[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52098-52100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26443]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-5903-2]
Performance Based Measurement System
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of intent.
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SUMMARY: The Environmental Protection Agency (EPA) plans to implement a
Performance Based Measurement System (PBMS) for environmental
monitoring in all of its media programs to the extent feasible. The
Agency defines PBMS as a set of processes wherein the data quality
needs, mandates or limitations of a program or project are specified,
and serve as criteria for selecting appropriate methods to meet those
needs in a cost-effective manner. Where PBMS is implemented, the
regulated community would be able to select any appropriate analytical
test method for use in complying with EPA's regulations. It is EPA's
intent that implementation of PBMS have the overall effect of improving
data quality and encouraging advancement of analytical technologies.
[[Page 52099]]
The Agency anticipates proposing amendments to certain of its
regulations, as needed, to incorporate PBMS into its regulatory
programs.
DATES: Comments should be sent to the address listed below by November
5, 1997.
ADDRESSES: Commenters must send an original and two copies of their
comments referencing docket number F-97-PBMA-FFFFF to: RCRA Docket
Information Center, Office of Solid Waste (5305G), U.S. Environmental
Protection Agency Headquarters (EPA, HQ), 401 M Street, SW, Washington,
DC 20460. Hand deliveries of comments should be made to the Arlington,
VA, address listed below. Comments may also be submitted electronically
by sending electronic mail through the Internet to: rcra-docket@. Comments in electronic format should also be
identified by the docket number F-97-PBMA-FFFFF. All electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption.
Commenters should not submit electronically any confidential
business information (CBI). An original and two copies of CBI must be
submitted under separate cover to: RCRA CBI Document Control Officer,
Office of Solid Waste (5305W), U.S. EPA, 401 M Street, SW, Washington,
DC 20460.
Public comments and supporting materials are available for viewing
in the RCRA Information Center (RIC), located at Crystal Gateway I,
First Floor, 1235 Jefferson Davis Highway, Arlington, VA. The RIC is
open from 9 a.m. to 4 p.m., Monday through Friday, excluding federal
holidays. To review docket materials, it is recommended that the public
make an appointment by calling (703) 603-9230. The public may copy a
maximum of 100 pages from any regulatory docket at no charge.
Additional copies cost $0.15/page. For information on accessing paper
and/or electronic copies of the document, see the SUPPLEMENTARY
INFORMATION section.
FOR FURTHER INFORMATION CONTACT: For general information, contact the
RCRA Hotline at (800) 424-9346 or TDD (800) 553-7672 (hearing
impaired). In the Washington, DC, metropolitan area, call (703) 412-
9810 or TDD (703) 412-3323.
For specific information regarding this notice, contact Carol
Finch, Executive Director, Environmental Monitoring Management Council
(8101R), U.S. Environmental Protection Agency, 401 M Street, SW,
Washington DC 20460 (202) 564-6638.
SUPPLEMENTARY INFORMATION: Historically, some 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
in 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 a minimum level of
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. For example, in EPA's
water programs, alternative test procedures program are described at 40
CFR 136.4, 136.5, and 141.27. In most cases, EPA's regulations require
that alternative methods be approved by the Agency before they are used
in regulatory compliance applications.
In general, the approval processes have proven to be lengthy and
often it takes several years to receive approval for a proposed method
or method modification. This approach of specifying required methods
and approving new methods has been identified as a major barrier to the
use of innovative monitoring technology. In order to address these
concerns, EPA's Environmental Monitoring Management Council (EMMC)
established a Work Group of scientists representing EPA's Headquarters
and Regional offices to consider the advisability of establishing a
performance-based approach to specifying analytical testing
requirements. Based on the recommendations of the work group, the
Agency has decided to incorporate the PBMS approach into its programs,
to the extent feasible.
The Agency intends that PBMS 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 would normally continue to allow use of its current
required methods as well.
The Agency has defined PBMS as a set of processes wherein the data
quality needs, mandates or limitations of a program or project are
specified, and serve as criteria for selecting appropriate methods to
meet those needs in a cost-effective manner. Under PBMS, the Agency
would identify relevant performance characteristics of analytical
methods and would specify quantitative performance criteria for each of
those characteristics without prescribing specific procedures,
techniques or instrumentation. Individual EPA programs may need to
adopt a phased approach to specifying performance criteria and
performance criteria may be linked to specific instruments, techniques,
or methods in the initial phase. However, EPA's ultimate goal is to
specify performance criteria that are not linked to methods,
techniques, or instruments.
Performance criteria may be established for characteristics such as
method precision and accuracy, for example. These performance criteria
would be designated based on the question(s) or decision(s) to be
addressed by the subject measurement, the level of uncertainty that is
acceptable, the ease with which method performance can be verified, and
other factors. The criteria may be published in regulations or in
technical guidance documents, depending on the individual program.
