Federal Advisory Committee on Detection and Quantitation Approaches and
Uses in Clean Water Act (CWA) Programs (FACDQ)

Virginian Suites

1500 Arlington Blvd.

Arlington, VA 22209

S.S. Virginian Conference Center

Wednesday -- Friday, June 6-8, 2007

**Draft Summary of Meeting #7**

Decisions at Meeting #7

\*Note: Highlighted votes are straw polls and not official votes taken
by the Committee. All votes reflect the order they were considered and
voted on during the meeting.

**[1. Meeting Summary #6]{.underline}**

The FACDQ agrees to approve the summary from Meeting #6, with the
following revisions: Correction of name spellings for Tim Fitzpatrick
and David Piller and removal of "(except California)" from locations
within the document.

***Vote*: 18 Agree, 0 Not Opposed, 0 Disagree** *(6/6/07 AM)*

**[2. Pilot Study Results & Draft Pilot Study Report]{.underline}**

The FACDQ agree to use the Pilot Study results and the May 24, 2007
Draft Pilot Study Report to inform decision-making on choosing a
procedure(s).

***Vote*: 15 Agree, 1 Not Opposed, 2 Disagree** *(6/6/07 AM)*

**NOT APPROVED**

**[3. DQOs Decision]{.underline}**

The FACDQ recommends that EPA Office of Water use the *EPA Guidance on
Systematic Planning Using the Data Quality Objectives Process* in all
Clean Water Act (CWA) programs.

*Straw Vote*: 17 Agree, 1 Not Opposed, 0 Disagree *(6/6/07 PM)*

***Vote*: 17 Agree, 0 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

**[4. Measurement Quality Objective (MQO) Decisions]{.underline}**

**[A. False Positive Rate MQO]{.underline}**

The FACDQ recommends that a ≤ 1% False Positive rate be used for
Detection.

*Straw Vote*: 18 Agree, 0 Not Opposed, 0 Disagree *(6/6/07 PM)*

***Vote*: 17 Agree, 0 Not Opposes, 0 Disagree, 1 Absent** *(6/8/07 PM)*

**[B. Proposed additional language for MQOs -- Future
Methods]{.underline}**

> The FACDQ recommends that during the DQO process, EPA will give
> special attention to assuring the analytical method produces
> comparable results, at or near the QL~nat~, on split samples, analyzed
> in different labs with the same method, and will specifically describe
> the steps taken in the proposed rule.

*Straw Vote*: 16 Agree, 1 Not Opposed, 1 Absent *(6/8/07 PM)*

***Vote*: 14 Agree, 3 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

**[C. MQOs for Quantitation for Promulgated Methods]{.underline}**

> The FACDQ recommends that for promulgated methods in 40 CFR Part 136
> without established MQOs, the initial MQO for Quantitation upon
> implementation of the new quantitation procedure is a specific False
> Negative rate (≤ 5%) to be implemented through a multiplier of the
> Detection Limit (determined by the FACDQ recommended Single Lab
> Procedure for Detection). The Precision and Accuracy MQOs for
> individual analytes/methods would be generated and promulgated, as the
> data to support those MQOs becomes available.
>
> The FACDQ requests that the Technical Work Group establish or
> recommend a procedure to add MQOs to existing methods.

*Straw Vote*: 17 Agree, 0 Not Opposed, 0 Disagree, 1 Absent *(6/7/07
PM)*

***Vote*: 17 Agree, 0 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

> **[D. Limits for QL MQOs for Future Promulgation of New or Updated
> Methods]{.underline}**
>
> The FACDQ recommends the Technical Work Group develop recommendations
> for target MQO bounds for compliance and enforcement that define
> Quantitation. The TWG will bring these recommendations back to the
> FACDQ.

For example:

> A. Precision ≤ 30% RSD

B.  Accuracy (measured as recovery for single determination) = 20-180%

C.  False Negative rate ≤ 10%

D.  Ratio of Accuracy to Precision must be no less than 1.0

> Example: 40% Recovery / 20% RSD = 2 O.K.,
>
> Example: 20% Recovery / 30% RSD = .66 Not Acceptable

*Straw Vote*: 13 Agree, 5 Not Opposed, 0 Disagree *(6/8/07 PM)*

***Vote*: 12 Agree, 5 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

**[E. MQO Bounds]{.underline}**

> The FACDQ recommends that EPA establish quantitative MQO bounds for
> relevant Data Quality Indicators (DQIs) that define Quantitation for
> intended CWA uses. These bounds would be offered for public comment by
> EPA.

*Straw Vote*: 13 Agree, 4 Not Opposed, 1 Disagree *(6/8/07 PM)*

***Vote*: 9 Agree, 7 Not Opposed, 1 Disagree, 1 Absent** *(6/8/07 PM)*

**NOT APPROVED**

**[F. MQOs for Future Promulgation of Methods]{.underline}**

> The FACDQ recommends, for future method promulgation, that target MQOs
> for DQIs, such as Precision, Accuracy, Method Specified Qualitative
> Identification, and False Negative error rates derived from the DQO
> process, be established for Quantitation Limits in Part 136. If the
> target MQOs cannot be met, EPA may promulgate with rationale.

*Straw Vote*: 9 Agree, 9 Not Opposed, 0 Disagree *(6/8/07 AM)*

[]{.mark}

[]{.mark}

> [The FACDQ recommends, for future method promulgation, that target
> MQOs for Precision and Accuracy derived from the DQO process be
> established for QLs in Part 136. In addition, DQIs such as method
> specified quality identification and False Negative error rate would
> be considered. If the target MQOs cannot be met, EPA may promulgate
> with rationale.]{.mark}

[*Straw Vote*: 9 Agree, 5 Not Opposed, 4 Disagree]{.mark} *(6/8/07 AM)*

**[5. Multi/Inter Lab Approaches]{.underline}**

The FACDQ asks the Technical Work Group to develop a recommended process
for determining a QL~nat~.

*Straw Vote*: 18 Agree, 0 Not Opposed, 0 Disagree *(6/8/07 AM)*

***Vote*: 17 Agree, 0 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

The FACDQ recommends that EPA promulgate how QL~nat~ is derived.

*Straw Vote*: 10 Agree, 6 Not Opposed, 2 Disagree *(6/8/07 AM)*

*Straw Vote*: 10 Agree, 7 Not Opposed, 1 Absent *(6/8/07 AM)*

***Vote*: 7 Agree, 10 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

[]{.mark}

[The FACDQ recommends that EPA develop a procedure for establishing a
QL~nat~ using the framework identified by the FACDQ. The Technical Work
Group will develop this framework for FACDQ consideration.]{.mark}

[*Straw Vote*: 6 Agree, 10 Not Opposed, 1 Disagree, 1 Abstained]{.mark}
*(6/8/07 AM)*

[The FACDQ asks the Technical Work Group to develop a recommended
procedure(s) for determining QL~nat~.]{.mark}

[*Straw Vote*: 16 Agree, 1 Not Opposed, 1 Disagree]{.mark} *(6/8/07 AM)*

[The FACDQ recommends that EPA establish after public comment how
QL~nat~ is derived.]{.mark}

[*Straw Vote*: 9 Agree, 4 Not Opposed, 5 Disagree]{.mark} *(6/8/07 AM)*

[]{.mark}

[The FACDQ recommends that EPA develop a Multi Lab Procedure for
establishing a QL~nat~ using the framework identified by the FACDQ. The
Technical Work Group]{.mark} [will develop this framework for FACDQ
consideration.]{.mark}

[*Straw Vote*: 0 Agree, 1 Not Opposed, 13 Disagree, 4 Abstained]{.mark}
*(6/8/07 AM)*

[]{.mark}

[The FACDQ asks the Technical Work Group to develop a recommendation for
a process that considers both Multi and/or Inter Lab Procedures in
developing a QLnat.]{.mark}

[*Straw Vote*: 13 Agree, 3 Not Opposed, 1 Disagree, 1 Absent]{.mark}
*(6/8/07 AM)*

**[6. Recommendations on Procedures]{.underline}**

**[A. The FACDQ recommends the Technical Work Group]{.underline}**
**[continue to develop the specifics for the following:]{.underline}**

[Single Laboratory Detection Limit Procedure]{.underline}

> The ACIL Procedure, with modifications indicated by the Pilot Study
> results and informed by concepts from the Consensus Group and LabQC
> Procedures, is recommended for a Single Laboratory Detection Limit
> Procedure.

***Vote*: 17 Agree, 1 Not Opposed, 0 Disagree** *(6/8/07 AM)*

**[B. The FACDQ recommends the Technical Work Group continue to develop
the specifics for the following]{.underline}:**

[Single Laboratory Quantitation Limit Procedure]{.underline}

> The ACIL Procedure, with modifications indicated by the Pilot Study
> results and informed by concepts from the Consensus Group and Lab QC
> procedures, as well as decisions by the FACDQ at its June 2007
> meeting.

