[Federal Register Volume 61, Number 139 (Thursday, July 18, 1996)]
[Notices]
[Pages 37463-37471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18178]
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[[Page 37464]]
ENVIRONMENTAL PROTECTION AGENCY
[FRL-5538-5]
Performance Evaluation Studies Supporting Administration of the
Clean Water Act and Safe Drinking Water Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public meeting; invitation for public comment.
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SUMMARY: By today's action, EPA invites public comment on and announces
a public meeting to discuss options under consideration regarding the
Agency's role in laboratory performance evaluation (PE) studies
supporting administration of the Clean Water Act and Safe Drinking
Water Act. EPA is reevaluating the federal role in the implementation
of PE studies in light of current funding limitations, as well as the
Agency's inability to create a dedicated fund for any fees collected
under existing user fee authority. Based on the written comments
received, as well as discussions at the public meeting, EPA intends to
determine the appropriate federal role in the administration of PE
studies supporting water programs. For further information contact
Wendy Blake-Coleman by phone at 202-260-5680 or by facsimile at 202-
260-7926.
DATES: EPA will conduct a public meeting on August 27, 1996 in
Washington D.C. to obtain further input on the Agency's options for
administering PE studies supporting water programs. The information
obtained at the meeting, along with written comments, will be used to
refine current options, determine whether other options should be
considered, and decide which options should be eliminated from
consideration. Registration for the meeting will begin at 8:30 AM. The
meeting will be held from 9:00 AM to 4:00 PM. Meeting arrangements are
being coordinated by DynCorp, Inc. To register contact Cindy Simbanin,
DynCorp Inc., 300 N.Lee Street, Suite 500, Alexandria, Va. 22314. Cindy
can be also be reached by phone at 703-519-1386 or by facsimile at 703-
684-0610.
Written comments on today's notice must be received by no later
than 60 days from publication to assure prompt consideration by the
Agency. No facsimiles (faxes) will be accepted. People who want receipt
of their comments acknowledged should include a self addressed, stamped
envelop.
ADDRESSES: The public meeting will be held at the Jefferson Auditorium,
United States Department of Agriculture (USDA), 14th and Independence
Avenue SW., Washington DC 20250. The auditorium is in the USDA South
Building Wing 4. Send written comments on today's notice and/or the
public meeting to: PE Studies Docket Clerk, Water Docket (MC-4101),
U.S. Environmental Protection Agency, Room M2616 401 M Street, SW.,
Washington, DC 20460. A copy of the comments are available for review
at EPA's Water Docket at the above address. For access to the Docket
materials, call (202) 260-3027 between 9:00 a.m. and 3:30 p.m. for an
appointment. Comments should be accompanied by any references cited in
the comments. People commenting are also requested to provide an
original and a copy of the written comments and enclosures.
EPA will also accept comments electronically. Comments should be
addressed to the following Internet address: ow-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption. Electronic versions
will be transferred into a paper version for the official record. EPA
will attempt to clarify electronic comments if there is an apparent
error in transmission. Comments provided electronically will be
considered timely if they are submitted electronically by 60 days from
publication. EPA is experimenting with electronic commenting, therefore
people commenting may want to submit both the electronic comments and
duplicate paper comments.
FOR FURTHER INFORMATION CONTACT: Ms. Wendy Blake-Coleman, Office of
Water (4102), U.S. Environmental Protection Agency, 401 M Street, SW.,
Washington, DC 20460. Telephone Number: (202) 260-5680.
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 (water programs). Unfortunately, funding levels
to support these PE programs has not remained consistent with the
environmental monitoring requirements of the respective water programs.
EPA's Office of Research and Development (ORD), the Office of Water
(OW) and the Office of Enforcement and Compliance Assurance (OECA) are
exploring alternative mechanisms to overcome funding shortfalls to
better address the needs of State and federal water programs.
Although laboratory participation in the Agency's PE studies has
been free of charge, recent resource limitations have caused the Agency
to restrict participation to those laboratories nominated by State and
EPA Regional offices. The Agency believes that the continued viability
of these studies may depend upon the transfer of costs to the user
community so that the PE program supply can meet demand. Because the
Agency lacks authority under the Independent Offices Appropriations
Act, 31 U.S.C. Sec. 9701, to create a dedicated fund to support PE
studies through a user participation fee, EPA has been exploring
alternatives to assign some portion of the program to an organization
with the ability to recover costs for a specified component of the PE
studies program.
An EPA work group considered many options for assuring the
continued viability of the PE studies program. The work group assessed
several options that had a single provider manufacturing and
distributing all the PE samples. A single provider rather than multiple
providers has the major benefit of assuring that all study participants
are treated exactly the same. EPA is such a single provider, and it's
financial inability to continue this role was one of the reasons this
effort was begun.
