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Procedures for Detection and Quantitation

Policy Workgroup

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

Summary of Policy Work Group Conference Call #6
February 27, 2006
1:00 – 2:55 p.m. EST

The final Policy Work Group conference call in advance of the March 29-30 FACDQ meeting will be on Monday, March 6, at 1:00 PM EST. The call-in number is 1-866-299-3188. The participant code is 2025661045#.

Welcome and Introductions

Facilitator Alice Shorett convened the conference call at 1:00 PM EST and called the roll of participants. She briefly reviewed the agenda for the call.

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Meeting Summary Review and Approval

The draft summary of the February 6 Policy Work Group call was approved as drafted.

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EPA Constraints on the Pilot Project

Ms. Shorett called on Mary Smith of EPA to share the agency's current thinking about timing. As the agency charged with moving the FACDQ process along, Ms. Smith said that she and her staff had looked at the FACDQ charter which ends in May 2007 and the additional time that taking the FACDQ's consensus recommendations through the rulemaking process would take - a year and a half to two years. Looking backwards from that time, they had concluded that the pilot study could take no more than six months. She also said that she has $2 million set aside for the pilot study, an amount she thought was robust enough to do a good pilot study. In sum, EPA's constraints are a six-month pilot, from start to finish, at a cost of no more than $2 million.

She mentioned that Dick Reding had told the Technical Work Group about these constraints on its last call. The implications for the March FACDQ meeting were that the advisory committee needed to make decisions - such as, the number of labs, number of procedures, specific analytes to test -- so her staff could put contracts in place between the end of March and the summer FACDQ meeting so the pilot could start right away after the summer meeting and be completed in six months.

In the round robin of the caucuses that followed, the caucuses generally supported this approach. Larry LaFleur noted the guidance that the Technical Work Group would need to figure out the pilot test. He said this would require a focus on what is most important to accomplish.

In response to a question about how labs would be selected to participate in the pilot study, Ms. Smith indicated that EPA had on-call contracts that could be used. The agency also expected to have labs volunteer to participate.

Mike Murray encouraged EPA to make sure the participating labs were a representative slice of labs in terms of their capabilities, staff levels, size, etc. Mr. Reding assured him that would be part of the selection process.

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What do we want procedures to do?

Ms. Smith said that the experience of presenting a straw proposal to the MQO Subgroup that had sparked a good discussion had led them to develop a straw proposal on "what we want a procedure to do" for this call. She said that she and Dick Reding had contacted Jim Pletl and asked him to work with them to develop a straw proposal for discussion on this call and to present at the March FACDQ meeting. The goal was to have a direction to give to the Technical Work Group for designing the pilot study.

This was the background, she said, to an Excel document, with two sheets, that had been distributed in advance of the Policy Work Group call. One sheet listed all of the characteristics in the matrix. She said that the three of them had gone through the characteristics and had assigned Highs, Mediums, and Lows to all of the characteristics for detection and quantitation, for the pilot study. They had then moved the characteristics that had primarily "highs" (keeping their original numbers in the matrix) into a second sheet. She said they were floating this second sheet as a straw proposal and wanted feedback from the Policy Work Group on the draft.

Jim Pletl added that the intent of the straw was to try to get consensus on broad concepts to assist in the design and conduct of a pilot test.

The Policy Work Group reviewed the straw priority list and, after adding two additional characteristics -- #14 Consistent or Chronic Blank Bias Addressed and #15 Intermittent Blank Contamination-- agreed by consensus to recommend the list of high priority characteristics to the advisory committee at its March meeting for discussion and a decision.

The consensus list follows:

Characteristics to Test in the Pilot Study
# Characteristics Detection
Procedures		 Quantitation
Procedures
1. Bias (produces an estimate) H H
2. Precision (produces an estimate) H H
3. % False Negatives H M
4. % False Positives H H
5. Qualitative Identification Considered M H
Evaluation of Method Performance
8. Limit Evaluation Freq.
(Temporal Variability)		 H H
9. Data Generation Freq.
(Temporal Variability)		 H H
10. Reflect Routine Perf.
(Temporal Variability)		 H H
11. Addresses Matrices H H
12. Evaluates Entire Test Method H H
14. Consistent or Chronic Blank Bias Addressed    
15. Intermittent Blank Contamination    
Degree of Procedural Complexity
23. Data Processing
24. Laboratory Procedures
25. Is it a Clearly Written Procedure?
26. Can the Procedure be Clearly Written?
27. Ability to Communicate Concepts		 H H
28. Cost/Resources H H
Data Types
36. One Size Fits All
This covers "flexibility", "censored", and "uncensored" methods		 H H

Ms. Smith said that before a final decision could be made the committee would want the Technical Work Group to tell them what we would and would not get. She said she expected an iterative process where we would learn at every step of the way.

