support for the Water Permits Branch
WPB implementation of the NPDES Permit Program requires the
performance of specific QA functions which include scheduling
portions of the ESD QA activities. WPB acts upon the results
obtained by the ESD internal monitoring activities in accordance
with EPA regulations under 40 CFR Part 30. WPB takes appropriate
action against non-responding participants in ESD's quality
assurance efforts.
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Water Permits Section also takes appropriate action against
NPDES permit violations if Delegated State action is inadequate.
Inherent in the process is a detailed review of the available
DMR monitoring data and its quality.
Specific Staff Responsibilities
Within the WPB, the following individuals are responsible
for oversight of program and QA activies under the NPDES
Program in States listed.
Individual
Section Chief
Section Chief
QA Responsibility
Delaware & West Virginia
Virginia, Maryland &
District of Columbia
Section Chief
Pennsylvania
In addition, the following individuals have specific QA duties.
Individual
Staff Specialist
Staff Specialist
QA Responsibility
Regional Coordinator
of the PCS Computer
System
DMRQA contact for WPB
5.0 Concepts and Considerations of Quality Assurance Project Plans
The Water Permits Branch (WPB) participates in the National
PCS Computer system; QA considerations are a significant
component of this effort. The WPB provides enforcement support
for portions of ESD's QA effort and identifies major dischargers
for scheduling of federal NPDES inspections. The various
type of inspections - Performance Audit Inspections (PAI);
Compliance Sampling Inspection (CSI); Compliance Evaluation
Inspections (CEI) - and the DMR-QA studies provide the necessary
QA overview activities for WPB. All of these QA activities
are performed in accordance with existing SOPs; therefore,
WPB is not required to develop QA Project Plans or Data Quality
Objectives (DQOs).
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6. Resources
The Hater Management Division allocates resources to the
various branches and sections responsible for performing their
respective program functions including the QA activities
identified above.
4.1.4.5 Chesapeake Bay Program Office
The primary goal of the Office is to further develop and implement
a management system which is designed to maintain and improve the
overall water quality of the Chesapeake Bay. The Chesapeake Bay is
a critically important natural and economic resource but is subject
to many pressures. Authorization for the Chesapeake Bay Program is
derived from the 1976 Appropriation Act (PL 94-116). EPA was directed
to conduct an in depth study of the Chesapeake Bay, the result of
which may also be applicable to other estuarine zones.
Region III has the responsibility to develop an effective and
implementable water quality management plan for the Chesapeake Bay.
The Program emphasizes the coordination and utilization of existing
programs being conducted by EPA, State and local planning and
regulatory agencies, and other federal agencies active in the areas
of water quality and resource management.
Due to the complexity of the program and its geographical separation
from the Regional Office, a separate QA Program Plan has been developed
and is discussed in Part 4 of the Regional QA Program Plan.
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APPENDIX C
AIR MANAGEMENT DIVISION
ORGANIZATIONAL COMPONENTS AND PROGRAM SPECIFIC
OA PROGRAM PLANS
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4.1.5. Air Management Division
Background
The Air Management Division (AMD) is responsible for Region III
activity regarding implementation of the Clean Air Act and for radiation
programs. AMD manages a portion of the Regional federal grants and
contracts funding process while overviewing State/Local air monitoring
programs. Air Management Division works closely with Headquarters (HQ)
EPA, particularly with the Office of Air and Radiation (OAR). Headquarters
reviews all State Implementation Plan (SIP) revisions. The Annual Southern
Pines Workshop in July is a part of the interfacing between HQ and the
Regions. Within Region III, the Division interfaces with ESD on all air
monitoring projects. Furthermore, AMD interfaces with the State/Local
Agencies through annual air audits, the annual Air Directors meeting, the
105 Grant process and 105 mid-year grant reviews. Also, all newly promul-
gated federal regulations must be enforced through the State/Local Agency.
Air monitoring responsibilities of the Air Management Division are
accomplished as follows. The Environmental Monitoring Section of the
Environmental Services Division is the primary monitoring .and Quality
Assurance Contact for AMD. AMD depends on ESD to perform inspections
and report results. As such, it does not have environmental monitoring
responsibilities of its own.
Organizationally, AMD is comprised of two Branches: Air Programs
Branch and Air Enforcement Branch. The Air Programs Branch is primarily
responsible for Regional State Implementation Plan (SIP) processing,
major SIP activities, emissions trading policy, and the inspection/
maintenance (I/M) and antitampering programs for automobiles. The Air
Enforcement Branch is responsible for Stationary Source Activities such
as New Source Performance Standards (NSPS) and National Emission Standards
for Hazardous Air Pollutants (NESHAPS) as well as tracking case development.
4.1.5.1 Air Programs Branch
The Air Program Branch (APB) is responsible for State Implementation
Plans, emissions trading policy and the inspection/maintenance program for
automobiles. The Air Programs Sections evaluate the Air Monitoring networks
in their States annually and suggest new monitor locations or the relocation
of monitors based on source location. For example, if a new source is
starting up and it will have high SO2 emissions, the Sections work with
ESD and the Source Emissions and Evaluation Section on location of an SO2
monitor which will measure the impact of that source on the ambient air.
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When special projects are contracted out under a Level of Effort
(LOE) contract, the APB project officer for the LOE contract is
responsible for making sure that any data received is quality assured.
When filling out a Statement of Work for an LOE contract, the project
officer must fill-out a QA form which requires OA reports if environ-
mental measurements are to be taken. The OA form also asks whether a
OA Project Plan is to be submitted and how much the environmental
measurements will cost. The project officer from the Air Programs
Branch is responsible for the QA on an LOE contract. The Air Programs
Branch is composed of three sections, the Pennsylvania/West Virginia
Section (PA/WV); the Delaware/Maryland/Virginia/District of Columbia
Section (DELMARVA/DC); and the Source Emissions and Evaluation Section.
A. Quality Assurance Responsibilities for the Air Programs Branch
1• Goal
The goal of the Air Programs Branch is to ensure that all ambient
air monitoring data received from State Agencies and through outside
contractors in Region III are of known precision and accuracy.
2. Policy
It is the policy of the Air Programs Branch to use only quality
assured ambient air data to assess overall air quality in Region III.
The Air Programs Branch will conduct internal QA activities during
the implementation of the Clean Air Act.
3. Specific Staff Responsibilities
Within the Air Programs Branch the following individuals are
responsible for oversight of QA activities for the collection of air
data performed by the Branch.
A. PA and WV Section
Individual QA Responsibilities
Section Chief - must approve all LOE Contracts
for the Section.
- must concur on specific area
redesignations which rely on
air monitoring data.
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PA Project Officer - has oversight for air monitoring
data generated in PA.
- OA oversight for LOE contracts
let in PA.
WV Project Officer - has oversight for air monitoring
data generated in WV.
- OA oversight for LOE contracts
let in WV.
B. DELMARVA/DC Section
Individual
Section Chief
QA Responsibilities
- must approve all LOE contracts
for the Section.
- must concur on specific area
redesignations which rely on
air monitoring data.
DE and DC Project Officer - has oversight for air monitoring
data generated in DE and DC.
- QA oversight for LOE contracts
let in DE and DC.
MD and VA Project Officer - has oversight for air monitoring
data generated in MD and VA.
- OA oversight for LOE contracts
let in MD and VA.
C. Source Emissions and Evaluaton Section
Personnel in this Section work primarily with meterological data.
Staff relies on the private contractors who collect the data for OA. Any
State generated metorological data received by the staff is checked for
OA by the EMS of ESD.
4. Resources
The Air Management Division relies on the Environmental Monitoring
Section of ESD for the bulk of its QA responsibility. The ESD Workplan
allocates resources to the EMS to perform the QA functions for the Air
Programs Branch.
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4.1.5.2 Air Enforcement Branch
The Air Enforcement Branch (AEB) oversees the compliance programs of
each State within the Region. In this capacity the Branch works with the
States to assure that necessary source inspections are completed and
proper corrective actions are taken where needed. Should a State agency
have difficulty in bringing a source into compliance, the Branch may take
enforcement actions of its own. Since a large portion of the Clean Air
Act (CAA) delegates authority to the individual States, the Branch's role
is to make certain that each State is properly carrying out its enforcement
program. With regard to those parts of the program not accepted by all
States, such as the National Emission Standards for Hazardous Air PollutanCs
(NESHAP), the Enforcement Branch will take the lead. Overall, the goals
are to bring noncomplying sources into compliance with State or federal
regulations and to pursue enforcement actions with penalties if sources
choose not to adhere to regulations or agreemments. The AER is divided
into two sections, Enforcement Policy and State Coordination Section; and
the Enforcement Case Activities Section. The former is responsible for
overview of State/Local compliance/enforcement programs and the latter
is responsible for developing cases.
A. Quality Assurance Responsibilities for the Air Enforcement Branch
1. Goal
The goal of the Air Enforcement Branch is to make certain that State
Implementation Plans concerning compliance and enforcement activities are
properly enacted in each of the State/Local Agencies in Region III. Also,
the AEB is directly responsible for enforcing those federal regulations
not delegated to the State/Local Agencies.
2. Policy
The AEB must be certain that all work completed by contractors with
respect to facility inspections is quality assured. The potential for
case development and subsequent legal action mandates that OA be completed.
In most cases, various parts of 40 CFR cite specific test methods that
are to based for determing compliance with the regulations.
3. Specific Staff Responsibilities
The Branch utilizes quality assurance procedures when it is using
data to issue a Notice of Violation to a source. In order to be certain
that results are accuate, the contractor responsible for the analysis
must follow test procedures listed in the Code of Federal Regulations.
