United States Office of Water EPA 800-D-96-001
Environmental Protection Washington, DC 20460 July 17, 1996
Agency
"Externalization" of ERA'S
Water Laboratory
Performance Evaluation
Programs
Options Paper
Draft-July 17, 1996
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"EXTERNALIZATION" OF EPAS
WATER LABORATORY PERFORMANCE
EVALUATION PROGRAMS
OPTIONS PAPER
Draft
July 16, 1996
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TABLE OF CONTENTS
ACRONYMS ii
INTRODUCTION 1
BACKGROUND 1
Assumptions Used in Evaluating Potential Options 2
Implementation Issues and Assumptions 3
Consistency Within a Multiple Provider System 5
Role of Stakeholders 5
Relationship of NELAC to the Redesigned Program 5
Process and Criteria for Developing and Selecting Options 6
Organization of the Options Paper 8
Definition of Terms 9
DESCRIPTIONS OF OPTIONS 13
Option 1: EPA Oversees PE Study Providers 14
Option 2: NIST Oversees PE Study Providers 21
Option 3: States Oversee Private Sector PE Study Providers 30
Option 4: Private Sector Third Party Oversees PE Study Providers 38
Option 5: EPA-designated Third Party Oversees National Program 46
Option 6: No EPA Involvement in Water PE Studies 54
Option 7: No National Accreditation/Oversight of PE Study Providers 60
Option 8: EPA Oversees One or More Government or Non-profit PE
Study Providers 66
APPENDIX A EPA Requirements for National Consistency Among Multiple PE
Study Providers A-l
APPENDIX B Table of Performance Evaluation Externalization Responsibilities
Under Each Option B-l
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ACRONYMS
A2LA American Association for Laboratory Accreditation
AA Assistant Administrator
ANSI American National Standards Institute
CWA Clean Water Act
DW Drinking Water
DMRQA Discharge Monitoring Report Quality Assurance
ELAB Environmental Laboratory Advisory Board
EMMC Environmental Monitoring Management Council
EMMP Environmental Monitoring Management Program
EPA Environmental Protection Agency
FACA Federal Advisory Committee Act
FTE Full Time Equivalents
IAG Interagency Agreement
NELAC National Environmental Laboratory Accreditation Conference
NELAP National Environmental Laboratory Accreditation Program
NERL-CI National Exposure Research Laboratory - Cincinnati
NIST National Institute of Science and Technology
NSF National Science Foundation
NVLAP National Voluntary Laboratory Accreditation Program
NY New York
ORD Office of Research and Development
OW Office of Water
PE Performance Evaluation
QA Quality Assurance
SDWA Safe Drinking Water Act
SSA Standards Setting Authority
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EXTERNALIZATION OF EPA's WATER LABORATORY
PERFORMANCE EVALUATION PROGRAMS
INTRODUCTION
EPA is reevaluating the Federal role in the implementation of the Water Performance
Evaluation (PE) Study Program in light of current funding limitations as well as the Agency's
inability to create a dedicated fund for any fees collected under the existing user fee authority. In
May of 1994, EPA's Assistant Administrators for Water, Research and Development, and
Enforcement and Compliance Assurance instructed staff in the Office of Water (OW) and the
Office of Research and Development (ORD) to establish a Water Laboratory PE Redesign Work
Group. They charged the Work Group with: (a) streamlining the current operation; and (b)
redesigning the current program to make it more effective and to address gaps in coverage, and
completing a scheme to make the study self-supporting. The Water Laboratory PE Redesign
Work Group was formed in August 1994 and first met in September 1994. The Work Group
consists of approximately 35 members from OW, ORD, OECA, and the Regional Environmental
Services/Sciences Divisions. In addition, several States have been invited to provided input
during the development of options for all three charges. This paper outlines the options under
consideration by the Work Group for making the studies self supporting and highlights the
Agency's role in Water Laboratory PE Studies under each option.
BACKGROUND
Since the 1970s, the Agency has been conducting laboratory performance evaluation (PE)
studies to support the various water programs administered by the States and EPA under Clean
Water Act (CWA) and the Safe Drinking Water Act (SDWA). The PE studies involve preparing
solutions of known concentrations of analytes, sending the samples to participating laboratories
for analysis, and scoring the results against performance criteria that are statistically or
empirically based 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 EPA's overall program for assuring the quality of the
environmental measurements conducted to implement both the Clean Water Act (CWA) and the
Safe Drinking Water Act (SDWA).
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). Although participation in the WS study is not federally compelled,
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many State drinking water laboratory certification programs rely on the 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.
Participation in the WP is not federally compelled, however, many States require laboratories to
participate in the WP study 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
EPA. EPA, in turn, sends PE samples directly to the NPDES 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.
The PE studies are sent to over 9000 laboratories and NPDES permittees annually at a
cost to EPA of $2.5 million in extramural resources and approximately 15 Office of Research
and Development FTEs and approximately 8 to 10 Regional FTEs. Ensuring an adequate source
of funding for these studies has been a concern of the Agency for nearly a decade. As a first step
in implementing cost savings measures for the PE studies, later this year, the Office of Research
and Development is conducting a combined WP and DMRQA study. This combined study will
result in a projected annual program savings of approximately $0.3 to 0.5 million. Additional
cost reductions are necessary however, in order to ensure continuation of the studies.
Assumptions Used in Evaluating Potential Options
Various assumptions were made at the outset of the process to develop alternative
funding options for the Water PE Study Program. These assumptions were based on the charge
to the Work Group by senior Agency managers, current Agency policies, legal restrictions, and
other important concerns identified by the Work Group. The assumptions are:
The redesigned program must ensure high standards, credibility with the public and
private sectors, consistent national standards, and responsiveness to the needs of the
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regulatory, regulated, and laboratory support communities. In order to ensure these
conditions are met, the Work Group assumed that EPA must retain significant
leadership responsibility in the standards setting process selected for the program.
EPA will not have the resources to continue to produce and distribute PE study kits free
of charge (e.g., the status quo will not continue). Under the redesigned program,
organizations external to EPA will produce the water PE studies and participants in both
the public and private sectors will have to pay to participate in studies.
All options addressed by the options analysis must be within the scope of EPA's statutory
authorities.
Every effort will be made to implement the redesigned program as soon as possible.
Regardless of the option selected, the redesigned program must be implemented no later
than Fiscal Year 2000.
At least a two year lead time will be provided to the states in order to give them sufficient
time to implement any necessary statutory, regulatory and budgetary changes, based on
past written assurances from ORD management.
EPA has tried and has not been able to obtain fee retention authority for this program
from Congress and therefore, having EPA collect fees from the states and/or private
sector to pay for the operation of the program cannot be considered as an option in the
foreseeable future.
EPA will not provide funding or "seed money" to any non-government organization for
purposes of establishing the program.
In order to encourage endorsement by all EPA Offices, EPA Regions, and the States, the
option development and selection process will be coordinated with the EMMC and
National Environmental Laboratory Accreditation Conference (NELAC).
Implementation Issues and Assumptions
Because of the large number of stakeholder groups involved (i.e., EPA, the states,
participating commercial and government laboratories, commercial vendors, the regulated
community, and others), implementation of the redesigned program will require considerable
attention to identifying and addressing the implementation concerns of the states and private
sector. As a first step toward ensuring that implementation issues are identified from as many
perspectives as possible, the Work Group agreed that steps would be taken to obtain input
through several efforts such as formal notice and comment procedures, a public meeting,
dialogues with various stakeholder groups, and extensive review of the options paper by EPA
regional and state program representatives. The Work Group is also working directly with
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representatives from the National Institute of Standards and Technology (NIST) to ascertain
whether NIST will be able to assist with a redesigned program. In addition, the Work Group
chairs have developed a process for coordinating the efforts of the National Environmental
Laboratory Accreditation Conference (NELAC) Proficiency Testing Committee with the Water
Laboratory PE Redesign Work Group to ensure that these two efforts remain as consistent as
possible and maintain compatible schedules to the extent practical.
The Work Group agreed to four assumptions regarding implementation, which apply to
all options presented in this paper. These assumptions are:
• The redesigned program will not result in any significant changes to existing EPA
regulatory requirements or compliance monitoring programs. The regulatory
requirement to successfully complete at least one PE study per year in order to maintain
laboratory certification under the Safe Drinking Water Act will remain in place, for
example. EPA will also retain the requirement that all major NPDES permit holders
participate in one DMRQA study each year.
• Authorities delegated to the states under the Clean Water Act and the Safe Drinking
Water Act and related federal regulatory provisions also will not change in any
substantive way as a result of the redesigned program. For example, under the
current SDWA regulations (40 CFR 141, et seq.), certified drinking water laboratories are
required to obtain an appropriate PE study from EPA (i.e., the Office of Research and
Development in Cincinnati, OH) or from the state in which they maintain or seek
certification. This requirement can be interpreted to mean that laboratories can obtain a
study directly from the State or from a provider designated by the accrediting body in the
state in which they maintain or seek certification. Under this existing system, states have
the authority to require that their laboratories participate in the EPA studies or to
designate an alternate source for PE studies. This aspect of the program will not change
as a result of the redesign.
