DEVELOPMENT
             OF
    AGENCY-WIDE
QUALITY CONTROL
        PROGRAM
        February  1973
  U.S. Environmental Protection Agency
     Office of Monitoring Systems
      Quality Assurance Division

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                                26804
    DEVELOPMENT
             OF
    AGENCY-WIDE
QUALITY CONTROL
        PROGRAM
        February 1973
  U.S. Environmental Protection Agency
     Office of Monitoring Systems
      Quality Assurance Division

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                    TABLE OF CONTENTS


                                                      Page

INTRODUCTION 	     1-3

ELEMENTS OF A QUALITY ASSURANCE PROGRAM	    4-18

    Development and Issuance of Procedures ....    4-11

        Sampling-Procedures	     6-7

        Method Selection Procedures	    8-10

        Laboratory Procedures	   10-11

    Intra-laboratory Quality Control 	   11-15

        Quality Measurement and Performance
        Evaluation	   11-14

        Personnel Staffing and Training	   14-15

    Inter-laboratory Quality Control 	   15-16

    Management	   16-18

        Program Evaluation 	      17

        Certification	   17-18

        Communication	      18

CURRENT STATUS AND NEEDS 	   19-30

    Water	   22-24

    Pesticides	   24-27

    Air	   27-28

    Radiation	   28-30

IMPLEMENTATION 	   31-44

    Organizational Plan	   32-39

    Projects and Schedules 	   39-44

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                                                        Page


QUALITY CONTROL PROGRAM FOR STATE  AND
 LOCAL AGENCIES	   45-70

COMMENTS ON PLAN  BY  HEADQUARTERS'  STAFF,
 REGIONS, AND  NERC's	   71-80

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                            1

                    Executive Summary
              DEVELOPMENT OF AN AGENCY-WIDE
                 QUALITY CONTROL PROGRAM
Introduction
     The primary goals of a quality control program are
to improve and document the accuracy and validity of
environmental measurements.  In achieving these goals/
quality control must be imposed on nearly all segments of
monitoring activities and should cover personnel/ methods
selection/ equipment, and data handling procedures.  A
total quality control program is composed of four major
elements:
          -  Development and issuance of procedures

          -  Intra-laboratory quality control

          -  Inter-laboratory quality control

             Monitoring program evaluation and
             certification.

All these elements are equally essential to a successful
quality control program and must be developed and carried
out simultaneously.

Current Status
     The on-going EPA quality control activities are
quite varied for the different media and categorical
programs.  Certain groups exist within EPA that presently
provide some support for quality control.  These are:
Air/ NERC-Research Triangle Park; Water/ NERC-Cincinnati and
NERC-Corvallis; Pesticides, NERC-Research Triangle Park/
Perrine; and Radiation, Winchester and NERC-Lasi Vegas.
The programs for water, pesticides/ and radiation have been
operational for several years/ and we estimate that they
are providing approximately 50 percent of the support
necessary in their area of monitoring.  The program in air
was just established in January of this year and is the
most critical area.  A major deficiency of these programs
is that they are almost entirely voluntary, i.e. EPA
monitoring activities are not required to participate.
The Regional quality control programs are lacking in most
areas and are not properly supported.

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                           11

Implementation Plan

     A quality control program can succeed only if it is
given authority and made mandatory for all areas supplying
environmental data.  The plan calls for central authority
and for adherence to prescribed guidelines by the operating
monitoring programs.  It recommends that a uniform
control is implemented over all EPA data and that it must
be carried out by the operating programs.  Although the
program (resources) is limited to EPA, it must in the
future be extended to include State and local agencies
and contracting laboratories.

     The organizational elements primarily involved in
this program are the Office of Monitoring, quality control
groups at the NERC's  and the Surveillance and Analysis
Divisions in the Regional Offices.  Other programs with
monitoring interests will primarily have review
responsibilities.

     Nine specific project areas have been identified in
this plan which are necessary for achieving the goals of
the quality control program.  These are:

             Preparation and Issuance of Procedures
             and Guideline Manuals

             Repository of Standard Reference Material
             (SRM) and Samples (SRS)

             Operation of Intra-laboratory Quality Control

          -  Operation of Inter-laboratory Quality Control

             Evaluation of Instruments both for
             Laboratory and Field Use

             Quality Control - Site and Laboratory
             Evaluation

             Development and Management of Certification
             Program

          -  Communication and Coordination

          -  Quality Control - Training.

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                           Ill

The plan calls for immediate  action, and projects that the
total quality control activity will be, to a large extent,
operational by July  1973.  Completion dates for the various
tasks have been established and they are consistent with
this goal.

Resouj:ce_

     The proposed quality control program will require al-
location of resources for three organizational elements:

          -  Office of Monitoring — to direct and.
               coordinate the program

          -  NERC's — to implement and support the
               program

          -  Regions — to implement the program.

Not all of the resources needed for the quality control
program are new requirements.

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                      INTRODUCTION



     Measurements are made daily of pollutants present in



the environment and being discharged from a multitude of



sources with the resultant data being used in all facets



of pollution control.  These data are used in investigating



the effects of pollution on human health, in determining



the types of environmental quality standards that should be



promulgated, and in providing evidence for enforcement



actions.  The measurements are made by numerous agencies



and private organizations at a large number of field stations



and laboratories.  Much of the data are stored in the



Environmental Protection Agency's (EPA) data banks where



it is used to establish nation-wide appraisals of environ-



mental quality, and subsequently, to aid in specific



decision-making processes.  Regardless of the end uses of



the data, it is necessary that the accuracy and validity of



the data be known in order that the actions taken can be




technically supported.



     The primary goals of the quality control program are



to improve and document the accuracy and validity of environ-



mental monitoring measurements.  In order to achieve these



goals, quality control must be imposed on nearly all phases



of monitoring activities—from sampling site selection to



data formatting.  Quality control should include personnel,



methods selection, equipment, and data handling procedures.

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                            2



Quality control applies not only to these components indi-



vidually, but also to their interrelationships and



functioning as a total system.



     The benefits derived from an Agency-wide quality con-



trol program will amply justify the resources expended.  In



addition to assuring that the accuracy and validity of the



data can be verified, an active quality control program,



through the use of uniform procedures, will enhance the



utilization of personnel, facilities, and equipment.  The



data gathered by the various laboratories and field stations



will become comparable.  Once accepted at the Federal and



hopefully the non-Federal level, the promulgation of instru-



ment specifications will undoubtedly improve the quality



of instruments, laboratory apparatus, and commercially pro-



duced reagents.  Furthermore, the implementation of a qual-



ity control program will increase the overall credibility of



the Agency, thereby, strengthening its means for enforcement.



     A quality control program is a continuing activity.



The program must be flexible in responding to changes in



monitoring requirements for the various media.



     Quality control practices are inherent in any monitor-



ing or laboratory operation--personnel must be trained,



instruments must be calibrated, and uniform operating proce-



dures must be developed and followed.  Thus, the structuring

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                            3



of an Agency-wide quality control program does not imply



that all of the activities to be undertaken are new and



require new resources.  The program implies that activities



must be identified and expanded, and if necessary, developed



into an Agency-wide quality control framework which is



given emphasis and authority for supporting the Agency's



requirements.



     This report presents an implementation plan for an



Agency-wide quality control program.  Because of the urgent



need to upgrade the quality of EPA's monitoring activities,



the plan calls for immediate action and projects that the



total quality control activity will be, to a large extent,



operational by July 1974.  In addition, sections are



included that describe the various elements of a quality



control program and summarize the existing quality control




activities.

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                            4

         ELEMENTS OF A QUALITY ASSURANCE PROGRAM

     A total quality control program  is composed  of  four

major elements:

          •  Development and issuance of procedures.

          •  Intra-laboratory quality control program.

          •  Inter-laboratory quality control program.

          •  Monitoring program evaluation and
             certification.

All  these elements are equally essential to a successful

quality  control program and must be developed and carried

out  simultaneously.  This section of the report describes

each element and its subelements  (Table 1) necessary to

provide  a basis for understanding the proposed plan  for a

total quality assurance program.

Development and Issuance of Procedures

     A basic requirement of a quality control program is a

series of manuals describing the procedures to be followed

during the course of sampling, analysis, and data handling.

It is the use of such prescribed procedures that  provide a

uniform  approach in the various monitoring programs and

which allow the evaluation of the validity of data produced.

Procedures are needed for all of the facets of a  monitoring

program—from criteria to be used in locating stations to

the  formats to be used in reporting the data.  The required

procedures may be grouped into three categories—sampling,

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                  TABLE I
       Elements of Quality Control



DEVELOPMENT AND ISSUANCE OF PROCEDURES

    Sampling Procedures

      Site selection criteria
      Station design criteria
      Sampling criteria
      Calibration procedures

    Methods Selection Procedures

      Methods selection criteria
      Compendium of recommended methods
      Equivalency determination

    Laboratory Procedures


INTRA-LABORATORY QUALITY CONTROL

      Staffing control
      Training programs
      Use of correct procedures
      Performance evaluation


INTER-LABORATORY QUALITY CONTROL

      Cross-check sample program
      Methods evaluation studies


MONITORING PROGRAM EVALUATION AND CERTIFICATION

      Periodic review/evaluation
      Certification

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                            6



methods selection, and laboratory procedures.  A brief



description of each of these follows:



     Sampling Procedures



           (a)  Site selection — The selection of sampling/



monitoring sites is the responsibility of each monitoring



program, however, guidelines must be established that govern



the specific placement of monitors or the exact location



where the sample is to be taken.  Such rules or guidelines



are necessary to ensure that the measurements made or the



samples taken are representative and comparable.  For example,



in the case of air pollution monitoring, criteria must be



established specifying the allowable nearness of inlet



probes to buildings or, in the case of water monitoring, the



depth at which samples are taken.



           (b)  Station or instrument — Measurements may be



severely affected by the type and configuration of the facil-



ities used in collecting the sample.  For example, in some



situations, variability in voltage, temperature, and humidity



can influence the measurements.  Consequently, operational



parameters must be specified and controlled.  Similarly,



design characteristics must specify the types of monitors



and special equipment which must be accommodated.  Adherence



to station design criteria will provide optimum use of

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                            7



equipment, ease of operation, minimum maintenance, and



reduced data losses.




