[Federal Register: July 22, 2009 (Volume 74, Number 139)]
[Notices]
[Page 36198-36200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy09-63]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-ORD; FRL-8930-3]
Flexible Approaches to Environmental Measurement--The Evolution
of the Performance Approach
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Assuring the quality of environmental measurements is
essential to the implementation of the Environmental Protection
Agency's (EPA's or the Agency's) environmental programs, both
regulatory and voluntary. In an October 6, 1997, Notice of Intent (FRL-
5903-2), the Agency outlined a ``Performance Based Measurement System
(PBMS)'' concept
[[Page 36199]]
which was expected to ``* * * have the overall effect of improving data
quality and encouraging advancement of analytical technologies.'' EPA
has recently revisited the 1997 concept, gauged the Agency's progress
towards achieving its goals, and redefined steps needed to ensure
continued progress.
The Agency has determined that while specifying performance
criteria in a manner that is independent of methods, techniques, or
instruments may be possible, developing a single protocol for the
validation of these measurements that could be applied to all
measurements, including measurements made with techniques yet to be
invented, may not be possible. Accordingly, EPA is introducing
principles that reflect flexible approaches to environmental
measurement. These principles capture the Agency's experience of the
past ten years, set the stage for future progress in improving data
quality, and encourage the advancement of environmental measurement
technologies.
Key goals for this flexible approach are as follows: Increased
emphasis on flexibility when choosing sampling and analytical
approaches to meet regulatory requirements for measurements;
development of processes for validation to confirm measurements meet
quality requirements; increased collaboration with stakeholders to
develop validation processes for new measurement technology; and timely
assessment of new or modified technologies, methods, and procedures.
The purpose of this notice is to provide the public with an up-to-
date communication on the Agency's progress to Flexible Measurement--
The Evolution of the Performance Approach.
FOR FURTHER INFORMATION CONTACT: For specific information regarding
this notice, contact Lara Autry, Environmental Protection Agency,
Office of the Science Advisor, E243-05, 109 TW Alexander Drive,
Research Triangle Park, NC 27709; telephone number: 919-541-5544; fax
number: 919-541-4261; e-mail address: autry.lara@epa.gov.
SUPPLEMENTARY INFORMATION: The Forum on Environmental Measurements
(FEM) is a standing committee of senior EPA mangers established to
develop policies to guide the EPA measurement community in validating
and disseminating methods for environmental monitoring; for ensuring
that monitoring studies are scientifically rigorous, statistically
sound, and yield representative data; and for employing a quality
systems approach that ensures that the data gathered and used by the
Agency is of known and documented quality. The Forum was established to
promote consistency and consensus within the EPA on measurement issues.
Historically, most EPA programs have specified required analytical
methods to be used by the regulated community in the analysis of
environmental samples for regulatory compliance purposes. EPA has
published its methods in regulations and a number of compendia, such as
``Manual of Methods for Chemical Analysis of Water and Wastes'' and
``Methods for the Determination of Organic Compounds in Drinking
Water.'' The requirement to use specific analytical methods for
compliance purposes is one of several means for assuring appropriate
consistency and reliability in environmental monitoring.
In certain instances, in order to provide regulated parties with
the flexibility to use alternative methods, EPA programs have
established administrative processes by which the public could submit a
proposed method for Agency review and approval. Before alternative
methods are used in regulatory compliance applications, EPA's
regulations require that such methods be approved by the Agency through
formal rulemaking.
In past instances, the approval processes have been lengthy. For
example, in some cases, the approval process took several years to
receive consent for a proposed method or method modification after the
Agency completed its evaluation. The approach of specifying required
methods and approving new methods was identified as a major barrier to
using innovative monitoring technology. In order to address these
concerns, EPA's former Environmental Monitoring Management Council
(EMMC) established a work group of scientists representing EPA's
Headquarters and Regional offices to consider the advisability for
establishing a performance-based approach to specifying analytical
testing requirements. Based on the work group's recommendations in
1997, the Agency announced its intent to incorporate the PBMS approach,
to the extent feasible, into its programs.
