United States
Environmental Protection
Agency
Office of Research and
Development
600/8-77-008
July 1977
&EPA
Quality Assurance
Research Plan
FY 1978-82
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RESEARCH REPORTING SERIES
Research reports of the Office of Research and Development, U.S. Environmental
Protection Agency, have been grouped into nine series. These nine broad cate-
gories were established to facilitate further development and application of en-
vironmental technology. Elimination of traditional grouping was consciously
planned to foster technology transfer and a maximum interface in related fields.
The nine series are.
1 Environmental Health Effects Research
2. Environmental Protection Technology
3 Ecological Research
4. Environmental Monitoring
5 Socioeconomic Environmental Studies
6 Scientific and Technical Assessment Reports (STAR)
7. Interagency Energy-Environment Research and Development
8. "Special" Reports
9 Miscellaneous Reports
This report has been assigned to the "SPECIAL" REPORTS series. This series is
reserved for reports targeted to meet the technical information needs of specific
user groups. The series includes problem-oriented reports, research application
reports, and executive summary documents. Examples include state-of-the-art
analyses, technology assessments, design manuals, user manuals, and reports
on the results of major research and development efforts.
This document is available to the public through the National Technical Informa-
tion Service, Springfield, Virginia 22161.
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EPA-600/8-77-008
July 1977
QUALITY ASSURANCE RESEARCH PLAN
FY-1978 - FY-1982
by
Quality Assurance Work Group:
Thomas W. Stanley, Chairman
Office of Monitoring and Technical Support
Gregory J. D'Alessio
Office of Energy, Minerals and Industry
Victor Randecker
Office of Health and Ecological Effects
James T. Stemmle
Office of Planning and Review
Louis' G. Swaby
Office of Air, Land and Water Use
OFFICE OF RESEARCH AND DEVELOPMENT
U.S. ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, DC 20460
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DISCLAIMER
This report has been reviewed by the Office of Research and Development,
U.S. Environmental Protection Agency, and approved for publication. Mention
of trade names or commercial products does not constitute endorsement or
recommendation for use.
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ABSTRACT
The Office of Research and Development (ORD), through its Office of
Monitoring and Technical Support, is responsible for developing an Agency-wide
quality assurance program to enable the U.S. Environmental Protection Agency
CEPA) to implement its regulatory mission and associated monitoring functions.
The major thrust of this document is to identify and justify the resources
required by ORD to develop the quality assurance tools, techniques, and
services needed by other program offices, the Regions, and the States to
generate valid data. This five-year planning document describes the quality
assurance program in terms of goals, objectives, and functional elements;
summarizes the current status of ORD's ongoing quality assurance efforts;
discusses Agency and program needs; and delineates the resources and approaches
required to develop and carry out a dynamic quality assurance program which
will ensure scientifically valid environmental measurements.
This report is intended as a guide for planning the resources required to
develop the quality assurance tools, techniques and services needed by other
EPA program offices, the Regions, and the States to generate valid data. This
document is not intended to establish organizational responsibilities within
the Agency, or to identify the resources required to implement quality
assurance within the various EPA monitoring programs and the Regional offices.
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TABLE OF CONTENTS
Page
ABSTRACT Ill
EXECUTIVE SUMMARY viii
ACKNOWLEDGMENTS , xv
SECTION
I. INTRODUCTION 1
GOALS AND OBJECTIVES 1
ELEMENTS OF A QUALITY ASSURANCE PROGRAM . . 2
Standardization and Validation of Measurement Systems .... 2
System Standardization Protocol 3
Measurement Method Equivalency Protocol 4
Discussion 5
Quality Control 6
Development and Issuance of Guidelines and Procedures ... 7
Intralaboratory Quality Control 9
Interlaboratory Quality Control 10
Quality Control Coordination and Training 10
Laboratory Certification 11
Discussion 11
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TABLE OF CONTENTS (Continued)
SECTION Page
II. CURRENT STATUS AND RESEARCH NEEDS 13
STANDARDIZATION AND VALIDATION OF MEASUREMENT SYSTEMS 13
Air 13
Current Status 14
Future Research Needs 15
Water and Water Supply 16
Current Status 16
Future Research Needs 17
Biological Materials and Other Environmental Media 18
Current Status 18
Future Research Needs 18
QUALITY CONTROL 19
Air 19
Current Status 20
Future Research Needs ...... 21
Water and Water Supply 22
Current Status 23
Future Research Needs 25
Biological Materials and Other Environmental Media 27
Current Status 27
Future Research Needs 28
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TABLE OF CONTENTS (Continued)
SECTION page
Quality Control Training and Laboratory Certification .... 29
QUALITY ASSURANCE IN RESEARCH LABORATORIES 29
Current Status 30
Future Needs 30
QUALITY ASSURANCE EFFORTS RELATED TO THE ENERGY PROGRAM .... 30
Current Status 30
Future Needs 30
•
III. RESOURCE LEVELS AND IMPLEMENTATION OPTIONS 31
SUMMARY OF RESOURCES 33
IMPLEMENTATION UNDER VARIOUS RESOURCE OPTIONS 35
Option 1 35
Option 2 36
Option 3 36
CHARTS - QUALITY ASSURANCE IMPLEMENTATION PLAN 38
IV. SUMMARY HIGHLIGHTS OF EPA REGIONAL COMMENTS 50
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EXECUTIVE SUMMARY
INTRODUCTION
The Office of Research and Development (ORD), through its Office of
Monitoring and Technical Support (OMTS), is responsible for developing an
Agency-wide quality assurance program to enable the U.S. Environmental
Protection Agency (EPA) to implement its regulatory mission and associated
monitoring functions.
Over the past several years, EPA has promulgated many regulations and
standards that require frequent or routine monitoring of ambient air and
water, wastewater discharges, public drinking water supplies, emissions from
stationary and mobile pollution sources, lead and phosphorus in gasoline, and
special categories of hazardous substances such as radionuclides, pesticides,
and carcinogens. To meet these monitoring requirements, EPA's quality
assurance program must provide validated measurement systems, reference
standards, and the necessary quality control materials and services.
This multiyear planning document:
o Describes the quality assurance program in terms
of goals, objectives, and functional elements.
o Summarizes the current status of ORD's ongoing
quality assurance efforts.
o Discusses*Agency and program needs.
o Delineates the resources and approaches required
to develop and carry out a dynamic quality
assurance program which will ensure scientifically
valid environmental measurements.
This document is not intended to establish organizational responsibili-
ties within the Agency, or identify the resources required to implement
quality assurance within the various EPA monitoring programs and the Regional
Offices. The major thrust of this document is to identify and justify the
resources required by ORD to develop the quality assurance tools, techniques,
and services that other program offices, the Regions, and the States need to
generate valid data.
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Goals and Objectives
The overall goal of the quality assurance program is to ensure that the
environmental data EPA uses are sufficiently accurate, precise, and reliable
to meet Agency needs at a reasonable cost. To achieve this goal, the EPA
quality assurance program must:
o Provide precise, accurate, reliable, and cost-
effective sampling techniques, analytical methods,
and data formatting procedures to all organizations
upon whom the Agency depends for its environmental
monitoring data.
o Provide quality control materials, guidelines, and
services to ensure that all environmental data based
upon these techniques, methods, and procedures are
statistically valid and legally defensible.
o Provide for continuous review and evaluation of
monitoring programs to ensure that an approved
quality assurance program is being implemented
throughout the Agency.
Elements of a Quality Assurance Program
The quality assurance program covers two major functions:
o Standardization and validation of total measurement
systems.
o Development and implementation of quality control
practices and techniques to document data quality
and systems performance.
A detailed description of the EPA quality assurance effort, along with
implementation plans and organizational responsibilities, was set forth in
two separate strategy documents approved by the Agency in 1973.1>2
CURRENT STATUS AND RESEARCH NEEDS
EPA's quality assurance program was not identified as a separate program
element until FY-1973, although many related activities were in operation
long before. Since that time, the quality assurance program has tried
desperately to increase its outputs to meet the requirements of established
environmental regulations and standards.
Measurement Methods Standardization Strategy Document, September 1973.
2
Development of Agency-wide Quality Control Program, February 1973.
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Some of the program goals and objectives cited above have been realized
for measurements of ambient air and surface water quality. Also, notable
progress has been made in developing reference samples and testing measurement
systems for stationary air pollution sources and for wastewater discharges.
In addition to the standardization efforts, quality control efforts have
resulted in increased availability of reference samples and materials, on-site
evaluations of all Regional laboratories, regularly scheduled interlaboratory
performance tests, procedures and criteria for evaluating and certifying water
supply laboratories, and automated laboratory systems.
Although much progress has been made, many Agency quality assurance needs
have not been met. Among the important unmet needs are:
o Development of a comprehensive methods standardi-
zation and quality control effort to support the
water supply program, including laboratory
certification.
o Validation and approval of test procedures,
promulgated under Section 304(g) of the Federal
Water Pollution Control Act Amendments of 1972,
for guidelines regulations and the development of
an interlaboratory quality control to support the
validity of the Discharge Monitoring Reports.
o Development and expansion of quality assurance
efforts for noncriteria air pollutants, research
monitoring programs, Consent Decree Pollutants, and
toxic substances.
o Development of quality assurance training and
establishment of a mechanism for improved coordina-
tion between EPA program offices, Regional Offices,
and laboratories.
o Development of guidance manuals for siting and
validating monitoring stations and optimizing
environmental monitoring networks.
RESOURCE LEVELS AND IMPLEMENTATION OPTIONS
Quality assurance is, for the most part, a "level-of-effort" activity,
and the resources (dollars and positions) directly impact the scope of work
with respect to the number and types of monitoring programs that can be
covered. An optimum quality assurance program should provide:
o Valid measurement and quality control systems to
support implementation by program offices and the
Regions of regulations and standards at reasonable
cost.
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o Continuous review and evaluation of the perfor-
mance and data quality of monitoring systems.
o Support for monitoring emergency episodes,
environmental quality trends, and special research
studies.
Since there are major differences among some of the various types of
monitoring activities, many of the quality assurance functions and research
outputs must be duplicated to meet specific requirements with respect to
pollutants measured, source and concentration levels, environmental matrix in
which the pollutant is found, and purpose for which the data are being
obtained. Therefore, the quality assurance effort may appear the same from
year to year, while, in reality, it is addressing radically different monitor-
ing and data quality problems.
Summary of Resources and Implementation Options
A summary of resource options along with implementation approaches is
given below:
Option 1
FY-1977 FY-1978 FY-1979 FY-1980 FY-1981 FY-1982
$M 5.3 5.3 6.3 8.5 10.0 10.0
MY 67 67 67 67 67 67
Under Option 1, the FY-1978 program will not change substantially from
the FY-1977 program. In fact, there will need to be some curtailment and/or
redirection in current activities to provide a critical mass for addressing
"highest" priority areas. For example, in the water measurements area,
emphasis will be given to meeting critical needs for the programs on water
supply and National Pollution Discharge Elimination System permits.
In the air measurements area, the quality assurance efforts will concen-
trate primarily on standardization and improvement of measurement methods for
stationary sources, limited performance audits of source measurements,
maintenance of reference samples and materials, and continuation of the
interlaboratory tests for ambient air measurements.
Also, under Option 1, the ongoing quality assurance efforts for measure-
ments of biological materials and other environmental media will continue at
the same level as in FY-1977. Primary emphasis will be upon support of the
pesticide residue monitoring program and of radiochemical measurements for
milk, food, and soil.
In later years, and projecting no change in man-years, the quality
assurance effort will be expanded and improved in those areas that can be done
extramurally: laboratory and field evaluation of sampling and analysis
systems; preparation and distribution of quality control samples for routine
use; and development and publication of quality control procedures, methods
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manuals, and the like. Those efforts requiring dedicated in-house personnel
will not substantially improve validation of measurement methods and approval
of alternate test procedures; on-site evaluation of laboratories; interlabora-
tory performance tests and development of the associated standard reference
samples; and direct technical assistance to laboratories that need to improve
performance and data quality.
Option 2
FY-1977 FY-1978 FY-1979 FY-1980 FY-1981 FY-1982
$M 5.3 6.3 8.5 10.0 10.0 10.0
MY 67 77 87 87 87 87
Resource Option 2 represents an increase of $1M and 10 positions for
FY-1978. This increase will be allocated to support Standards of Performance
for New Stationary Sources under the Clean Air Act, effluent guidelines
regulations under Section 304(g) of the Federal Water Pollution Control Act
Amendments, and the Safe Drinking Water Act. More specifically, $500K and
5.5MY will be allocated to support the water supply program, including test
procedures, reference samples, and laboratory certification. The remainder of
the FY-1978 increase, $500K and 4.5MY will be used to support effluent
guidelines regulations, performance audits for air pollution source measure-
ments, and critical measurements of noncriteria air pollutants.
