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3 SILOXANES ENVIRONMENTAL MONITORING ECA 

4 MEETING

5 TAKEN DECEMBER 12, 2013

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6 In Attendance:

7 Ward Penberthy Karluss Thomas

8 Trent Doyle

9 Kathy Plotcke

10 Cathy Fehrenbacher

11 Russell Mait

12 Tala Henry

13 Steve Anderson

14 Mark Seltzer

15 Charles Staples

16 Nhan Nguyen

17 Karen Eisenreich

18 Debra McNett

19 David Tobias
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1 Sara Pollack

2 Allison Starmann

3 Paul Lewis

4 Brad Goodwin

5 Paul DeLeo

6 Raymond Ludwiszewski

7 Tracy Guerrero

8 Wendy Koch

9 Karen Vail

10 Joe Avcin

11 Kristen Smith

12 Noriko Shibuya

13 Neil Patel

14 Hugh Flack

15 Lisa DuMars

16 On the Phone:

17 Gene Browning

18 Betsy Carlton

19 Sean Bursick

20 Lynne Blake-Hedges

21 Steve Reynolds
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1 * * * * * *

2 MR. PENBERTHY: Okay. My name is 

3 Ward Penberthy. I'm deputy director of the Chemical 

4 Control Division here at EPA. Why don't we go around 

5 the room this way? 

6 MR. SELTZER: I'm Mark Seltzer, attorney

7 advisor in the Chemical Control Division. 

8 MR. STAPLES: Charles Staples, a 

9 contractor -- an environmental science contractor with 

10 SEHSC. 

11 MS. PLOTCKE: Kathy Plotcke with Dow 

12 Corning. 

13 MR. THOMAS: Karluss Thomas with 

14 SEHSC. 

15 MR. DOYLE: Trent Doyle with Keller 

16 Heckman, outside counsel to SEHSC.

17 MR. MAIT: Russell Mait, Evonic.

18 MR. WEBB: Keith Webb, (Inaudible) 

19 Chemical Corporation.

20 MS. DuMARS: Lisa DuMars, Momentive.
6

1 MS. HENRY: Tala Henry, director of the 

2 Risk Assessment Division in OPPT.

3 MS. Fehrenbacher: Cathy Fehrenbacher, 

4 chief of the Exposure Assessment Branch in the Economic 

5 Exposure and Technology Division, EPA.

6 MR. GOODWIN: Brad Goodwin, AAAS 

7 Fellow in the Chemical Control Division.

8 MS. EISENREICH: Karen Eisenreich, a 

9 toxicologist in the Risk Assessment Division. 

10 MS. POLLACK: Sara Pollack, a 

11 toxicologist in the Risk Assessment Division.

12 MS. SELBY-MOHAMEDU: Yvette 

13 Selby-Mohamedu, Associate Chief of the Exposure 

14 Assessment Branch. 

15 MR. TOBIAS: David Tobias, Exposure 

16 Assessment Branch.

17 MR. DeLEO: Paul DeLeo, American 

18 Cleaning Institute.

19 MR. LUDWISZEWSKI: Raymond 

20 Ludwiszewski, Gibson Dunn. 
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1 MS. McNETT: Deborah McNett, Dow 

2 Corning.

3 MS. GUERRERO: Tracy Guerrero, 

4 SEHSC.

5 MS. KOCH: Wendy Koch consultant to 

6 Evonic.

7 MS. VAIL: Karen Vail, SEHSC.

8 MR. NGUYEN: Nhan Nguyen Branch 

9 Chief, Chemical Engineering Branch

10 MR. AVCIN: Joe Avcin, engineer EPA.

11 MS. SMITH: Kristen Smith, Momentive.

12 MS. STARMANN: Allison Starmann with 

13 SEHSC.

14 MS. SHIBUYA: Noriko Shibuya, 

15 Shieseido.

16 MR. PATEL: Neil Patel, Economics, 

17 Exposure and Technology Division, OPPT.

18 MR. ANDERSON: Steve Anderson from 

19 EPA's Office of General Counsel. 
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1 MR. PENBERTHY: Okay. Paul Lewis 

2 will be here shortly. He's attending a high-level meeting 

3 on fracking, so another wonderful topic. 

4 So we should go on the phone and just hear 

5 who's on the phone. Can people on the phone start 

6 identifying themselves?

7 MS. CARLTON: This is Betsy Carlton, 

8 Bluestar Silicones.

9 MR. BROWNING: This is Gene 

10 Browning, (inaudible) of America.

11 MR. BURSICK: Sean Bursick, Proctor & 

12 Gamble.

13 MS. BLAKE-HEDGES: Lynne Blake14 Hedges, Office of Pollution Prevention and Toxics, EPA.

15 MS. RIZUTTO: Pat Rizutto, Bloomberg 

16 BNA.

17 MR. REYNOLDS: Dave Reynolds, inside 

18 EPA.

19 MR. GRIFFITH: Patrick Griffith, 

20 National Association of Clean Water Agency. 
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1 MR. PENBERTHY: Is that everyone on 

2 the phone? Okay. So Karluss, you sent me the list of 

3 unresolved issues. Are there any other issues besides 

4 these or --

5 MR. THOMAS: There are a couple of --

6 there are a few things at the end that we'll want to talk 

7 about from the standpoint of editorial type changes or just 

8 comments to some of the language, but what I've tried to 

9 list here are what we would consider the major issues. 

10 MR. PENBERTHY: Okay. So everything 

11 else should be relatively simply disposed of?

12 MR. THOMAS: We certainly hope so. 

13 MR. PENBERTHY: Apart from these, 

14 maybe?

15 MR. THOMAS: Yes. 

16 MR. PENBERTHY: Okay. All right. So 

17 why don't we start on the first one?

18 MR. THOMAS: Sure. And actually, 

19 before we get started, I just -- I think I wanted to thank 

20 EPA on behalf of SEHSC for continuing to be patient as 

21 we work through this. 
10

1 One of the things I also wanted to note with 

2 respect to the remaining issue and in terms of our 

3 viewpoint on those issues, we've actually started to have 

4 pretty substantial discussions with a number of contractors 

5 with respect to trying to identify some expertise that's 

6 going to actually do the work for us. 

7 And I just wanted you to be aware that -- a 

8 number of our positions with respect to these issues have 

9 been informed by those discussions, so a lot of practical 

10 implications from the standpoint of how we do the work, a 

11 lot of that feedback, has been informed by those 

12 discussions we've had with contractors. 

13 MR. PENBERTHY: Okay, great. You 

14 know, it's our goal to have a complete document finished 

15 at the end of the day today that we can all be satisfied 

16 with. So that's our ultimate objective and we'll stay here 

17 as long as it takes, so --

18 MR. THOMAS: Okay. 

19 MR. PENBERTHY: Then all right. Go 

20 ahead. 
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1 MR. THOMAS: So I'll just start walking 

2 through these one by one. On the timing for the quality 

3 assurance plan and for the study plans, we're happy with 

4 the language that's in the current version of the document. 

5 The one thing I think we wanted to point 

6 out -- and I think it's very important -- there are going to 

7 be substantial timing implications if EPA does not approve 

8 these plans in the specified. So for example, if EPA does 

9 not provide some feedback or ultimately approve the plans 

10 within the time frame that's laid out, we're looking at 

11 substantial delays in actually the program moving forward. 

12 So we're talking six months, along those times, if we can't 

13 get the feedback from EPA within the 60 days, I think, 

14 that's allotted for that. 

15 MR. PENBERTHY: Okay. You did 

16 request that we – a time limit -- I'm trying to find where 

17 we expressed that. What page did you say that was? I

18 think it's on Page 8. 

19 MR. THOMAS: Section 9. It says, "EPA 

20 shall approve the QAPP within 60 days of receipt if it 

21 meets the requirements of this ECA." 
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1 So again, I think the language is acceptable. 

2 I just wanted to highlight, again, that if we -- if there are 

3 delays associated with that feedback or if there is some 

4 misunderstanding with respect to whether the plan meets 

5 requirements, again, we just want it to be clear that there 

6 are going to be substantial delays associated with the 

7 program if we don't have those met. 

8 MR. PENBERTHY: I'm trying to find 

9 exactly where -- what page that is. 

10 UNIDENTIFIED FEMALE: Under study 

11 and right above testing, in that statement. 

12 MR. PENBERTHY: Okay. So we're 

13 happy with that?

14 MR. THOMAS: Okay. Yeah, happy with 

15 that. The other thing, Number 2, Force Majeure, this is a 

16 topic, as you know, that's -- we've kind of gone back and 

17 forth over for quite some time. After carefully reviewing 

18 the language in the text, we're comfortable with it. So 

19 we're happy that the language with respect to Force 

20 Majeure is going to satisfy our needs, so I think we're 

21 good for that one. 
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1 MR. PENBERTHY: Okay. Then I think 

2 we've basically took most of your language from the start, 

3 so --

4 MR. THOMAS: Okay. 

5 MR. PENBERTHY: -- good enough. 

6 MR. THOMAS: So Number 3, the use of 

7 one lab for analytical analyses. I think here in several 

8 places EPA has included language with respect to contract 

9 laboratory vendors, and in other places using only one 

10 laboratory. I think here our request would be that the 

11 language be made consistent in terms of the language in 

12 the actual ECA document and the language that's in the 

13 test standards. And I guess from the standpoint of 

14 consistency, our preference would be to maintain some 

15 flexibility. 

