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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 #16
September 6, 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 20, 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

Welcome and Introductions

Facilitator Alice Shorett convened the conference call at 1:00 PM EST and called the roll of participants. She briefly outlined the agenda and meeting documents. Agenda items included:

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Meeting Summary Review and Approval

The draft summary of the August 23 Policy Work Group meeting was approved as drafted, with the following corrections:

Alice Shorett recommended and the group agreed to cancel the October 4 meeting to avoid a conflict with the National Pretreatment & Pollution Prevention Workshop scheduled October 4-6, 2006 and to add a call on October 26. Triangle said it would revise the schedule and work plan/topics to reflect this change.

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Review Prescriptive/Descriptive Approaches and Agree on Proposed Approach

Alice Shorett asked Larry LaFleur to present the document he had drafted, "Approach to a Hybrid Prescriptive/Descriptive CWA Program." Mr. LaFleur said that he had tried to follow the EPA 1994 Guidance Document and specifically referenced Part 136. The key items were:

  1. specific recommendations on how detection/quantitation would be determined in the future;
  2. which procedure(s) would be recommended; and,
  3. how they would be implemented in the NPDES program to create a level playing field for laboratories.

Because of matrix effects, he cautioned the committee to be careful in how it characterizes the most sensitive method. He recommended that the most sensitive method be used only for water quality standards below LQ, not for all permit testing. He noted that laboratories currently demonstrated proficiency according to the 40 CFR, Part 136 procedures. He suggested that the Policy Work Group needed to discuss what was needed to demonstrate capability and proficiency to quantify results.

Mr. LaFleur noted that there were circumstances when laboratories needed to provide lowest levels, so recommendations were needed for how to accomplish this. He said that he would not want five different procedures for five different uses.

In response to a question, Mr. LaFleur said that the approach did not mandate or block the use of a method table, although he said that the Industry Caucus did not see a need for such a table because of the difficulties that could arise when talking with permitting agencies. The group agreed to put on hold discussions about use of a method table.

Mr. LaFleur pointed out that the terms prescriptive and descriptive were confusing and not well defined. Instead, he had begun using the term "promulgated quantitative level" rather than "prescriptive."

Nan Thomey said that the terminology issue (promulgated vs. prescriptive) was important to the Laboratory Caucus. She said laboratories were concerned that if limits were set prescriptively, labs would need to demonstrate that they could meet the limits. Because labs had to report results for other regulatory programs (e.g., RCRA, etc.) and many labs had only one data reporting field, it would be difficult to report for different programs. Different regulatory requirements could result in problems for the laboratories with respect to reporting and data systems. She also noted that some labs would be able to handle differing censoring units for varying regulatory programs (CWA, RCRA, etc.) but some would not. Ms. Thomey pointed out that it required additional work for labs to be able to do this; it was not a one-time set-up process that drove it. The group agreed to return to this issue in the future.

Mary Smith asked Mr. LaFleur if his approach (Part 136, with EPA in the national data role) would lend itself to Mr. Mugan's approach (receiving method data from labs not affiliated with EPA). Mr. LaFleur stated that he didn't see a conflict and confirmed that his proposal would not require EPA to be the initial data generator. EPA could solicit outside information.

Mike Murray asked for clarification regarding the last sentence of the second paragraph under Method Promulgation regarding "method developer". Mr. LaFleur explained that the statement was a caveat to note that not all labs were required to do that.

Tom Mugan then presented the approach he had taken in preparing the document, "Prescriptive versus Descriptive." He said he thought that Mr. LaFleur's approach and his were not far apart. Mr. Mugan said that the problem he was trying to solve—and the main difference between the two approaches—was how EPA could set the ML and MDL for compliance purposes for methods where they did not now exist.

Mr. Mugan's approach involved a clearinghouse where data would be received, along with Mr. LaFleur's idea of "calling" for the data (versus having data trickle in from time to time). Such a process would produce automatic updates. If there were a way to put a procedure for how to deal with the numbers into rule, perhaps there wouldn't be a need to go through a formal rulemaking process. (He said that he had checked with legal counsel to see if an automatic-update process could be used in the promulgated rule.) He said he had also tried to present information about regulatory applications, lab certification programs, and the concept of having descriptive numbers available for labs to use for other purposes.

Mr. Mugan said that Wisconsin would like to have the lowest level data (detection and quantitation) for use in determining reasonable potential. For compliance, he said, Wisconsin wanted data at LQ and above. He noted that a two-tiered system would be more complex.

Alice Shorett asked Mr. Mugan to clarify how his approach complemented or fit with the approach presented by Mr. LaFleur. Mr. Mugan said that he liked the last paragraph in Mr. LaFleur's approach, noting that he wanted to find a way to get detection and quantitation levels where they did not currently exist and to have a way to update them, if needed.

Ms. Shorett asked Mr. Mugan to explain the updating process. Mr. Mugan noted that he did not know when the next big change in method technology would occur and thought that the group could rely on input from the lab representatives. He felt a procedure was needed that would provide a way to come up with levels in the very near future, along with a mechanism to update them.