The Option 2 resources in FY-1978 are not adequate, in dollars or
man-years, to provide a comprehensive quality assurance effort to support
existing regulations, and the resources certainly do not provide coverage of
Consent Decree Pollutants, ocean dumping regulations, etc.
The resource allocation of Option 2 in later years allows for gradual
development, implementation, and maintenance of a national quality assurance
effort covering all existing and currently planned air and water regulations,
standards, and monitoring requirements.
Option 3
FY-1977 FY-1978 FY-1979 FY-1980 FY-1981 ?Y-1982
$M 5.3 8.5 9.5 10.5 11.5 12.0
MY 67 87 90 90 90 90
Under Option 3, the gaps in the current program can be quickly closed and
a comprehensive quality assurance program developed for all existing and
currently planned environmental monitoring regulations and standards.
The $3.2M and 20MY increase requested in FY-1978 would be allocated
approximately as shown below.
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Activity Funded
$K(MY)
Standardization of water supply measurement methods
reference samples, guidelines, and assistance to
Regions and States for laboratory certification . .
Quality assurance program for monitoring reports on
wastewater discharges, including some on-site
inspections of laboratories
Standardization and approval of Section 304(g) test
procedures and establishment of a measurement methods
equivalency program
Performance audits for stationary source
measurements
Performance audits and measurement system
evaluation for hazardous substances and other
noncriteria air pollutants
Standardization and optimization of measurement
systems for Consent Decree Pollutants in water and
wastewater discharges
Ancillary activities (reports, data audits,
coordination, meetings, workshops) . . . .
1,200(5)
200(3)
450(3)
260(4)
340(3)
700(1)
50(1)
At the Option 3 level of resource allocation, the program in later years
is designed to provide the reference or standard monitoring methods, quality
control procedures, associated standard reference materials, and quality
control program audits that are needed by either the Agency's operational
monitoring programs or the States. Also provided are expert advice and
technical assistance to correct deficiencies in the performance of measure-
ments systems and operators.
SUMMARY HIGHLIGHTS OF REGIONAL COMMENTS
This document attempts to focus on the needs of the EPA Regional Offices
as the primary users of the quality assurance research outputs and services.
The Regions require these outputs in order to carry out the Agency's
mandated monitoring requirements and/or to assist the States. Therefore, the
last section of this document presents a brief summary of comments on future
quality assurance plans received from the 10 EPA Regional Offices. These
comments have been tabulated and arranged according to the number of Regions
identifying the same area of concern. For example, most, or all Regions,
have Identified four common needs: (1) comprehensive long-term quality
assurance plans for the Regions; (2) standardization protocols for
measurement methods and an approval mechanism for methods suggested as
alternatives to those promulgated with regulations and standards;
(3) a system to quantify data quality and to reject data out of control; and
(4) quality control and reference samples for routine use. Other Regional
xlii
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comments range from needs for validating more of the test procedures for
Section 304(g) to certifying laboratories analyzing public drinking water.
This document attempts to address the Regional and other quality assurance
needs through the development of a reasonable plan for the research that will
be done over the next 5 years.
xiv
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ACKNOWLEDGMENTS
Acknowledgment is made to the Environmental Monitoring and
Support Laboratories at Cincinnati, Ohio, Las Vegas, Nevada, and
Research Triangle Park, North Carolina for their participation and
inputs in the preparation of this document. Appreciation is
extended to Bob Booth, John Clements, Arthur Jarvis, Gene Esterly,
Wayne Ott and Linda Smith for their suggestions and comments.
A special appreciation is extended to Gladys Bennie who typed
this manuscript.
xv
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I. INTRODUCTION
The Office of Research and Development (ORD), through its Office of
Monitoring and Technical Support (OMTS), is responsible for developing the
measurement systems and the quality control techniques and services that the
United States Environmental Protection Agency (EPA) needs to implement an
Agency-wide quality assurance program. This multiyear planning document:
o Describes the quality assurance program in terms
of goals, objectives, and functional elements.
o Summarizes the current status of ORD's ongoing
quality assurance efforts.
o Discusses Agency and program needs.
o Delineates the resources and approaches required
to develop and carry out a dynamic quality
assurance program that will ensure scientifically
valid environmental measurements.
This document is not intended to establish organizational responsibil-
ities within the Agency or to identify the resources required to implement
quality assurance within the various monitoring programs and EPA Regional
Offices. Nonetheless, ORD is fully aware that the success of any quality
assurance effort rests with the individual monitoring activities and that a
significant amount of its effort must be expended to control and document
data quality. Recognizing that quality assurance resources should be
identified and planned for, this document emphasizes the identification and
Justification of the resources required by ORD to develop the quality
assurance tools, techniques, and services that other program offices, the
Regions, and the States need to generate valid data.
GOALS AND OBJECTIVES
The overall goal of the quality assurance program is to ensure that the
environmental data EPA uses are sufficiently accurate, precise, and reliable
to meet Agency needs at a reasonable cost. To achieve this goal, the EPA
quality assurance program must:
o Provide precise, accurate, reliable, and cost-
effective sampling techniques, analytical methods,
and data formatting procedures to all organizations
upon whom the Agency depends for its environmental
monitoring data.
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o Provide quality control materials, guidelines
and services to ensure that all environmental
data based upon these techniques, methods, and
procedures are statistically valid and legally
defensible.
o Provide continuous review and evaluation
of monitoring programs to ensure that an
approved quality assurance program is being
implemented Agency-wide.
ELEMENTS OF A QUALITY ASSURANCE PROGRAM
The quality assurance program covers two major functions:
o Standardization and validation of total measure-
ment systems.
o Development and implementation of quality control
practices and techniques to document data quality
and systems performance.
A detailed description of the EPA quality assurance effort, along with
implementation plans and organizational responsibilities, was set forth in
two separate strategy documents approved by the Agency in 1973. ' These
documents need to be updated to reflect the many changes that have occurred
within EPA since 1973; only the elements of the quality assurance program
described in this document have remained fairly constant. However, the
descriptions of the quality assurance elements have been condensed and
placed in the forepart of this document to aid the reader in understanding
the research effort described herein.
Standardization and Validation of Measurement Systems
The efforts to standardize measurement systems are directed towards
improving the basic monitoring tool — the measurement method — which
consists of five closely related modules:
o Criteria for selecting sampling sites.
o Sampling techniques.
o Sample work-up.
o Analysis of the sample.
o Presentation of the data.
Measurement Methods Standardization Strategy Document, September 1973.
2
Development of Agency-wide Quality Control Program, February 1973.
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The two major elements of a program of measurement method standardization
are protocols for system standardization and for measurement method
equivalency.
System Standardization Protocol
A number of steps are involved in development and implementation of the
system standardization protocol:
Identification of methodology needs — Methodology needs arise from
statutory requirements, needs identified within the Agency, and needs
identified outside the Agency. The methodology needs identified must be
responsive to the Agency's priority missions. The standardization process
is both costly and lengthy. Therefore, identification of specific needs
must be done well in advance of deadlines to allow coordination of the
standardization process with the schedules of the activities requiring
standardized measurement systems. Methodology needs are solicited from
program offices and Regional Offices, as well as from all ORD technical
support elements. Methods standardization needs can be specifically identi-
fied as a single need or they can be highlighted in relation to other areas
such as development of criteria and standards. Measurement methodology needs
can also be identified by evaluating new priority pollutants and by the
experience gained from field programs, as well as from health and ecological
effects and other research groups.
Selection of candidate methods* - Once a task for the standardization
of a method for measuring a pollutant has been approved and funded, existing
methods applicable to the pollutant of concern are subjected to critical
theoretical analysis and preliminary laboratory and field testing. This
process yields a first approximation of the applicability and limitations of
the method — that is, detection limit, sensitivity, and susceptibility to
interferents. Measurement methods from the literature may be considered for
inclusion on the list of candidate methods. Also, measurement methods from
any other source Cfor example, methods developed by EPA's Office of Air,
Land, and Water Use or by independent suppliers) may be considered for
inclusion. When this process identifies no satisfactory method, research
requirements will be identified and communicated to those responsible for
research on methods development in ORD.
Evaluation and testing to select tentative methods — Candidate
methods are then subjected to intensive testing in a single laboratory to
*A candidate method is any method of sampling or analysis advanced by a
requesting party or selected by EPA as suitable for adoption as a standar-
dized method and eventual designation as a reference method of measurement
for criteria pollutants.
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verify predictions made by theoretical analysis. Tentative methods will be
identified that meet minimum requirements in terms of accuracy, precision,
specificity, reliability, operational efficiency, and cost. A tentative
method should represent the best state-of-the-art and show acceptable per-
formance under a number of conditions that simulate those of the prospective
user.
Collaborative testing — Collaborative testing is an important step in
validation of any method of measurement to determine, on a statistical basis,
the limits of error that can be expected when the method is used by a typical
group of investigators. Collaborative testing is generally quite expensive.
Accordingly, only those methods deemed to be particularly critical to the
Agency's regulatory functions will be selected from the list of tentative
methods for collaborative testing.
The collaborative or interlaboratory testing of a method Is a vital part
of the development and standardization of analytical procedures. It ensures
that the procedure is clear and complete and establishes with confidence the
limits of precision and accuracy that may be claimed for the method. High-
purity reference materials, standard reference samples, and spiked samples
are used as required to validate the method. All of the data obtained are
statistically analyzed and evaluated. The total measurement system
(sampling, flow measurements, analysis, etc.) is fully characterized as to
its sensitivity, accuracy, precision, reliability, range, and limits of
detection. Interferents, stability of reagents, and maintenance may also be
considered during method validation.
Endorsements and publication — Once the method has been validated, it
is reviewed and endorsed by the quality assurance activity and other appro-
priate Agency elements for technical content and adherence to the standardi-
zation protocol. For methods that are not part of regulations, this is the
highest level of endorsement required before the method is declared a
"standardized method" and is published in the EPA Environmental Monitoring
Series or in other publications. For methods that support standards and are
to be promulgated or cited in regulations, the method is transmitted through
normal channels for approval, for example, working groups and Steering
Committee. Final endorsement is made by the Steering Committee. The method
is then transmitted to the Administrator for approval as a "standardized
reference method" and is published or cited in the Federal Register. Copies
of a reference method will be widely distributed within EPA so that the
method may be quickly and conveniently integrated into the appropriate
monitoring programs.
Measurement Method Equivalency Protocol
Promulgation of a reference method(s) in any environmental standard
requires determining "equivalency" of alternate methods. The equivalency
will be determined through use of an official EPA test protocol that will
provide a legally credible basis for comparison of the two methods. The
basic premise is that, within the provisions of the protocol, the proof of
equivalence rests with the individual, organization, or company submitting a
candidate method for approval as an equivalent method. This requires that
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the requesting party demonstrate that his candidate method meets certain
performance specifications and/or generates valid data that have a consistent
relationship with the published reference method. EPA then systematically
reviews these data, possibly with limited in-house testing, and either
accepts the evidence or indicates where performance specifications have not
been met; in-house testing may be necessary to make some judgments.
Considering the large number of air quality, water quality, and other
emission standards that will be published and the large number of instruments
or methods that will be proposed for each standard, this activity will
require substantial manpower and laboratory facilities in future years.
Discussion
Standardization and validation of measurement methods are costly and
time-consuming. However, the availability and selection of scientifically
proven, appropriate, and cost-effective measurement methods very often
impinge on a variety of EPA decisions and actions — setting of standards,
promulgation of many regulations, evidence for enforcement, guidance to State
and local agencies, and the like. The lack of adequate and consistent
methodology may seriously impair these activities. The lack of a good
measurement method may delay promulgation of a given standard or result in
later modification or withdrawal of an established standard. Regulations
concerning ambient and source standards must specify the measurement methods
to be used in determining compliance, and these methods must be routinely
applicable, at a reasonable cost if possible. EPA guidance to State and
local agencies regarding the measurement methodology to be used must be con-
sistent throughout the Agency. Also, the Agency could not fulfill its
enforcement responsibilities if an accused polluter could successfully attack
and discredit EPA's method for gathering environmental data. For these
reasons, EPA must verify its measurement methodology through a laboratory-
oriented scientific standardization effort that meets all challenges. EPA's
measurement methods can best be defended through the implementation of a
standardization protocol — the exhaustive, collaborative, replicative,
interlaboratory testing of the method for its accuracy and precision under
the conditions required by environmental standards or other EPA requirements,
and the statistical analysis of these tests to validate the performance of
the method in the hands of typical analysts under a variety of anticipated
conditions.