• EPA and the states will receive all of the information needed to fulfill the
requirements of regulatory, compliance monitoring, and laboratory certification
programs under the redesigned program. Consequently, any approved PE study
provider, whether a government organization or a commercial entity, will provide reports
to EPA and the states sufficient to meet program needs. At a minimum, such reports will
include all information currently provided to the EPA Regions and the states under the
existing program.
• In order to facilitate reporting, electronic methods of transmission utilizing
standardized data formats will be developed and implemented to the maximum
extent possible.
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Consistency Within a Multiple Provider System
All of the options presented in this paper include the use of a system involving multiple
providers of PE studies. Under such a system, multiple providers would conduct the PE studies
according to established standards in an effort to meet and better serve the needs of the different
PE programs as well as reduce EPA costs for the studies. The Work Group recognized that
moving from the current single-supplier system to a system involving multiple providers will
introduce concerns regarding consistency in PE studies. Consequently, the Chairperson of the
Work Group requested several members to convene a committee to examine the issue of
achieving national consistency in a multiple provider system and to identify the critical elements
required to achieve an acceptable level of consistency. The draft report generated by this
committee, "EPA Requirements for National Consistency Among Multiple PE Study Providers, "
is presented as Appendix A to this document.
Role of Stakeholders
The Work Group recognizes that the Water PE Study program and redesign effort have
important roles 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 Committee (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 ensure that no duplication of efforts occurs and to ensure that
the outcomes of these efforts reflect consistent monitoring policy.
The Work Group also recognizes that working with external stakeholders such as the
States, NPDES permit holders, drinking water suppliers, private laboratories, PE study providers,
and State/Trade Associations will be key in the decision making process. Consequently, the
Office of Water is taking steps to ensure that stakeholder groups have an opportunity to comment
on the redesign options. This summer, OW will hold a public meeting in Washington, B.C., for
the purpose of taking comment on the ten options presented in this paper. In addition, OW will
undertake additional outreach efforts such as use of conference calls, small discussion groups,
and electronic bulletin boards. The intent is to provide external stakeholders an opportunity to
discuss the options under consideration and mutually determine the best way to address any
concerns prior to selecting a preferred option.
Relationship of NELAC to the Redesigned Program
One of the Work Group's goals is to have a program that is suitable for inclusion in the
National Environmental Laboratory Accreditation Conference (NELAC). NELAC serves as
national standards-setting body for environmental laboratory accreditation. The members of
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NELAC—state and federal regulatory and non-regulatory programs having environmental
laboratory oversight, certification, or accreditation functions plus the private sector in a
nonvoting role—come together to develop consensus standards through the NELAC committee
structure and at two annual meetings. Participants agree to adopt the NELAC consensus
standards for use in their own programs in order to achieve a uniform national program in which
environmental testing laboratories will be able to receive one annual accreditation that is
accepted nationwide. As part of this uniform national laboratory accreditation program, NELAC
intends to develop standards for a proficiency testing program that addresses all fields of testing,
including drinking water and wastewater.
The intent of the NELAC standards setting process is to ensure that the needs of EPA and
state regulatory programs are satisfied in the context of a uniform national laboratory
accreditation program. The EPA recognizes that using NELAC processes as an important part of
EPA's Water PE Study Redesign options will enable states, environmental testing laboratories
and PE study providers to give input into the evaluation and selection process early enough in the
process to have a significant impact on the direction of the Water PE Study redesign effort. It is
hoped that a mutual effort will minimize the impact of the redesigned Water PE Study program
on the states and lead to participation in the new Water PE Study program by all states so that the
NELAC goal of a uniform national laboratory accreditation program can be achieved.
Consequently, as stated previously, the Work Group chairs have developed a process for
coordinating the efforts of the NELAC Proficiency Testing Committee with the Redesign Work
Group to ensure that these two efforts remain as consistent as possible and maintain compatible
schedules to the extent practical.
Process and Criteria for Developing and Selecting Options
Initially, the Water Laboratory PE Redesign Work Group defined a comprehensive set of
options that included the full range of scenarios from bringing the program in house (conducting
all activities using EPA facilities, equipment and staff) to establishing a private sector program in
which EPA has no role. 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.
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 eight options involve transferring all or some component of the PE study
program to organizations other than EPA (see Table 1). They will be evaluated against seven
evaluation criteria. Wherever possible, quantitative scores will be used to indicate both rank
order and absolute difference between options. Whenever quantitative evaluations can not be
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made, but one option can be said to be better than another with respect to a specific factor,
options will be rank ordered only. The seven evaluation criteria are as follows:
Criterion #1: Legal Considerations
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.
Criterion #2: National Consistency
Each option would be evaluated against the 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.
Criterion #3: 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.
Criterion #4: 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.
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Criterion #5: Adverse Impact on States
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.
Criterion #6: 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.
Criterion #7: 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.
Organization of the Options Paper
The remainder of this paper presents a description and evaluation of each of the
remaining seven options. The discussion of each option consists of the following components:
A summary table that describes the responsibilities of the Standards Setting
Authority, the PE Study Provider Accreditation Body, and the PE Study
Provider(s);
• A brief narrative summary of each option;
• A time line that identifies the key steps in implementation of the option and the
estimated date of completion for each step;
• A summary table providing estimated costs to all stakeholder groups; and
A summary of key factors affecting the ranking of each option, by evaluation
criterion.
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Definition of Terms
In reviewing the administration of existing EPA PE study programs and developing
various options for future administration, the Work Group 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 Work Group 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 Work Group has made certain assumptions about the different components that
might be transferred to other entities. Those assumptions are also explained.
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.
PE Study Providers: Organizations that supply PE study samples to environmental testing
laboratories.
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.
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.
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.
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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 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, Pub. L. No. 104-113, § 12(d), 110 Stat. 783 (to be codified at 15 U.S.C. § 272 note).
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, Pub. L. No. 104-113, § 12(d),
110 Stat. 783 (to be codified at 15 U.S.C. § 272 note).
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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.
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 options considered by the Work Group are summarized in the section of this
document entitled "Descriptions of Options" and in Table 1. The organization(s) responsible for
specific activities of performance evaluation study program functions under each of the eight
options being considered are presented in Appendix B of this document.
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Table 1. Summary of Options Considered
Option
Number
1
2
3
4
5
6
7
8
Standards
Setting
Authority
EPA
EPA
EPA
EPA
3rd Party
None
EPA
EPA
PE Study
Provider
Accreditation
Body
EPA
NIST
States
3rd Party
3rd Party
States/3rd Party
None
EPA
PE Study
Provider
Private
Sector\States
Private
Sector\States
Private
Sector\States
Private
Sector\States
Private
Sector/States
Private
Sector/States
Private
Sector\States
Gov'tA
Non-profit
Cost to EPA
for this
Option ($K)*
*
*
*
*
*
*
*
*
Approximate
Time Needed to
Implement This
Option
2 yrs.
1 yr, 9 mo.
4 yrs.
3 yrs.
3 yrs.
2 yrs.
2 yrs.
2 yrs.
To be added, pending information collection and analysis.
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DESCRIPTIONS OF OPTIONS
Roles and Responsibilities
Detailed Fact Sheets
Implementation Plans,
Costs, and Timetables
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 1: EPA Oversees PE Study Providers
Roles and Responsibilities
Option 1: EPA Oversees PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set national standards for accreditation of PE
Study Providers
PE STUDY PROVIDER
ACCREDITATION BODY
EPA would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
Design and maintain the national data base
PE STUDY PROVIDERS
Interested states and private sector suppliers
would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Maintain accreditation and cooperate in EPA
oversight activities
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PE Externalization
Options Paper Detailed Fact Sheet for Option 1
Option 1: EPA Oversees PE Study Providers
Summary
Standard Setting Authority
EPA would serve as the Standards Setting Authority and as the PE Study Provider
Accreditation Body. EPA staff would establish the national standards and standards for
accrediting PE Study Providers. This activity would be closely coordinated with NELAC
initially and could be transferred to NELAC eventually once national consensus standards are
available for water laboratory PE Studies. Accreditation standards would be based on current
regulations, policies, and practices applicable to the WS, WP, and DMRQA studies.
PE Study Provider Accreditation Body
EPA would also serve as the PE Study Provider Accreditation Body and would design a
national accreditation program, determine which PE Study Providers should be accredited, and
conduct periodic compliance monitoring activities (such as on-site audits and proficiency testing
through ampule verification). EPA would publish a list of accredited PE Study Providers at least
annually.
EPA would also continue to maintain a national data base. The purpose is to enable EPA to
evaluate performance of the PE Study Providers, laboratory performance, and method
effectiveness and make changes as necessary.