           (c)  Sampling and preservation criteria --



Procedures must be established that govern the manner in



which samples are collected and handled.  These procedures



should include the following:




               (1)  Use of equipment and materials for



collecting, preserving, and transporting the samples.



               (2)  The length of sampling periods.



               (3)  The types of accompanying information



needed.



In order that meaningful data are obtained, a sound statis-



tical basis for determining the frequency and duration of



sampling/monitoring must be used in the program design.



Such procedures must be provided in the manuals.  Specific



procedures must also be established that document the chain-



of-custody of samples needed for enforcement actions and



for samples taken at or near points of suspected violations.



           (d)  Calibration procedures — To ensure that data



generated by automatic or integrating field sampler-analyzers



are valid, procedures for routine field calibration of




these instruments must be specified.  The calibration fre-



quency, as well as the procedures used, should be identified




and described.

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                            8

     Method Selection Procedures

          (a)   Compendium of recommended methods — Many

different methods are available for measuring pollutants in

environmental media.  Some methods have been promulgated

by groups within EPA.  Other methods have been published

by groups such as the American Public Health Association

(water), the American Society for Testing and Materials

(air/water), and the Intersociety Committee (air).  The

Environmental Protection Agency has the statutory responsi-

bility to promulgate environmental, source, and effluent

standards which includes a method of collection and

analysis.  To ensure the use of standard, reference, or

equivalent methods throughout the Agency, an approved com-

pendium of standard, reference, or equivalent methods must

be developed for all pollutants in all media and published

for all monitoring activities.

               •  Method selection procedures based
                  on standardization activities -
                  The cornerstone of any quality
                  control program is the uniform
                  use of acceptable methods and
                  procedures.  The need for stand-
                  ard methods of sampling, analysis,
                  and data handling is readily
                  apparent, and the use of such
                  methods between cooperating lab-
                  oratories removes methodology as
                  a variable in the comparison or
                  joint use of data.  The use of
                  standard or equivalent methods is
                  particularly important when

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                            9

                  laboratories are providing data
                  to central data banks such as
                  STORET and NADIS.  The routine
                  use of non-standard or non-
                  approved methods within an
                  agency raises serious doubts as
                  to the validity of the data
                  reported.

               •  Methods selected must be pre-
                  sented in a concise, easy-to-
                  follow format.  The format will
                  indicate:  principle, appli-
                  cability, range, sensitivity,
                  interferences, accuracy and
                  precision, apparatus, calibra-
                  tions , reagents, procedures for
                  sampling and analysis, calcula-
                  tions, references or bibli-
                  ographies, and special
                  precautions necessary for
                  handling and/or disposing of
                  hazardous materials and reagents.

               •  Based on past experience,
                  generally applicable criteria
                  for the selection of acceptable
                  methods for environmental
                  monitoring should be recommended
                  by a panel of experts represent-
                  ing the ultimate users.  The
                  measurement technique will
                  exhibit sufficient precision
                  and accuracy to meet the data
                  needs of EPA.  Furthermore, the
                  necessary equipment should be
                  available at many laboratories
                  and be adequate for the routine
                  examination of a large number of
                  samples.  In addition, the
                  validity of the technique should
                  be tested.

          (b)  Method selection criteria — All EPA labora-

tories will be encouraged to utilize the same methods for

measuring pollutants.  The methods which may be selected

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                           10




will be described in an EPA-approved compendium.  Where



more than one method is available, the selection criteria



will be based on the applicability of the method, its



comparability with methods used in other laboratories, and



its ability to meet requirements of the data user.



Specific guidelines for selection of alternative methods



and procedures should be included in all manuals.



          (c)  Equivalency determination criteria —



Individual monitoring activities may decide to utilize



methods that differ from the prescribed EPA reference



method.  It is necessary to establish guidelines to ascertain



that the results of the particular monitoring method



employed is equivalent to EPA-approved methods and, hence,



valid data can be obtained.



     Laboratory Procedures



          Bias and variability in data may result from



variation in the general design and construction of facili-



ties.  Differences in the equipment, apparatus, and reagents



used by laboratories can also contribute to both the bias



and variability of data which decreases the reliability



and comparability of results between laboratories.  The



functional design of a laboratory—the use and maintenance



of equipment, standardization of reagents, temperature, and



humidity—influences the reliability of data.  Therefore,

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                           11

it is extremely important that quality control procedures

concerning standard laboratory requirements and practices

be developed, promulgated, and followed.  These guide-

lines should cover all facets of routine laboratory

operations and maintenance of equipment and apparatus.

Intra-laboratory Quality Control

     Quality Measurement and Performance Evaluation

          To maintain a high level of competence in daily

activities, quality control must be implemented in the

field and at the bench using a system of checks to determine

the accuracy and precision of results and the performance of

monitors and analysts.  Intra-laboratory quality control

is a continuing in-house activity to ensure the output of

valid data.  The specific objectives of the program are

to devise and implement procedures that:

               •  Measure and control the precision
                  of procedures and instruments.

               •  Measure and control the accuracy
                  of analytical results.

               •  Ensure data output is computer
                  compatible.

               •  Present data in proper format.

               •  Document performance of instru-
                  ments and analysts.

               •  Document training needs.

               •  Identify weak methodology and
                  consequently research needs.

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                           12

          An intra-laboratory quality control program

employs several important tools/techniques:

               •  Standard Reference Materials (SRM)
                  are substances which qualify as
                  absolute quantities against which
                  other like substances can be
                  calibrated.  The SRM, typically
                  produced by organizations like
                  the National Bureau of Standards,
                  is used to prepare standard
                  reference samples (SRS)  for lab-
                  oratory application.

               •  Standard Reference Samples (SRS)
                  are preparations or known amounts
                  of standard reference materials
                  added to an actual environmental
                  sample which has been previously
                  analyzed.  The amount of the sub-
                  stance found in the sample is a
                  "true" indication of the accuracy
                  of the method for a given measure-
                  ment.  The use of the standard
                  reference samples measures the
                  extent of interferences which
                  cannot be obviated.

                  Quality control charts should be
                  an integral part of a quality
                  control program.  Figure 1, which
                  shows the summation of the dif-
                  ferences squared for replicate
                  samples, is one form of a quality
                  control showing trends.
                  Additional control charts
                  are recommended where standard
                  deviations are  (d = V«/«7£ ) for use
                  on a daily basis to establish
                  rapidly if an analysis is out
                  of control on a given day.  Once
                  precision and accuracy data are
                  available on the method and the
                  analyst  (from the use of SRM/SRS),
                  systematic daily checks are
                  necessary to ensure that valid

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                                  13
                  QUALITY  CONTROL  CHARTS

       = The summation of the  difference  squared  for  replicate  samples,
                             NO APPARENT TREND
lid2)
           SAMPLE SET NO.
     ANALYSIS  IN  CONTROL
Kd2)
           SAMPLE SET NO.
     ANALYSIS OUT OF  CONTROL
            UPPER  LIMIT
                       APPARENT TREND EVIDENT
ltd2)
           SAMPLE SET NO.
     ANALYSIS OUT OF CONTROL
            LOWER LIMIT
I(d2)
          SAMPLE SET NO.
     ANALYSIS OUT OF  CONTROL
            UPPER  LIMIT
                                 FIG.  1

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                           14

                  data are being generated.  From
                  these daily precision and accuracy
                  data, quality control charts can
                  be constructed and maintained
                  to determine when the method used
                  is producing valid data, when the
                  data are questionable, or when a
                  trend is detected which must be
                  investigated and corrected.

                  Several techniques are available
                  for constructing quality control
                  charts and plotting subsequent
                  data.  The two techniques currently
                  used by EPA are the Shewhart
                  technique and the Cumulative-
                  Summation technique.   For both
                  techniques, precision control
                  charts are constructed from
                  duplicate sample analyses, and
                  accuracy control charts are con-
                  structed from spiked sample
                  analysis.

     Personnel Staffing and Training

          An important part of intra-laboratory quality

control is proper staffing and the continuous training of

personnel.  Guidelines need to be established and made

available to all laboratories concerning the qualifications

(training and experience)  that are necessary to perform

the various tasks.  For example, the operation of a gas

chromatograph will typically require a professional

scientist with considerable experience.  On the other hand,

many routine functions can be adequately performed by

entrance grade technicians.  Staffing guidelines will assist

the laboratories in selecting and deploying personnel.

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                           15

The rapidly changing methodology of environmental monitor-

ing requires that the personnel undergo periodic training—

both formal and on-the-job.  Training courses in method-

ology as well as quality control practices will need to

be incorporated into EPA's formal training program and some

requirements will need to be established for all monitoring

personnel to participate.

Inter-laboratory Quality Control

     An inter-laboratory quality control program serves to

select and evaluate methods, characterize their precision

and accuracy, and provide data for evaluating both lab-

oratory and analyst performance.  This aspect of quality

control is referred to as cross-check sample studies or

methods evaluation studies.  Specific objectives of this

program are to:

          •  Measure the precision of reproducibility
             of methods of analysis within various
             programs.

          •  Identify interference in different
             sampling environments.

          •  Measure the precision and accuracy of
             results between laboratories.

          •  Provide a mechanism for evaluation and/or
             certification of laboratories and
             analysts.

          •  Detect weak, improper, or impractical
             methodology.

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                           16

          •  Detect training needs and upgrade
             laboratory performance.

          •  Assist laboratories or programs in
             obtaining new resources.

     Participating laboratories should be provided with

standard reference samples, instructions, and data forms

necessary to test methods under certain prescribed condi-

tions.  The results should be submitted to a coordinating

laboratory where they are statistically evaluated to

determine the accuracy and precision of the method.  More-

over, they are also evaluated to determine the general

applicability of the method and to rate the performance

of the laboratories and analysts.

     This type of activity involving laboratories in evalua-

ting methods is necessary to provide a sound statistical

model.  Single laboratory tests introduce both method and

laboratory bias, and the results obtained may have little

relationship to the "true" reliability.  All operating

quality control programs have used an inter-laboratory quality

control program as a mechanism for methods standardization

and selection.

Management

     Certain aspects of implementing and maintaining a

quality control program require actions and decisions which

affect total operation or reflect position/policy of the

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                           17



Agency.  These include program evaluation, certification,



and communications.



