Contract Number S2643B9040
Task Order #2643082960
Project #2643038
EPA Publication Number: 821-2-04-004
Situation Assessment Report
on
Detection and Quantitation Approaches and
Uses in Clean Water Act (CWA) Programs
U.S. Environmental Protection Agency
Engineering and Analysis Division
Office of Science and Technology
Office of Water
Submitted by
Triangle Associates, Inc.
811 First Avenue Suite 255
Seattle, WA 98104
under subcontract to
SRA International, Inc.
Alexandria, VA
December 2004
Detection and Quantitation Approaches
in Clean Water Act Programs
Situation Assessment Report
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Triangle Associates, Inc.
December 2004
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Situation Assessment Report on
Detection and Quantitation Approaches and Uses
in Clean Water Act Programs
Table of Contents
INTRODUCTION 3
BACKGROUND 4
FEASIBILITY 5
CATEGORIES OF STAKEHOLDERS 6
KEY ISSUES AND INTERESTS OF EPA AND STAKEHOLDER GROUPS 7
KEY ISSUES ACROSS ALL STAKEHOLDER GROUPS 12
GOALS AND PURPOSE OF THE STAKEHOLDER PROCESS 14
PRODUCT OF THE STAKEHOLDER PROCES S 14
PROCEDURAL ISSUE RELATED TO THE STAKEHOLDER PROCESS 15
PARTICIPATION 16
PROCESS DESIGN RECOMMENDATION 18
PROTOCOLS 20
CONCLUSION 20
APPENDIX A:
List of Interviewees 21
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Situation Assessment Report
on Detection and Quantitation Approaches and Uses
in Clean Water Act Programs
Introduction
This report describes the findings and recommendations of Triangle Associates, a neutral third
party, who conducted a situation assessment concerning issues related to detection and
quantitation1 approaches and uses in Clean Water Act programs. EPA authorized the situation
assessment to explore the feasibility and design of a stakeholder process to obtain additional
stakeholder input on procedures for the development of detection and quantitation limits and
uses of these limits in Clean Water Act programs.
Situation Assessment Process
Triangle Associates conducted the situation assessment through telephone interviews in October
and November 2004 with representatives of key stakeholder groups that have an interest in
detection and quantitation. Those interviewed included representatives of states, industry,
laboratories, environmentalists, standards-setting and testing organizations, and federal agencies,
including EPA. EPA sent letters to potential interviewees in advance, explaining the purpose of
the situation assessment and encouraging their participation in the interview process. Triangle
Associates scheduled the interviews and sent the questions in advance so the interviewees had
time to consider their responses. Triangle Associates told the interviewees that the themes from
the interviews would be summarized in the report but that no one's name would be identified
with specific comments.
Altogether, Alice Shorett and Vicki King of Triangle Associates conducted 28 interviews. In
seven cases, the interviews included two or three people, bringing the total number of those
interviewed to 37. (See Appendix A for the list of those interviewed.) The telephone interviews
ranged in length from 40 minutes to an hour and a half; most lasted about an hour.
During the interviews, Triangle Associates asked interviewees to describe their history with
detection and quantitation issues, the key technical and policy questions associated with
detection and quantitation, and the technical issues over which there has been disagreement and
how the technical issues affect policy. The remainder of the interviews focused on interviewee
recommendations for a potential stakeholder process, including its goals, purpose, product,
participants, informational needs and other design issues.
This report is based on the results of those interviews.
'Quantitation is the term in common usage among analytical chemists for the act of
quantifying or quantification of volume or concentration.
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Background
EPA approves test procedures (analytical methods) at 40 CFR Part 136 for monitoring of
pollutants in wastewater under the Clean Water Act (CWA). Appendix B to Part 136 contains
the Definition and Procedure for the Determination of the Method Detection Limit (MDL). The
MDL is defined as "the minimum concentration of a substance that can be measured and
reported with 99% confidence that the analyte concentration is greater than zero and is
determined from analysis of a sample in a given matrix containing the analyte." The MDL
definition and procedure were promulgated (i.e., published through rulemaking) on October 26,
1984 (49 FR 43430), and have remained unchanged since promulgation. Many of the analytical
methods promulgated at 40 CFR Part 136 contain MDLs.
Discharger's laboratories use the MDL procedure to perform measurements of pollutants
required to be reported in National Pollutant Discharge Elimination System (NPDES) permits
under section 402 of the Clean Water Act (CWA), and for certifications issued by States under
section 401 of CWA.
Also on October 26, 1984, EPA codified the minimum level of quantitation (ML) in footnotes to
Table 2 in EPA Method 1624 and footnotes to Tables 3 and 4 in Method 1625. In those
footnotes, EPA defined the ML as "the minimum concentration at which the analyte must give a
recognizable mass spectrum and acceptable calibration point." Subsequently, EPA expanded the
definition to "the minimum concentration at which the analytical system must give a
recognizable signal and acceptable calibration point for the analyte." (See, e.g., the Glossary at
the end of EPA Method 1613 and 1631 promulgated at 40 CFR Part 136, Appendix A).