PE Study Providers
The private sector and interested States would assume the 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 requiring
the laboratory to participate, and to EPA.
Laboratories desiring to participate in PE studies following EPA standards use a PE study
provider on the EPA list. The laboratories pay a participation fee to their PE study provider.
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 1
OPTION 1 TIME TABLE
COMPLETION DATE
ACTIVITY OR MILESTONE
December 1, 1996*
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
April 1, 1997
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish
October 1, 1997
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures; publish
April 1, 1998
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution **
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
October 31, 1998
Implement Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report f
* Assumes final option selection occurs by October 1, 1996.
** Assumes that EPA will require 60 days to complete each accreditation and a total of 15 vendors will be
accredited.
f Assumes each vendor will require 60 days to distribute first study after receipt of accreditation. Vendors will
begin designing and producing their initial studies as they are notified of accreditation. All vendors should
receive accreditation by August 31, 1998.
Draft Document
July 16, 1996
16
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 1
OPTION 1 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies and Accreditation of PE Study
Providers: Prepare draft standards; facilitate internal EPA review and
concurrence; facilitate coordination with NELAC; revise/finalize
standards; publish
Design PE Study Provider Accreditation Program: Design
application and application review process; develop checklists for
application review and on-site assessments consistent with standards;
design documentation procedures; design/develop information
management and tracking system; prepare standard operating
procedures; develop revocation/appeals process; design
communication procedures
Implement PE Study Accreditation Program: Distribute
applications; receive/process/review applications; conduct on-site
assessments; prepare reports; implement information management and
tracking systems; conduct communications/information distribution
Obtain Accreditation: Prepare and submit application; participate in
on-site assessment; respond to requests for additional information
Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive
and process results; report
National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug;
implement
ESTIMATED COST TO STAKEHOLDER GROUPS
(S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
$40K
0.25 FTE
$50K
1.5 FTE
S150K
N/A
N/A
BID
STATES
N/A
N/A
N/A
N/A
NELAC
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
ELAB
ELAB
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
17
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 1
OPTION 1 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Routine Costs
Update National Standards: Identify issues; develop changes and
revise standards; facilitate EPA review/concurrence; publish
Maintain PE Study Provider Accreditation Program: Conduct re-
accreditation; take revocation actions as needed; conduct routine
communications; accredit new PE Study Providers; make changes to
procedures/checklists/reports consistent with updated standards;
conduct ampule verification program
Conduct Studies: Design studies; announce; manufacture and
distribute materials, receive and process results; report
Maintain PE Study Provider Accreditation: Participate in annual
on-site assessment; provide information as required; participate in
QA/ampule verification program
Participate In Studies: Select PE Study Providers); analyze
materials; prepare results reports
National Data Base: Conduct data entry /verification; make
modifications consistent with updated standards as needed; make
improvements/corrections as needed; develop routine reports; monitor
status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS
(S AND FTE)
EPA
0.25 FTE
$30K
BID
N/A
N/A
N/A
BID
STATES
N/A
N/A
NELAC
NELAC
N/A
N/A
PROVIDERS
N/A
N/A
All costs
recovered thru
fees
ELAB
N/A
N/A
LABS
N/A
N/A
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NELAC States choosing to serve as PE Study Providers will incur some costs. NELAC is assisting in estimating potential costs.
Draft Document
July 16, 1996
18
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PE Externalization
Options Paper Detailed Fact Sheet for Option 1
Option 1: EPA Oversees PE Study Providers
Evaluation
The principal advantage of this option is that it is less disruptive and costly for the states than
other options. Its chief disadvantage is that EPA lacks direct statutory authority to accredit PE
study providers.
SCORE
Legal Concerns
EPA lacks direct statutory authority to accredit PE study providers.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary and is based on State interest in using the EPA studies.
Process for approving PE study providers could be subject to claims that EPA is
interfering with private sector competition.
National Consistency
Depends on specificity of the national standards and resources available for EPA
oversight of PE study providers.
Quality of PE Studies
Depends on availability of EPA resources for conducting on-site audits and a sample
verification program.
Draft Document July 16, 1996
19
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PE Externalization
Options Paper Detailed Fact Sheet for Option 1
Cost to EPA
PE study design, manufacturing, distribution, and data management/scoring functions
would be supported with user fees.
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), oversight of PE study providers, data base development
and maintenance, and reporting of scores to states/regions.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
State expenditures should be limited to purchasing PE studies for certification of State
laboratories. States need not incur oversight costs for monitoring the performance of PE
study providers.
Any states that serve as PE study providers would be subject to EPA
oversight/accreditation.
Cost of Program to Laboratory Community
Laboratories would pay market prices for participating in PE studies.
EPA would have no leverage for ensuring that small laboratories are offered affordable
studies of limited scope. PE providers will determine whether specialized materials and
studies can be offered based on profitability.
Only a portion of total program costs would be passed on to regulated community; EPA
would retain responsibility for costs of oversight and standards
development/maintenanc e.
Implementation Timetable
Requires approximately 2 years to implement following final selection (Time Table
assumes decision October 1, 1996).
TOTAL FOR OPTION 1
Draft Document July 16, 1996
20
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 2: NIST Oversees PE Study Providers
Roles and Responsibilities
Option 2: NIST Oversees PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set national standards for accreditation of PE
Study Providers
Enter into a Memorandum of Agreement with
NIST
Work closely with NIST to ensure that the
studies meet EPA's needs
Conduct an annual review of the NIST
program
PE STUDY PROVIDER
ACCREDITATION BODY
NIST would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
Design and maintain the national data
base
Produce and distribute primary reference
standards
PE STUDY PROVIDERS
Interested states and private sector suppliers
would:
Manufacture and distribute PE studies
Score results and report to EPA, NIST and
the states
Maintain accreditation and cooperate in
NIST oversight activities
Draft Document
July 16, 1996
21
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PE Externalization
Options Paper Detailed Fact Sheet for Option 2
Option 2: NIST Oversees PE Study Providers
Summary
Standard Setting Authority
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.
PE Study Provider Accreditation Body
NIST's NVLAP would serve as the PE Study Provider Accreditation Body. NIST would
oversee compliance with the national standards through 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 cover their accreditation costs. 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. NIST would
also develop primary reference standards which would be distributed to all accredited PE Study
Providers.
PE Study Providers
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; analyzes 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 requiring
the laboratory to participate, and to NIST. The report to NIST would provide a summary of how
the laboratories have varied and how they have performed relative to EPA's performance criteria.
The PE Study Providers would prepare and characterize each batch of samples within a study
according to approved protocols involving value assignment against NIST-provided primary
reference standards. PE Study Providers would pay a fee to NIST for their accreditation.
Laboratories desiring to participate in the Water PE Studies employing EPA/NIST standards
would have to pay a participation fee to the private sector or State PE Study Providers.
Draft Document July 16, 1996
22
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 2
OPTION2 TIMETABLE
COMPLETION DATE
ACTIVITY OR MILESTONE
December 1, 1996*
Final Announcement: Prepare responses to comments; prepare/revise/finalize
FRN; facilitate internal EPA review/concurrence; publish FRN (EPA)
April 1, 1997
Establish EPA/NIST MOU: Prepare draft agreement; facilitate internal EPA and
NIST reviews; revise/finalize/execute (EPA & NIST)
Develop Process for Annual Review of NIST Studies: Develop review process;
facilitate internal EPA review/approval and NIST review (EPA & NIST)
May 1, 1997
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish in Federal Register
(EPA)
October 1, 1997
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures (NIST)
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
(NIST)
January 1, 1998
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution **
July 1, 1998
Complete Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report (NIST) f
Beginning March 1, 1998
Generate and Distribute Standard Reference Materials: Develop production
plan and schedule; obtain equipment and materials; produce and package; conduct
quality control and quality assurance; distribute to PE Study Providers
* Assumes final option selection occurs by October 1, 1996.
** Date NIST will begin accepting applications for accreditation. Assumes that NIST will require 60 days to
complete each accreditation.
f Assumes each state or vendor will require 60 days to distribute first study after receipt of accreditation.
Draft Document
July 16, 1996
23
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 2
OPTION 2 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies and Accreditation
of PE Study Providers: Prepare draft standards;
facilitate internal EPA review and concurrence;
facilitate coordination with NELAC; revise/finalize
standards; publish
Establish EPA/NIST MOU: Prepare draft agreement;
facilitate internal EPA and NIST reviews;
revise/finalize/execute
Design PE Study Provider Accreditation Program:
Design application and application review process;
develop checklists for application review and on-site
assessments consistent with standards; design
documentation procedures; design/develop information
management and tracking system; prepare standard
operating procedures; develop revocation/appeals
process; design communication procedures
Implement PE Study Accreditation Program:
Distribute applications; receive/process/review
applications; conduct on-site assessments; prepare
reports; implement information management and
tracking systems; conduct
communications/information distribution
Obtain Accreditation: Prepare and submit
application; participate in on-site assessment; respond
to requests for additional information
Generate and Distribute Standard Reference
Materials: Develop production plan and schedule;
obtain equipment and materials; produce and package;
conduct quality control and quality assurance;
distribute to PE Study Providers
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
$40K
0.1 FTE
0.1 FTE
N/A
N/A
$3M
NIST
N/A
N/A
0.1 FTE
0.25 FTE
$50K
1.5 FTE
S150K
N/A
Costs
recovered
from EPA
STATES
N/A
N/A
N/A
N/A
N/A
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
N/A
ELAB
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
July 16, 1996
24
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 2
OPTION 2 SUMMARY OF ESTIMATED COSTS
r""O 1 J!jl_;J!jlVlJ!jl^ 1
Initial Costs, cont.
