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Procedures for Detection and Quantitation

Technical Workgroup

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

Summary of Technical Work Group Conference Call #18
January 18, 2006
1:00 – 3:00 p.m. EDT


The next Technical Work Group call is scheduled for Wednesday, February 1, from 1:00 - 3:00 PM EST. The call-in number is 866-299-3188; access code is 2025661045#.

Future Meeting Dates

Subsequent Technical Work Group calls are scheduled on a biweekly basis, at 1:00 PM EST, as follows:

Depending on FACDQ product development, the Technical Work Group may have to set additional meetings in order to complete work efforts.

Action Items

The Technical Work Group agreed to the following action items during the 18 January 2006 conference call:

Jim Pletl will finalize a draft document for a Policy Work Group discussion about what the committee wants a procedure to do.

The Single-Lab Subgroup will schedule a meeting for the week of 23 January to continue work of designing a pilot study.

The Calibration Design Study Group (a.k.a. Multi/Inter-Lab Subgroup) will:

A new LC Subgroup (Tom Georgian (lead), David Kimbrough, Richard Burrows, John Phillips, Brad Venner, Steve Bonde and Tim Fitzpatrick) will schedule a conference call to discuss options for determining LC for censored methods. Tom Georgian will prepare a summary of the email discussion for the conference call.

Ken Miller will:

Triangle will:

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Welcome and Introductions

At 1:00 PM Bob Wheeler, facilitator, welcomed participants to the call, conducted a roll call of Technical Work Group members and observers, and briefly reviewed the agenda for the meeting. He suggested a couple of revisions to the agenda to accommodate one member's schedule.

Mr. Wheeler asked for comments on the draft 11 January 2006 Technical Work Group meeting summary. Several minor recommendations for change were noted. Those were:

The 11 January 2006 Technical Work Group meeting summary was approved with the above changes.

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Single-lab Subgroup Report

Bob Wheeler started the discussion by saying he would allow flexibility in the conference call protocols to accommodate participants who had actively been involved in the electronic discussion of determining LC for censored methods.

Richard Burrows began by saying he had not managed to schedule a subgroup conference call since the last Technical Work Group meeting so there was nothing to report from the subgroup. However, he did report that David Kimbrough sent him some more data that was forwarded to Ken Miller.

Mr. Burrows said significant discussion took place via email since the last Technical Work Group meeting regarding options for determining LC for censored methods. He said one of the items that seems to be causing the most consternation is the choice for "non-detect". Although some participants of the discussion suggested this should be LD, Mr. Burrows said this was really a separate question that, while important, was not covered in the document he previously distributed. He said several members and participants had been involved in the electronic discussion, and encouraged all members of the Technical Work Group to review the document and submit suggestions.

Members agreed that some of the discussion that had occurred was more geared toward uses, and effectively a Policy Work Group issue to discuss. After further discussion, a subgroup of members and participants was identified and charged with distilling into a document the cogent issues and perspectives from the discussion of options for determining LC for censored methods. This document would then go through the Technical Work Group to the Policy Work Group for discussion. Members of the subgroup are: Tom Georgian (lead), David Kimbrough, Richard Burrows, John Phillips, Brad Venner, Steve Bonde and Tim Fitzpatrick.

Mr. Wheeler summarized by saying that Tom Georgian would make an attempt to put the synthesized discussion into a document for discussion during a subgroup conference call next week. He encouraged the group to meet only once to refine the draft and forward through the Technical Work Group to the Policy Work Group for discussion in February.

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Policy Workgroup Update

Bob Wheeler started the discussion by saying that he, Jim Pletl, Larry LaFleur and Dick Reding were tasked with developing a document on a fundamental question of what the committee wants in a procedure. He said that the four of them met via conference call and that Jim Pletl was working to finish a draft for distribution to the Policy Work Group in time for their next meeting on 23 January.

