MEASUREMENT METHODS
STANDARDIZATION
STRATEGY DOCUMENT
September 1973
U.S. Environmental Protection Agency
Office of Monitoring Systems
Quality Assurance Division
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MEASUREMENT METHODS
STANDARDIZATION
STRATEGY DOCUMENT
September 1973
Quality Assurance Division
Office of Monitoring Systems
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TABLE OF CONTENTS
Paqe
I. INTRODUCTION 1-5
Need for an Agency-wide Quality Assurance
Program 1
Goals and Objectives 1
Existing Standardization Responsibilities .... 1
Activities of the Office of Research
and Development 2
Standardization activities not in the
Office of Research and Development 2
Gaps in the Standardization Program 3
Components of Measurement Methods and
Standardization 4
II. PHASES OF THE STANDARDIZATION PROGRAM 6-24
A. Elements of the Standardization
Program 6
1. Development and issuance of the
standardization protocol 6
a. Identification of methodology
needs 8
b. Selection of candidate methods ... 10
c. Evaluation and testing to
select tentative methods 10
d. Collaborative testing 10
e. Endorsements and publication 11
2. Equivalency determination 13
3. Data formatting and instrument data
systems compatibility guidelines 14
B. Implementation of the Standardization
Program 14
1. Organization plan « 15
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a. Premises 15
b. Standardization program
responsibilities 15
(1) Office of Monitoring
Systems 16
(2) Standardization activities
at NERC Laboratories 17
(3) Research activities 17
(4) Program Offices 18
(5) Intra-agency Quality
Assurance Coordinating
Committee 18
(6) Steering Committee 19
(7) Other Agency laboratories .. 19
(8) External standardization
organizations 20
2. Projects and schedules 20
a. Protocol for standardization .... 21
b. Compilations of sampling
procedures 21
c. Compilations of available
analytical methods 23
d. Equivalency 23
(1) Equivalency of air
methodology 23
(2) Equivalency of water
methodology 23
(3) Other measurements 24
e. Data output .., 24
III. METHODS STANDARDIZATION PROGRAMMING 25-38
Introduction 25
Lead-time Requirements 26
Standardization Costs 27
Programming Level 1—Present Resource
Allocations 29
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1. Standardization of air
methodology 29
2. Standardization of water
methodology 31
3. Standardization of radiation
methodology . 32
4. Standardization of pesticides
methodology 32
5. Standardization of noise
methodology . 33
6. Standardization of solid waste
methodology 33
Programming Level 2—Critical Needs 33
1. Standardization of air
methodology 33
2. Standardization of water
methodology 34
3. Standardization of radiation
methodology 34
4. Standardization of pesticides
methodology 34
5. Standardization of noise
methodology 34
6. Standardization of solid waste
methodology 35
Programming Level 3—Meeting Environmental
Standards Needs for Methods 35
1. Standardization of air
methodology 35
2. Standardization of water
methodology 35
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Page
3. Standardization of radiation
methodology 36
4. Standardization of pesticides
methodology 36
5. Standardization of noise
methodology 36
6. Standardization of solid waste
methodology 36
Programming Level 4—Most Standardization
Needs - . 36
1. Standardization of air
methodology 36
2. Standardization of water
methodology 37
3. Standardization of radiation
methodology 37
4. Standardization of pesticides
methodology 37
5. Standardization of noise
methodology 37
6. Standardization of solid waste
methodology 37
COMMENTS ON PLAN BY HEADQUARTERS, REGIONS, AND
NERC's 39
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LIST OF TABLES
Page
Table 1. Phases of the Standardization Program 7
Table 2. Milestones for Preparing Final
Standardization Protocol 22
LIST OF FIGURES
Figure 1. Elements of the Standardization
Protocol 9
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1
Executive Summary
STRATEGY FOR AGENCY-WIDE MEASUREMENT
METHODS STANDARDIZATION
Introduction
To maintain and improve the quality of environmental
monitoring measurements used by the Environmental
Protection Agency (EPA), the Administrator assigned
central responsibility for monitoring quality assurance
activities to the Office of Monitoring Systems in EPA
Order No. 1110.22B. A comprehensive plan for quality
control of monitoring operations has,been developed and
approved. The present document describes a program of
measurement methodology standardization designed to com-
plement the quality control activities and, thus, provide
complete quality assurance of environmental monitoring
data.
The long-range goal of the standardization program is
to assure that accurate, precise, reliable, and cost-
effective methods (manual and/or automatic) are available
for all of the Agency's environmental monitoring measure-
ments. The plan does not address development of method-
odology, but covers selection and preliminary evaluation,
focusing on collaborative, exhaustive, replicative, and
statistically significant studies of method performance
under a variety of conditions as applied by typical operat-
ing laboratory personnel. Such procedures provide the
statistical and legal validity that enables EPA to set and
enforce unequivocal environmental or source performance
standards.
Current Status
EPA acquired a variety of standardization activities
upon its formation and assigned most of them to the Office of
Monitoring Systems. The oldest is the Analytical Quality
Control Laboratory (now referred to as the Methods Develop-
ment and Quality Assurance Research Laboratory) at the
National Environmental Research Center in Cincinnati, which
has developed a fairly complete manual of methods for water
pollution measurements. Many of these methods have been
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collaboratively tested. A more recent development is the
reasonably well-supported activity for air pollution
measurement standardization at the National Environmental
Research Center at Research Triangle Park, North Carolina.
This Facility is now working to overcome a backlog of
methodology requirements stemming from the Clean Air Act.
A number of smaller activities within the Office of
Monitoring Systems are oriented specifically toward pesti-
cides and radiation. Some standardization and testing
activities are also carried out by the Office of Pesticides
Programs and the Office of Air and Water Programs. A small
extramural standardization activity has been initiated by
the Office of Noise Abatement. Also, Regional as well as
other EPA laboratories are continually modifying, testing,
and developing methods, some of which may contain elements
of the validation process.
Scope of Standardization Operations
At least three operations are necessary to obtain and
utilize environmental data: (1) network design; (2)
measurement of appropriate parameters; and, (3) analysis
of the data. The standardization plan addresses only the
second operation. While taking this approach, we still
recognize that statistically-reliable networks are
essential. However, such developments involve long-term
efforts.
Our immediate concern is the quality of our basic
monitoring tool, the measurement method, comprised of four
closely related modules: (1) sampling techniques; (2)
sample work-up; (3) analysis of the sample; and, (4) presen-
tation of the data. Properly integrated and tested, these
four modules comprise a standardized method. With this
approach, the Agency can save resources in the short term
by testing only those modules of a method that have not
been previously tested. For example, atomic absorption
spectrophotometers are commonly used for elemental analysis
of both air and water samples—they need not be collabora-
tively tested over and over for each new method. In this
way, problem areas in a method are more quickly highlighted
and new methods may be approved after simpler, less-
expensive testing. Under the modular concept, various
programs within the Agency may utilize' common methodology
to the exact degree which provides the greatest practical
benefits.
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Implementation
In order to meet the unsatisfied operational method-
ology requirements of monitoring activities throughout the
Agency, available sampling techniques and analytical
methods are being compiled. Experience gained with these
methods will provide a valuable head start toward the
required scientific validation while also identifying
methods which need further development.
Preparation of an Agency standardization protocol will
begin in the immediate future (utilizing existing practices
wherever applicable). The protocol will describe a logical,
step-by-step procedure for identifying, testing, and
evaluating monitoring methodology. This protocol will be
followed rigorously by quality assurance program personnel,
and we have recommended that its use be mandatory throughout
the Agency to ensure a consistent level of confidence in
measurement methodology (see Action Memorandum).
Methodology equivalency protocols are in preparation.
Adherence to these protocols will ensure intercomparability
of environmental data generated by different methods.
All Agency programs will be required to report their
standardization activities to the quality assurance program
for coordination and review. In this way, improved
methodology will achieve the widest distribution in the
shortest time while unnecessary duplication of effort will
be eliminated. An ideal vehicle for this coordination would
be an Intra-agency Quality Assurance Coordinating Committee,
which is being proposed separately.
Resources
To meet the Agency's needs, the standardization program
has had to allocate its resources to the highest priority
requirements. Accordingly, response to many important
requirements must be delayed. We have defined four levels
of activities which are responsive to these requirements.
The first level is our response to the highest priority items
or Status Quo. At the Status Quo level ($1,25OK and 29 MY) ,
we are unable to provide timely and reliable reference
methods to support environmental standards when they are
promulgated. At Level 2_ ($1,900K and 38 MY), we will meet
the most critical needs of the Agency including support for
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most environmental standards. Level _3 ($2,440K and 42 MY)
would provide an additional capability to evaluate several
methods proposed as equivalent and to provide reference
methods for a few widely used measurements, even if they
are not associated with environmental standards. Finally,
at Level 4_ ($2,870K and 48 MY), we could initiate valida-
tion activities for the most widely used methods employed
in research or trend monitoring, in addition to the basic
work included in all lower levels.
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I. INTRODUCTION
Need for an Agency-wideQuality Assurance Program
The Administrator assigned monitoring quality assurance
responsibilities in EPA Order No. 1110.22B to the Deputy
Assistant Administrator for Monitoring Systems and directed
that he develop and implement an Agency-wide measurement
methods standardization and quality control program. The
program would assure that environmental data produced by
Federal, State, and local agencies are compatible, accurate,
and legally defensible. The quality control portion of the
program was approved for implementation on February 13, 1973.
The standardization program now needs to be approved for
implementation to fulfill the mandate' delegated to the
Office of Research and Development (ORD).
Goals and Objectives
The single overall goal of the quality assurance pro-
gram is to ensure that environmental quality data used by
the Environmental Protection Agency (EPA) are sufficiently
accurate, precise, and reliable to meet Agency needs at a
reasonable cost.
Objectives leading to the achievement of this goal
include: (1) designing and implementing an appropriate
Agency-wide organizational framework for standardization;
(2) developing a protocol for standardization; and, (3)
implementing a vigorous standardization program.
Existing Standardization Responsibilities
The standardization of a measurement method takes place
after the research on that method has been completed and
is done in support of operational monitoring and enforcement
programs requiring reliable measurements. Due to the
interdisciplinary and inter-program relationships, most
of the standardization activities inherited by EPA are now
located at the National Environmental Research Centers
(NERC) and their satellite laboratories under the manage-
ment of the Office of Monitoring Systems (QMS). Some
additional standardization and quality control activities
are carried out by other EPA programs.
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1. Activities of the Office of Researchand
Development
The Office of Research and Development maintains
centralized programs for methods standardization designed
to support the critical measurement methods needs of the
Office of Air and Water Programs (OAWP), the Office of
Hazardous Materials Control (OHMC), the Office of Enforce-
ment and General Counsel (OEGC), and the Regions. These
activities are located at NERC-Research Triangle Park (RTF),
NERC-Cincinnati, and NERC-Las Vegas. With increasingly
effective communications and coordination within our ORD
programs, we are realizing significant benefits over past
efforts in terms of the development of analytical procedures.