The work group initially believed that an ideal candidate for a
single provider would (1) be an entity of the Federal government and
(2) be capable of charging for PE samples. The National Institute of
Standards and Technology (NIST) met these requirements. Accordingly,
in-depth discussions were held with NIST personnel to determine whether
it could take over this role from the EPA. After much consideration,
NIST management decided that such a role was not compatible with the
NIST mission and this scenario was eliminated as an option.
The remaining 8 options involve transferring all or some component
of the PE study program to organizations other than EPA. A draft
report, ``Externalization of EPA's Water Laboratory Performance
Evaluation Programs,'' prepared by the EPA describes the options
considered, the advantages and disadvantages of each, the estimates of
costs to the Agency for each, and the estimates of time required to
implement each option.
All of the options presented involve the use of a multiple PE study
provider system: a partnership between the States, non-profit
organizations and/or the private sector. Under this system, the
multiple providers would conduct the PE studies according to
established
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standards in an effort to meet and better serve the needs of the PE
programs(s), as well as reduce EPA costs and resources. Key criteria
have been identified by the Agency to ensure national consistency,
scientific integrity, and the appropriate quality of material to be
prepared and distributed by multiple PE study providers. The draft
report, ``EPA Requirements For National Consistency Among Multiple PE
Study Providers,'' identifies these criteria and their rationale. This
draft report is contained in Appendix A of the draft report,
``Externalization of EPA's Water Laboratory Performance Evaluation
Programs.''
To obtain a copy of the document, call the Water Resource Center at
260-4786 or write the Office of Water Resource Center (RC4100), U.S.
EPA, 401 M Street SW, Washington DC 20460. A single copy of the
document can be picked up at the Water Resource Center in room M2615
Monday through Friday between 8:30 a.m. and 5 p.m. The document has
also been placed on the Internet for public review and downloading at
the following location: gopher.epa.gov.
I. Background of EPA-Supported PE Studies
The EPA-supported PE studies involve preparation of solutions of
known concentrations of analytes of environmental concern, sending the
samples to participating laboratories for analysis, and scoring the
results against statistically-based or empirically-based performance
criteria to determine whether the laboratory has demonstrated
acceptable performance. PE studies are a valuable indicator of a
laboratory's competency to analyze water samples. The PE studies also
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.
In total, EPA conducts 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
(although, in limited instances, by EPA). Many State drinking water
laboratory certification programs rely on EPA's Water Supply (WS) PE
study program to provide a critical element for laboratory
certification.
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. Although 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. Regions and States use the results to
identify laboratories that may need follow-up inspections.
Historically, EPA administered the DMRQA studies through NPDES
``major'' permittees, who would transmit the DMRQA test samples to the
laboratories who conducted compliance monitoring for such permittees.
Starting in FY 1996, the DMRQA program is structured slightly
differently. Now, the NPDES permittee instructs the laboratory that
conducts compliance monitoring for the permittee to request the samples
they need from the EPA. EPA, in turn, sends PE samples directly to the
identified laboratory. 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.
In the event EPA decides not to externalize the Water PE Study
Program, changes may continue to be made in the operation and design to
improve the integrity of the program, fill in gaps, and reduce costs.
II. Development of Program Options and Definition of Terms
In reviewing the administration of existing EPA PE study programs
and developing various options for future administration, the Agency
defined its terms to identify the various roles of actors in the
implementation of the programs. Currently, the primary actors in PE
studies include EPA, permittees and laboratories, and in many
instances, participating States. EPA currently oversees contractor
preparation and distribution of samples directly to the laboratories.
Results are returned to EPA, either directly by the laboratory, or, for
DMRQA, by the permittee. For the purpose of evaluating different
options to transfer portions of the PE Study programs to other
entities, the Agency identified the various components of the PE Study
program and the different roles currently played by EPA. The
definitions below identify different components and roles that might be
transferred to an entity other than EPA. In defining these terms, the
Agency has made certain assumptions about the different components that
might be transferred to other entities. Those assumptions are also
explained.
a. Environmental Testing Laboratories: Any public or private sector
laboratory that participates in approved laboratory performance
evaluation programs in order to: Obtain or maintain certification/
accreditation under EPA or State water programs, meet DMRQA
requirements, or fulfill internal quality assurance or training
requirements.
b. PE Study Providers: Organizations that supply PE study samples
to environmental testing laboratories.
c. PE Study Provider Accreditation Body: Organization authorized to
evaluate PE Study Providers using national standards and to accredit
those PE Study Providers that meet the standards.
d. Standards Setting Authority: Organization responsible for
determining the operation of the particular national water program
(concerned with laboratory capacity), for setting the national
standards for water PE studies and establishing national standards
applicable to PE Study Providers.