16 MR. PENBERTHY: Okay. Where is that 

17 type of reference?

18 MR. DOYLE: In the body of the ECA, it 

19 would be at Section 9A, Page 7, on my copy. 

20 MR. PENBERTHY: Okay, all right.
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1 MR. DOYLE: It's referenced there that if 

2 multiple commercial laboratories are actually used 

3 (inaudible). It's referenced there talking about multiple 

4 labs. There is only -- each of the test standards, there's 

5 actually -- it's specifying you shall use one lab, and we 

6 want to make sure that that gets modified to accommodate 

7 flexibility if, in fact -- I mean, obviously that's our intent, 

8 but just so we can make sure there's some flexibility there 

9 if we need a second lab. 

10 MR. PENBERTHY: Well, let me explain 

11 what our concern there was. You know, we know that 

12 these are difficult analyses to do and it's to the benefit of 

13 the quality of the day-to-day results that a single lab would 

14 be done. And the way we drafted this, I think you'll notice 

15 that in each of the media test standards we wanted each of 

16 the -- all of the testing for each of the media to be in a 

17 single laboratory at least, but it's our preference that they

18 all be tested at one lab. So that's the way it's drafted right 

19 now. 

20 MS. PLOTCKE: I mean, I think -- so the 

21 way language is that you have, it says, "The use of only
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1 one laboratory is most desired." We actually agree with 

2 that completely. That is our preference as well, but one of 

3 the things we are just trying to do is to put in 

4 contingencies; if something were to happen, that we would 

5 have some back-up. 

6 So we just want that flexibility, and then 

7 that and the test standards is a little more -- shall have one 

8 laboratory. So we want to make sure that that flexibility

9 of this language is really also consistent with what it says 

10 in the test standard. 

11 MR. DOYLE: So if you look at section --

12 MS. PLOTCKE: So we're of the same 

13 mindset. 

14 MR. DOYLE: So Section 8A, it appears 

15 and it also appears in Section 9A of the ECA, and then if 

16 you look at how the language is worded there -- so Section 

17 8A is, "Preferably all samples should be analyzed for D4 

18 at one commercial testing laboratory..." --

19 MR. PENBERTHY: Okay. So that 

20 expresses our preference? 
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1 MR. DOYLE: Yes. So that's -- that's 

2 exactly right. We -- we're fine with that. The only part 

3 about that -- and not to jump ahead about that provision 

4 right there -- is where we say one commercial testing 

5 laboratory -- it says, "...known to have appropriate 

6 expertise with D4 analyses..." 

7 In our waiving -- that whole "known to 

8 have appropriate expertise" part could just all be struck. I 

9 mean, I don't -- I'm not sure known to who, and at this 

10 point in time the method of validation, the EPA doing the 

11 GLP, that's what's going to sort of establish that the lab is -

12 - has appropriate expertise in doing analyses (inaudible) 

13 ahead of time. I mean, we're obviously going to choose a 

14 vendor we think has appropriate expertise, but I just don't 

15 see that that really counts as much. 

16 So now if we --

17 MR. PENBERTHY: Well, hold on, hold 

18 on, hold on: Go ahead, Kathy. 

19 MS. FEHRENBACHER: I thought that in 

20 prior discussions and, in fact, in the draft that the SEHSC 

21 submitted we had included language about working with 
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1 the laboratory to make sure they had the required 

2 expertise. And that's where we're coming from with this 

3 language, known to have appropriate experience. 

4 MR. MAIT: Well, let's do this: We're 

5 planning on going through with whatever lab is selected to 

6 ensure that the methods and techniques are all validated as 

7 if they went in the lab like whether it's a company lab or 

8 not. If that's what you mean by that, then it's going to be 

9 okay. If prior knowledge before we select the lab, that's 

10 where the challenge comes in. That's where Trent's 

11 concern comes from. 

12 MR. PENBERTHY: So if we change the 

13 language from "known to have" to just say "that has 

14 appropriate expertise," wouldn't that essentially --

15 MR. MAIT: As long as it -- is it preferred -

16 - as long as it's considered from a timing issue that we're 

17 going to going to have the opportunity to give them that --

18 okay. 

19 MR. PENBERTHY: I don't think that's 

20 necessarily --
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1 MR. MAIT: I don't want it to be an a priori 

2 thing. It would be better if we're allowed to give them that 

3 validation time so that they know they can achieve what is 

4 expected in the test plans. 

5 MR. DOYLE: We're certainly going to put 

6 them through the validation process just like we 

7 established in the test standards and so forth. 

8 MR. PENBERTHY: So is it okay -- so one 

9 commercial testing laboratory that has appropriate 

10 experience? 

11 MS. PLOTCKE: Can you say has or will 

12 acquire? 

13 MR. ANDERSON: That has at the time of 

14 the testing. 

15 MS. PLOTCKE: Oh, yes. 

16 MR. DOYLE: That's what I was getting at, 

17 is the timing issue on that. 

18 MR. PENBERTHY: Go ahead, Steve. 

19 MR. ANDERSON: That has appropriate --

20 whatever it is -- experience at the time the testing occurs. 

21 It sounds like that's the --
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1 MS. PLOTCKE: That's the -- yeah. 

2 MR. PENBERTHY: That's the issue. 

3 Okay. Let me just read that sentence as I have it. So I 

4 say, "Preferably all samples should be analyzed for D4 at 

5 one commercial laboratory that has appropriate expertise 

6 with the D4 analyses of the samples of the types collected 

7 in this testing program when the testing occurs." Is that 

8 okay? 

9 MR. DOYLE: Yes. 

10 MR. THOMAS: Yes. 

11 MR. PENBERTHY: Okay. Now, you 

12 mentioned there's other places? 

13 MR. DOYLE: Yes. 

14 MR. PENBERTHY: Can we clean the 

15 other places up on this draft? 

16 MR. DOYLE: Let's flip back to the test 

17 standards, so back at the Appendices. 

18 MR. PENBERTHY: Okay. So I assume 

19 we'll start at Appendix 4? 

20 MR. DOYLE: Appendix 4. Let's go to the 

21 section that says, "Analysis of influent and effluent 
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1 samples for D4." The very first sentence there says, 

2 "All influent and effluent samples and accompanying QA 

3 samples shall be analyzed for D4 at one commercial 

4 testing laboratory known to have appropriate expertise 

5 with D4 analyses to be conducted." 

6 MR. PENBERTHY: Okay. Here you'll 

7 notice that it's limited to influent and effluent samples; it's 

8 not all samples. 

9 MR. DOYLE: I understand that. The 

10 concern is, if in the middle of the program or somehow we 

11 need to, you know, have another lab be involved, that we 

12 want to make sure we have that flexibility. I mean, 

13 obviously, our intent is to have one lab do everything. 

14 That's what's intended. 

15 MR. PENBERTHY: Does the saying 

16 change (inaudible)? 

17 MR. DOYLE: Yeah. I think you mirror 

18 the language that you have in the body of the ECA, which 

19 is, "Preferably testing should be conducted in one lab," 

20 and Steve's qualifier at the end, too. 
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1 MR. PENBERTHY: So that was Section 8. 

2 Okay. So you would -- so we would delete this first 

3 sentence and replace it with the sentence we just 

4 constructed? 

5 MR. DOYLE: Yes. 

6 MR. PENBERTHY: Are you satisfied with 

7 that? 

8 MS. PLOTCKE: Yeah, that's fine. 

9 MR. PENBERTHY: Okay. So we'll 

10 mirror the sentence on -- insert the sentence from Page 6. 

11 MR. DOYLE: It's going to be essentially

12 that same edit for each one of the other test standards. 

13 MR. PENBERTHY: Okay. Hold on, just 

14 let me just check. I'll just circle that on each of them so I

15 know. 

16 Okay. So that would be on Page 30; that 

17 would be the same on Page 6? Okay. We'll keep going. 

18 Okay. Again, on Page 35. Page 35, the 

19 biosolids; Page 40, on sediment; Page 48, biota. 

20 Is that all of them? 

21 MR. DOYLE: I think so. 
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1 MR. PENBERTHY: Okay. Is this now 

2 resolved, this issue? 

3 MS. FEHRENBACHER: So let me just 

4 confirm what we're saying here. For -- our preference is to 

5 have all samples collected or analyzed for D4 at one 

6 commercial testing laboratory. And then for each of the 

7 media, we did want to have samples for each media 

8 analyzed at one commercial laboratory? 

9 MR. DOYLE: That's our intent as well. 

10 However, we wanted to make sure there's that flexibility; 

11 if something goes awry and we need to bring another lab 

12 on board, that we can have that flexibility to do that. 

13 MR. MAIT: We've had discussions. 

14 We've had discussions with potential vendors and this 

15 question came up of -- there are potential situations where 

16 somebody can't perform and we want to be in a position 

17 that doesn't impact overall the whole program by not

18 having somebody in the back seat that we can bring on 

19 board, revalidate, and to move forward so the program 

20 doesn't get delayed. That's the thinking. 
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1 MR. PENBERTHY: So on Page 48, in lieu 

2 of that first sentence, we would strike the first sentence. 

