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Note: EPA no longer updates this information, but it may be useful as a reference or resource.

Please see www.epa.gov/nsr for the latest information on EPA's New Source Review program.

July 6, 1979 Environmental Protection Agency Quality Assurance Policy Statement 7.2

THE TEXT YOU ARE VIEWING IS A COMPUTER-GENERATED OR RETYPED VERSION OF A PAPER PHOTOCOPY OF THE ORIGINAL. ALTHOUGH CONSIDERABLE EFFORT HAS BEEN EXPENDED TO QUALITY ASSURE THE CONVERSION, IT MAY CONTAIN TYPOGRAPHICAL ERRORS. TO OBTAIN A LEGAL COPY OF THE ORIGINAL DOCUMENT, AS IT CURRENTLY EXISTS, THE READER SHOULD CONTACT THE OFFICE THAT ORIGINATED THE CORRESPONDENCE OR PROVIDED THE RESPONSE.

7.2

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Region IV, Surveillance and Analysis Division,
College Station Rd., Athens, Ga 30365

DATE: JUL 6 1979

SUBJECT: Environmental Protection Agency Quality Assurance Policy Statement

FROM: James H. Finger, Director
Surveillance and Analysis Division

TO: Division Directors and Office Chiefs

THRU: John C. White, Regional Administrator
Region IV

SUMMARY

Responsibility for the Regional Quality Assurance Programs is within the Surveillance and Analysis Division where it has been for several years. A lot has been accomplished in select areas, but many areas are sadly lacking at present. Mr. Costle recognizes the need for uniform quality assurance activities, agency-wide, in all monitoring activities which he has expressed in the attached EPA Quality Assurance Policy Statement.

Of particular interest, the policy statement has defined monitoring "as all environmentally related measurements which are funded by the EPA or which generate data mandated by the EPA." This includes not only the activities performed by EPA personnel, Federally funded State and local agencies, and private industries, but also their contractors.

We recognize this is a monumental task and there are a lot of obstacles to be overcome, but most of what we have already accomplished has been done with limited or no guidance or regulations. Mr. Costle is very serious about this policy being implemented agency-wide. We are very serious about fulfilling our responsibilities within Region IV to ensure that any decisions made or enforcement actions taken are based on scientifically valid and defensible data of known accuracy and precision. Because of the way Region IV is organized, your full cooperation is essential to the effective implementation of the agency's quality assurance policy. Wade Knight has been designated as the Regional Analytical Quality Control Coordinator for water. Doyle T. Brittain has been designated as the Regional Analytical Quality Control Coordinator for air. From time to time these persons will need to work with you or members of your staff concerning quality assurance.

In the future all grants and contracts and EPA mandated industry monitoring will have to contain standard language on quality assurance. To ensure effective implementation of a region-wide quality assurance program we request that:

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    * you notify us in advance of all meetings which will result in monitoring programs being initiated or renewed,

    * you provide copies of all draft monitoring project proposals, and grant and contract applications to us for review, and

    * you provide copies of all draft monitoring reports to us for review.

ACTION

I request that you notify members of your staff of this new policy and that you provide us with your full support.

BACKGROUND

May 30, 1979 memo from Douglas M. Costle to Regional Administrators.
Subject: Environmental Protection Agency (EPA) Quality Assurance Policy Statement

James H. Finger

Attachment

cc:

    Jim Wilburn
    Tommie Gibbs
    Winston Smith
    Doyle T. Brittain
    Jim Silva
    Bobby Carroll
    Wade Knight
    Mike Carter
    Lee Tebo
    John Hagan
    John Marlar
    Jim Patrick
    Jim Scarborough
    Roy Clarke
    Ralph Jennings
    Lee Tebo
    Gary Hutchinson
    George Harlow

QUALITY ASSURANCE POLICY STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

JANUARY 24, 1979

PREFACE

Under present Environmental Protection Agency (EPA) order the Office of Research and Development (ORD) is responsible for the development of Agency- wide quality assurance programs. Current activities include: Evaluation and standardization of total measurement systems -- sampling, analysis, data collection and presentation; preparation of quality assurance criteria, guidelines and manuals; preparation and distribution of reference samples and materials; interlaboratory testing of systems' and operator performance; on-site inspection of laboratories and performance audits; data audits and development of statistical methodology; and quality assurance assistance and participation in training programs. These activities comprise the current quality assurance effort which, on a voluntary basis, support EPA, State, and other monitoring programs.

Agency policy will now require participation in an Agency-wide quality assurance program by all Regional Offices, Program Offices, EPA Laboratories, and those monitoring and measurement efforts supported or mandated through contracts, regulation or other formalized agreement. This requirement includes quality assurance programs for the States which will be cooperatively developed with them and implemented through the Regional Offices. The ORD is delegated primary responsibility for developing the national quality assurance program and directing and coordinating its implementation.