However, while the contractor is responsible for following the appropriate
procedures, the personnel using the data must make certain that the
necessary OA is being completed. The following individuals are responsible
for OA activities in the Air Enforcement Branch.
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A. Enforcement Policy and State Coordination Section
Individual OA Responsibilities
Section Chief
State Project Officer
must approve all contracts for
source inspections,
must approve all contracts that
provide state programs assistance
responsible for making certain
that all contractor calculations
and information are correct,
oversight for making certain
that contractor tests and
procedures are quality assured
by subcontractor.
B. Enforcement Case Activities Section
Individual
Section Chief
QA Responsibilities
- must approve all contracts issued
for assistance in case development,
i.e. i nspections.
Program Officers
responsible for preparing contractor
assistance plans for all case
developmemt.
Asbestos Coordinator
Overview proper chain-of-custody
when gathering asbestos samples
NESHAP Coordinator
certify that contractor inspection
results address all applicable
NESHAP regulations
4. Resources
The AEB obtains the services of the Environmental Monitoring
section of ESD to complete the majority of Its OA responsibilities.
Funds are allocated to the EMS to accomplish the OA functions associated
with source inspections.
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APPENDIX D
HAZARDOUS WASTE MANAGEMENT DIVISION
ORGANIZATIONAL COMPONENTS AND PROGRAM SPECIFIC
QA PROGRAM PLANS
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A.1.6 Hazardous Waste Management Division
The Hazardous Waste Management Division (HWMD) is responsible for
all Regional activities regarding the following programs - Resource
Conservation and Recovery Act (RCRA); Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA) or Superfund; Federal
Insecticide, Fungicide and Rodenticide Act as ammended (FIFRA); the
Toxics Substances Act (TSCA) and the Emergency Response. HWMD is
responsible for permitting and compliance as well as enforcement for
facilities storing hazardous waste. HWMD is also responsible for
TSCA and FIFRA enforcement. HWMD manages Federal grants and contracts
funds and ensures that QA matters are properly reflected in budgets,
QA Plans, and work/operating plans. HWMD serves as the technical
and program authority for all hazardous waste environmental monitoring
activities within the Region. The Division recommends to the Regional
Administrator goals, priorities and objectives of the Regional solid
waste, hazardous materials and Superfund Programs.
The Environmental Services Division (ESD), provides the Hazardous
Waste Management Division with technical assistance relevant to the
collection and analysis of environmental samples. This includes Regional
management of the Contract Laboratory Program (CLP) and FIT Contract;
review of CLP data, and preparation of QA Project Plans for Superfund/'
RCRA monitoring activities ESD conducts. HWMD will develop QA Project
Plans for all Superfund/RCRA and emergency response monitoring activities
it conducts. QA Project Plans developed by State/Local Agencies will
be approved by the HWMD, with assistance from ESD when requested. QA
Program Plans will be approved by ESD with HWMD concurrence.
Organizationally the Division is composed of four branches: Waste
Management Branch, Hazardous Waste Enforcement Branch, Superfund Branch
and Toxics and Pesticides Branch.
4.1.6.1 Waste Management Branch
The Waste Management Branch (WMB) operates under the authority
of 40 code of Federal Register Parts 260-70. Under this authority,
WMB has the program management responsibilities for the Resource
Conservation and Recovery Act (RCRA). WMB conducts the RCRA permitting
for hazardous waste transport, storage and disposal facilities. WMB
also serves as the technical and program authority for all hazardous
waste and environmental monitoring activities related to RCRA permitting
within the geographical boundaries of Region III. The environmental
monitoring activities associated with permitting program process are
entirely conducted externally by States and contractors through EPA
grants and contracts. All monitoring projects must be done in conformance
with approved Quality Assurance (QA) Program Plans and Projects Plans.
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The Waste Management Branch (WMB) is composed oE four sections -
three (3) State Sections and the Support Section.
Support Section
The Support Section within the Hazardous Waste Management Branch is
responsible for meeting the QA objectives of the Branch. The Support
Section is also responsible for coordinating State grants, reviewing and
approving all QA Project Plans performed under level of effort contracts.
State Sections
The State Sections are composed of three sections - Pennsylvania;
West Virginia and Virginia; and Maryland, Delaware and the District of
Columbia. The State Sections within the WMB are responsible for ensuring
that the State program managers, or if the State elects, the State
central laboratory, submits a QA Program Plan as part of the State
Authorization Program. The QA Program Plans are referred to the Environ-
mental Services Division (ESD) for review and approval. ESD provides
the State program managers with the approved State Program Plan for
submittal in the grant package.
A. QA Responsibilities for the Waste Management Branch
1 • Go a 1
The goal of the WMB is to ensure that all environmental data generated
and processed by contractors and State agencies will be scientifically
valid, of known precision and accuracy, of acceptable completeness,
representativeness, and comparability and where appropriate, legally
defensible.
2. Policy
It is the policy of the Branch that there shall be sufficient QA
activities conducted within the Branch to ensure that all environmental
data generated and processed by contractors and State agencies will be
scientifically valid, of known precision and accuracy, of acceptable
completeness, representativeness, and comparability and where appropriate,
legally defensible. This goal can be achieved by ensuring that adequate
QA steps and procedures are used throughout the entire monitoring process
(from initial study planning through data usage).
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Specifically it is the policy of the Branch that:
(1) Each RCRA monitoring program conducted by State laboratories
and contractors which generates environmental data will
develop and implement QA programs. The QA program will
ensure that all data will be scientifically valid, of known
precision and accuracy, and comparability and where appropriate,
legally defensible. The QA program will ensure that adequate
resources (both monetary and staff) are provided to support
the QA effort.
(2) All environmental data generated will be of known and acceptable
quality to the program office. The data quality information
developed with all environmental data will be documented
and available as requested for purposes of audits conducted
by the Environmental Services Division (ESD).
(3) The intended use(s) of the data will be defined before the
data collection effort begins, so that appropriate QA measures
may be monitoring objectives. The determination of this
level of data quality shall also consider the prospective
data needs of secondary users. Data Quality Objectives will
be established to ensure the utility of monitoring data for
its intended use. The intended data uses, level of quality,
specific QA activities, and data acceptance criteria needed
to meet the data quality needs of these uses will be described
in each monitoring activity's QA Project Plan.
(4) Quality assurance activities will be designed in the most
cost-effective fashion possible without compromising Data
Quality Objectives.
The Branch QA program shall meet the following requirements:
(1) The Branch QA Contact (BQAC) will be the technical authority
for all QA matters within the Branch. The BQAC will review,
comment, and concur on all 8ranch QA Program Plans. The
BQAC will be the focal point for interaction with ESD, States,
and contractors to ensure that Agency QA requirements are met.
(2) Branch Project Officers will inform the BQAC of activities
relating to QA within specific monitoring programs and
facilitate development and implementation of QA programs.
(3) Facilities, equipment and services which, directly or
indirectly, impact data quality or integrity shall be
routinely inspected by ESD.
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The purpose of this Branch document is to define and describe tne
QA and Quality Control (QC) policies and responsibilities prescribed by
the Waste Management Branch, in accordance with the Agency's mandated QA
program. The document is designed to provide a logical connection of
the Agency QA policy and the implementation of such policies in the
Branch. This document is intended to assist the Branch project officers
and managers in the uniform implementation of QA requirements for the
Branch contracts, cooperative agreements, and interagency agreements.
3. Assignment of Responsibilities
In order to properly manage the QA activities of environmental
monitoring programs within the Branch, all QA management responsibilities
are assigned to the Branch Quality Assurance Contact (BQAC). The BQAC
shall be under the administrative direction of the HWMD Deputy Director
or his designee.
a. Branch Quality Assurance Contact Responsibilities:
1) Serve as the official Branch contact for all QA matters
of the Branch.
2) Respond to QA needs, resolve problems, review QA documents
and answer request for guidance or assistance.
3) Assure that QA program requirements are integrated into
the overall State/EPA agreement process and grants.
4) Participates in QA audit reviews of the Branch.
b. Technical Specialists Responsibilities:
To ensure that a satisfactory level of QA capability is maintained
in the Branch, the BQAC will be able to request technical assistance
from technical specialists within ESD.
The specific duties which will be assigned to the ESD technical
specialists are as follows:
L) Assist BQAC with technical aspects of QA related to their
expertise in air, water, toxic substances, hazardous waste,
chemistry, field operations and data operations.
2) Conduct field and laboratory performance audits.
3) Inform BQAC of need for new methods.
4) Conduct compliance monitoring inspections.
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4. Communication/Reporting/Work
The purpose of communications is
different monitoring programs can eff
programs, perform activities, and res
of a QA Program Plan is to facilitate
ment of guidance documents and the is
Plan
to ensure that staff personnel in
ectively develop and implement such
olve problems. One responsibility
communications through the establish-
suance of procedures.
5. QA Operations for Contracts, Grants and Interagency and Formalized
Agreements
The originating Program Manager shall notify the Branch QA Contact
of all contracts and interagency/formalized agreements during the planning
phase. The Branch QA Contact shall ensure that all requests for proposals
will- contain an acceptable description of the QA requirements prior to
advertisement. The Branch QA Contact shall ensure that QA Plans are
acceptable prior to awarding of a contract or interagency agreement.
The QA Program Plans shall be reviewed and approved by ESD. The Program
Manager/Project Officer shall review and evaluate the use of these plans.
Upon completion of the monitoring activities, the Program Manager/Project
Officer shall assess the actual performance of the planned activity and
subsequent results.
6. Program Evaluation
Audits are the principal means in the Branch QA program to determine
compliance with established QA Program Plans. ESD has the authority and
responsibility to conduct State and contractor laboratory audits and
provide the BQAC a copy of the audit report.