          Program evaluation — Involves periodic review



and assessment of all quality control activities as



necessary to determine their proper functioning, effective-



ness, and reliability.  Evaluations are necessary at least



quarterly and should be comprehensive enough to include



all field and laboratory activities related to monitoring.



Special attention should be given to field procedures and



calibration, performance of laboratories and analysts, and



adequacy of manuals/methods, training, etc.  This evaluation



should provide the basis for a quarterly quality control



status/needs report to Regional Administrators, Center



Directors, and Headquarter's elements.



          Certification — This is an important subelement



of the management activity which involves formal approval



and/or endorsement of acceptable performance by a laboratory



or analyst.  Certification is directly relatable to the



inter-laboratory quality control.  Certification implies



that performance of analysts and laboratories is acceptable



with respect to an established population average.  It is



important to note that certification does, in both fact and



concept, imply endorsement by EPA and, as such, can have



serious impact/repercussions on our enforcement actions and

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                           18

our contracting systems.   Since EPA's experience in con-

ducting certification programs is limited/ it is necessary

to review other programs  existing outside EPA and select

the best available information to develop guidelines for

EPA.  Certification programs may first be applied to EPA

laboratories and then expanded to include States and

others on a voluntary basis.

          A reasonable and valid alternate approach to a

certification program would be to. require all laboratory/

field activities supplying monitoring data to EPA to oper-

ate within certain prescribed guidelines for intra-laboratory

quality control and participate in EPA's inter-laboratory

quality control program.   This alternative will provide

documented evidence of laboratory/analyst performance and,

hence, the validity of the data.

          Communication — For a quality control program to

succeed, a necessary subelement is an adequate information

exchange program.  The following types of activities are

included:

               •  Reports from meetings of a
                  quality assurance committee.

               •  Reports from central files
                  of information on request/
                  use of  SRM and SRS.

               •  Reports of quality control
                  conference.

               •  Quality Control Newsletter.

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                CURRENT STATUS AND NEEDS




     Many elements of quality control are currently being




practiced to some degree at EPA and other environmental




monitoring programs.  The quality control programs for the




different media and categorical programs are quite varied—




ranging from rather comprehensive activities in some areas




to essentially non-existent activities in others.  What-




ever the case, all of the on-going activities suffer from




the lack of established requirements resulting in essen-




tially voluntary and partial participation by individual




programs and laboratories.  The problem is further com-




pounded by the decentralization of monitoring activities.




     The effort thus far, then, has been uncoordinated,




fragmented, and operated with minimal resources.  The results




have been unsatisfactory.  Much of the data have been of




invalid or questionable quality.  For example, more than 20




percent of the air quality data gathered from the State and




local agencies for insertion into the National Air Quality




Data Bank was not useable.  In addition to loss of data,




this represents considerable waste of both manpower and




resources.  Since different methods, equipment, or proce-




dures have been used to monitor separate locations, various




programs have produced data that are not comparable.  In




many instances, analyses are being made without proper

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reagents, without calibration, and by unqualified analysts.



This has resulted, for the most part, in a data base that



is of questionable validity and, therefore, limited utility.



In developing a plan, it is necessary to assess the present



status of our quality control programs, evaluate their



needs, and provide solutions.



     Each of the current programs in quality control has a



record of accomplishments and capabilities as well as cer-



tain shortcomings.  Although quality control programs are



under way for air, water, radiation, and pesticide monitor-



ing, they all are notably lacking in several areas.  The



most critical deficiencies are lack of established procedures



for sampling methodology, field calibration, equivalency



determination, and the lack of performance evaluation and



certification.  Comparable quality control programs for noise



or solid waste monitoring are non-existent.  The current



capabilities for each media's quality control program are



the subject of Figure 2.  While the estimated degrees of



accomplishment are subjective, they indicate relative



strengths of the current programs.  It is estimated that



the quality control programs for water, pesticide, and radia-



tion monitoring are about 50 percent complete.  However,



the quality control activity for.air monitoring which has



just begun is inadequate.  The major accomplishments and

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          STATUS  OF EXISTING  QUALITY CONTROL ACTIVITIES    JUNE'72
                     (AS PERCENT TOWARD FULL ACTIVITY)
   MEDIA
0%
50%
100%
AIR
WATER
PESTICIDES
SOLID WASTES
RADIATION
NOISE
                                   FIG. 2

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                           22

shortcomings of each quality control program are high-

lighted below.

          Water — The quality control activities for

monitoring water and wastewater are centered at the Analyt-

ical Quality Control Laboratory (AQCL) at the National

Environmental Research Center  (NERC) in Cincinnati.  This

program has been in existence for more than five years.

However, the limited resources available have not allowed

for the development of a comprehensive program.  The major

accomplishments and deficiencies of the water quality

control program are:

             Accomplishments

              (1) Compendium of Methods (latest
                   issuance in 1971)

              (2) Intra-laboratory Quality Control
                   Manual (1971)

              (3) Inter-laboratory Quality Control
                    (maintenance of SRS repository
                   for cross-check sample studies
                   and methods evaluations)

              (4) Laboratory procedures guide-
                   lines (1971)

              (5) Quality Control Newsletter
                    (issued periodically)


             Deficiencies

              (1) The methods manual does not
                   include instrumental,  bio-
                   logical, and microbiological
                   measurements (external
                   methods exist)

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                           23

              (2) Technical assistance to field
                   laboratories is provided on
                   an ad hoc basis.

              (3) The sources of SRM are not well
                   established.

              (4) The production of SRS fall
                   short of demand.

              (5) Reports of methods evaluated
                   are not timely.

              (6) Laboratory manual needs to be
                   updated.

              (7) The scope of the present
                   program is not geared to meet
                   the expanding needs of the
                   Regions.

              (8) Participation by laboratories
                   is voluntary.

          In addition to the activities of the Analytical

Quality Control Laboratory, the Water Supply Research

Laboratory, NERC-Cincinnati, conducts limited quality con-

trol services for State laboratories concerned with

drinking water standards.  This laboratory, started in

1953 as part of a training program, supplies reference sam-

ples and uses and recommends use of the 13th Edition of

Standard Methods for Water/Wastewater Analyses.  In

addition, it prepares a training manual which includes

some quality control procedures.  Moreover, the Water Supply

Research Laboratory participates in a certification program

for State bacteriological and chemistry laboratories.

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                           24



          Additionally, Consolidated Laboratory Services,



NERC-Corvallis,  has conducted an intra-laboratory quality



control program for water quality data since its inception



and has improved to the point of being a near model



system.  This program has recently extended this activity



to its satellite laboratories, and NERC-Corvallis requires



that quality control be practiced by all contractors



assisting it in acquisition of water quality data.  This



Laboratory has also developed a Sampling Handling and



Verification System (SHAVE) which assures continued integ-



rity of the sample from collection to analysis to data



reporting.  A simplified description is portrayed in Figure



3.  It should be noted that NERC-Corvallis works closely



with AQCL-Cincinnati by using its methods, supporting



lake eutrophication studies, and participating in other



special projects.



          Pesticides — The Primate and Pesticide Effects



Laboratory under NERC-RTP conducts an inter-laboratory



quality control program for pesticides monitoring.  This



program is almost totally dedicated to supporting the Com-



munity Pesticides Studies and the State Services Labora-



tories.  Under this program, quality control services are



available to 18 laboratories which are under contract to



EPA.

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                     25
SAMPLE HANDLING AND VERIFICATION SYSTEM
                   SOURCE
                 COLLECTION
                    CODE
                     LOG
                 ANALYSIS
                    DATA

                  (VERIFICATION)
                   STORET
                    USERS
                                        FIG. 3

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                           26

          The complexity of pesticide analysis requires

extensive quality control activities.  Hence, the scope of

the services provided by the Primate and Pesticide Effects

Laboratory is extensive.  Standard reference materials

and samples and standardized materials for gas chroma-

tographic columns are provided as well as technical assist-

ance, training, repair, and maintenance of both gas

chromatographs and mass spectrometers.  An inter-agency

agreement  (December 22, 1971) established a repository of

standard reference materials from which the Food and Drug

Administration (FDA) and State and local enforcement

authorities may draw standards.  The major accomplishments

and deficiencies of the program are highlighted below.

             Accomplishments

              (1)  Compendium of Methods

              (2)  Inter-laboratory quality control

              (3)  Intra-laboratory quality control

              (4)  Methods evaluation program

              (5)  Technical assistance and training

              (6)  Standard Reference Materials


             Deficiencies

              (1)  Methods are not recommended for
                   enforcement actions and are
                   not official EPA methods.

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                           27

              (2) The cross-check sample program
                   is inadequate to meet needs
                   of the Regions.

              (3) No quality control manuals are
                   available.

              (4) The methods evaluation program
                   should be expanded to Regional
                   participation.

              (5) Technical assistance and train-
                   ing must be expanded and
                   redirected to include Regional
                   needs.

              (6) Standard reference materials
                   are not analyzed and
                   maintained.

          Air — A formal quality control program for air

monitoring activities was initiated in January 1972.  It is

located in the Quality Assurance and Environmental Monitor-

ing Laboratory, NERC-RTP.  The slow start in this area is

due primarily to lack of resources and from difficulties

encountered in developing standard reference materials for

gases as well as delivery systems to generate standard

reference samples.  Although some of these initial diffi-

culties have now been resolved, and a quality control program

is under way, much remains to be done.  The implementation

of quality control for air monitoring is the most critical

area.  The current status of this program is briefly

described below.

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                            28

              Accomplishments

              (1)  Reference methods have been
                    promulgated with Air Quality
                    and Source Performance
                    Standards.

              (2)  Standard reference materials
                    have been developed for
                    sulfur dioxide, nitrogen
                    dioxide, carbon monoxide,
                    and some hydrocarbons.

              (3)  Methods for suspended particulates,
                    sulfur dioxide, and carbon
                    monoxide have been evaluated
                    and tested.


              Deficiencies

              (1)  No compendium of EPA-approved
                    methods has been developed.

              (2)  No delivery systems have been
                    developed to generate
                    standard reference samples.

              (3)  No quality control manuals or
                    guidelines have been
                    developed.

              (4)  No cross-check sample program
                    has been initiated.