For example, measurement methods for pesticides in water,
air, and land, and in plant and animal tissues are now
being developed jointly between methods development groups
at NERC-RTP and NERC-Cincinnati.
These efforts are eliminating unnecessary duplica-
tion and serving to aggregate our limited personnel
resource into "critical interdisciplinary arrays" which
allow us to most effectively meet standardization goals.
At the present time, the Office of Monitoring Systems has
no programs for standardization of solid waste or noise
measurement methodology. We expect to activate a noise
program at NERC-Las Vegas at some future date.
2. Standardization activities not in the Office of
Research and Development
Each Program Office has retained a final review
over methods in its area of activity and promulgates these
methods to support environmental standards.
The Office of Air and Water Programs is developing
and testing methods for measuring emissions in the air from
mobile and stationary sources. The Office of Noise Abatement
and Control has contracted with the National Bureau of
Standards (NBS) to develop and standardize methods for
measuring the noise output of regulated items. The Office
of Pesticides Programs (OPP) has an in-house quality assurance
effort which includes development and standardization of
methods and the distribution of standard reference materials.
Methods are collaboratively tested by OPP and the Food and
Drug Administration (FDA) laboratories. In some instances,
the Regions have taken action to supply themselves with
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standard reference materials and samples for methods stand-
ardization. An example is the Region IX reference sample
of San Francisco Bay sediment. Work of this nature meets
a legitimate need and will be recognized as we develop and
implement the standardization protocol.
Gaps in the Standardization Program
1. At the present time, we are still two to three
years behind in standardized methods needed for air and
water standards.
2. There are not now available standardized methods
for measuring specific radionuclides expected to be found
in effluents from nuclear facilities.
i
3. Methods for measurement of pesticides in tissues
and soils have not been validated by standardization
procedures.
4. There are no standardized methods now available for
the vast area of marine monitoring.
5. Until recently, the Office of Research and Develop-
ment was conducting a small effort in the standardization
of methodology for solid waste and solid waste processing
characterization. This nucleus has been effectively
terminated by recent budget cuts and redirections. Never-
theless, many measurements cannot be taken by simple
adaptations of methods developed for air or water programs
(e.g., the heat content of waste to be incinerated).
6. We also have no standardization resource commit-
ments to meet the methods needs of the Office of Noise
Abatement and Control.
7. Development of the equivalency protocols is lagging.
8. At the present time, mostly non-standardized
measurement methods for research and trend monitoring are
used to provide the data for criteria development. Data so
generated have an unknown degree of uncertainty associated
with them. Use of these data for criteria development
introduces a like degree of uncertainty in the reliability
of subsequent standards. This uncertainty can be avoided
only through the use of standardized methods.
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Components of Measurement Methods and Standardization
Measurement, in general, can be regarded to be made up
of a series of steps or modular functions. Sequentially,
these functions are sampling, sample work-up, analysis, and
data output. In some recent in situ measurement methods,
these functions have been consolidated into a single
instrumental method.
Sampling is the removal from the environmental con-
tinuum of a portion of the pollutant for detailed investi-
gation. Sampling involves containerizing a discrete volume
of polluted air, water, soil, or biological materials or
it may involve partitioning the pollutant directly from
these media into a filtering or absorbing device or into
another fluid (e.g., the absorption of the sulfur dioxide
pollutant in air into a solution of potassium tetra-
chloromercurate). Additionally, it includes those pro-
cedures necessary to preserve the sample. In all of these
sampling methods, we must accurately know what fraction of
the pollutant passes from the environmental continuum into
the sample. Standardization of the sampling method
establishes the reproducibility of this relationship.
This relationship must be shown to be stable or to follow
predictable changes from the time the sample is taken to
the time the sample is worked up for analysis.
Sample work-up consists of the preparation of the
sample by concentration of pollutant, removal of inter-
fering substances, etc., for the analytical procedures to
follow. It must be established that all pollutant losses
during sample work-up can be quantitatively accounted for
and are reproducible within statistically acceptable
limits.
Analytical methods are designed to give accurate
estimates of the true amount of pollutant remaining in the
worked-up sample. The standardization procedure assures
that these values are reproducible within statistically-
acceptable limits. The value derived from the analytical
method adjusted for predictable losses in sampling and
sample work-up gives the estimation of the true concentration
of the pollutant in the environmental continuum.
The analytical method is the last step in the measure-
ment method that we must standardize to assure that data
are of a consistently acceptable quality. However, it is
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also highly desirable that compatible formats for auto-
matic analytical data output be utilized to assure that
our large and increasing data base can be adequately
evaluated in a timely fashion.
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II. PHASES OF THE STANDARDIZATION PROGRAM
There are two major phases in the proposed stand-
ardization program: (a) establishing the elements of the
standardization program; and, (b) implementing the
standardization program (Table 1). A discussion of
these two phases follows.
A. Elements of the Standardization Program
The standardization program consists of three
basic elements: (1) the standardization protocol (Figure 1);
(2) equivalency guidelines; and, (3) instrumental data
output formatting guidelines.
1. Development and issuance of the standardi-
zation protocol
The standardization protocol consists of sci-
entific and statistical procedures prescribed by EPA to
evaluate and validate its analytical measurement methods.
The protocol prescribes the criteria for initial reviews
for methods selection, provides guidelines and details for
initial testing, and finally, provides the guidelines and
requirements for final validation and endorsement of the
standardized method.
Minimally, the initial screening for accepta-
bility of the method is determined by theoretical evalua-
tions or cursory experimental analysis based on chemical,
physical, or biological principles. The initial review
is designed to provide a first approximation of the
ultimate applicability and limitations of the method such
as sensitivity and degree of susceptibility to interferents.
In many instances, this initial review will have been
completed by the methods research program. The protocol
logically proceeds to further single laboratory or field
testing, confirms or rejects the predictions based upon
the theoretical review, and provides the criteria for
designating the method as tentatively validated. The pro-
tocol then sets out the criteria for the subsequent
controlled multi-laboratory collaborative testing of the
method. And, finally, the protocol provides the statis-
tical design criteria for analysis of the results of the
collaborative test for either rejection or full validation
of the method. Because the standardization protocol
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TABLE 1
Phases of the Standardization Program
PHASE 1; Establishing the Elements of the
Standardization Program
Development and issuance of
the standardization protocol
i
Guidelines for determining
equivalency
Guidelines for designating
reference methods
Guidelines for instrumental
data output formats
PHASE2; Implementing the Standardization
Program
Establishment of the standard-
ization program organizational
and technical framework
Implementation and operation
under the standardization
protocol and equivalency
guidelines
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will have impact throughout the Agency, it must be devel-
oped and approved in concert with all appropriate elements
of the Agency.
A diagram showing these relationships is
illustrated in Figure 1. The initial draft of the stand-
ardization protocol is being prepared by the standardiza-
tion activity. A first review for endorsement will be
made by the quality assurance and related standardization
activities at the National Environmental Research Centers.
The draft protocol will be transmitted to the Office of
Research and Development, the Office of Air and Water
Programs, the Office of Hazardous Materials Control, and
the Office of Enforcement and General Counsel for review
and endorsement.
The steps in the standardization process are
discussed more fully in the following sections:
a. Identification of methodology needs —
Methodology needs arise from considerations of statutory
requirements, needs identified within the Agency, and
needs identified outside the Agency. Needs for measure-
ment methods must be identified to be responsive to the
Agency's priority missions. The standardization process
is lengthy and identification of needs well in advance of
deadlines will allow coordination of the standardization
process with the schedules of the activities requiring
standardized measurement methods. The Office of Research
and Development has institutionalized a need identification
and reviewing system. Needs are solicited from the
Program Offices and Regional Offices as well as from the
Office of Research and Development elements. Methods
standardization needs can be specifically identified as a
single need or they can be highlighted in need statements
pertaining to other areas such as criteria and standards
development, as well as through projections relating to new
priority pollutants from the experiences of field programs
and from processes and effects and other research groups.
Periodically, contracts and grants have been awarded to
make five- to ten-year technology forecasts and predictions
of related pollution loadings. These can also serve to
identify measurement needs. All submitted needs will be
subjected to preliminary reviews by the quality assurance
program for first approximation priorities. Final
prioritization will be made after review by all
appropriate parties, work groups, or caucuses. These
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Figure 1
ELEMENTS OF THE STANDARDIZATION PROTOCOL
NEEDS
• Methodology
Selection
Sampling
Analysis
CANDIDATE
METHODS
• Theoretical
Analysis
• Experimental
Testing
TENTATIVE
METHODS
• Single
Laboratory
Validation
• Wide Field
Use
EPA VALIDATED
STANDARDIZED
METHOD
• Validation
• Endorsement
OUTPUT
• Publish
• Methods
Legistative
Requirements
Health
Effects
Regional
Requirements
Program
Requi rements
Collate
Literature
Search
Expert
Opinion
Limited
Evaluation
and Review
Review
Formal
Evaluation
Edit
Format
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reviews will determine if methods are available and will
determine the relative needs for a method and pronounce-
ment of final priorities. The final priority lists are
made the subject of Environmental Research Objective
Statements (EROS), Research Objective Achievement Plans
(ROAP), and Tasks for funding considerations.
b. Selection of candidate methods* —
Once a task for standardization of a method for measuring
a pollutant has been approved and funded, the known methods
applicable to the pollutant, the media, and the measure-
ment purpose under consideration are subjected to theoret-
ical analysis and limited laboratory and field testing for
first approximations of applicability and limitations such
as detection limitations, sensitivity, and susceptibility
to interferents. Measurement methods from the literature
or from any other source, within or without EPA, may be
considered for inclusion on the list of candidate methods.
When no satisfactory method can be identified which meets
a particular need through this process, methodology
research requirements will be identified and the stand-
ardization process will be delayed. Candidate methods are
those which successfully pass this initial screening.
c. Evaluation and testing to select
tentative methods — Candidate methods which have been
selected for further testing are then subjected to inten-
sive single laboratory testing to verify predictions made
by theoretical analysis. The best methods which meet
minimum requirements will then be designated as tentative
methods. Minimum requirements are those which will be
defined by protocol for accuracy, precision, specificity,
reliability, interferents, etc. Operational constraints
such as cost, cycle time, and temperature limits will be
based upon user requirements and state-of-the-art
technology. This initial screening and testing may
involve both research and program personnel. A tentative
method is one which shows acceptable performance under a
number of conditions but which has not been collaboratively
tested.
d. Collaborative testing — Collaborative
testing is an important step in the validation of any
*A candidate method is any method of sampling or analysis
advanced by a requesting party as suitable for adoption
as a standardized method and eventual designation as a
reference method.
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method of measurement to determine, on a statistical
basis, the limits of error which can be expected when the
method is used by a typical group of investigators.
Collaborative testing is generally quite expensive.
Accordingly, only those methods which are deemed to be
particularly sensitive for the Agency's regulatory
functions will be selected from the list of tentative
methods for collaborative testing.