Details of the ML may be defined differently in different methods, owing to the differing nature
of the methods. For example, in Method 1631, the ML is defined as "The lowest level at which
the entire analytical system must give a recognizable signal and acceptable calibration point for
the analyte. It is equivalent to the concentration of the lowest calibration standard, assuming that
all method-specified sample weights, volumes, and cleanup procedures have been employed." In
Method 1677, the ML is defined as "The level at which the entire analytical system shall give a
recognizable signal and acceptable calibration point, taking into account method specific sample
and injection volumes." The ML is the minimum concentration of an analyte that can be
measured and reported with a stated degree of confidence. The ML is contained in some of the
methods promulgated at 40 CFR Part 136.
In 1999, several industry groups filed suit against EPA (Alliance of Automobile Manufacturers,
et al. v. EPA, No. 99-1420, (D.C. Cir.) as a result of EPA revisions of a test used to measure
mercury concentrations at low levels, and in October, 2000, the parties reached a settlement
agreement that required EPA to assess procedures to determine detection and quantitation limits
under EPA's CWA programs by November 1,2004.
On March 12, 2003, EPA published two notices in the Federal Register. One announced the
availability of a draft Technical Support Document that described EPA's reassessment of
detection and quantitation concepts and procedures (68 FR 11791), and the second proposed
revisions to the MDL and ML definitions and procedures (68 FR 11770).
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Many of the 126 comments EPA received in response to the Federal Register notices were
critical of the assessment and proposed revisions. Rather than proceeding with the revisions,
EPA decided to withdraw the proposed rule and contract with a neutral third party to conduct a
situation assessment. The purposes of the situation assessment were to obtain additional input
on technical and policy issues related to detection and quantitation and to explore the feasibility
and design of a stakeholder process. EPA announced this decision in a Federal Register notice
dated September 15, 2004 (69 FR 55547). EPA selected Triangle Associates, Inc. of Seattle to
conduct the situation assessment.
On November 8, 2004, EPA published a notice of document availability in the Federal Register
with EP As revised assessment of detection and quantitation concepts and procedures (69 FR
64704) and published a notice withdrawing the March 12, 2003, proposal (69 FR 64708). The
withdrawal stated that a vast majority of commenters did not favor the proposed revisions and
that EPA planned to work with stakeholders to evaluate one or more of the approaches submitted
in comments on the proposal.
Feasibility
As a result of the interviews conducted for the situation assessment, Triangle Associates finds
that a stakeholder process to address detection and quantitation issues has a good chance to
achieve consensus on revised detection and quantitation approaches and uses in Clean Water Act
programs.
Triangle Associates found unanimity across the stakeholder groups on the pressing need to
address detection and quantitation. All of those interviewed felt that consensus (or majority
support) for revised testing methods would be a significant improvement that would allow the
parties to better meet their needs and interests. Triangle also found high interest in a consultative
process that would bring the key stakeholder groups together to work collaboratively with EPA
to develop revised detection and quantitation methods. In return, the stakeholders are looking to
EPA for a similar commitment to collaboration.
There is optimism that a stakeholder process can be successful because participants will not have
to "start at zero." Those interviewed are aware of, and, in some cases, have helped to develop,
alternative approaches to those currently in regulation and guidance. These approaches are seen
as a good starting point for discussion although some of those interviewed suggest that reaching
resolution will not be quick or easy.
For the stakeholder process to be successful, the parties indicate that the group should reach
agreement, collaboratively, on the group's purpose and product at the outset; EPA alone should
not determine the outcome. Indeed, it is Triangle's opinion that the more collaborative the
process can be and the greater the commitment there is from EPA to use the consensus results of
the process, the more successful the process will be. Success is also contingent on narrowing the
focus to selected top priority issues and achieving results within a year or so.
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There is recognition across the board that the environmental community perspective has been
largely missing from discussions related to detection and quantitation and an acknowledgment
that participation of the environmental community is essential to developing acceptable revised
detection and quantitation methods. There is also a desire to involve in the process state
governments that regulate wastewater through National Pollution Discharge Elimination System
(NPDES) permits. Both stakeholder groups expressed interest in participating.
Agreement on the importance of detection and quantitation approaches that have consensus
support, the willingness to work collaboratively with EPA and other stakeholder groups to reach
this result, the existence of a number of alternative approaches as a starting point for discussion -
all suggest that a consultative process has a significant likelihood to succeed.
Based on our professional experience and judgment, Triangle Associates has identified the
following conditions for a stakeholder process to be successful:
• EPA commits to review and consider consensus recommendations of the stakeholder
process in future revisions of detection and quantitation approaches and uses in Clean
Water Act programs.
• EPA has a structured internal team throughout the process that spans the participating
units and advises the negotiating team who speaks on behalf of EPA.
• A balance of the interests are at the table.
• Independent technical expertise is available to the stakeholder process.
• EPA provides travel to entities that cannot otherwise participate.
• The scope of the discussion and the resulting product can be accomplished in a year or
so.
Categories of Stakeholders
Triangle Associates identified five categories of key stakeholders. We recommend that EPA
invite representatives from each of the categories to participate in the stakeholder process:
• State Government
• Industry
• Wastewater Treatment Plants
• Environmental Laboratories
• Environmentalists
In addition to these categories, Triangle Associates recommends that the following parties serve
as technical resource to the consultative process:
• Other federal agencies that use EPA methods for detection and quantitation or that have
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significant technical expertise on the issues.
