[Federal Register Volume 62, Number 113 (Thursday, June 12, 1997)]
[Notices]
[Pages 32112-32113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15414]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-5840-2]


Performance Evaluation Studies Supporting Administration of the 
Clean Water Act and Safe Drinking Water Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the decision by the Environmental 
Protection Agency (EPA) to transfer components of the laboratory 
performance evaluation (PE) studies programs that the Agency has 
conducted to assess laboratories testing drinking water and wastewater 
to the private sector. Under the externalized program, EPA would issue 
standards for the operation of the program, the National Institute of 
Standards and Technology (NIST) would develop standards for private 
sector PE suppliers and would evaluate and accredit PE suppliers, and 
the private sector would develop and manufacture PE materials and 
conduct PE studies. The results of these studies would be made 
available to the study participants (participating analytical 
laboratories and in the case of DMRQA studies to permittees) and to 
those government organizations that have the responsibility for 
administering programs supported by the studies (e.g., state, federal 
agency). This decision should ensure the continued viability of the 
existing PE programs and should permit the eventual expansion of 
environmental laboratory PE studies to other media and analytes while 
maintaining government oversight.

FOR FURTHER INFORMATION CONTACT: Stephen W. Clark, Office of Ground 
Water and Drinking Water (OGWDW), U.S. EPA, 401 M Street, SW., 
Washington DC 20460 [telephone number (202) 260-7159]; Rick Colbert, 
Office of Enforcement and Compliance Assurance (OECA), U.S. EPA Ariel 
Rios, 1200 Pennsylvania Ave., NW., Washington DC 20044 [telephone 
number (202) 564-2320]; or Robert Graves, Office of Research and 
Development (ORD), U.S. EPA/NERL, 26 W. Martin Luther King Dr., 
Cincinnati, Ohio 45268 [telephone number (513) 569-7197].

SUPPLEMENTARY INFORMATION: Since the 1970s, EPA has been conducting 
laboratory PE studies to support the various water programs 
administered by the States and EPA under the Clean Water Act and the 
Safe Drinking Water Act. In a PE study, a participating laboratory 
analyzes a test sample (a PE sample) that is prepared and distributed 
by the entity conducting the study. In the EPA-supported PE studies, a 
single EPA contractor prepared test samples which were sent to 
participating laboratories for analysis. EPA then scored the results 
against statistically-based or empirically-based performance criteria 
to determine whether the laboratory demonstrated acceptable 
performance. The results were then supplied to the study participants 
and the government agencies responsible for reviewing the performance 
of said participants.

What is the Purpose of a PE Study?

    PE studies are a valuable indicator of a laboratory's competency to 
analyze water samples. The studies are used to assess a laboratory's 
ability to conduct analysis and produce meaningful and reliable 
environmental data. In some States, the State may certify or accredit 
individual laboratories to conduct analysis within the State. The PE 
studies serve as one component of the overall federal program to assure 
quality in environmental measurement to implement the Clean Water Act 
and the Safe Drinking Water Act. EPA has also relied on the data to 
assess the capability of the nation's environmental laboratory 
community to conduct analysis for certain analytes. If EPA found that a 
disproportionate number of laboratories did not seem able to properly 
analyze the samples for a given analyte, EPA used that information to 
identify areas where additional method development was warranted.
    EPA has been conducting three PE study programs to support 
nationwide implementation of water programs:
    Water Supply (WS) study program, which includes chemistry, 
microbiology, and radiochemistry PE studies, supports implementation of 
the Safe Drinking Water Act. Under the Safe Drinking Water Act, 
laboratory certification programs are administered primarily by States 
(and, in very limited instances, by EPA). Many State drinking water 
laboratory certification programs have required ``successful'' 
participation in EPA's Water Supply (WS) PE study

[[Page 32113]]

program as an element for laboratory certification by the State.
    Water Pollution (WP) study program, which includes chemistry PE 
studies, tests laboratories' abilities to analyze for common surface 
water quality pollutant parameters and supports 25 to 30 State 
wastewater and other environmental laboratory certification programs. 
Many States conduct laboratory accreditation programs in support of the 
National Pollutant Discharge Elimination System (NPDES) permitting 
program under the Clean Water Act. Though participation in the WP is 
not federally compelled, many States require laboratories to 
participate in EPA's Water Pollution (WP) PE study program as a basis 
for accreditation under State laws.
    Discharge Monitoring Report Quality Assurance (DMRQA) study 
program, which includes inorganic chemistry and whole effluent toxicity 
(WET) PE studies, is used as one tool for ensuring the quality of 
monitoring data submitted by National Pollutant Discharge Elimination 
System (NPDES) permittees. Historically, EPA administered the DMRQA 
studies through NPDES ``major'' permittees, who would transmit the 
DMRQA test samples to the same laboratories that conduct compliance 
monitoring for such permittees. Beginning in FY 1996, NPDES permittees 
were instructed to notify their laboratories to request and receive the 
necessary samples directly from the EPA. NPDES permittees are required 
to participate in the DMRQA study under the authority of Clean Water 
Act section 308. Thus, though laboratories are not directly required to 
participate, participation is effectively or indirectly required by 
market forces.