Technical system audits conducted by ESD will include on-site
qualitative evaluation of the QA system and physical facilities for
sampling and analysis.
7. Data Quality Objectives (DQOs)
The environmental monitoring activities associated with the RCRA
Permitting Program for the WMB are entirely conducted externally by
authorized States and by level-of-effort contractors. The authorized
States and contractors are responsible for developing and managing the
Data Quality Objectives for each program.
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8. Resources
The responsibilities and duties of the BQAC are delegated to a senior
technical staff member within the RCRA Support Section. The resources
are allocated in a chemist position for the QA responsibilities outlined
in the position description.
Additional funding is diverted from the land disposal permitting
allocations as needed. This funding is translated into permit writers
man-hours to review OA Project Plans submitted by contractors.
4.1.6.2 Hazardous Waste Enforcement Branch
The Hazardous Waste Enforcement Branch's purpose is to manage
enforcement lead response programs as required by CERCLA and to
enforce the provisions of RCRA. Many of the functions of the Branch
are to support the remedial and removal activities of the Superfund
Branch, or mirror the same activities using enforcement resources or
the Potentially Responsible Parties for a site.
There are five sections within the Branch - Pennsylvania CERCLA
Remedial Enforcement; DELMARVA, WVA CERCLA Remedial Enforcement; CERCLA
Removal Enforcement; Pennsylvania RCRA Enforcement; and the DELMARVA,
DC/WVA RCRA Enforcement. This portion of the OA program covers the
following three sections:
1. Pennsylvania CERCLA Remedial Enforcement
2. DELMARVA, WVA CERCLA Remedial Enforcement
3. CERCLA Removal Enforcement
4.1.6.2.1 Pennsylvania CERCLA Remedial Enforcement Section
4.1.6.2.2 DELMARVA, WVA CERCLA Remedial Enforcement Section
These two sections within the Hazardous Waste Management Enforce-
ment Branch are responsible for: implementing enforcement lead remedial
actions at sites on the National Priority List (NPL); identifying
Potentially Responsible Parties (PRPs) who may have contributed waste
to a site; negotiating with PRPs to perform investigations and site
remediation; overseeing design and construction activities at sites; and
pursuing cost recovery from PRPs where necessary. They work closely
with the remedial Response Section of the Superfund Branch and perform
many of the same functions on those sites having Potentially Responsible
Parties.
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As part of these responsibilities, Remedial Investigations, Inspec-
tions and field sampling are performed to provide the technical data
necessary to evaluate remedial action alternatives. Inspections and
sampling which are used for enforcement actions are conducted by the
States; the Environmental Services Division; the PRPs and Contractors
under the National Technical Enforcement Support (TES) contracts, the
Field Investigation Team (FIT) and Remedial (REM) contracts. The
Enforcement Project Managers (EPM) decide who does which protions of
the work, after coordination with the other organizations; review of
authorities, MOUs, etc., and consultation with management.
4.1.6.2.3 The CERCLA Removal Enforcement Section
The CERCLA Removal Enforcement Section is responsible for the
identification of PRPs and cost recovery for fund financed removal
activities taken at uncontrolled hazardous waste sites by the Emergency
Response Section of the Superfund Branch. In addition, this Section
pursues enforcement channel's to have PRPs perform actual Site Removal
activities and oversees the PRPs clean up.
A. Quality Assurance Responsibilities for the CERCLA Enforcement Sections
1. Goal
The goal of the CERCLA Enforcement Sections is to ensure that data
utilized for choosing a remedial action at a site or developing a
compliance determination or an enforcement order will be scientifically
valid, defensible and of known and acceptable precision and accuracy.
2. Policy
The CERCLA Enforcement Sections OA policy is to use data that has
been gathered by the States, the Environmental Services Division,
the PRPs and contractors in accordance with the National Contingency
Plan (NCP), approved sampling and analysis plans and all applicable
guidances developed by the National program offices. Oversight is
accomplished through a combination of detailed work plan review and
establishing Data Quality Objectives.
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General Quality Assurance Responsibilities
- The responsibility for data QA.JLies with the groups doing the
sampling and the analysis. The sampling in the CERCLA Program is
done by the PRPs, the States, EPA contractors (TES, REM, FIT) or
the Environmental Services Division based on a determination by the
EPM in Section 4.1.6.2.2 The analyses may be conducted in many
different laboratories.
- Remedial Investigation workplans may be reviewed by the EPM in
accordance with the "Guidance on Remedial Investigations Under
CERCLA" (EPA/540/G-85/002, June 1985). This guidance manual has
specific requirements for sampling plans, Quality Assurance plans
and data evaluation which implement the requirement of §300.68(k),
Remedial Site Sampling, of the NCP.
- EPA contractors must meet defined OA/QC protocols specified in
the national contract. EPA contractors also develop sampling
plans for sampling inspections which are reviewed by the Project
Officer responsible for the site to assure the sampling will
satisfy the enforcement objectives. The QA/QC portions of the
sampling plans are reviewed by the Quality Assurance Officer
in the Central Regional Laboratory (CRL).
Specific Staff Responsibilities for Quality Assurance
The Project Officers have several Ouality Assurance functions which
include:
(a) Technical review of the site's sampling and analysis plans,
including developing Data Quality Objectives. These outline
what questions need to be answered by the data collected and
what level of sampling effort and data quality is needed to
reach these objectives. Specific technical guidance and a
workbook is under development in Headquarters. Secondary data
users are not normally existant and all the data is gathered
primarily for enforcement actions.
(b) Developing technically specific orders which identify the level
of data quality required including the number and location of
samples, the frequency and duration of sampling, the parameters
measured, and the detection limit to be achieved.
(c) Observing sampling events and conducting field evaluation of
sampling techniques.
(d) Reviewing and assessing analytical data collected by PRPs, States,
EPA contractors and ESD after it has been validated to determine
if the original Data Quality Objectives were met.
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(e) The Project Officers are able to request specific assistance
from the Branch specialists in Toxicology, Hydrogeology or from
the Senior Enforcement Project Manager. This assistance is
normally used in the review of major documents submitted to EPA.
(f) No further OA/QC review is normally done on the results. If,
based on questions raised during preliminary review, the
Project Officer feels that a detailed review is necessary or
some other reason would require it, the Environmental Services
Division (ESD) at the Central Regional Laboratory, and EPA
contractor resources are requested to perform the review.
5. Resources
The Hazardous Waste Enforcement Branch allocates positions and
funds to the Environmental Services Division to provide QA/QC
support and conduct CERCLA site inspections when requested by
the EPM and agreed to by management of both Divisions. The
Environmental Services Division Work Plan allocates resources to
the various Branches and Sections in ESD responsible for OA/QC.
Additional resources are available through the EPA contracts
(TES,FIT,REM) to accomplish certain aspects of OA/QC.
4.1.6.2.4 PA RCRA Enforcement Section
The PA RCRA Enforcement Section (PARES) is responsible for enforcing
the provisions of the Resource Conservation and Recovery Act (RCRA) in
Pennsylvania. Pennsylvania is an authorized State and operates its own
regulatory program over hazardous waste. PARES oversees the operation of
the State program to ensure compliance with the approved State regulations.
PARES is also responsible for compliance with the 1984 RCRA Amendments
since Pennsylvania is not authorized for those provisions. Inspections
and sampling which are used for enforcement actions, are conducted by
the States, the Environmental Services Division, the regulated community
and private contractors under the national Technical Enforcement Support
(TES) contracts.
4.1.6.2.5 The DELMARVA/DC/WV RCRA Enforcement Section
The DELMARVA/DC/WV RCRA Enforcement Section (DELMARVA/DC/WV RES)
is responsible for enforcing the provisions of the Resource Conservation
and Recovery Act in Delaware, Maryland, Virginia, Washington D.C. and
West Virginia. All the States and the District are authorized and operate
their own regulatory program over hazardous waste. DELMARVA/DC/WV RES
oversees the individual State programs to ensure regulated community
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compliance with the approved State regulations. DELMARVA/DC/WV RES is
also responsible for enforcing the 1984 RCRA Amendments since the States
have not been authorized for those provisions. The inspections and
sampling upon which compliance determinations and enforcement actions
are based, are conducted by the respective States, the Environmental
Services Division, the regulated community and private contractors under
the national TES contracts.
A. Quality Assurance Responsibilities for the RCRA Enforcement Sections
(4.1.8.2.4 and 4.1.8.2.5)
1. Goal
The goal of the RCRA Enforcement Sections (RES) is to ensure that
data utilized for compliance determinations and in enforcement orders
will- be scientifically valid, defensible and of known and acceptable
precision and accuracy,
2. Policy
The RCRA Enforcement Sections' QA policy is to use data that have
been gathered by the States, the Environmental Services Division, the
regulated community and the TES contractors in accordance with approved
sampling and analysis plans and all applicable guidances developed by
the National Program Offices.
3. General Quality Assurance Responsibilities
- The responsibility for data QA lies with the groups doing the
sampling and the analysis. The sampling in the RCRA program is
done by the owner/operator, the States, the TES contractors or
the Environmental Services Division. The analyses are conducted
by their respective laboratories.
- The regulations require that the facility owner or operator
must obtain and analyze samples in accordance with EPA Test
Methods for Evaluating Solid Wastes (SW-846). For groundwater
sampling, the owner operator must develop and follow a ground-
water sampling and analysis plan which is subject to State
and Agency review and approval.
- The States are required to take samples and perform analysis
in accordance with approved USEPA methods. The State programs
are authorized under the RCRA authorities. The development
and maintenance of acceptable State QA/QC programs has been
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integrated into the overall State - EPA Agreement (SEA) process.