In a program where PBMS is implemented, the regulated community
would be required to demonstrate that the measurement method to be used
meets the specified performance criteria by documenting both initial
and continuing method performance according to a required protocol.
Regulated parties would also be required to maintain records
documenting initial and continuing demonstrations of method
performance. They would also be required to maintain written
certification that they have used appropriate quality assurance and
quality control procedures. PBMS would apply to most physical,
chemical, and biological measurements conducted either in laboratories
or in the field. PBMS would not apply to method-defined parameters,
that is, parameters for which the method defines the property (e.g.,
Toxicity Characteristic Leaching Procedure under the Resource
Conservation and Recovery Act, five-day Biochemical Oxygen Demand under
the Clean Water Act, and airborne and stationary source particulate
matter under the Clean Air Act) or for situations where it would be
impractical or cost prohibitive to define the property except by using
a reference method (e.g., where a stable reference standard cannot be
prepared). Additionally, PBMS may not be applied to analytical services
obtained under
[[Page 52100]]
contract by EPA which are subject to specific methods and Statements of
Work, such as the Superfund Contract Laboratory Program (CLP).
EPA intends to implement PBMS on a program-specific basis. Each of
EPA's programs is presently developing a plan for implementation. Each
implementation plan will address the specifics of how PBMS will work in
specific regulatory programs. The plans will address, for example, the
scope of PBMS application within the program (i.e., which measurements
will be subject to PBMS), any record keeping or documentation
requirements, and the specific steps that will be taken by EPA to
implement PBMS within the program. The Agency's goal is for each Office
to prepare a plan for implementing PBMS by September of 1997 and move
to implementation of PBMS by September 1998.1 Any required
extensions of the 1998 implementation goal will be considered on a
case-by-case basis based on implementation steps outlined in each
program's plan.
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\1\ In several cases, EPA programs have already taken steps to
begin implementation of PBMS. See: Update 3 of SW-846 Methods (62 FR
32452) and the Methods Approval Streamlining Proposal (62 FR 14975)
for examples in EPA's hazardous waste and water programs,
respectively.
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Once implementation plans are finalized, the Agency may publish
additional notices to inform the public of specific implementation
actions to be taken and the proposed schedule for those actions. In
addition, as individual programs take steps to amend existing
regulations for the purpose of implementing PBMS, notices of proposed
rulemakings will be published. Throughout this process, EPA intends to
provide ample opportunity for the public to comment on specific aspects
of PBMS implementation. For example, the Agency plans to engage in a
dialogue, both inside and outside EPA, to get input from various
stakeholders on how to best implement PBMS. We will seek input from all
affected parties regarding PBMS implementation in all of EPA's
programs. Today's notice is a general announcement of our intent to
implement PBMS in EPA programs. EPA will consider any comments provided
in response to this notice. The following is a list of issues that
commenters may wish to address:
1. The potential environmental benefits or consequences that may be
achieved through implementation of PBMS.
2. The potential implications for improvements in environmental
monitoring technology through implementation of PBMS.
3. The potential costs or cost savings (to the regulated community,
laboratories, or others) that may result from PBMS implementation.
4. The potential impacts of PBMS on small entities.
5. The potential effect of PBMS on compliance monitoring and
enforcement of regulatory and statutory requirements. For example:
--potential challenges to state enforcement programs that will result
from implementation of PBMS.
--The level of expertise necessary for EPA and state inspectors to
successfully determine the adequacy of a PBMS method.
--The resource and training implications of PBMS, especially for state
environmental programs.
--The impact (if any) of PBMS on industry's ability to determine
compliance with Federal and/or state regulations and applicable permit
conditions.
6. The potential effect of PBMS on the public's ability to
understand and monitor facilities within their communities.
7. The advantages and disadvantages of using method performance
criteria and documentation requirements for establishing that methods
achieve required performance levels.
8. The adequacy of the draft checklists for identifying and
describing documentation requirements.
9. The need for EPA and state regulatory agencies to receive
written notice where PBMS methods will be used by regulated parties.
10. The feasibility of applying PBMS to the various environmental
measurements required by individual EPA programs.
To assist in program-specific implementation, the Agency has
developed a draft set of generic checklists and companion instructions
to describe the recommended documentation for an initial and continuing
demonstration of method performance. Individual programs would use
these generic checklists, with program-specific requirements, as
appropriate, to delineate the records that would be required for
compliance with PBMS. The checklists are one of a number of technical
tools EPA would use to implement PBMS and communicate the requirements
and guidelines associated with PBMS to the public. Copies of the draft
generic checklists are available on EPA's Internet home page (http://
www.epa.gov/pbms) or from the Docket.
Today's notice is not a final agency action and creates no rights
enforceable by any party in litigation with the United States.
Dated: September 30, 1997.
Carol M. Browner,
Administrator.
[FR Doc. 97-26443 Filed 10-3-97; 8:45 am]
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