3 And on Page 48, if you strike that first sentence and say, 

4 "Preferably all samples should be analyzed for D4 at one 

5 commercial testing lab that has appropriate expertise with 

6 the D4 analysis of samples of the types collected in this 

7 testing program when the testing occurs." That's okay? 

8 MR. DOYLE: Right. 

9 MS. FEHRENBACHER: So what would 

10 be a situation where you would need to use a second 

11 laboratory? 

12 MR. MAIT: Some crazy act of God or 

13 something like that. That's what we're --

14 MS. PLOTCKE: Or if a laboratory closes 

15 down. 

16 MR. MAIT: Or burns down. 

17 MS. PLOTCKE: Goes out of business, you 

18 know. 

19 MS. FEHRENBACHER: But you switch 

20 labs and you go back to all the samples? 

21 MS. PLOTCKE: Yes. 
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1 MR. DOYLE: The intent is not to farm this 

2 out to a bunch of different labs. The intent is to have all 

3 the analyses for all the different matrixes done at the same 

4 lab.

5 UNIDENTIFIED MALE: Whether it's, 

6 you know, the initial lab that runs in the -- whatever kind 

7 of problem there is, we need to go to a backup lab. 

8 MR. PENBERTHY: I think the way this 

9 was constructing it was -- our preference was to have all 

10 the samples from all the media in one lab.

11 MS. PLOTCKE: Right. 

12 MR. PENBERTHY: And then our 

13 requirement, when we drafted this, was at least each media 

14 have the same. 

15 MS. FEHRENBACHER: That's right. 

16 MR. PENBERTHY: So we are somewhat 

17 being somewhat more flexible. 

18 MS. FEHRENBACHER: Yes, we are. 

19 And I just wanted to make sure that we were okay with --

20 MS. PLOTCKE: I mean, the intent is to 

21 have every sample, and so -- of all the same media 
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1 analyzed at the same lab, but all samples. So this is only

2 contingency planning for a natural disaster kind of thing 

3 that, you know, we've asked the contractors to put in place 

4 just in case something, you know, unforeseen happens, but 

5 we don't expect that to happen. We don't want that to 

6 happen. Our intent is one laboratory does all the sample 

7 analysis for the whole program as well as each matrix. 

8 MR. MAIT: So the point is, from the 

9 project managers ' standpoint we want to minimize the 

10 potential risk of not meeting its time schedule by not 

11 having a potential backup in the event that it was needed. 

12 If it's never needed, we'll never use it. 

13 MS. HENRY: But in particular for a 

14 specific media, if you're part way through and have to 

15 switch, you got to go back and do them all at the same lab. 

16 MR. DOYLE: That's not what they're 

17 saying. That's not really what they want to do. 

18 MS. HENRY: Well, that's inconsistent. If

19 you can switch midstream, it's inconsistent with all 

20 samples that we will have. 
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1 MR. DOYLE: Preferably, all samples 

2 should be analyzed at one lab. That's what our aim is to 

3 do. If something happens -- you know, let's say we go 

4 through the whole first campaign, if you will, the whole 

5 first sampling event at all the sites, have them all analyzed, 

6 then we wait the three months between, as prescribed, go 

7 do the -- if something happens in those intermediate 

8 periods with the lab -- I don't know. We can imagine a 

9 whole host of scenarios -- we want to make sure that we 

10 had the flexibility if we need to bring another lab up. That 

11 goes to the validation that we can do that under this ECA. 

12 That's really what it is. It's just for -- we want to make 

13 sure we can make the project schedule. 

14 In that situation, we're not going to go back 

15 and repeat all the whole first-phase sampling because we 

16 were supposed to use a different lab. The labs are going to 

17 have to have to go through validation, you know, the 

18 second lab. I mean, that's -- you know, I mean, these are 

19 all out there. 

20 MR. PENBERTHY: There are retained 

21 samples. 
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1 MS. PLOTCKE: Not on everything 

2 because they won't be of value if -- well, some of them 

3 from a stability standpoint. I mean, this is really just, you 

4 know, that unforeseen kind of -- I mean, we've had some 

5 wild weather, tornados, hurricanes. I mean, if the lab we 

6 happen to be at has something like that that totally shuts it 

7 down, we want a backup -- that's all -- but it's not our 

8 intent to go anywhere else once we start. 

9 MS. FEHRENBACHER: I prefer that the 

10 language in the ECA specify the intent. And it seems that 

11 we're all in agreement that the intent is that for each media 

12 we would prefer the samples to be analyzed at one 

13 laboratory, and then it sounds like you want to have a 

14 contingency in place in case you're not able to meet that --

15 MR. PENBERTHY: So how about we 

16 change the language on -- that's on Page 6 and say --

17 instead of preferably to say, "All samples should be 

18 analyzed for D4 at

19 one commercial laboratory that has appropriate expertise 

20 with D4 analysis of samples of the types collected in this 

21 program when the testing occurs unless there are 
28

1 unforeseen catastrophic circumstances," something along 

2 those lines. Because that's -- see, "preferably" is 

3 somewhat flexible and what we're trying to do --

4 MR. DOYLE: Exactly. 

5 MR. PENBERTHY: Well, it's too flexible 

6 and what we're trying to do is limit it, that the -- be clear 

7 about when this would happen. 

8 MR. DOYLE: I mean, to me -- there's a 

9 Force Majeure clause when you deal with a lot of these 

10 catastrophic kind of things. Here we didn't -- honestly

11 didn't think this was going to be that big of a deal. We 

12 wanted to -- we expressed our intent. 

13 And there's a trust factor, but at the end of 

14 the day I think -- to me, if it says, "Preferably all samples 

15 should be analyzed for D4..." as stated, I mean, that's the 

16 preference. That's our intent. We've restated it multiple 

17 times. It provides for that. Obviously, if we're going to do 

18 something different midstream, I mean, everyone is going 

19 to be notified of that. I mean, I don't -- I mean, to me, we 

20 could try to wordsmith this and -- to find all of these kind 
29

1 of contingency events, but to me that's an exercise of 

2 futility. 

3 MR. ANDERSON: Or one option might be 

4 to sort of go along what you were thinking, having an 

5 "unless" clause at the end, but link it and say unless there's 

6 an event that would qualify under the Force Majeure 

7 provision at such and such. 

8 MR. PENBERTHY: Would you be happy

9 with that? We'll just cross preferably, start it with all, and 

10 then unless there's a Force Majeure. 

11 MR. MAIT: Yes, because that would be 

12 what we would be anticipating, obviously, under those 

13 conditions. Even if that provision wasn't in there, the lab 

14 wasn't available, we would invoke Force Majeure and this 

15 time the schedule would be blown anyway and we'd be 

16 back renegotiating the time frame and so on. 

17 MS. STARMANN: I'm sorry, I know I'm 

18 not at the table. I'm not sure about Force Majeure -- if that 

19 would qualify for some of the lab situations that -- Force 

20 Majeure is somewhat narrowly defined in this agreement. 
30

1 UNIDENTIFIED FEMALE: What's your 

2 name? 

3 MS. STARMANN: Allison Starmann. 

4 MR. PENBERTHY: Let's go back and take 

5 a look at what it is. 

6 MR. ANDERSON: And there's also the 

7 regulation section, 790.68 where you have unforeseen 

8 circumstances. 

9 MS. STARMANN: You’d have to be 

10 known in advance to qualify. 

11 MR. PENBERTHY: I'm trying to find the 

12 Force Majeure section, what it says. 

13 So it's caused by circumstances beyond its 

14 control or control of -- any entity controlled by the 

15 signatory company. So how is that limited? 

16 MR. DOYLE: Well, I think my preference 

17 is to -- and the reason we stuck the provision in there in 

18 the first place and -- where we talk about the labs is so that 

19 we don't get into arguments about what does or doesn't 

20 qualify as Force Majeure. I mean, that's the -- that --
31

1 MR. PENBERTHY: Well, I guess what we 

2 do want to avoid is the situation where the lab says, oh, 

3 this is harder than we thought, we're going to charge you 

4 twice as much; and you say, well, that's too much, we 

5 want to go to a different lab, then we have to go through 

6 the program. 

7 MR. DOYLE: That's not what was 

8 intended. 

9 MR. PENBERTHY: I know that's not 

10 intended, but is that a scenario that could --

11 MS. PLOTCKE: I think we put 

12 appropriate controls in place. 

13 MR. MAIT: I think -- obviously, we've 

14 fairly well engaged the contractors and I think there's a 

15 clear understanding of expectation of what they have to 

16 do. They've obviously looked at the preliminary test 

17 standards and so on. So the idea of whether they can 

18 perform or not, I think it's well-understood that they can. 

19 It's a matter of achieving -- you know, as 

20 we've said, we're going to get them validated, so they

21 should be able to be in a position to execute what -- again, 
32

1 we're concerned about things that are well beyond our 

2 control, but I'm not a lawyer here. 