National Data Base: Design data base and reporting
formats; develop instructions/reporting formats for PE
Study Providers; test/de-bug; implement
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Review/Update EPA/NIST MOU: Conduct annual
program review; agree on changes required; prepare
draft revised MOU; facilitate internal EPA and NIST
reviews; revise/finalize/execute
Maintain PE Study Provider Accreditation
Program: Conduct re-accreditation; take revocation
actions as needed; conduct routine communications;
accredit new PE Study Providers; make changes to
procedures/checklists/reports consistent with updated
standards; conduct ampule verification program
Maintain PE Study Provider Accreditation: Meet
annual reporting requirements; participate in ampule
verification program; cooperate in annual on-site
assessment
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
N/A
N/A
0.25 FTE
$30K
0.1 FTE
N/A
N/A
NIST
BID
N/A
0.1 FTE
0.1 FTE
BID
N/A
STATES
N/A
NELAC
N/A
N/A
N/A
NELAC
PROVIDERS
N/A
ELAB
NIST
N/A
N/A
N/A
ELAB
LABS
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
July 16, 1996
25
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 2
OPTION 2 SUMMARY OF ESTIMATED COSTS
r""O 1 J!jl_;J!jlVlJ!jl^ 1
Routine Costs, cont.
Produce Standard Reference Materials:
Manufacture materials to maintain stock; maintain
ordering/ shipping/billing systems
Conduct Studies: Design studies; announce;
manufacture and distribute materials, receive and
process results; report
Participate in Studies: Select PE Study Providers);
analyze materials; prepare results reports
National Data Base: Conduct data entry /verification;
make modifications consistent with updated standards
as needed; make improvements/corrections as needed;
develop routine reports; monitor status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
N/A
N/A
N/A
N/A
NIST
Costs
recovered
from EPA and
PE Providers
N/A
N/A
BID
STATES
N/A
NELAC
N/A
N/A
PROVIDERS
N/A
All costs
recovered thru
fees
N/A
N/A
LABS
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
26
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PE Externalization
Options Paper Detailed Fact Sheet for Option 2
Option 2: NIST Oversees PE Study Providers
Evaluation
This option would achieve a high level of national consistency, provided that the states are
willing to participate. However, those states that have their own PE study programs would likely
object to paying NIST for accreditation. This option has the further advantage that it would
make a large portion of the program self-supporting and it therefore minimizes the continuing
costs of the program to EPA. Initially, EPA would have to provide $3 million to NIST for start-
up, or find other federal partners and/or private sector partners willing to help capitalize the NIST
program as well as pay for that portion of the program NIST has not assumed during the first
three years.
SCORE
Legal Concerns
Avoids the issue of whether EPA has direct statutory authority to accredit PE study
providers.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary and is based on State interest in using the EPA studies.
Process for approving PE study providers could be subject to claims that EPA and NIST
are interfering with private sector competition.
National Consistency
Depends on specificity of the national standards and resources available for EPA
oversight of NIST program.
An acceptable level of consistency is likely to be achievable.
Quality of PE Studies
Use of NIST primary reference standards for traceability ensures that all providers are
using analytes from a single, documented source. This could reduce the likelihood of
errors.
Draft Document July 16, 1996
27
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PE Externalization
Options Paper Detailed Fact Sheet for Option 2
EPA could work with NIST to establish a quality system that meets EPA's standards.
Cost to EPA
NIST estimates that it would need one-time funding of $3 million from EPA to develop
NIST primary reference standards for use by accredited PE study providers.
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), negotiating an interagency agreement with NIST
(initially and annually), and oversight of the NIST program.
Program for accrediting and overseeing PE study providers would be self-supported using
fees paid by PE study providers to NIST.
PE study manufacturing, distribution, data base maintenance, and scoring functions
would be supported with user fees paid by laboratories to accredited PE study providers.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
State expenditures should be limited to purchasing PE studies for certification of State
laboratories. States need not incur oversight costs for monitoring the performance of PE
study providers.
Any states that serve as PE study providers would be subject to NIST
oversight/accreditation. This might to be objectionable to the states.
Cost of Program to Laboratory Community
Laboratories would pay market prices for participating in PE studies.
EPA and NIST would have no leverage for ensuring that small laboratories are offered
affordable studies of limited scope. PE providers will determine whether specialized
materials and studies can be offered based on profitability.
Private sector PE providers would pay costs of accreditation/oversight, with the exception
of the initial $3 million investment for developing benchmark standards.
Draft Document July 16, 1996
28
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PE Externalization
Options Paper Detailed Fact Sheet for Option 2
Implementation Timetable
Requires approximately 1 year and 9 months to implement.
TOTAL FOR OPTION 2
Draft Document July 16, 1996
29
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 3: States Oversee Private Sector PE Study Providers
Roles and Responsibilities
Option 3: States Oversee Private Sector PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set national standards for accreditation of PE Study
Providers
Implement a program for approving state PE Study
Provider accreditation programs
Design and maintain the national data base
PE STUDY PROVIDER
ACCREDITATION BODY
States would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
PE STUDY PROVIDER
Interested states and private sector
suppliers would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Maintain accreditation and cooperate in
state oversight activities
Draft Document
30
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 3
Option 3: States Oversee Private Sector PE Study Providers
Summary
Standard Setting Authority
EPA would serve as the Standards Setting Authority for the Water PE Study program and
would maintain the national data base. EPA would also design and implement a program for
overseeing State PE Study Provider accreditation programs consistent with the national
standards. This activity would be closely coordinated with NELAC.
PE Study Provider Accreditation Body
The States would serve as PE Study Provider Accreditation Bodies. The States would
establish individual programs for accrediting private sector PE Study Providers, individually or
collectively through NELAC. The States would each determine the authorized PE Study
Providers in 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.
PE Study Providers
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. Those states able to retain fees would charge PE Study Providers for
accreditation.
Environmental testing laboratories would use any PE Study Provider approved by the
laboratory accrediting authority in the State where they are operating. Laboratories desiring to
participate in the Water PE Studies would have to pay a participation fee to the private sector or
State PE Study Providers.
Draft Document July 16, 1996
31
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 3
OPTION 3 TIME TABLE
COMPLETION DATE
ACTIVITY OR MILESTONE
December 1, 1996*
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
April 1, 1997
Develop State PE Provider Program Oversight Process: Develop criteria and
review process; facilitate internal EPA review and concurrence; coordinate with
states
May 1, 1997
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish
October 1, 1998**
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures (STATES)
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
(EPA)
October 1, 1999
Complete State Program Approvals: Review required documentation; conduct
on-site assessments; make initial determination; negotiate necessary changes with
states; issue final approvals
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution (STATES)
May 1, 2000f
Complete Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report
* Assumes final option selection occurs by October 1, 1996.
** Allows states 2 years, from decision date of October 1, 1996, to make any necessary statutory, regulatory, and
budgetary changes.
f Estimated date when all accredited vendors will complete their initial studies. Some may occur sooner.