Oversight is accomplished by ESD through a combination of OA
document reviews and systems audits on the implementation of
these QA documents.
- The TES contractors must meet defined OA/QC protocols specified
in the national contract. The TES contractor also developes
sampling plans for sampling inspections which are reviewed by
the Compliance Officer responsible for the facility to assure
that the sampling will satisfy the enforcement objectives.
The OA/QC portions of the sampling plans are sometimes reviewed
by the laboratory Quality Assurance Officer in the Central
Regional Laboratory (CRL).
- .All EPA sampling in the RCRA program is conducted by the
Western Regional Laboratory and Engineering Center (WRLEC)
and the CRL of the Environmental Services Division. The
WRLEC and CRL Quality Assurance Officers are responsible for
sampling, analytical data quality and review of the OA/QC
portions of the sampling plans. The RCRA compliance officers
identify the facilities to be inspected by ESD, and sometimes
recommend specific sampling to support enforcement actions.
The types of inspections that ESD is required to perform
(that include sampling) are Case Development Investigation
and Comprehensive Groundwater Monitoring Evaluation.
4. Specific Staff Responsibilities
- Every RCRA facility that is inspected or is generating sampling
data has an individual Compliance Officer assigned to it. The
assignments are by geographical area, with any facilities in
a specific geographic area being the responsibility of the
Compliance Officer for that area. The Compliance Officers
review all inspection reports to determine facility compliance
and need for enforcement action by EPA and the adequacy of
State compliance actions.
- The RCRA hydrologists have several Quality Assurance functions
which include:
a) Technical review of facilities' groundwater sampling and
analysis plans.
b) Observing facilities' sampling events and conducting field
evaluation of sampling techniques.
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c) Evaluating analytical data collected by facilities, States,
contractors and ESD to determine if releases from the facility
of hazardous waste or constituents to the environment are
occuring.
d) Developing technically specific orders which determine the
level of data quality required, including the number and
location of samples, the frequency and duration of sampling,
the parameters measured, and the detection limit to be
achieved.
e) Review proposals and plans submitted by owner operators in
response to compliance orders describing the level of data
quality to be developed.
5. Resources
The Hazardous Waste Enforcement Branch allocates positions and funds
to the Environmental Services Division to provide QA/OC support and
conduct inspections and data reviews. The Environmental Services
Division Work Plan allocates resources to the various Branches and
Sections in ESD responsible for performing QA functions.
4.1.6.3 Superfund Branch
The Superfund Branch is responsible for the development and
management of the CERCLA Program and to implement the Clean Water Act,
Section 311 Oil and Spill and Response Program.
In support of the CERCLA Program, the Branch conducts and/or
coordinates the assessment and investigation of dumpsites and other
potential response actions. It also directs the preparation of remedial
action plans for Superfund sites in Region III. The Superfund Branch
also manages the preparation and review of detailed technical feasibility
studies, final remedial measures design(s) and other necessary activities
for the amelioration of threats to human health and the environment.
In support of the Section 311, the Branch is responsible for the
implementing the Regional and Sub-regional Contingency Plans for
combating spillage of oil and hazardous materials in cooperation with
the U.S. Coast Guard and State and local agencies. The Branch conducts
and coordinates cooperating agency and industry responses to oil and
hazardous materials spills pursuant to the requirements of the Clean
Water Act and the Comprehensive Environmental Response and Liability Act
as amended in 1986, including containment and cleanup actions, assistance
to enforcement investigations and assessment of environmental damage.
Within the Superfund Branch there are three Sections:
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4.1.6.3.1 Site Investigation and Support Section
This Section is responsible for Superfund site identification and
initial site inspections. If, based on the initial inspections, a site
appears to pose a significant threat to the environment or public health,
a hazard ranking system model score will be calculated for the site and
if the score is high enough (above 28.50), the Section will prepare the
necessary documentation to place the site on the National Priorities List
(NPL). Field sampling and data collection activities are conducted by
private contractors under the National Field Investigation Team (FIT)
Contract.
4.1.6.3.2 Site Response Section
This Section is responsible for implementing Superfund financed
remedial response actions at NPL sites. These activities include managing
Remedial Investigations and Feasibility Studies (RI/FS) to support the
selection of a remedial cleanup action. The RI/FSs are conducted either
by a private contractor under the National Remedial Response Contract or
by a State Agency which has retained a private contractor. During
implementation of the cleanup action, Region III oversees the data
collection activities of the private contractors implementing the actions.
4.1.6.3.3 Emergency Response Section
This Section is responsible for implementing EPA's Immediate Removal
Program required by CERCLA and the CWA Section 311 Oil Spill Program.
The Section manages private contractor data collection activities under
the National Immediate Removal Contracts and oversees State response
actions taken in response to spills (ie. truck accidents).
A. Quality Assurance Responsibilites for the Superfund Branch
1. Goal
The goal of the Superfund Branch is to ensure that data
generated to support the Region's Superfund Program will be
scientifically valid, defensible and of known and acceptable
precision and accuracy to support decision making.
2. Policy
The Superfund Branch QA policy is to follow the requirements
of the National Contingency Plan and all applicable guidances
developed by the National program offices.
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3. Specific Quality Assurance Responsibilities
Each Section in the Branch has specific responsibi1ites and
guidances to follow.
a. Site Investigation and Support Section
The initial processing of sites after their discovery is carried
out according to the instructions on EPA Form 2070-8 (5-80),
"Potential Hazardous Waste Site Identification". Such discoveries
may originate from citizens' complaints, OSHA citations, State
leads, or federal projects. Preliminary Assessments are carried
out according to the guidance provided by EPA Form 2070-12 (7-81),
"Potential Hazardous Waste Site, Preliminary Assessment." Basic
guidance for the promulgation of site inspection and data compil-
ation is found in EPA Form 2070-13 (7-81), "Potential Hazardous
Waste Site, Site Inspection Report." In Region III this function
has been enhanced to include narratives concerning site layout,
history, hydrogeology, toxicology, and other pertinent information.
Guidance covering these narratives and other related functions
such as site inspections and sample collections is found in "NUS
Corporation Work Plan for the Performance of Site Inspection,
Revision if I." (Copy available from the Office of the CERCLA
Branch Chief). All site sampling data are subjected to QA reviews
developed by ESD, (i.e., Quality Assurance Section at the Central
Regional Laboratory). Site Inspection Reports are reviewed by
the Section hydrogeologist, toxicologist, and site investigation
officers for technical and scientific validity and accuracy.
If, after a review of this information, it becomes apparent to
the site investigation officer to indicate that this site should
be considered for the National Priorities List (NPL), it is
subjected to a scoring system according to instructions found in
the "Uncontrolled Hazardous Waste Site Ranking System, A Users
Manual." These scores are reviewed by OA officers of the Mitre
Corporation.
b. Site Response Section
Remedial Investigations, whether federal or State lead projects,
are conducted in accordance with the "Guidance on Remedial
Investigations Under CERCLA" (EPA/540/G-85/002, June 1985).
This guidance manual has specific requirements for sampling
plans, QA Plans and data evaluation which implement the
requirement of §300.68(k), Remedial Site Sampling, of the
NCP. All site specific sampling and QA Plans development by
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contractors or a State are reviewed and approved by the
Region III site Project Officer in accordance with the RI
Guidance manual and in coordination with the OA Section of
the Central Regional Laboratory. Data collection activities
during remedial cleanup actions are also supported by site
specific sampling and OA plans and are reviewed by the Site
Manager.
c. Emergency Response Section
This Section has a designated QA Coordinator and has developed
its own Quality Assurance Manual which specifies sampling
plan development procedures, analytical procedures and data
review and evaluation procedures and responsibilities.
4. Specific Staff Responsibilities
Every site that is inspected by the Branch has an individual
project manager assigned to the site.
a. Site Inspection and Support Section
r>ite Inspection Officer (SIO) - The SIO reviews and approves
sampling plans developed by the FIT for PA/SI's. Each PA/SI
report contains a detailed review and discussion of the
quality of the data collected. The FIT follows the OAPjP
required by the specific provisions of the contract it has
with EPA headquarters.
b. Site Response Section
Assigned to each site is a Remedial Project Manager (RPM).
The RPM is required by the NCP to review and approve
sampling/QA Plan, with a concurrence signature from the
Regional Quality Assurance Officer. The QA Section of the
CRL also reviews the OA Plans.
c. Emergency Response Section
Assigned to each site is an On Scene Coordinator (OSC). The
OSC has the broad responsibility to insure that the proper
sampling and QA functions are performed during an emergency
response. The Section has a designated QA Coordinator and a
Quality Assurance Manual to assist the OSC in carrying out
these responsibilities.
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Concepts and Considerations of Quality Assurance Project Plans
The purpose of site characterization QA/QC is stated in the
report "Guidance on Remedial Investigations Under CERCLA",
EPA/540/G-85/002, June 1985. Its purpose is to ensure that the
data collected are of known and sufficient quality to assess
contamination at the site qualitatively and quantitatively.
QA/QC site characterization encompasses two important aspects
and should be stated in the QA Project Plan.
° Records of traceability and adherence to prescribed protocols,
complete descriptions of relaxed or lax quality control, and
corrective actions.
° Data on the quality of the data collection and analyses,
deficiencies that may affect quality, and the uncertainty
limits for results.
Thus, the QA Project Plan should address the elements contained
in QAMS-005/80.