Activities included in standardization of measurement systems are:
o Selection of measurement systems that EPA and
others have demonstrated to be cost-effective
and reliable for routine monitoring of regulated
environmental pollutants.
o Thorough and rigorous evaluations of measurement
systems under real or simulated laboratory and
field conditions.
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o Preparation of statistically valid test pro-
cedures that can be used to establish the
precision and accuracy of the total measurement
system, including the error contributed by its
various components (sample collection, sample
stability, sample presentation, analysis, and
data handling and reduction).
o Interlaboratory comparison of the measurement
system to determine the precision and accuracy.
o Promulgation of the measurement system(s) as an
EPA reference or recommended method for regulated
pollutants.
o Establishment and operation of a mechanism to
allow demonstration and use of equivalent methods.
o Coordination of a national standardization effort
through participation in intra- and inter-Agency
committees and national and international
standard-setting organizations.
In the context of these activities, measurement method standardization
is a key part of the quality assurance activity. To assure the quality of
environmental measurement data, methodology must be available and used that
has demonstrated capability to make reliable measurements for its intended
purpose. Measurement method standardization stands between research and
quality control. EFA's research program conceptualizes and creates measure-
ment methodology based upon state-of-the-art scientific and engineering
knowledge. Standardization operates independently of research and is closely
related to quality control. The vital statistics that are necessary to
quantify and control the data generated by a measurement system are provided
through the standardization efforts.
Quality Control
The quality control effort completes the Agency's quality assurance
program by ensuring that validated methods are used in production of
environmental data and that laboratories maintain and document the acceptable
levels of performance established for measurement systems through the
standardization efforts.
The basic elements of a quality control program are:
o Development and Issuance of quality control
guidelines and procedures.
o Intralaboratory quality control.
o Interlaboratory quality control.
o Quality control coordination and training.
o Laboratory certification (evaluation procedures
and acceptance criteria).
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All these elements are important to the success of the quality control
activity, and each element should be developed and carried out simultaneously.
Development and Issuance of Guidelines
and Procedures
A basic requirement of a quality control program is a series of guide-
line manuals describing the procedures to be followed in sampling, analysis,
and data handling. Such prescribed procedures provide a uniform approach in
the various monitoring programs and allow evaluation of the validity of data
produced. Procedures are needed for all 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:
o Sampling.
o Methods selection.
o Laboratory.
Sampling procedures — A number of separate requirements is a necessary
part of sampling procedures:
o Site selection. The selection of sampling/
monitoring sites is the responsibility of each
monitoring program. However, guidelines are
needed that govern the placement of monitors
or the location where the sample is to be
taken to meet specific monitoring objectives.
Such 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.
o Station or instrument. Measurements may be
severely affected by the type and configuration
of the facilities 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, and
calibration procedures must be developed and
used. Similarly, design characteristics must
specify the types of monitors and special equip-
ment that must be accommodated. Adherence to
criteria for designing stations will ensure
optimum use of equipment, ease of operation,
minimum maintenance, and reduced data losses.
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o 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:
- Use of equipment and materials for collecting,
preserving, and transporting the samples.
- Length of sampling periods.
- Types of accompanying information needed.
In order to obtain meaningful data, a sound statistical basis for deter-
mining the frequency and duration of sampling/monitoring must be used in the
design of monitoring programs. Such procedures must be provided in the
manuals. Specific procedures must also be established that document the
chain-of-custody of wastewater samples collected for enforcement actions and
for samples of receiving water taken at or near points of suspected
violations.
o Calibration procedures. To ensure that data
generated by automatic or integrating field
sampler-analyzers are valid, procedures must be
specified for routine field calibration of these
instruments. The calibration frequency, as well
as the procedures used, should be identified and
described.
o Special procedures. With the proliferation of
continuous monitors, automated samplers, and
in situ analyzers, procedures need to be developed
for procurement of advanced monitors based upon
performance specifications. Such technical pro-
cedures should be based upon performance testing
under real conditions. This activity is closely
related to development of test protocols for
equivalency determination. Also, other procedures
are needed to provide uniform chain-of-custody for
handling enforcement action samples, performance
specifications for automatic samplers for effluents
and surface waters, and procedures for evaluating
the adequacy and accuracy of flow measurement
devices.
Methods selection procedures — Many different methods are available
for measuring pollutants in environmental media. Some have been promulgated
by EPA, while others have been published by groups such as the American
Public Health Association (water), the American Society for Testing Materials
(air/water), and the Inter-Society Committee (air). EPA has the statutory
responsibility to promulgate environmental, emission source, and waste
effluent standards, including specifications of the appropriate method of
measurement, collection, and analysis. To ensure the use of standard,
reference, or equivalent methods throughout the Agency, an approved compen-
dium must be developed for all pollutants in all media and published for all
8
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monitoring activities. To ensure that this requirement is prescribed as
Agency policy and uniformly followed, an intra-Agency committee on measure-
ment method standardization should be established.
Laboratory procedures — Where routine monitoring of regulated
pollutants is concerned, all EPA laboratories will be requested to utilize
methods described in an EPA-approved compendium or document any alternate
procedures employed. Where more than one method is available, the selection
criteria will be based upon the applicability of the method, its comparabil-
ity with methods used in other laboratories, and its ability to meet require-
ments of the data user. Specific guidelines for selection of alternative
methods and test procedures for routine monitoring should be developed and
distributed Agency-wide. Also, it is extremely important that quality
control procedures concerning standard laboratory requirements and practices
be developed, promulgated, and followed. These guidelines should cover all
facets of routine laboratory operations and maintenance of equipment and
apparatus.
Intralaboratory Quality Control
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 document the accuracy and precision of results and the performance
of monitors and analysts. Intralaboratory quality control is a continuing
requirement to ensure the output of data for which statistical confidence
limits can be shown. The specific objectives of the program are to adopt
and implement procedures that:
o Ensure use of proper procedures and measurement
methods.
o Measure and control the precision of procedures
and instruments.
o Measure and control the accuracy of analytical
results.
o Ensure data output is uniform and/or compatible
with Agency and national outputs.
o Present data in proper format.
o Document performance of instruments and analysts.
o Document training needs.
o Identify weak methodology and, consequently,
research needs.
o Ensure that quality assurance practices are
followed and documented In those laboratories
supplying data to EPA.
-------
The ORD quality assurance program is directed, in part, toward providing
the materials and services to support intralaboratory quality control
activities.
Interlaboratory Quality Control
An interlaboratory quality control program serves to continuously
evaluate measurement methods to characterize their precision and accuracy,
as well as to provide data for evaluating measurement methods, laboratories,
and analyst performance. This aspect of quality control is referred to as
cross-check sample studies and/or interlaboratory performance tests.
Specific objectives of the program are to:
o Provide a credible repository of standard
reference samples and materials for testing
performance of total measurement systems.
o Measure the precision or reproducibility of
methods of analysis within various laboratories
and programs.
o Measure the precision and accuracy of results
between laboratories.
o Provide a mechanism for evaluation of laboratories
and analysts.
o Detect weak, improper, or impractical methodology.
Participating laboratories are provided standard reference samples,
instructions, and data forms necessary to test measurement methods under
certain prescribed conditions. The results are submitted to a central
coordinating laboratory where they are statistically evaluated to determine
the accuracy and precision of the method. Moreover, the test data are
evaluated to determine the general applicability of the method for a specific
purpose, and to evaluate and compare the performance of laboratories and
analysts.
This type of activity involving laboratories in evaluating 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 interlaboratory quality control program as a mechanism
for methods standardization and selection.
Quality Control Coordination and Training
To succeed, a quality control program requires coordination to ensure
adequate and timely exchange of information, and training to correct
deficiencies identified via laboratory performance tests and on-site evalua-
tions. The following types of activities are included:
10
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o Reports from meetings of quality assurance
committees.
o Reports from central files on requests and use
of Standard Reference Materials and Standard
Reference Samples.
o Reports of quality control conferences.
o Quality control newsletters.
o Quality control workshops and seminars.
o Reports on training needs.
Laboratory Certification
Certification is an important subelement of the quality assurance
management activity and involves formal approval and/or endorsement of
acceptable performance by a laboratory or analyst. Certification is
directly relatable to the interlaboratory quality control. Certification of
a laboratory documents that the laboratory has met all of the prescribed
acceptance criteria of a certifying authority such as EPA. These acceptance
criteria include: proper equipment and facilities; the required personnel
with adequate training and experience; the necessary instrumentation,
properly calibrated and maintained; documentation that quality control is
being practiced; and documentation that the analysts/technicians have
performed an acceptable analysis of blind standard reference samples.
Discussion
Quality assurance practices are a critical part of any reliable environ-
mental monitoring operation — reliable measurement systems must be used,
instruments must be calibrated and maintained, uniform quality control
procedures must be established and followed, performance and data must be
audited, and personnel must be trained. Thus, the elements of any viable
monitoring strategy must be directly linked to the essential elements of the
quality assurance strategy, as shown in Figure 1.
The current 'quality assurance program is unable to validate all of the
measurement systems necessary to support existing regulations and standards
or to provide the quality control guides and tools needed by individual
monitoring programs.
The growth of monitoring programs, the rapid expansion of the energy
program, the promulgation of the interim drinking water regulations, the
impending water supply laboratory certification program, and the Agency's
growing interest and concern with heavy metals, trace elements, organic
carcinogens, and other hazardous substances — all present new challenges to
the quality assurance program. The increasing complexity of interaction,
liaison, and communication between EPA and other Federal, State, and local
agencies involved in or concerned with environmental monitoring points to
the critical need for a well-planned, coordinated, comprehensive, integrated,
multimedia quality assurance program.
11
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ENVIRONMENTAL MONITORING PROGRAMS
•
INS
AN
AUTO
SYS1
Silt SELECTION 1 H
r^^^H
,
f
ITU
0 "
MATED
FEMS
t
SAMPLING
*
SAMPLE PRESERVA
*
LABORATOR'
ANALYSIS
I ' \
DATA VALIDATIO
,
li*
H*-
r FIELD
ANALYSIS
1
GUIDELINES/TECHNICAL ASSISTANCE
VALIDATED PROCEDURESfTRAINING
VALIDATED PROCEDURES/TRAINING
REFERENCE/EQUIVALENT METHODS
QUALITY CONTROL GUIDES
QUALITY CONTROL SAMPLES
ON-S1TE EVALUATIONS
PERFORMANCE CHECKS
AUTOMATED LABORATORIES
WORKSHOPS/SEMINARS
DATA
AUDITS
Figure 1
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II. CURRENT STATUS AND RESEARCH NEEDS
This section examines the progress made in implementing an Agency-wide
quality assurance program and the future research required to provide
adequate support for existing and planned environmental monitoring activities.
The current status and future research needs of the two major elements of the
ongoing quality assurance program are described as they relate to air, water,
and other environmental media of concern. In addition, new .directions in
quality assurance programs for research laboratories and energy programs are
discussed briefly.
EPA1s quality assurance program was not identified as a significant
program element until FY-1973, although many related activities were in
operation long before. Since that time, the program has tried desperately
to increase its outputs to meet the requirements of established environmental
regulations and standards. Major progress towards providing support for
EPA's regulatory mission has resulted since formalization and recognition of
the quality assurance program. Major highlights of the accomplishments from
very late FY-1973 and early FY-1974, as well as the current status of the
quality assurance program, are described below.
STANDARDIZATION AND VALIDATION OF MEASUREMENT SYSTEMS
The major efforts of concern in the measurement system standardization
area are:
o Development and implementation of formal
standardization protocols for "reference"
measurement systems required by EPA
regulations and standards.
o Statistical validation of measurement systems
with respect to precision and accuracy.
o Development of equivalency protocols to ensure
efficacy of methods used as alternatives to
those promulgated by EPA.
In these major areas of activity, the current status and future research
needs are described below for pollution measurements related to air, water,
and biological materials and other environmental media.
Air
Standardization efforts related to air pollution have focused on measure-
ment methods to support the National Ambient Air Quality Standards (NAAQS),
13
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Standards of Performance for New Stationary Sources (SPNSS), National
Emission Standards for Hazardous Air Pollutants (NESHAP), Fuel and Fuel
Additives Regulations (FFAR), and Mobile Source Emission Standards (MSES).
Current Status
Standardization protocols for air pollution measurements systems have
evolved from various contractual efforts underway since FY-1973. However,
the testing and evaluation procedures used to validate measurement methods
have not been documented and endorsed for general use by organizations
outside ORD. Consequently, there are presently no written test protocols
and criteria for acceptance of standardized measurement systems except those
systems standardized by EPA.