The collaborative testing, or inter-
laboratory test, of a method is a vital part of the
development and standardization of an analytical proce-
dure to ensure that the procedure is clear and complete
and to establish with confidence the limits of precision
and accuracy which may be claimed fpr 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 method is fully characterized
as to its sensitivity, accuracy, precision, reliability,
range, and limits of detection. Additional requirements
in terms of interferents, cost, cycle time, power source
stability, reagents, operator training, physical environ-
ment, and maintenance may also be considered during
method validation.
e. Endorsements and publication — Once
the method has been validated by collaborative testing or
other procedures as may be deemed appropriate for the end
use, it is reviewed and endorsed by the quality assurance
activity and other appropriate Agency elements for
technical content and adherence to the standardization
protocol. For methods which are not part of regulations,
this is the highest level of endorsement required before
the method is declared a "standardized method" and is
published by the quality assurance activity in the
Environmental Monitoring Series or in other publications.
For methods which support standards and are to be prom-
ulgated or cited in regulations, the method is transmitted
through normal channels for approval, e.g., working groups
and Steering Committee. Final endorsement is made by the
Steering Committee before the method is then transmitted
to the Administrator for approval as a "standardized
reference method" and is published or cited in the
Federal Register. Loose-leaf copies of reference methods
will receive widespread distribution within EPA so that
the method may be quickly and conveniently integrated
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into the Agency's monitoring program. The concept of
reference method is discussed in greater detail below.
It should be noted that this concept is quite different
from past uses in the Agency of this term.
Definition of the Term
"Reference Method"
As used in the Measurement Methods Standard-
ization Strategy document* only a single
method is to be selected by EPA and desig-
nated as its reference method for a single
environmental pollutant or parameter under
the range of conditions for which the method
is applicable. The environmental pollutant
or parameter measurement may be a chemical*
physical, or biological quantity related to
environmental quality. A method so desig-
nated must have acceptable accuracy and
precision performance characteristics which
have been scientifically and statistically
validated by multiple laboratory collabora-
tive tests under a variety of anticipated
user conditions. The method must be readily
available to a prospective user laboratory.
This will preclude designation of very
expensive* sophisticated methods as refer-
ence methods even though they may be the
most accurate methods available because they
would not be available to the large majority
of prospective user laboratories. No method
will be declared by the Agency as its
reference method without full validation.
Under most conditions3 only reference methods
will be made part of the Agency's regulatory
promulgations. In most instances* such
promulgations should be delayed until appli-
cable "reference methods" are available.
Under very extenuating circumstances* use of
"tentative methods" which have not been fully
validated may be required by the Agency to
support its regulatory promulgations. Such
usage must clearly designate the interim
status of such methods. Tentative methods
will be replaced by fully-validated reference
methods as soon as they become available.
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Proper caveats must be included in promul-
gations which include "tentative methods"
clearly explaining their limitations.
The reference method is the bests readily
available method. Under most circum-
stances 3 it will be expected that the
reference method will be the method of
choice of most user laboratories. When
other methods must be used for any reason,
their equivalence to the performance
characteristics of the reference method
must be demonstrated to assure that data
generated by their use is equivalent to
that generated by the reference method and
that statistically valid comparisons can
be made between such data and that
generated by use of the reference method.
2. Equivalency determination
The concept that there can be only a single
reference method in an environmental standard for a
given pollutant requires that a provision be made for
determining equivalency of alternate methods. The
equivalency of a method to an official EPA reference
method will be determined through the use of an official
EPA test protocol which 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
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. The Environmental
Protection Agency 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. Considering the large
number of air, water, and categorical quality and
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. This activity must
be given visibility by the quality assurance activities
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either as individual tasks within Research Objective
Achievement Plans, or better, as the main objective of
such a plan.
3. Data formatting and instrument data
systems compatibility guidelines
A final step in any determination is the
recording of data in some form, generally obtained from
an electrical signal (for example, a photometer reading).
Common methods now in use are manual recording and
strip charts; however, because of the continually
increasing volume of data to be collected, there is a
growing trend toward the use of more sophisticated data
handling techniques with the electrical signal converted
to a digital signal and recorded directly into a computer-
compatible format. In order to encourage this desirable
trend and meet increased Agency data handling requirements,
the instruments which perform the final step in an analysis
should be standardized in their mode of data presentation
and manual data handling techniques should present data in
a compatible form for entry into automated data handling
systems. Therefore, data formatting and instrument data
system compatibility are considered in the standardization
process. The standardization program will assure coordin-
ation between designers of data collection and storage
systems and designers of automated environmental monitor-
ing instruments by publishing instrument data output
guidelines.
B. Implementation of the Standardization Program
Implementation of the standardization program
is concerned with two major types of activities:
(1) the establishment of an organizational and technical
framework for all Agency standardization activities;
and, (2) the routine operation of the standardization
program under the guidelines established by the protocol
and related activities. Whereas the first activity is
primarily concerned with management and policy responsi-
bilities of the various organizational elements, the
second activity is mainly concerned with the management
of resources such as delineation of projects and tasks
and the timetables that must be met. In this section of
the report, these items are described and analyzed and
the implementation plan is given.
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15
1. Organization plan
a* Premises — The organizational plan
for the Agency's standardization program is based on the
following premises:
• It is the responsibility of EPA
to promulgate official reference
methods in support of environ-
mental pollution standards and
to publish standardized methods
for other widely used environ-
mental measurements.
• The Environmental Protection
Agency will not publish, as
reference methods, any method
that is unvalidated.
• Standardization of methods may
be initiated by any laboratory
under the approved Agency's
protocol.
• Standardization activities are
centrally coordinated to avoid
unnecessary duplication.
• Standardization of methods
follows an Agency-wide uniform
and rigorous protocol of sound
technical procedures for
approving methods and techniques.
• There is close liaison with all
functional elements and lab-
orator,ies of the Agency.
• There is optimum interaction with
all appropriate external
organizations.
b. Standardization program responsibilities
A number of laboratories now within EPA were set up by
predecessor agencies for the sole purpose of testing and
standardizing methods. Since incorporation into EPA, these
laboratories have, in general, continued to perform the
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16
same functions. There are also other laboratories, both
within and outside EPA, engaged in standardization
activities. Therefore, one of our high priority objec-
tives is to coordinate standardization activities across
the Agency. This will assure uniform quality of methods
which have been standardized while meeting user needs
completely and utilizing the available facilities,
expertise, and resources in the most cost-effective manner,
These objectives will be accomplished through rational
assignment of methods standardization responsibilities
coupled with a strong emphasis on the standardization
protocol which encourages inter-laboratory communication
and cooperation. The specific functions of the various
organizational segments are given below.
(1) Office of Monitoring Systems —
The Office of Monitoring Systems has the primary responsi-
bility for coordination and technical guidance in stand-
ardization activities. The Office of Monitoring Systems,
in cooperation with the research activities and all other
Program Offices and Regions, has the following
responsibilities:
• Develops the necessary protocols,
guidelines, and procedures for
the standardization activity.
• Organizes and leads advisory com-
mittees for the development and/or
review of guidelines and methods.
• Coordinates the implementation of
an Agency-wide standardization
program.
• Insures that the established
guidelines are being followed.
• Collates and maintains a con-
tinually updated and prioritized
list of monitoring methodology
needs.
• Maintains information on all EPA
standardization activities to
minimize unnecessary duplication.
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17
• Devises and implements a system
for the evaluation and determina-
tion of manual and instrumented
equivalent methods for sampling
and analysis.
• Publishes approved analytical
methods and sampling techniques
and other guidelines as necessary.
• Provides for technical assistance
when requested in the area of
analytical methodology and
sampling techniques.
(2) Standardization activities at
NERC Laboratories — Technical aspects of the standardi-
zation program will be implemented mainly by the standard-
ization activities at the NERC's. These laboratories
have, in addition to providing technical support to the
Office of Monitoring Systems, the following major
responsibilities: (1) designing and conducting col-
laborative testing programs; (2) evaluating test results;
(3) determining method and instrument equivalence; and,
(4) providing technical assistance.
Technical responsibilities
within the Office of Research and Development for the
various media and categories currently are as follows:
standardization activities in air are conducted within
the Quality Assurance and Environmental Monitoring
Laboratory (QAEML) at NERC-RTF; those in water are con-
ducted within the Analytical Quality Control Laboratory
(AQCL) at NERC-Cincinnati; and pesticides activities are
conducted within the Primate and Pesticides Effects
Laboratory (PPEL) at NERC-RTP. NERC-Corvallis and
NERC-Las Vegas are to be brought into the standardization
program through assignments of tasks in standardization
not being executed at the other NERC's, e.g., standardiza-
tion of noise measurement methodology, standardization
of data collection and formatting, and development of
laboratory programs verifying instrumentation equivalency.
(3) Research activities — Because
of the close interface between methods research and
methods standardization activities, the role of methods
research programs in standardization activities cannot
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18
be neglected. In many cases, the methods research groups
will provide an essential function in assisting the
quality assurance activities in the initial review of
a method based on theoretical analysis of basic physical,
chemical, and biological principles. The initial
review may include experimental analysis of the method
followed by evaluation of a working prototype of the
instrument or procedure under a range of single laboratory
conditions which could include field testing. The
research activities will also provide valuable inputs
by their participation in collaborative testing and
methods endorsement required by the standardization
protocol.
(4) Program Offices — The Office of
Air and Water Programs, the Office of Hazardous Materials
Control, the Office of Planning and Management, and the
Office of Enforcement and General Counsel, in addition to
the other elements of the Office of Research and Develop-
ment, assist the Office of Monitoring Systems in develop-
ing requirements, formulating the standardization protocol,
establishing priorities, and conducting technical
investigations. These are the organizational units
that will specify needs and will be the users of the
standardization product. Their participation in the pro-
gram is essential. Assistance includes participation on
advisory committees to deal with major policy issues and
to coordinate program operations. To facilitate coordina-
tion, each Program Office will designate an advisory
program coordinator who will provide continuing liaison
with the Office of Monitoring Systems.
(5) Intra-agency Quality Assurance
Coordinating Committee (IQACC) — A formal mechanism to
provide communication and coordination between the users
and producers of the standardization product is essential.
For this reason, a duly constituted intra-agency
committee has been proposed. This committee is to be
composed of the Director, Quality Assurance Division, one
representative from each National Environmental Research
Center, and representatives from the Office of Air and
Water Programs, the Office of Enforcement and General
Counsel, the Office of Hazardous Materials Control, and
the Office of Planning and Management. Also, the Regions
will have two representatives appointed by the Office of
Regional Liaison. The committee's primary function will
be to assist and advise the Office of Monitoring Systems
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19
in fulfilling its coordination role and to serve as a
forum for the resolution of major policy issues concerning
quality assurance.