Because the primary aim of the QA program is to ensure that the
data are reliable, rather than to ensure that a poorly conducted
program is adequately documented, the QA/QC aspects of site
characterization should be planned in advance as an integral part
of the investigation. Factors that must be considered in this
planning include an evaluation of the types of data needed, the
required level of certainty, and the availability of data collection
and assessment procedures that can provide the desired level of
reliability cost effectively. These QA/QC factors vary according
to the investigation phase. For example, the uncertainty limits
demanded for data during an initial investigation (i.e., for
essentially qualitative assessments) may be much broader than those
required during detailed assessments. The essential point is
that data limitations must be known and must be in accordance
with the "necessary and sufficient" philosophy governing RI
planning and activities.
Resources
The Superfund Budget incorporates resources for QA activities.
The distribution of those resources within the Region is determined
by the Regional Resource Distribution Process that occurs in the
summer prior to the start of the fiscal.
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7. Training
The Hazardous Waste Management Division (HWMD) will provide training
for identified program specific QA needs. ESD will conduct a training
course for QA Project Plan development for the HWMD Superfund Branch.
Predevelopment meetings for problem sites, for site specific training
and for resolution of legal problem will be held when deemed necessary
by the program manager and/or project office.
4.1.6.4 Toxics and Pesticides Branch
The Toxics and Pesticides Branch (TPB) is responsible for managing
and overseeing the Toxics Substances Control Act (TSCA) Sections 4,5,6
and 8 programs, the Asbestos-in-schools program, and the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). The TPB is also responsible for
reviewing and approving State grants (which include QA Program Plans and
QA Project Plans) for several of these programs. The purpose of this
Branch document is to define and describe the QA policies and responsibilities
of the Toxics and Pesticides Branch, and is intended to assist the Branch
in the uniform implementation of QA requirements of the Branch monitoring
programs, grants and contracts. The individual program responsibilities
are described below:
TSCA Program
The Toxics Substances Control Act (TSCA), (Public Law 94-469,
90 STAT. 2003) is the basis for several programs within the Branch.
Section 5: "Manufacturing and processing notices."
The Premanufacturing Notification (PMN) Program operates under
40 C.F.R. § 720 "Premanufacturing notification", 40 C.F.R. § 721
"Significant new uses of chemical substances", and 40 C.F.R. § 723
"Premanufacturing notification exemptions". The EPA Region III staff
performs inspections, determines compliance, and provides technical
support to the regulated community. The inspections involve record-
keeping and document audits only, no environmental samples are taken.
Case development for administrative complaints is done either by
Headquarters or the Regional Office.
Section 6: "Regulation of hazardous chemical substances and mixtures."
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PCB Program
The PCB Compliance Monitoring Program operates under 40 C.F.R.
§ 761 and is the only program in the Toxics and Pesticides Branch that
regularly takes environmental samples. The staff reviews inspection
reports for compliance and either issues closeout letters, or issues
Notices of Noncompliance (NON), or makes recommendations to Regional
Counsel for Administrative/Civil/Criminal Complaints. The staff provides
technical support to the regulated community and develops inspection
schemes for ESD and for the State of Maryland Agreement. Inspections are
performed by ESD and the State of Maryland, and often include environ-
mental sampling. Under exceptional circumstances, such as citizens
complaints and immenient hazards, the TPB will conduct some inspections.
EPA Region III has a cooperative agreement with the State of Maryland.
Maryland is the only state within Region III that regulates PCBs. The
state inspectors combine federal PCB compliance inspections and State
PCB compliance inspections. EPA has provided Maryland with specific
guidance in the type of procedures to be employed in the inspections,
reporting, and laboratory analysis of samples. A PCB Quality Control
Officer has been assigned (by Maryland) to review each inspection report
for completeness before it is forwarded to the Region III office. Maryland
has agreed to utilize all QA and QC program elements of the Clean Water
Act (CWA) and the Resource Conservation and Recovery Act (RCRA) that have
been adopted by the State and Region III in performing the inspections.
This includes sampling, lab analysis, and chain of custody procedures.
The PCB Program has a strong commitment to QA. Sample collection
procedures and results must be statistically valid, legally defensible,
and reproducible. Sample collection is done with the use of SOPs.
Samples are taken at the inspector's discretion.
The PCB Program intends to develop or to assist in the development
of any SOPs that will need to be included in the future. Sample analysis
procedures are quality controlled at the Central Regional Laboratory in
Annapolis, Maryland.
Environmental sample analysis data are used in the following ways:
- Determining amount and extent of PCB contamination.
- Evidence in supporting PCB enforcement actions.
- Determining proper disposal procedures for suspected
PCB items.
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Section 8. "Reporting and retention of information.
The TSCA Section 8(a) is the Program on Preliminary Assessment
Information Reporting, and operates under 40 C.F.R. § 704 "Reporting
and recordkeeping requirements", 40 C.F.R. § 710 "Inventory reporting
requirements", and 40 C.F.R. § 712 "Chemical information rules".
The TSCA Section 8(b) is the Program on Chemical Inventory Reporting.
TSCA Section 8(c), the Program on Recordkeeping and Reporting
Allegations of Adverse Reactions, operates under 40 C.F.R. § 717.
The EPA staff performs inspections, determines compliance, and provides
technical support to the regulated community. The inspections involve
recordkeeping and document audits only, no environmental samples are
taken. Case development for administrative complaints is done either
by Headquarters or the Regional Office.
Good Lab (GLP) Program
The Good Lab Practice Program (GLP) operates under TSCA (48 FR
53922) and FIFRA (48 FR 53946). Laboratory inspections are performed
while a study is in progress to ensure that the testing facilities
are adequate and meet all the study requirements. The EPA Region III
staff performs the inspections. The inspections involve recordkeeping,
SOPs, and document auditing only, no environmental samples are taken.
Headquarters provides the technical auditors and develops enforcement
actions.
Asbestos Program
The Asbestos Program operates i-nder 40 C.F.R. § 763, "Friable
Asbestos-Containing Material in Schools: Identification and Notifi-
cation". The EPA staff is responsible for reviewing all inspection
reports, and deciding if the facility is in compliance, or warrants
a NON, or requires recommendation of Administrative Action. Asbestos
inspections are performed by TPB and the State Program Offices in
West Virginia and Maryland. Inspector training is provided by Drexel
University of Philadelphia, PA. EPA inspectors do not sample materials,
they are required only to determine the location of any friable material.
(State inspectors from West Virginia and Maryland may take grab samples
at the inspector's discretion. If the material is found to be asbestos,
the school is required to do statistically valid sampling, as described
below.)
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If friable material is found and the school has not previously
sampled the material, either the Board of Education is issued a
NON, or a recommendation for a Civil Complaint is made. The NON
includes a certification form that the school is to sign and send
back to EPA within 30 days, stating that all schools are currently
in compliance. Administrative actions are recommended for schools
with large amount of friable materials. To come into compliance a
school , or contractor of the school , must sample and analyse a
representative area of the friable material (using sampling method
described in "Asbestos in Buildings: Simplified Sampling Scheme
for Friable Surfacing Materials", EPA 560/5-85-030a October 1985),
and if found to be asbestos, building occupants must be properly
notified. Removal of the friable material is not required.
The school has the option of declaring the friable material to
be asbestos without any sampling. Proper notification of personnel
is then required.
Schools are not required to send in sample analysis results.
However, approximately 10% of schools are reinspected (generally within
one year) to assure compliance.
FIFRA Program
The Pesticide Program operates under the Federal Insecticide,
Fungicide, and Rodenticide Act as Amended (FIFRA), (86 STAT. 973-999).
Each State and the District of Columbia in Region III has two grants
to perform the work required under FIFRA. One grant is for enforcement,
and the other is a certification and training grant. Each grant recipient
has developed and completed a QA Program Plan and a OA Project Plan,
which have been approved. The EPA staff oversees and reviews each State's
work. All environmental sampling is done by the grant recipients.
A, QA Responsibilities for the Toxics and Pesticides Branch
1. Goal
It is the QA goal of the Toxics and Pesticides Branch to ensure
that all environmental data generated and processed will be scienti-
fically valid, of known precision and accuracy, representative
completeness and where appropriate, legally defensible. This goal
can be achieved by ensuring that QA steps and procedures are used
throughout the entire monitoring process.
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2. Policy
The Toxics and Pesticides Branch (TPB) is committed to sound
OA practices. This commitment is consistent with the goals of the
Administrator's QA Policy Statement, and EPA Order 5360.1 and AO
C.F.R. Part 30, Section 503.61. The OA policy is to define and
describe the QA and quality control (OC) policies and responsibilities
of the Branch, and is intended to assist the Branch in the uniform
implementation of QA requirements of the Branch monitoring programs,
grants, and contracts.
a. Specifically, it is the policy of the Branch that:
- All environmental data generated will be of known and
acceptable quality. Data assurance activities will be
be designed in the most cost effective fashion possible
without compromising Data Quality Objectives.
- Each monitoring program which generates environmental data
will develop and implement QA Project Plans/SOPs which will
specify the detailed procedures required to assure quality
data. The QA Project Plans will be approved by ESD.
- All contractors and State Agencies interfacing with the
Branch are obligated to perform QA as part of their
agreement.
- All monitoring programs will ensure that acceptable OA
requirements are included in all applicable external
monitoring activities funded by EPA.
3. Specific QA Responsibilities for the Toxics and Pesticides Branch (TPB)
In order to properly manage the QA activities of environmental
monitoring programs within the Toxics and Pesticides Branch, specific QA
responsibilities will be handled in the following ways:
a. The Branch will ensure QA is an identifiable activity by including
QA in all agreements with contractors and States. The Branch Program
Grant Managers are responsible for ensuring QA is integrated into all
grants. The State or Agency receiving the grant is responsible for
ensuring QA Plans have been established. The TPB will be responsible
for developing or assisting in the development and implementation
of QA Project Plans/SOPs for the required environmental monitoring.
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b. The Branch Quality Assurance Contact is responsible for QA
activities within the Branch, including:
- The official Branch contact for all QA matters of the Branch.