***Vote*: 16 Agree, 2 Not Opposed, 0 Disagree** *(6/8/07 AM)*

**[7. Uses Decisions]{.underline}**

**[A. DL]{.underline}**~nat~

> The FACDQ recommends the Policy Work Group explore the deletion of
> DL~nat~, the possible policy changes to the document, and their
> implications for bringing back to the FACDQ. The Policy Work Group
> will also explore other policy issues not completed at the June 2007
> meeting.

*Straw Vote*: 15 Agree, 3 Not Opposed, 0 Disagree *(6/807 PM)*

***Vote*: 16 Agree, 1 Not Opposed, 0 Disagree, 1 Absent** *(6/8/07 PM)*

B.  **[Uses Document]{.underline}**

> The FACDQ directs the FACDQ Work Groups to use the straw vote
> decisions as a starting point for writing the Uses portion of the
> Final Report and other activities subject to revisions based on a
> final vote to occur later.

***Vote*: 16 Agree, 0 Not Opposed, 0 Disagree, 2 Absent** *(6/8/07 PM)*

-   ***A subscript "nat" is used to designate the nationally-promulgated
    DL or QL -- DL~nat~ or QL~nat~***

-   ***A subscript "lab" is used to designate the laboratory-specific DL
    or QL -- DL~lab~ or QL~lab~***

-   ***A subscript "per" is used to designate the permit-specified QL --
    QL~per~***

-   ***A subscript "st" is used to designate the state-optional DL or QL
    -- DL~st~ or QL***

1.  **Lab-Determined Detection Limits (DL~lab~s) and Quantitation Limits
    (QL~lab~s)**

***Recommendation***: The FACDQ recommends that EPA promulgate the
descriptive single-laboratory procedure(s) recommended by the FACDQ for
individual laboratories to determine their Detection and Quantitation
Limits. The procedure(s) should have the following two capabilities:

a.  Demonstrate the lab's performance at a specified level.

b.  Determine the lowest possible value achievable by the lab.

The FACDQ further recommends that the descriptive procedure(s) replace
the one currently in 40 CFR Part 136 Appendix B.

2.  **Method Promulgation**

***Recommendation***: The FACDQ recommends that when the EPA promulgates
future analytical methods in 40 CFR Part 136, Detection Limits
(DL~nat~s) and Quantitation Limits (QL~nat~s) shall be included with the
methods using the procedure(s) recommended by the FACDQ.

3.  **Verification of Laboratory Proficiency of Detection and
    Quantitation Limits**

***Recommendation***: The FACDQ recommends developing a process for
initial and on-going verification of DL~lab~s and QL~lab~s by
laboratories. This recommendation includes the following guidance:

-   The FACDQ recommended procedure (e.g., what goes into 40 CFR Part
    136 Appendix B) should include on-going verification of DL~lab~ and
    QL~lab~ (either explicitly within the procedure or as an
    "attachment" if the FACDQ chooses to recommend a consensus
    procedure)

-   Meeting MQOs for use

-   Separate initial vs. on-going verifications

-   Strive for feasibility, practicality, representativeness, and
    cost-effectiveness

4.  **Future Updates of Promulgated Analytical Method *DL~nat~s* and
    *QL~nat~s***

***Recommendation***: The FACDQ recommends that EPA periodically review
current capabilities of promulgated analytical methods. The focus of
this review should be on methods where there have been significant
improvements in Detection or Quantitation Limits or on methods that do
not contain DL~nat~s or QL~nat~s. This review would be particularly
important for cases where Detection and Quantitation Limits are critical
to the permit program (e.g., those required for very low WQBELs). EPA
should focus on analytes for which current methods provide poor
performance or do not meet program needs. Using best judgment and where
resources are available, EPA shall update DL~nat~ and QL~nat~ limits on
an on-going basis. EPA should also consider information submitted by
states and/or other qualified third parties. EPA shall publish a Federal
Register Notice announcing the DL~nat~s and QL~nat~s it proposes to
update. Provisions later in this document are for the purpose of
providing EPA with robust data sets for updating and or creating
DL~nat~s and QL~nat~s.

5.  **The FACDQ recognizes that the existence of WQBELs at
    concentrations less than quantitation limits presents a number of
    NPDES-related issues.** These include appropriate approaches for:

-   Calculating monthly averages

-   Determining compliance with daily maximum limits and monthly average
    limits

-   Reporting data, and

-   Appropriate compliance response in light of data uncertainty and the
    need for the protection of public health and the environment.

> To deal with these various issues, the FACDQ recommends a balanced
> response as outlined below.
>
> States that have been delegated the NPDES program from EPA have the
> authority under the Clean Water Act to adopt regulatory provisions
> that are different, but no less stringent than, those required under
> federal regulations. Such provisions, if authorized or not prohibited
> by state law, would operate in lieu of the following recommendations
> and could include a QL~st~ value lower than the nationally promulgated
> QL~nat~. In that case, the QL~st~ applicable under the state program
> would be used for determining compliance, reporting, and other
> applicable requirements.
>
> **A.** [Recommendations for NPDES Permits and Compliance Uses where a
> QL~nat~ exists and for WQBELs at concentrations less than
> QL~nat\ .\ ~]{.underline}If the permitting authority requires use of a
> method more sensitive than the method for which a QL~nat~ exists, go
> to section B:

1)  The FACDQ recommends that a Part 136 DL~nat~ and QL~nat~ determined
    by the procedure recommended by the FACDQ be promulgated for each
    method/analyte combination which shall be the upper bound for lab
    performance. The regulator shall insert QL~per~s in permit or in
    rule as appropriate. The default QL~per~ is the lowest Part 136
    promulgated QL~nat~. The regulator would then consider whether the
    method associated with this QL~nat~ is the most appropriate method
    considering sensitivity, selectivity, and/or matrix effects and
    adjust the QL~per~ accordingly.

2)  The permit shall also contain a condition that the permittee's
    QL~lab~ shall be at or below the QL~per.~ The permit shall require
    permittees to report DL~lab~s and QL~lab~s as determined by the
    procedure recommended by the FACDQ and maintain such information for
    a period of at least five years.

3)  For a list of analytes as defined by EPA, the permittee shall ensure
    that the DL~lab~s and QL~lab~s are determined using the steps of the
    procedure to determine the lowest possible value by the lab for
    setting QL~lab~s and DL~lab~s.

4)  The FACDQ further recommends, for purposes of updating Part 136
    DL~nat~s and QL~nat~s, that EPA require the lab-specific information
    be reported in the Integrated Compliance Information System (ICIS).

5)  Implementation in NPDES Permits:

> **a)** Set average and daily maximum permit limits at the WQBEL.
>
> **b)** Assign zero for values less than the permit QL~per~ when
> determining average and daily maximum discharge levels.
>
> Rationale: While the FACDQ recognizes that values between a given
> laboratory's DL~lab~ and QL~lab~ have a higher level of uncertainty,
> the science suggests they are unlikely to be zero. However, assigning
> a non-zero value where an analyte is detected below the QL~per~ (DBQp)
> would have significant compliance and enforcement implications.
> Therefore, the committee recommends assigning a zero in these cases.

1.  To determine NPDES permit compliance, compare average and daily
    maximum discharge levels, calculated in accordance with item (d.ii.)
    below, to the respective WQBEL.

> d\) A permittee must report to the permitting authority all
> information in the following manner:

i.  When reporting daily maximum sample results:

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i.  For values less than the DL~lab~, report "ND" (not detected) on the
    DMR.

ii. For values greater or equal to the DL~lab~ and less than the
    QL~per~, report "DBQp" (detected below QL~per~) on the DMR.

iii. For values greater than or equal to the QL~per~, report the actual
     values on the DMR.

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ii. When reporting averages:

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a.  Where all values used to calculate an average are less than DL~lab~,
    report "ND" on the DMR.

b.  Where all values used to calculate an average are greater than or
    equal to DL~lab~ but less than QL~per~, report "DBQp" on the DMR.

c.  When values used to calculate an average are a combination of ND and
    DBQp values, report "DBQp" on the DMR.

d.  When any value used to calculate an average is greater than or equal
    to QL~per~, report on the DMR the average as calculated in item
    (5.A.5.b) above.

    i.  Additional reporting requirements:

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a.  The regulator shall require that the permittee report the DL~lab~
    and QL~lab~ (for purposes of updating methods and to determine
    compliance with the conditions of the permit.) The permitting
    authority shall report the DL~lab~, QL~lab,~ and QL~per~ for each
    analyte to EPA in ICIS.

b.  The regulator may require the individual numeric result for any
    value that is greater than or equal to the DL~lab~ and less than the
    QL~per~ be reported in a supplemental report.

c.  The permittees shall maintain individual numeric results for a
    period of at least five years.