Specific advisory tasks which
the committee may perform with respect to the standardiza-
tion program include: (1) review of methods which are
proposed for adoption as official EPA reference methods
to ensure that the protocol for standardization has been
followed; (2) evaluation of progress toward standardization
goals; (3) identification of areas of duplication and
suggestion of mechanisms to avoid duplication; and,
(4) through its technical subcommittees, formulation and
recommendation of protocols for standardization and other
technical guidelines necessary for the implementation of
an Agency quality assurance program.
(6) Steering Committee — The role
of the Steering Committee in the promulgation of environ-
mental standards has been established by the Agency.
Therefore, actions taken by the standardization program,
such as the standardization protocol, reference methods,
and equivalency determinations, must be routed through
the Steering Committee for endorsement.
(7) Other Agency laboratories — Any
program or laboratory desiring the designation of a method
as a standard method may perform the necessary tasks
providing that they follow the protocol and submit infor-
mation on their standardization efforts to the quality
assurance activity for review for compliance with the
protocol. If the information shows that the method has
been properly evaluated according to the Agency's standard-
ization protocol and if the method itself meets user needs
in terms of accuracy, precision, and other considerations,
then the method may be approved and published as a standard
method. Endorsement by the Steering Committee and approval
by the Administrator will be necessary if the method is to
support regulations and be designated as a reference method.
An important and critical element
of a standardization program is the collaborative testing
and evaluation of tentative methods. Participants in these
activities will include EPA laboratories as well as outside
cooperating laboratories—other Federal, State, local,
industrial, academic, usually on a voluntary basis (in
certain instances, it becomes desirable to conduct such
tests by contract). Where external laboratories participate
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20
in the collaborative testing program, Regional Surveillance
and Analysis Divisions will be used to coordinate such
testing activities within their Regions. Also, where
particular expertise resides in a Regional laboratory,
that laboratory may actively participate in identification
and evaluation of methods. Regional Surveillance and
Analysis Divisions will have representation on all stand-
ardization coordinating committees through the Office of
Regional Liaison.
(8) External standardization
organizations — Since the standardization program will
have national impact, EPA will strive to utilize informa-
tion from and cooperate with all outside interests,
Federal, private, and international, in the development
and establishment of approved analytical methods. The
modes of involvement will be through encouraging coopera-
tion or participation of key EPA personnel on a personal
basis with established professional organizations such
as:
• American Society for Testing
and Materials (ASTM)
• American Public Health
Association (APHA)
• Association of Official
Analytical Chemists (AOAC)
• Air Pollution Control
Association (APCA)
Methods standardized by such organizations will be
considered for adoption as reference methods by EPA.
2. Projects andschedules
This section on projects and schedules deals
only with the near-term portion of the program. Scheduling
for actual standardization of methods is dealt with in
the section on resources which follows this section.
A methods standardization program requires a
twofold effort. The first is the establishment of the
organizational framework and procedures, or protocol,
under which the EPA standardization program will operate.
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21
The second is the actual implementation of this program
which includes testing, evaluating, and publishing
standard methods and official EPA reference methods.
Projects and milestones have been identified for both
and are presented in this section of the report.
Although ideally the implementation follows
the establishment of the framework and protocols,
legislative mandates demand that existing programs not
be interrupted or delayed. These existing programs are
attempting to meet mandated needs on a crash basis.
There is an urgent and continuing need to compile can-
didate and tentative methods for immediate use to form
a base line until fully-evaluated methods become available.
Overall, five major tasks have been delin-
eated. These are briefly described below and milestones
for each are shown in Table 2.
a. Protocol for standardization —
In developing the protocol, the document will be concerned
with more than just technical considerations. Certain
legal and administrative issues will require interactions
for resolution between the quality assurance activities
and elements from the Office of Enforcement and General
Counsel and other Program and Regional Offices. The
basic protocol will be developed by the Office of Monitor-
ing Systems with the assistance of the standardization
activities at the NERC's. The milestones for preparing
the final protocol document are shown in Table 2. The
final document will be submitted for review and endorsement
to all offices concerned with monitoring.
b. Compilations of sampling procedures —
In some cases, the requirement for uniformity In sampling
is so pressing that the immediate circulation of reasonably
well-characterized candidate sampling methods throughout
the Agency is preferable to waiting for the results of
thorough collaborative testing programs. This is partic-
ularly true where legal requirements exist but resources
for standardization are not adequate to conduct evaluation
and collaborative testing on several different methods
at once. In order to meet these needs with minimum delay,
the Office of Monitoring Systems and the standardization
groups at the NERC's will assemble compendia of sampling
methods. These compendia will not have the status of
official EPA reference methods,"But will be candidate
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Table 2
MILESTONES FOR PREPARING FINAL STANDARDIZATION PROTOCOL
Activity
Protocol for Standardiza-
tion
Compilations of Sampling
Procedures
Update for Compilation
of Abstracts of
Analytical Methods
(air, pesticides,
radiation, solid
waste, water)
Equivalency
Air*
Water
Instrument Data System
Compatibility
Guidelines
Standardization of
units
FY 1974
1st Quarter
Jul
*°
•*?
Aug
*P
Sep
^
*£
4f
2nd Quarter
Oct
*
Nov
Dec
A D
-*P
3rd Quarter
Jan
-rf
Feb
Mar
^
-*C
*'
4th Quarter
Apr
May
Jun
to
to
^
Key: 0 = Conceptualization Study
*Currently being considered by the Steering Committee. D _ oraft
R - RFP
C = Contract Awarded
NOTE: This chart is based on the assumption that the p = publish
strategy is approved prior to October 1, 1973. s = Submit to Administrator
for Approval
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23
sampling methods for use by Agency laboratories subject
to restrictions and caveats on the use of data.
c. Compilations of available analytical
methods — As with sampling, there is a continuing need
in the Agency for up-to-date information on available
analytical methodology. There is also a long-term need
for a unified set of approved Agency reference/standardized
methods; however, in some cases, the advantages of using
a reasonably well-characterized candidate or tentative
reference method outweigh the benefits of waiting for the
fully-evaluated and tested method particularly in cases
where the candidate or tentative method appears to have
good potential for eventual publication as an official EPA
reference method. To meet the short-term need, the Office
of Monitoring Systems, in concert w,ith the NERC's, will
prepare compendia of candidate and tentative methods. In
fact, the first edition of a compendia of abstracts of
over 400 methods has just been published by the Office of
Monitoring Systems.
d. Equivalency — The Environmental
Protection Agency has adopted a policy to permit the use
of measurement methods equivalent to the official methods
adopted by the Agency. The activities described in this
section are intended to give the user of an alternate
method an opportunity to demonstrate equivalency under a
fair and impartial procedure which will encourage innova-
tion and advancement of the state-of-the-art while
maintaining high standards of quality and assure the
intercomparability of data.
(1) Equivalency of air methodology —
A draft equivalency document for measurements required by
the National Ambient Air Quality Standards (NAAQS) has
been prepared by NERC-RTP and is currently awaiting Agency
approval. The document covers instrumentation and
methodology and includes details on test procedures and
performance specifications. Similar guidelines will need
to be required for measurements called for in the New Source
Performance Standards (NSPS) and the National Emissions
Standards for Hazardous Air Pollutants (NESHAP).
(2) Equivalency of water methodology —
NERC-Cincinnati has developed interim equivalency guidelines
for water methodology required by Section 304(g) of the
Federal Water Pollution Control Act amendments of 1972.
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24
This includes information on test procedures, standard
reference materials, referee methods, and statistical
handling of data to verify results. Permanent guidelines
must still be developed.
(3) Other measurements — Eventually,
we will need equivalency guidelines covering other
measurements such as pesticides, radiation, noise, and
solid waste. Since there are no EPA promulgated standards
requiring reference methods in these areas, the need for
equivalency guidelines for these is less urgent.
e. Data output — Guidelines must be
prepared which will enable the Standardization process to
extend to the output terminal of electronic instruments
to enable direct digital input to computerized data banks.
This activity, to be undertaken by the Office of Monitor-
ing Systems, will require close cooperation with the
organizational elements responsible for the Agency's
data systems. Without their participation, such guidelines
cannot be prepared.
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25
III. METHODS STANDARDIZATION PROGRAMMING
Introduction
The first portion of this document has discussed
our strategies, protocols, and guidelines to organize and
implement the Agency-wide standardization program. In
reality, the ultimate product of the standardization
effort is not strategies, protocols, or guidelines, but
the standardized method whose validity has been estab-
lished to high degrees of scientific and statistical
certainties and a series of reports that makes these
validated methods available to the monitoring community.
Again, confronted with realities, our output of stand-
ardized methods is directly related* to the resources in
terms of funds and manpower which the Agency deems appro-
priate for this effort. We have, therefore, included
in this chapter on Methods Standardization Programming,
options at four successive programming levels describing
what standardization outputs the Agency can realize
with its commitment of resources.
In our first option, we describe our present resource
commitments for standardization. We are lagging seriously
in providing standardized methods for air standards which
were promulgated in 1971. We are now confronted with
needs for standardized methods for water standards which
will not be fulfilled in a timely manner. To date, we
have not been confronted with standards for pesticides,
radiation, or other categorical standards. We are initiating
standardization in some of these areas on a very modest
scale in anticipation of future needs.
At the second programming level which we discuss, we
will be able to make positive headway in closing the gap
in our standardized methods needs for past environmental
standard promulgations.
At the third programming level, we could keep abreast
of our needs for standard methods support of environmental
standards in a timely manner.
And, finally, at the fourth programming level, we
could start to standardize some of the more widely used
research methods. Much of the data generated by the use
of such methods will be used to develop the criteria for
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26
eventual environmental standards. Standardization of such
methods will assure continuity of data reliability and
intercomparability with data that will eventually be
generated by monitoring activities from reference methods.
We have also included in this chapter a representa-
tive example of necessary lead times to have a standardized
method available at the time an environmental standard is
promulgated, and a brief example of the expected costs
for standardization of a measurement method.
Lead-time Requirements
The schedules for the standardization of individual
methods are closely linked to the needs of the Program
Offices and Regions, statutory requirements, anticipated
legislation, research results, and the Office of Research
and Development's need statements submitted through cog-
nizant authority. A case in point is the requirement for
validated methodology for air quality measurements levied
upon the Office of Research and Development by the Office
of Air and Water Programs. In this request, this office
established a "control schedule" for approximately 30 pol-
lutants which imposed a timetable for providing official
EPA reference methods. These requirements included both
techniques for ambient as well as source measurements. In
order to meet this "control schedule," the measurement
methods must be available well in advance of the actual
environmental standard promulgation schedule. The
requisite lead times are shown below:
Lead time in
months
National Ambient Air Quality 15
Standards
New Source Performance Standards 12
National Emissions Standards for 12
Hazardous Air Pollutants
Mobile Source Emissions Standards 24-36
Fuel and Fuel Additives Regulations 18
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27
In addition to these lead times, we must also add up
to approximately one year which is the time required for
the actual methods standardization process. Thus, ideally,
standardization of a method must begin two to three years
prior to the promulgation of the standard. Until now,
this type of advance notice and planning has not been
possible and, for this reason, we are now playing
"catch up."