Draft Document
July 16, 1996
32
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 3
OPTION 3 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies and Accreditation of
PE Study Providers: Prepare draft standards; facilitate
internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards;
publish
Design PE Study Provider Oversight Program:
Determine type of program needed; design documentation
and review procedures needed; design/develop
information management and tracking system; develop
revocation/appeals process; design communication
procedures
Implement PE Study Oversight Program:
Receive/process/review applications; conduct on-site
assessments; prepare reports; implement information
management and tracking systems; conduct
communications/information distribution
Obtain Accreditation: Prepare and submit application;
participate in on-site assessment; respond to requests for
additional information
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
Design State Oversight Program: Define critical
program elements; develop review protocol; establish
review schedule; coordinate with states
National Data Base: Design data base and reporting
formats; develop instructions/reporting formats for PE
Study Providers; test/de-bug; implement
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
S40K
N/A
N/A
N/A
N/A
0.25 FTE
$50K
BID
STATES
N/A
N/A
NELAC
NELAC
N/A
N/A
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
ELAB
ELAB
N/A
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
July 16, 1996
33
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 3
OPTION 3 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Maintain PE Study Provider Accreditation Program:
Conduct re-accreditation; take revocation actions as
needed; conduct routine communications; accredit new
PE Study Providers; make changes to
procedures/checklists/reports consistent with updated
standards
Maintain PE Study Provider Accreditation: Meet
annual reporting requirements; participate in ampule
verification program; cooperate in annual on-site
assessment
Conduct Studies: Design studies; announce;
manufacture and distribute materials, receive and process
results; report
Participate in Studies: Select PE Study Providers);
analyze materials; prepare results reports
Conduct State Oversight Program: Conduct state
program reviews; generate reports; conduct follow-up
activities as needed; negotiate changes with states as
needed
National Data Base: Conduct data entry /verification;
make modifications consistent with updated standards as
needed; make improvements/corrections as needed;
develop routine reports; monitor status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$30 K
N/A
N/A
N/A
N/A
0.25 FTE
$30K
BID
STATES
N/A
NELAC
N/A
NELAC
N/A
NELAC
N/A
PROVIDERS
N/A
N/A
ELAB
All costs
recovered thru
fees
N/A
N/A
N/A
LABS
N/A
N/A
N/A
N/A
ELAB
N/A
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
34
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PE Externalization
Options Paper Detailed Fact Sheet for Option 3
Option 3: States Oversee Private Sector PE Study Providers
Evaluation
The chief advantage of this option is that most of the costs of the program are transferred to the
industry or states, causing EPA's costs to be minimized. Since the states would have the option
of designing their own single or multiple source program, there is high potential for variability in
state programs, which would impact negatively on national consistency and could cause
laboratories and PE providers to need multiple accreditation.
SCORE
Legal Concerns
Avoids issue of whether EPA has direct statutory authority to accredit PE study providers
or direct the states to use specific sources for PE studies.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary based on State interest in using the EPA studies.
National Consistency
Depends on:
Specificity of national standards;
Availability of EPA resources to oversee states; and
States' abilities to establish effective accreditation and oversight programs.
Likely to be a high degree of variability based on experience in other programs.
Quality of PE Studies
Large number of oversight organizations (states) and PE study providers increases
probability of errors and complexity of quality assurance.
Cost to EPA
PE study design, manufacturing, distribution, and data management/scoring functions
would be supported with user fees paid by laboratories to PE study providers.
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 3
Accreditation and oversight of PE study providers would be supported by user fees paid
to the states by private sector PE study providers, where possible, or supported with state
resources.
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), oversight of state programs, and data base development
and maintenance.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
States would need to provide resources to support the accreditation and oversight
program for PE study providers. Some states may be able to charge an accreditation fee
to make the program self-supporting. Others may not be able to obtain the statutory
authority to charge fees. For those states, this would be the most expensive option.
Any state that serves as a PE study provider would not need to make any changes, except
those necessary to ensure compliance with the national standards.
Not clear whether the states would be willing to establish reciprocal agreements. If not,
PE study providers would have to obtain approval from every state in which they conduct
business.
Cost of Program to Laboratory Community
Laboratories would pay market prices for participating in PE studies.
Private sector PE study providers would support state accreditation/oversight programs
with user fees in some states.
EPA would have no leverage for ensuring that small laboratories are offered affordable
studies of limited scope. PE providers will determine whether specialized materials and
studies can be offered based on profitability.
Without reciprocity among the states, PE study providers would have to obtain multiple
accreditation. Even with reciprocity, PE study providers might have to pay licensing or
other fees to every state in which they do business.
Draft Document July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 3
Implementation Timetable
Requires approximately 4 years to implement.
TOTAL FOR OPTION 3
Draft Document
July 16, 1996
37
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 4: Private Sector Third Party Oversees PE Study Providers
Roles and Responsibilities
Option 4: Private Sector Third Party Oversees PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set criteria for selection of third party PE
Study Accrediting Bodies
Set national standards for accreditation of PE
Study Providers
Implement a program to oversee the PE
Study Provider Accrediting Bodies
Design and maintain the national data base
PE STUDY PROVIDER
ACCREDITATION BODY
Interested states and qualified third parties
would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
PE STUDY PROVIDERS
Interested states and private sector suppliers
would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Maintain accreditation and cooperate in EPA
oversight activities
Draft Document
July 16, 1996
38
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PE Externalization
Options Paper Detailed Fact Sheet for Option 4
Option 4: Private Sector Third Party Oversees PE Study Providers
Summary
Standard Setting Authority
EPA would serve as the Standards Setting Authority for the Water PE Studies. EPA would
set the national standards; set technical performance standards for accrediting PE Study
Providers; set standards for selecting qualified accrediting bodies; and select and oversee PE
Study Provider accrediting bodies. All of these functions would be closely coordinated with
NELAC and could be transferred to NELAC once they have developed consensus water
laboratory PE study standards. EPA would also maintain the national data base.
PE Study Provider Accreditation Body
One or more third party 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.
PE Study Providers
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 requiring the laboratory
to participate, and the PE Study Provider Accreditation Body. 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 EPA's performance criteria.
Environmental Testing Laboratories would use any accredited PE Study Provider or the
State, where States choose to be the provider. Laboratories desiring to participate in the Water
PE Studies employing EPA Standards would have to pay a participation fee to the PE Study
Provider.
Draft Document July 16, 1996
39
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 4
OPTION 4 TIME TABLE
COMPLETION DATE
December 1, 1996*
April 1, 1997
July 1, 1997
January 31, 1998
September 1, 1998
January 1, 1999
October 1, 1999
ACTIVITY OR MILESTONE
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish
Design PE Study Provider Accreditation Body Qualification Program:
Develop application process; develop documentation and communication
processes; design necessary support systems (information management and
tracking); design review procedures; obtain required EPA approvals
Publish Notice of Accreditation Body Qualification Program: Prepare/revise/
finalize FRN; facilitate internal EPA review/concurrence; publish FRN
Implement PE Study Provider Accreditation Body Qualification Program:
receive applications; conduct reviews, make selections
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures (3rd Parties)
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution
Complete Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report
Assumes final option selection occurs by October 1, 1996.
Draft Document
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 4
OPTION 4 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies and Accreditation
of PE Study Providers: Prepare draft standards;
facilitate internal EPA review and concurrence;
facilitate coordination with NELAC; revise/finalize
standards; publish
Design and Implement PE Study Provider
Accreditation Body Qualification Program: Develop
application process; develop documentation and
communication processes; design necessary support
systems (information management and tracking);
design review procedures; obtain required EPA
approvals; conduct reviews; make selections
Design PE Study Provider Accreditation Program:
Design application and application review process;
develop checklists for application review and on-site
assessments consistent with standards; design
documentation procedures; design/develop information
management and tracking system; prepare standard
operating procedures; develop revocation/appeals
process; design communication procedures
Implement PE Study Accreditation Program:
Distribute applications; receive/process/review
applications; conduct on-site assessments; prepare
reports; implement information management and
tracking systems; conduct
communications/information distribution
Obtain Accreditation: Prepare and submit
application; participate in on-site assessment; respond
to requests for additional information
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
National Data Base: Design data base and reporting
formats; develop instructions/reporting formats for PE
Study Providers; test/de-bug; implement
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
$40K
0.25 FTE
$30K
N/A
N/A
N/A
N/A
N/A
3RD PARTIES
N/A
N/A
N/A
ELAB
ELAB
ELAB
N/A
BID
STATES
N/A
N/A
N/A
N/A
N/A
NELAC
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
N/A
ELAB
ELAB
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
July 16, 1996
41
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 4
OPTION 4 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Maintain PE Study Provider Accreditation
Program: Conduct re-accreditation; take revocation
actions as needed; conduct routine communications;
accredit new PE Study Providers; make changes to
procedures/checklists/reports consistent with updated
standards; conduct ampule verification program
Maintain PE Study Provider Accreditation: Meet
annual reporting requirements; participate in ampule
verification program; cooperate in annual on-site
assessment
Conduct Studies: Design studies; announce;
manufacture and distribute materials, receive and
process results; report
Participate in Studies: Select PE Study Provider(s);
analyze materials; prepare results reports
National Data Base: Conduct data entry /verification;
make modifications consistent with updated standards
as needed; make improvements/corrections as needed;
develop routine reports; monitor status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$30K
N/A
N/A
N/A
N/A
N/A
3RD PARTIES
N/A
ELAB
N/A
N/A
N/A
BID
STATES
N/A
N/A
NELAC
NELAC
N/A
N/A
PROVIDERS
N/A
N/A
ELAB
All costs
recovered thru
fees
N/A
N/A
LABS
N/A
N/A
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
42
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PE Externalization
Options Paper Detailed Fact Sheet for Option 4
Option 4: Private Sector Third Party Oversees PE Study Providers
Evaluation
Under this option, many aspects of the program would become self-supporting and EPA's costs
would be significantly reduced. The states may object to the use of a third party to oversee PE
study providers.
