[Federal Register Volume 74, Number 139 (Wednesday, July 22, 2009)]
[Notices]
[Pages 36198-36200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17402]


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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: [email protected].

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

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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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