Standardization Costs
It is estimated on the basis of past experience that
the cost to standardize a measurement method can be as
high as $100,000 and require four man years of effort.
This estimate was made on the following assumptions:
• Several existing methods are
available in the scientific
literature, but the specific
procedure suitable for EPA
requirements has not been
identified.
• A thorough screening effort is
required to identify the best
methods and to evaluate their
applicability.
• The selected procedures must be
collaboratively tested under
actual laboratory operating
conditions.
The individual tasks leading to a fully-standard!zed
method are itemized below with associated required
resources.
Task MY Dollars
Literature search 0.1 2,500
Preliminary laboratory 0.4 10,000
examination of alternative
methods
Selection of best approach 0.1 2,500
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28
Task MY Dollars
Preparation of preliminary 0.1 2,500
method description and
procedure
Testing method at various 0.3 7,500
concentrations of pollutant
Testing method in actual 1.0 25,000
samples
Identifying interferences 0.1 2,500
Modify procedure to eliminate 0.4 10,000
interferences and retest
Determine single laboratory 0.4 10,000
precision and accuracy
Determine multi-laboratory 1.0 25,000
precision and accuracy
Publish and distribute 0.1 2,500
Using an actual case, the cost breakdown on the three
collaborative tests which were performed on ambient air
methods for sulfur dioxide, particulates, and carbon
monoxide follows:
Contract Cost;
Item Cost
Direct materials $ 19,600
Direct labor (staff & shop) 107,960
Overhead 104,264
Travel
Other direct charges
Fixed fee
Total
In-house Support; 0.5MY (est.) or $14,000
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29
Estimated standardization cost per pollutant:
Contract cost $293,821
In-house cost 14,000
Total $307,821
Cost per pollutant $307,821*3 - $102,607
It must be recognized that for these methods there was no
corraborative data from other sources and, thus, the high
cost.
In some cases, a method may have been already fully
evaluated and validated by a recognized standards-setting
organization such as ASTM or APHA. In these cases, EPA
may only need to conduct a very limited review and the
cost of obtaining an EPA approved standardized method
would be considerably reduced.
Programming Level 1—Present Resource Allocations
1. Standardization ofair methodology
A large portion of the current program consists
of completion of projects that were started in 1972 and
1973. These projects, totalling $1,377,000, are listed
below:
• Collaborative testing of methods
for nitrogen oxides, sulfur dioxide,
and sulfuric acid mists from sulfuric
acid plants, particulates from power
plants, and visible emissions from
several stationary sources (Group I) •
• Collaborative testing of methods
for carbon monoxide from petroleum
fluid catalytic cracking units,
sulfur dioxide from refinery gas
burning, and hydrogen sulfide from
fuel gas reprocessing (Group II).
• Sulfur dioxide and sulfuric acid
mists from copper, lead, and zinc
smelters (Group IIA).
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30
• Methods for mercury and beryllium
for the National Emissions Standards
for Hazardous Air Pollutants.
• Collaborative testing of the chemi-
luminescent method for ozone,
several methods for nitrogen oxides,
and the 24-hour sampling procedures
for sulfur dioxide, collaborative
test for the hydrocarbon method,
and verification of the guidelines for
determining equivalency for the
National Ambient Air Quality
Standards.
• Development of new and improved
materials and techniques for
calibrating air pollution devices.
New starts in PY 1974 include:
• Standardizing a particulate method
for a selected Group II or III
industry.
• Evaluating and collaborative testing
of methods for total respirable
solids from Kraft paper mills,
fluorides from aluminum reduction
plants, nitrogen oxides and sulfur
oxides from gas turbines, and
fluorides and phosphates from
fertilizer plants (Group III).
• Evaluating collaborative testing
results for three ambient methods.
• Testing of a permeation device for
nitrogen dioxide.
• Developing standards for ozone,
carbon monoxide, zero air, and
sulfate for ambient measurements
and reference standards for sulfur
dioxide, nitrogen oxides, and
hydrogen sulfide from stationary
sources.
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31
These additional efforts approved for FY 1974 will cost
$753,000 and require 7.7 man years.
At our present programming level in FY 1974, we
have not been able to initiate any new starts for antici-
pated new ambient air methods. We are also lagging in
our efforts to catch up with our source measurement
methods requirements. Our efforts to produce standardized
reference materials for methods standardization are also
lagging behind our requirements.
2. Standardization of water methodology
In response to the requirements of the new Water
Bill, 72 parameters were identified for control under the
effluent permit program. In fulfillment of Section 304(g),
validated measurement methods have been issued for 30 of
these parameters. Forty-two methods must still be vali-
dated for accuracy, precision, and reliability before the
totality of the immediate requirements can be met. There
are also no validated methods to support the ocean dumping
permit program. In this area, adaptation of methods
developed for fresh waters to marine waters will require
considerable effort. We are equally hard pressed for
validated methods for the measurement of some of the pol-
lutants that are being declared as toxic pollutants in
fulfillment of Section 307(a) of PL 92-500.
The programming level for FY 1974 will allow for
completing the report of a joint preliminary study on com-
parative methods for the analysis of mercury which was
conducted with the American Society for Testing and
Materials (ASTM), analyzing the results of the collabora-
tive test for 10 trace metals, completing the report for
the collaborative test for 10 pesticides in water,
collaboratively testing the spectrophotometric and fluori-
metric methods for chlorophyll analysis, and preparing a
manual of biological methods. These efforts will cost
$50K and require 2.5 man years.
Continuous monitors for influent and effluent
streams are being evaluated and design and performance
specifications for single parameter monitors are being
prepared. Similarly, effluent and intake stream automatic
sampling devices and specifications for data output,
handling, and transmission systems are being developed and
evaluated. These efforts will cost $105K and require 4.5
man years.
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32
The total standardization effort for water will
cost $155K and require 7.0 man years.
At this programming level, very little work can
be undertaken to fulfill the methods requirements of the
effluent discharge and ocean dumping permit program or the
toxic materials standards. In addition, the much needed
standardization for biological, microbiological, and
viral measurement methods will be indefinitely delayed.
3. Standardization of radiation methodology
For radiation measurement requirements, a compen-
dium of 38 single laboratory-tested methods to measure
radionuclides associated with aqueous wastes from nuclear
facilities has been published. These methods have not
been validated by collaborative tests. Analytical methods
are also being developed and evaluated for radioactive
gases in in-plant waste streams, radioactive effluents
discharged in marine environments, and long-lived radio-
active materials from reprocessing plants. Single
laboratory tests are also being made on the performance
of thermoluminescent detectors for radionuclides.
Some standardization of sampling techniques for
radionuclides in soil, biota, and air is also being
conducted.
The total radiation standardization effort will
cost $292K and require 12.8 man years.
The present program will not include any collabo-
rative testing for measurement methods for environmental
ionizing or non-ionizing radiation nor will it allow
adequate standardization of sampling techniques for radio-
nuclide content of plants, animals, soil, and air in the
environment of nuclear facilities and fuel reprocessing
plants.
4. Standardization of pesticides me_thodolqgv_
Present activities include field testing of a
system to measure pesticides in air, economic evaluation
of a completely automated system for analysis of pesticides,
collaborative testing of a method for alkyl phosphate
pesticides in association with the re-entry problem, and
evaluation of the electrolytic conductivity detector for
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33
chlorinated pesticides. The program is strongly oriented
toward methods for pesticides in food and animal tissues.
This effort will cost $50K and require 1.5 man years.
Methods currently being developed for sampling pesticides
in air and water will need to be standardized.
5. Standardization of noise methodology
No standardization activities for noise measure-
ment methodology exists within ORD. The National Bureau
of Standards is conducting some methods standardization for
EPA's Office of Noise Abatement and Control.
6. Standardization of solid waste methodology
The solid waste standardization activity was dis-
continued pending review of the entire program. Some
measurement methods such as heat content are unique to
solid waste management and will need to be standardized.
Resource Summary—Programming Level 1; The current
standardization effort costs $1250K and requires 29.0 man
years of effort. Additionally, carry-over funds totalling
$1377K represent contractual obligations that will be
completed in FY 1974. At this level, we have made
standardized methods available for about 55 pollutants
over a period of three years and are in the process of
standardizing about 26 additional methods. Some of the
additional methods are alternative methods for pollutants
for which collaboratively tested methods are already
available, for example, sulfur dioxide, nitrogen dioxide,
and ozone.
Programming Level 2—Critical Needs
Critical needs identified at this programming level
are the requirements for standardized methods imposed by
promulgated environmental standards.
1. Standardization of air methodology
At this level, the standardization of source
measurement methods will be accelerated, whereby, the
methods requirement for sources through Group III indus-
tries would be met by the end of FY 1974 or early FY 1975.
This schedule would, of course, be highly dependent on
the easy adaptability of Group I industry methods to the
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34
succeeding groups. In the event that interferents preclude
each adaptability, completely new methods would be
required at considerably higher costs and require more
time. This level of effort would also expand the capability
to evaluate equivalency guidelines and methods.
The new activities would cost $200K and require
2.3 man years for a total program cost of $953K and
10 man years.
2. Standardization of water methodology
The increased efforts would be used to accelerate
the efforts to meet the requirements of the effluent dis-
charge and ocean dumping permit programs and the toxic
substances standards. The acute limitation on funds and
manpower will make it very difficult to fulfill all of
these requirements in less than two to three years. The
new activities would cost $200K and require 2.2 man years
for a total program cost of $355K and 9.2 man years.
3. Standardization of radiation methodology
We will, as in Level 1, fulfill single laboratory
testing requirements for the most important radionuclide
measurements from nuclear devices and facilities. In
addition, a program of collaboratively testing of these
methods will be started. These methods will be needed for
the EPA nuclear facility radiation inspection program.
Level 2 incremental costs would be $40K and require 0 man
years for a total program cost of $334K and 12.8 man years.
4. Standardization of pesticides methodology
Analytical methods which have been standardized
in the past will be published. Increased emphasis will be
placed on sampling methodology for water and air samples.
Level 2 incremental costs would be $70K and require 1.5
man years for a total program cost of $120K and 3.0 man
years.
5. Standardization of noise methodology
A base program will be started by developing a
framework for standardization of noise methodology. Actual
collaborative testing would be started in the succeeding
year. Level 2 incremental costs would be $30K and 2 man
years for a total program cost of $30K and 2 man years.
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35
6. Standardization of solid waste methodology
At this level, most of the measurement methodology
requirements of solid waste programs would be met through
simple adaptations of methods known to be acceptable in
other areas (such as New Source Performance Standards for
incinerator emissions). The most critical methodology needs
which are unique to solid waste would be fulfilled by a
dedicated effort of $30K and 1 man year (compared with no
effort under Level 1).
Resource Summary—Programming Level 2; To meet the
most critical needs for standardized methods would require
$650K and 9 man years over the current resource allocations
for a total program cost of $1900K and 38 man years. This
would permit us to initiate standardization of 27 critically
required additional methods which still leaves many water
and radiation methods unstandardized.