A number of measurement systems related to air standards and regulations
have been'standardized. Ambient air methods have been evaluated, collabora-
tlvely tested, and approved for five pollutants:
Pollutant Method
Suspended particulate High-volume samples
CO NDIR
SOj Pararosaniline
Oxidant Chemiluminescent
NO. Chemiluminescent
Sodium arsenite
TGS-ANSA
Continuous Saltzman
In addition to collaborative testing of methods, problems concerning
calibration of continuous air monitors and stability of manually collected
samples have been investigated and documented in ORD program reports to the
general air pollution monitoring community, including the EPA Regional
Offices and the States. Methods have been evaluated and collaboratively
tested for several types of stationary sources:
Source Pollutant EPA Method No.
Power plants Particulate 5
SO 6
NO 7
x
Opacity 9
Municipal incinerators Particulate 5
Cement plants Particulate 5
Opacity 9
Sulfuric acid plants SO /SO Sulfuric acid mist 8
Nitric acid plants N0x 7
Opacity 9
Chlor-alkali plants Mercury 101
Ceramic plants Beryllium 104
14
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In addition, the problems associated with use of one specific measurement
method for a variety of source types have been and continue to be investi-
gated. For example, one measurement method for particulate matter is
generally proposed for use in a multitude of industrial sources. Extensive
revisions have been proposed for a number of reference methods
(Federal Register 41 23060, June 8, 1976), and much of the information in
the suggested revisions results from these investigations and the
collaborative tests that were conducted. An equivalency program is opera-
tional for measurements in ambient air, and many instrumental methods have
been approved as equivalent or reference procedures.
Along with promulgation of SPNSS and NESHAP, EPA has adopted a series
of reference test methods. These include not only manual and instrumental
methods, but also such methods as visual opacity determinations. At present,
requests to approve equivalent methods have been limited. Nevertheless, the
Office of Air Quality Planning and Standards has expressed the need to
provide the States with criteria or guidelines to apply in determining
equivalency for approval of measurement methods for stationary sources of
air pollution. The Agency should actively pursue development of such
criteria or guidelines.
Future Research Needs
It is important that EPA seriously consider development and promulga-
tion of protocols that will at a minimum establish performance and other
acceptance criteria for those measurement methods designated as reference or
equivalent.
Standardization efforts, while establishing validated methods, have
also uncovered flaws in measurement methods that must be corrected. In
anticipation of future regulations and to acquire air quality data for
making important environmental decisions, standardized methodology (both for
ambient air and for stationary sources) is needed for the following air
pollutants: hydrogen sulfide, sulfates, nitrates, sulfuric acid, particulate
by size, reactive hydrocarbons, benzidine, vinylidene chloride, ethylene
dibromide, vinyl chloride, polynuclear aromatics, polychlorinated biphenyls,
benzene, trichloroethylene, dichlorobenzidine, chlorinated naphthalenes,
lead, arsenic, chromium, cadmium, mercury, plutonium, krypton-85, and
asbestos.
Measurement equivalency efforts should be expanded to cover SPNSS and
NESHAP for situations such as the following:
o In States that have requested delegation of
authority to enforce SPNSS or NESHAP,
equivalency of State-adopted methods must be
determined.
15
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o For sources where the frequency of testing is
high (for example, fluoride or vinyl chloride)
and where EPA methods are required, either directly
or indirectly (for example, under Section lll(d) of
the Clean Air Act Amendments), the equivalency of
less expensive techniques must be determined.
o Equivalency must be assessed of new instrumental
or manual techniques that evolve which are
potentially superior (e.g., less costly, more
precise, or of greater utility in enforcement) to
current measurement methods.
Water and Water Supply
Most recent standardization efforts in the water pollution measurements
area have been directed towards meeting the monitoring requirements of the
Federal Water Pollution Control Act Amendments of 1972, Public Law 92-500.
Under Section 304(g) of this Act, more than 120 test procedures for waste-
water analyses have been promulgated. Program emphasis and priorities have
focused on evaluation of the measurement methods required to show compliance
with permit conditions for wastewater effluents.
In addition, the Safe Drinking Water Act of 1974, Public Law 93-523,
requires that test procedures and quality control be a part of the primary
drinking water standards. Immediate consideration must be given to
validation of test procedures that have been promulgated to show compliance
with maximum contaminant levels for trace inorganics, trace organics
(including pesticides), and bacteria.
Also, the Marine Protection, Research, and Sanctuaries Act of 1972,
Public Law 92-532, requires in Section 102(a) that quality assurance on
analytical methodology be developed as needed for the Administrator to
establish criteria for evaluating discharge permits that "shall consider ...
the effects on human life and values, the effects on fisheries, all marine
life, shorelines and beaches...[and] the effect on marine ecosystems".
A major new effort in the coming years must include validation and
standardization of test procedures that can be used for physical, chemical,
radiological, and biological measurement of marine waters and ecosystems.
Current Status
In the areas of water and wastewater analyses, formal interlaboratory
studies have been completed for validating methods for minerals, nutrients,
biochemical oxygen demand, mercury, and cyanide. Validation studies will be
completed in early FY-1977 for trace metals, petroleum hydrocarbons in brine,
and chlorophyll. Tentative reference methods have been collaboratively
tested for radioactive pollutants (including gross alpha and gross beta
activities, tritium, total radium, radium-226, strontium-89, and
16
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strontium 90) in water and wastewater. Two methods for analysis of plutonium
in soil, pyrosulfate fusion and dissolution by acid digestion, were
collaboratively tested. A round-robin study involving measurement of aqueous
solutions of polonium-210 was conducted. Manuals of recommended radio-
analytical methods are available for general and specific radiation measure-
ments. Manuals are also available for physical, chemical, biological, and
microbiological measurements of water and wastewater.
To improve the efficiency of laboratories and increase the level of
quality control over the data produced, one Regional, one research, and one
quality assurance laboratory have been automated. Automated laboratory
systems use minicomputers to operate standard laboratory instruments, ensure
quality control of the data, manage sample control, and prepare timely
reports. Feasibility studies have been conducted in several other Regional
laboratories and the National Enforcement and Investigation Center to
determine the need and cost-effectiveness of automated laboratory systems.
Future Research. Needs
Some of the most critical research needs in the water pollution
measurements area include:
o Development of protocols/criteria for validation
and standardization of the total water measurement
system Cas previously described for air pollution
measurements).
o Evaluation and validation of measurement methods
and monitoring system support standards and
regulations for municipal and industrial effluents,
ocean disposal, drinking water, ambient water
quality, and hazardous substances.
o Evaluation and validation of methods for analysis of
radium-22'8, iodine-131 (low levels), cesium-134,
plutonium, uranium, and americium in water.
o Evaluation of current water measurement methods for
applicability to leachates from solid waste disposal
sites.
o Continuation of support for development of automated
quality control laboratory systems.
o Development and standardization of a computerized
system for evaluating, analyzing, and reporting
interlaboratory performance test data.
o Statistical validation of flow measurements, sampling,
sample preservation procedures, and equivalency proto-
cols as appropriate.
17
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o Development and evaluation of screening methods
for hazardous substances.
o Evaluation and development of performance
specifications for automatic sampling and monitor-
ing instrumentation.
o Development and implementation of an equivalency
program for water measurement methods.
Biological Materials and Other Environmental Media
Standardization activities outside the air and water area include
measurements of a variety of pollutants and/or their metabolites in plant
and animal tissues, blood, urine, and soil. This effort supports studies
to determine transport mechanisms and fate of pollutants, critical receptors,
and the like.
Current Status
To date, major emphasis has focused on pesticide residues and radio-
nuclides. Among the major outputs are:
o A manual of methods for the analysis of pesticide
residues has been published, and many of the
measurement methods have been thoroughly evaluated
and subjected to collaborative testing.
o Various gas chromatographic columns and column
materials have been standardized for separation
of pesticides.
o Two methods for plutonium in soil — pyroaulfate
fusion and dissolution by acid digestion — have
been collaboratively tested.
o Manuals of recommended radioanalytical methods
have been prepared for general and specific
radiation measurements.
Future Research Needs
Future needs for standard reference methods for measurement of
radioactive pollutants include: strontium-89 and -90, gamma emitters,
and iodine-131 (low levels) in milk; radium-228, cesium-134, iodine-131,
and uranium in water; and uranium and thorium in soil. Also, existing
collection and analysis methods for sediments must be evaluated.
In the area of pesticide residue analysis, future efforts should
include evaluation and validation of measurement methods routinely used by
the Regions and States for residues in soils, tissues, etc. Also, some
measurement method (to be identified by the Office of Pesticide Programs)
18
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for pesticides in mothers' milk, animal tissues, blood, urine, and soils
needs to be collaboratively tested.
In addition to new starts and/or expansions of efforts, current ongoing
quality assurance efforts — for example, reference samples and cross-check
sample studies — should be continued. In the radiation performance
measurements area, program efforts will include support for the Nuclear
Regulatory Commission. Also, there is a continuing need to develop and make
available standard reference samples of pesticides, radionuclides, and other
hazardous materials in biological materials and other environmental media.
QUALITY CONTROL
Quality control activities focus on the timely provision of instruc-
tional guides, reference materials, systems performance evaluations, and
technical assistance needed to assure the validity and legal defensibility of
all the data required by the Agency to carry out its regulatory mission.
Emphasis is given to current compliance monitoring for wastewater, potable
water, ambient air, stationary source emissions, etc. The major outputs
include:
o Updated and improved guidelines and manuals for
quality control of analytical techniques/data,
and sampling/siting.
o Certification procedures and acceptance criteria
for laboratories and analysts.
o Development and provision of reference samples
and materials, with Increased emphasis on
hazardous and toxic substances.
o Continuation of interlaboratory performance tests
for measurement of pollutants in biological mater-
ials and other environmental media, as well as for
special monitoring studies in the western energy
corridor.
The current status and research needs are described below for the
quality control activity in air, water, and biological materials and other
environmental media.
Air
Currently, development activities are primarily concerned with the
quality control systems, guidelines, and reference material needed to assure
the quality of data from ambient air and stationary source measurements.
Program emphasis is directed towards criteria pollutants for which regula-
tions and standards have been established. However, during most fiscal years,
some emergency efforts are needed for special studies — for example,
vinyl chloride, kepone, ethylene dibromide, and lead. Therefore, plans based
upon currently known needs and priorities must be flexible enough to meet
19
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crisis situations without disrupting the total quality assurance program.
Current Status
Development and issuance of information and procedures include guide-
lines for development of quality assurance programs for ambient air and
stationary sources, a quality control handbook for air pollution measurements,
and guidelines for on-site evaluation of laboratories.
Intralaboratory quality control is being supported through development
of reference materials, standards, and,instrumentation for use by individual
laboratories and monitoring activities. Among the major outputs are:
Pollutant Device or Material
SO Freeze-dried sulfite-TCM
NO2 Aqueous sodium nitrite
Particulate Flow audit device for high-volume samples
CO CO/air in cylinders
Sulfate/nitrate Glass fiber filter strips containing SO-
NO^ ions
Lead Glass fiber filter strips containing lead
Lead-Gasoline
Phosphorus—Gasoline
Gross alpha/beta 2" or 4" diameter air filters
Plutonium-239 2" or 4" diameter air filters
Krypton-85 Cylinders of krypton-85 in air
Although resources for energy programs are handled separately, there is
a heavy involvement in intralaboratory quality control in support of 25
agencies monitoring air in eight western States where new energy sources are
being developed. Included are on-site evaluations, quarterly performance
audits, and analytical support for a number of pollutants.
The Assistant Administrator for Research and Development has directed
all ORD laboratories to develop quality assurance plans covering all appro-
priate research and monitoring activities. Support for these intralaboratory
quality control efforts is provided as requested.
Interlaboratory quality control efforts include: development and
demonstration of techniques for on-slte evaluation of monitoring support
laboratories, all Regional laboratories, the National Enforcement and
Investigation Center laboratories, and one Sta^e laboratory, as well as
direct assistance to Regions in evaluation of radiation laboratories; and
development of reference samples and materials that can be used for inter-
laboratory performance tests. The following performance surveys are carried
out semiannually (except as noted):
20
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Pollutant
S02
CO
N02
Partlculate (annually)
Sulfate/nitrate
No. of surveys
to date
4
3
2
2
Approximate no.
of participants
165
120
120
150
60
The following special performance surveys are carried out as noted:
Program
Radiation
National Air Sam-
pling Network
Los Angeles Auto-
mobile Catalyst
Studies
Community Health
Environmental Sur-
veillance Studies &
Community Health
Air Monitoring
Program
Unleaded gasoline
Pollutant
Gross alpha/beta
Plutonium-239
S00, NO-
S00, NO.