e. National Standards for Water PE Studies: Nationally-applicable
standards which establishes for the Water PE studies:
--Analytes to be included in each of the studies;
--Concentration ranges for each analyte in the PE samples for each type
of study; and
--Scoring/evaluation criteria to be used in evaluating the data to
determine acceptable performance
Ideally, national standards for Water PE Studies would be reviewed
and published periodically (at least annually) and would incorporate
the specific regulatory and non-regulatory requirements of the water
programs. Depending on the administration option selected, such
standards might be published in the Federal Register as a notice, or as
a guidance document, or both. If the administration option selected
involves EPA in standard setting, EPA would attempt to use
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technical standards developed or adopted by voluntary consensus
standards bodies, consistent with section 12(d) of the National
Technology Transfer and Advancement Act of 1995, Public Law 104-113,
section 12(d), 110 Stat. 783 (to be codified at 15 U.S.C. 272 note).
f. National Standards for Accreditation of Water PE Study
Providers: Technical performance standards that establish the minimum
level of performance to be achieved by a PE Study Provider as a
condition of accreditation. Accreditation standards might include, at a
minimum, technical standards for:
--Procedures necessary to ensure that each study is a fair and
representative test;
--Adequacy of PE manufacturing facilities and equipment, including
criteria describing adequate manufacturing and analytical testing
components;
--Minimum required qualifications and experience of the personnel
involved in all aspects of PE study design, manufacture, distribution,
data evaluation, reporting, and data storage/retrieval;
--Adequacy of quality systems used by PE Study Suppliers to ensure the
quality of PE studies; and
--Any other aspects of PE studies deemed necessary to ensure the
consistency and quality of PE studies.
Ideally, national accreditation standards would be performance-
based and would not reflect a highly prescriptive approach to PE study
development and production. For example, accreditation standards might
specify the components of an adequate quality system for PE study
design, manufacture, and distribution. Accreditation standards might
require that accredited PE Study Providers develop and maintain
standard operating procedures for the various aspects of their
processes, but would not specify the exact procedures to be used.
National accreditation standards might be published in the Federal
Register, as a guidance document, or both. Such standards would be
reviewed and revised periodically, as deemed necessary by the Standard
Setting Authority. If the administration option selected involves EPA
in standard setting for accreditation, EPA would attempt to use
technical standards developed or adopted by voluntary consensus
standards bodies, consistent with section 12(d) of the National
Technology Transfer and Advancement Act of 1995, Public Law 104-113,
section 12(d), 110 Stat. 783 (to be codified at 15 U.S.C. 272 note).
g. Primary Reference Standards: Analyte-specific standards that
could be developed, for example, by the National Institute for
Standards and Technology (NIST), an organization within the U.S.
Department of Commerce, and used by all accredited PE Study Providers
to ensure the traceability of PE materials. Properly prepared PE
materials would have analyte concentrations with true values that are
directly traceable to the primary reference standards.
III. EPA Decision-Making Process: Role of Stakeholders
EPA recognizes that the Water PE Study program has important roles
to play in other on-going Agency and external efforts related to
environmental monitoring and quality assurance. In particular, efforts
undertaken by EPA's Environmental Monitoring Management Council (EMMC)
regarding the establishment of a performance-based system for
analytical methods, national environmental laboratory accreditation,
and integration of EPA's analytical methods all relate to the water PE
study program. Consequently, EPA has and will continue to coordinate
its effort to re-configure the water PE study program with these other
related activities to minimize duplication of efforts and to ensure
that the outcomes of these efforts reflect consistent monitoring policy
nationwide.
EPA also recognizes the need to coordinate this effort with
external stakeholders. Of key importance is the EPA-sponsored National
Environmental Laboratory Accreditation Conference (NELAC), a voluntary
association of State and Federal Officials that also includes private
sector membership in a nonvoting role. The purpose of NELAC is to
promote environmental laboratory data of known quality through national
consensus performance standards for environmental laboratories to be
consistently implemented by State and federal accrediting authorities
nationwide.
One component of the NELAC national program will be a self-
supporting proficiency testing program that would address all fields of
environmental testing, including drinking water and wastewater. One
goal of the Water Laboratory PE Study externalization effort is to
design a system that is amenable to incorporation into the NELAC
national environmental laboratory accreditation program. To this end,
EPA is soliciting the input of the NELAC Proficiency Testing Committee,
Board of Directors, and the Agency FACA Committee, known as the
Environmental Laboratory Advisory Board, on options for the Water
Laboratory PE Program.
Working with external stakeholders such as the States, NPDES permit
holders, drinking water suppliers, private laboratories, PE study
providers, and State and National trade associations about changes to
the Water laboratory PE Study program will be key in the decision
making process. In addition, to the public meeting EPA is convening
this August, EPA intends to pursue additional outreach efforts with
these stakeholders. The intent is to provide all stakeholders an
opportunity to discuss the options under consideration and mutually
determine the best way to address any concerns prior to an Agency
decision on a preferred option.