Programming Level 3—Meeting Environmental Standards Needs
for Methods
At the third programming level, needs for standards
methods support of environmental standards could be met in
a much more timely manner.
1. Standardization of air methodology
In addition to the activities at Levels 1 and 2,
the program to validate methods proposed as equivalent to
EPA reference methods would be expanded. Also, at this
level, some standardization activities and development of
related standard reference materials could be undertaken in
anticipation of new regulations. Level 3 incremental costs
would be $237K and require 1 man year for a total program
cost of $1190K and 11.0 man years.
2. Standardization of water methodology
In addition to activities at Levels 1 and 2, the
program would be accelerated to allow standardization of
methods required by the permit program in a much more timely
and responsive manner. Level 3 incremental costs would be
$17OK and require 1 man year for a total program cost of
$525K and 10 man years.
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36
3, Standardization of radiation methodology
There is no proposed increase over the critical
level for the radiation measurements standardization
program. Level 3 incremental costs would be $0 and
require 0 man years for a total program cost of $325K
and 12.8 man years.
4. Standardization of pesticides methodology
In addition to activities at Levels 1 and 2, we
will initiate a continuing program for validating equiva-
lent methods. Level 3 incremental costs would be $70K
and require 1 man year for a total program cost of $190K
and 4 man years.
5. Standardization of noise methodology
In addition to our activities in Level 2, we will
initiate a standardization effort for measurement method-
ologies. This effort would need to be closely related with
the acoustic' s group at NBS. Level 3 incremental costs
would be $7OK and require 1 man year for a total program
cost of $100K and 3.0 man years.
6. Standardization of solid waste methodology
There is no proposed increase over the critical
level. Level 3 incremental costs would be $0 and require
0 man years for a total program cost of $30K and 1 man
year.
Resource Summary--Programining Level 3; We could meet
most of our higher priority needs-above the critical level
with an incremental resource increase of $550K and 4 man
years for a total program cost of $2440K and 42 man years.
Programming Level 4—Most Standardization Needs
At programming level 4, most standardized methods
requirements for environmental standards could be met in
a responsive and timely manner. In addition, other
commonly-used methods could also be standardized.
1. Standardization of air methodology
t
At this level of effort, standardized methods
could be provided eventually (once we are caught up) for
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37
virtually all commonly-used measurements within the Agency
whether they are directly in support of environmental
standards or simply used for routine trend monitoring or
research. In addition, we would be able to evaluate a
substantial number of "equivalent methods" each year within
our own laboratories greatly increasing the confidence
associated with their use. This provides a useful
mechanism for EPA's monitoring activities to keep abreast
of the state-of-the-art. Level 4 incremental costs would
be $200K and require 3 man years for a total program cost
of $1390K and 14 man years.
2. Standardization of water methodology
Reference methods would be validated for most
routinely-used physical, chemical, microbiological, and
biological methods. Sampling procedures would be developed
and evaluated for both ambient and effluent measurements.
Equivalency guidelines would be published and candidate
methods evaluated for equivalency. Specifications for
instrumentation and instrument data output would be
developed. Level 4 incremental costs would be $30OK and
require 3 man years for a total program cost of $825K and
13.0 man years.
3. Standardization of radiation methodology
No change from Level 2.
4. Standardization of pesticides methodology
No change from Level 3.
5. Standardization of noise methodology
No change from Level 3.
6. Standardization of solid waste methodology
No change from Level 2.
Resource Summary—Programming Level 4; At this level
of resource availability, we coula start to standardize
some of the methods we more routinely use for research and
trend monitoring. This would lead to an improvement in
the quality of data from which effects criteria are
developed. We could initiate this expanded standardization
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38
activity with an incremental resource increase of $500K
and 6.0 man years for a total program cost of $2865K and
48 man years.
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39
Comments on "Measurement Methods Standardization
Strategy" Document
INTRODUCTION
In August 1972, the Office of Monitoring Systems dis-
tributed a draft standardization strategy for Agency-wide
review and comment. The responses were nearly unanimous
in endorsing the concept of an Agency-wide standardization
program. Many comments indicated a need for clarification
of the roles to be played by various components, particu-
larly Regional Surveillance and Analysis Divisions and
the National Environmental Research Centers. Some objec-
tions were raised with respect to the appraisal of
current status and capabilities of ongoing programs.
The major issues raised by the review are given below.
(1) Degree of centralization; While the majority
of reviewers approved of the concept of a centrally-directed
standardization program, a few with existing in-house
programs felt they should retain their responsibilities.
On the basis of the majority of reviewers and the mandate
of EPA Order No. 1110.22B, the revised strategy calls for
at least the coordination and review of all standardiza-
tion activities by the Office of Monitoring Systems with
-one option being complete transfer of all standardization
resources to the Office of Monitoring Systems.
(2) Use of the Federal Register; Most, but not
all, of the reviewers felt that EPA should be able to
publish official reference methods without using the
Federal Register. The revised draft allows for publica-
tion in an appropriate form depending upon requirements.
(3) Coordination; Several comments reflected
great interest in the establishment of formal and informal
means of communication and coordination, in fact, some used
the reply as a vehicle to communicate their immediate
needs for standardized methods. The need for effective
communication has been recognized in the strategy and
efforts are underway to establish an Intra-agency Quality
Assurance Coordinating Committee.
Many other minor revisions have been incorporated
directly into the revised strategy document.
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40
SUMMARY OF COMMENTS
REGION I
REGION IV
(1) The plan is well conceived and
represents a sound and realistic
approach to meet a fundamental
need.
(2) The EPA Regional Offices should
fully participate in collabora-
tive testing and act as a focal
point for such testing with
non-EPA offices in the Regions.
(3) Assure adequate provisions for
updating methods.
(1) The Analytical Quality Control
Laboratory in Cincinnati has had
an excellent program for water
methods evaluation and
standardization for over
four years.
(2) Existing system should be
strengthened particularly in the
program areas with weak
standardization methods.
(3) Need for more reference samples
and collaborative testing.
(4) Methods should be published in a
manual rather than in the Federal
Register. This would allow both
"official EPA standards" and
"provisional EPA standards."
(5) Collaborative testing should be
in-house. External laboratories
should be encouraged to participate
through Regional framework.
(6) Collaborative testing should be
directed by the NERC's. All EPA
laboratories should participate.
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41
REGION VI
REGION VII
REGION VIII
(7) The Surveillance and Analysis
Divisions should have explicitly
recognized input into identification
and prioritization of measurement
needs.
(1) Strategy document does not ade-
quately tell how standardization
programs will be implemented.
Does not show how Regional
Surveillance and Analysis Divisions
will be involved.
(2) Resource allocations show no monies
or positions allocated to Regions.
(3) Peels standard methods development
is one of the most critical areas
for future EPA activities,
particularly in relationship to
States and localities.
(4) Regions should coordinate inter-
actions with States/localities
starting from beginning of
standardization process.
(1) The proposal adequately expresses
needs for development of a program
of this scope and magnitude.
(2) Need for publishing standard methods
in the Federal Register.
(3) Resource allotments and emphasis
accorded to microbiological methods
is not sufficient. Need for
dramatic increase here dictated
by recent instrumented methods.
(4) More emphasis should be placed on
Regional Surveillance and Analysis
Divisions rather than NERC's "ivory
towers."
(1) Proposals in general well construed
and presented.
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42
(2) Standardization of environmental
monitoring methods and procedures
urgently needed within the Agency.
(3) Status of old FWPCA-U.S. Geological
Survey (USGS) Memorandum of Agree-
ment should be resolved. This
assigned ambient water quality data
gathering to USGS.
(4) Draft gives impression that exist-
ing water methodology standardiza-
tion is non-existent which is
definitely not the case.
(5) Sampling and sample preparation
procedures should receive greater
emphasis.
(6) Indicate how other Federal agencies
will interface with this program.
REGION IX (1) Office of Enforcement and General
Counsel should be involved in methods
review. This is especially impor-
tant for sampling procedures
particularly with regard to chain
of custody.
(2) Overall treatment of data handling
seems inadequate. Feels existing
systems, e.g., SAROAD, NEDS, and
SOTDAT, should be amalgamated.
<3) Too little emphasis on organic
chemical techniques.
(4) Inadequate treatment of bacteriological
methods.
(5) Some emphasis should be given to
encouraging outside collaboration,
e.g., through program grants.
(6) Consideration should be given to
equivalency testing for water
sampling and testing instruments.
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43
REGION X
Office of
Hazardous
Materials
Control
Office of
Radiation
Programs
(7) No resources are identified for
Regional participation.
(8) Alternatives at different levels
of resources should be identified.
(9) Sampling techniques should be
given more emphasis.
(10) Regional participation should be
given greater emphasis.
(1) The report is comprehensive and
well presented.
/
(2) Publication of a method in the
Federal Register does not assure
its credibility with the scientific
community. ASTM methods are of
value because they have been
thoroughly tested.
(3) Duties of the policy and advisory
committees are not well defined.
(4) Cost and time schedule to implement
the proposed program are ambiguous.
(1) Not clear if comments made on
revision of EPA Order No. 1110.22A
were taken into account in this
draft.
(1) Draft comprehensive in most respects,
Excellent working paper on which
to build.
(2) Advisory committee should be
immediately activated.
(3) Standardization activities of other
agencies, e.g., AEC, national
societies, such as ASTM, ANSI,
ANS, should be given more emphasis.
(4) Industry standards should be
accepted if they are consistent
with EPA program requirements.
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44
Office of
Solid Waste
Management
Programs
Office of
Toxic
Substances
(5) Not convinced that program
direction and management should be
centralized in one office.
(6) The draft ignores the Office of
Radiation Programs' non-ionizing
radiation program.
(7) Dose concept is very important for
radiation methods and should be
recognized in the draft. Pathway
media are important here. (Sub-
sequent discussions with the Office
of Radiation Programs have resolved
this question.)
(8) Existing Office of Radiation
Programs' activities should be
recognized.
(1) Standardization of sampling and
analytical methods vitally needed
and essential to EPA.
(2) Need for avenues of communication
between Office of Monitoring Systems
and operating programs. Standarizing
must respond rapidly to needs of
operating programs.
(3) Provision of technical assistance to
outside world is function and
responsibility of operating programs.
(4) Identifies specific areas where
standardized methods are needed.
(1) Well thought out proposal. Proposal
appears to be fundamentally sound.
(2) Why should EPA have its own standard
methods instead of quasi-official
compendia?
(3) Federal Register is a cumbersome
route to promulgate standard
methods; should be through EPA Order
mechanism.
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45
(4)
(5)
(6)
Office of
Pesticides
Programs
(7)
(1)
(2)
(3)
(4)
Office of (1)
Air and Water
Programs
(2)
Does not feel standard analytical
procedures should apply to bio-
logical properties or engineering
performance.
Insufficient effort given to feed-
back from persons in the field.
Make up of the advisory committee
too vague. Operations program
should be represented directly not
through the Assistant
Administrators.