• Nationally-recognized experts (academics, researchers) who are effective communicators
on technical issues, as needed.
Key Issues and Interests of EPA and Stakeholder Groups
This section identifies, by entity, the key issues and interests that were identified during the
interview process by EPA and stakeholder groups. (A summary of key issues across groups
follows in the next section.)
US Environmental Protection Agency
EPA is responsible for implementing the Clean Water Act. Section 304(h) of the Clean Water
Act requires EPA to "promulgate guidelines establishing test procedures for the analysis of
pollutants...." EPA approves and publishes analytical methods at 40 CFR Part 136 to support
monitoring and reporting of chemical pollutants under the Clean Water Act.
Based on the interviews, Triangle understands that EPA's key interests relative to detection and
quantitation are to develop procedures and approaches that are:
• Scientifically sound
• Practical, implementable, and cost-effective
• Supported by consensus among key stakeholder groups
If the stakeholder process results in a consensus recommendation, Triangle Associates strongly
recommends that EPA use the results in developing a new rule concerning the MDL.
State Government
EPA delegates responsibility for implementing many water programs to state governments.
State water quality programs regulate discharges of pollutants to surface and ground waters by
writing wastewater discharge permits for sewage treatment plants and industrial discharges.
States use risk-based data to set water quality standards. Some states have used detection and
quantitation specifications in setting permit limits. They use laboratory results to measure
compliance with permits. State environmental laboratory managers also support regulatory and
compliance programs by consulting on the "reasonableness" or achievability of permit limits.
States certify environmental laboratories; they use MDLs as a checklist or required performance
criterion.
States raised concerns that the promulgated methods are versions of technologies that are old.
The old technologies do not allow laboratories to "see" as low as the toxicity level of some
pollutants (for example, PCBs, PAHs, dioxin). States say they need a compliance determination
process for constituents which cannot be "seen" in the laboratories. (Some states are using the
MDL as the permit limit for pollutants that are toxic at levels hundreds of times below what can
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be detected in a laboratory; the regulated community opposes this approach because they say
that data quality at the MDL is "unreliable.")
States also point out that newer technologies have allowed advances in detection and
quantitation that result in lower numbers. They say they would like to adopt the lower numbers
in permits but the regulated community resists this change.
One state raised the fact that regulatory agencies have focused on the EPA priority pollutant list.
In light of the fact that thousands of new chemicals are being produced and introduced into the
waterways, with no systematic investigation of their presence or possible effects, it recommends
developing screening procedures and encouraging states (with funding) to begin looking in a
systematic way for these new chemicals.
States say that EPA has provided guidance on quantitation limits in wastewater but has not
standardized an approach. Consequently, there is variability across the country on how
quantitation limits are set. States say they are vulnerable to challenges by the regulated
community because quantitation is not in statute.
States are also interested in addressing the variability in performance among laboratories that are
a result of differences in laboratory equipment and laboratory analyst training and experience.
States believe it is important to pilot test the approach/es developed through the stakeholder
process to ensure they work as expected before being finalized. Several states said they want the
results of a stakeholder process to be used to revise current regulation; one state said that
regulation would be helpful in many circumstances while, in others, guidance would provide
more flexibility in implementation.
Based on the interviews, Triangle understands that the key interests of states are in developing
detection approaches that
• Are scientifically sound.
• Generate accurate and reliable results in laboratories.
• Will be viable in the vast maj ority of situations that arise, nationwide.
• Are clearly described, with all the detail, so the procedures are not subject to
interpretation.
• Address the variability in results within a laboratory as well as between laboratories.
• Are cost-effective.
Industry
Industry focuses primarily on issues related to quantitation (MLs) because quantitation levels are
typically used in writing permits. (The exceptions, as noted above, are permits set by some
states at the MDL level for constituents like PCBs and dioxin that are toxic at levels far below
what can be detected in laboratories. As noted above, industry opposes permits at the MDL level
because of the variability of data quality at the MDL.) Industry points out that water-quality-
based permit limits for some constituents are very low (often parts per billion), and it is hard to
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measure to that level. The lower the level, the harder it is to measure. Some permits are set so
low that almost any detection becomes reportable as a non-compliance. Industry feels it is often
penalized for measurement variability rather than actual pollution levels. Since every decrease
in permit limits makes treatment and compliance costs rise, this is an important issue for the
regulated community.
Industry notes that MDLs were not created to be used as the cornerstone for regulation and
compliance, but they have increasingly been used for that purpose. Permits are often written in
the context of an MDL achieved by a particular laboratory. If other laboratories cannot achieve
that MDL number, it becomes problematic for a permittee to show it is in compliance.
Industry identifies a significant number of problems with the current MDLs and MLs. They say
these methods:
• Do not deal with interlaboratory and intralaboratory variability.
• Do not provide guidance on what to report if a laboratory gets different results on
different days.
• Are subject to spiking level errors.
• Produce different results depending on the matrix.
• Are ambiguous, which results in different laboratories conducting the MDL differently
and producing results that are not consistent across the country.
• Produce precise results but those results may not be accurate.
• Control for false negatives but not for false positives. The current MDL procedure
results in unacceptably high numbers of "false positives" ("ghosts" that often disappear
in subsequent tests) that can lead to increased requirements and costs for monitoring,
fines for failure to comply with permits, and a bad reputation.
