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Procedures for Detection and Quantitation

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

Summary of Technical Work Group Conference Call #21

March 1, 2006
1:00 – 3:00 p.m. EST

The next Technical Work Group call is scheduled for Wednesday, March 8, 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:

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Action Items

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

Triangle will summarize the Technical Work Group discussion of setting MQOs prior to pilot testing procedures and forward to the Policy Work Group for its discussion of the topic.

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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.

Discussion of Draft Meeting Summary

Mr. Wheeler asked for comments on the draft 15 February 2006 Technical Work Group meeting summary. There were no comments and the summary was approved as drafted. Some members requested the materials be sent out for review sooner than they have been of late. There were too many documents to review in too little time for this meeting. Mr. Wheeler apologized and ensured members that materials are being sent, in one email, as soon as they are all complete.

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Expected Products for the Federal Advisory Committee

Mr. Wheeler briefly reviewed expectations for products to be forwarded to the federal advisory committee for its March meeting. The expected Technical Work Group products are:

Upcoming Subgroup Conference Calls

Mr. Wheeler explained that the Regression-based Subgroup ( 1:00 PM EST) and Single-lab Subgroup ( 3:15 PM EST) both have conference calls this Friday, 3 March 2006. He said the Single-lab Subgroup is inviting all Technical Work Group members to participate in its discussion and he encouraged all those members that could to attend.

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Parameters for Pilot Testing: Discussion of Setting MQOs for Pilot Testing

Mr. Wheeler said the Single-lab Subgroup recently had a lot of discussion regarding parameters for pilot testing. He said Richard Reding clearly articulated some parameters within which the agency must work to successfully conduct a pilot test, and that it was important to share those parameters with the full Technical Work Group. In response to those parameters, the Single-lab Subgroup and Policy Work Group have been struggling with whether MQOs needed to be set prior to commencing the pilot test.

Jim Pletl said that a subgroup of Policy Work Group members and EPA began by discussing the feasibility of assigning MQOs to a long list of desirable characteristics in a procedure, which now number 39 total (see Consolidated Procedure Characteristics Matrix, Version 7). Establishing MQOs for 39 characteristics before the pilot test begins is impractical. So, the subgroup attempted to prioritize the list of 39 characteristics. The priority list includes 19 characteristics (see Uses and Characteristics Matrix, 28 February 2006).

Mr. Pletl emphasized that there is no attempt to eliminate the discussion of setting MQOs, but a focus on getting broad agreement among the federal advisory committee of the characteristics that must be addressed in a procedure.

Mr. Reding echoed Mr. Pletl’s comments and added that parameters were placed on the pilot test due to the tight timeline within which work must be completed. The federal advisory committee’s charter expires in May 2007. Rulemaking would take approximately 1 ½ years beyond that, after which method validation would occur. It is therefore several more years before a new detection and quantitation procedure will be implemented.

In an effort to complete the pilot in time for the federal advisory committee to take action under the existing charter, he said it is necessary for the Technical Work Group to have enough direction after the March meeting to get contracting underway for the pilot test. The hope is to address a few needs in March so that pilot testing can commence following the July meeting. The needs that must be addressed at the March federal advisory committee meeting are:

Several Technical Work Group members commented that a full-blown rulemaking and method validation process may not be necessary. After rulemaking, once a procedure is published, laboratories and users will simply implement the new procedure. Additionally, as new analytical methods are developed, that will be done under the auspices of the new procedure.

The group then discussed the difference between a procedural and a data gathering pilot test. Many in the group agreed that if a procedural pilot test is conducted, MQOs will need to be set prior to conducting the pilot. After a lengthy discussion about the need to set MQOs and the type of pilot test to conduct, Mr. Wheeler asked how many of the members felt MQOs must be set prior to commencing the pilot. Eight members responded saying they believe MQOs must be set before conducting the pilot, or at least before receiving the data from a pilot test. All of the Technical Work Group agreed that a procedural validation study was also necessary to test the final procedure recommended by the federal advisory committee.