While the Office of Monitoring
Systems has the lead role, the
activity is of pronounced interest
to all segments of the Agency.
In favor of participating in such
a program. It would have value to
the current operational monitoring
programs.
The Office of Pesticides Programs
should be utilized in development
of standardization procedures.
The National Pesticides Monitoring
Panel has a task force to write a
manual on field sampling techniques
and data analysis methods for
pesticides monitoring.
The Office of Pesticides Programs
is currently standardizing the
computer codes and processing of
all types of information; this
effort should be coordinated with
the Office of Research and
Development.
Need for monitoring standardization
is critical.
Need plan to assure quality control
associated with monitoring data.
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46
NERC-RTP
Office of
Director
(3) Draft does not discuss adequately
the standardization of sampling
procedures or data handling.
(4) Pails to provide recognition of
requirements to attach quality
control confidence to all data
available to analysts. To accom-
plish this, there is a pressing
need for ORD to provide analytical
laboratory identification,
published laboratory methods,
and grades for each laboratory
and its techniques.
(1) Real need for a unified position
in several areas of standardization.
Draft serves quite well to bring
together a logical statement of
EPA's overall standardization
policy.
(2) Conflict regarding who is responsi-
ble for preparing methods for
promulgation with regulatory
standards: Office of Air and
Water Programs or Office of Research
and Development?
(3) A possible conflict on policy with
respect to where the responsibility
for equivalency protocol lies.
(4) There has not been effective involve-
ment by the NERC-RTP standardization
program in the activities of
standards development of the Office
of Air and Water Programs.
Strategy document seems like good
vehicle to propose policy in this
area.
(5) No serious problems with funding
levels. Role of standardization
activities outside EPA must be
considered, e.g., ASTM.
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47
NERC-RTP
Emission
Standards and
Engineering
Division
NERC-RTP
Quality
Assurance and
Environmental
Monitoring
Laboratory
(6) Specific factors to be considered
in accepting a method as reference
should be carefully considered,
possibly expanding list.
(1) Comments on lead times for methods
associated with New Source
Performance Standards and National
Emissions Standards for Hazardous
Air Pollutants. Standardization
data lags standard developments
program.
(1) Basically a good document.
*
(2) Feels "standardized methods" should
be "reference methods" for compari-
son. Concept of "candidate methods"
for comparison with "reference
method" and designation of these as
"equivalent methods" when they meet
certain requirements in comparison
with the "reference method." This
will assure that best scientific
technology is employed in critical
areas.
(3) Does not feel that all "official
reference methods" should be
promulgated in the Federal Register
but should be in manuals instead.
(4) Feels that telemetering activities
have limited use in Agency and
should be restricted primarily to
specific research projects.
(5) Does not agree that Regional
Surveillance and Analysis Divisions
should do collaborative testing,
but should be included as a
collaborative laboratory.
(6) Responsibility of Headquarter's
Standardization Branch is to provide
overall policy guidance and
coordination in standardization
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48
areas across all media. NERC
operating laboratories have
responsibility for standardiza-
tion activities for methods
evaluation, tentative methods,
recognizing candidate methods, etc.
(7) Feels we should prepare "reference
methods" and not "standard methods."
(8) Most important requirements of a
reference method are accuracy and
precision which are usually
established by collaborative
testing.
(9) What should be the involvement of
outside organizations such as NBS,
ISC, etc., in EPA's standardization
strategy?
(10) What specific things must be
determined when a method is
under development?
(11) Interferences and costs generally
not determined in collaborative
testing.
(12) Federal Register should be used
with discretion for promulgating
a method. It should not be used
in all cases.
(13) Does not feel that the Regional
Surveillance and Analysis Divisions
have capability to conduct a
collaborative test in air methods.
(14) Wants some policy on what EPA's
relationship with other "standard
methods" organizations should be.
(15) Feels there should be more communi-
cation between the Office of Air
and Water Programs and NERC-RTP so that
each can be aware of the others needs
in the standards-setting program.
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49
NERC-
Las Vegas
NERC-Cin
Office of
Director
NERC-Cin
Analytical
Quality
Control
Laboratory
(1) Document is well written and should
be given total support throughout
the Agency.
(2) Supports EPA quality assurance
strategy.
(3) Brings up possible duplication of
activity in radiation with NERC-
Cincinnati.
(1) Ultimately support for standardiza-
tion can be related to long-term
economic and environmental dividends
greatly exceeding »the cost of
standardization.
(2) Methods standardization is an
expensive, tedious, laboratory
task which will require a
significant chunk of resources.
(3) Methods defensibility lies in the
exhaustive, collaborative,
replicative, and statistically-
significant studies of its performance
in any analyst's hands under a
variety of conditions.
(1) Suggests improved terms or defini-
tions for "candidate method,"
"tentative method," and "standard
method."
(2) Does not believe establishment of
equivalency can be left solely to
the p'roposer in the private sector,
but that some EPA collaborative
testing is required for this
evaluation.
(3) Responsibility for selection of an
EPA method cannot be transferred
to an outside group.
(4) Asks for careful selection of factors
to be weighed in selecting a
reference method.
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50
NERC-Cin (1)
Radiochemistry
& Nuclear
Engineering
Laboratory (2)
NERC-Cin
Solid Waste
Research
Laboratory
(3)
(1)
Draft provides a good overview of
ORD programs and planning in
standardization.
Variety of media may necessitate
several methods for same
radionuclide.
Participation of external groups
should be given added emphasis.
The Solid Waste Research Laboratory
feels it urgent that solid waste
tested methods be available as
quickly as possible.
The above comments were submitted by the following
individuals:
REGION I
REGION IV
REGION VI
REGION VII
REGION VIII
REGION IX
REGION X
Office of
Hazardous
Materials
Control
Edward V. Fitzpatrick, Director
Surveillance and Analysis Division
John A. Little, Director
Surveillance and Analysis Division
Eloy R. Lozano, Director
Surveillance and Analysis Division
Garry L. Fisk, Director
Surveillance and Analysis Division
Keith O. Schwab, Director
Surveillance and Analysis Division
Paul DeFalco, Jr.,
Regional Administrator
Gary L. O'Neal, Director
Surveillance and Analysis Division
G. R. Comstock, Director
Management and Program Evaluation
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51
Office of
Radiation
Programs
Office of
Solid Waste
Management
Programs
Office of
Toxic
Substances
Office of
Pesticides
Programs
Office of
Air and Water
Programs
NERC-RTP
NERC-LV
NERC-Cin
William A. Mills, Director
Criteria and Standards Division
H. Lainer Hickman, Jr., Director
of Operations for Solid Waste
Farley Fisher, Chemist
L. E. Miller
Pesticides Programs Manager
Robert L. Sansom
Assistant Administrator
R. R. Goodwin, Director
Emission Standards and Engineering
Division
Office of Air Quality Planning
and Standards
Paul A. Kenline, Director
Program Coordination Staff
S. David Shearer, Director
Quality Assurance and Environmental
Monitoring Laboratory
John B. Clements, Chief
Methods Standardization Branch
Quality Assurance and Environmental
Monitoring Laboratory
J. R. McBride, Deputy Director
National Environmental Research Center
Andrew W. Breidenbach, Director
National Environmental Research Center
Dwight G. Ballinger, Director
Analytical Quality Control Laboratory
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52
NERC-Cin Bernd Kahn, Director
(Cont) Radiochemistry and Nuclear
Engineering Laboratory
D. F. Bender, Project Manager
Support Services Branch
Solid Waste Research Laboratory
eu.8. GOVERNMENT PRINTING OFFICEU974 546-317/323 1-3
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\
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
2 0 1973
OFFICE OF
RESEARCH AND DEVEI_OPM =
SUBJECT: Measurement Methods Standardization
Strategy Document — ACTION MEMORANDUM
FROM: Assistant Administrator
Research and Development
TO: The Acting Deputy Administrator
THRU: AX
/
How should the measurement methods standardization activ-,^
ity be structured in order to meet the Environmental
Protection Agency's goals with respect to the selection
and promulgation of measurement methods to be used in
pollution monitoring?
DISCUSSION
Background - The availability and selection of sci-
entifxcally proven, appropriate, and cost-effective
measurement methods very often impinge on a variety of
EPA decisions and actions—the setting of standards, the
promulgation of many regulations, evidence for enforce-
ment, 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
method may delay our promulgation of a given standard or
result in later modification or withdrawal of an estab-
lished standard. Regulations concerning ambient and
source standards must specify the measurement methods to
be used in determining compliance; these methods must be
routinely applicable at a reasonable cost. Our guidance
to State and local agencies regarding the measurement
methodology to be used must be consistent throughout the
Agency. Also, the Agency could not fulfill its
enforcement responsibilities if an accused polluter
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could successfully attack and discredit our environmental
data measurement methodology. For this reason, we must
verify our measurement methodology through a laboratory-
oriented scientific standardization which cannot be
successfully challenged. Our methods defensibility lies
in the proper application of a standardization protocol—
the exhaustive, collaborative, replicative, inter-
laboratory testing of the method for accuracy and pre-
cision under the conditions required by environmental
standards or other requirements of our Agency, and the
statistical analysis of these tests to validate the per-
formance of the method in the hands of typical analysts
under a variety of anticipated conditions.
In this sense, standardization stands intermediate
between research and quality control. Our research pro-
gram conceptualizes and creates measurement methodology
based upon state-of-the-art scientific and engineering
knowledge, together with the skillful application of cur-
rently accepted scientific principles. Standardization
operates independently of research and is closely related
to quality control, providing maximum credibility to the
methods validation procedure by minimizing the research or
operational laboratory biases associated with either an
extremely high level of competence and familiarity with
the method or an average level of competence and total
unfamiliarity with the method. Our quality control pro-
gram complements standardization and completes the Agency's
quality assurance program by assuring that validated
methods are used in the production of environmental data
and that laboratories maintain the validated, legally-
acceptable levels of performance which have been
established for methods by the standardization program.
Present Status - Current Agency standardization activ-
ities have been thoroughly reviewed and a comprehensive
plan for an EPA standardization program developed setting
forth organizational strategy, delineating technical
projects and tasks, and briefly discussing resource
requirements for this program. Present activities in
standardization are inadequate to provide, the. JOiicEal-
lengeable methods which we need to support our progxams.
Some of our problems are technical in nature; others which
are addressed here are organizational and procedural.
In short, the basic problem is the lack of a coordinated
and logical approach to standardization which has resulted
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in the proliferation and use of methods of questionable
reliability and utility. In fact, EPA has been criticized
for its inability to provide adequately tested methods
and give uniform and credible guidance to the various
internal and external monitoring programs. The major
causes are:
1. Many EPA programs and laboratories are
involved in selection of methods and unilateral standard-
ization efforts. This, frequently results in the selection
and use of statistically unreliable methods.
2. In many areas, competing methods for
measuring specific pollutants have been made available
from different components of EPA.