- Review all Branch QA Plans,
- Participate in Management System Audit review of Region III QA.
- To ensure that a satisfactory level of Branch QA capability is
maintained in Region III, the QA Contact will be able to request
(with supervisory approval) technical assistance from the technical
specialists of ESD within the resources available under the
Regional workload allocations.
4. Concepts and Consideration of Quality Assurance Project Plans
A. Data Quality Objectives
The Toxics and Pesticides Branch has the responsibility for
ensuring that Data Quality Objectives have been established in external
monitoring activities (such as the State grants). Internally, there
is only one program in the Branch that routinely collects environmental
samples - the PCB Compliance Monitoring Program. The quality of the
The State or Agency responsible for managing a particular program
will be responsible for establishing Data Quality Objectives for that
program.
5. Resources
No separate monies or staff have been designated for QA activities
in the Toxics and Pesticides Branch. All QA activities will be integrated
into the regular workload.
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APPENDIX E
ENVIRONMENTAL SERVICES DIVISION
ORGANIZATIONAL COMPONENTS AND PROGRAM SPECIFIC
OA PROGRAM PLANS
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4.1.7 Environmental Services Division
The Environmental Services Division (ESD) collects, analyzes
and evaluates environmental quality data in support of Regional and
National programs, including air, water and hazardous waste programs.
ESD directs and coordinates surveillance and monitoring services
within the Region and provides necessary laboratory analytical
services in support of various Regional and National environmental
monitoring activities. The Division provides advice and assistance
to State and local agencies concerning laboratory and field techniques,
methodology and quality assurance/quality control as well as laboratory
analyses when required to assure success of field investigations.
It conducts special studies, investigations, analyses and surveys
to acquire the necessary data to support program offices within EPA.
Also, ESD implements monitoring programs to meet Regional and National
obj ectives.
ESD is responsible for Managing for Environmental Results and
integrating the environmental management programs, providing technical
assistance and the transfer of technology, and for overseeing the
environmental management of Federal Facilities.
The Environmental Services Division also has management responsi-
bilities for the Regional Quality Assurance Program. ESD will prepare
QA Project Plans and/or Standard Operating Procedures for all environ-
mental monitoring activities it conducts. These QA Plans will be
developed according to National and Regional QA requirements and
specifications. Implementation of the program responsibilities
assigned to ESD are carried out by the Division's components: the
Environmental Management Branch, the Environmental Impact and Marine
Policy Branch, the Central Regional Laboratory and the Western Regional
Laboratory and Engineering Center.
4.1.7.1 Environmental Management Branch
The Environmental Management Branch (EMB) is responsible for
ambient water quality monitoring, ambient air quality monitoring,
stationary source monitoring, the evaluation of State and local
agencies' environmental investigations and surveys in support of
Regional and National programs such as the National Dioxin Study and
the National Surface Water Survey. The Branch is also responsible
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for coordinating all Regional research and development, and technology
transfer activities, and provides technical assistance to the Region
and State agencies. EMB coordinates all data collection and evaluation
activities for long term trend analyses and problem identification;
working with the media programs, EMB coordinates the development of
the Region's high priority, multi-media problem areas for inclusion
in the Environmental Management Report (EMR). The Branch depends
upon two sections to carry out its functional responsibilities; the
Environmental Programs Section, which is responsible for program
management, and the Environmental Monitoring Section, which provides
EMB with its technical monitoring capability.
4.1.7.1.1 Environmental Programs Section
The Environmental Programs Section (EPS) within the Environmental
Management Branch is responsible for meeting ESD's ambient water
monitoring objectives. EPS is responsible for reviewing QA Program
Plans, Work Plans, and QA Project Plans pertaining to ambient water
quality monitoring and assessment activities funded by EPA Region
III. EPS is also responsible for evaluating the implementation of
the QA activities described in these plans. During the review and
preparation of work plans, QA Project Plans and water quality assess-
ments, EPS is responsibile for recommending water monitoring projects
and locations to other divisions and the States.
A. Quality Assurance Responsibilities for Environmental Programs Section
1. Goal
The goal of the Environmental Program Section is to ensure
that the ambient water monitoring data collected with EPA
funds and resources are scientifically valid, defensible and
of known precision and accuracy.
2. Policy
The Environmental Programs Section QA policy is to conduct
internal monitoring activities and oversee external monitoring
activities in accordance with EPA regulations under 40 CFR
Part 30. Oversight of external monitoring activities will
be accomplished through a combination of QA document reviews
and systems audits on the implementation of these documents.
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3. Specific Quality Assurance Responsibilities
a- EPS responsibilities for internal ambient monitoring
activities are:
(1) Update the Regional QA Program Plan to reflect changes
in EPS policy and responsibilities.
(2) Develop QA Project Plans for all monitoring activities.
Specific tasks include:
- Identify data needs based on a thorough review of
existing chemical screening data, bioscreening
data, data collected by dischargers on receiving
water quality, fish kill data, information
collected from the NPDES Permit and Enforcement
Programs, results of analyses of the dilution
available to dischargers, reports from earlier
water quality analyses, citizen complaints,
results of intensive surveys and fixed station
monitoring, data on existing land uses, and any
other data on water quality.
- Based on the data needs identified, develop
detailed project objectives which include a
discussion of how the data collected will be
used to meet those objectives.
- Establish Data Quality Objectives which define
the specific levels of quality required for the
data based on a common understanding of the
intended use of the data, the measurement
process, and the availability of resources
(See Section 5.0).
- Define Quality Control protocols for measuring
whether the Data Quality Objectives are being met
during the study.
- Incorporate the above items into QA Project
Plans which includes all sixteen elements
identified in QAMS-005/80, "Interim Guidelines
and Specifications For Preparing Quality
Assurance Project Plans".
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(3) Conduct all ambient water quality monitoring in accordance
with the respective QA Project Plan.
(4) Document all aspects of the monitoring process to reflect
the implementation of the QA Project Plans.
b. EPS responsibilities for external ambient monitoring
act ivities are :
(1) Overview State and river basin commission ambient water
monitoring program development and implementation to
ensure integration of quality assurance/quality control
requirements. Regional Project Officers in the Water
Division are held accountable for the management of
Section 106, 205(g), and 205(j) grants to the States
and river basin commissions for external ambient monitoring
activities. EPS is responsible for informing the Regional
Project Officers of any quality assurance/quality control
requirements that are not being met by them so that
corrective action can be taken. Specific tasks include:
- Review State and river basin commission QA Program Plans.
- Review and approve their QA Project Plans. These plans
should be developed using the same process identified
for internal QA Project Plan development. This will
be the basis for review of their documents.
- Evaluate State and river basin commission progress in
developing and implementing OA Program and Project
Plans through review of quarterly progress reports and
participation in the mid-year grant reviews.
- Conduct annual QA system/performance audits to ensure
that the quality of the data generated by the States
and river basin commissions is acceptable and consistent.
Take corrective action that may be required by the audits.
(2) Assist States and river basin commissions with non-routine
monitoring. Identify QA needs, resolve problems, and
answer requests for guidance or assistance in the area
of ambient water quality monitoring.
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Specific Staff Responsibilities
Within EPS, the workload for the specific Quality Assurance
responsibilities identified above is distributed among
the staff as follows:
Posi t ion
QA Responsibility
Section Chief
Approve external QA Project Plans
and ensure that all internal and
external ambient water quality
monitoring activities are in
accordance with EPA QA policy
Water Monitoring
Coord inator
Oversee external monitoring
activities for Virginia, Maryland,
Susquehanna River Basin Commission,
Chesapeake Bay Program
Water Monitoring
Coordinator
Oversee external monitoring
activities for West Virginia,
District of Columbia, Interstate
Commission on the Potomac River
8asin, Ohio River Sanitation
Commission
Water Monitoring
Coordinator
Oversee external monitoring
activities for Pennsylvania,
Delaware, Delaware River Basin
Commission
Risk Assessment
Coordinator
Oversee all internal monitoring
activities
Concepts and Considerations of Quality Assurance Project
Plans
Data Quality Objectives
During the process of developing Quality Assurance (QA) Project
Plans, EPS has given special consideration to the formulation
of Data Quality Objectives. Without establishing clear guide-
lines for the quality of data to be achieved in a study, the
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the ambient water quality data collected will not be
scientifically valid, defensible and of known and acceptable
precision and accuracy. EPS has the responsibility for
ensuring that Data Quality Objectives are established
in both internal and external monitoring activities.
The development of Data Quality Objectives requires a valid
experimental and statistical project design. The key aspects
of data quality that must be addressed by these objectives
are precision, accuracy, representativeness, comparability,
and completeness. The level of data quality which is appropriate
for a given project is determined by careful consideration
of the intended use of the data, the measurement process,
and the availability of resources. After an acceptable
project design is agreed upon by both management and technical
personnel, a complete description of the Data Quality Objectives
should be included in the QA Project Plan.
The primary elements which determine the level of data quality
achieved in a project are (1) the number of samples, (2) the
location of the samples, (3) the frequency and duration of
sampling, (4) the selection of parameters for measurement
and (5) the accuracy and precision of parameter measurements.
The influence of each of these elements should be carefully
considered in the project design.
The appropriate number of samples for a given project can
be determined by analysis of historical data on the
concentrations and the level of variance for the parameters
under consideration. If historical data does not exist,
these numbers can be estimated. However, estimation will
decrease the confidence of the results. If the parameter to
be measured has historically been quite variable in the
water source being analyzed, a greater number of samples
will be required to accurately characterize that water source.