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6)  Permits shall include language that triggers additional steps when a
    "significant number of" (to be determined in the permitting process)
    DBQp values are reported. These steps may include additional or
    accelerated monitoring, analytical studies such as matrix studies,
    pollutant minimization programs, or other permit conditions outside
    of the determination of compliance with effluent limitations.
    Reports under such provisions will be done outside of the DMR
    reporting process, except that any additional effluent testing
    performed using approved analytical methods as part of the special
    studies must be reported according to the protocol in (5.A.5.d.iii).

**B.** [Recommendations for NPDES Permits and Compliance Uses for WQBELs
when no QL~nat~ exists:]{.underline}

> **1**) In the absence of QL~nat~, the permitting authority is free to
> establish it's method for determining compliance for analytes that
> have limits/water quality standards at a level lower than that which
> can be detected and/or quantified.
>
> **2)** For a list of analytes as defined by EPA, the permittee shall
> ensure that the DL~lab~s and QL~lab~s are determined using the steps
> of the procedure to determine the lowest possible value by the lab for
> setting QL~lab~s and DL~lab~s.
>
> **3)** The FACDQ further recommends, for purposes of developing Part
> 136 DL~nat~s and QL~nat~s, that EPA require the lab-specific
> information be reported in the Integrated Compliance Information
> System (ICIS).
>
> Note: The FACDQ recommends that EPA reconsider the usefulness of this
> requirement after time.

**7. Other Uses to Consider**

***Recommendation***: The FACDQ tabled the discussion on recommendations
regarding the use of Detection and Quantitation for other uses including
but not limited to the following:

-   ambient monitoring 305(b)

-   pretreatment

-   non-regulatory operational monitoring

-   stormwater monitoring

-   other studies, such as fish tissues or biosolids characterization

-   reasonable potential analysis

-   effluent guidelines development

-   limit derivation

-   development of water quality criteria

**8. Alternative Test Procedures**

***Recommendation***: The FACDQ tabled the option of developing
recommendations to EPA on updating the Alternative Test Procedures (ATP)
program. The FACDQ recommends that the ATP program be updated to be
consistent with recommendations in this document.

9\. Great Lakes Initiative (GLI)

*Recommendation:* The FACDQ recommends that FACDQ recommendations should
not supersede the current GLI provisions. There is no significant
conflict between the anticipated FACDQ recommendations and the GLI.

**[8. Matrix Effects (Use 6.)]{.underline}**

The FACDQ recommends that EPA consider how Matrix Effects impact
Detection and Quantitation. The FACDQ requests that the Policy Work
Group bring back a conceptual recommendation including details to be
considered.

***Vote*: 17 Agree, 1 Not Opposed, 0 Disagree** *(6/8/07 PM)*

**[9. Implementation of the FACDQ Recommendation]{.underline}**

The FACDQ recommends "9. Implementation of the FACDQ Recommendation" be
removed from the Uses Document for consideration by a work group.
However, the importance of these issues related to Uses should not be
separated. A work group of the FACDQ is tasked with bringing
recommendations on the implementation issues back to the FACDQ.

***Vote*: 18 Agree, 0 Not Opposed, 0 Disagree** *(6/8/07 PM)*

Day 1 -- Wednesday, June 6, 2007, 9:00 AM -- 8:00 PM

\*Note: All perspectives offered at the meeting are not reflected in
this summary. However, audio tapes of the entire meeting are available.

**Opening and Introductions**

Richard Reding, EPA Designated Federal Officer (DFO), opened the meeting
at 9:00 AM and welcomed the participants. Alice Shorett, facilitator,
then introduced the facilitation team from Triangle Associates and
initiated a round of introductions of the advisory committee members.
Ms. Shorett and Mr. Reding noted the absence of Committee members Steve
Bonde and David Kimbrough.

Ms. Shorett observed that the committee had made significant progress
over the past two years toward achieving the objectives in the
Committee's charter, which were to "provide advice and recommendations
on approaches for the development of detection and quantitation
procedures and uses of these procedures in Clean Water Act (CWA)
programs." For example, at the committee's December meeting, the
Committee had agreed to a document describing the Uses the Committee
wants a recommended procedure to fulfill. The Committee had also
concluded that it needed more time to fully complete the objectives of
the charter and had requested that the Committee's charter be extended
to allow further progress.

She reported significant Committee work that had occurred since the
December meeting, including

-   A meeting of the ***Pilot Study Analysis Team*** in Seattle in
    January to discuss the findings of the Pilot Study and outline the
    Pilot Study Report and Procedures Report.

-   Eighteen ***Technical Work Group*** meetings focused on the Pilot
    Study Report and Procedures Report; additional work on Measurement
    Quality Objectives (MQOs); and recommendations related to
    procedures, including recommending a modified Single Lab Procedure
    for Detection.

-   Seven *Policy Work Group* meetings, including an in-person meeting
    in Seattle, to further refine the Uses document and to make progress
    on issues regarding Data Quality Objectives (DQOs), implementation,
    and verification.

Ms. Shorett recalled advice at the July 2006 meeting from Ephraim King,
EPA's Director of the Office of Water, who had urged the Committee to
"find the issues you can get close to resolution on." Using this
approach, he said, the Committee had "a wonderful opportunity to find
middle ground and set the future in terms of CWA method decision-making
for the next 20-30 years." Where the Committee could not reach
agreement, Mr. King had urged the members to identify the divergent
opinions and move on.

Ms. Shorett encouraged members to listen carefully and to search for
ways to develop a package that would meet the needs of all the interests
around the table. This would require give and take, she said.

Ms. Shorett then turned the microphone over to Mary Smith of EPA.

**Welcome from EPA**

Mary Smith thanked the Committee members for their hard work. She said
that the Committee's charter had been extended because of the progress
made. Ms. Smith said she hoped the Committee would reach a consensus on
Uses at this meeting and continue to push as far as they could on other
issues so that the FACDQ could wrap up successfully in December.

**Agenda Overview and Grounding**

Ms. Shorett then briefly reviewed the agenda for the three-day meeting
and the Committee's ground rules for consensus decision-making. She
pointed to the Final Report Outline on the wall and encouraged Committee
members to focus on the "gaps" that needed to be filled so that the
Final Report Work Group could begin its task.

The goals for the meeting, she said, were to:

-   Approve December 2006 FACDQ Meeting #6 Summary

-   Agree to use the Pilot Study results and Pilot Study Report to
    inform decision-making on choosing a procedure/s

-   Make fundamental decisions on Method Quality Objectives (MQOs)

-   Recommend procedure(s) or, at a minimum, an approach for making
    final decisions on recommended procedure/s

-   Agree on the Uses document

-   Discuss and provide direction on implementation, Data Quality
    Objectives (DQOs), and verification

-   Make assignments to the Policy Work Group, the Technical Work Group
    and the Final Report Work Group

**Review and Approval of Draft Meeting Summary #6 (December 6-8, 2006)**

Ms. Shorett asked the committee for comments on the summary of Meeting
#6. After agreeing to the changes described in the box below, the
Committee approved the summary of Meeting #6.

**Caucus Reports on Outreach, Approaches, and Expectations for the
Meeting**

Ms. Shorett asked each caucus to report any outreach it had conducted.

**Caucus**

-   The *State caucus* expressed optimism on reaching agreement at this
    meeting and a willingness to agree to disagree if a consensus could
    not be reached.

-   The *Public Utilities caucus* said its approach was to be forward
    thinking, especially in terms of a final recommendation to EPA. It
    encouraged the Committee to step back from the details of the issues
    in dispute and to search for agreement on general concepts and to
    remember that the recommendations the Committee came to needed to be
    understandable, in lay-person's terms, to all of their constituents.

-   The *Industry caucus* echoed many of the previously-stated
    sentiments and said that a measure of the meeting's success would be
    EPA's decision to continue the Committee's work.

-   The *Environmental Community caucus* echoed the need to avoid
    getting caught up in the details and to lose sight of the progress
    made over the past two years.

> Rick Rediske reported that he had recently attended the 50^th^ Great
> Lakes Conference and had heard quite a bit of agreement from
> researchers on the need to have uniform standards for Detection and
> Quantitation as well as MQOs. He said there was real interest among
> scientists on the issues the Committee was addressing.

-   Richard Burrows of the *Environmental Laboratory caucus* told the
    Committee he has discussed the American Council of Independent
    Laboratories (ACIL) procedure with constituents and that he would
    consider this meeting a success if the Committee made the decisions
    necessary to complete a recommendation for a Single Lab procedure.
    He mentioned that a national environmental conference would be held
    at the end of August which the National Environmental Laboratory
    Accreditation Conference (NELAC) and EPA would attend and that
    members of the FACDQ would present in a "Detection and Quantitation"
    section. He emphasized that the meeting would be a great opportunity
    to spread the word about the FACDQ's recommendations. Cary Jackson
    added that he would like to invite two of his constituents, who
    might be impacted by FACDQ recommendations, to the September FACDQ
    meeting.

Mary Smith thanked the caucuses for their statements. She asked the
Committee to be efficient in reaching consensus at this meeting and
encouraged clarity in its recommendations.