IV. PE Study Management Options
In developing options for consideration, EPA envisioned that an
efficient water PE study program would consist of three core functions:
(1) national standard setting for PE studies, (2) designation
(selection and/or approval) of organizations to manufacture PE
materials and administer PE studies, and (3) actual production and
administration of the PE studies. Each of the options considered by EPA
reflect permutations of these three core functions--variations on which
organization(s) or type of organization(s) would fulfill the three
functions.
Using these core functions, the EPA developed 8 different options
for consideration. These 8 options reflect a range of possibilities.
The options, however, are not exhaustive. The options do, however,
represent the range of reasonable options available to EPA.
The 8 options considered by the Work Group are summarized below and
in Table 1.
Option 1: EPA Oversees PE Study Providers
EPA would serve both as the Standards Setting Authority and as the
PE Study Provider Accreditation Body. EPA would establish the national
standards and standards for accrediting PE Study Providers.
Accreditation standards would be based on current regulations,
policies, and practices applicable to the WS, WP, and DMRQA studies.
EPA would also determine when PE Study providers comply with the
national PE study provider standards, and conduct periodic compliance
monitoring activities (such as on-site audits and proficiency testing
through ampule verification). EPA would publish a list of PE Study
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Providers meeting such standards periodically (presumably, at least
annually).
EPA would continue to maintain a national data base. The purpose of
the national database would be to enable EPA (and States) to evaluate
performance of the PE Study Providers, laboratory performance, and
method effectiveness and make changes as necessary.
Private sector entities and/or interested States would assume the
responsibility for conducting water PE studies. The PE Study Providers
would: produce the PE materials (including PE samples); distribute the
PE studies to participating laboratories; analyze client lab
measurement data; determine acceptance limits according to procedures
established by EPA; and report results (in the appropriate format and
detail) to the participating laboratories, the organization accrediting
the laboratory (or otherwise requiring laboratory participation), and
to EPA. The report to EPA would provide a summary of variation among
participating laboratories and how they have performed relative to
EPA's performance criteria.
Laboratories desiring to participate in PE studies following EPA
standards would use a PE study provider from a list developed by EPA.
The laboratories would pay a participation fee to their PE study
provider.
Option 2: NIST Oversees PE Study Providers
EPA would be the Standards Setting Authority for the Water PE Study
program. EPA would work with NIST to establish the operational and
technical standards to be used for accrediting private sector and State
PE Study Providers. NIST would be responsible for publishing the
accreditation standards. Both standards setting functions would be
closely coordinated with NELAC. NIST would also develop primary
reference standards which would be distributed to accredited PE Study
Providers. NIST's National Voluntary Laboratory Accreditation Program
would serve as the PE Study Provider Accreditation Body. NIST would
oversee compliance with the national standards through periodic
(presumably annual) on-site audits and validation of the quality of PE
studies developed by the private sector and States. NIST would collect
a fee from participating PE Study Providers to recover costs associated
with the NIST accreditation program.
Table 1. Roles and Responsibilities Under Options for Externalization of PE Program
----------------------------------------------------------------------------------------------------------------
Standards setting PE study provider
Option Number authority accreditation body PE study provider *
----------------------------------------------------------------------------------------------------------------
Option 1: EPA Oversees PE Study EPA would set national EPA would accredit one Private sector
Providers. standards and standards or more companies and organizations and
for accreditation of PE states to provide PE States would
Study Providers based on studies and would manufacture and
the current program. closely monitor the distribute PE studies.
quality of the studies.
EPA would review PE data
and issue PE reports..
Option 2: NIST Oversees PE Study EPA would set national NIST would serve as the Private sector
Providers. standards for the water Accreditation Body and organizations and
PE studies. maintain the national states would
data base.. manufacture and
distribute PE
materials.
Option 3: States Oversee Private EPA would act as the State governments would Private sector
Sector PE Study Providers. Standards Setting serve as the organizations and
Authority and would accrediting bodies.. states would
oversee state PE Study manufacturer and
Provider accreditation distribute PE studies.
programs. EPA would also
design and maintain the
national data base.
Option 4: Private Sector Third EPA would set national Government or private Private sector
Party Oversees PE Study standards and standards sector organizations organizations and
Providers. for accreditation. EPA with expertise in states would
would also oversee the accreditation would manufacture and conduct
accreditation bodies. serve as Accreditation PE studies.
Bodies..
Option 5: EPA-Designated Third Third party non-profit Third party, non-profit Private sector
Party Oversees National Program. organization (e.g., NSF, organization would organizations and
A2LA, ANSI, ELAP) would accredit suppliers and states would
be responsible for monitor PE material manufacture and
setting standards and production to ensure distribute PE
operating the program. that operational and materials, collect and
quality standards are compile PE data.
met.