              (5)  Lack of standard gas mixtures.

              (6)  Lack of source and emission test
                    procedures.

          Radiation — The Analytical Quality Control Service

of the Office of Radiation Programs located at Winchester,

Massachusetts, which had been providing an inter-laboratory

quality control program for radiation measurements since

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                           29



1962, has been relocated to NERC-Las Vegas.  It is currently



known as the Office of Quality Assurance-Radiation.  The



present program consists of conducting cross-check sample



studies for EPA contract laboratories and utility companies.



Standard reference samples for radionuclides are provided



to other Government agencies and private organizations as



requested.  The Office of Quality Assurance-Radiation col-



laborates with groups such as the American Society for



Testing and Materials, the American Public Health Association,



and the Association of Official Analytical Chemists in test-



ing radiochemical methods of analysis.  Technical assistance



in developing quality control programs is provided to EPA



and other laboratories on an ad hoc basis.



          In addition to developing an operational intra-



laboratory quality control program, this program conducts



quality control activities with States, the International



Atomic Energy Agency, the World Health Organization, and the



U.S. Atomic Energy Commission laboratories.  A functional



system for collecting, handling, and analyzing large numbers



of samples has been developed.  Moreover, data processing



and reporting have been computerized.  The computer program



generates quality control charts of measurement accuracy and



precision.  The program also conducts a field sampling course



and provides for the certification of participants.

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                           30

          The current status of this activity is briefly

summarized below.

             Accomplishments

             (1)  A compendium of radiochemical
                   methods of analysis has been
                   published.

             (2)  A cross-check sample studies
                   program has been developed.

             (3)  A methods evaluation program
                   has been developed.


             Deficiencies

             (1)  A compendium of EPA-approved
                   methods has not been
                   promulgated.

             (2)  A quality control manual has
                   not been developed.

             (3)  Training and technical assist-
                   ance to support Regional
                   needs is inadequate.

             (4)  Methods evaluation studies are
                   not comprehensive.

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                           31

                     IMPLEMENTATI ON

     In the development of an Agency-wide quality control

strategy, two overriding issues must be considered and

resolved:

          •  What should be the scope of coverage?
             (EPA only or include State and local
             and other programs)

          •  What should be the extent of control?

     Environmental monitoring data are produced by many

organizations, both governmental and private.  The Environ-

mental Protection Agency, State and local agencies, and

other Federal agencies are involved in environmental moni-

toring.  The State and local efforts are especially exten-

sive and the data are routinely placed into EPA's data

systems.  In the private sector, contracting laboratories

and private industry are involved in the measurement and

analysis of pollution.

     Because of EPA's reliance on outside organizations for

the production of environmental data, the quality assurance

program should extend outside EPA.  Only in this manner

can EPA support the data it uses and, consequently, the

actions that are taken.  Therefore, at a minimum, the qual-

ity assurance program should embrace EPA's own programs,

the State and local laboratories, and the contracting

laboratories conducting work for EPA.  The quality control

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                           32



strategy presented herein is based upon the development of



the tools and procedures for a quality control program



which can easily be extended from a regional base to



State, local, and contract laboratories.



     A quality control program is doomed to failure if it



is not given authority and is not adhered to by the organ-



izational elements that it encompasses.  Usefulness of the



procedures, manuals, and training programs will be limited



if the operating programs are not required to incorporate



them into their monitoring activities.  The successful



implementation of the quality assurance program has two



requisites.  First, the program should be emphasized so



that it becomes widely accepted.  Secondly, the program



should have sufficient authority to support the control



activity necessary to produce valid data.



     This section of the report presents an organizational



plan and a listing of projects, tasks, and schedules.



          Organizational Plan



                (1)  The program must be authoritative/



compulsory.



                (2)  The program must be centrally directed



and coordinated, yet allow for individual program



implementation.

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                           33




                (3)  At least initially, the program must



utilize existing facilities and areas of competence.




                (4)  The program must provide for centrali-



zation of all elements of the program that lend themselves



to such organization, as in provision of SRM and prepara-



tion of SRS.




                (5)  The program must provide for routine



exchange of quality control information.



                (6)  The program must be responsive to all



operating monitoring programs.



                (7)  The program must extend outside EPA,



both in terms of building the program and providing service.



          Accordingly, four levels of activities and respon-



sibilities are necessary:



                (1)  Program Management, planning, and



coordination -- In order to ensure the development of a



uniform quality control program that meets the needs of all



monitoring activities, it is necessary to centralize



general management, planning, and coordination.  In this way,



each program receives equitable emphasis and is evaluated



by a single standard.



                (2)  Program review and concurrence — Since



monitoring activities within EPA are carried out independ-



ently by the various organizational elements (i.e., Regions,

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                           34




Program Offices, Enforcement, and Research), the quality



control program should be developed and operated in concert



with these offices.  The responsibilities of each monitor-



ing activity, therefore, is to identify its needs and



review and concur on proposed Agency-wide quality control



programs.



                (3)  Technical procedures, development, and



technical support — A sound quality control program can



only be developed and operated if the field programs are



supported by central quality control groups.  It is these



groups, located at the NERC's, that will assist in program



development, develop and test the procedures before routine



field application, provide necessary materials, and render



assistance as needed.



                (4)  Program implementation and operation —



Quality control must be implemented by each of the operating



monitoring programs within the guidelines and directives



provided.   This implies that monitoring programs in each of



the Regions and those in Program Offices, Research, and



Enforcement will conduct their own quality control programs.



To ensure that these programs operate within central



directives, close liaison must be maintained between indi-



dual monitoring activities and the central quality



assurance activity.

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                           35

     Specific program functions and responsibilities have

been determined.  They are designed to provide the Agency

with an effective quality control program for all moni-

toring activities.  The proposed program takes advantage

of currently available expertise in order to implement a

quality control program responsive to the Agency's needs.

          Office of Monitoring;  The Office of Monitoring

will assume overall responsibility for the direction and

coordination of both the development and implementation of

the quality control program.  It will continually review and

assess the program's progress and efficacy.  These respon-

sibilities will be carried out in concert with the appro-

priate elements of the NERC's.  Specific tasks require the

Office of Monitoring to:

               •  Issue directives and guidelines
                  for quality control to operating
                  monitoring programs.

               •  Prepare and review program plans.

               •  Ensure that .technical assistance
                  is provided to Regions and other
                  monitoring programs.

               •  Develop and direct a laboratory
                  certification program.

               •  Evaluate the effectiveness of
                  continuing quality control
                  programs and provide biannual
                  status reports.

               •  Coordinate requisite training
                  programs.

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                           36

               •  Maintain a rapid information
                  exchange system that will
                  notify appropriate organiza-
                  tions of important changes
                  and events relating to
                  quality control.

               •  Establish an internal quality
                  assurance committee necessary
                  for program coordination.

               •  Provide a central focal point
                  within EPA on all matters
                  pertaining to quality control
                  of monitoring activities.

          National Environmental Research Centers;   The

technical support elements of the quality control program

will be located at the National Environmental Research

Centers.  The quality control groups at these Centers will

be responsible for providing the necessary tools for

operating monitoring programs as required.  Responsibilities

for particular environmental media and categories are

specified as follows:

               •  Air — NERC-RTP

               •  Pesticides — NERC-RTP  (Primate and
                                Pesticide Effects
                                Laboratory)

               •  Radiation — NERC-Las Vegas

               •  Water — NERC-Cincinnati

               •  Solid Waste and Noise — responsibilities
                    for the quality control activities
                    have not yet been assigned.

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                           37

          Responsibilities of these quality control groups

will include the following tasks:

               •  Develop and provide standard
                  reference materials/samples.

               •  Direct and coordinate intra-
                  and inter-laboratory quality
                  control programs.

               •  Develop quality control
                  procedures.

               •  Provide technical assistance
                  in quality control.

          Regions:  Each Regional Office will implement the

quality control program for all appropriate monitoring

activities through an officially designated full-time

quality control coordinator.  Specific Regional tasks

include:

               •  Centralization of Regional
                  authority for quality control
                  activities.

               •  Operation of intra-laboratory
                  quality control programs to
                  assure adherence to EPA
                  procedures and guidelines for
                  all monitoring activities.

               •  Provision of technical assist-
                  ance to State and local agencies.

               «  Participation in methods
                  selection and in cross-check
                  sample studies.

               •  The review of each program to
                  provide a quarterly status/
                  needs report to the Office of
                  Monitoring.

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                           38

               •  Participation in the develop-
                  ment and implementation of
                  quality control training
                  activities.

               •  Provision of technical support
                  and assistance as required for
                  certification programs.

          Office of Categorical Programs;  Develop require-

ments and review quality control plans for the monitoring

of hazardous materials, radiation, pesticides, solid waste,

and noise.

          Office of Air and Water Programs:  Develop require-

ments and review plans for quality control activities of

air and water monitoring, both ambient and source.  The

Office of Air and Water Programs will be responsible for the

general management of data acquisition and storage and will

review and concur in this aspect of the quality control

program.

          Office of Enforcement and General Counsel;  Review

and concur in all quality control activities which support

enforcement and case preparation.  The Office of Enforcement

and General Counsel will establish case preparation monitor-

ing guidelines and provide manuals to appropriate program

managers and operational elements.

          Office for Regional Liaison;  Review and concur in

all quality control activities which relate to Regional

responsibilities.  The Office for Regional Liaison will also

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                           39



actively participate in all communication and coordination



activities.



          Projects and Schedules



               The implementation of an Agency-wide quality



control program will require the accomplishment of a series



of projects.  In total, nine separate projects with numerous



tasks have been identified.  The accomplishment of these



projects and tasks will require the efforts of many EPA



organizational elements—most notably the Regional Surveil-



lance and Analysis Divisions, the quality control groups at



the NERC's, and the Office of Monitoring.  It must be



remembered, however, that each monitoring program will need



to expend resources for quality control.



               A brief description of each project, including



the objectives they fulfill, is included below-



               Project 1:  Preparation and Issuance of



Procedures and Guidelines Manuals — The result of this pro-



ject will be "loose-leaf" manuals that will include uniform



procedures for the entire monitoring activity.  The proce-



dures are to be used by all environmental monitoring activi-



ties within and outside EPA.  The project calls for continual




expansion and updating of these manuals as more and better



information becomes available.  Primarily, the manuals and



inserts will be developed by the quality control groups at

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                           40




the NERC's.  In some instances, the issuance of procedures




and guidelines may involve only review and compilation of




existing materials.  For others, it may require extensive




surveys of actual field and laboratory investigations.