**Pilot Study Report**

Robert Wheeler introduced the Pilot Study Report as a summary that was
intended for those who were not on the Technical Work Group. He then
introduced Ken Miller, an independent consultant from CSC Inc., who gave
a brief PowerPoint presentation on the Pilot Study.

Mr. Wheeler then invited Technical Work Group members to comment on the
Report and to answer questions from the FACDQ. Technical Work Group
members offered the following comments and responses to Committee
questions:

*Information about the Pilot Study and the Pilot Study Report*

-   Because of resource and time constraints the Technical Work Group
    had selected specific analytes for testing. The success and failure
    rates of Detection reflected a mixture of 'well behaved' analytes
    and 'tough' ones. If the entire list of known analytes had been
    analyzed, the success rate would have been much higher.

-   The data spread was similar for all analytes tested.

-   Not all labs volunteered to do all of the analytes in method 300.

-   Some of the procedures assumed that labs were at similar performance
    capabilities; but that may not have been the case. The non-normally
    distributed data may have had an affect.

-   All data units were in micrograms per liter. MQOs were quantified by
    % recovery or Relative Standard Deviations (RSD).

-   The Pilot Study Report attempted to sort out the cause of failures,
    whether it was a procedure failure, a method failure, a lab failure,
    or some combination.

*Pilot Study Results*

-   The Pilot Study produced a considerable amount of data that are well
    suited for decision-making.

-   There were significant differences in values among labs for both
    Detection and Quantitation determinations, on the order of several
    orders of magnitude for some test values.

-   Generally speaking, the ACIL Procedure met the Pilot Study MQOs more
    frequently than the other procedures tested*.* The Lowest
    Concentration-Minimum Reporting Level (LC-MRL) did quite well but
    its targets were more stringent than the Pilot Study MQOs; thus, for
    some methods, a limit could not be estimated. The American Society
    for Testing and Materials Standards (ASTM)'s Interlaboratory
    Detection Estimate (IDE) did better on an Inter-Lab basis and the
    Interlaboratory Quantitation Estimate (IQE) came close to target
    RSDs.

After discussion, the Committee considered whether or not to agree to
use the Pilot Study results to inform decision-making on choosing a
procedure. Some Committee members indicated a concern that the results
in the Pilot Study Report had not been thoroughly considered and
evaluated. After discussion, the Committee was not able to reach
consensus on a motion in favor of using the Pilot Study results to
inform decision-making on choosing a procedure.

**Procedures Report**

Mr. Wheeler introduced the Procedures Report as a product that the
Technical Work Group had put a lot of time and energy into and
introduced Brian Englert, Environmental Scientist, U.S. EPA, who gave a
brief PowerPoint presentation on the report. Mr. Wheeler then opened the
discussion and asked Technical Work Group members to answer questions
from the Committee. Technical Work Group members offered the following
comments and responses to Committee questions:

-   The report has a lot of useful information, but it is not complete
    and, therefore, should be considered a work in progress.

-   It is a summary of how the procedures the Committee is considering
    compared against the criteria in the document, "What Do We Need A
    Procedure To Do?"

-   The report did not reflect Technical Work Group consensus.

-   A thorough discussion of procedures had to be limited until the
    Committee agreed on MQOs.

**Technical Work Group Procedures Recommendations**

Richard Burrows summarized the modifications he and a subgroup of the
Technical Work Group had made to the ACIL Single Lab Procedure, the
procedure the Technical Work Group was recommending to the FACDQ as a
Single Lab Procedure for Detection. The modifications were designed to
address the conditions where the ACIL Procedure had not worked well in
the Pilot Study and to incorporate some of the advantages of some of the
other procedures under consideration. These included strengthening the
requirement for the 2x multiplier (which all labs had not followed
reliably in the Pilot Study) and better addressing intermittent blank
contamination.

Technical Work Group members commented that they had considered making
modifications to other procedures but favored a modified ACIL Procedure
as the Single Lab Detection Procedure for the following reasons: it had
the highest probability of success, given time and resource constraints;
it was fairly well-developed; and it met 14 of 15 criteria in the
document, "What Do We Need A Procedure to Do?"

The Technical Work Group indicated that a modified ACIL Procedure was
likely also a good choice for the Single Lab Quantitation Procedure, but
said that the Group had not reached consensus on eliminating the LCMRL
procedure for Quantitation.

**Committee Discussion on Procedures Recommendations**

A member asked whether the ACIL Single Lab or the modified ACIL Single
Lab Procedure addressed what a lab would do when a test value was below
what a lab could positively identify. After discussion, the Committee
requested that the ACIL authors include guidance on how labs should
evaluate data near or above the Detection Limit and how verification
should be addressed within the procedure.

In the discussion, it was noted that while modifications could be made
to the procedure, it was still necessary to know what the target was.
For that to happen, MQOs had to be established; therefore, the MQO issue
needed to be resolved first.

The Committee, therefore, moved to a discussion of Data Quality
Objectives/Method Quality Objectives (DQO/MQOs) before making decisions
on procedure recommendations.

**DQOs/MQOs**

Mr. Wheeler invited Committee member Jim Pletl to start this session by
presenting his proposal to focus and reach agreement on broad DQO
concepts before addressing specific MQO issues. Mr. Pletl said that the
DQO process could be developed in the same way that the Committee had
developed the document, "What Do We Need A Procedure To Do?" He said
that the DQO process could be an iterative one for matching needs with
tools and helping one decide if the performance of a method was adequate
to make a decision. The process could have the following steps: first,
decide what the uses are; second, determine the informational needs,
and, third, decide what tools would meet those uses and needs.

Mr. Wheeler then distributed a Technical Work Group document entitled,
"Role of MQOs in Implementation of FACDQ Candidate Detection and
Quantitation Procedures" (Document# FACDQ7-05). The intent of the
document, he said, was to facilitate Committee discussions and
decision-making related to MQOs. The FACDQ reviewed and discussed the
content of the handout and agreed to discuss both DQOs and certain
aspects of MQOs, such as applying a multiplier to the Detection Limit
and considering minimum bounds.

After discussion, the Committee recommended that EPA follow the DQO
process, a process that presently exists in EPA guidance.

The Committee assignment over lunch was to work in caucuses to review
and discuss the handout and to consider their caucus' positions related
to DQOs and MQOs.

**Lunch Break**

**DQOs/MQOs Discussion (continued)**

The FACDQ reconvened after lunch to discuss DQOs and MQOs. (The MQO
document was projected on a screen before the Committee.) Mr. Wheeler
facilitated the Committee's extended discussion of MQOs for different
uses and appropriate recommendations to EPA. Several caucuses offered
additional options and revised language that were added to the MQO
document.

The Committee then met in caucuses to discuss the MQO document and
proposed language.

After the Committee reconvened, the Committee took a straw poll on two
of the items in the revised MQO document: a recommendation related to
using the EPA Guidance on Systematic Planning using the Data Quality
Objectives Process and a recommendation on a False Positive rate. The
results were as follows:

After the straw votes, the Committee had another extended discussion of
MQO options for different uses, such as future promulgation of methods
and Quantitation for promulgated methods.

At the end of the discussion, it was agreed that the facilitators would
prepare a brief summary of the issues and options for a subgroup to
develop a proposal to present to the Committee on Day 2.

**Public Comment**

There was no public comment.

**Wrap-up and Adjourn for the Day**

Robert Wheeler asked designated subgroup members to arrive at 8:00 AM
the following morning, an hour before the meeting was to convene, to
discuss the revised MQO language recommendation.

Mr. Wheeler briefly reviewed the agenda for the next day and noted that
its focus would be on the Uses document.

Richard Reding, DFO, adjourned the meeting at 8:00 PM.

Day 2 -- Thursday, June 7, 2007, 9:00 AM -- 6:30 PM

**Welcome and Agenda Review**

Richard Reding, DFO, opened the meeting at 9:00 AM and turned the
meeting over to the facilitator, Alice Shorett.

Ms. Shorett reported that the subgroup formed late on Day 1 had met at
8:00 AM to work on a "hybrid" MQO/DQO concept and would present its
proposal later in the day. The first agenda item would be a discussion
of the Uses document.

**Revised Uses Document**

Ms. Shorett recalled that the Policy Work Group had met in Seattle to
further refine the Uses document, focusing specifically on items that
had been presented in gray-scale in the summary of the December 2006
FACDQ meeting. She said that the document reflected a package that
included a balance of elements that were essential to every caucus. She
asked the Committee to keep that balance in mind while working through
the document. She then asked Tom Mugan to review the changes the Policy
Work Group proposed.