• Lack consistency with international consensus standards which industry believes is
required by the National Technology Transfer and Advancement Act (Public Law 104-
113).
• Lack consistency with other EPA programs (including the Safe Drinking Water Act).
Based on the interviews, Triangle understands that industry's interest is in working with EPA
and other key stakeholder groups to develop revised methods to replace what is currently at 40
CFR Part 136 Appendix B. The revised methods should be scientifically-defensible; should
address the problems listed above, should be practical to implement, result in accuracy, fairness,
and consistency across the county, at a reasonable cost. Industry would like the revised methods
to be consistent with international standards and to be usable across all EPA programs.
Wastewater Treatment Plants
Operators of large municipal wastewater treatment plants echo most of industry's criticisms of
the current MDL and ML methods, mentioned above.
Some cite an additional concern: they say they have data to indicate that the relationship
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between the MDL and ML in EPA guidance does not exist across all analytes. Using a multiple
of the MDL to generate the ML either grossly over- or underestimates the ML.
Given the problems they see with the current MDL methods, the uncertainties about data quality,
and the negative consequences of inaccurate data for regulated entities, wastewater treatment
plant laboratories express concern about signing statements that the data are true and accurate.
Based on the interviews, Triangle understands that the interests of municipal wastewater
treatment plants are in sound science, good statistics, accurate and reliable results, including
assurance and clarity about the quality of the data, and practical procedures that laboratory
analysts can understand and implement consistently. They want the revised approaches to
become codified in a rule that replaces what is at 40 CFR Part 136 Appendix B.
Environmental Laboratories
Environmental laboratories repeat many of the concerns identified above by states, industry and
municipal wastewater treatment plants about data quality and accuracy, false positives and false
negatives, uncertainty about reporting results, and variability in the laboratory, both day-to-day
and over longer periods of time as samples are processed.
One laboratory expressed skepticism that the MDL procedure, which is purely statistical and
mathematical, works even when a laboratory has newer equipment and experienced analysts and
noted that they do not have confidence in the data they generate. The laboratory also said that
neither their customers nor their staff understand what the numbers mean.
Laboratories also say the procedure is arduous to conduct and expensive.
They raised a concern about the way MDLs are being used from a business perspective, as a
marketing tool. The assumption by potential customers is that the lower your MDL, the "better"
your laboratory is. In discussions with potential clients, they are told they must be able to
achieve a certain MDL - specified in a contract - or they do not get the job.
Another concern about the MDL procedure relates to accreditation. It was pointed out that
laboratories have to be able to do the MDL to be accredited. However, if laboratories cannot
agree on how to do the procedure, they ask how laboratories across the country can be
accredited.
Several laboratories express skepticism that a "one-size-fits-all" approach will work. They
believe that more than one approach for detection may be needed for different technologies.
Based on the interviews, Triangle understands that the interests of environmental laboratories are
to reach agreement on MDL procedures that produce accurate data, that are practical and clearly
described so the analysts can carry them out consistently, that are not too arduous, and that are
cost-effective. They say they need to understand and to be able to explain what the numbers
mean to their staffs and their customers. They have an interest in consistency across all EPA
program areas because it would result in efficiencies for their customers.
Environmentalists
As noted above, the environmental community has been largely absent from national discussions
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concerning detection and quantitation methods since the 1970s when a lawsuit by the Natural
Resources Defense Council resulted in an expansion of EPA's list of toxic pollutants of concern
from 65 chemicals to!29 Priority Pollutants. Environmentalists are frequent participants in
policy-level discussions concerning water quality, at the grassroots, regional and national levels
but they have not generally been participants in technical discussions about detection and
quantitation methods and the issues associated with them. However, through interviews with
several scientists at environmental organizations and with consultants who have represented
environmental organizations in the past, we were able to identify the following issues and
concerns from the environmental perspective.
A key concern is the fact that water quality standards for some pollutants (PCBs, PAHs, among
others) are many times lower than levels that can be detected in laboratories using MDL
procedures and current technology. Since permits are typically set at levels that can be "seen" in
the laboratory, environmentalists say it is important - and should be a priority - to provide
incentives to improve the capability of equipment to detect pollutants at lower levels and to have
laboratories invest in the newer equipment. As more sensitive analytical methods and equipment
become available, they say that permit limits should be lowered to reflect the increased
capability. They also want to know how revised detection and quantitation methods would be
applied in the real world of permit writing and compliance.
Since states typically require permittees to use EPA-approved testing methods, environmentalists
would like EPA to take the lead in providing more tools for state and local municipalities to use
to test for effects (such as bioassays in organisms or sediment toxicity tests) and to be able to
require their wastewater treatment plants to use those tools, especially for detecting
bioaccumulatives.
In cases where certain pollutants are toxic at much lower levels than can reliably be detected in a
laboratory, they think it makes sense to have permits identify any detection as a violation. They
also focus on how to control pollutants that are hazardous below the minimum detection limit.
One spokesperson says that a critical first step in addressing detection and quantitation methods
is to find out how states are using detection and quantitation limits in writing permits and the
testing that is required of permittees - to provide a context for addressing MDLs and MLs.