Introduction

The EPA operates under the legislative authority of various Congressional Acts which mandate the responsibilities the Agency must fulfill in order to protect and enhance the Nation's environment. In accordance with this mission, the Agency establishes and oversees the attainment of standards for environmental quality which protect public health and welfare. This effort requires extensive research and monitoring for the systematic collection and evaluation of physical, chemical, biological, and other data related to pollution effects, sources, transport, and control. These data must be scientifically valid, defensible, and of known precision and accuracy -- this is the goal of the Agency's quality assurance program.

This document presents the basic management requirements and a brief description of organizational responsibilities.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

MAY 30 1979

THE ADMINISTRATOR

MEMORANDUM
----------
TO: Deputy Administrator
Director, Science Advisory Board
Director, Office of Regional and Intergovernmental Operations
Regional Administrators
Assistant Administrators
General Counsel

SUBJECT: 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 each of you shares my concern about the need to improve our monitoring programs and data; therefore, I know that you will take the necessary actions that will ensure the success of this effort.

Douglas M. Castle
Attachment

Management Requirements and
Organizational Responsibilities

The quality assurance program will be centrally directed and will be implemented by the organizational elements that it encompasses. The implementation of the quality assurance program has two primary requisites. First, the program must be given direct attention by top management so that it is implemented as policy on an Agency-wide basis. Second, the program must have sufficient resources and authority to support a national program effort.

Management Requirements. The quality assurance program will be compulsory for all Agency-supported or required environmentally related monitoring and measurements which generate data for EPA use. Each monitoring effort initiated by any office must have as part of its program acceptable quality assurance. Its acceptability will be determined by consistency with specific criteria developed by a centrally planned, directed, and coordinated quality assurance program. Program implementation will make optimum use of existing Agency resources and expertise, and provide for the least disruption of ongoing activities. The program will extend outside the EPA, both in its structure and in its responsibility to provide services.

Organizational Responsibilities. A brief description of organizational responsibilities is given below. A more detailed explanation of functions and responsibilities will be included in an Agency-wide implementation plan.

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Office of Research and Development (ORD). The ORD will be the focal point for quality assurance policy and will be responsible for: The development of guidelines and criteria; the coordination and direction of the implementation of the Agency program; review, evaluation, and approval of program quality assurance plans and activities, including those stipulated in regulations; and annual, or more frequent, reports to the Administrator on the program progress and efficacy.

Program Offices. The Program Offices will be responsible for implementing the quality assurance plans covering all monitoring and measurement activities within their purview and for ensuring that intra and extramural monitoring programs are consistent with Agency policies and guidelines. For the purpose of this policy, the ORD is considered a Program Office and this responsibility includes the monitoring and measurement efforts of the ORD research laboratories and their contractors.

Regional Offices. Regional Administrators will be responsible for the implementation and coordination of the mandatory quality assurance activities within their regions. This responsibility also includes external monitoring and measurement activities of States, local agencies, and others covered by the Agency quality assurance plan.

Quality Assurance Advisory Committee. As soon as practicable an advisory committee will be formed to ensure proper coordination

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of the national quality assurance effort. The committee will have representatives from the Program Offices, staff offices, Regional offices, and the States and will serve as an advisory group for the development of quality assurance policy. This committee will be chaired and administratively supported by the ORD.

Mechanism for Appealing Quality Assurance Decisions. Responsibility for the resolution of issues pertaining to the approval of quality assurance plans or activities will be at the lowest level of authority consistent with the scope of the monitoring or measurement effort. The ORD unit with responsibility for quality assurance will refer national, interprogram, unacceptable plans and other unresolved issues to the Assistant Administrator for Research and Development for decision after consultation with the appropriate Assistant Administrator or Regional Administrator.

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cc:
    Ms. Blum (A-101)
    Mr. Mausshardt (A-101)
    Dr. Dowd (A-101)
    Mr. Roush (A-101)
    Ms. Bernstein (A-130)
    Mr. Drayton, Jr. (PM-208)
    Mr. Durning (EN-329)
    Mr. Jorling (WH-556)
    Mr. Hawkins (AW-443)
    Dr. Gage (RD-672)
    Mr. Trakowski (RD-680)
    Mr. Jellinek (TS-788)
    Regions I-X

    Work Group:
    C. Brunot (RD-680)
    J. Clements (EMSL-RTP)
    W. Cox (OANR/OAQPS)
    B. Fairless (Region VII)
    C. Hendricks (WH-550)
    S. Hiemstra (PM-222)
    A. Jarvis (EMSL-LV)
    J. Melone (PM-223)
    B. Nussbaum (EN-340)
    W. Oldaker (Region I)
    D. Olson (EM-338)
    J. Pawlow (WH-553)
    J. Rasnic (EN-341)
    C. Ross (Region V)
    T. Stanley (RD-680)
    S. Wastler (TS-793)
    J. Winter (EMSL-CI)

    Steering Committee:
    J. Finger (Region IV)
    M. Halper (TS-793)
    F. Leutner (WH-553)
    D. Lyons (EN-338)
    M. Mlay (PM-222)
    W. Sayers (RD-682)
    R. Smith (ANR-443)


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