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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 #17
September 20, 2006
1:00 – 3:00 p.m. EST

Calls will be held from 1:00 to 3:00 PM, Eastern Time, on the following dates: September 28, October 18 and 26, November 1, 15 and 29.

The call in number is 1-866-299-3188, and the access code is 202-566-1000#.

Action Items

Triangle will summarize the discussion of the merged hybrid approach and forward the notes to Tom Mugan and Larry LaFleur for their use in revising the document.

Welcome and Introductions

Facilitator Alice Shorett convened the conference call at 1:00 PM ET and called the roll of participants. She briefly reviewed the agenda with participants, saying the primary focus of the meeting will be a discussion of the merged hybrid approach developed by Larry LaFleur and Tom Mugan.

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Meeting Summary Review and Approval

Ms. Shorett asked for comments to the draft summary from the September 6 Policy Work Group (PWG) meeting. The draft summary was approved with the following corrections:

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Merged Hybrid Approaches

Alice Shorett asked Larry LaFleur and Tom Mugan to review with the PWG the process used to merge their respective hybrid (prescriptive and descriptive) approaches into one.

Mr. LaFleur said that the two of them tried to see where the two approaches were similar and focused on updating those sections. The key focus was on "future updates." Mr. Mugan added that the two of them tried to incorporate elements of both of the previous documents as well as all the comments they had previously received.

Ms. Shorett suggested the group take up a discussion of the document section by section.

Method Promulgation

Larry LaFleur started by saying that the revised document does not contain any references to LC or LQ, since the committee is preparing to have a discussion in December of the appropriate terminology to be used (i.e. ISO/IUPAC or other). He said the recommendation reflects the desire to have one procedure instead of multiple procedures for specific circumstances. Tom Mugan added that this section is intended to be used for the promulgation of new methods.

Alice Shorett then asked the group if there were any clarifying comments or questions. Dave Akers asked whether this one procedure is intended to be the one the committee would be recommending. Mr. LaFleur said that while the committee has not forced itself to decide upon one or more procedures yet, the proposal reflects the desire some committee members have expressed to have just one procedure.

Mary Smith asked how alternative test procedures (ATPs) would work under this proposal. She explained that there are currently two types: those submitted by private companies and those done by EPA. Mr. LaFleur said ideally there would be a nationwide approval for all industries for a pollutant category. EPA would do nothing different from other petitioners. He did acknowledge that getting down into the specifics of ATPs (Tiers 1 and 2) would be a little more difficult. He said that in looking at method promulgation in the broadest sense, the group should consider the criteria that should be required to approve new testing methods.

Nan Thomey asked if this recommendation would prevent a laboratory from reporting data for their customers that is lower than a prescribed limit. Mr. LaFleur said that really has to do with data reporting, but that nothing in the entire proposal would prevent labs from reporting data to customers that were lower than prescribed limits. All labs would simply need to meet or exceed that nationally-promulgated limit.

Ms. Shorett then asked each caucus to state whether they agreed with the proposal after hearing the clarifying comments and suggestions.

Environmental Labs: Nan Thomey said that the labs could agree to the recommendation so long as the ability for labs to report data to their customers below the quantitation limit is addressed somewhere in the entire proposal.

States: Dave Akers said it was a good product to work from and finalize. Tom Mugan said the state caucus is pretty close to agreement on a nationally-promulgated quantitation limit.

Public Utilities: David Kimbrough and Chris Hornback both agreed that a nationally-promulgated quantitation limit was a reasonable approach.

Environmental Community: Michael Murray said that the recommendation looks good. He said he sent some comments to Mr. LaFleur and Mr. Mugan that the committee needs to think about its relationship with EPA and what they do with the committee's recommendations. It may be more efficient to start thinking about these products as components of a final report and tailor the language that way. He also agreed that it would be nice to have a single approach for all parameters.

EPA: Mary Smith said she had nothing to add to the recommendation in this section.

Industry: Larry LaFleur said the Industry caucus supports the recommendation in this section. The caucus has two questions for the group to consider in further refining the recommendation:

  1. What are the characteristics of the quantitation and detection limits that are consistent with the uses to which the committee agrees?
  2. What does a table have to do with method promulgation?

At that point, Alice Shorett asked for comments to the concept of publishing a table in a promulgated rule.

Nan Thomey said that as long as there is a process to demonstrate a lower quantitation limit that could be reported to customers, a table would not affect that ability. Cary Jackson said there is a lag time between method approval and promulgation in a rule (40 CFR Part 136). Sometimes, methods will successfully go through an ATP approval process, but implementation will not happen until 1-3 years later when the method is published in the rule.

Tom Mugan said that a table in a rule would make it easier for permit writers to locate the correct numbers for permits. There were some concerns about making that step too easy, though. Another benefit, he said, could be that all the parameters would be listed and it would be clear that there were not promulgated levels for the vast majority of them.

The group then engaged in a lengthy discussion of the scope of a table in a rule, and what information would or would not be included in such a table. There were various suggestions, but they can all be summarized as falling into one of three types of tables.