Based on the interviews, Triangle understands that the interests of the environmentalists are in
having protective standards in place that reflect sound science and the potential health and
ecological threats of chemical pollutants and having strong discharge limits in place to let
standards be met. They have an interest in the development of more sensitive equipment that can
detect at lower levels and in having incentives in place for environmental laboratories to invest
in the new equipment. They have an interest in having controls on pollutants to reduce impacts
to people and ecological systems.
Key Issues Across All Stakeholder Groups
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There was broad agreement among stakeholder groups on the need for revisions to the MDL and
ML to address the following issues:
• Need for common set of terms and concepts: Across all stakeholder groups
interviewees said it was essential to reach agreement at the outset of a stakeholder
process on a common set of terms and concepts to be used in the process. This will
include a clear statement of what each term means, an explanation of the statistical and
analytical assumptions on which concepts are based, and clarity on how they are to be
used with respect to detection and quantitation. They see achieving this common set of
terms and concepts as a prerequisite to productive dialogue and to evaluating alternative
approaches to detection and quantitation that have been proposed.
Data quality, reliability, and accuracy: Interviewees indicate that the ambiguities in the
testing procedure to determine the MDL in Appendix B to Part 136 result in inconsistent
results. They point out that when multiple laboratories are given the same task to
perform, different laboratories carry out the procedure differently, yielding different
results. Interviewees point out that the MDL procedure itself produces precise results,
not accurate results. They say the problem of data accuracy is greatest when the
detection levels of the constituents they are testing are very low. For permittees, the
reliability and accuracy of results are key. If test results show they are not in compliance
with permits, they can be fined, required to increase monitoring, and marked for
increased enforcement scrutiny. Permittees feel they are often fined for the variability of
data at the "noise" level, not for actual pollution. They say detection at such low levels
has them and the laboratories chasing "ghosts." Often when tests are repeated, the
"ghosts disappear." Some interviewees question the validity of the testing procedure
itself while others say they do not understand what the numbers mean.
• Reporting: Some stakeholders say excluding "non-detects" skews the data. Laboratories
point out that they have no guidance on what numbers they should report if they perform
the MDL procedure on different days and get different results - which they say can
happen as they run samples over days, weeks and months.
• Variability in MDL results within and between laboratories: Most of those
interviewed pointed to the variability in MDL results within and between laboratories as
a major problem. The variability is a result of differences in equipment, analyst training
and experience, conditions in the laboratories themselves, ambiguities in the procedure,
and the matrix, among other factors. Laboratories with more sophisticated, newer
equipment can achieve lower numbers than laboratories with older equipment. This can
be a problem for a customer that has to change laboratories and the MDL the new
laboratory produces is higher than the MDL achieved by the former laboratory. In such a
case, permittees say that compliance and enforcement officials assume the difference is a
result of increased pollution rather than a difference in laboratory capabilities.
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• Variability among states in setting MLs: States say that EPA has provided guidance
on a variety of methods for determining quantitation limits but has not standardized the
approach. Consequently, there is variability on how quantitation limits are set across the
country. States say they are vulnerable to challenges by the regulated community
because determining quantitation is not in statute.
• Permit limits for constituents with toxicity levels that are below equipment detection
capabilities: A key concern is the fact that water quality standards for some pollutants
(PCBs, PAHs, among others) are many times lower than levels that can be detected in
laboratories using MDL procedures and current technology. States say they need a
compliance determination process for constituents which cannot be "seen" in the
laboratories. Environmentalists focus on a different aspect of this issue. Since permits
are typically set at levels that can be "seen" in the laboratory, environmentalists say it is
important - and should be a priority - to provide incentives to improve the capability of
equipment to detect pollutants at lower levels and to have laboratories invest in the newer
equipment. As more sensitive analytical methods and equipment become available that
allow "seeing" pollutants at lower levels, they say that permit limits should be lowered to
reflect the increased capability.
• •• Reducing permit limits in response to increased equipment capability: States and
environmentalists point out that newer technologies have allowed advances in detection
and quantitation that result in lower numbers. They say they would like to adopt the
lower numbers in permits but the regulated community is resistant to this change.
• Updating old methods to match modern technology: States raised concerns about the
fact that the promulgated methods were designed for technologies that are now old. They
say there is a need to update the methods to respond to the improved capabilities of
modem equipment.
• Uses of the MDLs and MLs: As noted above, some of those interviewed point out that
the MDL was originally intended to be a simplified statistical procedure to show that
laboratories were in good working order, not to be the cornerstone of regulation and
compliance, roles which they have subsequently taken on. The regulated community
objects to having the MDL put in permits because of the variability of data at the MDL
level. Others question the validity of the procedure for generating the ML as a multiple of
the MDL; they say the relationship in the formula does not exist across all analytes.
Environmentalists say they want to know how revised detection and quantitation methods
would be applied in the real world of permit writing and compliance.
• Accreditation: Environmental laboratories have to be able to do the MDL to be
accredited. However, if laboratories can't agree on how to do the procedure, they ask
how laboratories across the country can be accredited.
• One-size-fits-all versus multiple approaches: A number of those interviewed are
skeptical that a single approach will work. They suggest that more than one approach
may be needed for different technologies, perhaps for different analytes. Whatever
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approaches are developed, however, must be procedurally clear so they result in
consistent results across laboratories nationwide.