3 MR. DOYLE: I think we need to avoid 

4 getting -- we're trying to argue about what the contractor 

5 could or couldn't have controlled, which is literally --

6 comes up in the Force Majeure provision. I mean, I think 

7 that goes beyond -- I mean, you know, we kind of stated 

8 we wanted the flexibility if it comes up. We don't 

9 anticipate it coming up. It's -- and that's why you put the 

10 provision in in the first place. 

11 I mean, at some point we've communicated 

12 what our intent is. We've stated it multiple times. It's on 

13 the record. I mean, it's -- to me, if we leave the flexibility

14 in there, that's consistent with accommodating our needs. 

15 We've stated, you know, what we're going to do to 

16 accommodate, you know, what you prescribed. 

17 MR. SELTZER: The only scenario you 

18 provided was if the lab were to flood or something along 

19 those lines, and that would fit within -- that would be 

20 encompassed in the Force Majeure section. Are there 
33

1 other scenarios you're thinking might not and you're 

2 worried about --

3 MS. PLOTCKE: Well, I think what 

4 Trent's point is is we can't control everything. We can't 

5 control everything for them. I mean, and so --

6 MR. DOYLE: I mean, that lab may decide 

7 to, you know, go out of the business of providing, you 

8 know, this kind of, you know, analytical work. I mean, we 

9 can't control -- maybe it gets sold. Maybe they get bought, 

10 you know. I mean, it's -- maybe, you know, all the staff, 

11 you know, will leave. You know, there's just a whole host 

12 of things that could happen. 

13 UNIDENTIFIED MALE: Breaks down 

14 and they can't fix it. 

15 MR. DOYLE: Yeah, you know, they've 

16 got equipment that breaks down. I mean, I don't want to 

17 get into this situation where we argue about whether that's 

18 Force Majeure or not. I mean, that's not an efficient 

19 process for anybody. We want to get the program done. 

20 That's what we thought by doing this in the first place, was 

21 to get the program done. 
34

1 MS. FEHRENBACHER: I think the 

2 reason that we're pretty strongly in favor of keeping the 

3 language that all samples for individual media be analyzed 

4 by one laboratory is for the data-quality issue. 

5 There's a small number of samples being 

6 collected and analyzed for media. And if you split those 

7 samples among laboratories, then you're introducing 

8 variability -- inter-laboratory variability on top of the other 

9 potential areas of variability and uncertainty. And because 

10 of the small number of samples, you need to maximize the 

11 data quality aspects. And one way of doing that is to 

12 ensure that at a minimum each of the -- all of the samples 

13 for each media are analyzed by one laboratory. 

14 MS. PLOTCKE: And that is our intent as 

15 well because we agree completely from a data-quality

16 perspective. And so that's the intent that we're going in 

17 with, that all of them would be analyzed at one laboratory. 

18 If something were to happen and we had to use a backup 

19 laboratory, we would be sure that that laboratory was 

20 trained and validated and accounted for any potential 

21 variability. 
35

1 MS. FEHRENBACHER: And again, 

2 would all of the samples be analyzed --

3 MS. PLOTCKE: I mean, we wouldn't 

4 know what -- you know, if something happens in the 

5 middle of doing something and they -- we have to make 

6 that shift to go to the backup laboratory, but we would 

7 make sure that --

8 MR. SELTZER: To cite the reg, 790.68 

9 A2 III, it says, "Not technically feasible unforeseen 

10 circumstances such as lack of laboratory availability." I 

11 mean, that sounds like that and a reg goes to right what 

12 you're talking about, any of the issues talking about is 

13 right there. 

14 MR. DOYLE: It seems like that will be 

15 your right consistent with your --

16 MR. SELTZER: And we can cite to that in 

17 addition to Force Majeure, if you want -- I think one of the 

18 previous --

19 MR. PENBERTHY: So let's go back to 

20 where we were. So if we start with -- delete the Preferably 

21 and say unless there is -- what was it? 
36

1 MR. SELTZER: Unforeseen 

2 circumstances such as lack of laboratory availability. 

3 MR. PENBERTHY: As defined --

4 MR. SELTZER: As defined in 790.68 A2, 

5 III. 

6 MR. PENBERTHY: If there is unforeseen 

7 -- give me the right words. 

8 MR. SELTZER: Unforeseen 

9 circumstances such as lack of laboratory availability. 

10 MR. PENBERTHY: Such as --

11 MR. SELTZER: A lack of laboratory

12 availability. 

13 MR. PENBERTHY: As noted in section --

14 MR. SELTZER: 790.68 A2, III. 

15 MR. PENBERTHY: Is that okay? 

16 MS. PLOTCKE: Yes. 

17 MR. DOYLE: Yes. 

18 MR. THOMAS: Yes. 

19 MR. PENBERTHY: Okay. That's a 

20 reasonable outcome -- okay, fair enough. So we'll change 

21 that all and that will be the sentence. The next one was 
37

1 site specific sample times. Could you explain what your 

2 issue is? 

3 MS. PLOTCKE: Yeah. Actually, I'm not 

4 sure we really have an issue there, so I think we'll 

5 probably find out that we just wanted to clarify. It says, 

6 "Site characterization". And we wanted to make sure that 

7 that's what we had referred to in the past, is we would 

8 evaluate the site, evaluate the biology of the site, and come 

9 up with the plan of what we would expect to be there. 

10 So as long as we're in agreement with that, 

11 then --

12 MR. PENBERTHY: Okay. Where is this 

13 in the text? 

14 MS. PLOTCKE: This is --

15 MR. DOYLE: Appendix 1 near the end of 

16 the appendix. It's the last bullet point in the list. It says, 

17 "Site characterization for benthic invertebrate and fish 

18 sampling, including species that are expected to be 

19 collected for analysis." 

20 MR. PENBERTHY: Okay. So all of these 

21 dots refer -- evolve from the sentence above them. A 
38

1 detailed sampling plan shall be prepared for each site and 

2 included as part of the overall study plan submitted to 

3 EPA. The sampling plans shall include...", and then all of 

4 those items? 

5 MS. PLOTCKE: Mm-hmm. 

6 MR. PENBERTHY: Okay. So --

7 MR. STAPLES: Our concern is some of us 

8 read it differently than others and that's -- we wanted to be 

9 sure that this particular part of the site characterization 

10 planning is not presampling, not pre-field work, but, in 

11 fact, it is conversations with local officials who are --

12 might be knowledgeable so that these -- we might be able 

13 to identify species that might be there, should be there. 

14 We're going to try to collect, but not that we have done 

15 presampling, pre-field work. 

16 MR. PENBERTHY: Okay. Do you see --

17 I don't see -- they're not presampling, but they will ask 

18 questions. 

19 MS. PLOTCKE: You're going to 

20 understand the biology and -- yeah, yeah. 
39

1 Okay. We just wanted to make sure we 

2 were on that same page; that's all. 

3 MR. STAPLES: Dramatically affects the 

4 schedule. 

5 MR. MAIT: Strictly precautions, right? 

6 MS. PLOTCKE: Yeah. 

7 MS. FEHRENBACHER: And we 

8 appreciate you checking in with us. 

9 MS. PLOTCKE: Yeah. We just want to 

10 make sure. 

11 MS. FEHRENBACHER: It's good for us 

12 to all be on the same page. 

13 MR. PENBERTHY: Okay. Number 5. 

14 MR. THOMAS: Yes. This is the selection 

15 criteria for the industrial POTWs. This is Appendix 2. 

16 There is a sentence here that relates to the D4 

17 concentration at the POTWs. It says, "D4 concentrations 

18 in the wastewater treatment plant influent shall be 

19 reasonably expected to be at least one part per billion." 
40

1 And I think that's going to be difficult from 

2 the standpoint of presampling. We had not intended to do 

3 any presampling, so I think --

4 MR. PENBERTHY: What we meant by 

5 "reasonably expected" is not sampling, but an engineering 

6 calculation, something along those lines. I mean, what 

7 we're trying to get at here is there's reasonable assurance 

8 that there's actually D4 in the wastewaters. 

9 MR. THOMAS: Sure, sure. And I think 

10 the language prior to that sentence is sufficient to 

11 accomplish that. It says, all wastewater treatment sites 

12 selected for monitoring must be currently processing 

13 wastewater from one or more industrial sites known to be 

14 a D4 processor or formulator as documented through 

15 industrial user surveys, or other readily available 

16 information. We think that language is sufficient to --

17 MR. PENBERTHY: I mean, processing 

18 wastewater doesn't mean it contains wastewater, so the 

19 sentence is a little bit weak in that processing wastewater -

20 - you would have to at minimum say, containing D4. 
41

1 MR. THOMAS: It says known to be a D4 

2 processor. 

3 MR. PENBERTHY: Yeah, but that doesn't 

4 mean the wastewater is -- actually contains D4. I mean, 

5 the D4 processor might not have any water releases, D4 

6 water releases. 

7 MR. THOMAS: Right, but that's the whole 

8 point of the exercise. 

9 MR. MAIT: But then there wouldn't be a 

10 discharger, it seems redundant.

