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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 #34
August 2, 2006
1:00 – 2:30 p.m. EST

The Technical Work Group's regularly scheduled call was held on Wednesday, August 2 from 1:00 p.m. - 2:30 p.m., EDT. The call-in number for all calls is 866 299-3188 and the participant code is 202 566 1045#. The schedule of future Technical Work Group conference calls is:

Action Items

A Subgroup on intermittent method blank contamination was established (Ken Osborn, Tim Fitzpatrick, John Phillips and Bob Avery) to investigate the issues and bring to the Technical Work Group in October.

Bob Avery and John Phillips will send old information to the entire group regarding the instructions for the MMA study.

Richard Burrows and John Phillips will insert their respective responses for the quantitation procedures in the matrix.

Ken Miller will contact Rick Rediske regarding the MMA data and information on labs that submitted erroneous results.

Triangle will:

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Welcome and Introductions

At 1:00 p.m., 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.

Mr. Wheeler also reviewed the assignments to the Technical Work Group as a result of the last committee meeting.

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Meeting Summaries from July 5

Mr. Wheeler asked for comments to the draft July 5 meeting summary. There were no comments and the summary was approved as drafted.

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Report on FACDQ Meeting #5

Mr. Wheeler reported on the July 13-14 federal advisory committee meeting. The committee approved the pilot study design, as presented to the committee. An informal discussion session the evening before the meeting was very helpful in addressing any remaining questions on the design. Most of the rest of the meeting was focused on uses of detection and quantitation.

Michael Shapiro and Ephraim King attended the meeting on the second day and engaged the committee in a good discussion of moving forward. Mr. Shapiro listened to the reasons for an extension of the FACDQ charter through December 2007. This short extension beyond May 31, 2007 would provide time to digest the pilot study results, and perhaps write a revised detection and/or quantitation procedure(s). Mr. Shapiro agreed to start the paperwork for an extension, but the decision to process it would depend on significant progress being made on the other FACDQ issues, e.g. uses and reporting, at the December 6-8, 2006 meeting. Mr. King encouraged the committee to be realistic about where real progress on consensus could be made, and frankly admit where it was less likely.

The committee added a meeting in December of this year, since there was a lot more discussion remaining before completing uses and other policy issues. The committee was also receptive to and requested an extension of its charter beyond May 2007 in order to ensure sufficient time to consider the results of the pilot study data.

Tim Fitzpatrick asked whether there was any progress made on getting a transcript of the committee's fourth meeting. Mr. Wheeler explained that the facilitation team had received 150 pages of transcript of the decision in question from that meeting, and was reviewing it and exploring ways to move forward.

Report on Status of Pilot Study

Mr. Wheeler asked Ken Miller to report the status of the decision on setting spiking levels, as well as an overall report on the status of the pilot study. Mr. Miller explained the need to pick 12 spike levels (11 non-zero levels) that will be used in the pilot study. The spike levels should represent the range of both detection and quantitation limits for the regression and single-lab approaches.

Mr. Wheeler said that Richard Reding recently sent out a summary of the breakdown of laboratory size and laboratory type that submitted bids for the pilot study.

With regard to the existing (MMA) data, Mr. Miller asked how some of the differences in results should be interpreted for the pilot study. He explained that some labs in the MMA study did not report their final results, and so the data do not meet the established qualitative identification criteria. After substantive discussion on the topic, the group agreed that any data that do not meet the qualitative identification criteria will not be used. However, that data could be used in determining other factors, such as false positive or negative rates, and as such would be treated as a non-detect in those cases. The group also raised the issue that none of the procedures currently being considered in the pilot study provide specific guidance on how to deal with this situation.

The group briefly described the schedule of the pilot study and when labs would be notified of their successful bids. Mr. Miller noted that the original schedule in the pilot study design has slid by about 10 days due to the extension of the deadline for receiving bids. Ken Miller also committed to contacting Rick Rediske regarding the data in the MMA study that were misidentified by labs.