Option 6: No EPA Involvement in EPA would develop and None required, but the Private sector
Water PE Studies. publish national states, third party organizations and
standards. organizations, and the states would
private sector could manufacture and conduct
establish an oversight PE studies.
program.
Option 7: No National EPA would serve as the None.................... Private sector
Accreditation/Oversight of PE Standard Setting organizations and
Study Providers. Authority and would states would
establish guidance that manufacture and conduct
includes national PE studies in
standards for PE studies accordance with EPA
and performance guidance.
standards for PE Study
Providers..
Option 8: EPA Oversight of One or EPA would set national EPA would accredit PE Non-profit organizations
More Government or Non-profit PE standards and would also Study Providers. and states would
Study Providers. oversee the PE Study manufacture and conduct
Provider accreditation PE studies.
bodies.
----------------------------------------------------------------------------------------------------------------
* Under all options it is assumed that providers would collect PE data, conduct statistical treatments, compile
reports and distribute them to the appropriate States and EPA.
[[Page 37468]]
NIST would maintain a national data base, accessible to EPA staff
which would enable NIST and EPA to evaluate PE Study Providers'
performance, laboratory performance, and method effectiveness.
The private sector and interested States would assume
responsibility for conducting Water PE Studies. The PE Study Providers
would: produce the PE materials; distribute the PE studies to
participating laboratories; analyze client lab measurement data;
determine acceptance limits according to procedures established by EPA;
and report results (in the appropriate format and detail) to the
participating laboratories, the organization accrediting the laboratory
(or otherwise requiring laboratory participation), and to NIST. The
report to NIST would provide a summary of variation among laboratories
and how laboratories performed relative to EPA performance criteria.
The PE Study Providers would prepare and characterize each batch of
samples within a given study according to standardized protocols to
determine the ``true concentration value'' of an analyte in the sample
(e.g., consistent with NIST-provided primary reference standards). PE
Study Providers would pay a fee to NIST for accreditation.
Laboratories desiring to participate in the Water PE Studies
employing EPA/NIST standards might be required to pay a participation
fee to the private sector or State PE Study Providers.
Option 3: States Oversee Private Sector PE Study Providers
EPA would serve as the Standards Setting Authority for the Water PE
Study program and would maintain the national data base. EPA would
design and implement a program to assure an appropriate level of
consistency among State PE Study Provider accreditation programs.
Participating States would serve as PE Study Provider Accreditation
Bodies. States would establish individual programs for accreditation of
private sector PE Study Providers, individually or collectively through
NELAC. The States would each determine the PE Study Providers
authorized to distribute materials within their States. The States
would also oversee compliance with the national standards through
periodic on-site audits and ampule verification programs.
Alternatively, any State could choose to serve as the PE Study Provider
for all laboratories that it certifies or accredits (No State would be
required to participate in any such program).
The private sector and interested States would conduct the Water PE
Studies. The PE Study Providers would produce the PE materials;
distribute the PE studies to participating laboratories; analyze client
lab measurement data; determine acceptance limits according to
procedures established by EPA; and report results (in the appropriate
format and detail) to the participating laboratories and EPA. Depending
on applicable state law, the participating State might charge PE Study
Providers for accreditation.
Environmental testing laboratories would use any PE Study Provider
approved by the State. Laboratories desiring to participate in the
Water PE Studies might be required to pay a participation fee to the
private sector or State PE Study Providers.
Option 4: Private Sector Third Party Oversees PE Study Providers
EPA would serve as the Standards Setting Authority for the Water PE
Studies. EPA would establish national standards; establish technical
performance standards for accreditation of PE Study Providers;
establish standards for selection of qualified accreditation bodies;
and select and oversee PE Study Provider accreditation bodies. All of
these functions would be closely coordinated with NELAC and could be
transferred to NELAC when NELAC develops consensus water laboratory PE
study standards. EPA would also maintain the national data base.
One or more third parties would serve as the Water PE Study
Provider Accreditation Body. The Water PE Study Provider Accreditation
Body(ies) would oversee compliance with the EPA standards through
annual on-site audits and ampule verification programs. The Water PE
Study Provider Accreditation Body(ies) would collect a fee from
participating PE Study Providers to cover their accreditation and for
ongoing reaccreditation costs.
The private sector and interested States would conduct the Water PE
Studies. The PE Study providers would: produce the PE materials;
distribute the PE studies to participating laboratories; analyze client
lab measurement data; determine acceptance limits according to EPA-
established procedures; and report results (in the appropriate format
and detail) to the participating laboratories, the organization
accrediting the laboratory (or otherwise requiring laboratory
participation), and the PE Study Provider Accreditation Body. The
report to the PE Study Provider Accreditation Body would provide a
summary of variation among laboratories and how laboratories performed
relative to EPA performance criteria.