               Project 2:  Provide a Repository of Standard




Reference Materials and Samples — The result of this pro-




ject will be stockpiles of standard reference materials and




samples for testing and evaluating all aspects of monitor-




ing.  This will include ambient, emission, and effluent




monitoring as well as fuel additive and pesticide registra-




tion.  The tasks to be accomplished include identification




of sources of standard reference materials and development




of standard reference samples including appropriate delivery




systems.  In some cases, such as hazardous materials, special




procedures will be developed for handling, storage, and use.




Whenever possible, standard reference materials will be




obtained from outside organizations, such as the National




Bureau of Standards, and will be produced internally only




when not available elsewhere.




               Project 3:  Operation of Intra-laboratory




Quality Control —  This is a continuing project which will




be carried out by all on-going monitoring programs.  This




effort includes resources spent calibrating instrumentation




and equipment, conducting laboratory performance checks,

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                           41



maintaining daily control charts, etc.  This project also



includes technical assistance rendered to other organiza-



tions to improve or upgrade their programs.



               Project 4;  Operation of Inter-laboratory



Quality Control — This project is a continuing activity



involving the quality control centers and the operating



monitoring programs.  Its results will be documentation of



laboratory, method, and analyst performance.  Performance



will be continually evaluated by use of computerized control



charts which will show performance levels and data quality.



               Project 5;  Laboratory and Field Evaluation



of Instruments -- The result of this project will be a series



of reports and papers that will provide a scientific basis



for selection of pollution monitors.  For the most part,



this involves review of operational data from monitors which



are currently in the field or are used in laboratories.  The



data will be evaluated and organized into a user performance



report which will be made available to all prospective users.



This activity will be primarily carried on by the NERC's.



               Project 6;  Quality Control - Site and




Laboratory Evaluation -- This project provides external checks



on the performance of on-going monitoring activities.  One




task is the periodic evaluation of EPA's monitoring programs



by the quality control groups of the NERC's and the Office of

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                           42
Monitoring personnel.  A second task is the evaluation of
State and local monitoring programs by the quality control
elements of the Surveillance and Analysis Divisions.  These
checks may range from site inspections and review to actual
field calibrations using mobile units.
               Project 7;  Development and Management of
a Certification Program —_The result of this project will be
to establish and maintain qualified laboratories and analysts
for EPA and other monitoring activities.  Certification
programs will be the culmination of all the quality control
activities.  Performance levels will be established against
which the performance of each laboratory will be judged, and
upon approval, certificates will be issued and renewed
periodically.  The actual mechanisms to be followed and the
extent of the programs are yet to be investigated.  Alterna-
tives must be weighed as to whether the program should be
mandatory and whether it should be extended to external lab-
oratories.  The frequency with which the program should be
updated must also be considered.
               Project 8:  Communication and Coordination —
This project provides the overall management of the quality
control program and ensures continuity of all operations.
Some of the tasks under this project are concerned with
information exchange.  The newsletter, the information system,

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                           43




and the conferences will provide a mechanism whereby the



people engaged in quality control can share their experiences



and resolve problems.  Quality control activities within EPA



must depend upon the expertise of outside organizations.  A



task under this project will ensure that the necessary con-




tacts are maintained.  The development of a successful



quality control program involves numerous policy and major



technical decisions.  It is proposed under this project that



an internal quality assurance committee be established.



               Project 9;  Quality Control - Training — This



project will serve to coordinate and develop training courses



and lectures concerning the use of approved methods and



quality control practices.  The intent of this project will



be to work with the formal EPA training programs to ensure



that the proper courses are developed and given.  No sepa-



rate training program is to be developed.  In order that all



monitoring professionals and technicians may be accommodated,



an attempt will be made to make the requisite courses



available through selected colleges or junior colleges.



Courses on methodology and quality control practices might



be incorporated into the chemistry programs of selected



schools (primarily evening schools) via the grant mechanism.



An alternative is to provide on-the-job training at the



Regional or NERC laboratories.  An important aspect of this

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                           44




project will be to develop mechanisms for ensuring that all



appropriate monitoring personnel take advantage of these



courses.

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                           45

               QUALITY CONTROL PROGRAM FOR
                STATE AND LOCAL AGENCIES
INTRODUCTION
     In June of this year, the Office of Monitoring pre-

pared and distributed for review a proposal for an Agency-

wide quality control program.  Comments have now been

received from most of the Program and Regional Offices and

their suggestions have been incorporated into the plan.

The plan discusses and sets forth the organizational strat-

egy to be employed and delineates the projects and tasks

that must be done.  A further analysis is required to focus

on the scope of coverage and the extent of control that the

EPA quality control program should have.  This paper

addresses these points and makes recommendations regarding

these issues.  Thus, the "plan," together with this issue

paper, constitutes the strategy for an Agency-wide quality

control program.

     The primary issue is whether the quality control pro-

gram should be limited to the internal EPA monitoring

activities or be extended to cover State and local agencies,

contracting laboratories, EPA grant recipients, and the

manner in which it should be implemented.  What are the

alternatives and their costs?  The other major consideration

is the extent of control needed to ensure reliable and

defensible data.  What are the costs associated with the

various alternative "control levels?"

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                           46

     Should EPA's quality assurance program be extended
     to external monitoring programs?

     Although stated as an unresolved issue, the question

of extending the EPA quality assurance program to external

laboratories, namely State and local agencies, is rather

academic.  The very nature in which the monitoring

functions and responsibilities are carried out by the

State and local agencies and the Federal pollution control

agencies dictate the need for a broadly based quality

assurance program encompassing all these activities.  This

conclusion is based on the following:

          (1)  EPA depends upon State and local data.

          (2)  EPA has and will continue stipulating
               requirements for State and local
               monitoring programs^

          (3)  EPA as well as State and local data
               are routinely entered into joint
               information systems for common useage.

     The resources available for monitoring activities have

always been limited, requiring that the maximum use be made

of the "monitoring dollar."  Wherever possible, duplication

of effort must be avoided and the available data must be

used to serve a multitude of purposes and by the various

agencies or organizations requiring the data.  The data

needs by EPA are many and varied ranging from evaluating

compliance with standards to determining the health effects

that occur at different levels of pollution.  The current

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                           47



or projected EPA monitoring capabilities fall far short of



the level of effort that is needed.  In the future, as in



the past, EPA will need to depend to a large extent upon



monitoring data produced by the State and local agencies.




In fact, the current level of effort by the State and local



agencies for monitoring the more common pollutants surpass



those of EPA by a factor of nearly 10 in the case of air



monitoring and by a factor of more than five for water quality



monitoring.  Full use should be made of these data.



     Before EPA can place full reliance upon these data,



their accuracy and precision must be known and fall within



acceptable limits.  The use of data generated by numerous



agencies and laboratories for a common purpose (e.g., delin-



eation of nation-wide trends) required that these data be



of acceptable quality and be comparable.  Only through an



active quality assurance program can EPA verify the State



and local data it uses and upgrade the data where necessary.



       In many instances, EPA now places monitoring require-



ments upon State and local agencies by specifying the pol-



lutants that need to be measured, the number of stations



that must be installed, types of instrumentation, frequency




of sampling, etc.  It follows that the requirements for data




quality should be made part of these requirements.

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                           48

     Many agencies and organizations, governmental and

private, use environmental data from the EPA environmental

data systems, e.g., SAROAD and NEDS.   It is extremely

desirable that all of the data entered into these systems

be, if not of the same quality, of acceptable and known

accuracy and precision.  A good quality assurance program

can meet this goal.

          RECOMMENDATION:  Because of the above reasons, it

is recommended that State and local monitoring programs be

covered under the EPA quality assurance program.


     How should the EPA quality assurance program be
     operated with respect to the State and locaT
     monitoring programs?

     There are several basic options available to EPA in the

formulation of the strategy for a quality control program

for State and local monitoring activities.  They differ in

the requirements that EPA wishes to place upon the State

and local programs.  Each option must be very carefully con-

sidered in terms of the improvements in data that would

result and in the resources that EPA must expend.  Since the

number of operating agencies and their laboratories is large,

a systematic and coordinated effort is required to implement

a successful program.  Furthermore, the acceptance of the

program by the individual State and local agencies is a

necessity because without their willing participation the

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                           49

quality assurance program will fail.  A well designed and

operated quality assurance program will greatly enhance

our future working relationships with the State and local

monitoring activities.  A poorly operated program can have

the opposite effect and must be avoided.

     In all, three approaches have been identified.  They

are:  (1) mandatory participation;  (2) voluntary participation;

and, (3) voluntary participation with some requirements as

to the data.

     The first option would require the participation of all

State and local monitoring activities that impinge on the

mandated EPA responsibilities.  Under this option, EPA would

require the States to adhere to EPA monitoring guidelines,

use EPA designated standard reference materials and samples,

and participate in inter-laboratory testing and evaluation.

These requirements could be levied upon the States through

regulations concerning national environmental standards.

The major advantages and disadvantages of this approach are:

          Advantages:

              •  Full participation by all monitoring
                 programs is assured.

              •  The "weak" programs can be readily
                 identified and corrective actions
                 can be instituted.

              •  Data of better quality would ensue.

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                           50
                 Uniformity of data would be
                 increased through use of common
                 and approved techniques
                 nationwide.
          Disadvantages:

              •  Another EPA requirement for
                 States could "worsen"
                 relationships.

              •  The required EPA resources for
                 immediate implementation of
                 the program are nearly prohib-
                 itive.  (The average Region
                 would require about four to five
                 qualified individuals to admin-
                 ister the program.  The volume
                 of standard reference materials
                 and samples required would
                 increase tenfold.)

              •  The legal issues concerning
                 requirements will delay start
                 of the program.