At the same time, the Agency intended that PBMS would provide the
regulated community with flexibility in conducting required
environmental monitoring, expedite the use of new and innovative
techniques, and result in less costly approaches to conducting required
monitoring and measurements. Under PBMS, the Agency envisioned that
this approach would continue to allow use of its current required
methods as well.
EPA has revisited the 1997 concept, gauged the Agency's progress
towards achieving its goals, and redefined steps needed to ensure
continued progress. EPA has determined that while it may sometimes be
possible to specify performance criteria in a manner that is
independent of methods, techniques, or instruments, the development of
a single protocol for validating these measurements that could be
applied to all measurements, including measurement made with techniques
yet to be invented, is simply not possible. Accordingly, EPA is
introducing flexible approaches in environmental measurement. These
flexible approaches capture the Agency's experience of the past ten
years, set the stage for future progress in improving data quality, and
encourage the advancement of environmental measurement technologies.
The key goals for the flexible approaches are as follows.
(1) Increase Emphasis on the Flexibility of Choosing Sampling and
Analytical Approaches To Meet Regulatory Requirements for Measurements
Setting measurement requirements begins with indentifying goals and
considering such factors as action levels, technology performance,
mandates, and/or limitations of the program or project. These goals may
be applied broadly across a program and established by a program
office, or may be specific to a project or permit. Goals are translated
into measurement requirements, which may take a variety of forms. In
some applications, a general requirement on accuracy may be present;
while in others, measurement requirements may be coupled to a
technology, method, or procedure (e.g., criteria for evaluating
modifications to published reference methods).
The Agency recognizes that some of its measurement quality
requirements that appear throughout its regulations may be more
specific than necessary, and it will strive to make these requirements
more flexible as time and resources permit.
(2) Develop Processes for Validations That Confirm That Measurements
Meet Quality Requirements
A validation process should provide evidence that measurement
quality requirements are achieved. According to ISO 17025,\1\
``validation is the confirmation by examination and the provision of
objective evidence that the particular requirements for specific
[[Page 36200]]
intended use are fulfilled.'' Validation is typically performed in two
phases. The first phase provides evidence on general performance of a
measurement system for a range of materials that define a matrix class;
the second phase (often called ``verification''), demonstrates that the
requirements for a specific use are met. Both phases are important for
scientific and legal defensibility.
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\1\ ISO/IEC 17025 General requirements for the competence of
testing and calibration laboratories.
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More general measurement requirements call for more specific
validation processes. A general requirement on accuracy that is
specified in a manner independent of technique, method, or instrument
should be accompanied by detailed validation for each method of
measurement. Conversely, a measurement quality requirement to use a
particular procedure can require essentially no validation, as a
detailed procedure often includes a complete specification of required
quality control activities.
EPA intends to develop processes for validation that allow for an
appropriate choice of specificity. For some applications, validation
processes may continue to use defined procedures with ongoing quality
control. For other applications, validation processes may place
emphasis on greater flexibility and include verification that the
requirements for a specific use are achieved.
(3) Increase Collaboration With Stakeholders To Develop Validation
Processes for New Measurement Technology
Validation required for new technology may be difficult to specify
in advance due to the wide variety of performance issues which may be
encountered. The Agency anticipates that developing validation
processes for applications of new technology will require collaborating
with stakeholders to ensure timely development of these processes.
During this process, the Agency expects to continue to play a key role
in the validation development.
(4) Timely Assessment of New or Modified Technologies, Methods, and
Procedures
In the event that the measurement requirements in a program are
specific to a technology, method, or procedure, the Agency is committed
to the assessment of proposed alternatives to these requirements and to
rendering timely decisions of these alternatives when approval is
sought.
Today's notice is not a formal agency action, but a statement of
the Agency's approach to environmental measurement flexibility. It
creates no rights enforceable by any party in litigation with the
United States.
Dated: June 30, 2009.
Kevin Teichman,
Acting EPA Science Advisor.
[FR Doc. E9-17402 Filed 7-21-09; 8:45 am]
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