Practicality and implementability of the current procedures: Laboratories say the
current procedures are hard to understand and to carry out consistently. Looking to the
future., they want to be able to put protocols in place that are clear and produce results
that are reliable. Interviewees say that procedures for detection and quantitation must be
ones that laboratories across the country can carry out in the same way so that they
produce consistent results.
Cost: Laboratories across the nation produce MDLs to become certified and to meet their
customers' needs. They say that carrying out the current procedure at 40 CFR Part 136
Appendix B is time-consuming, arduous, and costly. They and their customers want
testing procedures that produce statistically valid results at reasonable cost.
Goals and Purpose of the Stakeholder Process
In light of this array of issues and concerns, there was broad agreement across all stakeholder
groups that the goals and purpose of the stakeholder process should be to come up with
procedures for determining detection and quantitation limits that are scientifically-defensible,
acceptable to most or all, easy to carry out, and that are practical and cost efficient. The
procedures should produce accurate, consistent, and uniform results. They should become the
nationwide standard for how detection and quantitation are determined.
At noted above, there was unanimity across stakeholder groups that an essential first step to
achieving the goals and purpose of the stakeholder process is to reach agreement on a common
set of terms and concepts so everyone uses the terms and concepts in a consistent way.
There was also broad agreement that once revised approaches have been agreed to, guidelines
for interpretation of the results should be provided so there is clarity around what the numbers
mean and how they should be used.
Product of the Stakeholder Process
Stakeholder groups generally agreed that the product of the consultative process should be
revised detection and quantitation approaches for use in Clean Water Programs that have
consensus support among the stakeholder groups. In addition, there should be clarity on the
interpretation and acceptable uses of the MDLs and MLs in permitting and compliance.
Most of those interviewed said they want the revised MDL procedures to go through rulemaking
and replace the current rule at 40 CFR Part 136 Appendix B. One state was unsure whether the
needs of its water quality program would be better served by having revised procedures in
regulation or in guidance.
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In describing the MDL procedure, stakeholders said they do not want concepts, generalities or a
"bible" that is subject to interpretation. They want the procedures to be clear and practical, with
all the detail, almost like a cookbook. The result, they say, would lead to uniformity and
consistency across all laboratories.
Procedural Issue Related to the Stakeholder Process
If EPA decides to convene a stakeholder process to address detection and quantitation
approaches and uses in Clean Water Act programs, stakeholder groups want EPA to be an active
participant in the process. This is important because EPA is responsible for issuing detection
and quantitation procedures for Clean Water Act programs; it is, therefore, in EPA's interest to
help shape revisions to the detection and quantitation approaches (the stakeholder group's
expected product). Given this stakeholder preference, Triangle recommends that EPA consider
establishing a stakeholder process under the rules of the Federal Advisory Committee Act.
Participation
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Triangle Associates recommends that EPA invite five categories of stakeholders to participate in
the stakeholder process2:
Interested Stakeholders
Affected Stakeholder Roles &
Responsibilities
Possible Groups
State Government
Set water quality standards and
permit limits
Test, monitor and enforce
compliance
Certify laboratories
Experience working to resolve
these issues and geographical
diversity
ASIWPCA
Invited states
Industry
Discharge to water bodies
Discharge to wastewater
treatment plants
Reflect a range of sizes
Reflect different effluents
Inter-Industry Analytical
Group
Wastewater Treatment
Plants
Treat wastewater
Reflect interests of large and
small facilities
AMSA
WEF
Environmental
Laboratories
Conduct water quality analysis
for reporting and compliance
ACIL: Large private
Small private
2The Society for Testing and Materials (ASTM) was identified as an important
participant in a stakeholder process by a number of those interviewed. However, Triangle
Associates recommends that ASTM not have an official seat at the table. It is both likely and
recommended that individuals associated with ASTM participate in the consultative process as
representatives of specific stakeholder groups. Their participation will be particularly valuable
in technical discussions of MDL and ML approaches.
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Interested Stakeholders
Affected Stakeholder Roles &
Responsibilities
Possible Groups
Environmentalists
Are knowledgeable about water
quality testing from a policy
perspective
Are knowledgeable about
technical issues associated with
detection and quantitation
approaches
NWF
Invited technical
consultants and attorneys
who represent
environmental groups in
legal matters
In addition, Triangle recommends that the process have access to two additional categories of
parties that would provide technical expertise to the process:
• Other federal agencies that use EPA methods for detection and quantitation or that have
significant technical expertise on the issues, including US Department of Defense and US
Geological Survey.
Nationally-recognized experts (academics, researchers, specialists) who are effective
communicators on the technical issues.
Representatives of industry, wastewater treatment plants and environmental laboratories have a
long history of working on this issue. They expressed interest and willingness to participate in a
stakeholder process.
States have been less involved in these issues but they also expressed great interest in
participating if they receive assistance with travel costs.
In Triangle's opinion, the biggest challenge will be effective involvement of the environmental
community in the process. Many environmental groups are small, grassroots organizations with
locally-focused agendas; such organizations have not been engaged in discussions about
detection and quantitation. Staff with the appropriate technical backgrounds and organizational
budgets adequate to fund environmental community participation in a stakeholder process are
very limited in number. In light of these facts, Triangle recommends that the process include
individual representatives who have the appropriate backgrounds to provide perspectives from
the environmental community.
a
EPA, as convener of the stakeholder group, will have a seat at the table. It is recommended that
EPA coordinate internally among the Office of Water; Office of Enforcement and Compliance
Assurance; the Office of Research and Development; the Office of Policy, Economics and
Innovation; and the Office of the General Counsel so EPA's representative is able to bring EPA
perspectives to the table.