Environmental Testing Laboratories would use any accredited PE
Study Provider or the State, where States choose to be the PE Study
provider. Laboratories desiring to participate in the Water PE Studies
employing EPA Standards might have to pay a participation fee to the PE
Study Provider.
Option 5: EPA-Designated Third Party Oversees National Program
This option is essentially a privatized program which would use a
process similar to the Drinking Water Additives Program. See 53 FR
25586 (July 7, 1988).
EPA would establish competitive process for selecting an
organization to act as a Standard Setting Authority; publish that
competitive process to reach as many potential competitors as possible,
for example, in the Commerce Business Daily or Federal Register; and
encourage non-profit, third-party standard organizations to respond.
EPA would grade the proposals and select the Standard Setting
Authority.
The selected Standards Setting Authority would develop consensus
industry standards for PE samples/studies. EPA would be a participant
in this process. Current EPA standards and/or forthcoming NELAC draft
standards may serve as the model for the industry to develop the
consensus industry standards for PE samples/studies.
The Standards Setting Authority may also assume the role of the
Water PE Study Provider Accreditation Body or may select/contract with
other third party organizations to certify private sector and State PE
study providers. The Water PE Study Provider Accreditation Body(ies)
would oversee compliance with the consensus industry standards through
periodic on-site audits and ampule verification. The Water PE Study
Provider Accreditation Body or the Standards Setting Authority would
maintain a national data base. The Water PE Study Provider
Accreditation Body(ies) would collect a fee from participating PE Study
Providers to recover the costs associated with accreditation and for
ongoing reaccreditation costs.
The private sector and interested States would conduct the Water PE
Studies. The PE Study providers would: produce the PE materials;
distribute the PE studies to participating laboratories; analyze client
lab measurement data; determine acceptance limits according to
procedures established by the Standards Setting Authority; and report
results (in the appropriate format and detail) to the participating
laboratories, the organization accrediting the
[[Page 37469]]
laboratory (or otherwise requiring laboratory participation), and the
PE Study Accrediting Body and/or the Standards Setting Authority. The
report to the PE Study Provider Accreditation Body would provide a
summary of how the laboratories have varied and how they have performed
relative to the SSA's performance criteria.
Environmental testing laboratories would use any accredited PE
Study Provider. Laboratories desiring to participate in the Water PE
Studies might have to pay a participation fee to the PE Study Provider.
Option 6: No EPA Involvement in Water PE Studies
This option would represent complete disinvestment by EPA. EPA
would notify the States and the public of its intention to discontinue
the Water PE Studies and publish the national standards. On the
preannounced date, EPA would discontinue its involvement in water PE
Studies. EPA would no longer maintain a national data base.
States would arrange for their own PE Study programs, to the extent
necessary to meet State needs, and manage those programs to meet State
regulatory requirements. States would direct laboratories to one or
more private sector or State PE Study Providers. The individual States
would each decide who would: produce the PE materials; validate the PE
Study materials; distribute the PE studies to participating
laboratories; analyze client laboratory measurement data; determine
acceptance limits in accordance with State-specified procedures; and
report results. The individual States would determine their individual
needs for a data base. The States might also organize and conduct a
cooperative national program through NELAC.
Environmental testing laboratories would use PE Study Provider(s)
authorized in the State where they do business. Laboratories might pay
a participation fee directly to the State or PE Study Provider.
Option 7: No National Accreditation/Oversight of PE Study Providers
EPA would serve as the Standard Setting Authority for the Water PE
Study Program. EPA would publish the national standards and performance
standards for PE Study Providers as non-binding federal guidance (which
States may elect to adopt for regulatory purposes under State laws).
EPA might maintain a national data base in order to monitor the
effectiveness of PE studies. Any private sector company or State entity
would be eligible to provide PE studies to participating environmental
testing laboratories. The market place would police itself, i.e., the
PE material suppliers (private sector companies) through trade
associations,
f28((caretU*caretUcaretcaretcaretScaretIcaretTh
e Certified Reference Material Manufacturing Association (CRMMA), could
develop voluntary (non-regulatory) criteria and protocols for PE
manufacturers who might participate for market-based purposes.
Participating PE study laboratories and EPA Regional and State
regulators--the ``Water PE Study customers''--would individually
determine which PE study providers provided quality products that met
their needs.
The private sector and/or interested States would assume
responsibility for conducting Water PE Studies. The Water PE Study
Providers would produce the PE materials; distribute the PE studies to
participating laboratories; analyze client lab measurement data;
determine acceptance limits according to EPA guidance; and report
results (in the appropriate format and detail) to the participating
laboratories, the organization accrediting or certifying the laboratory
(or otherwise requiring laboratory participation), and to EPA. The
report to EPA would provide true values of measured analytes, reported
values of participating laboratories, and an evaluation of how the
laboratories performed relative to EPA's performance criteria.