11 If they had no effluent -- they wouldn't --

12 MR. PENBERTHY: My point is they

13 could have effluent that doesn't have D4 in it. We want to 

14 be sure that we're sampling facilities --

15 MR. MAIT: But that is some of the 

16 dilemma, is there is no -- without presampling there's no 

17 way to confirm that position. Well, that's an absolute, 

18 right? If you know it, then somebody's actually analyzed 

19 it. Otherwise, it's somebody's opinion that it's there. 
42

1 MR. PENBERTHY: I mean, if it wasn't 

2 receiving D4 from a processing facility, then it would be 

3 basically an Appendix 3 facility, correct?

4 MR. THOMAS: An Appendix 3 facility --

5 right, right, right. 

6 MR. PENBERTHY: Well, that doesn't 

7 make sense to us. So what is the assurance that there's 

8 actually going to be D4 in that wastewater?

9 MR. THOMAS: Other than to go out and 

10 measure it, which is the whole point of the monitoring --

11 MR. PENBERTHY: Well, can the facility

12 operator tell you, yes, we released before? 

13 MR. MAIT: Typically, the experience is 

14 with things like that, you would complete a survey for that 

15 -- when they're doing these types of investigations, 

16 basically, Categorical Standards of Manufacturing is the 

17 Agency here who tends to regulate. 

18 You do a survey. You provide information 

19 to the operator of the facility that says, these are the types 

20 of processors I have, this is the materials processed, this is 
43

1 the type of, you know, pretreatment or whatever it is that 

2 we have, is it known to you or whatever. 

3 Because frankly, I'm not aware that -- the 

4 people who are going to be asking other than -- potentially

5 the industrial folks who are in this room would know 

6 whether it's in the effluent or not, so we're stuck with -- the

7 only way you really know is you pretest. 

8 MS. PLOTCKE: They may know they

9 process it, formulate it, but each of the systems that they

10 have could be removing it. They don't know that. 

11 MR. PENBERTHY: So let's go back one 

12 step further. So how are you going to identify these --

13 MR. MAIT: The sites would be identified 

14 as we've discussed before. There's certain categorical 

15 standards, you know, classifications, that are known to 

16 process materials like D4, and then --

17 MR. PENBERTHY: (Inaudible). 

18 MR. MAIT: Then you would then have --

19 as part of the recon on the POTW, we would work with --

20 through our contractor, work with that POT operator to go 

21 back to their dischargers to complete a survey, do you 
44

1 process with D4, are you manufacturing with D4, is it 

2 known to be in your effluent, is it suspected to be in your 

3 effluent. That's typically what I see on these surveys. 

4 MR. PENBERTHY: I think that's okay as 

5 long as -- but that's -- how do we put that in this text?

6 MR. THOMAS: We got here through 

7 industrial user surveys, and that was what was just 

8 described. 

9 MS. PLOTCKE: And it says, "as 

10 documented," so there will be -- those surveys would be 

11 on record. 

12 MR. PENBERTHY: All right. One thing 

13 we did -- I propose adding another sentence at that point, 

14 then it would be in the second sentence in the paragraph, 

15 after -- the first sentence would be, the Study Plan shall 

16 detail the factors that were used to select each of the sites 

17 for testing." 

18 And then we would want to add a sentence

19 along the lines of, "The Study Plan shall provide an 

20 explanation of why D4 concentration in influent are 

21 expected to be above the surface water MDL specified in 
45

1 Appendix 5." So we want to know there's actually a water 

2 release. 

3 MR. THOMAS: We may not be able to 

4 know. 

5 MR. PENBERTHY: Well, you would 

6 know if you did the survey, right? 

7 MR. THOMAS: Well, just because there's 

8 a water release doesn't mean you'll be able to detect it or 

9 that it's going to be above the MDL. I mean, that's --

10 MR. PENBERTHY: Well, every facility

11 that was tested in the Canadian said you had 

12 concentrations over --

13 MR. THOMAS: Not in the surface water 

14 concentrations. In fact, I remember --

15 MR. PENBERTHY: Yeah. Well, I'm 

16 talking about the influent. 

17 MR. DOYLE: Well, the influent you'd 

18 have to --

19 MR. PENBERTHY: Correct. That's what 

20 I'm talking about. I mean -- you follow? 
46

1 UNIDENTIFIED MALE: It still 

2 (inaudible) presampling or not. I mean, you know, we're 

3 not going to make representations about it. 

4 MR. THOMAS: We would have to 

5 actually meet that. I mean, certainly it sounds like you 

6 could reasonably expect that to be the case; but to confirm 

7 it, we'd have to go out and --

8 MR. PENBERTHY: Well, that's what we 

9 said, reasonably expected. 

10 MR. THOMAS: Right, but to make that --

11 to show that, you would actually have to go out and do the 

12 testing. 

13 MR. MAIT: I mean, my personal view is if 

14 folks are processing it, they have discharge, things like 

15 that; whether they're pretreating or not, is there potentially

16 a quantifiable amount? Probably. But absolutely? You 

17 know, that's a pretty tall standard to take without actually 

18 doing the analysis. 

19 MR. THOMAS: And that's what we're 

20 trying to avoid, the need to go out and do the presampling. 
47

1 MR. PENBERTHY: Well, the intent is not 

2 presampling. I mean, obviously, we're not -- we're trying 

3 to be sure that there's waste being treated. And how do we 

4 assure that? And you know, the paranoid person would 

5 say, well, you're just going to pick facilities that are closed 

6 systems and they have absolutely no chance of a water 

7 release, and that's not what we're interested in. 

8 MR. MAIT: But if the survey is offered by 

9 the -- let's say for the POTW, the folks that are discharging 

10 to them, if they're completing the survey where they are 

11 asked, known to be present or suspected to be present, 

12 then you would be relying on their knowledge of their 

13 effluent. 

14 MR. PENBERTHY: But I'm saying that 

15 that would be sufficient. 

16 MR. MAIT: Okay. Well, that's fine. 

17 MR. DOYLE: We just can't -- I can't 

18 qualify that further by saying that that equates to being 

19 above the method detection line. 

20 MS. FEHRENBACHER: So if we were to 

21 add after the wastewater influent shall reasonably be 
48

1 expected based on the industrial site -- the industrial user 

2 survey and other readily available information to be at 

3 least one parts per billion, would that --

4 MR. THOMAS: The one part per billion is

5 always going to be problematic because the only way to 

6 confirm that is to go out and measure it. Everything you 

7 said up until the one part per billion, I think, is fine. I 

8 mean, we certainly want to make sure we're testing 

9 facilities that process D4, but we can't attest to, on the 

10 front end, what the concentrations are going to be. 

11 MR. PENBERTHY: So how about we say

12 the waste -- a study that says that you want to do -- you 

13 say the wastewater influent shall reasonably be expected 

14 to contain D4?

15 MR. THOMAS: Yes.

16 MR. NGUYEN: Have a measurable 

17 amount. 

18 MR. PENBERTHY: So we have the 

19 proposal the wastewater influent shall reasonably be 

20 expected to have a measurable amount of D4? 
49

1 MR. DOYLE: I like the first one. That's 

2 the whole point. We don't know. Based on these surveys, 

3 we're going to qualitatively determine that -- through the 

4 surveys, that the site releases wastewater to the POTW 

5 that has D4 in the effluent. 

6 MR. PENBERTHY: Okay. How did you 

7 just say it? 

8 MR. DOYLE: Whether it's measurable, 

9 whether it's --

10 MR. PENBERTHY: Well, let's put the 

11 words you just said into a reasonable sentence. 

12 MR. PENBERTHY: Let's start with --

13 we've got our first sentence, "All wastewater sites selected 

14 for monitoring must be currently processing wastewater 

15 from one or more industrial sites known to be a D4 

16 processor or formulator." 

17 MR. PENBERTHY: And then we need the 

18 wastewater treatment plant influent --

19 MR. DOYLE: Shall reasonably be 

20 expected to contain D4 based on -- as documented through 

21 industrial user surveys --
50

1 UNIDENTIFIED MALE: Or other readily 

2 --

3 MR. DOYLE: Or other readily available 

4 information. I mean, maybe they've done (inaudible). 

5 MR. FLACK: Well, you start the sentence 

6 with D4 concentrations, so you expect --

7 MR. PENBERTHY: So let me get this. 

8 "The wastewater treatment plant influent shall reasonably

9 be expected to contain D4 based on..." -- and is it this 

10 phrase up here, and industrial user surveys --

11 MR. DOYLE: Or other readily available 

12 information, yes. 

13 MR. MAIT: That would be the basis to 

14 inform us that we have a reasonable expectation that it be 

15 present. 

16 MR. DOYLE: And this is going to be 

17 documented in the Study Plan, so it's going to all come 

18 through EPA. You know, you're going to get to see sites, 

19 we pick the basis, we pick the sites. This sets out the 

20 standard for everything. 
51

1 MR. MAIT: So Ward, think of it this way. 

2 If the surveys come back and the dischargers to the 

3 POTWs say, not expected to be present, obviously that's 

4 not --

5 UNIDENTIFIED MALE: We would be 

6 putting it into a different category, would we not, just as 

7 you suggested? 