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Process Design Recommendation
Based on the interviews and our professional judgment, Triangle makes the following process
recommendations.
Scope of Work
The scope of work of the stakeholder group would be to reach agreement on:
• A common set of terms and concepts
• One or more specific approaches and procedures for detection and quantitation for use in
Clean Water Act programs (not all EPA programs)
• Interpretation and uses of the numbers that result from the testing procedures
Federal Advisory Committee
To initiate the stakeholder process, Triangle recommends that EPA consider establishing a
formal advisory committee in accordance with the Federal Advisory Committee Act (FACA).
As required under FACA, all plenary meetings of the stakeholder group would be announced in
the Federal Register and open to the public.
Design
Triangle Associates recommends that the stakeholder group process consist of plenary and
technical work group sessions. Plenary sessions would focus on policy issues, provide direction
and assign tasks to a technical work group, review draft technical work group products, and
reach agreements. Plenary sessions are expected to be in-person meetings.
Between plenary sessions one or more technical work groups are recommended to carry out
tasks assigned at plenary sessions, develop draft products, and report their findings to plenary
sessions for review, further direction, and approval. Technical work groups would reflect a
balance of the interests participating in the stakeholder process. It is expected that the work of
these groups would be accomplished primarily through conference calls.
Facilitation
A process facilitator would manage the overall stakeholder process as well as the plenary
sessions. A technical facilitator would facilitate technical work groups to develop draft products
for review and consideration at plenary sessions.
Recommended Work Flow
Triangle recommends that in the initial plenary session, the committee reach agreement on a set
of organizational protocols, define the problem to be resolved, identify informational needs, and
confirm a schedule of meetings (plenary and technical), hi light of the problem statement, the
group would reach agreement on the goals, purpose, and product of the stakeholder group.
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Members would articulate the interests they bring to the table relative to the problem to be
addressed. They would also hear a brief history of detection and quantitation approaches and
their uses to provide a context for their work.
At this meeting, the committee would be expected to initiate work on a set of topics and issues
that would continue throughout the process. Work would be accomplished both in plenary
session (approximately four to five sessions, one to two days in length) as well as through the
work of a technical work group between plenary sessions. The number of technical work group
meetings and conference calls would depend on the assignments from the plenary sessions. Their
work is expected to focus on the following:
• A set of common definitions and concepts for use in the stakeholder process
• Evaluation criteria for screening alternative approaches
• Evaluating proposed methods for detection and quantitation
• Interpretation and uses of the MDL and ML (detection and quantitation) numbers in the
permitting process
Once the committee has reviewed the alternatives, it would select detection and/or quantitation
procedures to pilot test, to see if the results match expectations. The group will provide direction
on what analytes will be used for the pilot testing, which laboratories will conduct the tests, and
a schedule for carrying out the tests. The group will also agree on what they expect the results of
the pilot testing to show and clarify how the numbers generated through the pilot tests should be
used in reporting and compliance.
After the pilot tests have been conducted, the technical work group would review and analyze
the results relative to the evaluation criteria and prepare a report of findings to present at the next
plenary committee meeting. At this meeting, the plenary committee would be expected to:
• Review the technical work group's assessment and evaluation of the procedures that were
pilot tested and
• Reach consensus on revised approaches and procedures for detection and quantitation.
The group would also be expected to make a recommendation on how quantitation should be
determined - whether it should be linked to the MDL or not - and whether the procedure for
quantitation should be in a rule or in guidance.
If the stakeholder process results in a consensus recommendation on revised approaches and
procedures for detection, Triangle recommends that EPA use the results in subsequent
rulemaking to amend 40 CFR Part 136 Appendix B for detection.
Protocols
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At its initial meeting, Triangle Associates recommends that the stakeholder plenary committee
develop procedural ground rules to govern its discussions. The proposed ground rules would
cover the following:
• Expectations of Committee members
• Composition of the Committee, including access to technical resources; use of a work
group to carry out specific tasks and prepare draft products for Committee review and
consideration
• Decision-making (definition of consensus)
• Responding to media contacts
• Public input at Committee meetings
• Summaries of Committee and work group meetings and their distribution
• Schedule of meetings and planned completion date
• Roles and responsibilities of the facilitators
Conclusion
Triangle Associates, as neutral third party situation assessor, finds that convening a stakeholder
group to address detection and quantitation procedures for use in Clean Water Act programs is
feasible and appropriate. Provided EPA is as collaborative in its approach to this process as
possible and that the conditions of success identified above on page 6 are met, Triangle
Associates believes that the group has a good chance of successfully reaching consensus on
revised testing methods and procedures for detection and quantitation approaches and uses in
Clean Water Act programs.