Alice Shorett asked for EPA input about the approaches. Mary Smith noted that a lot of good concepts had been presented and said that she had shared the information with General Counsel (Mr. Richard Witt) who was on the call to make comments. She cautioned that if EPA were to be the sole generator of data, the system would bog down. She noted that labs might have data EPA could use to update the numbers. Her concern was primarily with the rulemaking process/procedural part.

Mr. Witt emphasized that it was very difficult to write a rule that would allow an automatic update for detection and quantitation numbers. He said a big concern was how to address the requirement for public comment on data that would support the changes, regardless of who generated the data. An additional question related to the uncertainty as to when and how the automatic update provision would be triggered (e.g., by individual permits or by the Part 136 rule). Mary Smith noted that bringing stakeholders into the process made the rulemaking process go more smoothly and efficiently.

Nan Thomey suggested that perhaps the NELAC PT (National Environmental Laboratory Accreditation Conference Proficiency Testing) Board program might provide a mechanism for data gathering and analysis. She noted that it was a recognized program that was accepted by the states and laboratories.

Dick Reding asked if there would be enough concentration ranges for the proficiency testing. Ms. Thomey responded that it would take a lot of thought. Her questions included whether or not the data being gathered would be appropriate; if the data could be gathered from the reporting labs; and if accredited labs were following prescribed EPA methods.

Mr. LaFleur said the committee should describe a procedure that did what it wanted it to do. Ms. Thomey added that an approach should not be excluded just because the group thought there was nobody to do it.

Given the cost and effort required for rulemaking, Mr. LaFleur noted that it would be appropriate to assess the need for updating a method. It wouldn't be useful to have an automatic update if the update were not cost-effective or needed. The discussion concluded that the timing and frequency of updating should be left to EPA's discretion.

Mary Smith said that there was not a lot of demand to revisit all the methods. Realistically, the focus in the first round should be on the pollutants and methods determined to be most important. Subsequent rounds could be a judgment call. She said that the FACDQ might want to recommend a time frame for updates (e.g., every five years). Labs could be interviewed for input on what was needed. That information would give more structure to the updating process while still leaving it to EPA discretion.

Alice Shorett asked for clarification on the existing process. Ms. Smith noted that EPA was not currently updating the old detection/quantitation limits. The process was usually initiated for a new method. It was typically a multi-lab process: EPA analyzed data generated by six or more labs and determined what made sense. EPA then set limits and proceeded with the rulemaking process, along with proposing the method.

In response to a question about whether or not EPA could go to a direct final rule given the assumption that a national level was promulgated and EPA wanted to simply update a variable, Ms. Smith said she thought it would be doubtful. It typically resulted in reverting to the full process (re-proposing) if EPA received even one comment, which added time rather than saving it.

Ms. Shorett then asked participants for their reactions to the two proposed approaches:

Environmental Community: Mike Murray said he found Mr. Mugan's approach intriguing. While recognizing challenges with respect to public comment and updating, he said that Mr. Mugan's approach provided a reasonable way to deal with everything, if the practical issues of making the changes could be solved. He said he generally preferred the Mugan approach to the LaFleur approach. His concern was how labs operated in the real world and how that varied (vs. routine analyses). He said that, ideally, limits could be derived that reflected routine lab practices.

Public Utilities: Chris Hornback said that he could see the two approaches working together. He noted that the Mugan approach was more detailed about how levels might be established and presumed they would be promulgated in rulemaking. He said that the LaFleur approach made more sense to him, although he was reserving judgment. David Kimbrough noted that he had commented on the Mugan approach via earlier email.

Laboratories: Cary Jackson said that doing annual or bi-annual updates would be difficult to implement. He questioned what would happen when detection/quantitation limits changed. A key point was that when a lab decided it could not meet a limit, it would start to make changes (re: calibration or its limits) to address the problem. Nan Thomey reiterated her earlier comments regarding cases where technology lagged behind what was needed. She emphasized that labs needed to know the complete list of compounds and methods for which limits were promulgated. This would be key for lab buy-in to the process.

States: Dave Akers said he thought that both approaches were good and had good information. The Mugan approach had the element of rulemaking to accommodate future changes and outlined practical issues and suggested solutions. The LaFleur approach also raised issues that needed to be addressed, such as proficiency.

Industry: Larry LaFleur noted that an update should not be forced; updating should be left to EPA discretion. He suggested that the two approaches could be merged rather than choosing one or the other. He asked the Policy Work Group if he and Mr. Mugan should work together to produce a merged approach.

It was agreed that Policy Work Group members would review the two approaches, focusing on caucus priorities, approach(es) the caucuses did not want to lose, and ideas about the two approaches. Group members were to provide input directly to Mr. LaFleur and Mr. Mugan (with copies to Triangle) by close of business on September 11. Triangle agreed to email the assignment to Policy Work Group. Larry LaFleur and Tom Mugan would then draft a merged approach reflecting the comments they had received. Triangle would distribute a new merged document to the Policy Work Group by September 15th.

Ms. Shorett noted that another idea had been to prepare a list of compounds that were being addressed. Ms. Smith noted that EPA had started a list and agreed to distribute it to the Policy Work Group.