2,
ions, lead
Period
Quarterly
Quarterly
Quarterly
Weekly
S02, N02, S04/N03 ions
Lead and phosphorus
Weekly
On request
Regional teams have been providing on-site and classroom instruction in
the conduct of field/laboratory inspections of air monitoring programs.
Biennial technical meetings are held with all Regional quality control
coordinators. Although Headquarters has provided some assistance to the
Regions to conduct quality assurance workshops, the level of effort is not
providing the training needed to improve State programs. There is no current
plan or effort to certify air monitoring support laboratories.
Future Research Needs
ORD needs to develop an adequate program for air monitoring programs to
use to strengthen their individual intralaboratory quality control of data
on emissions from stationary sources. The Agency should expand significantly
its ability to provide technical assistance and training on quality assurance.
Stationary source measurements and all currently unaudited criteria pollutant
measurements should be audited periodically.
Specific requirements include:
o Updates of quality control guides and manuals at
least every 2 years. (A mechanism is needed for addi-
tions or deletions without publishing new manuals.)
21
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o Development and maintenance of reference materials
and quality control samples for all criteria air
pollutants and for hazardous substances.
o Establishment of a standards laboratory to provide
interlaboratory calibrations for air measurements
and traceability of reference materials and samples
to the national standard measurement system at the
National Bureau of Standards (NBS).
o Continuation of the current program of periodic
performance audits and expansion of the program to
include performance audits of dynamic gas delivery
systems and stationary source measurements.
o Improvement and expansion of the Air Pollution
Training Institute's quality assurance courses.
o Increased participation in development and conduct
of Regional quality assurance workshops.
o Development and expansion of capability and mater-
ial for conduct of regularly scheduled special
audits (external) of a variety of important
monitoring programs (for example, RAMS, CHAMP,
CHESS, exposure chambers).
o Expansion of capability and conduct of laboratory
evaluations, including air monitoring stations,
and a reporting mechanism to assist Regions
planning effective use of resources.
o Development of a mechanism to screen air pollution
monitoring data before they go into the national
data banks.
Water and Water Supply
Development and implementation of a strong national quality control
program are of vital importance to EPA's mission to protect and improve the
quality of our national water resources. Over the past 3 years since the
expansion of quality assurance efforts for water measurements, tremendous
advances have been made towards improving the quality control for water and
wastewater measurement data. However, additional efforts are needed to
establish a viable national quality control effort, particularly for potable
waters, marine waters, biological monitoring, self-monitoring wastewater
programs, and toxic substances.
22
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Current Status
The following guidelines and procedures have been developed and issued:
o Analytical quality control manual for water and
wastewater laboratories.
o Procedures for on-site evaluation of water and
wastewater laboratories.
o Procedures and acceptance criteria for certifica-
tion of drinking water laboratories.
o Manual of measurement methods for water and wastewater.
o Biological methods manual.
o Microbiological methods manual.
o Brochure entitled "Environmental Radioactivity
Laboratory Intercomparison Studies Program 1977,"
which describes the cross-check sample studies
program for radioanalysis of environmental samples.
o Brochure entitled "Radioactivity Standards
Distribution Program 1977," which describes the
distribution and proper use of quality control
samples and other reference materials.
o Preliminary quality control manual for radiation
measurements.
o Contract reports on feasibility of laboratory
certification, a handbook for sampling and
preservation of water and wastewater samples, and
procedures for evaluation of environmental monitoring
laboratories.
o A procedures and criteria manual for certification of
water supply laboratories.
o Interim radiochemical methodology for drinking water.
The responsibility for implementing intralaboratory quality control
rests with the individual laboratory and monitoring programs. Intralabora-
tory quality control Is Identified in this plan to cover research outputs and
technical services that are directly relatable to day-to-day conduct of
quality control within the laboratory and in the field.
23
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Development and implementation efforts in intralaboratory quality
control include:
o Development and distribution to water labora-
tories each year of 5,000-7,000 sets of quality
control samples for checking data from analysis
of water and wastewater for minerals, nutrients,
trace metals, biological oxygen demand, linear
alkylate sulfonate, pitrilotriacetic acid, and
chlorophyll.
o Contract development of 12,000 quality control
reference samples for river sediment, suspended
solids, and petroleum hydrocarbons.
o Contract development of 10,500 mineral, nutrient,
trace metal, and oxygen demand reference samples;
5,000 samples for sludges.
o Distribution of approximately 1,500 calibrated
samples containing radionuclides to State and
private laboratories each year.
o Distribution to laboratories of mixed radionuclide
solutions prepared by NBS for calibration of Nal
detectors.
o Distribution, under an interagency agreement with
NBS, of calibrated solutions of radium-228 to
laboratories engaged in radioanalysis of public
drinking water supplies.
o Continuation of cross-check samples program for
radionuclides.
Interlaboratory quality control development and implementation efforts
include:
o On-site evaluation of all EPA Regional labora-
tories and the National Enforcement and
Investigation Center laboratories.
o Development of a computerized pilot system for
increasing efficiency of interlaboratory
performance tests, data analysis, and preparation
of reports.
o Interlaboratory performance tests for water and
wastewater measurements, including radioanalysis
of gross alpha, gross beta, gamma, tritium,
plutonium-239, and radium-226.
24
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o Development and maintenance of standard reference
materials and samples needed for interlaboratory
calibrations and performance tests.
o Direct assistance to the Regions In on-slte
evaluations of radiochemistry laboratories.
o Formal agreement with NBS to establish and
document the traceablllty of the Environmental
Monitoring and Support Laboratories to the
national measurement system for the analysis of
selected radlonuclldes.
Quality control training and laboratory certification efforts include:
o Biennial technical meetings with all Regional
quality control coordinators.
o Training of Regional laboratory evaluation teams
in proper use of procedures and protocols for
on-site inspection of water and wastewater
laboratories.
o Evaluation of procedures and acceptance criteria
for certification of drinking water laboratories.
Future Research Needs
As monitoring systems are improved, as systems are standardized and
validated, and as monitoring programs expand or change emphasis, quality
control guides, procedures, and manuals must be updated. Some specific needs
are:
o Manual of validated sampling and sample
preservation procedures.
o Updated manual of methods for water and
wastewater.
o Guidelines for chain-of-custody of enforcement
samples developed in cooperation with Office
of Enforcement.
o Quality control guidelines for performance
specifications, calibration, and maintenance
for continuous water quality monitors and
automatic samplers.
o Updated quality control manual to cover potable
waters.
o Manual of measurement methods for sediments.
25
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Intralaboratory quality control requires considerably more emphasis than
it has received in the past. Some progress has been made as a result of the
EPA Regional laboratory evaluations and the requirement for quality
assurance plans in all ORD laboratories. However, in future planning, a
timetable should be developed and the required resources provided for
follow-up activities in the Regional laboratories and for the evaluation and
assessment of quality control procedures in all EPA laboratories. The need
for existing and new quality control samples continues to grow. In particu-
lar, the materials required for quality control of potable waters
measurements (heavy metals, trace elements, radionuclides, pesticides,
organic carcinogens, and other hazardous substances) must be produced and
distributed on a national basis. Continued support for intergovernmental
program assignments in water supply will be required through FY-1980. This
arrangement provides support for the Regions in laboratory certification, and
also provides, on-the-job training for selected persons from many of the
States.
The interlaboratory quality control program for water measurements has
made progress in many important areas. As participation in the program
grows, many additional reference materials must be produced, and traceability
studies must be conducted to ensure their accuracy. Also, performance tests
required by the pending water supply laboratory certification program must be
conducted. Better coordination is required between the three Environmental
Monitoring and Support Laboratories (EMSL) and the various monitoring programs
underway in other parts of EPA. (Limited EMSL staff cannot maintain liaison
with all monitoring programs.) The standardization of reporting
definition(s) of minimum detectable limit(s), control limits, and
uncertainties must be discussed and agreed upon if the Agency is to have an
internally consistent interlaboratory quality control program. Some specific
needs are:
o Traceability of measurements to the national
measurement system at NBS, which was not discussed
in the 1973 strategy document, should be addressed;
resources should be included to ensure the trace-
ability of Agency reference materials and samples,
as far as possible.
o Standard reference samples and performance audit
samples are needed to support existing and planned
EPA standards and regulations for municipal and
industrial effluents, ocean disposal, drinking
water, and ambient water quality.
o Standard reference samples and performance audit
samples are needed for hazardous substances
promulgated in compliance with Section 307(a) of the
Federal Water Pollution Control Act Amendments.
o The laboratory intercomparison studies program, which
is designed to evaluate (audit) laboratory performance,
assess the quality of analytical procedures, and ensure
26
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that environmental data produced by Federal,
State, and private laboratories are compatible,
accurate, and legally defensible, should be
continued.
o Development of data audit systems should be
continued for all water quality information
systems.
Quality assurance efforts for the energy program are considered sepa-
rately. However, many of the outputs and activities discussed will be
needed to support assessment of impact on water quality during the exten-
sive development of energy sources in eight western States.
Biological Materials and Other Environmental Media
Quality control efforts in biological materials and other environmental
media are focused on providing support for the monitoring of pesticides and
radionuclides in tissues and other environmental media. Much of the effort
in this area represents long standing commitments to the pesticides community
studies program and the Radiation Alert Network. State, private, and
contract laboratories are provided quality assurance research outputs and
quality control services.
Current Status
Quality control guides and procedures include:
o Quality control manual for analysis of pesticide
residues in plant and animal tissues, blood,
urine, etc.
o A preliminary quality control manual for radio-
chemical analysis of milk, food, soil, etc.
o Brochures describing the use of standard reference
samples of radionuclides and the interlaboratory
cross-check sample program.
Intralaboratory quality control activities include:
o Provision of quality control samples for pesticides
and radionuclides.
o Standardized gas chromatographic column packings
for separation of pesticide residues.
o Direct technical assistance and consultation.
27
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Intel-laboratory quality control activities include:
o Regularly scheduled interlaboratory performance
tests for 13 to 19 contract laboratories that
service the pesticide community studies program.
o Monthly and quarterly cross-check sample studies
for radiochemical analysis of milk, food, and
soil.
o On-site evaluation of State radiochemical labora-
tories as requested by the Regions.
o Cross-check sample studies to support the Nuclear
Regulatory Commission (NRC).
Quality control training and laboratory certification efforts include:
o Participation in national conferences and seminars.
o Consultation to Regions, NRC, Energy Research and
Development Administration, etc.
o Provision of laboratory performance reports to
NRC to support its licensees and licensees contract
laboratories.
Future Research Needs
Monitoring strategies and research plans currently being prepared for
pesticides, carcinogens, and hazardous materials will impact future needs in
this important and diverse area of quality control. However, based upon
current knowledge, projected needs are:
o Quality control guides and manuals to be updated
at least once every 3 years.
o Provision of quality control samples for pesticide
residues and radiochemical analysis to be continued
and expanded.
o Interlaboratory comparison studies for pesticides
and the cross-check sample program for radionuclides
to be continued and repositories of standard reference
samples to be maintained. The Regions will require
assistance in conducting on-site evaluation of
laboratories, performance, and data audits.
o Quality control training needs are critical in this
area and include training for EPA, State personnel,
and others in the complex analysis of pesticides and in
quality control techniques for pesticide residue and
28
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radiochemical measurements. Coordination and
communication between program offices, Regions,
and laboratories need to be improved.
Quality Control Training and Laboratory Certification
Although Headquarters participates in the conduct of Regional quality
control workshops, the level of effort directed towards direct training in
the use of quality control practices is far below what is needed. Immediate
consideration should be given to expanding our national training programs to
include quality control. Specific requirements are:
o Preparation of instructional materials for use
both nationally and Regionally.
o Continuation of the biennial meetings of Regional
quality control coordinators.
o Participation in Regional qaulity assurance
workshops, seminars, and conferences.
o Publication of quality control information.
o Conduct of a national quality assurance conference
and workshop.
o Conduct of workshops specifically for on-site
evaluation of water supply laboratories.
The evaluation procedures and acceptance criteria for certifying water supply
laboratories are generally acceptable to user groups. However, the
implementation and management of the program present many problems. Of
particular concern to the Regions is their lack of expertise needed to conduct
on-site evaluations of State and local radiochemical laboratories. Requests
from the Regions indicate that they are going to depend upon EMSL-Las Vegas
personnel to directly assist in this area.
QUALITY ASSURANCE IN RESEARCH LABORATORIES
The quality assurance program in EPA has concentrated on ambient and
source measurements. Research activities, including dose-effects experiments,
have historically not been addressed by this program. As a result, while the
biological scientist in EPA uses accepted procedures, such as National
Institutes of Health guidelines for animal handling and care, dose determina-
tions have not been uniformly subjected to similarly rigid quality assurance
procedures. For instance, the research laboratories do not routinely
participate in formalized split sample programs, nor do they formally require
careful documentation, including the purity of chemicals used in their
research.