SCORE
Legal Concerns
Avoids issue of whether EPA has direct statutory authority to accredit PE study
providers.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary based on State interest in using the EPA studies.
Process for approving PE study providers could be subject to claims that EPA is
interfering with private sector competition.
Process for approving PE study providers could be subject to claims that EPA is
interfering with private sector competition.
Process for selecting and overseeing the third-party oversight organization would be
subject to claims regarding potential conflicts of interest.
National Consistency
Level of consistency would depend on:
Specificity of the national standards;
Quality of EPA's oversight program;
States' willingness to participate.
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 4
Quality of PE Studies
Use of multiple providers increases probability of error.
Oversight program should not be resource-limited. EPA could work with the third party
to design a quality system that meets EPA standards.
Cost to EPA
Almost all aspects of the program would be supported with user fees:
Laboratories would pay fees to PE study providers to support manufacturing,
distribution, and data management/scoring functions.
PE providers would pay fees to the third-party accreditor to support accreditation
and oversight.
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), selection and oversight of the third-party accreditor,
and data base development and maintenance.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
Any state that serves as a PE study provider under the program would need to be
accredited by the third-party. States have already voiced a strong objection to this type of
program through NELAC and other NELAC-related discussions.
Cost of Program to Laboratory Community
Laboratories would pay market prices for participating in PE studies.
Private sector PE study providers would support the third-party accreditation/oversight
program through user fees.
Draft Document July 16, 1996
44
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PE Externalization
Options Paper Detailed Fact Sheet for Option 4
EPA would have no leverage for ensuring that small laboratories are offered affordable
studies of limited scope. PE providers will determine whether specialized materials and
studies can be offered based on profitability.
If states establish their own programs instead of participating in the national program, PE
study providers may have to obtain multiple accreditation or pay licensing or other fees to
every state in which they do business.
Implementation Timetable
Requires approximately 3 years to implement.
TOTAL FOR OPTION 4
Draft Document July 16, 1996
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 5: EPA-designated Third Party Oversees National Program
Roles and Responsibilities
Option 5: EPA-designated Third Party Oversees National Program
STANDARDS
SETTING AUTHORITY
Third Party selected by EPA would:
Set national standards for PE studies
Set national guidance for PE Study
Provider performance
PE STUDY PROVIDER
ACCREDITATION BODY
Interested states and qualified third parties
would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
PE STUDY PROVIDERS
Interested states and private sector
suppliers would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Maintain accreditation and cooperate in
EPA oversight activities
Draft Document
July 16, 1996
46
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PE Externalization
Options Paper Detailed Fact Sheet for Option 5
Option 5: EPA-designated Third Party Oversees National Program
Summary
This is essentially a completely privatized program which would use a process similar to the
one employed to privatize the Drinking Water Additives Program.
Standard Setting Authority
EPA would establish competitive process for selecting an organization to act as a Standard
Setting Authority (SAA); publish the process in the Commerce Business Daily/Federal Register;
and encourage non-profit, third-party standard organizations to respond. An appropriate group of
EPA staff (Headquarters and Regional staff from OW, OECA, ORD and OGC) would grade the
proposals and select the SSA.
The selected SAA 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.
PE Study Provider Accreditation Body
The SSA may 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 annual on-site audits and ampule verification.
The Water PE Study Provider Accreditation Body or the SSA would maintain a national data
base. 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.
PE Study Providers
The private sector and interested States conduct the Water PE Studies. The PE Study
providers: produce the PE materials; distribute the PE studies to participating laboratories;
analyzes client lab measurement data; determine acceptance limits according to procedures
established by the SSA; and report results (in the appropriate format and detail) to the
participating laboratories, the organization accrediting the laboratory or requiring the laboratory
to participate, and the PE Study Accrediting Body and/or the SSA. The report to the PE Study
Draft Document July 16, 1996
47
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PE Externalization
Options Paper Detailed Fact Sheet for Option 5
Provider Accreditation Body provides a summary of how the laboratories have varied and how
they have performed relative to the SSA's performance criteria.
Environmental Testing Laboratories use any accredited PE Study Provider. Laboratories
desiring to participate in the Water PE Studies would have to pay a participation fee to the PE
Study Provider.
Draft Document July 16, 1996
48
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 5
OPTION 5 TIME TABLE
COMPLETION DATE
December 1, 1996*
April 1, 1997
July 1, 1997
January 31, 1998
September 1, 1998
January 1, 1999
October 1, 1999
ACTIVITY OR MILESTONE
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate industry/government consensus building
process; revise/finalize standards; publish
Design Third Party Selection Process: Develop application process; develop
documentation and communication processes; design review procedures; obtain
required EPA approvals
Publish Notice of Third Party Selection Process: Prepare/revise/finalize FRN;
facilitate internal EPA review/concurrence; publish FRN
Implement Third Party Selection Process: Receive applications; conduct
reviews; make selection
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures (3rd Party)
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
(3rd Party)
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution **
Complete Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report
* Assumes final option selection occurs by October 1, 1996.
** Assumes each state or vendor will require 60 days to distribute first study after receipt of accreditation.
Draft Document
July 16, 1996
49
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 5
OPTION 5 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
Design and Implement Third Party Selection Process:
Develop application process; develop documentation and
communication processes; design review procedures;
obtain required EPA approvals; conduct reviews; make
selection
National Standards for Studies and Accreditation of PE
Study Providers: Prepare draft standards; facilitate
industry/government consensus building process;
revise/finalize standards; publish
Design PE Study Provider Accreditation Program:
Design application and application review process; develop
checklists for application review and on-site assessments
consistent with standards; design documentation
procedures; design/develop information management and
tracking system; prepare standard operating procedures;
develop revocation/appeals process; design communication
procedures
Implement PE Study Accreditation Program: Distribute
applications; receive/process/review applications; conduct
on-site assessments; prepare reports; implement
information management and tracking systems; conduct
communications/information distribution
Obtain Accreditation: Prepare and submit application;
participate in on-site assessment; respond to requests for
additional information
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
National Data Base: Design database and reporting
formats; develop instructions/reporting formats for PE
Study Providers; test/de-bug; implement
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
0.10 FTE
N/A
N/A
N/A
N/A
N/A
N/A
3RD PARTY
N/A
N/A
ELAB
ELAB
ELAB
ELAB
N/A
BID
STATES
N/A
N/A
N/A
N/A
N/A
NELAC
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
N/A
ELAB
ELAB
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 5
OPTION 5 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Oversee Third Party: Conduct annual program review;
determine changes needed; report; negotiate changes
Maintain PE Study Provider Accreditation Program:
Conduct re-accreditations; take revocation actions as
needed; conduct routine communications; accredit new PE
Study Providers; make changes to
procedures/checklists/reports consistent with updated
standards; conduct ampule verification program
Maintain PE Study Provider Accreditation: Meet annual
reporting requirements; participate in ampule verification
program; cooperate in annual on-site assessment
Conduct Studies: Design studies; announce; manufacture
and distribute materials, receive and process results; report
Participate in Studies: Select PE Study Provider(s);
analyze materials; prepare results reports
National Data Base: Conduct data entry/verification; make
modifications consistent with updated standards as needed;
make improvements/corrections as needed; develop routine
reports; monitor status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$30K
0.1 FTE
N/A
N/A
N/A
N/A
N/A
3RD PARTY
N/A
ELAB
ELAB
N/A
N/A
N/A
BID
STATES
N/A
N/A
N/A
NELAC
NELAC
N/A
N/A
PROVIDERS
N/A
N/A
N/A
ELAB
All costs
recovered thru
fees
N/A
N/A
LABS
N/A
N/A
N/A
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 5
Option 5: EPA-designated Third Party Oversees National Program
Evaluation
This option was eliminated because with no EPA involvement in standard setting, there is a
strong potential for national consistency and quality to fall below acceptable levels.
Legal Concerns
Drinking Water Additives Program establishes precedent.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary based on State interest in using the EPA studies.
Process for approving PE study providers could be subject to claims that EPA is
interfering with private sector competition.
Process for selecting the third party oversight organization would be subject to claims
regarding potential conflicts of interest.
National Consistency
Level of consistency would depend on:
Specificity of the national standards;
Quality of the national accreditation/oversight program for PE study providers;
States' willingness to participate.
Quality of PE studies
National quality assurance program would be supported by user fees and should not be
resource-limited.
Does not ensure that quality assurance program will meet EPA standards.
Cost to EPA
All aspects of the program would be supported with user fees:
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 5
Laboratories would pay fees to PE study providers to support manufacturing,
distribution, and data management/scoring functions.
PE providers would pay fees to the third-party to support development of national
standards, accreditation, and oversight.
EPA resources would be needed for selecting a third party, announcing the change in the
program, and participating in the standard-setting process.
Impact on States
Implementation schedule allows time for states to obtain necessary budget appropriations
or make statutory/regulatory changes.