Laboratories desiring to participate in PE studies would purchase
the appropriate PE samples from the PE study provider(s) acceptable to
the applicable laboratory accreditation authority, declare to the
applicable laboratory accreditation authority that the PE samples are
for official evaluation, and pay a participation fee to a PE study
provider.
Option 8: EPA Oversight of One or More Government or Non-profit PE
Study Providers
EPA would serve as the Standards Setting Authority and as the PE
Study Provider Accreditation Body. EPA would establish national
standards; establish technical performance standards for PE Study
Providers; design and implement an accreditation program for PE Study
Providers (including on-site accredits and ampule verification
studies); and accredit PE Study Providers. The universe of accredited
Water PE Study providers would include only government (e.g., States)
and other not-for-profit organizations. EPA would maintain the national
data base. All of EPA's functions would be closely coordinated with
NELAC and could be transferred to NELAC once NELAC develops consensus-
based PE standards.
One or more governmental or not-for-profit entities would serve as
the Water PE Study Providers. The Water PE Study providers would
conduct the Water PE Studies. The PE Study Providers would produce the
PE materials; distribute the PE studies to participating laboratories;
analyze client lab measurement data; determine acceptance limits
according to EPA procedures; and report results (in the appropriate
format and detail) to the participating laboratories, the organization
accrediting the laboratory (or otherwise requiring laboratory
participation), and to EPA.
Environmental testing laboratories would acquire Water PE samples
from authorized PE Study Provider(s). Laboratories might be required to
pay a nominal participation fee to their PE Study Provider.
V. Option Selection Criteria
EPA intends to evaluate the Water PE Study implementation options
against identified selection criteria. Thus far, EPA has identified
seven selection criteria, explained below. The Agency invites public
comment on these seven criteria, as well as any other selection
criteria EPA should consider.
1. Cost to EPA: Each option would be evaluated with respect to its
costs to EPA in terms of both personnel and costs. Options which costs
less to government agencies would generally be preferred.
2. Impact on States and Ease of Implementation: Each option would
be evaluated to determine the budgetary, statutory, regulatory,
programmatic and other impacts that they would have on participating
States. Options would be evaluated for the costs and problems the
States might incur under each option. Options with substantial adverse
impacts on the States would be not favored.
3. Implementation Timetable: Each option would be evaluated
relative to how long it would take to be implemented. Options which can
be implemented faster would be considered more favorably.
4. Legality of Option: Each option would be evaluated to determine
whether EPA has the necessary authority to implement the option under
existing legal authorities. Options which may require statutory
amendment or enactment would generally be not favored (for the
implementation timetables concerns identified in criterion 2 above).
5. National Consistency: Each option should be evaluated against
the
[[Page 37470]]
following measures for the degree to which:
a. Participating laboratories are evaluated on similar bases and
subjected to the same standards;
b. The probability of a laboratory ``passing'' a particular study
is independent of the PE study supplier;
c. A common measure can be applied to all data received from
participating laboratories regardless of PE study sample supplier;
d. To the extent applicable under the option considered, data from
different PE study suppliers could be combined into a national data
base; and
e. Water PE Samples used by the participating laboratories would be
of equal ``challenge,'' irrespective of PE study supplier.
6. Quality of PE Studies: Each option would be evaluated relative
to the ease with which the homogeneity, accuracy and stability of the
samples can be monitored.
7. Cost of Program to Laboratory Community: Each option would be
evaluated for its implementation cost to participating laboratories.
Lower cost options would be favored. One ``cost'' that we have not been
able to quantify--interstate reciprocity--would be important to EPA
decision making. Any option that would require a laboratory desiring to
do business in more than one State to participate in multiple PE
studies (or bear higher participation fees) would be less favored
compared to an option where the costs of multi-state operations are
low.
VI. Cost Estimates for Participating Laboratories
EPA estimates that full participation in the chemistry and
microbiological studies for either a WP or WS series program would cost
between $800-$1400 per study. This does not include any costs that
might be passed on as a result of instituting a PE Study Provider
Accreditation Body Program. Some States may require full participation
in two WP or WS studies per year to be accredited by the State.
However, since most laboratories are not required to be accredited for
all analytes covered in a study, the costs to participate in a given PE
study could be as low as $100 per study for laboratories analyzing only
conventional analytes such as Biological Oxygen Demand, PH, and Total
Suspended Solids. No cost estimates are currently available for Water
PE studies that assure laboratory capacity to measure radioactivity or
whole effluent toxicity.