Why is EPA Externalizing the PE Study Function?

    In the past, EPA conducted the PE studies with no cost to the 
participating laboratories. As part of the Government's efforts to save 
resources and to externalize those activities that are not inherently 
governmental functions and that can be conducted by the private sector, 
the Agency reassessed its continued operation of the programs.
    EPA had considered numerous options for externalizing the PE 
studies program. EPA explained these options in the Federal Register at 
61 FR 37464--37471 (July 18, 1996). After considering the comments 
received, the Agency decided on a program where EPA would issue 
standards for the operation of the program, the NIST would develop 
standards for private sector PE suppliers and would evaluate and 
accredit PE suppliers, and the private sector would develop and 
manufacture PE materials and conduct PE studies. In addition, as part 
of the program, the PE providers would report the results of the 
studies to the study participants and to those organizations that have 
responsibility for administering programs supported by the studies 
(e.g., State and EPA for WS and WP studies; EPA for DMRQA studies). The 
Agency believes that this option (Option 2 of the proposed Options) 
would best serve the public interests.

When Will Externalization Occur?

    EPA and NIST anticipate that NIST would begin to take applications 
for accrediting private sector PE suppliers beginning in the summer of 
1998. The agencies further anticipate that the first class of 
commercial sector PE providers would be accredited by the January of 
1999 and, accordingly, ready to begin to service laboratories with PE 
studies shortly thereafter. Therefore, the final studies conducted by 
EPA would include: DMRQA 18 (aquatic toxicity samples to be shipped 
June 1998; chemistry samples to be shipped July/Aug 1998); WP 40 
(samples to be shipped July/Aug 1998); WSM 30 (microbiological samples 
to be shipped April 1998); WS 41 (chemistry samples to be shipped May/
June 1998); Radiochemistry study entitled, ``Gamma in Water Performance 
Evaluation Study'' (samples to be shipped Nov 1998).

What Would Change in PE Studies?

    The new PE Studies program would serve the same purposes as did the 
previous PE Studies program. Though the mode of operation would change, 
the information and data supplied to the States (and EPA Regions) would 
not. Under the new structure, EPA would remain the Standards Setting 
Authority for the Water PE Study program. [For explanation of terms, 
see 61 FR 37464-37471.] EPA would work with NIST to establish the 
operational and technical standards to be used for accrediting private 
sector PE Study Providers and would oversee compliance with the 
national standards. NIST would publish the accreditation standards. 
Both standards setting functions would be closely coordinated with the 
National Environmental Laboratory Accreditation Conference (NELAC).
    NIST has indicated that its National Voluntary Laboratory 
Accreditation Program (NVLAP) would serve as the PE Study Provider 
Accreditation Body. NIST intends to collect a fee from PE Study 
Providers to recover costs associated with the NIST accreditation 
program. NIST would also develop primary reference standards, which 
NIST would sell to PE Study Providers.
    The private sector and/or States (who, in some cases, currently 
conduct their own PE studies) would have the opportunity to become 
accredited PE study providers. The private sector PE Study Providers 
would: produce and value assign the PE materials according to NIST 
protocols; distribute the PE samples to participating laboratories; 
analyze client lab measurement data; calculate acceptance limits 
according to procedures established by EPA; and report results (in the 
appropriate format and detail) to the participating laboratories, 
appropriate state authorities, EPA, and NIST.
    Under the new system, States would have several options for 
obtaining the PE study data for laboratories subject to their 
accreditation program. Three such options include: States may require 
laboratories to participate in a specific private sector PE programs 
and have the results sent to the State by the PE study provider; States 
may elect to serve as PE study providers themselves (as some States do 
now); or States may permit a laboratory to participate in any 
accredited PE study and have the results sent to the State. In all 
cases, States would be able to receive all the information that was 
previously provided by the EPA. The only additional costs that States 
should experience as a result of these changes are those associated 
with purchasing PE studies from the private sector for their own 
laboratories.

    Dated: May 28, 1997.
Robert Perciasepe,
Assistant Administrator for Water.

    Dated: May 27, 1997.
Robert J. Huggett,
Assistant Administrator for Research and Development.

    Dated: May 30, 1997.
Steven A. Herman,
Assistant Administrator for Enforcement and Compliance Assurance.
[FR Doc. 97-15414 Filed 6-11-97; 8:45 am]
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