Ms. Shorett asked to continue the discussion of the concept of publishing a table in a promulgated rule without considering all of the logistics of how such a table would be populated or what it would include.

Chris Hornback said he had nothing to add to the previous discussion, although he thought the original idea of a table was to publish an update to all the methods in one place at one time in the rule, and given the discussion today, he is not sure how a table would be used in a rule.

Mary Smith said a table in the rule would be a good idea. She hears that the average for permit writer turnaround is about every 18 months, so the more information they have, the better it would be for everyone. A table would be difficult to implement, but not impossible. She said she sees a table likely having three parts: (1) methods that have undergone the new procedure; (2) methods that have not undergone the new procedure; and (3) analytes that do not have associated limits. Her feeling was that the "most sensitive" should not be used because there is enough controversy around what that means. Regarding matrix effects, those could be footnoted in a table to the extent that information is known and has been previously documented in rule.

Future Updates

Tom Mugan said this was originally a way to have an "auto-update," but the comments received indicated that would not work. However, there needs to be a way to update existing methods at any point in time, which is what the proposal in this section describes.

Larry LaFleur said that in the committee's recommendation, it would establish an approach for how updates would occur, but discretion would be left to EPA to determine cost-effectiveness of a method update.

Mary Smith said she thought the recommendation in this section was well-written, and that she appreciates the built-in flexibility afforded her agency. She likes the option to get data from other labs, although there would need to be a pre-qualification process in order to use those data. This approach incorporates a way to notice commenters who review data the agency uses.

Michael Murray had concerns around the language of determining whether an update would be cost-effective. He said his assumption is that there would also be programmatic needs that would drive method updates. The recommendation should have specific reference to the needs under the Clean Water Act. He also noted that the second paragraph of this section sounds different from initially populating a table or establishing values. He said he feels more comfortable with a systematic approach to determining limits from labs already using a method.

NPDES Permits and Compliance Uses

Alice Shorett asked for comments to this section. Dave Akers started by saying that the recommendation was good and suggested that it makes sense to have language in the regulation explanations of what to do in certain circumstances. For example, a method may need to be used that is approved at or below the WQBEL. If that method does not exist for a particular parameter, the most sensitive method rule would apply.

Nan Thomey suggested that addressing the labs concerns in this section may confuse the issue. She suggested caution in describing when zero would be used so that data that is known to be false is not reported. This prescriptive approach proposed currently says to use zero for values under the quantitation limit when, at the same time, data exists that prove the number is not zero. From a scientific standpoint, there are concerns with using zero when statistics show that is not the case.

David Kimbrough said the "most sensitive method" issue is an important one. A completely prescriptive approach can exist that allows for the use of multiple methods so long as the MQOs are being met. The use of the most sensitive method in certain circumstances will need to be clearly defined.

Michael Murray said, on the issue of assigning zero below the quantitation limit, one option of calculating values for compliance and enforcement was to assign some value between detection and quantitation that he believes is still on the table for consideration. With regard to note #2 in the proposal, he said that it seems to address Ms. Thomey's earlier point of allowing labs to report data to customers that are lower than the quantitation limit.

Remainder of Merged Approach

Given limited time remaining in the meeting, Alice Shorett asked the group to consider the remainder of the document all together, which included the topics of "Initial Demonstration of Proficiency by Laboratory" and "Implementation of the FACDQ Recommendation."

Several comments were made regarding verification using QA samples on a per-batch basis. While the group made no specific suggestions to revise the recommendation, they acknowledged that this is a contentious issue among the committee, and that the Policy Work Group will need to spend time discussing the issue and making a recommendation to the committee.

Michael Murray commented on the initial demonstration section asking for clarification in formatting. He correctly pointed out that the "other uses" and "proposed approach" sections were subheadings under the initial demonstration section.

Regarding implementation of the FACDQ recommendation, Mary Smith said it will be more efficient to incorporate it all in one Federal Register Notice. She reminded everyone that in the meantime, the old procedure is not removed. Implementation will need to be carefully thought through so that elements of the recommendation are not lost as the new procedure is being implemented. She also commented that proficiency may pose an issue for labs if a new procedure is implemented.

Alice Shorett then summarized the discussion, reviewing where the group progressed and where discussion was still needed. In particular, she said the group will still need time to discuss the notion of a prescribed detection limit and verification of limits. She said that Triangle would summarize the discussion and send the notes to Tom Mugan and Larry LaFleur for their use in revising the proposal.

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Additional Conference Call, Wrap Up and Adjourn

Alice Shorett asked the group if they were available for an additional conference call to discuss the rest of today's agenda. The majority of the group was available for a conference call on Thursday, September 28 from 12:00 - 2:00 PM, ET.

She explained that the purpose of that call will be to discuss uses and matrix effects. She encouraged members of the group to discuss matrix effects with their caucus members and come to the next meeting ready to discuss any issues the respective caucuses may have. She thanked all for their participation and concluded the call at 3:00 PM (ET).

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