Any state that serves as a PE study provider under the program would need to be
accredited by the third-party. States have already voiced a strong objection to this type of
program through NELAC and other NELAC-related discussions.
Economic Impact
Laboratories would pay market prices for participating in PE studies.
Private sector PE study providers would support the third-party standard setting and
accreditation/oversight programs through user fees.
EPA would have no leverage for ensuring that small laboratories are offered affordable
studies of limited scope. PE providers will determine whether specialized materials and
studies can be offered based on profitability.
If states establish their own programs instead of participating in the national program, PE
study providers may have to obtain multiple accreditations or pay licensing or other fees
to every state in which they do business.
Implementation Timetable
Requires approximately 3 years.
TOTAL FOR OPTION 5
Draft Document July 16, 1996
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 6: No EPA Involvement in Water PE Studies
Roles and Responsibilities
Option 6: No EPA Involvement in Water PE Studies
STANDARDS
SETTING AUTHORITY
EPA would:
Set national guidance for PE studies
PE STUDY PROVIDER
ACCREDITATION BODY
Interested states and third parties would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
PE STUDY PROVIDERS
Interested states and private sector
suppliers would:
Manufacture and distribute PE studies
Score results and report to the states
Draft Document
July 16, 1996
54
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PE Externalization
Options Paper Detailed Fact Sheet for Option 6
Option 6: No EPA Involvement in Water PE Studies
Summary
This is a completely privatized program. 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 PE Studies. EPA would no longer maintain a
national data base.
Standard Setting Authority
There would be no single Standard Setting Authority. States could structure their own PE
Study programs, if they thought one was necessary, and manage them to meet regulatory
requirements.
PE Study Providers
States would direct their laboratories to one or more private sector or State PE Study
Providers. It would be up to each individual State to 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. It would also be up to each individual State to
determine if they need a data base. The States could also organize and conduct a cooperative
national program through NELAC.
Environmental Testing Laboratories would use PE Study Provider(s) accepted in the State
where they do business. Laboratories would pay a participation fee directly to the State or PE
Study Provider.
Draft Document July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 6
OPTION 6 TIME TABLE
COMPLETION DATE
December 1, 1996*
April 1, 1997
October 1, 1998**
ACTIVITY OR MILESTONE
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish
Initial Studies: Design studies; develop study plan; announce study; obtain
standard reference materials; manufacture materials; verify materials; distribute
materials; receive and process results; report
* Assumes final option selection by October 1, 1996.
** Allows states 2 years to make necessary statutory, regulatory, or budgetary changes.
Draft Document
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 6
OPTION 6 SUMMARY OF ESTIMATED COSTS
«,S™,ENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies: Prepare draft
standards; facilitate internal EPA review and
concurrence; facilitate coordination with NELAC;
revise/finalize standards; publish
Obtain Accreditation: Prepare and submit
application; participate in on-site assessment; respond
to requests for additional information
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Conduct Studies: Design studies; announce;
manufacture and distribute materials, receive and
process results; report
Participate in Studies: Select PE Study Providers);
analyze materials; prepare results reports
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
N/A
N/A
N/A
N/A
N/A
N/A
3RD PARTY
N/A
ELAB
N/A
N/A
ELAB
N/A
N/A
STATES
N/A
N/A
NELAC
NELAC
N/A
NELAC
N/A
PROVIDERS
N/A
N/A
ELAB
ELAB
N/A
All costs
recovered thru
fees
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
ELAB
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 6
Option 6: No EPA Involvement in Water PE Studies
Evaluation
This option has an even greater potential than Option 7 to result in national consistency and
quality falling below acceptable levels.
Legal Concerns
None.
National Consistency
There would be no controls to ensure national consistency.
Market forces (i.e., competitiveness) should weed out the bad performers.
Quality of PE Studies
No national quality assurance program. Market forces (i.e., competitiveness) would
eliminate bad performers.
Legal Concerns
None.
National Consistency
There would be no controls to ensure national consistency.
Market forces (i.e., competitiveness) should weed out the bad performers.
Quality of PE Studies
No national quality assurance program. Market forces (i.e., competitiveness) would
eliminate bad performers.
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 6
Cost to EPA
Only minimal EPA resources would be needed for announcing the decision.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
States would have to decide whether to establish their own multiple or single-source
programs.
Uniformity in state programs could only be achieved on a voluntary basis through
NELAC.
Cost to Laboratory Community
Impact would vary from state to state. PE study providers may be subject to participating
in numerous, highly variable state programs, which is likely to be costly.
Implementation Timetable
Requires approximately 2 years to implement.
TOTAL FOR OPTION 6
Draft Document July 16, 1996
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 7: No National Accreditation/Oversight of PE Study Providers
Roles and Responsibilities
Option 7: No National Accreditation/Oversight of PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set national guidance for PE Study Provider
performance
Design and maintain the national data base
PE STUDY PROVIDER
ACCREDITATION BODY
None.
PE STUDY PROVIDERS
Interested states and private sector suppliers
would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Draft Document
60
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 7
Option 7: No National Accreditation/Oversight of PE Study Providers
Summary
Standard Setting Authority
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
guidance. EPA would also maintain a national data base in order to monitor the effectiveness of
PE studies.
PE Study Providers
Any private sector company authorized by the laboratory accreditation body in the state they
are operating 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, such as, the Certified Reference
Material Manufacturing Association (CRMMA) would develop criteria/protocols to which PE
manufacturers would adhere voluntarily, in order to maintain their competitive market share.
The PE customers i.e., participating PE study laboratories and regional/state regulators, would
determine which PE study providers were providing quality products that met their needs.
The private sector and interested States would assume responsibility for conducting Water
PE Studies. The PE Study Providers 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/certifying the laboratory or requiring the
laboratory to participate, and to EPA. The report to EPA provides analyte true values,
participating laboratories reported values and an evaluation of how the laboratories have
performed relative to EPA's performance criteria.
Laboratories desiring to participate in PE studies would purchase the appropriate PE
samples from the provider of his/her choice, declare up-front that the PE samples are for official
evaluation, and pay a participation fee to a PE study provider.
Draft Document July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 7
OPTION 7 TIME TABLE
COMPLETION DATE
December 1, 1996*
April 1, 1997
October 1, 1998**
ACTIVITY OR MILESTONE
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
National Standards for Studies: Prepare draft standards; facilitate internal EPA
review and concurrence; facilitate coordination with NELAC; revise/finalize
standards; publish
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
Initial Studies: Design studies; develop study plan; announce study; obtain
standard reference materials; manufacture materials; verify materials; distribute
materials; receive and process results; report
* Assumes final option selection occurs by October 1, 1996.
** Allows states 2 years to make necessary statutory, regulatory, or budgetary changes. Initial studies could begin
as soon as the summer of 1997.
Draft Document
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 7
OPTION 7 SUMMARY OF ESTIMATED COSTS
coSTELEMraT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies: Prepare draft
standards; facilitate internal EPA review and
concurrence; facilitate coordination with NELAC;
revise/finalize standards; publish
Initial Studies: Design studies; develop study plan;
announce study; obtain standard reference materials;
manufacture materials; verify materials; distribute
materials; receive and process results; report
National Data Base: Design data base and reporting
formats; develop instructions/reporting formats for PE
Study Providers; test/de-bug; implement
Routine Costs
Update National Standards: Identify issues; develop
changes and revise standards; facilitate EPA
review/concurrence; publish
Conduct Studies: Design studies; announce;
manufacture and distribute materials, receive and
process results; report
Participate in Studies: Select PE Study Providers);
analyze materials; prepare results reports
National Data Base: Conduct data entry /verification;
make modifications consistent with updated standards
as needed; make improvements/corrections as needed;
develop routine reports; monitor status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS (S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
$30K
N/A
BID
0.25 FTE
$30K
N/A
N/A
BID
STATES
N/A
N/A
NELAC
N/A
N/A
NELAC
N/A
N/A
PROVIDERS
N/A
N/A
ELAB
N/A
N/A
All costs recovered
thru fees
N/A
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
NIST Estimate to be supplied by the National Institute of Standards and Technology.
Draft Document
July 16, 1996
63
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PE Externalization
Options Paper Detailed Fact Sheet for Option 7
Option 7: No National Accreditation/Oversight of PE Study Providers
Evaluation
Under this option, EPA would achieve a significant cost savings. As in Option 5, however, there
could be high variability among state programs, which would reduce national consistency and
cause the industry to be subject to multiple, redundant PE Study Provider accreditation.
SCORE
Legal Concerns
None.
National Consistency
National standards would be the only controls on consistency and quality of PE materials.
Market forces (i.e., competitiveness) should eliminate bad performers.
Quality of PE Studies
No national quality assurance for PE studies. Market forces (i.e., competitiveness) should
eliminate bad performers.
Cost to EPA
PE study design, manufacturing, and distribution would be supported through user fees
paid by laboratories.
No costs associated with oversight of PE study providers.
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), and data base development and maintenance.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 7
States would have to decide whether to establish their own multiple or single-source
programs.