8 MR. PENBERTHY: Are you okay with 

9 that, Nhan? It all makes sense, the wastewater treatment 

10 plant --

11 MR. NGUYEN: I think first to have some 

12 explanation -- a fair explanation of the Study Plan that 

13 explains why we expect that the concentration and 

14 wastewater contains D4. Some kind of explanation --

15 MR. THOMAS: And we'll certainly have 

16 some explanation for why we expect there to be D4 in the 

17 influent, and that would be because the folks that release 

18 to that wastewater treatment plant say they use D4. 

19 MR. MAIT: And reasonably expect it to be 

20 present. 
52

1 MR. PENBERTHY: All right. So again, 

2 on the -- it says on the sentence, "The Study Plan shall 

3 detail the factors that were used to select each of the sites 

4 for testing," and then include an explanation of how -- and 

5 shall provide an explanation of why D4 is expected in the 

6 influent. 

7 All right. So here's the proposal I got. Can 

8 I read it to you? Are you okay?

9 MR. THOMAS: Mm-hmm. 

10 MR. PENBERTHY: Okay. So I'll go one 

11 more time with the sentence up on top just so we know 

12 what we're saying. 

13 "The wastewater treatment plant influent 

14 shall reasonably be expected to contain D4 based on 

15 industrial user surveys or other readily available 

16 information." 

17 And then in the paragraph below the dots, 

18 the first sentence, we'll extend it. It will read, the Study

19 Plan shall detail the factors that were used to select each of 

20 the sites for testing and shall provide an explanation of 

21 why D4 is expected in the influent." 
53

1 Okay. So the next one -- does anyone need 

2 clarification on what we just said or are you going on to 

3 that?

4 MR. THOMAS: So the next one is 

5 selection of non-industrial POTWs. 

6 MR. PENBERTHY: Okay. 

7 MR. THOMAS: And I think here --

8 MR. PENBERTHY: This is Appendix 3, I

9 take it?

10 MR. THOMAS: This is Appendix 3, yes. 

11 MR. PENBERTHY: Okay. Here we're 

12 comfortable with the language. I think we just wanted to 

13 acknowledge, I think, based on our previous 

14 recommendation, that the agency included some wording 

15 that we thought made the section more clear, in particular, 

16 the clause of Preferably no wastewater from D4 

17 manufactured processors or formulators, but I think we're 

18 good with this section. 

19 MR. PENBERTHY: Okay. So it's a non20 issue. 
54

1 MR. THOMAS: The next one is number of 

2 analyses. And I'm going to let our technical folks list 

3 them. 

4 MR. STAPLES: Okay. Mainly the things 

5 that were added in terms of number of samples were some 

6 extra QA samples, in other words, samples collected to be 

7 used for field spikes would be split and both the spiked 

8 and unspiked portions of those would be analyzed. So that 

9 adds a considerable number of samples for QA purposes. 

10 A total over the course of the program were roughly 

11 another 25 percent of the samples. 

12 Speaking with our analytical folks, it might 

13 provide some small additional positive QA concern, but it 

14 is an awful lot of samples. We're not going to say no, but 

15 it -- we consider it a relatively large additional number of 

16 samples for a really small benefit. 

17 MR. PENBERTHY: Well, you know, we 

18 had some difficulty with this issue, and I'll explain what 

19 our logic was. Obviously, we have a limited number of 

20 samples and sites for you to pick, so we definitely want to 

21 have as much assurance that the samples that we actually
55

1 do have taken are good samples. And so the way you 

2 could do that is with good QA, QC or more samples. You 

3 all are very insistent on fewer samples, and so that leaves 

4 us no choice in terms of boosting the QA so we know that 

5 the samples that are taken are good. 

6 MR. STAPLES: Well, what we have 

7 defined, I think, will get you to the same spot. Our 

8 analysts do say that this will provide a slight bit of 

9 additional positive benefit, not really necessary but --

10 MR. PENBERTHY: So we're good? 

11 MS. PLOTCKE: So we're fine, yeah. 

12 MR. DOYLE: Yes. 

13 MR. THOMAS: Yes. 

14 MR. PENBERTHY: We're on Item 8?

15 MR. THOMAS: Yes. So this is the 

16 method detection limit. I'll let Charles do that one as well. 

17 MR. STAPLES: And I'm just going to kind 

18 of tee this up, but we have in the room Dr. Deb McNett 

19 who is the -- one of the leading experts in terms of 

20 analyses of D4 in all media around the world. And I say

21 that truthfully because she is the person that's going to be 
56

1 basically in charge of training -- qualifying and training 

2 the laboratory that is selected for this, so as such she has 

3 considerable knowledge in terms of analytical 

4 methodologies. 

5 One of the challenges that we've had with 

6 explaining our position on method detection limits and so 

7 forth is that we can take a method that one lab uses and 

8 hand it to another laboratory, a very well-qualified 

9 laboratory, and they can adapt that method and start 

10 analyzing for D4. But according to the experts at Dow 

11 Corning, they will also start to find background 

12 contamination issues that are different with -- Dow 

13 Corning's were different from any other laboratory. 

14 And that will just take some time, and so 

15 where we're at on the appropriate level of detection is that 

16 we can accept the higher -- we can accept the levels --

17 limit of quantizations

18 you proposed for each of the media as long as we 

19 recognize and the tests reflect that those are the reportable 

20 limits for D4 analyses. We're not sure -- Dow Corning is 

21 not confident and not sure that any lab on the pace that this 
57

1 program is going to be conducted at can reach the MDLs, 

2 that the MDLs times three to get your LOQ -- if that LOQ 

3 was agreed to be the point of departure, that is the 

4 reporting limit, then we can agree to those. 

5 MR. PENBERTHY: And so basically

6 you're going to -- you wouldn't report non-detects? Is that 

7 what you're saying, you would only report when you 

8 actually detect above the LOQ? 

9 MR. STAPLES: Anything below the LOQ 

10 is a non-detect. 

11 MR. PENBERTHY: Is that conventional 

12 science? 

13 MS. PLOTCKE: Maybe we can go back 

14 to the text in the actual ECA, Trent. 

15 MR. THOMAS: --

16 if you want to look at -- there's a couple different spots 

17 here. We've got two locations really where this comes up 

18 -- or key locations. 

19 There's -- in Section 2 of the ECA, we 

20 talked about chemical subject of the ECA. Do you 

21 remember we had talked about -- this is a little different 
58

1 than your normal test plan or ECA because it's not 

2 toxicology testing. We've got -- here it says the ECA 

3 requires testing for the presence of D4 in specified 

4 wastewater treatment plant influent and effluent 

5 discharges, receiving streams, environmental matrices --

6 and here's the part we want to focus on -- at method 

7 detection limits specified in the test standards Appendices 

8 4 through 8. 

9 And our key comment here is, we would 

10 take that method detection limit and replace that with 

11 limits of quantization specified in the test standards in 

12 Appendices 4 through 8. 

13 Then if you go back to the individual test 

14 standards, that's what Kathy was referring to in terms of --

15 that's where it's been set out how the limits of quantization 

16 are calculated. And those were established based on a 

17 multiplication of the method detection limits that have 

18 been achieved in previous studies and multiply those --

19 originally we had -- if you recall, a practical quantification 

20 limit of five times the method detection limit. 
59

1 EPA has come back with a factor three 

2 times the method detection limit, and we're going to accept 

3 that as a limit of quantification. I think the point that 

4 Charles made is we want to make certain, when the data 

5 are reported, it's going to be -- if it's above the limit of 

6 quantization, it's reported as such. If it's below that, it 

7 would be essentially, as you rightly pointed out, Ward, it 

8 would be reported as less than the LOQ. 

9 MR. PENBERTHY: Okay. But that's not a

10 conventional approach to monitoring, is it? 

11 MR. DOYLE: I think that the challenge 

12 here is with the --

13 MR. PENBERTHY: You usually report 

14 the data that you get, right? So whatever you get is the 

15 number you get. You wouldn't filter it. 

16 MR. DOYLE: Remember, what we're 

17 going to qualify in these labs is to be able to achieve a 

18 limit of quantification of three times the -- because the 

19 method detection value that's being plugged in, that's from 

20 a prior study. That's not a study that these labs have done. 

21 That's from the prior studies that have been achieved. And 
60

1 that's what's going to use -- we're willing to use various 

2 values that have been pulled from these various studies to 

3 calculate a limit of quantification. 

4 We're just not certain that -- from a time 

5 standpoint, we're going to be able to get a particular lab to 

6 achieve a method detection limit that equals what's 

7 specified there; hence, going with the limit of 

8 quantification. I don't know if, Kathy, you have anything 

9 else to add. 

10 MS. PLOTCKE: So I think we may want 

11 to maybe go and talk about this if we can. 

12 MR. PENBERTHY: Sure. 

13 MS. PLOTCKE: But I want to make sure 

14 that we understand your position before we do that. 

15 MS. EISENREICH: I do have a question. 

16 So you're saying that you would use -- so we have an 

17 MDL from your literature, from all the literature -- we 

18 used the highest values we can find from your reported 

19 MDLs. So you're saying you're okay with using three

20 times that as the limit -- the LOQs; however, LOQs are 

21 typically calculated three times whatever MDL is achieved 
61

1 in the study, so to set a specific number is inappropriate. 