     The second option places no requirements on the external

programs.  The Environmental Protection Agency would make

the various aspects of the quality control program available

to the State and local agencies.  For example, EPA would

distribute methods and quality control guidelines and invite

the various laboratories to participate in the inter-

laboratory testing program.  The Environmental Protection

Agency would provide standard reference materials and samples

as requested, if available.  The advantages and disadvantages

of this approach are:

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                           51

          Advantages;
              •  Program can be started immediately
                 and expanded as resources and
                 expertise increase.   (For water
                 quality, radiation, and pesticide
                 measurements, this service is now
                 being provided through the NERC's.)

              •  An additional requirement is not
                 placed on the States.  This may
                 result in a program that may be
                 more acceptable.


          Disadvantages:

              •  It is probable that the programs/
                 laboratories in most need of
                 quality control would not volun-
                 tarily participate.

              •  Data of questionable quality would
                 still be submitted to EPA1s
                 information systems.

              •  The implementation of the system
                 may never reach full coverage.

     The third option would combine certain facets of the

previous two approaches.  The Environmental Protection Agency

would require that the validity of all of the monitoring

data submitted to EPA be documented.  The Environmental

Protection Agency would issue guidelines concerning the

information that must accompany the data.  Such information

could include sample history, analytical methodology/

calibration, and performance checks.  In addition, EPA would

continue to provide monitoring methods and guidelines,

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                           52

conduct inter-laboratory testing (on a voluntary basis),

and make standard reference materials and standard reference

samples available.   Certification may or may not be part

of this program.   The pros and cons of this option are:

          Advantages:

              •  The validity of all data submitted
                 to EPA is known.

              •  The program can be implemented
                 on a more timely basis and
                 expanded as resources become
                 available.

              •  The "weak" programs can be iden-
                 tified and assistance may be
                 offered.

              •  The latitude for quality assurance
                 given to the States should make
                 the program more widely acceptable.

              •  A less rigid approach to quality
                 control may better serve to
                 advance the state-of-the-art.

              •  The quality assurance program will
                 be self regulating.


          Disadvantages;

              •  At least initially, the overall data
                 quality may not be substantially
                 improved.

              •  EPA will need to be concerned with
                 a much greater number of methods
                 and procedures.

              •  The preparation and issuance of data
                 validity requirements will delay
                 the start of the program.

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                           53




     Ideally, the first option  (i.e., mandatory State par-



ticipation) will provide EPA with the best data base and



the most complete coverage.  Furthermore, since the States



would be required to adhere to EPA guidelines, the pro-



liferation of non-uniform methods and procedures would be



minimized.  This approach, however, does not appear possible



at the existing resource levels.  Once the requirements are



placed upon the States, EPA must be in a position to admin-



ister the program, which would include both technical



assistance and official evaluation functions.  Both of these



tasks will require substantial resources by the Regions and



the quality control support groups at the NERC's.



     The second option  (voluntary participation) is the



easiest for EPA to undertake.  In fact, the on-going programs



in water, radiation, and pesticides presently operate in



this manner.  Past experience has shown that these programs



are well accepted by the more qualified external programs/



laboratories.  However, the major weakness of this approach



is that the laboratories in most need of quality control do



not generally participate in a voluntary program.  It is



these programs/laboratories that are of primary concern to



the EPA quality assurance program.



     The third option eliminates the major disadvantages of



the other two approaches--the large resource requirements of

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                           54

the mandatory program and the limited coverage of the volun-

tary program.  The submission of "data quality" information

by the State and local agencies will provide a basis upon

which to judge the validity of the data EPA receives.  The

States, although invited to take part in the various ele-

ments of the EPA quality assurance program, are not required

to participate.  They can implement and carry on their own

quality control.  This approach does not place an over-

whelming resource requirement upon EPA immediately, yet pro-

vides for a way to review data validity.  An important

aspect of this option is that it provides a self-regulating

mechanism.  The need for the State and local agencies to

provide certain quality control statistics will encourage

them to upgrade their monitoring activities through increased

quality control practices.

     Development of a quality assurance program for
     State and local agencies

     The proposed strategy calls for both the stipulation of

certain quality control information that must accompany all

the data submitted to EPA and the provision of quality con-  >

trol services to the State and local agencies.  Each of

these are briefly discussed here as are the various options

that are available with respect to implementation of the

program.

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                           55




          "Quality Control" Information;  The data cur-



rently submitted to EPA, for the most part, consist only of



the results with a minimum of supporting information.



This supporting information is limited generally to site



location, sampling time and duration, method of analysis



used (sometimes),  and the agency reporting the data.  On the



basis of this information, it is impossible to evaluate the



validity of the data.



          With the help of additional statistics (that can



be compiled by each agency/laboratory and submitted with



the data), EPA could evaluate the data prior to acceptance



into the information systems used by EPA.  The supporting



information needed would consist of:



                (1)  Sample handling and verification methods.



                (2)  Details of the analytical method used.



                (3)  The type and source of standard reference



materials and standard reference samples used.



                (4)  Frequency of use of quality control or




check samples.



                (5)  Last time the program participated in an




inter-laboratory testing program.



          In addition, to aid in evaluating the validity



of data, "baseline" information on each laboratory's capabil-




ities would also be compiled and kept up to date.  This

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                           56




would contain information on each physical facility, equip-




ment, personnel, and the like.  This "baseline" information




together with the accompanying quality control statistics




would provide the basis for evaluating the validity of the




data submitted to EPA.




          There does not appear to be any alternatives to




this approach.  Therefore, the basic decision is how best to




develop and implement a program to gather this information.




The implementation strategy must consider the following:




               (1)  The quality control data  (including "base-




line" facts) should be compatible with EPA's data systems.




 (The checking of data validity is to be computerized.)




               (2)  The information required must be kept at




an absolute minimum.




               (3)  The submission of the accompanying infor-




mation must be made an integral part of the data flow from




State/local agencies to EPA.




          Implementing this portion of the program will require




the accomplishment of a series of tasks.  These tasks together




with suggested organizational responsibilities are given




below:




              (1)  Compilation of "baseline" information.




This information will serve to provide an initial rating of




the capability of an individual monitoring program/laboratory

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                           57

that submits data.   (In most likelihood, the capabilities

will be pollutant-oriented.)  It is proposed that a question-

naire be developed by the Office of Monitoring  (and the

NERC's) in concert with the Regional Offices and other

appropriate EPA elements  (including the information systems).

The information would be collected, compiled, evaluated by

the Regional Offices, and forwarded to the Office of Monitor-

ing through the appropriate information systems.  The

evaluation or "rating" scheme is to be devised by the pre-

viously named EPA organizations.  An annual update of this

information is envisioned.  The following sequence is

proposed:

                   •  Develop a questionnaire and
                      rating scheme.

                   •  Compile baseline information.

                   •  Baseline information included
                      in data systems  (to be
                      determined).

              (2)  Submission of "quality control" information.

This information, to be routinely supplied with all data,

will provide a statistically sound basis for evaluating the

validity of submitted data.  It is proposed that the list of

required "quality control" information be developed by the

Office of Monitoring  (with the NERC's), the Regional Offices,

and other appropriate EPA elements.  The participation of

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                           58




information systems (SAROAD, NEDS, etc.)   is essential,




since the routine evaluation or "flagging" of invalid or




questionable data is to be computerized.   Once developed,




the quality control information will become an integral




part of all data submitted to EPA.  The manner in which




the quality control information is to be collected and




incorporated into the system will need to be investigated.




          Quality Control Services;  According to the




recommended option, EPA will provide certain quality con-




trol services to the State and local monitoring programs/




laboratories.  The alternative approaches of the EPA involve-




ment are best discussed through the consideration of the




nine project areas considered in the "plan."  The organiza-




tional responsibilities for these tasks are given at the




end of this discussion.




                (1)  Preparation and issuance of procedures




and guidelines.  The manuals prepared and issued for EPA




monitoring activities  (see plan, page 4)  will be applicable




to State and local agencies.  Whether or not included under




EPA quality control, the State/local agencies would take




advantage of these manuals.  The only extra cost (minimal)




to EPA would be on publication and distribution.  There are,




however, two points that should be considered:

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                           59




                    (a)  State/local agency involvement in



their preparation and review.




                    (b)  Whether reordering of priorities



is necessary.




               In order that these manuals reflect the needs



of the States, take advantage of their expertise  (in some



areas, certain State/local laboratories are very advanced),



and receive wider acceptance, a mechanism for their partic-



ipation should be developed.  This may be either in the form



of scheduled advisory group meetings or purely on an ad hoc



basis.  The preparation of some guidelines may, in fact,



be "contracted" to a given State or States.  Since the pri-



orities for control are dictated by common legislation, the



priorities for methods or procedures should not vary between



EPA and the States.



               (2)  Provision of standard reference materials



and samples.   Standard reference materials and samples are



needed to calibrate monitoring and laboratory instrumentation,



to evaluate proposed new methods, and to maintain a con-



tinuous check on the validity of the data that are produced.



The success of an inter-laboratory quality assurance program



depends on the availability and use of high quality standard




reference materials and standard reference samples.  Cur-



rently, there is little or no control over the use of standard

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                           60



reference materials and standard reference samples  (type,



quality, frequency of use, etc.).  The State/local programs,



as well as other monitoring activities, obtain these mate-



rials from a wide variety of sources—EPA laboratories,



National Bureau of Standards, private laboratories, and in



some cases, the reference samples are being prepared by the



user laboratory itself.  Increased control on the production



and use of standard reference materials and standard refer-



ence samples is necessary if the State/local data are to



be upgraded and their validity assessed.  There are several



options available to EPA in making these materials available



to State/local programs.  These are:



                     (a)  EPA purchases the standard refer-



ence materials from appropriate sources such as the National



Bureau of Standards and private organizations, prepares



standard reference samples, and makes these materials avail-



able to State/local agencies at no cost.  (These repositories



could be maintained by the quality control groups at the



NERC's, Regional Offices, or both.)



                     (b)  EPA identifies and supports  (and



approves)  an external organization(s), such as the National



Bureau of Standards and private suppliers, as a central



repository for standard reference materials and standard



reference samples.   (The actual production cost of the

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                           61




materials would be borne by the users.  EPA would continue



the support of the development of these materials.  Although



the National Bureau of Standards would be a major source,



private suppliers could be designated as approved sources



of given materials.)



                    (c)  Combination of options 1 and 2.



EPA provides priority standard reference materials and stand-



ard reference samples as resources allow and identifies com-



mercial sources where these and other materials may be



obtained.