Mr. Mugan gave the Committee an overview of the Policy Work Group's
revised Uses document (Document \# FACDQ7-08). He explained the
nomenclature the Group used to define various Detection and Quantitation
Limits, as follows:

-   ***A subscript "nat" denoted a nationally-promulgated DL or QL --
    DL~nat~ or QL~nat~***

-   ***A subscript "lab" denoted a laboratory-specific DL or QL --
    DL~lab~ or QL~lab~***

-   ***A subscript "per" denoted a permit-specified QL -- QL~per~***

-   ***A subscript "st" denoted a state-optional DL or QL -- DL~st~ or
    QL~st~***

Mr. Wheeler then led the Committee through the document, use by use.
Member questions, responses, and comments are presented in the
discussion below each recommendation. In the few cases where the
Committee proposed revised language to a recommendation, those proposals
are shown.

[Note]{.underline}: *While the Committee reached tentative agreements
and conducted several "Straw Votes" for portions of the Uses document,
it did not have time to finalize agreements on the Uses document. The
Committee requested that the Policy Work Group consider certain
modifications to the document and report to the Committee during a
teleconference Committee meeting at some future date. Therefore,
agreements on Uses shown below are tentative and straw votes will need
to be finalized at a future Committee meeting.*

**1.** **Lab-Determined Detection Limits (DL~lab~s) and Quantitation
Limits (QL~lab~s)**

*Comment (Larry LaFleur)*: The intent of the following language:
"Demonstrate the lab's performance at a specified level or at its
reporting level for QL~lab~ and DL~lab~" is to use a procedure that
demonstrates one had met or exceeded QL~lab~.

*Comment (Richard Burrows)*: I think this procedure is not necessarily
to verify the lab's ability to meet a certain limit. It is to
demonstrate what the lab's capability is.

*Comment (Jim Pletl)*: The language should be changed to reflect that.

*Comment (Larry LaFleur)*: It is to do both. It is to demonstrate the
capability of the laboratory or to demonstrate that it can meet or
exceed specified performance criteria like a QL~nat~.

A note was made to the Final Report Work Group that clarity was needed
surrounding the language in, "at a specified level." The FACDQ
tentatively agreed to move forward with the following language.

**2*.* Method Promulgation**

*Question (Nan Thomey)*: Have we decided how QL~nat~ will be determined?

*Response (Tom Mugan)*: It will be method-performance based.

*Question (Larry LaFleur)*: Is the QL~nat~ health-based or
performance-based?

*Response (Tom Mugan):* When EPA nationally promulgates something, they
use a DQO process. Once EPA selects a method, it's what that method can
perform.

*Comment (Zonetta English)*: I am not comfortable with a QL~nat~ without
a specific implementation process.

*Question (Jim Pletl)*: Should the FACDQ recommend to EPA that it
promulgate how it will calculate national values or derive national
limits?

*Response (Chris Hornback)*: We don't want to dictate necessarily how
it's done, but, ultimately, I think people will want to see the
rationale or the process that EPA went through so there's some sort of
common methodology or understanding of the process.

*Response (Larry LaFleur)*: I think, at the bare minimum, we ought to
say that they ought to be promulgated so that they go through rule
making. If the FACDQ can get to guidance to EPA on how that ought to be
done, I think that would be very desirable.

*Question (Nan Thomey)*: Are the QL~nat~s just for new methods or for
existing methods?

*Response (Tom Mugan)*: It is for new and updated methods.

*Comment (Richard Burrows*): I think there are serious problems with the
concept of DL~nat~ and I'd like to suggest we remove DL~nat~ entirely.

After further discussion, Tom Mugan asked the Committee to trust the
work of the Policy Work Group which had gone through similar discussions
and to see that the Policy Work Group had tried to make everything fit
together throughout the document. In other words, the Committee needed
to consider the Uses document as a package and not as separate sections.

The Committee also discussed the advisability of including a Table of
Detection Limit and Quantitation Limit values, as discussed at the
December 2006 Committee meeting, and concluded that it did not want to
proceed with that recommendation. A key consideration was the
difficulties of populating such a table. The Committee then agreed to
remove from the Uses document all language referring to a published
table of limits in a promulgated rule in 40 CFR Part 136.

The FACDQ also agreed to remove the following language from the Uses
recommendations but authorized the Final Report Work Group to consider
it when drafting an introductory paragraph: "These limits will serve to
define the minimum required performance of a laboratory and may assist
in comparing performance of one method to another (facilitating
selection of a method most suitable for a given use), and may define
important thresholds for use in evaluating compliance. (See the section
titled "NPDES Permits and Compliance Uses, Recommendation 5.A & B")."

**3.** **Demonstration of Laboratory Proficiency of Detection and
Quantitation Limits**[^1]

After discussion, the FACDQ agreed to the following changes in this
recommendation: replace "demonstration" with the word "verification;"
replace DL~nat~s and QL~nat~s with DL~lab~s and QL~lab~s; strike the
associated footnote; and add the bullet: "Meeting MQOs for use."

**4. Future Updates of Promulgated Analytical Method *DL~nat~s* and
*QL~nat~s***

The FACDQ agreed to leave this recommendation unchanged with the
understanding that "shall" (...EPA *shall* update DL~nat~ and QL~nat~
limits on an on-going basis.) would remain.

At this point the Committee broke for lunch and to work in caucuses on
three issues:

-   Recommendation "5." in the Uses document, where WQBELs are below
    Quantitation Limits,

-   The subgroup's proposal on DQOs/MQOs, and

-   The Technical Work Group's procedure recommendations, especially
    related to a Multi/Inter Lab Procedure(s).

**[Lunch Break and Caucus Time]{.underline}**

After lunch, the Committee turned to Recommendation "5." and reviewed
it, section by section, with the following results.

**5. The FACDQ recognizes that the existence of WQBELs at concentrations
less than quantitation limits presents a number of National Pollution
Discharge Elimination System (NPDES)-related issues.** These include
appropriate approaches for:

-   Calculating monthly averages

-   Determining compliance with daily maximum limits and monthly average
    limits

-   Reporting data, and

-   Appropriate compliance response in light of data uncertainty and the
    need for the protection of public health and the environment.

> To deal with these various issues, the FACDQ recommends a balanced
> response as outlined below.
>
> States that have been delegated the NPDES program from EPA have the
> authority under the Clean Water Act to adopt regulatory provisions
> that are different, but no less stringent than, those required under
> federal regulations. Such provisions, if authorized or not prohibited
> by state law, would operate in lieu of the following recommendations
> and could include a QL~st~ value lower than the nationally-promulgated
> QL~nat~. In that case, the QL~st~ applicable under the state program
> would be used for determining compliance, reporting, and other
> applicable requirements.
>
> **A.** [Recommendations for NPDES Permits and Compliance Uses where a
> QL~nat~ exists and for WQBELs at concentrations less than
> QL~nat\ .\ ~]{.underline}
>
> The Committee's discussion of this section centered on providing
> further detail if a permitting authority required the permittee to use
> a method that was more sensitive than the one for which there is a
> QL~nat.~ The Committee agreed to add a clarifying sentence.

1.  The FACDQ recommends that a Part 136 ***DL~nat~*** and ***QL~nat~***
    determined by the procedure recommended by the FACDQ be promulgated
    for each method/analyte combination which shall be the upper bound
    for lab performance. The regulator shall insert QL~per~s in permits.
    The default QL~per~ is the lowest Part 136 promulgated QL~nat~. The
    regulator would then consider whether this is the most appropriate
    method considering sensitivity, selectivity, and/or matrix effects
    and adjust the QL~per~ accordingly.[^2]

*Comment (Tom Mugan*): I'm concerned that there is no legal way to
implement the QL~per~.

*Question (Tim Fitzpatrick)*: What value would a regulator pick? If we
have a pollutant for which there is an existing sensitive method but no
QL~nat~ established or no ML established and an instrument vendor or EPA
promulgates a method; they're required to put a QL~nat~ in their newly
promulgated method. It's well above the existing method. The regulator
doesn't want to use the new method but how does he come up with a number
to put in the permit? How does he justify that?

*Response (Chris Hornback)*: A couple of meetings ago we built a lot of
intentional flexibility in here for the states to do essentially what
they wanted if this approach didn't work for them. Doesn't the language
above "A" or elsewhere in the document give states the ability to do
something different?

After discussion, it was agreed that there was a need to provide some
flexibility to the states on where the QL~per~ would be shown, so an
option of including it in a rule was agreed to for Committee
decision-making. The Committee discussed providing flexibility to the
regulator to consider if the QL~nat~ was the most appropriate method and
agreed to include it in their recommendation.

**2)** The QL~per~ shall be applicable for the term of the permit unless
the regulator reopens and modifies the permit. The permit shall also
contain a condition that the permittee's QL~lab~ shall be at or below
the QL~per.~ The permit shall require permittees to report DL~lab~s and
QL~lab~s as determined by the procedure recommended by the FACDQ and
maintain such information for a period of at least five years.

*Comment (Barry Sulkin)*: Permits can go on more than five years, even
up to ten and twenty years. More than half of the permit challenges I
work on are more than five years old, because they're problematic. If
you're trying to get consistency across the board, you don't want the
permits of competing industries to change at varying intervals: one,
five, or twenty years apart.