2 And I think our point with the MDL had -- the one I'm 

3 looking at happens to be from biota, so three and a half 

4 nonograms per gram, you would be less than that, up to --

5 your MDLs -- you should be able to achieve an MDL

6 that's up to three nanograms per based on all literature 

7 that's out there, the MDLs that have been reported. 

8 MR. DOYLE: I understand what you're 

9 saying, but --

10 MS. PLOTCKE: Yeah. What we're saying 

11 is the way those were achieved is -- there were a lot of 

12 special precautions taken in place, and that's why we were 

13 originally going with the practical. But what we're saying 

14 is we'll go based on what the lab is able to achieve, which 

15 is what you just said. You determine the MDL, and then 

16 the LOQ is three times that. But it's what they're able to 

17 achieve, not something that's cited in literature where 

18 special precautions and --

19 MS. EISENREICH: Right. The reason 

20 why these MDLs are in here are to give a maximum 

21 analytical benchmark essentially, so we want to make sure 
62

1 that the -- the analytical ability of the lab reaches a certain 

2 point. 

3 MS. FEHRENBACHER: And let me also 

4 ask some clarifying questions on the work that you're 

5 planning to do to get these analytical laboratories up to 

6 speed because I'm quite concerned about that. You have 

7 quite of bit of expertise with these chemicals and the 

8 precautions that folks need to take such as don't wear -- or 

9 don't use products that contain siloxane compounds, so it 

10 seems to me you must have a list of those precautions, 

11 some of which should be fairly straightforward. And I'm 

12 assuming that you're going to share that information. 

13 MS. PLOTCKE: And we already have 

14 with our candidates, yes. 

15 MS. FEHRENBACHER: And that you 

16 must have some assurance that the samples that they're 

17 going to be collecting and analyzing will be of high 

18 quality. And I'm also assuming that you're planning to 

19 have your experts from Dow or other laboratories that 

20 have that expertise to work with the laboratories and share 

21 their knowledge so that they understand that precaution. 
63

1 So what are some of the special precautions you think will 

2 be so difficult that other laboratories won't be able to meet 

3 MDLs that have been widely published in the literature. 

4 MS. PLOTCKE: So for example, some of 

5 the things that we've done, we may have a dedicated clean 

6 hood. You know, asking a laboratory to the -- to have a 

7 dedicated clean area when they're a commercial laboratory

8 is just challenging to do. 

9 So we're a smaller laboratory. We have the 

10 ability to do that, but a commercial laboratory -- certainly 

11 we have asked them to have as much of these precautions 

12 put in place as possible, but they are a commercial 

13 laboratory, so, you know, there's a lot that goes on at those 

14 commercial laboratories. 

15 This is what we do, so it's just that level --

16 or for us, it's what we do. This is what we do, these are 

17 our analyses that we do, and -- but for them, they're a 

18 commercial laboratory. They do a variety of things. We 

19 can't ask them to shut down their entire lab and do only

20 this project, so you have to -- but we've put all the training 

21 in place. 
64

1 They know the requirements. They will 

2 actually be tested after they're trained to ensure that they 

3 don't have contaminations. We put provisions in the 

4 agreements that they would have to sign indicating, if they

5 have samples, what's the ramifications and the 

6 consequences of that? 

7 So we've laid all of that out for them and 

8 we will do that and they will have that training, but it's just 

9 a level that we can go to in our laboratories because we're 

10 small groups. This is what we do. This is, you know, 

11 what we do every day. That can impact that, that level. 

12 MS. McNETT: And we've spent a decade 

13 or more getting to that level and determining where the 

14 sources of contamination can come from. For example, 

15 we've analyzed air in different laboratories even within our 

16 site, and we'll have laboratories that have air samples of --

17 that contain D4 14 times higher than another laboratory, 

18 and it takes time to identify where that source of 

19 contamination is. And on a schedule that this program is 

20 on, we can't guarantee that we're going to contract a 
65

1 laboratory that's not used to that to be able to identify all 

2 of their sources of contamination that are possible. 

3 MR. PENBERTHY: I think we've tried to 

4 be pretty generous here because we picked the high end of 

5 the ranges of all the MDLs of studies that you've done. 

6 And you know, I would think that if you couldn't achieve 

7 the method detection limits that are specified here, you'd 

8 have to come forward with a modification explaining that, 

9 and then describing what the MDL is and see if we would 

10 approve the modification. But I think the MDLs we've 

11 picked are pretty reasonable. I mean, they're what's 

12 required, you know, for risk assessment purposes to have 

13 meaningful data. 

14 MS. PLOTCKE: Deb, did you want to 

15 make a comment? Go ahead.

16 MS. McNETT: I'm just going to go from 

17 the 1985 EPA document describing practical 

18 quantification limits and it describes this issue, I think, 

19 very well in that a practical quantification limit is 

20 proposed as the lowest level achievable among 
66

1 laboratories within specified limits during routine 

2 laboratory operations. 

3 The PQL is significant because different 

4 laboratories will produce different MDLs even though 

5 they're using the same analytical procedure, same 

6 instruments, and same matrices. 

7 MR. PENBERTHY: That's why we picked 

8 an (inaudible) that you've already demonstrated. 

9 MS. McNETT: Not in all cases are they on 

10 the high end of the range. 

11 MR. PENBERTHY: All the ones here say

12 they are. 

13 MS. McNETT: For example, sediment, 

14 we've had a study where we had 8.5 nanograms per gram. 

15 And you're proposing 3.7 nanograms per gram in this 

16 version. 

17 MR. PENBERTHY: We picked studies 

18 that you've had published and we picked MDLs at the 

19 high-end range. 

20 MS. McNETT: Right. 

21 MR. TOBIAS: It was from
67

1 one study. That study had multiple MDLs. We took the 

2 highest one out of the study. So within that one study, 

3 there was the one we cited 3.7. There was also, I believe, 

4 .4, as the other one. And the 3.7 actually they thought was 

5 inflated, and there's a long explanation of why they 

6 thought it was inflated. 

7 MS. McNETT: But there's also another 

8 study reference that has 8.5 nanograms per gram. And 

9 those were different time periods and different levels of 

10 expertise for us to identify the contamination potential, 

11 and in that case it was a particular sample of Nitrogen gas 

12 that was used in a concentration step. But what I'm saying 

13 is we can't control for all the variables and points of 

14 contamination potential. 

15 MS. PLOTCKE: Debbie, maybe it would 

16 be good to state what you think the language should be. 

17 MS. McNETT: Okay. 

18 MS. PLOTCKE: And then we go, and 

19 then if you guys need to talk about it --

20 MS. McNETT: I need to find it here. I'm 

21 on Page 48 -- sorry, Page 30. And this is a paragraph that 
68

1 says, the MDL. And I'm going to start with the second to 

2 the last sentence where it states, "During method 

3 development the Knoerr 2013 analytical method for D4 I 

4 achieved a matrix-specific MDL of 0.037 in micrograms 

5 per liter and which shall be achieved for surface water 

6 testing." 

7 And then it goes on to say, "The specific 

8 level of detection shall be based on the LOQ, which shall 

9 be three times the MDL." 

10 I'm proposing -- or we are proposing that 

11 shall be achieved for surface water testing in that -- the 

12 end of the second to the last sentence be removed. 

13 MR. PENBERTHY: So if we did that how 

14 would we know the precision of the data that we were 

15 getting? You know, what are you agreeing to? How do 

16 we know what you're agreeing to? 

17 MS. McNETT: We will agree to report any 

18 level above the limit of quantification at three times -- in 

19 this case three times 0.037, which is 0.11. 

20 MR. LEWIS: And you want that to each 

21 environmental matrices? 
69

1 MS. McNETT: Right, changing the 

2 number appropriately, but --

3 MR. PENBERTHY: But how do we know 

4 the actual sensitivity test that you're performing? 

5 MS. McNETT: But you are agreeing to 

6 0.037? 

7 MS. PLOTCKE: Times three. 

8 MR. PENBERTHY: They're agreeing to 

9 three times the MDL, whatever the hell that might be. If 

10 they're not trying hard, it might be 5.3 or something. 

11 MS. PLOTCKE: No. We're okay with 

12 actually the MDLs that are specified in there. 

13 MR. THOMAS: Yeah, we're okay with 

14 that number. 

15 MS. PLOTCKE: So it's three times that 

16 would be the limit of quantification or the level of 

17 quantification. 

18 MR. PENBERTHY: But I mean, if you 

19 have that -- if you can -- why wouldn't you report levels 

20 between the MDL and the LOQ? It doesn't make sense. 
70

1 MS. PLOTCKE: Because it's below the 

2 limit of quantification. 

3 MR. STAPLES: And recall all of the 

4 MDLs that you are proposing are Dow Corning 

5 concentrations that have been developed over -- with a 

6 skill base over the course of many years. We're talking 

7 about having a couple of months to train a laboratory to do 

8 the best that they can. 

9 MS. FEHRENBACHER: So just to make 

10 sure that we understand you're okay with the MDL values 

11 that we've included, but you're only proposing to report 

12 values above the LOQs and any value below an LOQ 

13 would be a non-detect, would be reported as a non-detect. 