The QA Project Plan should include a discussion of the methods
used to determine the appropriate number of samples to be
taken and the level of accuracy this number of samples will
provide in characterizing the water source. Methods for
determining the appropriate number of samples are found in
the "Handbook for Sampling and Sample Preservation of Water
and Wastewater", EPA-600/4-82-029 (September L982).
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The location of sampling points on the project will require a
careful consideration of the project objectives. The QA Project
Plan should include a description of the rationale used to design
the sampling network and a discussion of the ability of this
network to accurately represent the water source being analyzed.
Whenever possible, the sampling network should be designed as a
simple random sample, a stratified random sample or a systematic
random'sample using methods that ensure freedom from bias and
allow statistical inference. A nonrandom sampling plan can be
used if justified by the study site, the parameters of interest,
or the type of study being undertaken. However, data usage will
be limited by the inability to extrapolate results from a biased
design.
As with the selection of sampling locations, the frequency and
duration of sampling will depend on the project objectives. The
QA Project Plan should include a discussion of the sampling
frequency and duration rationale. This element must take into
account variations due to factors such as seasonal and diurnal
periodicities which may influence the results of the study.
Sampling should be planned at a frequency and duration which
accurately characterizes the water source. In instances where
a good set of historical data is available, spectral analysis
should be used for determining sampling frequency because of its
accuracy and the simplicity of the final interpretation.
The final considerations in developing Data Quality Objectives
are the selection of parameters for measurement and the accuracy
and precision requirements for those measurements. The QA Project
Plan for a project should clearly establish which parameters
will be measured, how these parameters relate to the project
objectives, and what level of accuracy and precision will be
required in measuring these parameters. The plan should also
include details of the protocol to be followed to ensure that
the required accuracy and precision levels are achieved. Another
aspect of parameter selection is data comparability. If more
than one laboratory will be analyzing samples for a project, or
if the data collected are to be compared in any way to other
data, a discussion of comparability should be included in the
QA Project Plan.
Through careful consideration of each of the elements just described,
an overall evaluation of the ability of the proposed project to
meet the desired Data Quality Objectives should be possible.
Limitations (or obstacles) that impact completeness of the
project should be identified and included in the QA Project Plan.
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6. Resources
The Environmental Services Division Workplan allocates resources
to the various Branches and Sections responsible for performing
QA functions. EPS receives workyear allocations to conduct
the activities identified above.
4.1.7.1.2 Environmental Monitoring Section
The Environmental Monitoring Section (EMS) is responsible for
the technical management and implementation of environmental monitoring
programs, along with Stationary Source monitoring activities, in
support of Regional media programs to provide a data-baseline for
the evaluation of programs in implementation of the managing for
environmental results initiative. EMS also provides functional
guidance to program personnel in the Field Offices, and is responsible
for providing guidance, information, and training assistance' to
State and Local (S/L) Agencies on technical monitoring capability
issues. The Section reviews and evaluates State ambient air and
compliance monitoring programs. This Section also reviews Stationary
Source activities which consists of inspection of facilities, review
of stack tests and Continuous Emission Monitor(s) CEM audits.
(Acronyms used in the following sections are defined in the glossary
located on page 10 in this Appendix.
Quality Assurance Responsibilities for Environmental Monitoring
Sect ion
1. Goal
The goal of the Environmental Monitoring Section is to ensure
that the Ambient Air and Stationary Source monitoring data
collected with EPA funds and resources are scientifically valid,
defensible and of known and acceptable precision and accuracy.
2. Policy
The Environmental Monitoring Section's Quality Assurance policy
is to conduct ambient and CEM audit activities and oversee
external monitoring activities in accordance with EPA regulations
under 40 CFR Part 58 (Ambient) and Parts 60 and 61 (Stationary
Source). Oversight of external monitoring activities will
be accomplished through a combination of QA document reviews
and systems audits on the implementation of these documents.
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3. Specific Quality Assurance Responsibilities for EMS
The Region's Air Quality Assurance Coordinator is located in
the EMS. He has the overall task of coordinating the Air
QA work and review of QA data sent to the Region. The EMS
staff all performs basically the same QA related work with
the S/L Agencies assigned to them, as well as PSD, Special
Study Networks, and Stationary Source Compliance Inspections.
a. The Air QA Coordinator performs the following tasks
in addition to the QA work performed by the
Environmental Monitoring Section:
1) Reviews, coordinates, and sends OAQPS copies
of the annual National Air Montioring Systems
Audits of each of the eight 105 Grant Agencies.
2) Reviews QA Program and Project Plans, as well as, QA
Manual for PSD Networks and other Special Study Networks.
3) Reviews S/L Agency quarterly submission of P and A
data. Then writes quarterly QA Report based on P
and A data. Sends copies of these P and A forms to
EMSL, AMD, and each S/L Agency.
4) Reviews S/L Agency results from all EMSL Performance
Audits, and EMS Performance Audits.
5) Respond to QA needs, resolve problems, and answer
requests for guidance or assistance from S/L Agencies,
PSD Network operators, and others who request information
and assistance.
6) Interact with EMSL on technical problems particularly
as related to methods, instrumentation and new programs.
b, EMS Staff responsibilities for ambient air monitoring
activities are:
- Assure that the QA Program requirements are integrated
into the overall State/EPA Agreement Process and grants.
- Assist States in the development and implementation of
QA Program and Project Plans.
- Conduct performance audits of special studies and
SLAMS/NAMS monitoring networks.
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Appendix E
Revision No. 0
Date: 11-28-86
Page: 10 of 16
- Conduct Annual National Air Monitoring Systems Audit
on 105 Grant Agencies Monitoring Programs, by following
Section 2.0.11 of QA Handbook. Take corrective action
that may be required by audit findings.
- Conduct on-site field evaluations of monitoring sites,
for compliance with AO CFR 58 Appendix E.
- Review and evaluate the validity and quality of data
generated by monitoring agencies each quarter.
- Participate in the annual network review with AMD and
the S/L Agencies to make sure all data needs are satisfied.
- Conduct compliance monitoring inspections.
- Observe and review stack tests, procedures, and results.
- Observe and conduct CEM Audits on stationary sources.
4. Organization and Program responsibilities:
Section Chief
State Agency Coordinator PA DER Phila., AMS
State Agency Coordinator Alleg. Co., Pitts. WVA APCC
State Agency Coordinator D.C. DCRA MD AMA
State Agency Coordinator DE DNREC VA SAPCB
Glossary
A11 eg. Co , . Pi 11 s .
Allegheny County Health Department, Pittsburg
AMD
Air Management Division
CEM
Continuous Emission Monitor(s)
D.C. DCRA
Washington, D.C. Department of Consumer and
Regulatory Affairs
MD AMA
Maryland Air Management Administration
Environmental Control
NAiMS
National Air Monitoring Station
OAQPS
Office of Air Quality Planning and Standards
PA DER
Pennsylvania Department of Environmental Resources
Phila AMS
Philadelphia Air Management Services
P and A
Precision and Accuracy
PSD
Prevention of Significant Deterioation
S/L
State and/or Local Air Pollution Agency
SLAMS
State/Local Air Monitoring Station
VA SAPCB
Virginia State Air Pollution Control Board
WVA APCC
West Virginia Air Pollution Control Commission
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Regional QA Plan
Appendix E
Revision No. 0
Date: 11-28-86
Page: 11 of 16
5. Concepts and Considerations of Quality Assurance Project Plans
Data Quality Objectives
EMS has the responsibility for ensuring that Data Quality
Objectives are established in both internal and external monitoring
activities.
For internal activities, the project officer and the technical
staff discuss the problem being addressed, the resource and time
constraints for addressing the problem, and the information needed.
The technical staff develop specific questions to clarify what
information is needed, how the information will be acceptable.
After discussing these questions with the project officer, the
technical staff develops possible approaches for collecting the
necessary data and determines the quality that can be expected from
each approach.
As a minimum, the Data Quality Objectives will be expressed
quantitatively through specific requirements for detection/quanti-
tation limits, precision and accuracy for all types of measurements.
A qualitative description of data representativeness, comparability
and completeness will also be included. The selection of an approach
for use in the study will be made by the project officer based upon
recommendations from the technical staff. When internal monitoring
activities are conducted through a contract, the specific Data Quality
Objectives are included in the language of the contract.
For external monitoring activities, the State or Interstate
Agency responsible for initiating the project will establish Data
Quality Objectives and document their approach in the QA Project
Plan. EMS will review these plans to ensure that Data Quality
Objectives have been established and described quantitatively as
listed in 40 CFR 58, Appendicies A and B.
6. Resources
The Environmental Services Division Workplan allocates resources
to the various Branches and Sections responsible for performing QA
functions. EMS receives workyear allocations to conduct the activities
identified above.
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Appendix E
Revision No. 0
Date: 11-28-86
Page: 12 of 16
4.1.7.2 Environmental Impact and Marine Policy Branch
The primary functions of the Environmental Impact and Marine
Policy Branch (EIMPB) are to: (1) Assure a position of leadership
among federal installations in the control, prevention and abatement
of environmental pollution; (2) Correlate and comprehend the synergistic
effects of cumulative federal actions; (3) Ensure that the mandates
of the National Environmental Policy Act are fulfilled in letter and
spirit by EPA as well as other federal agencies; (4) Review and
evaluate applications for federal permits (Corps of Engineers and
Coast Guard) dealing with work in navigable waterways, and advise
the Corps concerning the use of sites for disposal of dredged materials;
(5) Prepare necessary documentation and inform the Regional Administrator
when his responsibilities under Section 309 of the Clean Air Act
of 1970 must be exercised; (6) Assist in securing public involvement
at all levels of the federal government to ensure that citizen concerns
are factored into the decision-making process; and (7) Carry out
regional responsibilities under the Marine Protection Research and
Sanctuaries Act of 1972 including the operation of the Ocean Dumping'
Permit Program; and (8) Ensure that Federal Facilities comply with
EPA regulations. The Branch is composed of two sections: the NEPA
Compliance Section and the Wetlands and Marine Policy Section.
