[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: [email protected]. 
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

[[Page 37465]]

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

[[Page 37466]]

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

[[Page 37467]]

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]
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