VII. Invitation for Public Comment
EPA has not concluded whether any of these options is feasible. So
that EPA can assure that the views of all affected stakeholder groups
on these options have been considered, the Agency requests that written
comments identify if the person commenting represents: (a) A State or
political subdivision of a State (city, county, etc.) or a non-federal
governmental regulatory agency; (b) an independent third-party
organization; (c) a private-sector PE study provider or reference
material producer; (d) affected environmental analytical laboratory; or
(e) regulated water discharger or drinking water supplier.
EPA invites comments on the following issues:
General comments
(1) How well does each option for the proposed structure for the
Water PE Study Program meet your organizational needs relative to: (1)
National standard setting for PE studies, (2) designation (selection
and/or approval) of organizations to manufacture PE materials and
administer PE studies, and (3) actual production and administration of
the PE studies.
(2) How do the variations in each option on which organization(s)
or type of organization(s) would fulfill the three functions
accommodate the needs of your organization and what would be the
favorable or unfavorable consequences of that variation?
Specific comments
Cost to EPA
(1) EPA intends that any portion of the PE study program not
transferred to another organization would not be funded by Water PE
study participants. What is the minimum role that EPA should retain in
each of the three intended function areas (identified above) to assure
a successful nationwide PE study program for laboratories analyzing
aqueous samples?
Adverse Impact on States and Ease of Implementation
(2) What budgetary, statutory, regulatory, programmatic and other
impacts would each of these options have on States?
(3) Are the estimated costs for States realistic? If not, what is a
realistic estimated cost? What is the basis for your estimate.
Implementation Timetable
(4) In the selection process, each option will be evaluated
relative to how soon it can be implemented. Are the time lines
presented in the options paper realistic? If not, why?
(5) Are there other implementation time issues related to your
involvement with the studies that need to be considered?
(6) Should the Water PE Studies be transferred from EPA all at once
or should there be a phased transition during which EPA should address
specific needs or shortcomings in the new process?
National Consistency and Interstate Reciprocity
(7) Most of the identified options would involve multiple private-
sector study providers. How could EPA assure that the probability of a
laboratory ``passing'' a particular PE study is independent of the PE
study supplier?
(8) How could EPA assure that a common measure can be applied to
all data regardless of study supplier?
(9) Should the data from different PE study suppliers be combined
into a national data base? Why?
(10) How can EPA assure that the samples, irrespective of study
supplier are of equal challenge?
(11) What are the interstate reciprocity issues that will arise
from the options presented?
Quality of PE Studies
(12) How should EPA attempt to ensure there will be adequate
safeguards to assure PE samples are homogeneous and stable?
(13) What recourse should a laboratory have if the laboratory
``fails'' a PE study due to factors outside the laboratory's control
(e.g., because the study provider assigns an incorrect true value or
distributes an unstable sample)?
Cost of Program to Laboratory Community
(13) Are the estimated costs for participating laboratories
realistic? If no, what do you believe to be realistic estimated costs?
Why? Will the fees have a significant impact on the way the person
commenting conducts business in the future?
VIII. Agenda Topics for Public Meeting in Washington, DC
The Agency expects a wide variety of organizations to have an
interest in whether and how the Agency should externalize all or part
of the Water PE Study program. The purpose of the public meeting on the
alternative funding options for the Water PE study programs is twofold:
(1) To present the options with pros and cons of each; and (2) to hear
balanced responses from
[[Page 37471]]
representatives from affected parties, including (a) State regulators,
(b) independent third-party organizations, (c) private-sector PE study
provider or reference material producers; (d) affected environmental
analytical laboratories; or (e) regulated water dischargers or drinking
water suppliers. Comments on the evaluation criteria and the accuracy
of the estimated costs and timeliness for each option are of special
interest. The first hour will be spent on presenting the options.
Attendees are invited to make a formal presentation on current
options or offer alternative options. Fifteen minutes will be allotted
for each presentation. Participants are asked to notify EPA of their
intention to make a presentation by August 10, 1996 and submit a
written summary no later than August 15, 1996. The intent is to
distribute a package of presentations to all participants at the
meeting. Please contact Cindy Simbanin at 703-519-1386 about your plan
to make a presentation at the meeting. Send written presentations for
the public meeting to: Cindy Simbanin, DynCorp Inc., 300 N. Lee Street,
Suite 500, Alexandria, Va. 22314. Presentations can also be faxed to
703-684-0610.
Dated: July 5, 1996.
Steven Herman,
Assistant Administrator for Enforcement and Compliance Assurance.
Dated: July 3, 1996.
Henry L. Longest II,
Acting Assistant Administrator for Research and Development.
Dated: July 3, 1996.
Robert Perciasepe,
Assistant Administrator for Water.
[FR Doc. 96-18178 Filed 7-17-96; 8:45 am]
BILLING CODE 6560-50-P