The need for a uniform approach to quality assurance, particularly in
dose-effects experiments, has become very important in view of the present
29
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emphasis on substance's that may have carcinogenic or other toxic effects at
very low doses, as well as the increasing reliance upon data obtained from
extramural researchers. Experience indicates that any regulatory action
(setting of standards, etc.) taken by the Agency will be scrutinized and
challenged by industry, environmentalists, and even other Federal agencies.
It should be emphasized that the investigators who conduct experiments
are, under all circumstances, responsible for the quality of their results and
the use of appropriate quality assurance practices.
Current Status
All ORD laboratories are preparing quality assurance plans tailored to
the specific research conducted in the individual laboratory. Also,
recognizing the critical role played by the health-related research programs,
EPA has awarded a contract for development of quality assurance protocols that
the Health Effects Research Laboratories and their extramural investigators
can use to control and document data quality.
Future Needs
The plans prepared by the EPA laboratories and the contract referred to
will identify the specific needs that must be addressed and will be
fundamental to the planning and implementation of this program in FY-1978.
QUALITY ASSURANCE EFFORTS RELATED TO THE ENERGY PROGRAM
ORD's Office of Energy, Minerals, and Industry coordinates a $100 million
per year energy-related environmental research and development program.
Various aspects of this interagency program require measurement and monitoring
efforts to provide environmental quality data to EPA and other Federal
agencies. Therefore, quality assurance support is required.
Current Status
Quality assurance was recognized as a key element in the formation and
implementation of the interagency program. Quality assurance requirements of
ongoing monitoring within the program are being coordinated with the
appropriate Environmental Monitoring and Support Laboratory.
Future Needs
Funding the quality assurance efforts for the energy program is separate
from other resource requirements discussed in this document.
30
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III. RESOURCE LEVELS AND IMPLEMENTATION OPTIONS
Over the past several years, EPA has promulgated many regulations and
standards that require frequent or routine monitoring of ambient air and
water, wastewater discharges, public drinking water supplies, emissions from
stationary and mobile pollution sources, lead and phosphorus in gasoline, and
special categories of hazardous substances such as radionuclides, pesticides,
and carcinogens. To meet these monitoring requirements, EFA's quality
assurance program must provide validated measurement systems, reference
standards, and the necessary quality control materials and services.
Quality Assurance is, for the most part, a level-of-effort activity, and
the resources available directly impact the scope of work with respect to the
number and types of monitoring functions that can be covered. An optimum
quality assurance program should provide:
o Valid measurement and quality control systems to
support implementation by program offices and the
Regions of regulations and standards at reasonable
cost.
o Continuous review and evaluation of the performance
and data quality of monitoring systems.
o Support for monitoring emergency episodes, environ-
mental quality trends, and special research studies.
The most essential activities and outputs include the following:
o An Agency-wide quality assurance management plan
endorsed by the EPA Administrator.
o Repositories of standard reference samples and
materials to support measurement methods validation,
internal quality control of field and laboratory
measurement systems, and external interlaboratory
performance checks and audits of measurement systems
and operators.
o Measurement standardization procedures and acceptance
criteria that can be used internally, externally, and
nationally for selection and endorsement of methods
for official EPA use.
31
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Guidelines for development of minimum quality
control programs for air, water, water supply,
biological materials, and other environmental
media.
Standardized and validated total measurement
systems for all current and planned regulations
and standards that require compliance monitoring.
Formal equivalency protocols for approval of
measurement methods/systems as alternative to
those methods promulgated,by EPA.
Quarterly interlaboratory performance tests
covering routine measurements and special
monitoring studies.
Standardized laboratory evaluation guidelines
and acceptance criteria that are acceptable to
EPA Regional, State, and local laboratories.
Annual on-site evaluation of Regional and other
EPA laboratories.
Annual instruction and support of Regional
evaluation teams so that they can uniformly and
effectively evaluate State and local laboratories
and monitoring programs.
Computerized system for screening out improbable
values and documenting the statistical quality of
the data from all monitoring systems that input
to the EPA data banks.
Compendia or manuals of measurement methods and
systems approved by EPA and updated biennially.
Continued and improved biennial meetings of the
Regional quality control coordinators. Meetings
should rotate among the 10 Regions with represen-
tation from those States in the Region where the
meeting is held.
The national work plan and committee for the Pilot
Secretariat for Measurement of Pollution under the
auspices of the International Organization of Legal
Metrology. (This is an international treaty
organization that the United States joined to
protect a favorable balance of trade with other
treaty nations.)
32
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The above functions and research outputs are critical to successful
implementation of a viable EPA quality assurance effort. Furthermore, since
there are subtle but major differences among the various types of monitoring
activities, many quality assurance functions and research outputs must be
duplicated to meet specific requirements with respect to pollutants measured,
source and concentration levels, environmental matrix in which the pollutant
is found, and purpose for which the data are being obtained. For example, a
measurement system and quality control program for measuring pesticides in
Industrial waste effluents will not be adequate for measurement of pesticides
in public drinking water because of the extreme differences in the concentra-
tion levels of the pesticides and the interferents present. The same type of
analogy can be made for ambient air measurements versus measurement of
stationary and/or mobile source emissions.
In addition to those functions and research that are critical to the
quality assurance program, other important types of outputs and ancillary
efforts are needed:
o Provide improved program coordination by establishing
an Intraagency Quality Assurance Advisory Committee.
o Develop instructional materials and support for
national and Regional quality assurance training
programs, workshops, and seminars to upgrade labora-
tory and field monitoring support activities.
o Develop system(s) for quantifying and reporting
quality assurance progress in terms of data quality
versus quantity, type, source, etc.
o Coordinate and support feasibility studies and,
where appropriate, develop laboratory automation
systems to Improve efficiency of analytical
operations, sample management, quality control,
and preparation of laboratory reports.
o Develop and publish a statistical quality control
handbook addressing the total needs of environ-
mental monitoring, including special research
monitoring studies and guides for interpretation
of data, along with a glossary of terms.
While not absolutely essential, the above items represent reasonable
requests made by the various national monitoring programs.
SUMMARY OF RESOURCES
Three options for funding the quality assurance effort are summarized
below:
33
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OPTION 1
FY-1977 FY-1978 FY-1979 FY-1980 FY-1981 FY-1982
$M 5.3 5.3 6.3 8.5 10.0 10.0
MY 67 67 67 67 67 67
OPTION 2
$M 5.3 6.3 8.5 10.0 10.0 10.0
MY 67 77 87 87 87 87
OPTION 3
$M 5.3 8.5 9.5 10.5 11.5 12.0
MY 67 87 90 90 90 90
The national scope and complexity of the quality assurance effort require
competent scientists to carry out the diverse functions of the program and to
establish effective communication with the monitoring community. Staff
requirements and funds must be considered in trying to arrive at a "hard needs"
or "optimum" budget. Consider these facts: Maximum use will be made of
contracts, grants, and interagency agreements for such efforts as development
of computer hardware and software for analyzing and reporting data from
collaborative tests and performance audits; quality control samples for
operation of intralaboratory quality control; investigations of sampling site
validations, sample collection, and sample preservation; field and laboratory
evaluations and tests of analytical methods and instruments; and preparation
and publication of guidelines, procedures, training materials, and methods
manuals. About 45 percent of the dollar resources will be used for these
types of extramural efforts. However, monitoring the cost-effective use of
extramural funds requires a staff experienced in environmental methodologies
and quality control.
On the other hand, EPA must maintain the responsibility for providing
expert advice and guidance on the use, operation, performance, and data output
for all monitoring methodologies and systems promulgated in suport of
regulations and standards. This means that the Agency's quality assurance
function must be adequately staffed to:
o Evaluate and validate measurement systems under real
and adverse operating conditions.
o Design and conduct tests to determine the reliability
and bias of measurement methods in the hands of a
cross-section of users.
o Advise others on the proper calibration and operation
of measurement systems based upon experience.
o Provide quality control guides and materials to docu-
ment the validity and accuracy of the data produced.
34
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o Provide continual overview of operational monitor-
ing systems, suggesting corrective actions when
malfunctions occur.
IMPLEMENTATION UNDER THE VARIOUS RESOURCE OPTIONS
Option 1
Under Option 1, the FY-1978 program will not change substantially from
the FY-1977 program. In fact, some curtailment and/or redirection in current
activities may be needed to provide a critical mass for addressing "highest"
priority areas. For example, in the water measurements area, emphasis will
be given to meeting critical needs for the water supply and permit program.
A level-of-effort activity will be carried out in the evaluation and
validation of measurement methods that have been promulgated, and a minimum
quality control program will be implemented. Program efforts that are most
likely to be restricted under this option include: automated laboratory
systems, provision of quality control samples, development of new standard
reference samples, marine water measurement methods, the number of measure-
ment methods that can be validated (participation in Regional quality
assurance workshops), and direct assistance to the Regions in the certifica-
tion of water supply laboratories. Under this option, all Agency quality
assurance needs requiring in-house man-hours will have to compete on a
priority basis for the limited manpower available.
In the air measurements area, the quality assurance efforts will
concentrate primarily on standardization and improvement of measurement
methods for stationary sources, limited performance audits of source measure-
ments, maintenance of reference samples and materials, and continuation of
the interlaboratory tests for ambient air measurements.
Also, under this option, the ongoing quality assurance efforts for
measurements of tissues and other environmental media will continue at the
same level as in FY-1977. Primary emphasis will be on the support of the
pesticide residue monitoring program and on the radiochemical measurements
for milk, food, and soil.
In the years beyond FY-1978, and projecting no change in man-years, the
quality assurance effort will be expanded and improved in those areas that
can be done extramurally: laboratory and field evaluation of sampling and
analysis systems; preparation and distribution of quality control samples for
routine use; and development and publication of quality control procedures,
methods manuals, and the like. Those efforts that require dedicated in-house
personnel will not substantially improve: measurement methods validation and
approval of alternate test procedures; on-site evaluation of laboratories;
interlaboratory performance tests and development of the associated standard
reference samples; and direct technical assistance to laboratories that need
to improve performance and data quality.
Activities and outputs under this resource option are summarized in
Charts 1-4.
35
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Option 2
Option 2 represents an increase of $1M and 10 positions for FY-1978.
This increase will be allocated to support Standards of Performance for New
Stationary Sources under the Clean Air Act, effluent guidelines regulations
under Section 304(g) of the Federal Water Pollution Control Act Amendments,
and the Safe Drinking Water Act. More specifically, $500K and 5.5MY will be
allocated to support the water supply program, including test procedures,
reference samples, and laboratory certification. The remainder of the FY-1978
increase, $500K and 4.5MY, will be used to support effluent guidelines
regulations, performance audits for air pollution source measurements, and
critical measurements of noncriteria air pollutants.
The FY-1978 level of resources in Option 2 is not adequate, in dollars
or man-years, to provide a comprehensive quality assurance effort to support
existing regulations, and it certainly does not provide for coverage of the
Consent Decree pollutants, ocean dumping regulations, etc.
In the years beyond FY-1978, the resource allocation of Option 2 allows
a gradual development, implementation, and maintenance of a national quality
assurance effort covering all existing and currently planned air and water
regulations, standards, and monitoring requirements.
The activities and outputs under this option are summarized in Charts
5-8.
Option 3
Under Option 3, the gaps in the current program can be quickly closed
and a comprehensive quality assurance program developed for all existing and
currently planned environmental monitoring. This option includes quality
assurance support for programs implementing the mandates of the Safe Drinking
Water Act, the Federal Water Pollution Control Act Amendments of 1972, the
Clean Air Act Amendments, the Federal Insecticides, Fungicides, and
Rodenticides Act, the Marine Protection, Research, and Sanctuaries Act of 1972,
and the Settlement Agreement and Consent Decree pollutants. This option also
includes the support and ancillary requirements associated with radionuclide
measurements as they apply to the above Acts, to the Atomic Energy Act and
amendments, and to EPA support to the Nuclear Regulatory Commission. In
FY-1978, the $3.2M and 20MY increases requested would be allocated
approximately as shown below:
Activity Funded
$K(MY)
Standardization of water supply measurement methods,
reference samples, guidelines, and assistance to
Regions and States for laboratory certification 1,200(5)
36
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Quality assurance program for monitoring reports on
wastewater discharges, including some on-site
inspections 200(3)
Standardization of Section 304(g) test procedures and estab-
lishment of a measurement methods equivalency program .... 450(3)
Performance audits for stationary source measurements .... 260(4)
Performance audits and measurement system evaluation
for Consent Decree pollutants and other noncriteria
air pollutants 340(3)
Standardization and optimization of measurement systems
for Consent Decree pollutants in water and wastewater
discharges 700(1)
Ancillary activities (reports, data, coordination,
conferences) 50(1)
At the Option 3 level of resource allocation, the program in the years
beyond FY-1978 is designed to provide the reference or standard monitoring
methods, quality control procedures, associated standard reference materials,
quality control program audits, and expert advice and assistance needed by
either the Agency's operational monitoring programs or the States in carrying
out their mandated monitoring requirements.