*Comment(Barry Sulkin)*: We're not directing how to interpret the data
like we are for permits. When you take a sample above and below a pipe,
sometimes it's a permit requirement and sometimes it's done by an
environmental group. It is the same body of water, but for different
uses. Do you want two different Detecion Limits and Quantitation Limits
to apply? Or do you always even know which one you're doing when you
fill up that bottle of water? What I would like to see is that EPA set
national standards with Detection Limits and Quantitation Limits and
tell the states to get consistent.

There was considerable discussion regarding the appropriate
recommendation given the variability in the life of permits*.* The
Committee agreed to remove sections of this recommendation that relate
to the life of the permit to resolve this issue.

1.  The permittee shall ensure that the DL~lab~s and QL~lab~s are
    determined using the steps of the procedure to determine the lowest
    possible value by the lab for setting QL~lab~s and DL~lab~s.

The Committee agreed to re-number 4) to 3) and include the language
below. The Committee additionally had a substantial discussion related
to whether or not the lab would need to test for the lowest DL~lab~ and
QL~lab~ s. Some of that discussion was as follows:

*Comment (Tom Mugan)*: We need to protect the environment. I feel pretty
strongly that we should be pushing the technology for these nasty
pollutants.

*Response (Richard Burrows)*: The permit ought to be what drives how
protective we are with the environment.

*Response (Nan Thomey)*: My understanding of the intent of this was for
the lab to make some attempt to be measuring as low as it can.

*Comment (Tim Fitzpatrick)*: I think we envisioned a double-tiered
procedure or set of procedures: one that allows you, if you need to, to
determine your lowest Detection and Quantitation Limit and another one
to verify or demonstrate that you can hit a particular targeted
Detection Limit or Quantitation Limit. Which one you follow depends on
your needs.

After discussion, the Committee agreed that for situations where QL~nat~
does exist and for situations where the WQBEL is below the QL~nat,~ it
would be important to determine the lowest possible value.

The Committee then discussed reporting results to the Integrated
Compliance Information System (ICIS) in "5.A.5."

2.  The FACDQ further recommends, for purposes of updating Part 136
    DL~nat~s and QL~nat~s, that EPA require that lab-specific
    information be reported in the Integrated Compliance Information
    System (ICIS).

The Committee readily agreed to this language, determined a new
numbering as shown in the Action below with the proviso that it be
considered in light of the whole document.

The Committee then discussed its recommendations for NPDES permits and
compliance uses for WQBELs when QL~nat~s do exist.

**6)** Recommendation for NPDES Permits and Compliance Uses for WQBELs
when QL~nat~s do exist:

The Committee determined that the title did not appropriately identify
what was intended in this section. The Committee therefore agreed to
rename the section, "Implementation in NPDES Permits" to more
appropriately identify the purpose of this section."

The Committee then reviewed the remaining sections of the Uses document;
the specific actions associated with each section are indicated below.

a.  Set average and daily maximum permit limits at the WQBEL.

b.  Assign zero for values less than the permit QL~per~ when determining
    average and daily maximum discharge levels.

> Rationale: While the FACDQ recognizes that values between a given
> laboratory's DL~lab~ and QL~lab~ have a higher level of uncertainty,
> the science suggests they are unlikely to be zero. However, assigning
> a non-zero value where an analyte is detected below the QL~per~ (DBQp)
> would have significant compliance and enforcement implications.
> Therefore, the committee recommends assigning a zero in these cases.

The Committee agreed that the rationale was important but that it might
more appropriately be located in the Final Report.

c.  To determine NPDES permit compliance, compare average and daily
    maximum discharge levels, calculated in accordance with item (ii.)
    above, to the respective WQBEL.

The Committee agreed to determine NPDES permit compliance, compare
average and daily maximum discharge levels, calculated in accordance
with item (ii.) above, to the respective WQBEL, but changing the wording
to accurately reflect the location of the section referred to.

d.  A permittee must report to the permitting authority all information
    in the following manner:

    i.  When reporting daily maximum sample results:

```{=html}
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a.  For values less than the DL~lab~, report "ND" (not detected) on the
    Daily Monitoring Report (DMR).

b.  For values greater or equal to the DL~lab~ and less than the
    QL~per~, report "DBQp" (Detected Below QL~per~) on the DMR.

The Committee agreed that Detected Not Quantified (DNQ) might not be the
appropriate term for results below QL~per~, and agreed to indicate a
need for EPA to develop some term that would indicate it was detected.

c.  For values greater than or equal to the QL~per~, report the actual
    values on the DMR.

    i.  When reporting averages:

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```
a.  Where all values used to calculate an average are less than DL~lab~,
    report "ND" on the DMR.

b.  Where all values used to calculate an average are greater than or
    equal to DL~lab~ but less than QL~per~, report "DBQp" on the DMR.

c.  When values used to calculate an average are a combination of ND and
    DBQp values, report "DBQp" on the DMR.

d.  When any value used to calculate an average is greater than or equal
    to QL~per~, report on the DMR the average as calculated in item
    (5.A.5.b) above.

The Committee discussed whether or not there was a need to include
recommendations for requiring a DL~nat~ and, if not, was there still a
need to include reference to DL~lab~. After discussion, the Committee
agreed to retain DL~lab~ until other decisions were made.

i.  Additional reporting requirements:

```{=html}
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```
a.  The regulator shall require that the permittee report the DL~lab~
    and QL~lab~ (for purposes of updating methods and to determine
    compliance with the conditions of the permit.). The permitting
    authority shall report the DL~lab~, QL~lab,~ and QL~per~ for each
    analyte to EPA in ICIS.

b.  The regulator may require the individual numeric result for any
    value that is greater than or equal to the DL~lab~ and less than the
    QL~per~ be reported in a supplemental report. Potential uses would
    be to determine reasonable potential and for public knowledge.

The Committee agreed that "shall" was the appropriate verb in iii.a.,
which would require the permittee to report the DL~lab~ and QL~lab~ (for
purposes of updating methods and to determine compliance with the
conditions of the permit). The permitting authority would additionally
be required to report the DL~lab~, QL~lab,~ and QL~per~ for each analyte
to EPA in ICIS.

The Committee also agreed that there was no need to specify what numeric
results reported in a supplemental report would be used for; therefore
the Committee agreed to remove the sentence that specified the uses of
such information

c.  The permittees shall maintain individual numeric results for a
    period of at least five years.

There were no changes to this part of the recommendation.

The Committee moved to Section 5.A.5 (formerly, Section 5.A.7) which
remained essentially the same: Permits shall include language that
triggers additional steps when a "significant number of DBQp values" (to
be determined in permitting process) are reported. These steps may
include additional or accelerated monitoring, analytical studies such as
matrix studies, pollutant minimization programs, or other permit
conditions outside of the determination of compliance with effluent
limitations. Reports under such provisions will be done outside of the
DMR reporting process, except that any additional effluent testing
performed using approved analytical methods as part of the special
studies must be reported according to the protocol in (5.A.5.d.iii).

The Committee then moved to Section 5.B, recommendations when no QL~nat~
exists.

**B.** [Recommendations for NPDES Permits and Compliance Uses for WQBELs
when no QL~nat~ exists:]{.underline}

> **1**) In the absence of QL~nat~, the permitting authority is free to
> establish its method for determining compliance for analytes that have
> limits/water quality standards at a level lower than can be detected
> and/or quantified.
>
> **2)** For a list of analytes as defined by EPA, the permittee shall
> ensure that the DL~lab~s and QL~lab~s are determined using the steps
> of the procedure to determine the lowest possible value by the lab for
> setting QL~lab~s and DL~lab~s.
>
> After discussion of 5.B.2, the Committee agreed that "shall" required
> was preferable to "could" require, in part because EPA strongly
> supported requiring such reporting. (In the Action below, the approval
> of the B.2) refers to the "shall" language.
>
> **3)** The FACDQ further recommends, for purposes of developing Part
> 136 DL~nat~s and QL~nat~s, that EPA require the lab-specific
> information be reported in the Integrated Compliance Information
> System (ICIS).
>
> Note: The FACDQ recommends that EPA reconsider the usefulness of this
> requirement over time.

The Committee discussed concerns about setting up a system without the
ability to discontinue a practice if it no longer generated useful
information. The Committee agreed to include an evaluation of the value
of collecting this information in the future.

6.  **Matrix Effects**

The Committee felt that including a recommendation on Matrix Effects
would be important but decided to postpone specific recommendations
until the next day.

**7. Other Uses to Consider**

***Recommendation***: The FACDQ tabled its discussion of recommendations
regarding the use of Detection and Quantitation for other uses including
but not limited to the following:

-   ambient monitoring 305(b)

-   pretreatment

-   non-regulatory operational monitoring

-   stormwater monitoring

-   other studies, such as fish tissues or biosolids characterization

-   reasonable potential analysis

-   effluent guidelines development

Jim Pletl proposed the following additional items:

-   limit derivation

-   development of water quality criteria

The Committee agreed to these additions.

