[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@
epamail.epa.gov. 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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