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Review Uses Draft Revisions and Agree on Narrowed Approach for Further Work

Alice Shorett referred everyone to the document about matrix effects (Addressing Matrix Effects - Potential Alternative Areas for Recommendations) and to the document on uses (Other Uses - Method Validation and Promulgation and QA/QC).

Matrix Effects

Larry LaFleur noted that document on matrix effects offered no recommendations on how to address the issues. Rather, it outlined items he thought were important to discuss and explore. The Other Uses document outlined other topics that had not yet been discussed and raised questions that the Policy Work Group needed to ponder.

Alice Shorett asked for comments from the caucuses.

EPA: Mary Smith commented that Mr. LaFleur had raised good and valid concerns. Richard Witt noted that there could be a procedure or modification to account for a matrix effect. The flexibility could be part of the permit regulations. He noted that states did that in some fashion now, but there was not a lot of consistency.

States: Dave Akers noted that Colorado allowed a permittee to develop a separate quantitation limit where it could demonstrate that there were matrix effects; he said he supported that. Tom Mugan said that he liked a matrix-specific limit vs. having EPA set levels over a wide range of matrices. His concern was that it might result in a level that was very high, too high for some matrices. He said he would be more conservative in setting those levels.

Mr. LaFleur clarified that he did not assume that there would be a checklist with the highest levels picked. EPA would do the formal data gathering and data-generating activity. He noted that EPA might want to task the Technical Work Group with making a recommendation on an appropriate, cost-effective means of demonstrating the robustness of analytical procedures with respect to matrix effects.

Labs: Nan Thomey requested that EPA devise a protocol that a permittee could use if there were a matrix problem and the level could not be achieved (for example, if EPA promulgated limits for WQBEL below LQ). She noted that labs needed a way to demonstrate the lowest level that could be achieved in the sample. Cary Jackson noted that he had been involved in a lot of method development and promulgation. He reported that, when validating a method, one looked at where the agent/pollutant came from. From there, method validation gathered matrices likely to contain that contaminant or agent. It was his experience that regulators allowed the facility to moderate or choose another method to meet its permit requirements. A method was never forced on a permittee. He recommended that Mr. LaFleur clarify what he meant by "sufficiently robust."

Mr. LaFleur said that he agreed with Mr. Jackson and referenced an ATP (Alternative Test Procedure) program for nationwide use. He asked if it were targeted at a mid-point level or a detection/quantitation level. Mr. Jackson reported that historically it had been targeted at a mid-level.

Environmental Community: Barry Sulkin said that he had questions about matrix effect. His concern was about site specific, alternative criteria used for effects. In 99.9% of examples, he said it weakened the permit limits. His cautioned against letting matrix effects drive decisions that would result in an increase in pollution.

Mike Murray asked for clarification of the Method Validation and Promulgation paragraph. Mr. LaFleur said that he had put the document forward to generate discussion and welcomed additional thoughts. He suggested that it be used as a framework for an assignment to the Technical Work Group, asking it to recommend how it would be accomplished. Ms. Thomey noted that if labs had a pathway so they would not be out of compliance, there could be tighter limits on those items that were promulgated (versus promulgating for exceptions).

Public Utilities: Chris Hornback asked if the intent were to address general recommendations, method validation and promulgation, and NPDES permitting, Mr. LaFleur noted that Industry asked that all three components be addressed. Mr. Hornback said that more discussion was needed and that it might not be feasible to address all three. David Kimbrough said that he agreed with Mr. Hornback's concerns.

EPA: Dick Reding asked if matrix effects could be documented, and if so, what process was then followed. Mr. LaFleur referred to EPA's so-called "Pumpkin Book" (document used for guidance) (PDF) (204 K, 53 pages, About PDF) and posed a scenario. In it, if the matrix broke the method, one consulted the guidance document for how to document the problem and then determined what could be done about the situation. From Industry's perspective, the current process was so open-ended that it really wasn't helpful and did not give any true relief.

Alice Shorett reminded the Group that the objective was to have a document on matrix effects that could be discussed by the FACDQ. She said it was important for members to talk with their stakeholders to get input on how best to frame the issue.

It was agreed that the assignment to the Technical Work Group, with a prioritized, specific list of questions, was needed in advance of the September 20 Policy Work Group call. It could then be sent to the Technical Work Group which would begin work on the assignment on its September 27 call.

It was agreed that Triangle would distribute this assignment with a September 13 deadline for input. The Policy Work Group needs to provide specific direction to the Technical Work Group on the following:

Triangle agreed to compile the responses and to distribute them in advance of the September 20 Policy Work Group meeting.

Other Uses

With respect to Mr. LaFleur's document on Other Uses, he noted that the committee appeared to continually bump up against several issues. The document attempted to capture those questions and issues and included ideas on where we could fold those other uses into the Group's discussion. He noted that substantial progress needed to be made regarding specifics and details and how they fit together as a whole. This item was placed on the next Policy Work Group Agenda.

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Wrap-up and Closing

Alice Shorett reviewed the assignments and asked the Group to look for them in an email no later than September 7. She thanked all for their participation and concluded the call at 3:00 PM (EDT).

Attendance

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