It was agreed that the list of priority characteristics would be sent to the FACDQ in advance of the March meeting and caucuses would be asked to be prepared at the meeting to say whether or not this was an acceptable list of what needed to be addressed. Direction from this meeting would help develop the study design.

Ms. Smith said that EPA would draft an introductory section for the priority characteristics, ask Jim Pletl to review it, and then include it in the pre-meeting packet. The group agreed to this approach by consensus.

The issue of prescriptive/descriptive approaches was raised during the discussion. It was agreed that a draft document presenting both approaches would be distributed before the March 6 call and that the issue would be addressed at the March FACDQ meeting.

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Set MQOs Before the Pilot Test or Conduct a Data-gathering Pilot without Setting MQOs?

After concluding their discussion of the priority characteristics for the pilot study, the Policy Work Group had a discussion about what recommendation to take to the March meeting concerning setting MQOs for the pilot study. Given the six month timeframe to complete the pilot, the group discussed two approaches to conducting the pilot study:

  1. setting MQOs in advance of the pilot study or
  2. conducting a data-gathering pilot without first setting MQOs.
Initial positions about these approaches
Caucus MQOs First Data-gathering pilot first Comments/Concerns
Industry   OK Larry LaFleur (with agreement of Roger Claff): Given a 6-month timeframe for the pilot test, the fact that we won't have time to evaluate how well procedures are written, and the fact that we will likely modify procedures anyway, the differences between a single lab and a regression-based lab approach go away. If we go to a data-gathering mode for the pilot, we'll probably not lose anything by not setting MQOs in advance.
States Ask TWG advice before deciding OK Tom Mugan: The Technical Work Group should tell us whether or not we can proceed without setting MQOs.
Dave Akers: Proceeding with the pilot without prescribing MQOs will let us see how methods perform across a range of values.
Environmental Labs   OK Nan Thomey: Proceeding without defining MQOs lets us keep flexibility. Larry's point about the need to revise procedures to improve them is good.
Cary Jackson: Agreed with Nan's points and also agreed with David Kimbrough that existing data have a lot of good information we can use.
Public Utilities Set MQOs
Concern about pilot test results without setting MQOs		   David Kimbrough: He said his position in favor of setting MQOs in advance, was clear.
Chris Hornback: If we do not set MQOs in advance, how will we answer the questions in the document, What do we need a procedure to do, if we don't ask them in a pilot study?
Jim Pletl: While agreeing that MQOs are important, he said it is possible to decide what one can look at in a study that allows us to compare procedures. In other words, we will need to be clear about how we will interpret the data.
Environmental Community Prefer to set MQOs   Mike Murray: He said he saw value in setting MQOs in advance because it would help to define spiking levels. It would also help to push procedures/analytical methods to test their sensitivity at low levels.

At the end of the discussion, Alice Shorett summarized the discussion as "cautious consensus" to proceed with a data-gathering pilot, without setting MQOs in advance. The group concurred with her summary.

It was emphasized that the pilot test design should focus on what we need (as opposed to want) from procedures and the pilot test design should identify the specific questions the pilot would answer.

It was decided to send this recommendation to the Technical Work Group for its consideration, with a request for a response before the March 6 Policy Work Group call concerning whether or not the Technical Work Group thought it could design such a pilot study.

Mr. LaFleur indicated that the Technical Work Group would have to go through a series of threshold questions to develop its response. It would also have to decide if it would pick from the existing procedures or revise them to meet the needs of the advisory committee. Given the short length of time before the March FACDQ meeting, he said the Technical Work Group would be unable to develop a new design to take to the meeting. He also said that the Technical Work Group would need the concurrence of the full committee at the March meeting on how to proceed with the pilot study design after the meeting.

In advance of the March 6 call, it was agreed that Triangle would work with Mary Smith, Larry LaFleur and Tom Mugan to prepare a discussion of the uses decision tree and to frame the discussion relative to reasonable potential.

With respect to the document, what do we want procedures to do, it was agreed to replace the word "want" in the heading with the word "need." Jim Pletl agreed to undertake to align the narrative document on what we need from procedures with the high priority characteristics and send it out to the Policy Work Group by Friday, March 3 so it could be discussed on the March 6 Policy Work Group call.

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Wrap-up and Closing

Ms. Shorett adjourned the call at 2:55 PM EST.

Attendance

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