4.1.7.2.1 NEPA Compliance Section
The NEPA Compliance Section rec
of detailed and final Environmental
to preparing and filing final EIS as
NEPA. The Section also acts as the
related controversial environmental
controversial because Section 309 of
interlocked with NEPA functions.
eives and coordinates the review
Impact Statements (EIS) in addition
mandated by Section 102(2) of
focal point for most Federal
issues. Many of these issues are
the Clean Air Act mandates are
4.1.7.2.2 Wetlands and Marine Policy Section
This section is responsible for reviewing and evaluating appli-
cation for federal permits (Corps of Engineers and Coast Guard)
pertaining to navigable waterways and the use of sites for disposal
of dredged materials. The Section is also responsible for regional
enforcement relative to unpermitted discharge of dredged or fill
materials into US waters. The Section is responsible for technical
evaluation and coordination of major water resource projects evaluated
under NEPA.
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Appendix E
Revision No. 0
Date: 11-28-86
Page: 13 of 16
Quality Assurance Responsibilities for the Environmental Impact
and Marine Policy Branch
1. Goal
The goal of the EIMP Branch is to ensure that any environmental
data generated by Branch activities is scientifically valid,
defensible and of known and acceptable precision and accuracy.
2. Policy
The Branch's quality assurance policy is to conduct all monitoring
activities in accordance with EPA regulations (40 CFR Part 30).
3. Specific Quality Assurance Responsibilities
a) Marine Protection Program
This program unit is responsible for monitoring ocean dumping,
ocean out falls and coastal processes (fisheries, resources). The
unit designs plans and schedules sampling surveys using Standard EPA
guidance. Field QA/QC procedures are established depending on the
parameter to be sampled and are implemented by the Office of Marine
Esturine Protection. The EPA Sampling Management Office determines
the actual analytical sampling program.
b) Federal Facilities
The Federal Facilities Unit is responsible for oversight of
federal facilities to determine compliance with EPA regulations.
This Unit overviews all regional activities regarding Federal
Facilities Compliance Inspections, and oversees the Department of
Defense/EPA Joint Resolution for the Chesapeake Bay. This activity
at times requires sample collection which then follows SOP's which
are included in specific OA Project Plans. Samples collected during
compliance inspections are analyzed (and data reports are prepared)
by the Region III Central Regional Laboratory (CRL).
c) NEPA Compliance Section
This Section is responsible for the Region's NEPA Mission Contract
which may require that samples be collected and analyzed in Individual
Scopes of Work (SOW). Attachment B, to the contract, describes the
approved QA activitives which includes a requirement that a contractor'
QA Project Plan be submitted and approved, by the Project Officer,
for any assignment requiring analytical data. (Copies of Attachment B
may be obtained from the NEPA Compliance Section Office). ESD will
also review the contractor's OA Project Plans.
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Appendix E
Revision No. 0
Date: 11-28-86
Page: 14 of 16
4. Specific Staff Responsibilities
Within EIMPB, the following individuals are responsible for the
QA associated with the above monitoring activities:
Individual
QA Responsibility
Section Chief
Senior Oceanographer
Federal Facilities Coordinator
Project Officer - Regional
Approves OA Project Plans
Marine Protection Program
Federal Facilities
Mission Contract
5. Concepts and Considerations of Quality Assurance Project Plans
As a minimum, the data collected will be expressed quantitatively
through specific requirements for detection/quantitation limits,
precision and accuracy for all types of measurements. A
qualitative description of data representaliveness, comparability
and completeness will also be included. The selection of an
approach for use in the study will be made by each of the
people noted above based upon recommendations from the technical
staff. When monitoring activities are conducted through a
contract, the specific Data Quality Objectives are included
in the language of the contract.
6. Resources
The ESD work plan allocates resources to the various Branches
and Sections responsible for performing OA functions. EIMPB
receives work year allocation, to conduct the activities
identified above.
4.1.7.3 Central Regional Laboratory
The Central Regional Laboratory (CRL) is responsible for the planning,
administration and management of the technical and analytical activities
carried out by its component Laboratory, Field Sections, Quality Assurance
Section; such activities include the sampling and analysis of environmental
specimens, and permit compliance monitoring and inspections. Located
in Annapolis, MD, the CRL maintains liaison with the Regional Office
administration and media program'offices , as well as with State and local
agencies. The CRL plans and conducts special conferences and seminars
to provide advice, guidance, assistance and training to State and local
environmental agencies, and coordinates the technology transfer and
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Appendix E
Revision No. 0
Date: 11-28-86
Page: 15 of 16
technical assistance programs conducted by its component Sections. The
CRL also has responsibilities to the Ouality Assurance Program. Due to
the complexity of overall operations, the Central Regional Laboratory
will develop a separate Facilities Plan, Part II, of the Region's OA
Program Plan.
A. CRL - Laboratory Section
The CRL Laboratory Section is responsible for performing analyses of
environmental samples for organic and inorganic chemical and microbiological
contamination, and provides an analytical capability for emergency response
situations. The Section assists State and local environmental agencies
by analyzing samples and by advising these agencies on analytical techniques.
The Section also provides technical assistance, advice, and expert testimony
for regional program offices, especially with regard to enforcement
related issues.
B. CRL - Field Section
The CRL Field Section performs a variety of field/engineering functions,
such as collecting of multi-media samples, conducting investigative
surveys and inspections, and providing technical assistance, within the
eastern portion of Region III.
C. CRL - Ouality Assurance Section
The CRL Ouality Assurance Section is responsible for ensuring that
all environmentally related measurements produced by Annapolis Office are
of known quality. Additionally, data produced by grantees and contractors
are assessed for usability or meeting user defined requirements. The
Section develops SOPs and Project Plans for internal operations and
reviews documents of a similar nature for external activities. The
Section also provides technical support to the Region's QA Program,
including the development of QA Program and Project Plans, administering
the Dischar^^ Monitoring Report Ouality Assurance Program, providing
audit samples, and assisting States in quality assurance and quality
assurance control. Specific activities and functions include:
(1) Review data genrated by the EPA Contract Lab Program (CLP) for
Superfund.
(2) Contract management/oversight of Region III CLP Laboratories.
(3) Inspections of State Laboratories for NPDES and SDWA.
(4) Management of Discharge Monitoring Report Quality Assurance in
Region III.
(5) Review of QA Project Plans.
(6) Conducting performance and system audits.
(7) Coordinating participation in Performance Evaluation Studies.
(8) Provide technical assistance and advice for Regional program
offices, States ,• commercial facilities, etc.
(9) Conducts training for Ouality Assurance.
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Appendix E
Rev i s i o n No. 0
Date: 11-23-86
Page: 16 of 16
4.1.7.4 Western Regional Laboratory and Engineering Center
The Western Regional Laboratory and Engineering Center (WRLEC),
composed of a Biology Group and a Field Section, provides field and
biological investigative assessments in support of Regional .and
National EPA air, water, and hazardous waste programs. The Office
provides advice and assistance to State and local agencies concerning
biological and field techniques, methodologies, and quality control to
assure the success of field investigations. The WRLEC also conducts
special studies, investigations, biological analyses, and surveys to
acquire the data needed to support EPA program offices, and implements
monitoring programs to meet regional and national objectives. Located
in Wheeling, WV, the WRLEC maintains liaison with the Regional Office
administration and media program offices, as well as with State and
local agencies.
A. WRLEC Biology Group
The WRLEC Biology Group conducts scientific investigations,
assessments, surveys, and consultative reviews of the effects of
waterborne contaminants on aquatic biota. It also conducts technical
evaluations and inspections of biological laboratories, and provides
consultation to water pollution control agencies in Region III while,
providing technical assistance on aquctic biology activities and
investigations relative to environmental control programs to EPA,
interstate, and international task forces, committees, and compacts.
B. WRLEC Field Section
Operating primarily in the western portion of Region III, the
WRLEC Field Section coordinates, plans, schedules, conducts,
evaluates, and reports on its field activities which monitor and
enforce compliance with EPA regulations for air, water, and hazardous
materials and wastes. The Section provides technical assistance
and support to government, industry, and private groups concerning
environmental monitoring and regulation compliance, and organizes
training workshops on field investigation techniques. The WRLEC
Field Section is also prepared to support emergency response
activi ties.
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APPENDIX F
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INTERIM GUIDELINES AND SPECIFICATIONS FOR
PREPARING QUALtTY ASSURANCE PROJECT PLANS
QAiMS-005/80
Office of Monitoring Systems and Quality Assurance
Office of Research and Development
United States Environmental Protection Agency
Washington, D.C. 20460
December 29, 1980
Copies Available From:
Charles Jones, Jr.
Regional QA Officer
Environmental Services Division
(215) 597-7210
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APPENDIX G
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GUIDANCE FOR PREPARATION OF COMBINED
WORK/QUALITY ASSURANCE PROJECT PLANS
FOR ENVIRONMENTAL MONITORING
(OWRS QA - 1)
Office of Water Regulations and Standards
United States Environmental Protection Agen
Washington, D.C. 20460
May, 1984
Copies Available From:
Charles Jones, Jr.
Regional OA Officer
Environmental Services Division
(215) 597-7210
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APPENDIX H
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Friday
September 30, 1983
Part VIII
Environmental
Protection Agency
General Regulation for Assistance
Programs
Copies Available From:
Charles Jones, Jr.
Regional QA Officer
Environmental Services Division
(215) 597-7210
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