Jim Pletl said the point he made at the last Technical Work Group meeting was that of timing. The group is currently in the process of designing pilot studies. One of the ways to make sure those studies meet the group's needs is to first identify those needs. In reviewing a number of documents from earlier in the process (e.g. draft criteria, interest statements), Mr. Pletl said it is clear that the federal advisory committee has not yet reached consensus on what a procedure should do. Mr. Pletl said he started posing various needs, based on uses that a study might examine. The Policy Work Group will need to make recommendations on what needs should be forwarded to the federal advisory committee for discussion at its March 2006 meeting.

Several Technical Work Group members had suggestions for framing the issue for the Policy Work Group. In particular, many uses are identified in the Clean Water Act. Since this is a topic of extensive discussion among the committee, it will be helpful to frame the issue of what the committee wants a procedure to do vis-à-vis uses. Also, it may be helpful to articulate the varying levels of information needed for the committee to make decisions (e.g. having pilot studies completed).

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Calibration Study Design Subgroup Report

Larry LaFleur said the Subgroup had met since the last Technical Work Group meeting. The focus of discussions was on:

The Technical Work Group discussed the definitions proposed by the Subgroup for multi- and inter-lab pilot studies. Mr. LaFleur said the Subgroup had reviewed these, received comments and were now recommending the definitions be placed in the glossary of terms. After a brief discussion of formatting and final revisions, the Technical Work Group approved the definitions for insertion in the glossary of terms. Cliff Kirchmer suggested a definition for calibration study design also be put into the glossary.

The group then discussed the draft hypothetical pilot study design developed by the Subgroup. The Subgroup chose to use method 200.8 in this example because of its sensitivity, comparability, availability and cost-effectiveness. Mr. LaFleur explained that the study would be phased and would integrate both multi- and inter-laboratory approaches. He said one of the potential disadvantages to this approach is that it inherently will take some time to complete. The design intentionally avoids running samples on the same day but instead tries to get a sense of recovery over a period of time. John Phillips suggested the Subgroup further clarify in Part C how samples would be submitted.

With regard to MQOs, Mr. LaFleur said the Subgroup discussed the possibility of considering a range of MQOs and agreed the study could accommodate that. A design could also consider several different MQOs and how those affect procedures, but Mr. LaFleur cautioned that would likely increase the cost and may cause laboratories to change their spike levels.

Ken Miller briefly explained, with regard to existing data sets, that the Subgroup currently has one from California that he is evaluating for the IDE/IQE. He said his preliminary analysis is that it looked like the spike ranges may be somewhat limited.

Mr. LaFleur concluded by saying that the Calibration Design Subgroup still needs to examine how a pilot will evaluate the IDE, Hubaux-Vos and LCMRL procedures. The subgroup will also discuss ways in which the pilot tests will be validated, and spend some more time discussing how the samples will be tested.

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Update of Ken Miller Tasks and Timeline

Bob Wheeler asked Ken Miller, EPA contractor working on several tasks for the Technical Work Group to summarize the tasks he was working on and projected timeline for completion. Those are summarized in the following table.

Ken Miller's Tasks and Timeline
Task Timeline for Completion
Filling in matrix of procedures and characteristics Delivered in time for the 1 February 2006 Technical Work Group meeting
Evaluating data for IDE/IQE for Calibration Study Design Deliver analysis in time for Subgroup call on Friday, January 20
Evaluating data for Single-lab Subgroup On-going; currently compiling lists of datasets and transferring the data to a database

With respect to the last task, Mr. Miller said he had not yet tried to make language and formatting consistent among the datasets and asked if that was something the group wanted. No one seemed to think that was necessary so long as the data was comparing the same analytical methods and parameters.

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Public Comment

No public comments were offered.

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Wrap-up and Closing

Mr. Wheeler summarized the action items from the discussion and thanked members for their hard work. He quickly reviewed an agenda for the 1 February 2006 Technical Work Group meeting, and adjourned the meeting at 3:00 p.m. EST.

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Attendance

Technical Work Group Members

Triangle Associates: Derek Van Marter and Robert Wheeler

Observers

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