**8. Alternative Test Procedures**

***Recommendation***: The FACDQ tabled the option of developing
recommendations to EPA on updating the Alternative Test Procedures (ATP)
Program. The FACDQ recommends that the ATP Program be updated to be
consistent with recommendations in this document.

*Comment* (Cary Jackson): I recommend that we make the recommendation
that the ATP Program needs to be updated to reflect any changes that are
promulgated.

The Committee agreed that it could not address this issue in more detail
because of time constraints, but it also agreed that the Committee
should provide direction to EPA on making the ATP process consistent
with other Committee recommendations.

The Committee agreed to table discussion of the need for Dl~nat~ in the
document until the next day.

**DQO/MQOs Continued**

Mr. Wheeler then reopened the discussion of MQOs from the previous day,
referring members to the subgroup's draft MQO document.

The first related to MQOs for Quantitation for Promulgated Methods.
Issues discussed included the needs of the procedure development work
group for a defined False Negative rate and a multiplier for initial
implementation of the procedure. After further discussion and edits, the
FACDQ took a straw vote on the following MQO decision.

Mr. Wheeler then called on Richard Burrows who reported the progress he
and his subgroup had made on developing a Single-Lab Procedure and their
need for Committee decisions on MQOs to enable them to develop a
procedure.

Richard Burrows then suggested that a group of people meet face-to-face
to develop and finalize the Single Lab Procedure that would meet the
needs of the Committee.

*Question (Tim Fitzpatrick)*: Do you anticipate developing a procedure
that would take other MQOs into account as they become available?

*Response (Richard Burrows)*: Yes.

*Question (John Phillips)*: Do you need to know the floor for the MQOs?

*Response (Richard Burrows)*: Probably; we could use guidance from the
group on that.

*Comment (Tim Fitzpatrick)*: I think the Technical Work Group could go
away and develop a proposal for a detection and quantitation procedure
that would include some constraints that make sense in the realm of what
constitutes Quantitation and bring it to the FACDQ in order to find out
if it is acceptable or not.

*Question (Cary Jackson)*: Did we agree on what the elements of the
multiplier are or are we asking the Technical Work Group to identify
what those elements are?

*Response (Richard Burrows)*: A multiplier will be based upon the 5%
False Negative rate that we've identified as desirable.

*Comment (John Phillips)*: You need to know what the Detection Limit is,
as a start, for the multiplier. You need to know what the precision and
accuracy are, too. You need to know those three elements and that you're
targeting a 5% False Negative rate.

**Public Comment**

There was no public comment.

**Wrap-up and Adjourn for the Day**

Robert Wheeler congratulated the Committee on the significant progress
it had made. He then briefly reviewed the agenda for the next day,
noting the decisions the Committee needed to make. He also reported that
Ephraim King, Director of the Office of Water, and Michael Shapiro,
Deputy Assistant Administrator for the Office of Water, would join the
Committee over lunch.

Alice Shorett asked the Final Report Work Group to meet at 7:15 AM the
following morning for a check-in discussion prior to the FACDQ meeting.

Richard Reding, DFO, adjourned the meeting at 6:30 PM.

Day 3 -- Friday, June 8, 2007, 8:00 AM -- 3:00 PM

**Welcome and Agenda Review**

Richard Reding, DFO, opened the meeting at 8:00 AM and turned the
meeting over to the facilitator, Robert Wheeler.

Mr. Wheeler welcomed the Committee to the final day of the meeting and
highlighted what the Committee needed to accomplish during the day. To
assist decision-making, he pointed to three new documents had been
distributed at their seats: a revised agenda for the day, a proposed
agreement on MQOs (drafted by a subgroup and refined to reflect
discussions on Day 2), and a document that addressed Matrix Effects.

**MQO Agreements**

Mr. Wheeler reviewed the proposed MQO agreement and reviewed the results
of the straw poll on MQOs the previous day. The Committee reviewed the
options in the document, made edits to some of them, and took straw
votes on the revised options.

[Note]{.underline}: *Brief summaries of Committee discussions precede
the Actions reported below.*

In the following two Actions, the Committee developed language that
addressed "target" MQOs for Precision and Accuracy that would be derived
from the DQO process. The group was also considered other DQIs and a
proposal to allow EPA to promulgate a method even if that method could
not meet the target MQOs. While the first proposal was not approved,
subsequent modifications allowed the Committee to reach agreement.

The Committee then moved on to a consideration of setting limits or
bounds for MQOs when considering quantitation.

*Question (Jim Pletl)*: What are the reasons that we would *not* want a
limit on MQOs in Clean Water Act programs?

*Comment (Michael Murray)*: In Seattle we talked about the issue of new
chemicals that may be developed and that may be of concern. We are just
starting to look for new methods to be developed to address this issue.
If you've got moderately tight MQOs, it may be difficult to meet those
for this new method, yet, the chemical is still out there.

*Response (Jim Pletl)*: I personally do not think the FACDQ should send
a message that it is acceptable to use data of *any* quality in Clean
Water Act programs. I'd be very concerned if we could not at least reach
consensus on that. There still has to be, I would hope, some limit or
bound on the quality of data that is used to make decisions in Clean
Water Act programs.

After some discussion the Committee voted but did not reach consensus on
the proposal.

Mary Smith told the Committee that she had disagreed with this proposal
because it was an important issue that EPA needed to discuss internally.
The Committee then considered and approved in a straw vote the following
alternative approach:

Mr. Wheeler reported that he had spoken with Richard Burrows briefly
during the break and that Mr. Burrows had said the Committee's decisions
were adequate for his Single Lab Procedure subgroup to proceed and
finalize a procedure recommendation.

**Multi/Inter Lab Procedure Discussion**

Mr. Wheeler called on Larry LaFleur to begin the Committee's
consideration of the Multi/Inter Lab Procedure issue. Mr. LaFleur
indicated that the Industry caucus' concerns related to two aspects of
data comparability: at the Quantitation level when two different labs
run the same sample and on use of the same method for a specific
analyte. He said if these issues were addressed in some way, the
Industry caucus would endorse a Multi Lab Procedure over an Inter Lab
Procedure. This made sense because an ACIL Modified Procedure was the
likely choice for Single Lab Detection and Quantitation determinations,
and it did not seem practical to have a totally separate Inter Lab
Procedure. He then proposed a recommendation, to be added to the section
on MQOs that was discussed, revised and then the subject of a straw
vote, which is as follows:

Given approval of the proposal, Mr. LaFleur said Industry would like for
the Committee to reach agreement on a framework for a Multi Lab
procedure that it could ask EPA or the Technical Work Group to flesh
out. However, a few Committee members indicated that they did not want
to jump to a Multi Lab approach. This led to Committee consideration of
a series of proposals that progressed from a Multi Lab approach to a
broader focus on how to determine the QL~nat~.

Rather than recommending a specific approach for determining QL~nat~,
the Committee focused instead on developing a process for determining
QL~nat~ and considering how the QL~nat~ would be implemented. After
straw votes on several proposals that were not approved, Committee
members reached agreement on requesting that the Technical Work Group
recommend a process for determining a QL~nat~ and recommending that EPA
promulgate how the QL~nat~ would be derived.

**Technical Work Group Recommendations on Procedures**

Mr. Wheeler introduced the Technical Work Group's document,
Recommendations on Procedures (Document# FACDQ 7-06), and pointed out
the Group's qualification about the document:

> *"Agreement was reached on the following recommendations at a
> Technical Work Group Meeting. Not all members were present (although
> all caucuses were represented) and there was insufficient time to
> obtain further input and consensus from Technical Work Group members
> not at the meeting."*

Committee members asked questions and discussed the results, after which
the Committee agreed it was premature to vote on a specific procedure.
It voted, instead, to ask the Technical Work Group to continue to
develop the ACIL modified procedure for Single Lab Detection and
Quantitation.

Regarding a Single Lab Quantitation Limit Procedure, Larry LaFleur said
he did not want a multiplier approach for future methods because
Industry felt that was largely the problem with the current approach. He
said he also thought the lab community would not welcome having
different approaches for existing and future methods, that is, a
multiplier approach for existing methods but not for future methods.
Richard Burrows said he saw it not as two different procedures but as
one procedure with additional steps.

Tim Fitzpatrick commented that he thought the procedure could be written
in such a way that would allow other MQOs to be a consideration in
determining the Quantitation Limit.

**Revised Uses Document**

Mr. Wheeler led the Committee through a discussion of the Revised Uses
document, beginning where the Committee had ended the previous day.