Uniformity among state programs could likely be achieved eventually on a voluntary
basis through NELAC.
Cost of Program to Laboratory Community
Impact would vary from state to state. PE study providers may be subject to participating
in numerous, highly variable state programs, which is likely to be costly.
Implementation Timetable
Requires approximately 2 years to implement.
TOTAL FOR OPTION 7
Draft Document July 16, 1996
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PE Externalization
Options Paper
Roles and Responsibilities Under Options
Option 8: EPA Oversees One or More Government or Non-profit PE Study Providers
Roles and Responsibilities
Option 8: EPA Oversees One or More Government or Non-profit PE Study Providers
STANDARDS
SETTING AUTHORITY
EPA would:
Set national standards for PE studies
Set national standards for accreditation of PE
Study Providers
Implement a program for overseeing PE
Study Provider Accreditation Bodies
Design and maintain the national data base
PE STUDY PROVIDER
ACCREDITATION BODY
EPA would:
Accredit PE Study Suppliers
Oversee PE Study Supplier performance
through on-site assessments and ampule
verification
PE STUDY PROVIDERS
Interested states, Federal government, and
non-profit suppliers would:
Manufacture and distribute PE studies
Score results and report to EPA and the
states
Maintain accreditation and cooperate in EPA
oversight activities
Draft Document
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 8
Option 8: EPA Oversees One or More Government or Non-profit PE Study Providers
Summary
Standard Setting Authority
EPA would serve as the Standards Setting Authority and as the PE Study Provider
Accreditation Body. EPA would set the national standards; set technical performance standards
for PE Study Providers. EPA would maintain the national data base. All of EPA's functions
would be closely coordinated with NELAC.
PE Study Provider Accreditation Body
EPA would also serve as the PE Study Provider Accreditation Body and would design a
national accreditation program, determine which PE Study Providers should be accredited, and
conduct periodic compliance monitoring activities (such as on-site audits and ampule
verification). EPA would publish a list of accredited PE Study Providers at least annually.
PE Study Providers
One or more neutral, government, or non-profit entities serve as the Water PE Study
Providers. The 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 requiring the laboratory to participate, and to EPA.
Environmental Testing Laboratories use the authorized PE Study Provider(s). Laboratories
would have to pay a participation fee to their PE Study Provider.
Draft Document July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 8
OPTION 8 TIME TABLE
COMPLETION DATE
ACTIVITY OR MILESTONE
December 1, 1996*
Announcement of Final Decision: Prepare responses to comments;
prepare/revise/finalize FRN; facilitate internal EPA review/concurrence; publish
FRN announcing option selected
April 1, 1997
National Standards for Studies and Accreditation of PE Study Providers:
Prepare draft standards; facilitate internal EPA review and concurrence; facilitate
coordination with NELAC; revise/finalize standards; publish
October 1, 1997
Design PE Study Provider Accreditation Program: Design application and
application review process; develop checklists for application review and on-site
assessments consistent with standards; design documentation procedures;
design/develop information management and tracking system; prepare standard
operating procedures; develop revocation/appeals process; design communication
procedures
April 1, 1998
Implement PE Study Accreditation Program: Distribute applications;
receive/process/review applications; conduct on-site assessments; prepare reports;
implement information management and tracking systems; conduct
communications/information distribution **
Complete National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug; implement
October 31, 1998
Complete Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive and process
results; report f
* Assumes final option selection occurs by October 1, 1996.
** Assumes that EPA will require 60 days to complete each accreditation and a total of 3 organizations will be
accredited simultaneously.
f Assumes each vendor will require 60 days to distribute first study after receipt of accreditation. All vendors
should receive accreditation by August 31, 1998.
Draft Document
July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 8
OPTION 8 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Initial Costs
Announcement: Prepare responses to comments;
prepare/revise/fmalize FRN; facilitate internal EPA
review/concurrence; publish FRN
National Standards for Studies and Accreditation of PE Study
Providers: Prepare draft standards; facilitate internal EPA review and
concurrence; facilitate coordination with NELAC; revise/finalize
standards; publish
Design PE Study Provider Accreditation Program: Design
application and application review process; develop checklists for
application review and on-site assessments consistent with standards;
design documentation procedures; design/develop information
management and tracking system; prepare standard operating
procedures; develop revocation/appeals process; design
communication procedures
Implement PE Study Accreditation Program: Distribute
applications; receive/process/review applications; conduct on-site
assessments; prepare reports; implement information management and
tracking systems; conduct communications/information distribution
Obtain Accreditation: Prepare and submit application; participate in
on-site assessment; respond to requests for additional information
Initial Studies: Design studies; develop study plan; announce study;
manufacture materials; verify materials; distribute materials; receive
and process results; report
National Data Base: Design data base and reporting formats; develop
instructions/reporting formats for PE Study Providers; test/de-bug;
implement
ESTIMATED COST TO STAKEHOLDER GROUPS
(S AND FTE)
EPA
0.25 FTE
$25K
0.25 FTE
$40K
0.25 FTE
$50K
1.5 FTE
S150K
N/A
N/A
BID
STATES
N/A
N/A
N/A
N/A
NELAC
NELAC
N/A
PROVIDERS
N/A
N/A
N/A
N/A
ELAB
ELAB
N/A
LABS
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Draft Document
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July 16, 1996
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PE Externalization
Options Paper
Detailed Fact Sheet for Option 8
OPTION 8 SUMMARY OF ESTIMATED COSTS
COST ELEMENT
Routine Costs
Update National Standards: Identify issues; develop changes and
revise standards; facilitate EPA review/concurrence; publish
Maintain PE Study Provider Accreditation Program: Conduct re-
accreditation; take revocation actions as needed; conduct routine
communications; accredit new PE Study Providers; make changes to
procedures/checklists/reports consistent with updated standards;
conduct ampule verification program
Conduct Studies: Design studies; announce; manufacture and
distribute materials, receive and process results; report
Participate In Studies: Select PE Study Providers); analyze
materials; prepare results reports
National Data Base: Conduct data entry /verification; make
modifications consistent with updated standards as needed; make
improvements/corrections as needed; develop routine reports; monitor
status and trends
ESTIMATED COST TO STAKEHOLDER GROUPS
(S AND FTE)
EPA
0.25FTE
$30 K
BID
N/A
N/A
BID
STATES
N/A
N/A
NELAC
N/A
N/A
PROVIDERS
N/A
N/A
All costs
recovered thru
fees
N/A
N/A
LABS
N/A
N/A
N/A
ELAB
N/A
Abbreviations
N/A Not applicable. No significant costs incurred by this stakeholder group for this activity.
BID Estimate in development (by ORD or OW).
ELAB Environmental Laboratory Advisory Board (ELAB) will assist with estimate.
Draft Document
July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 8
Option 8: EPA Oversees One or More Government or Non-profit PE Study Providers
Evaluation
Overall, this option is analogous to Option 1, with the exception that the study provider is a non-
profit rather than a profit organization. This option provides for a relatively high degree of
national consistency. The fact that EPA retains oversight responsibilities causes EPA's costs to
be somewhat higher than other options, but may make this option more appealing to the states.
SCORE
Legal Concerns
EPA may lack direct statutory authority to accredit PE study providers.
For-profit private sector PE study providers would likely object on legal grounds to
EPA's decision to disqualify profit-based organizations.
EPA could not compel the states to use the national program. State participation likely
would be achieved eventually on a voluntary basis through NELAC. Current
participation is voluntary based on State interest in using the EPA studies.
National Consistency
Level of consistency would depend on specificity of the national standards and resources
available for EPA oversight of PE study providers.
Quality of PE Studies
Depends on EPA resources available to fund on-site audits of PE study providers and a
PE sample verification program.
Cost to EPA
PE study design, manufacturing, distribution, and data management/scoring functions
would be supported with user fees.
Draft Document July 16, 1996
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PE Externalization
Options Paper Detailed Fact Sheet for Option 8
EPA resources would be needed for standard setting (initial standards development and
annual review/revision/updating), selection and oversight of qualified PE study providers,
and data base development and maintenance.
Impact on States
Implementation schedule allows ample time for states to obtain necessary budget
appropriations or make statutory/regulatory changes.
State expenditures should be limited to purchasing PE studies; they need not incur
oversight costs for monitoring the performance of PE study providers. This constitutes a
savings for some states.
Any states that serve as PE study providers would be subject to EPA
oversight/accreditation. This should not be objectionable to the states if they are involved
in the standard-setting process.
Cost of Program to Laboratory Community
Laboratories would pay market prices for participating in PE studies.
EPA could have leverage to ensure that small laboratories are offered affordable studies
of limited scope.
Only a portion of total program costs would be passed on to regulated community; EPA
would retain responsibility for significant costs of oversight and standards
development/maintenanc e.
Implementation Timetable
Requires approximately 2 years to implement.
TOTAL FOR OPTION 8
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