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Appendix A: List of Interviewees
Dave Akers, Section Manager, Water Quality Protection
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver CO 80246-1530
Bob Avery, Manager, Laboratory Services
Michigan Department of Environmental Quality
3350 North M.L.King Boulevard
Lansing MI 48906
Gary Beers, Permits Unit
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver CO 80246-1530
Dr. Gerald Bowes
Staff lexicologist and Chief, Standards Development Center
State Water Resources Control Board
10011 Street
Sacramento CA 95 812
Richard Burrows
Severn Trent Laboratories
4955 Yarrow Street
Arvada CO 80002
James Christman
Utility Water Act Group
Hunton and Williams
951 East Byrd Street
Richmond V A 23219
Roger Claff
American Petroleum Institute
1220 L Street NW, 9th Floor
Washington DC 20005-4070
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Gary Dechant (Consultant)
Analytical Quality Associates, Inc.
521 l/2 Shanne Street
Grand Junction CO 81504
Dr. Andy Eaton, Lab Director
AWWA Representative to the Joint Editorial Board
Standard Methods for the Examination of Water and Wastewater
Laboratory Director
MWHLabs
750 Royal Oaks Drive, Suite 100
Monrovia C A 91016
Zonetta English, Former ELAB Chair
Metropolitan Sewer District
4522 Algonquin Parkway
Louisville KY 40217
Albert Ettinger
Environmental Law and Policy Center
35 East Wacker Drive #1300
Chicago IL 60601
William T. Foreman, Ph.D., Research Chemist
Methods Research and Development Program
U.S. Geological Survey
National Water Quality Laboratory
MS-407, Bldg. 95, Entrance E3
Denver CO 80225-0046
Geoffrey Grubbs, Office of Water
Director, Office of Science and Technology
US EPA Headquarters
1200 Pennsylvania Avenue, NW, 4301T
Washington DC 20460
Jack Hall
American Society for Testing and Materials - International
Bldg. K1006
2012 Highway 58, Suite 1000
Oak Ridge TN 37830
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Jim Hani on, Office of Water
Director, Wastewater Management
US EPA Headquarters
1200 Pennsylvania Avenue, N.W., 4201M
Washington, DC 20460
Christopher Hornback, Director, Regulatory Affairs
Association of Metropolitan Sewage Agencies
1816 Jefferson Place, NW
Washington DC 20036-2505
Patty Lee, Laboratory Manager
Hampton Roads Sanitation District
PO Box 5911
Virginia Beach VA 23471
Larry LeFleur
Environmental Group, American Chemical Society
National Council for Air and Stream Improvement
PO Box 458
Corvallis OR 97339
Dr. Joe Lowry
USEPA National Enforcement Investigations Center
Denver Federal Center
Building 25 Door E-3,
Denver CO 80225
Tom Maloney, Chief of Quality Assurance
U.S. Geological Survey
National Water Quality Laboratory
MS-407, Bldg 95, Entrance E3
Denver CO 80225-0046
Beth McGee
Chesapeake Bay Foundation
Philip Merrill Environmental Center
6 Hemdon Avenue
Annapolis MD 21403
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Greg Mohrman, Director, National Water Quality Laboratory
U.S. Geological Survey
National Water Quality Laboratory
MS-407, Bldg 95, Entrance E3
Denver CO 80225-0046
Mike Murray
National Wildlife Federation
Great Lakes Natural Resource Center
213 West Liberty Street, Suite 200
Ann Arbor MI 48104
Ken Osbome, Quality Assurance Officer
East Bay Municipal Utility District
375 llth Street
Oakland CA 94623
John H. Phillips
Ford Motor Company and Alliance of Auto Manufacturers
EQO
3 Parklane Blvd, PTW Suite 950
Dearborn MI 48126
Mark Pifher, Director, Water Quality Control Division
Colorado Department of Public Health and Environment
4300 Cherry Creek Drive South
Denver CO 80246-1530
Jim Pletl, Environmental Scientist
Hampton Roads Sanitation District
PO Box 5911
Virginia Beach V A 23471
Bill Ray, Quality Assurance Program Manager
State Water Resources Control Board
10011 Street
Sacramento CA 95812
Steve Saiz, Environmental Scientist
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State Water Resources Control Board
10011 Street
Sacramento CA 95812
Jennifer Samson
Clean Ocean Action
P.O. Box 505
Sandy Hook NJ 07732
Jerry Schwartz
Senior Director, Water Quality Programs
American Forest & Paper Association
1111 19th Street, NW, Suite 800
Washington DC 20036
Mike Shapiro, Office of Water
Deputy Assistant Administrator
US EPA Headquarters
1200 Pennsylvania Avenue, N.W., 4101M
Washington, DC 20460
Mary Smith, Office of Water
Director, Engineering and Analysis Division
US EPA Headquarters
1200 Pennsylvania Avenue, N.W., 4303T
Washington, DC 20460
Barry Sulkin
Tennessee Public Employees for Environmental Responsibility (TN PEER)
4443 Pecan Valley Road
Nashville TN 37218
Nan Thomey
Environmental Chemistry, Inc.
2525 West Bellford, Suite 175
Houston TX 77054
Brad Venner
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USEPA National Enforcement Investigations Center
Denver Federal Center
Building 25 Door E-3,
Denver CO 80225
Bill Yancey
BP Chemicals Senior Regulatory Consultant
150 West Warrenville Road Bldg. 605
Mail Code 5A
Naperville IL 60563
U.S EPA Headquarters Library
Mail code 3404T
1200 Pennsylvania Avenue NW
Washington, DC 20460
202-566-0556
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