3. The available lead times and funding in many
cases do not allow satisfactory standardization effort
prior to required methods designation and promulgation.
4. The involvement of many laboratories in
"standardization" of similar methods leads to unnecessary
duplication of effort.
It is in search of a solution to these problems that we
propose the implementation of an Agency -wide standardization
program.
The need for a central management and coordination of
the Agency's activities in quality assurance was recog-
nized in the Deputy Administrator's April 18, 1972
memorandum on monitoring where the Office of Monitoring
Systems was charged with this responsibility. In response
to this directive, a comprehensive plan for an EPA quality
control program was developed which received Agency
approval on February 13, 1973.
and the enclosed, dacuments .complement, the quality . control
program and complete the strategy for a balanced quality
assurance program. Since the implementation of this
program requires the full cooperation of all components
of EPA involved with monitoring, the adopted strategy must
be formally recognized. This issue deals only with the
basic questions of operation and responsibility in the
attainment of the Agency's standardization goals.
In all, three options are presented for consideration
The basic question is the degree of central authority that
is required to implement .an adequate program.
-------
The Standard!zation Plan - The first draft of the
standardization plan was developed and distributed for
Agency-wide review late 1972. The majority of reviewers
agreed with the need for a clear, Agency-wide standard-
ization capability. Two separate sub-issues relating to:
(1) reference methods versus standard methods; and, (2)
methods promulgation are presented as Tab A. In Tab B,
we present the revised standardization strategy plan
which reflects the comments (Tab C) of the reviewers of
the first draft.
ALTERNATIVES
Three options are presented for consideration to correct
present weaknesses in EPA1s standardization activities.
These range from status quo to a level which would
provide a maximum confidence in the reliability of all
methods being used.
Option A; All standardization activities (all collabora-
tive testing and final technical approval)
are centralized within one program element—
Monitoring Quality Assurance. Methods are
standardized as required for operating
programs.
pro: 1. A central focal point is readily
available for guidance on
methodology.
2. Best possible mechanism is established
for timely development of uniform
standard methods.
3. Centralized standardization may
permit more economical use of
resources.
con: 1. Loss of individual program capability
(where it now exists) to respond to
their own priority (and unique) needs.
2. Some reassignment of functions and
reprogramming of resources are
necessary.
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3. Does not encourage method user to
work on modifying or improving
existing methods.
Option B; A basic standardization protocol is developed
and followed in all EPA methods testing
activities. Under this option, the quality
assurance program, as at present, would
conduct the bulk of standardization, provide
technical guidance, and, in addition,
coordinate all standardization activities
and serve as the EPA .clearinghouse for
methods of measurement. Individual labora-
tories could still conduct their own
standardization activities, if necessary,
within the provisions of the standardization
protocol.
pro: 1. Transfer of funds and functions is
not necessary.
2. A central focal point is readily
available for guidance on
methodology.
3. Increased uniformity in method quality
is effected through a common
standardization protocol.
4. Permits a better use of existing
resources.
con: 1. Some loss in flexibility of individual
programs.
2. An added administrative burden to
provide maximum coordination in keeping
close track of all methods
s tandardi z ati on.
Option C; Status quo. The quality assurance program
continues to conduct a major portion of the
standardization activities (as it now does)
and coordinates, inasmuch as possible, the
ongoing standardization activities. Each
program is free to conduct their own methods
evaluation program.
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pro
con
1. No transfer of resources or changes
in existing lines of authority.
2. Allows maximum flexibility for each
program.
1. Overall, the least efficient use of
limited resources is likely, due to
fragmented effort.
2. Proliferation of questionable
"standard methods" is continued.
3. Conflicting guidance regarding
measurements is still provided.
RECOMMENDATION
That Option B be approved for immediate implementation.
This will assure availability to the Agency and other
user groups of the most reliable, cost-effective
measurement methodology.
CONCURRENCES
AM, Aim
AG, Kirk
AF, Sansom
AB, Dominick
AO, Marienthal
Concur
Approve:
Disapproved
Date:
Concur
.
tl*u*>&Jt
Nonconcur
See Tab
Nonconcur
See Tab p_
Nonconcur
See Tab E_
onconcur
See Tab T]
Nonconcur
See Tab
Date
DateNQV
Prepared by: ARMQ:RBMedz and GOzolins:jl:WSM:x50660:8/13/73
3 Enclosures (listed on next page)
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3 Enclosures:
Tab A: Issues I and II
Tab B: The Plan for the "Measurement
Methods Standardization Strategy"
Document
Tab C: Comments on the Plan by Headquarters,
Regions, and NERC's
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ISSUE I
Should EPA require the use of Agency-wide "standard measure-
ment methods" or establish "reference methods" and permit
the use of equivalent methods?
DISCUSSION
Mandatory use of standard measurement methods would assure
that every analyst would use exactly the same methodology
and procedures of known accuracy and precision to measure a
given pollutant in a given media. On the other hand,
endorsement of standardized reference methods would estab-
lish required performance levels for accuracy and precision
while allowing the analyst to select or modify any suitable
method to measure a given pollutant. In both cases, the
performance of the laboratories would be maintained at
acceptable levels by our quality control program.
Development and use of methods by past Agency practices have
been a mix of the two approaches. Environmental quality
standards promulgated under the Clean Air Act were supported
by "reference methods." Because of time limitations,
these methods were not validated prior to their promulga-
tion. The use of methods equivalent to the reference
methods was specifically permitted. This pattern of usage
is now occurring in the water effluent permit program, e.g.,
reference methods and equivalency provisions.
As the standardization program becomes more centralized and
incorporates an accepted standardization protocol, a decision
must be made between two alternatives :
ALTERNATIVES
Option A; EPA develops and requires the use of "standard
methods."
pro: 1. Assures the comparability and compati-
bility of environmental data
irrespective of source.
2. Allows standardization of equipment
and instruments and simplifies and
allows economics of scale in their
purchase.
3. Brings about the greatest uniformity
in monitoring for monitoring systems
and environmental data.
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con: 1. Rigid adherence to the use of a
standard method frequently serves
only to codify obsolete methods.
2. Some methods now in use and not
complying to the standard method
would have to be discarded,
sometimes at great expense.
3. Would tend to stifle competitive
research to develop newer measure-
ment concepts that could provide
better quality data .faster and
more cheaply.
4. Prevents modifications of methods
or use of alternate methods when
conditions require such
modifications and changes.
5. This option would be inconsistent
with promulgated guidelines
which permit the use of "equivalent
methods" by non-EPA monitoring
activities.
Option B; EPA develops and endorses standardized
"reference methods" and provides for
the use of equivalent methods when
appropriate.
pro: 1. Does not stifle competitive
incentives to develop better
methodology.
2. Can be implemented to assure a
uniform, high quality. Agency-wide
standardization program with a
minimum of expense and disruption
of existing programs.
3. Does not administratively "lock
in" on obsolete methods.
4. Is consistent with existing
promulgations concerning
methodology.
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con: 1. Complicates instrumental and
procedural arrays due to methods
proliferation.
2. Makes task of quality control
more difficult.
RECOMMENDATION
Option B for developing and endorsing "reference methods"
is recommended for approval. The risk of extending
official sanction to obsolete methodology is too great to
lock ourselves into a "standard methods trap." However,
it must be emphasized that for any enforcement application
when an official standardized reference method is
available and applicable/ it must be used with no
deviations.
Approve:
Disapprover
Date:
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ISSUE II
Should it be Agency policy to promulgate only fully-validated
"reference methods" with environmental standards?
DISCUSSION
It has been Agency practice to publish a measurement method
by which a pollutant is to be measured together with the
environmental standard. Lead times for providing these
methods were so short that many unvalidated methods have
been promulgated with environmental standards. These
methods were designated in the regulations as "EPA
reference methods." Regulations ajlso include a provision
for equivalency.
This practice has proven to be unsatisfactory. In the case
of Ambient Air Quality Standards, one of the methods
selected was found to be inaccurate under most environ-
mental monitoring conditions. For another method, subse-
quent investigation showed that the level for which the
standard was set fell near the limits of detection of the
reference method. For this reason, only an extremely
skilled analyst can make measurements in the critical con-
centration region. Several other methods which were
selected in this manner are still being tested for relia-
bility. For these reasons, it has been deemed necessary to
tighten the requirements for reference methods.
Several conditions are being proposed in the strategy
document which must be met before a measurement method can
be designated a "reference method." These are: (1) the
method must be part of an environmental standard; (2)
there can be only one reference method applicable in a
particular concentration range for any given pollutant in
an environmental standard; (3) the reference method must
be fully validated by collaborative tests for accuracy,
precision, and concentration range of pollutant for which
it is applicable; and, (4) the reference method must be
readily available to the majority of the regulated user
groups. The provision for the use of equivalent methods
would still apply. These considerations lead to three
major options which must be evaluated for decision and
policy determination.
ALTERNATIVES
Option A; Only fully-validated reference methods shall
be promulgated with environmental standards.
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pro: 1. The best scientific support is
provided for monitoring support
of the standard.
2. The probability of retraction of
the method and/or the standard due
to poor methodology and questionable
data is materially lessened.
3. The comparability of the data from
measurements taken at different
times and in different places is
assured.
4. The probability of successful
challenge of the data and method
is remote.
con: 1. Promulgation of the standard may
be delayed due to the lack of a
fully-validated measurement method.
Option B; Any method regardless of degree of validation
may be promulgated with an environmental
standard. This is the status quo.
pro: 1. There is no delay in the promul-
gation of standards because any
available method can be used to
support the promulgation.
2. Allows fulfillment of legislative
mandates for standards within the
prescribed time frames.
con: 1. The method may be of questionable
accuracy and precision and monitor-
ing data might be too unreliable
to support regulatory actions.
2. Both the method and the standard
may have to be retracted because
of successful challenge by the
regulated user community.
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Option C: It is the policy of the Agency to promulgate
only fully-validated reference methods with
its standards. Under very extenuating
circumstances, when methods which are not
fully validated must be used, they must be
designated as "tentative methods" and
caveats pertaining to the limitations of
their use must be included in the regulation.
pro: 1. Allows fulfillment of the legislative
mandates for standards within the
prescribed time frames.
2. The regulated user community is
alerted to the tenuous nature of
the "tentative method" promulgation
and will expect its replacement
by a fully-validated "reference
method" when one is available.
3. The need to retract a reference
method is practically eliminated;
the retraction of a tentative method
is far less embarrassing.
con : 1. The tentative method may be of
questionable accuracy and precision
and the monitoring data may be
too unreliable to support
regulatory actions.
2. Both the tentative method and the
standard may be subjected to
successful challenge by the
regulated user community and have
to be retracted.
3. Data taken at different times and
at different places with the
tentative method may not be
intercomparable.
RECOMMENDATION
From a purely scientific point of view, Option A would be
recommended. However, EPA must be pragmatic, and there
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will be requirements for environmental standards and
regulatory actions that must be supported by best available
methodology regardless of validation. For this reason,
Option C is recommended for approval.
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