Under this option, more attention will be given to developing and carrying
out a quality assurance effort to meet the needs of research laboratories and
special monitoring studies.
It should be reemphasized that a successful quality assurance effort
requires a competent multi-disciplinary staff along with an adequate allocation
of funds. Only then can EPA accurately assess changes in the environment.
The challenge of rapid changes in advanced technologies, diversification of
industries, population changes and migrations, and new energy sources demand a
quality assurance effort flexible enough to meet long-term, short-term, and
emergency monitoring data requirements. As improved or new monitoring systems
are developed, and monitoring initiatives and emphasis change, the quality
assurance functions and research, outputs, in a generic sense, will be repeated.
Therefore, from year to year, the quality assurance program and outputs will
look the same, while meeting the demands for assuring data quality from
radically different and new types of monitoring activities.
Activities and outputs under this option, are summarized in Charts 9-12.
37
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CHART 1 - OPTION (1) QUALITY ASSURANCE IMPLEMENTATION PLAN* - GENERAL
Quality Assurance Activity/Output
FY
1977
EY
1978
PY
1979
FY
1980
FY
1981
PY
1982
00
Agency-wide Quality Assurance Management Plan
Measurement System Standardization Protocols -
Pilot Secretariat for Measurement of Pollution I
Regional Quality Control Coordinators Meetings I
Materials and Support for Regional/National Training -
Intraagency Quality Assurance Coordinating Committee -
Agency Quality Assurance Progress Reports
Statistical Quality Control Handbook/Glossary
Laboratory Automation Systems I
National Quality Assurance Conference
Regional Quality Assurance Workshops
Quality Assurance Reports to the Regions and States -
Quality Assurance Support for Research Laboratories I
1C
I
ID
ID
U
I
U
U
U
Future needs to be determined
*I « Implemented at minimum level
C = Continuing at previous level
D =• Decreased below minimum requirement
E = Expanded to adequate level
U - Updated
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CHART 2 - OPTION (1) QUALITY ASSURANCE IMPLEMENTATION PLAN* - AIR
Quality Assurance Activity/Output
Base Program
Guidelines, Procedures, Manuals
System Standardization/Validation
Reference Samples and Materials
Interlaboratory Quality Control
Performance Audits for Special Studies
Projected Program
FY
1977
I
I
ID
1C
ID
FY
1978
I
ID
ID
ID
ID
FY
1979
I
C
1C
C
C
FY
1980
IE
I
I
I
I
FY FY
1981 1982
by contract
as practicable
CO
Measurement System Standardization,
Validation Reference Samples, Perfor-
mance Audits for Consent Decree
Pollutants
Performance Audits for Stationary
Sources Measurements for New Source
Performance Standards
Measurement Method Evaluations Testing,
Reference Samples, and Materials for Non-
criteria Pollutants Including Sulfates
On-site Evaluation of Monitoring
Stations and System for Validation
of Sites
Technical Assistance and Follow-up on
Unsatisfactory On-site Evaluation and
Interlaboratory Performance Tests
ID
ID
ID
by contract
as practicable
ID
ID
by contract
as practicable
*I = Implemented at minimum level
C = Continuing at previous level
D = Decreased below minimum requirement
E = Expanded to adequate level
U = Updated
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CHART 3 - OPTION (1) QUALITY ASSURANCE IMPLEMENTATION PLAN* - WATER
Quality Assurance Activity/Output
FY
1977
FY
1978
FY
1979
FY
1980
FY
1981
FY
1982
Base Program
Guidelines, Procedures, Manuals I
System Standardization/Validation ID
Performance Specification for Samplers/Monitors ID
Reference Samples and Materials ID
Interlaboratory Quality Control ID
Projected Program
o Water Supply Measurement Methods Standardi- ID
zation; Reference Samples Performance
Tests; On-site Evaluations; Certification
Procedures
o Measurement Methods Equivalency Program -
for Effluent Guidelines, Others
o Quality Assurance Support for Discharge
' Monitoring Reports Including Some On-site
Evaluations
o Measurement System Validation and Perfor-
mance Tests for Consent Decree Pollutants
o Quality Assurance Support for Biological ID
and Microbiological Monitoring Efforts
o Technical Assistance/Follow-up Unsatisfac-
tory On-site Inspections and Performance
Evaluations
o Quality Assurance Program for Marine -
Waters, Ocean Dumping
ID
ID
1C
ID
ID
ID
1C
ID
ID
I
I
I
I
I
I
I
I
I
I
by contract
as practicable
by contract
as practicable
*I = Implemented at minimum level
C = Continuing at previous level
D - Decreased below minimum requirement
E = Expanded to adequate level
U = Updated
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CHART 4 - OPTION (1) QUALITY ASSURANCE IMPLEMENTATION PLAN* - BIOLOGICAL MATERIALS & OTHER ENVIRONMENTAL MEDIA
Quality Assurance Activity/Output
FY
1977
FY
1978
FY
1979
FY
1980
FY
1981
FY
1982
Basei Program
Guidelines, Procedures, Manuals
System Standardization/Validation
Reference Samples and Materials
Interlaboratory Quality Control:
Cross-check Sample Studies
On-site Evaluations
Projected Program
o Provide Measurement System Standardization
Support for the Consent Decree Pollutants
o Develop and Provide Standard Reference
Samples and Materials for the Consent
Decree Pollutants
p. o Develop and Provide Reference Samples for
Radionuclides in Milk, Food, Soil and
River Bottom Sediments
o Develop and Provide Reference Samples of
Pesticides in Mothers' Milk, Animal
Tissues, Blood, Urine, and Soil
o Provide Support for the Nuclear Regulatory
Commission
o Assist Regions in On-site Evaluations of
Radiochemical Laboratories
o Develop Quality Effort to Cover the
Analysis of Pesticide Formulations
I
ID
ID
I
ID
ID
ID
ID
ID
ID
ID
ID
ID
ID
C
C
C
I
I
I
by contract
as practicable
by contract
as practicable
*I - Implemented at a minimum level
C - Continuing at previous level
D - Decreased below minimum requirement
E - Expanded to adequate level
U • Updated
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CHART 5 - OPTION (2) QUALITY ASSURANCE IMPLEMENTATION PLAN* - GENERAL
ro
FY
Quality Assurance Activity /Output 1977
Agency-wide Quality Assurance Management Plan
Measurement System Standardization Protocols
Pilot Secretariat for Measurement of Pollution I
Regional Quality Control Coordinators Meetings I
Materials and Support for Regional /National Training
Intraagency Quality Assurance Coordinating Committee
Agency Quality Assurance Progress Reports
Statistical Quality Control Handbook/Glossary
Laboratory Automation Systems I
National Quality Assurance Conference
Regional Quality Assurance Workshops
Quality Assurance Reports to the Regions and States
Quality Assurance Support for Research Laboratories
FY FY FY FY
1978 1979 1980 1981
I U U U
_
I I I I
I I I IE
- - - I
I 1C 1C
- I I I
- - - I
ID I I I
- I - -
_
-
I 1C
FY
1982
U
-
I
IE
I
1C
I
-
I
I
-
-
-
*I = Implemented at minimum level
C = Continuing at previous level
D = Decreased below minimum requirement
E = Expanded to adequate level
U = Updated
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CHART 6 - OPTION (2) QUALITY ASSURANCE IMPLEMENTATION PLAN* - AIR
Quality Assurance Activity/Output
FY
1977
FY
1978
FY
1979
FY
1980
FY
1981
FY
1982
JS
u>
Base Program
Guidelines, Procedures, Manuals
System Standardization/Validation
Reference Samples and Materials
Interlaboratory Quality Control
Performance Audits for Special Studies
Projected Program
o Measurement System Standardization,
Validation Reference Samples, Perfor-
mance Audits for Consent Decree
Pollutants
o Performance Audits for Stationary
Sources Measurements for New Source
Performance Standards
o Measurement Method Evaluations Testing,
Reference Samples, and Materials for Non-
criteria Pollutants Including Sulfates
o On-site Evaluation of Monitoring
Stations and System for Validation
of Sites
o Technical Assistance and Follow-up on
Unsatisfactory On-site Evaluation and
Interlaboratory Performance Tests
I
I
I
I
ID
I
I
I
ID
ID
ID
ID
C
IE
IE
IE
IE
IE
1C
C
IE
IE
IE
IE
IE
IE
1C
C
IE
IE
IE
IE
IE
1C
C
IE
IE
C
IE
IE
1C
*I «• Implemented at minimum level
C - Continuing at previous level
D « Decreased below minimum requirement
E * Expanded to adequate level
U - Updated
-------
CHART 7 - OPTION (2) QUALITY ASSURANCE IMPLEMENTATION PLAN* - WATER
FY
Quality Assurance Activity/Output 1977
Base Program
Guidelines, Procedures, Manuals I
System Standardisation/Validation ID
Performance Specification for Samplers/Monitors ID
Reference Samples and Materials ID
Interlaboratory Quality Control ID
Projected Program
o Water Supply Measurement Methods Standard!- ID
zation; Reference Samples Performance Tests;
On-site Evaluations; Certification Procedures
o Measurement Methods Equivalency Program for
Effluent Guidelines, Others
o Quality Assurance Support for Discharge
Monitoring Reports Including Some On-site
Evaluations
o Measurement System Validation and Perfor-
mance Tests for Consent Decree Pollutants
o Quality Assurance Support for Biological ID
and Microbiological Monitoring Efforts
o Technical Assistance/Follow-up Unsatisfac-
tory On-site Inspections and Performance
Evaluations
o Quality Assurance Program for Marine
Waters, Ocean Dumping
*I • Implemented at minimum level
C - Continuing at previous level
D = Decreased below minimum requirement
E - Expanded to adequate level
U * Updated
FY FY
1978 1979
I IE
ID I
ID I
ID ID
ID IE
ID IE
I
ID C
ID IE
ID C
ID
ID
FY
1980
IE
I
IE
IE
IE
IE
C
C
C
IE
IE
IE
FY
1981
C
I
IE
IE
IE
C
C
C
C
IE
IE
IE
FY
1982
C
I
IE
IE
IE
C
C
C
C
IE
IE
IE
-------
CHART 8 - OPTION (2) QUALITY ASSURANCE IMPLEMENTATION PLAN*
MEDIA
- BIOLOGICAL MATERIALS & OTHER ENVIRONMENTAL
Quality Assurance Activity/Output
FY
1977
FY
1978
FY
1979
FY
1980
FY
1981
FY
1982
Base Program
Guidelines, Procedures, Manuals I
System Standardization/Validation ID
Reference Samples and Materials ID
Interlaboratory Quality Control:
Cross-check Sample Studies I
On-site Evaluations ID
Projected Program
o Provide Measurement System Standardization -
Support for the Consent Decree Pollutants
o Develop and Provide Standard Reference
Samples and Materials for the Consent
Decree Pollutants
o Develop and Provide Reference Samples for ID
Radionuclides in Milk, Food, Soil and
River Bottom Sediments
I
ID
ID
ID
C
ID
IE
IE
IE
IE
IE
ID
ID
IE
IE
IE
IE
IE
IE
IE
IE
IE
C
IE
IE
IE
C
IE
IE
IE
C
IE
IE
IE
C
IE
IE
IE
*I
C
D
E
U
o Develop and Provide Reference Samples of ID ID IE IE
Pesticides in Mothers' Milk, Animal
Tissues, Blood, Urine, and Soil
o Provide Support for the Nuclear Regulatory ID I C C
Commission
o Assist Regions in On-site Evaluations of ID ID C
Radlochemical Laboratories
o Develop Quality Effort to Cover the - - - ID
Analysis of Pesticide Formulations
= Implemented at minimum level
- Continuing at previous level
» Decreased below minimum requirement
• Expanded to adequate level
- Updated
IE IE
C C
C C
C C
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CHART 9 - OPTION (3) QUALITY ASSURANCE IMPLEMENTATION PLAN* - GENERAL
FY
Quality Assurance Activity/Output 1977
Agency-wide Quality Assurance Management Plan
Measurement System Standardization Protocols
Pilot Secretariat for Measurement of Pollution I
Regional Quality Control Coordinators Meetings I
Materials and Support for Regional /National Training
Intraagency Quality Assurance Coordinating Committee -
Agency Quality Assurance Progress Reports
Statistical Quality Control Handbook/Glossary
Laboratory Automation Systems
National Quality Assurance Conference
Regional Quality Assurance Workshops
Quality Assurance Reports to the Regions and States
Quality Assurance Support for Research Laboratories
FY
1978
I
I
1C
IE
-
I
I
-
I
I
I
I
I
FY
1979
U
U
1C
IEC
I
1C
1C
I
1C
-
IE
IE
IE
FY
1980
U
U
1C
IEC
IE
1C
IEC
»
1C
IE
IE
IE
IE
FY
1981
U
U
1C
IEC
IEC
1C
IEC
-
1C
-
IE
C
1C
FY
1982
U
U
1C
IEC
IEC
1C
IEC
-