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Single-lab Subgroup Report

Richard Burrows began by explaining recent subgroup discussions. The subgroup has discussed the feasibility of combining a single-lab study with a regression-based study. They have also discussed whether a single-lab data gathering study was necessary, what was needed to conduct a procedural single-lab study and whether L D would be included in such a study. The subgroup has also spent a considerable amount of time discussing existing data, primarily looking at the EPA Episode 6000 database. The subgroup intends to present some of the data analysis to the federal advisory committee to inform the discussion of MQOs at the next meeting.

The next subgroup meeting is scheduled for Friday, 3 March 2006 at 3:15 PM EST. Mr. Wheeler said all Technical Work Group members were encouraged to attend the conference call.

L C for Censored Methods Subgroup Report

Richard Burrows then explained his concerns over the discussion paper of consequences of omitting L D from pilot testing. He said the bathroom scale analogy could possibly skew readers’ understanding of the complexity of the issue. However, he agreed to draft a paragraph and insert it as a caveat to reading the analogy. Mr. Wheeler encouraged all Technical Work Group members to review the discussion paper and send any comments to Richard Burrows by Tuesday, March 7 so that he could finalize the paper for distribution to the federal advisory committee.

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Regression-based Design Subgroup Report

Larry LaFleur said that a copy of the draft study design was distributed to the Technical Work Group. He said the subgroup was struggling with validating how the procedure produced the desired results. He said members also received a very preliminary draft summary analysis of the existing data. The subgroup is also working with the purpose and objectives document to understand whether the design as currently drafted answers all the questions within. The subgroup will need to address the parameters of the pilot passed on from EPA. Mr. LaFleur said that because there are censored and uncensored methods being proposed for pilot testing, the subgroup does not see as much value in doing a phased approach.

Bob Wheeler said the next subgroup call is scheduled for Friday, March 3 at 1:00 PM, EST.

Proposed Analytical Methods

Bob Wheeler explained that the Single-lab Subgroup assembled a list of proposed analytical methods for pilot testing. He said the Regression-based Subgroup also participated in the choosing of appropriate methods. Brad Venner explained that the methods were not prioritized at this time. Mr. Wheeler reminded subgroup members that they were tasked a couple of weeks ago with attempting to prioritize a small list of analytical methods for pilot testing. Technical Work Group members said it would be difficult to prioritize a list of analytical methods without knowing exactly which type of pilot will be conducted (i.e. data gathering vs. procedural), and asked EPA for an estimate of costs for each analytical method currently proposed.

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Procedures-Characteristics Matrix

Bob Wheeler said the group has not been able to normalize the matrix produced by Ken Miller. He presented four options: (1) Withhold sending the matrix to the federal advisory committee; (2) Send the matrix with an explanation that the Technical Work Group did not reach consensus on it, but that it was produced by one person (and therefore more “normalized” than the previous version the committee received); (3) Individually respond to Ken Miller and see if the product could be completed on time to distribute to the committee; or (4) Discuss the matrix at the next Technical Work Group meeting in the hopes of finalizing it.

Technical Work Group members agreed to review the matrix and send comments to Ken Miller for him to make corrections. Members also agreed that the matrix is a better version than the one previously distributed to the federal advisory committee and that, with an introductory qualifier, it should be sent to the committee for review prior to the March meeting.

Public Comment

Ken Miller, EPA Contractor, asked whether it was true that a pilot study was either procedurally-based or data gathering. Larry LaFleur responded by saying that a small group has had several side conversations about using existing data to test methods. It would not be much of a stretch from the current regression-based design to generate a lot of useful data for the single-lab study.

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Wrap-up

Mr. Wheeler summarized the action items from the discussion and thanked members for their hard work. He reminded members that the next meeting was scheduled for 8 March 2006, and encouraged members to attend the Single-lab Subgroup call this Friday. He adjourned the meeting at 3:00 p.m. EST.

Attendance

Technical Work Group Members

Triangle Associates

Observers

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