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TWG Schedule and Topics through November

Mr. Wheeler said that a draft schedule was sent to the Technical Work Group in preparation for this meeting. The draft schedule sent out really only focused on getting the accurate dates for future meetings, and not so much the topics to be discussed. He asked the group to consider the assignments from the committee in talking through the topics to address at each meeting.

Mr. Wheeler also acknowledged a message from Cliff Kirchmer and a response from Tom Georgian announcing their departure from the process, and gave a number of various reasons for doing so. He asked the group if they wanted to consider any of those issues in the schedule as well.

Using the assignments from the committee, Mr. Wheeler asked for Technical Work Group for input on how to best address these assignments and when they should be addressed:

  1. Monitor the pilot - (every meeting)
  2. Further refine/develop calculations, analysis document (Meetings in August and September)
  3. Normalize the matrix - (2-3 meetings in October - November): in the next month, John Phillips and Richard Burrows will insert responses to their respective quantitation procedures.
  4. Develop procedures; new, modified and existing - (the pilot needs to be completed)
  5. Modify "features of the pilot" to include what will not be accomplished - (one or two meetings in October): Triangle will work with John Phillips to get the information from his original document into a new draft.
  6. Consider intermittent method blank contamination and make recommendations - (several meetings needed to address this starting in October): A subgroup of Ken Osborn, Tim Fitzpatrick, John Phillips and Bob Avery will work to address this and bring to the group in October.
  7. Consider ongoing confirmation/verification and make any recommendations - The interpretation of this is the ongoing confirmation that a lab would be conducting for quality control. (the pilot needs to be completed but the Technical Work Group could still discuss ideas related to this - September and October)
  8. Revise definitions (LC, LD, LQ, and terminology like MDL, MRL) - (not urgent, but should be addressed by the group before December)
  9. Consider matrix effects - (PWG should address this also): Larry LaFleur identified several levels to consider, such as (a) general statements about taking into account matrix effects, (b) developing a procedure a permittee can use to demonstrate matrix effects, and (c) developing a procedure to address matrix-specific detection and quantitation estimates.

The current draft schedule of Technical Work Group and Pilot Study Design Team meetings and topics will be revised by Triangle and sent out to the group in advance of the next meeting. John Phillips suggested any guidance or straw document that could be developed on uses or MQOs would also be very helpful at the next committee meeting in December.

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Calculations and Data Analysis

The group received a summary of input from caucuses at the last committee meeting regarding priorities for calculations and data analysis. Mr. Wheeler asked the group to look through these priorities and confirm that the facilitation team accurately captured suggestions from caucuses. He also asked Ken Miller if he had any questions or needed any further clarifications. Mr. Miller said he was pretty clear on the tiers of priorities for calculations and data analyses. Mr. Wheeler said these priorities would be discussed at the next Technical Work Group meeting.

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Normalized Matrix

Mr. Wheeler said the group had started this but had not finished. It was agreed that John Phillips and Richard Burrows would first update the matrix with adding characteristics for quantitation for the Consensus Group and ACIL procedures. The Technical Work Group will then work on normalizing the matrix. Mr. Phillips indicated he would also look at adding the ESC procedure into the matrix.

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Public Comment

Nicole Shao supported a brief discussion of emails from Cliff Kirchmer and Tom Georgian announcing their resignations from Technical Work Group participation for a variety of reasons. The discussion could occur at a future date. Ms. Shao said there were some concerns that the Office of Research and Development saw in Mr. Kirchmer's email that were similar to the concerns her office previously expressed to Richard Reding.

Larry LaFleur responded by saying Cliff's comments largely were addressing the direction the committee was taking and not necessarily the Technical Work Group and pondered whether the Technical Work Group was the right forum to have the discussion.

Bob Avery agreed that it needed to be discussed. The overall assessment is that the committee is moving away from an international standard. There could be a reaction or perception in the international community if the committee does indeed do that in the end.

Larry LaFleur suggested forwarding Mr. Kirchmer's email to the Policy Work Group members, as well.

Wrap-up and Closing

Mr. Wheeler thanked everyone for their time and adjourned the meeting at 2:30 PM EDT.

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Attendance

Technical Work Group Members

Triangle Associates: Robert Wheeler and Derek Van Marter

Observers

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