                    (d)  EPA requires that all agencies sub-



mitting data to EPA document the source(s) and quality of



the standard reference materials/standard reference samples



they use.   (The agencies would be free to select their own



source of these materials.)



               The first option assures the maximum EPA con-



trol over all monitoring data which it receives from the



State/local programs.   It also assures a much wider use of



these materials.  However, with present funding restrictions,



the logistics and the cost of providing this service may



seriously limit the scope of coverage.  Option 2 above would



reduce the cost to EPA.  This alternative requires that



external organizations have the necessary expertise and




willingness to develop and maintain such a repository.

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                           62




Moreover, a service "charge to the user" could reduce volun-



tary participation and delay the response to State/local



needs.  The third option (e.g., the provision of all standard



reference materials and standard reference samples to State



and local monitoring programs) would not place an over-



whelming requirement upon EPA.  It would allow EPA to develop



and provide reference materials on a priority basis.  The



identification of private and other governmental suppliers



of reference materials will allow EPA to maintain some con-



trol over their use.  This option, although requiring a



minimum of EPA resources, will not provide performance up-



grading in the various laboratories.  If it results in



proliferation of standard reference materials/standard



reference samples of unknown purity, the overall quality of



data will not be substantially improved.



               RECOMMENDATION:  For the reasons cited above,



option 3 is recommended to provide standard reference



materials and standard reference samples.



               (3)  Operation of intra-laboratory quality



control.  This activity is the responsibility of each program



and laboratory.  The need to submit quality control infor-



mation with the data will encourage the States and local



agencies to maintain an adequate quality control program

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                           63



within their laboratories.  Guidelines would be provided



through Project 1.  There would be no extra cost to EPA.



                (4)  Operation of inter-laboratory quality



control.  An inter-laboratory quality control program provides



an evaluation of the performance of individual laboratories



in conducting a given analysis or series of analyses.  This



activity also serves as the mechanism for evaluating new




methods.  An inter-laboratory quality control program  (cross-



check sample program) serves the interests of participating



laboratories by identification of their shortcomings.  It



also serves the interests of the data recipients by



documenting the validity of the data.



               As part of the recommended strategy, inter-



laboratory quality control would be provided to the State/



local agencies on a voluntary or service basis.  This proce-



dure, in fact, is currently being followed in the water,



pesticide, and radiation monitoring activities.  Under this



approach, the quality control groups at the NERC's would



conduct inter-laboratory tests  (issue test procedures and



samples and evaluate the results).  The State/local agencies




would be informed of these tests and invited to participate



(by the Regional Offices).  This approach raises the question



of extent of State participation in a voluntary program.



Experience has shown that the more qualified laboratories

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                           64




participate in a voluntary program of this type whereas




laboratories/programs most in need of performance improve-




ment do not participate.  Under the proposed program,




this should not happen.  The requirement for the State and




local monitoring programs to provide quality control infor-




mation as part of their data submission to EPA should serve




as a self-regulating mechanism.  Furthermore, it encourages




all programs to participate in inter-laboratory quality




control.



               (5)  Laboratory and field evaluation of




instruments.  This project area is intended to provide guide-




lines for selecting and evaluating instruments.  The extension




of the quality control program to the State/local agencies




would not require an additional effort on the part of EPA.




The experience of State/local agencies with methods and




instruments can provide valuable inputs to guideline




formulations.




               (6)  Quality control - Site and laboratory




evaluation.  This project provides external checks on the per-




formance of on-going monitoring activities.  These checks




may range from site inspections and review to actual field




calibration using mobile units.  This activity is a necessary




consequence of an on-going inter-laboratory program uncover-




ing weak or marginal performance of State/local monitoring

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                           65

programs.  Also, this project provides assistance, if

requested, by State/local programs.  This project area will

require considerable activity on the part of EPA which

would be carried out by the Regional Offices with the

assistance of the NERC's as required.

                (7)  Development and management of laboratory

certification program.  A most important issue in the develop-

ment of a strategy for extending the EPA quality control

activity to State/local monitoring programs is the question

of certification of State and local laboratories, analysts,

etc.  A certification program requires the establishment of

performance levels against which the performance of each

laboratory will be judged in terms of facilities, equipment,

personnel, participation in inter-laboratory quality control

programs, etc.  and, upon approval, the issuance and periodic

updating of certificates.  "Certification" is the culmination

of an inter-laboratory quality control program and carries

with it an official approval label.  The advantages and dis-

advantages of a formal certification program are discussed

below:

          Advantages;

              •  The evaluation of data validity
                 is improved.

              •  Laboratory performance is upgraded.
                  (The need for increased performance

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                          66
                 levels  can be  used as  a tool for
                 obtaining resources, high level
                 of personnel,  etc.)
          Disadvantages:

              •  The  current state-of-the-art is
                 not  sufficient to provide a strong
                 scientific  basis  for setting
                 performance levels.   (The setting
                 of performance levels assumes the
                 existence of model laboratories
                 against  which all others  would be
                 judged.  Statistical models may
                 or may not  be a sufficient basis.)

              •  Official certification may
                 "worsen" relationships with the
                 States.   (Another EPA require-
                 ment on  the States.)

              •  The  operation of  a certification
                 program  will require substantial
                 resources that can best be used
                 elsewhere.

              •  A certification program may be a
                 deterrent in continual development
                 and  improvement for the "certified"
                 programs/laboratories.

               RECOMMENDATION:  For the present, a formal

certification program is  not proposed.  It must be understood,

however, that many of the activities proposed as part of the

quality control program for  States, i.e.,  data requirements,

inter-laboratory tests,  etc., provide a mechanism for

continuous evaluation of  program/laboratory performance.

In effect, the "grading"  of  laboratories and their data

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                           67




(which will be carried out) constitutes a form of certifica-



tion, lacking only the formal approval of laboratory



performance.




               Once the quality control program is under



way, the question of certification should be reexamined.  In



the interim, EPA should continue to provide assistance to



those States that are developing their own certification



programs.



               (8)  Communication and coordination.  The




extension of quality control services to State/local programs-



will require a substantial coordination and management effort



by EPA.  Information on laboratory activities/capabilities



will need to be collected and maintained.  Problem areas will



need to be identified and addressed.  Continual updating of



the program will also be necessary.  These tasks will primarily



fall upon the Regional Offices.



               (9)  Training.  Training of quality control



specialists and monitoring personnel is an important part of



the quality control program.  The number of State/local



personnel  that will need training is large and requires sub-



stantial resources.  The following approach is recommended:



                    (a)   Workshops on quality control manage-



ment aspects, proposed for EPA programs, should also include




the appropriate State personnel.

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                           68




                     (2)  Specific courses on quality control




techniques, i.e., use of quality control charts, split




samples, etc., should be provided to State/local personnel




through the Regions.



                     (3X  Courses in the use of analytical




methods should continue to be part of EPA's training




program (see plan).




RESOURCE REQUIREMENTS




     The extension of the quality control program to the




State and local agencies will require EPA to provide resources




for:




           (1)  The initial development and the routine main-




tenance and evaluation of quality control information which




will accompany all data submitted to EPA; and,




           (2)  the provision of quality control services to




the State and local monitoring programs.




Whereas the first of these activities is independent of the




development of the EPA quality control program, the provision




of quality control services is closely allied to it.  Any




limitations placed upon the EPA program will reduce the




services accordingly.  Thus, for example, the lack of support




for the development and production of standard reference




materials and standard reference samples will reduce the

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                           69




number of these materials available for distribution to State



and local programs.




     The development and maintenance of quality control



information will require resources for:   (1) expansion of



the information systems  (NADIS, STORET, etc.) to accommodate



this information; and,  (2) the routine handling and evalua-



tion of the information.  The cost of reprogramming will



need to be determined.  The routine evaluation will require



one to two individuals to be assigned to each information



system for dealing with quality control problems.



     The provision of quality control services to the State/



local agencies should be primarily the responsibility of



the Regional Offices with technical support provided by the



quality control groups at the NERC's.  The main thrust of



this program, as pointed out earlier, will be to supply



standard reference materials and standard reference samples,



conduct inter-laboratory tests, provide technical assistance,



conduct periodic quality control checks, and make training



courses available to the appropriate State and local



personnel.




IMPLEMENTATION SUMMARY



     The increased dependence by EPA on the State/local



monitoring data requires that the quality control program




be implemented as soon as possible.  In most likelihood,

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                           70

the provision of quality control services will be insuf-

ficient at first—because of funding limitations and the

need for EPA to develop the basic quality control tools.

The following major milestones are proposed:

          •  Determine the mechanisms to be used
             for collecting and evaluating
             quality control information.

          •  Issue a list of quality control
             information needed.

          •  Initial "grading" of monitoring
             programs.

          •  States informed of quality control
             services.

          •  Program under way.

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                          71
              Comments on "Development of an
            Agency-wide Quality Control Program"
INTRODUCTION

     Earlier this year, the Office of Monitoring distri-
buted for review a proposal for an Agency-wide quality
control program.  Comments were requested from nearly 30
EPA organizational segments including the NERC's, Regions,
and Program Offices.  In all, some 20 responses were
received covering all of the Regional and many of the
other offices.  This paper summarizes their comments and
the major changes made in the document.  First, the
major comments and the resulting changes are discussed.
This is followed by a summary listing the individual
comments submitted.

DISCUSSION

     There was a general consensus throughout EPA that a
strong Agency-wide quality control program is urgently
needed.  Although most of the reviewers agreed with the
implementation strategy, there were some different points
of view regarding the manner in which the program should
be carried out.  The technical aspects of the program,
i.e., the description of the elements of a quality control
program were well received by the reviewers.  Some
objections were raised with respect to the appraisal of
current status and capabilities of the on-going programs.
Several reviewers felt that the report was overly
critical of some programs.  The major issues raised by the
review are given below.

         (1)  Varying degrees of quality control;  The
proposal included a recommendation that the degree of
quality control should be varied on the basis of the end
uses of data, e.g., data to be used for enforcement would
be produced under stricter quality control than, say, data
for trend assessment.   Several reviewers addressed this
issue and strongly recommended that all EPA data be
subjected to same control.  Their recommendations were
based on the argument that EPA shou-ld only produce data
of high quality, that the end uses of data are not
frequently known, and that strict quality control measures
are needed for trend and background monitoring where the
concentrations measured are much lower than for enforce-
ment.  On the basis of their arguments, the proposal was

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                          72

changed and now recommends a uniform degree of quality
control for all data.

