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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
April 12, 2006
1:00 – 3:00 p.m. EST

The next conference call is scheduled for Wednesday, April 26 from 1:00 - 3:00 p.m., EDT. The call-in number is 866 299-3188 and the participant code is 202 566 1045#. The schedule for future Technical Work Group conference calls is (Wednesdays from 1:00 - 3:00 p.m., EDT):

Action Items

Richard Reding will investigate the conference line snafu as reported for the second day of the last committee meeting.

Technical Work Group members will review the analyses of existing data conducted by Ken Miller and provide feedback to him by April 19th. Ken will begin reviewing the blank data sets and report out at the next Technical Work Group meeting.

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. The primary purpose of the meeting, he said, was to discuss the pilot study design and assemble a Study Design Team that would work as a subgroup to finalize the nuts and bolts of the pilot study.

Mr. Wheeler asked for comments to the draft summary from the March 15 Technical Work Group meeting. There were no comments and the summary was approved, as drafted.

FACDQ #4 Meeting Review

Richard Reding thanked everyone from the committee who stuck it out after the first full day of meeting to work through the Technical Work Group presentation in preparation for presenting it to the committee the following day. The group worked well into the evening in some very productive discussions.

Bob Wheeler reviewed the progress from the last committee meeting by recapping the agenda and the decisions that were made by the committee. He echoed Mr. Reding's comments that there was a lot of work conducted well into the evening between the two days of meetings.

In summary, the committee discussed uses and reached decisions on measurement quality objectives (MQOs) for the pilot study. Some of those MQOs were specific to analytical methods. Mr. Wheeler said there really was little time for a lengthy report out from the Technical Work Group, other than specifics related to the pilot and charging a Study Design Team with finalizing the finer details of the study.

In response to a question whether the summary of the meeting will be completed soon, Mr. Wheeler said that once the final draft is complete, a version will be sent to the committee. Mr. Reding said that a summary of the decisions made at the last committee meeting could go out to everyone in short order.

John Phillips said he received some feedback that some people from his constituency were having trouble connecting via the conference line on the 2nd day of the meeting. Mr. Wheeler responded that the facilitation team was not aware of that, but will look into it for the next meeting. He also said that the Technical Work Group assignments from the committee are listed at the end of the agenda.

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Pilot Study Design

The first assignment is to charge a Study Design Team comprised of one member from each caucus group with refining the pilot study design. The assignment to the Study Design Team was to reach agreement on pilot technical components such as the number of replicates and some of the other characteristics and objectives important for the pilot study to assess.

Mr. Wheeler suggested that although this subgroup will be focused on refining the pilot study design, it does not mean the Technical Work Group will have nothing to do in the interim. The Study Design Team will be bringing the design back to the full Technical Work Group soon. There are other assignments to complete, as well, such as the matrix of procedures and reviewing the analyses of existing data conducted by Ken Miller.

Richard Reding briefly updated the Technical Work Group on the status of the pilot study. In order to come up with a final design to present to the committee in July for approval, the Technical Work Group will need to find a way to meld the single and multi-lab approaches into one design.

After approval in July, the effort will be to collect data in September and October in time to conduct confirmation on that data and then distribute it to the various caucuses. In an attempt to facilitate coming together on a final draft design in short order, Mr. Reding proposed an in-person meeting with the Study Design Team sometime in the next couple of weeks.

While all this is going on, the Technical Work Group, with the help of Ken Miller, will continue to evaluate existing data. Mr. Reding said he envisions that during this process to finalize the pilot study, there will be a need to share information between the Policy and Technical Work Groups.

After a brief discussion of the descriptive versus prescriptive approach that Technical Work Group and committee members discussed the evening between the two day committee meeting last month, it was agreed that there were several suggestions that the prescriptive approach was not defensible and was really a non-starter for some caucuses. Mr. Reding suggested that the way most of the procedures are currently written, they pick up components of both prescriptive and descriptive approaches. The Technical Work Group agreed that this issue needed to be discussed further.

The following committee members from each caucus were named to the Study Design Team (meeting has been set in Denver for April 27-28, 2006):

Mr. Reding then briefly reviewed the PowerPoint presentation he prepared for the last committee meeting. He reviewed with the Technical Work Group some of the practicalities and logistics of creating and executing the pilot study in six months time. Given the tight timeline, he encouraged the Study Design Team to see if it could schedule an in-person meeting the week of April 24th. The idea would be to fly into Denver the afternoon before, work that afternoon, and then continue the entire next day.

Mr. Wheeler said Triangle would coordinate with members of the subgroup and propose dates during the week of April 24th and the week of May 1st. Once a date is confirmed, the facilitation team will finalize the logistics of a meeting space. In the interim, the Study Design Team will begin discussions of cost, number of laboratories, number of replicates and other technical issues in order to come to the in-person meeting ready and prepared to finalize the draft study design.

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Update on Evaluation of Existing Data

Ken Miller summarized his evaluation of the Episode 6000 data. He requested Technical Work Group direction for any further efforts on existing data, including the Episode 6000 data as well as other data sets, such as from the State of Florida. He said that at this point, there was a lot more existing blank data that could provide more information.

John Phillips reminded everyone that Tom Georgian provided feedback on the Episode 6000 analyses some time ago, and encouraged members to review that data for any questions or comments.

The Technical Work Group agreed to look at what Ken Miller has done already with the long-term blank analysis (Ken will resend his March 9th email), and give feedback to him by next Wednesday, April 19th. From that point forward, he will look at the additional blank data sets.

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Public Comment

Tom Georgian, US Army Corps of Engineers, asked whether the false negative rate of 99% was calculated at the LQ. He also asked that if the method provides for a calculation of the LC, then would the limit still be calculated at the LQ.

Wrap-up and Closing

Mr. Wheeler said the Technical Work Group calls resume on Wednesday, April 26, from 1 to 3 PM EDT. He adjourned the meeting at 3:00 PM EDT.

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Attendance

Technical Work Group Members

Triangle Associates: Robert Wheeler and Derek Van Marter

Observers

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