Mr. LaFleur repeated his recommendation to drop DL~nat~ and all
references to it from the document because, if DL~nat~ were not going to
be used, Industry should not be required to collect data for it. After
discussion, Tom Mugan proposed that the Policy Work Group investigate
the changes that would need to be made to the document to remove
DL~nat~. After more discussion the Committee reached agreement on the
following motion:

**Discussion with Michael Shapiro and Ephraim King**

Mary Smith introduced Ephraim King, Director of the Office of Science
and Technology, and Michael Shapiro, Deputy Assistant Administrator for
the Office of Water and led a round of introductions of all the FACDQ
members.

Mr. Shapiro and Mr. King both thanked the Committee for its hard work
and emphasized the Agency's appreciation for the FACDQ' s efforts and
progress. Mr. King acknowledged how much "time and effort" it takes
reach agreement on big principles and then to convert those agreements,
through constructive give and take, into products that we can all be
proud of and live by in the end.

Mr. King said that he, as well as others at the table, were in the
business of trying to get things done. He committed that he and Mr.
Shapiro would try their best to translate the balance, the advice, and
the recommendations the Committee developed into a useful regulatory
federal context."

*Question (Tim Fitzpatrick)*: Based on the input we've had from the
Drinking Water and the Solid Waste Programs, I think they are tagging
along with this process and following it closely, but I wonder if you
could give us some sense as to whether or not we might end up with
laboratories having to use different procedures or where the Agency is
heading, with the outcome of this process.

*Response (Ephraim King)*: If we reach agreement here, we're certainly
committed to see this through on the Clean Water Act side. We can do as
much as we can to educate the rest of the Agency about the benefits of
this approach. However, there are stakeholders in those other processes
that aren't at this table. It may be a long while before the Agency
finds itself in agreement that it would be better to have one set of
procedures across the board. If we are successful in this area, we
create a strong message and a signal to the rest of the Agency. And I
think stakeholders who have the kinds of concerns and problems that
brought us together to address will begin to create some external
interest in moving those programs towards a review of their activity as
well. I think you'll create an opportunity to create movement in that
area across the Agency. However, I don't want to over promise because I
know how hard it is to make progress.

The Committee then adjourned for lunch and further discussion with Mr.
King and Mr. Shapiro.

**Lunch Break**

**Matrix Effects**

After lunch, Mr. Wheeler called on Larry LaFleur to present his proposal
on Matrix Effects, as follows:

The FACDQ recommends EPA develop and promulgate procedures for:

1.  The level of validation of proposed part 136 procedures to document
    and assess applicability of the procedure to different matrix types.

2.  Procedures for demonstrating a matrix effect.

3.  Procedures for determining a matrix specific Detection and
    Quantitation Limits

EPA should strive for feasibility, practicality and cost-effectiveness.

Because of time constraints, the Committee agreed to assign this
proposal to a work group to develop a recommendation for the September
meeting; the assignment was to identify the details that should be
considered, but not to develop those details. After discussion, the
committee reached agreement on the following recommendation:

**Great Lakes Initiative (GLI)**

Mr. Wheeler then turned the Committee's attention to Use "10. GLI."
After discussion, especially around the use of the word "significant,"
the Committee took a final vote, as follows:

**Implementation of the FACDQ Recommendation**

Nan Thomey suggested that the implementation portion of the Uses
document be pulled because it did not characterize a Use of the
procedure. The Committee reached agreement on a proposal for a subgroup
of the Policy Work Group to bring recommendations on implementation to
the FACDQ at its September meeting.

**Final Votes on Actions**

After a discussion of the appropriate approach for converting "straw
votes" to "final votes," the Committee decided to go through the straw
poll votes, one by one, to finalize its decisions. The Committee
completed final votes in the following order:

Mr. Wheeler then introduced the following proposal to the Committee:

> "The FACDQ acknowledges that at the June, 2007 meeting, it reached the
> following consensus recommendations regarding the uses of detection
> and quantitation approaches in Clean Water Act programs with the
> understanding that the FACDQ will review a more complete Uses package
> after further work by the Policy Work Group."

The Committee discussed the proposal. Because many Committee members
wanted to evaluate the implications of deleting DL~nat~ before taking a
final vote on the Uses document, the Committee developed and reached
agreement on the following alternative proposal:

The Committee requested that a teleconference meeting be held before the
September 2007 FACDQ meeting which would allow the Committee to make
final recommendations on the Uses document, after the Policy Work Group
had been able to make appropriate changes.

**Public Comment**

There was no public comment.

**Wrap-up and Adjourn for the Day**

Robert Wheeler briefly reviewed the following assignments for the
Technical Work Group, Policy Work Group, and Final Report Work Group:

**[Technical Work Group Assignments]{.underline}**

-   Review and Make Recommendations on Definitions

-   Further Develop Procedure(s)

    -   Single Lab Detection Limit

    -   Single Lab Quantitation Limit

    -   Multi/Inter Lab

-   Finalize an Intermittent Blank Contamination Recommendation

-   Develop credentials for potential peer review of Pilot Study Report

-   Establish or recommend a procedure for adding MQOs to existing
    methods

-   Develop recommendations for target MQO bounds for compliance and
    enforcement that define Quantitation.

-   Develop a recommended process for determining a QL~nat~

**[Policy Work Group Assignments]{.underline}**

-   Address Implementation

-   Address Verification

-   Address DQOs

-   Provide guidance on Matrix Effects

-   Prepare introductory language in the Uses document for QL~per~

-   Explore the deletion of DL~nat~ and the possible policy changes and
    implications of removing it from the document, and bring this
    information back to the FACDQ

-   Explore other policy issues not completed at the June 2007 meeting

**[Final Report Work Group]{.underline}**

-   Develop Final Report

**[Closing]{.underline}**

Mr. Wheeler and Ms. Shorett thanked the Committee for its hard work.
They noted that the next FACDQ meeting would be a teleconference meeting
in late July or early August. They also confirmed the schedule of
remaining Committee meetings in 2007:

-   September 19-21

-   December 5-7

Both meetings are to be held at the FDIC in Arlington, VA.

Richard Reding, DFO, adjourned the meeting at 3:00 PM.

**MEETING ATTENDANCE**

**Committee Member Affiliation**

*Environmental Community*

> Michael Murray National Wildlife Federation
>
> Richard Rediske Grand Valley State University
>
> Barry Sulkin Environmental Consultant

*Environmental Laboratories*

> Richard Burrows Severn Trent Labs
>
> Cary Jackson HACH Company
>
> Nan Thomey Environmental Chemistry, Inc

*Industries*

> Roger Claff American Petroleum Institute
>
> Larry LaFleur National Council for Air and Stream Improvement
>
> John Phillips Alliance of Auto Manufacturers (Ford Motor Co.)
>
> David Piller Exelon Corp.

*States*

Dave Akers Colorado Dept of Public Health and Environment

> Bob Avery Michigan Dept of Environmental Quality
>
> Timothy Fitzpatrick Florida Dept of Environmental Protection
>
> Thomas Mugan Wisconsin Dept of Natural Resources

*Public Utilities*

> Zonetta English Louisville/Jefferson Co Metropolitan Sewer District
>
> Chris Hornback National Association of Clean Water Agencies
>
> Jim Pletl Hampton Roads Sanitation District

*EPA*

Mary Smith US Environmental Protection Agency

**Designated Federal Officer**

Richard Reding US Environmental Protection Agency

**Invited Speakers/Participants**

Brian Englert US Environmental Protection Agency

Ephraim King US Environmental Protection Agency

Michael Shapiro US Environmental Protection Agency

Kenneth Miller CSC, Inc.

**Facilitators**

Alice Shorett Triangle Associates, Inc.

Bob Wheeler Triangle Associates, Inc.

Cole Gainer Triangle Associates, Inc.

**Observers**

Joanne Dea US Environmental Protection Agency

Meghan Hessenauer US Environmental Protection Agency

Marion Kelly US Environmental Protection Agency

Nicole Shao US Environmental Protection Agency

Brad Venner US Environmental Protection Agency

Stephen Winslow US Environmental Protection Agency

Jim Christman Hunton & Williams

**DISTRIBUTED MATERIALS**

**Committee's Packet of Materials**

Agenda (June 6-8, 2007)

FACDQ #6 Draft Meeting Summary (December 6-8, 2006)

Draft Pilot Study Report

Draft Procedures Report

MQOs Approaches & Discussion

Technical Work Group Recommendations on Procedure

Multi/Interlab: Approaches and Discussion

Revised Uses Document

DQO Discussion

FACDQ Implementation Issues To Date

Verification

Final Report Work Group: Draft Schedule & Assignments

**Distributed at Meeting**

What do we need a procedure to do?

Revised Glossary of Terms

What The Pilot Does What The Post-Pilot Could Do

Proposed Language: Matrix Effects

Proposed Language: States MQO Compromise

Proposed Language: MQO Compromise

Proposed Language: MQO Agreement

MQO Continuum

[^1]: ***This is for a situation where a laboratory needs to demonstrate
    its performance at a specified level or at it's reporting level for
    QL~lab~ and DL~lab~***

[^2]: The revised language in this recommendation replaces
    Recommendation B from the December Uses document.