         (2)  Regional role in the development of guidelines;
Comments submitted by the Regional Offices addressed the
need for Regional input in the development of the proce-
dures and guidelines.  In their view a much greater
Regional input was called for than outlined in the proposal.
It was not intended to exclude the Regions from this very
important task.  The proposal was modified accordingly.

         (3)  Quality control over sampling:  Some reviewers
felt that the sampling portion of monitoring was not given
sufficient attention in the proposed quality control
program.  The general consensus was that it is extremely
important.   Changes were made in the document to give
increased emphasis on quality control relating to sampling.

         (4)  Compulsory quality control program;  The
proposal calls for a very strong and compulsory program.
Comments regarding this issue were quite varied.  Although
several reviewers supported a, compulsory program, some
felt that the proposed program was too authoritative and
under too much "strict Washington control."  If EPA is to
establish and implement an adequate program, it must be
adhered to by all monitoring programs.  No basic change
was made.

     In addition to the above, numerous changes were made
in the document in response to the comments.

SUMMARY OF COMMENTS

     REGION I      (1)   Does not agree that the degree of
                        quality control should be varied
                        according to uses of data.

                   (2)   Emphasizes that program must be
                        compulsory-

                   (3)   Emphasizes that program must cover
                        all aspects of monitoring.   Feels
                        that program is too much laboratory
                        oriented.

                   (4)   Does not think that the program
                        can be operational by July 1973.

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                     73
REGION II
REGION III
REGION IV
(1)   Feels  that the question of how,
     who,  and how many will direct and
     operate the program is not suf-
     ficiently described.

(2)   Comments that changes in design  and
     construction are not applicable  to
     existing facilities.

(3)   Recommends the use of additional
     control charts.

(4)   Recommends that a full-time quality
     control coordinator be designated
     in each Region.

(5)   Recommends a certification program
     for State and local programs/
     laboratories.

(6)   Recommends that a separate quality
     control group be set up for marine
     related monitoring.

(1)   Agrees with the proposed approach.

(2)   Recommends extending the program
     to State and local agencies.

(3)   The resources programmed for train-
     ing are underestimated.  Should
     be about two man years and $60,000
     per Region.

(4)   Raises questions concerning the
     detailed implementation of the
     program.

(1)   Agrees that a strong quality con-
     trol program is needed.

(2)   Suggests that resources be made
     available to the Regions for prep-
     aration of methods manuals and
     the provision of standard reference
     materials and standard reference
     samples.

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                     74
REGION V
REGION VI
REGION VII
(3)   Recommends the allocation of 10
     man years to Region IV for
     carrying out a certification
     program.

(4)   Does not agree with the statement
     that much of the existing data
     are questionable.

(5)   Recommends that every EPA
     reference method be interlab-
     oratory tested.

(6)   Recommends that EPA do not depend
     upon external organization for
     quality control.

(1)   Agrees with the approach, particu-
     larly with the recommendation that
     the program be compulsory.

(2)   Does not agree that the degree of
     quality control can be varied.
     All data should be of same quality.

(3)   Raises a question on how many
     laboratories can one quality con-
     trol office handle.

(1)   Questions the need for a certifica-
     tion program.

(2)   Thinks the schedule of projects and
     tasks are well laid out.

(1)   Agrees with the concept of an
     Agency-wide quality control
     program.

(2)   Thinks the program is under too
     much "strict Washington control."

(3)   All data must be subjected to same
     level of quality control.

(4)   Instructions on sampling site
     selection and calibration
     frequency.

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                     75
REGION VIII
REGION IX
REGION X
(5)   Laboratory certification is a
     must.

(6)   Resources and identity of the
     program are needed now.

(1)   Agrees  with the concept of the
     program.

(2)   Does  not agree with the estimated
     resource requirements for the
     Regions.   Recommends that such
     additional resources must be made
     available to the Regions.

(3)   Agrees  that the program should
     cover State and local efforts, but
     that  its scope should not be
     disproportionate to the available
     resources.

(1)   Regions should be involved in the
     development of guidelines, train-
     ing programs, etc.

(1)   Agrees  with the proposed program.

(2)   Thinks  guidelines for sampling
     may result in being too restrictive,

(3)   Feels that a formal laboratory
     certification program is several
     years away in Region X.

(4)   The issuance of standard reference
     materials and standard reference
     samples should be through Regional
     coordinators.

(5)   Suggests that Regions be involved
     in procedure and guideline
     development.

(6)   Recommends the inclusion of
     Regional coordinators in any
     Quality Control Intra-Agency
     Committee.

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                     76
Office of
Radiation
Programs
Office of
Categorical
Programs
(1)   Agrees  to the need to establish
     an Agency-wide quality control
     program.

(2)   Recommends that the existing
     radiation quality control group
     (activity)  at Winchester be more
     recognized and that EPA quality
     control programs for radiation
     measurements  be under the Office
     of Radiation  Program's control
     at Winchester.

(3)   Suggests  that quality control
     for the sampling end of monitor-
     ing be  emphasized more.

(4)   Thinks  that the report is too
     critical  of on-going quality
     control activities.

(5)   Suggests  an inconsistency between
     recommendations regarding "an
     authoritative/compulsory program"
     and the statement that quality
     control is the responsibility of
     the monitoring program which it
     serves.

(6)   Suggests  that the proposed mile-
     stones  are far too ambitious.

(1)   States  that the report is unclear
     regarding the development of
     standard  reference materials to
     support the pesticide registration
     program.

(2)   Recommends that guidelines on
     sampling  consider statistical
     basis  for design of sampling
     programs  and  schedules.

(3)   States  that there are a number of
     unresolved issues within EPA to
     adequately evaluate the proposal
     with respect  to inter-laboratory

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                     77
Office of
Water
Programs
NERC-RTP
NERC-LV
NERC-Cin
     quality control,  coordination,
     certification,  and training.

(4)   States  that the proposal does
     not consider the quality control
     activities  of Program laboratories.
     Suggests that these operate
     independently with the Agency-
     wide program as a point of
     reference.

(5)   States  that the proposed resources
     are excessive.

(1)   Comments that the program is
     realistic.

(2)   Recommends  that quality assurance
     must also include data storage
     and validation.

(1)   Agrees  with the proposal.

(2)   Does not favor a certification
     program at  this time.

(1)   Agrees  with the proposal.

(2)   Suggests that too much emphasis
     is  placed on standard methods.

(3)   Suggests the use of duplicate
     samples for intfa-laboratory  quality
     control.

(4)   Recommends  the shifting of radia-
     tion quality control from
     Winchester  to NERC-LV.

(1)   States  that the program cannot  be
     centrally imposed, but must be
     accepted by all elements.

(2)   The evaluation of current status
     does not give sufficient credit
     to  existing quality control
     programs in water and pesticide
     monitoring.

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                     78

NERC-Cin      (3)   The suggested sampling guidelines
(Cont)             are too restrictive.

              (4)   The specific roles of the Office
                   of Monitoring and the NERC's are
                   not adequately defined.

              (5)   The project/task descriptions
                   for water are not accurately
                   described.

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                           79

            Development and Review of the Plan

Quality Control Workshop

     An Agency-wide quality control workshop was held on
     February 16 and 17 to lay the groundwork for the
     Agency's quality control program.  The workshop was
     attended by approximately 50 individuals represent-
     ing all Regions, NERC's, and most of the Program
     Offices.
Review of the Quality Control Plan

     Comments on the plan were submitted by the
     following individuals:
       Region I


       Region II


       Region III


       Region IV


       Region V


       Region VI


       Region VII


       Region VIII

       Region IX


       Region X
       Office of
       Radiation
       Programs
-  E.V. Fitzpatrick,Director
   Surveillance & Analysis Division

   R.T. Dewling, Director
   Surveillance & Analysis Division

   J.G. Gardner, Deputy Director
   Surveillance & Analysis Division

   J.H. Finger, Chief
   Chemical Services Branch

   R.J. Bowden, Director
   Surveillance & Analysis Division

   E.R. Lozano, Deputy Director
   Surveillance & Analysis Division

   G.L. Fish, Director
   Surveillance & Analysis Division

   J.A. Green, Administrator

   B.D. Clark, Director
   Surveillance & Analysis Division

   G.L. O'Neal, Director
   Surveillance & Analysis Division

-  W.D. Rowe, Deputy Assistant Administrator

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            Office of
            Categorical
            Programs

            Office of
            Water
            Programs

            NERC-RTP
            NERC-LV

            NERC-Cin


            NERC-Corv
            Office of
            General
            Counsel
    80

G.R. Cornstock, Program and
  Management Operations
K.M. Mackenthun,  Director
Applied Technology  Division
S. Hochheiser, Chief
Quality Control  Branch

M.W. Carter, Director

D.G. Ballinger,  Director
Analytical Quality  Control Laboratory

D.F. Krawcyzk, Director
Consolidated Laboratories

B. Anderson, Staff  Chemist
. GOVERNMENT PRINTING OFFICE: 1974 546-317/297

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                        POINTS OF CONTACT FOR QUALITY CONTROL PROGRAM
  Media

Program
 Management
        Contact

Mr. Guntis Ozolins
 Director
        or
Mr. Thomas W. Stanley
 Chief
              Location

Quality Assurance Division
EPA Headquarters

Quality Control Branch
EPA Headquarters
  Phone No.

202/755-0646


202/426-2382
Water
Mr. Dwight G. Ballinger
 Director
Methods Development and Quality
  Assurance Research Laboratory
NERC-Cincinnati
513/684-2925
Air
Dr. S. David Shearer
 Director
Quality Assurance and Environmental
  Monitoring Laboratory
NERC-RTP
919/549-2106
Pesticides
Dr. William F. Durham
 Director
Pesticides and Toxic Substances
  Effects Laboratory
NERC-RTP
919/549-2655
Radiation
Mr. Richard E. Jaquish
 Chief
Technical Support Laboratory
NERC-Las Vegas
702/736-2969
                                                                                   Attachment

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