1C
I
IE
C
1C
*I = Implemented at minimum level
C = Continuing at previous level
D = Decreased below minimum requirement
E = Expanded to adequate level
U = Updated
-------
CHART 10 - OPTION (3) QUALITY ASSURANCE IMPLEMENTATION PLAN* - AIR
FY
Quality Assurance Activity /Output 1977
Base Program
Guidelines, Procedures, Manuals I
Systjem Standardization/Validation I
Reference Samples and Materials I
Inter laboratory Quality Control I
Performance Audits for Special Studies ID
Projected Program
o Measurement System Standardization,
Validation Reference Samples, Perfor-
mance Audits for Consent Decree
Pollutants
o Performance Audits for Stationary ID
Sources Measurements for New Source
Performance Standards
o Measurement Method Evaluations Testing,
Reference Samples, and Materials for Non-
criteria Pollutants Including Sulfates
o On-site Evaluation of Monitoring
Stations and System for Validation
of Sites
o Technical Assistance and Follow-up on
Unsatisfactory On-aite Evaluations and
Interlaboratory Performance Tests
PY
1978
I
IE
IE
IE
IE
I
IE
I
I
I
FY
1979
C
IE
IE
IE
IE
IE
IE
IE
IE
IE
FY
1980
C
IE
IE
IE
C
IE
IE
IE
IE
C
FY
1981
C
IE
IE-
IE
C
IE
1C
IE
C
C
FY
1982
C
IE
C
C
C
C
IE
IE
C
C
*I « Implemented at minimum level
C * Continuing at previous level
D - Decreased below minimum requirement
E • Expanded to adequate level
U - Updated
-------
CHART 11 - OPTION (3) QUALITY ASSURANCE IMPLEMENTATION PLAN* - WATER
Quality Assurance Activity/Output
FY
1977
FY
1978
FY
1979
FY
1980
FY
1981
FY
1982
oo
Base Program
Guidelines, Procedures, Manuals I
System Standardization/Validation ID
Performance Specification for Samplers/Monitors ID
Reference Samples and Materials ID
Interlaboratory Quality Control ID
Projected Program
o Water Supply Measurement Methods Standard!- ID
zation; Reference Samples Performance Tests;
On-site Evaluations; Certification Procedures
o Measurement Methods Equivalency Program for -
Effluent Guidelines, Others
o Quality Assurance Support for Discharge
Monitoring Reports Including Some On-site
Evaluations
o Measurement System Validation and Perfor- -
mance Tests for Consent Decree Pollutants
o Quality Assurance Support for Biological ID
and Microbiological Monitoring Efforts
o Technical Assistance/Follow-up Unsatisfac- -
tory On-site Inspections and Performance
Evaluations
o Quality Assurance Program for Marine -
Waters, Ocean Dumping
IE
IE
IE
IE
I
IE
ID
I
ID
ID
ID
IE
IE
IE
IE
IE
IE
IE
IE
IE
I
IE
IE
C
IE
IE
IE
IE
IE
C
IE
IE
IE
IE
IE
C
IE
C
IE
C
C
C
IE
IE
C
C
C
C
IE
C
IE
IE
C
*I = Implemented at minimum level
C = Continuing at previous level
D = Decreased below minimum requirement
E = Expanded to adequate level
U = Updated
-------
CHART 12 - OPTION (3) QUALITY ASSURANCE IMPLEMENTATION PLAN*-BIOLOGICAL MATERIALS & OTHER ENVIRONMENTAL MEDIA
Quality Assurance Activity/Output
Base Program
Guidelines, Procedures, Manuals
System Standardization/Validation
Reference Samples and Materials
Inter laboratory Quality Control:
Cross-check Sample Studies
On-site Evaluations
Projected Program
o Provide Measurement System Standardization
Support for the Concent Decree Pollutants
o Develop and Provide Standard Reference
Samples and Materials for the Consent
Decree Pollutants
S o Develop and Provide Reference Samples for
Radionuclides in Milk, Food, Soil and
River Bottom Sediments
o Develop and Provide Reference Samples of
Pesticides in Mothers' Milk, Animal
Tissues, Blood, Urine, and Soil
o Provide Support for the Nuclear Regulatory
Commission
o Assist Regions in On-site Evaluations of
Radiochemlcal Laboratories
o Develop Quality Effort to Cover the
Analysis of Pesticide Formulations
FY
1977
I
ID
ID
I
ID
-
-
ID
ID
ID
ID
-
FY
1978
I
I
I
I
I
I
I
I
I
I
I
ID
FY
1979
IE
IE
IE
IE
IE
I
I
IE
IE
C
IE
I
FY
1980
IE
IE
IE
IE
IE
IE
IE
IE
IE
C
C
IE
FY
1981
C
IE
IE
IE
C
IE
IE
IE
IE
C
C
C
FY
1982
C
IE
IE
IE
C
IE
IE
IE
IE
C
C
C
*I - Implemented at minimum level
C - Continuing at previous level
D - Decreased below minimum requirement
E » Expanded to adequate level
U - Updated
-------
IV. SUMMARY HIGHLIGHTS OF EPA REGIONAL COMMENTS
In developing this multiyear quality assurance research plan, the
Regional offices were considered the primary users of the quality assurance
outputs and services. Therefore, this document has attempted to address the
specific needs of the Regions as expressed in their comments on an earlier
draft. The Regional comments are presented in summary form in this final
section. The comments that follow are arranged according to the number of
Regions expressing the same or similar concern for specific types of quality.
assurance outputs:
o The Regional quality assurance efforts, resources,
roles, and responsibilities are not identified and
clarified in the plan. A similar plan is needed to
cover the Regions and recommendations for the States.
o Protocols should be well defined and coordinated for
measurement method standardization, measurement
method equivalency determinations and alternate test
procedure recommendations.
o A mechanism is needed to quantify data quality,
establish procedures for handling data out of control,
measure sampling reliability, and estimate progress
and cost-effectiveness of quality assurance programs.
o Reference samples are critical to the success of a
quality control program and should include samples for
ambient waters, ocean disposal, air, pesticide residues,
etc.
o More emphasis should be given to the evaluation and
validation of all existing measurement methods,
particularly the Section 304(g) test procedures and
measurement methods for marine waters.
o Improved communication is needed between the quality
assurance efforts of the Regions, the EMSL's, and
Headquarters, including more frequent meetings of
Regional quality assurance coordinators, and an
intraagency quality assurance advisory committee.
o Training within the Agency needs to be expanded to
include quality assurance, both test procedures and
quality control, at the "grass roots" level — an
impossibility without travel funds.
50
-------
Guidelines are needed for development of minimum
quality control requirements for air and water
program managers and for research and monitoring
contracts.
There is a need to improve and continue the quality
assurance program for pesticides in water, particu-
larly methods evaluations, collaborative tests, and
guidelines. Also, there is no quality assurance
program for pesticide formulations.
A mechanism is needed for establishing quality
assurance priorities in terms of specific compounds,
sampling methods, etc. A table of priorities should
be established for all media, and an ORD effort
should be made to coordinate all programs into a
single set of priorities.
Validated measurement methods are needed for sludge
sampling, preservation, and analysis, and for
sediment sampling and analysis.
Greater emphasis should be given to validation of
bioassay procedures, microbiological measurements,
evaluation of methods being used routinely by EPA
and others, and coordination of methods developed
by other Federal agencies.
Nationally consistent guidelines should be
developed for chain-of-custody for water and
wastewater samples.
Quality assurance guidelines should be published for
sample site selection, sampling techniques, flow
measurements, and sampling frequencies under
Section 208 of the Federal Water Pollution Control
Act Amendments.
There should be some consistency among the various
quality assurance groups with respect to procedures,
terminology, etc.
There is a need to establish and adopt minimum
acceptance criteria for approval of laboratories,
particularly for water supply.
Quality control guides are very good for air, but
there is a need to improve guides for water measure-
ments .
Any laboratory certification program should be
mandatory for both EPA and the States.
51
-------
o Preplanning in the area of toxic substances is
very good; field screening techniques and methods
are needed for hazardous and toxic substances.
o More emphasis should be given to quality assurance
related to mobile sources, for example, vapor
recovery and unleaded fuel.
o In the view of the Regions, the concept of quality
assurance for the research laboratories appears to
be a very good idea!
o Quality assurance procedures are needed for
continuous SO2 analyzers and for their calibration
in the range of 5 to 10 parts per million; also,
improved measurement method calibration procedures
are needed for N02 and ozone.
o EPA management needs to make a strong commitment
to quality assurance throughout the Agency.
o Additional resources are needed by ORD and the
Regions to provide more technical assistance to
State air programs.
o The current funding of the Intergovernmental
Personnel Act appointees for the Regional water
supply program will be needed through 1980;
however, the program should be reviewed each year
for effectiveness.
o Ongoing efforts to automate laboratories should be
reviewed for appropriateness as a part of the
quality assurance program.
It should be noted that these comments are merely the views of the
Regions on an earlier version of the quality assurance plan. Some of these
comments raise issues that should be addressed by management at various levels
of the Agency. Where possible, we have addressed these comments in the
present version of the plan. We hope that we will have the opportunity to
present some of the more critical issues to top levels of management for
resolution.
52
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TECHNICAL REPORT DATA
(Please read luslmctions on the reverse before completing)
. REPORT NO.
EPA-600/8-77-008^
47TITLE AND SUBTITLE
2.
3. RECIPIENT'S ACCESSION>NO.
Quality Assurance Research Plan,
FY 1978-82
5. REPORT DATE
Inly 1977 (Issuing date)
6. PERFORMING ORGANIZATION CODE
. AUTHOR(S)
Thomas W. Stanley
8. PERFORMING ORGANIZATION REPORT NO
I. PERFORMING ORGANIZATION NAME AND ADDRESS
Office of Monitoring and Technical Support - Wash., DC
Office of Research and Development
U.S. Environmental Protection Agency
Washington, DC 20460
10. PROGRAM ELEMENT NO.
1HD621
11. CONTRACT/GRANT NO.
12. SPONSORING AGENCY NAME AND ADDRESS
Same as above.
13. TYPE OF REPORT AND PERIOD COVERED
In-house
14. SPONSORING AGENCY CODE
EPA/600/00
15. SUPPLEMENTARY NOTES
In-house planning document
T6. ABSTRACT ~~ " ~ ~ ~~
The Office of Research and Development (ORD), through its Office of Monitoring
and Technical Support, is responsible for developing an Agency-wide quality assurance
program to enable the U.S. Environmental Protection Agency (EPA) to implement its
regulatory mission and associated monitoring functions. The major thrust of this
document is to identify and justify the resources required by ORD to develop the
quality assurance tools, techniques, and services needed by other program offices, the
Regions, and the States to generate valid data. This five-year planning document
describes the quality assurance program in terms of goals, objectives, and functional
elements; summarizes the current status of ORD's ongoing quality assurance efforts;
discusses Agency and program needs; and delineates the resources and approaches
required to develop and carry out a dynamic quality assurance program which will
ensure scientifically valid environmental measurements.
17.
KEY WORDS AND DOCUMENT ANALYSIS
DESCRIPTORS
b.IDENTIFIERS/OPEN ENDED TERMS
c. COSATI Field/Group
Pollution, Water pollution, Air pollution.
Sanitary engineering, Water supply,
Environmental engineering, Civil
engineering, Quality control, Quality
assurance, Project planning
Environmental Data
Environmental Measurement
05A
13B
18. DISTRIBUTION STATEMENT
RELEASE TO PUBLIC
19. SECURITY CLASS (ThisReport)
UNCLASSIFIED
21. NO. OF PAGES
69
20. SECURITY CLASS (Thispage)
UNCLASSIFIED
22. PRICE
EPA Form 2220-1 (9-73)
53
U.S. OOVERmENT PRINTING OFFICE : 1977 0-141.037
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