14 So we would never know --

15 MS. PLOTCKE: Less than LOQ. 

16 MS. HENRY: But if you're agreeing to the 

17 predefined MDL and three times that, it's a fixed number. 

18 MR. STAPLES: 0.11 micrograms per liter. 

19 MS. FEHRENBACHER: But really below 

20 the LOQ, you have really no assurance that -- you know, 

21 you're really drastically limiting our assurance of the 
71

1 values that you're analyzing and the accuracy, the 

2 accuracy of those values. 

3 MR. PENBERTHY: And you’re filtering 

4 the raw before you send it to us -- out. I just don't 

5 understand that. 

6 MS. PLOTCKE: I mean, what you're 

7 really saying is because there's that level of uncertainty. 

8 There's a greater level of uncertainty in that number, and 

9 so it's below that limit of quantification. That's all you're 

10 really saying. 

11 MR. PENBERTHY: Why don't you just 

12 explain that in your report and report the raw data? I

13 mean, that's typically what people do in science, don't 

14 they? 

15 MS. PLOTCKE: You could see it in 

16 multiple ways. 

17 MS. FEHRENBACHER: That's our 

18 standard practice, is to record -- record the raw data with 

19 the MDL and the LOQ and not the (inaudible). 

20 MR. STAPLES: And I will just say this as 

21 a nonanalytical chemist, but based on my long dialogs 
72

1 with analytical chemists is that we don't think we can train 

2 a lab that's not analyzed D4 and all these matrices in the 

3 months that we have to do to reach the Dow Corning 

4 method. 

5 MR. PENBERTHY: I mean, if that's the 

6 case, then what you should do is file for a modification 

7 that explains what --

8 MR. THOMAS: Can we take 10 or 15 

9 minutes to just kind of talk a little bit about this and maybe 

10 this would be a good time for a break anyway? 

11 MR. PENBERTHY: Sure. (A recess was 

12 taken)

13 MR. THOMAS: One thing we thought 

14 would be helpful for clarification, can you give us some 

15 sense for how the agency typically treats data that's 

16 reported below the LOQ? 

17 MR. PENBERTHY: Well

18 typically we report the LOQ -- well, I'll give you my

19 understanding and then let (inaudible) tell you. I think 

20 typically we report all of the raw data and then in these 

21 kinds of reports we certainly define the MDL and define 
73

1 the LOQ, and then we will define what actually is meant 

2 by a nondetect. And so we wouldn’t be filtering data like 

3 this, typically in a sound science basis, it would be unusual 

4 -- I think it would be very hard for us to agree to that kind 

5 of thing. 

6 MR. THOMAS: But in terms of the 

7 subsequent analysis, does the -- do data above the LOQ 

8 get treated in the same manner as those that are below the 

9 LOQ? You just report in all of the data and --

10 MR. PENBERTHY: Right. And then the 

11 arguments start, but the data speaks for themselves. Why

12 does -- what's the average? What's a nondetect level? But 

13 the data is there; it's present. So we're going to need to 

14 have that. I just don't think we could agree with your 

15 proposal where we would filter data and keep raw data out 

16 of the record of what's available. 

17 MR. THOMAS: And I don't think that was 

18 the intent. I think the idea was more to have some relative 

19 acknowledgement that the quality of those data are 

20 different. Otherwise, there would be no point of having an 

21 LOQ. 
74

1 MR. PENBERTHY: Right. I understand 

2 that and we understand that there's difficulties -- maybe 

3 difficulty in meeting the MDLs, but we also know that 

4 Canada did a study and they met similar MDLs. And so 

5 we know while this is a difficult issue -- it may be 

6 problematic -- it is something that's can be dealt with. 

7 And to the extent -- we can insert language 

8 into this ECA that says, we recognize achieving the MDL 

9 may be difficult and may require modification, if 

10 necessary. But then if that was going to happen, we'd 

11 need to know precisely what has occurred and why 

12 (inaudible). 

13 MS. PLOTCKE: You know, to be honest,

14 our real concern is the ability of the labs to achieve these 

15 MDLs, and particularly in the time frame that we're 

16 dealing with. As Deb said, we've been doing this for a 

17 decade, so we have a lot of learnings that -- yes, we will 

18 try to transfer as much as possible in the training and 

19 everything, but we are concerned. 

20 So we just want to make sure that there's a 

21 way to manage that concern. So if there's a better way to 
75

1 do it by putting some language about -- what happens if 

2 they're not able to achieve it, then let's look at that. 

3 MR. PENBERTHY: Right. And we can 

4 add a sentence in here on the -- you know, along the lines 

5 of in the event the MDL for a specific media that's being 

6 measured couldn't be achieved, SEHSC will -- I don't 

7 know what the right verb is -- apply for a modification 

8 under the procedures and explain why EPA recognizes 

9 that this could be an issue. 

10 MR. DOYLE: Conceptually, I understand 

11 (inaudible), but the key is we really want to make sure --

12 we'd like to capture, engage, recognition of the challenge 

13 of the issue. So I think the language you used, I think, 

14 Ward, most recently when you said the agency recognizes 

15 that achieving these MDLs may present challenges. 

16 MR. PENBERTHY: Okay. So let me start 

17 putting a pen here. 

18 UNIDENTIFIED FEMALE: Is that for 

19 Part 2? 

20 MR. PENBERTHY: No. I think we'll 

21 leave Part 2. And this will be a sentence in each of the test 
76

1 standards 4 through 8, that EPA recognizes that 

2 laboratories may have difficulty obtaining -- achieving the 

3 as-specified MDL. In this event -- what's the proper noun, 

4 test sponsors? Test sponsors shall seek a modification --

5 shall seek an ECA

6 modification as specified under --

7 MR. SELTZER: 40 C.F.R., 790.68. 

8 MR. ANDERSON: Actually, I don't think 

9 it would be the principal test sponsor. I think it would be 

10 the signatory company. 

11 MR. SELTZER: You're right. It's mutual 

12 companies. We define it that way. 

13 MR. PENBERTHY: Under 790.68. And 

14 then we will repeat that in each -- repeat it in each of the 

15 test standards?

16 MR. THOMAS: Yes. 

17 MS. PLOTCKE: Do we want to specify

18 the time or -- I mean, does it matter. I mean, if we're not --

19 we will -- we can probably define the timing. 

20 MR. PENBERTHY: If the scheduling gets 

21 off, you need to seek a modification. 
77

1 MS. PLOTCKE: Anyway, so you're right. 

2 Yeah, yeah, okay. 

3 MR. MAIT: One leads to the other. 

4 MR. DOYLE: The only challenge that I 

5 think would be the timing of the -- the timing of the 

6 modifications. The 790.68 rule we have are prescriptive 

7 about the timing of submitting applications for schedule 

8 modifications. 

9 MR. PENBERTHY: What's your concern? 

10 MR. DOYLE: Well, I just want to make 

11 sure that the -- you know that -- depending upon -- I guess 

12 maybe it's a concern about nothing insomuch as depending 

13 upon when this happens in the process, whether we could 

14 meet the 60-day window, which, I guess, it shouldn't be a 

15 problem assuming these occur early on in the program, 

16 you know, during the validation portion, so maybe you 

17 think it's not a real concern. I'm just looking at the timing 

18 provisions of 790.68. 

19 UNIDENTIFIED MALE: Well, I think 

20 we're okay. 
78

1 MR. PENBERTHY: I mean, this whole 

2 section agrees that it's sort of meant for the situation. Do 

3 you have any input on this, on the 790? 

4 MR. DOYLE: We're okay. We just want 

5 to make sure that we thought through the timing. I had to 

6 make sure that we weren't going to, you know, practically

7 speaking, not have time to actually submit a request for 

8 modification. 

9 MR. MAIT: The lab validation process is 

10 one of the first things we're going to (inaudible), so --

11 UNIDENTIFIED MALE: Any bad news 

12 would be heard early. 

13 MR. THOMAS: So I think we're Good on 

14 this one. 

15 MR. PENBERTHY: 60 days, right? Okay, 

16 thank you. 

17 MR. THOMAS: All right. Thank you. 

18 So the next one was the collecting influent 

19 samples one residence time apart. And this is Appendix --

20 this is either five or seven. I think it's five. The issue is 

21 the collection of influent and effluent samples for analysis 
79

1 of D4. And the language specifies that the samples will be 

2 taken at least one wastewater treatment plant residence 

3 time apart, if practical. 

4 MR. DOYLE: That's Appendix 4. It's 

5 right before the Figure 1. 

6 MR. PENBERTHY: Okay. You 

7 understand that this is specific to influent and effluent, 

8 correct? 

9 MR. THOMAS: Yes, correct, correct. 

10 MR. PENBERTHY: Okay. So what is the 

11 specific concern?

12 MR. THOMAS: The specific concern is 

13 that the residence time at some POTWs could vary

14 between hours and days. And given the number of 

15 samples that need to be taken, you're talking -- you're 

16 substantially increasing the amount of time required to do 

17 sampling at each site, which is going to not allow us to 

18 achieve the 60-day goal. 

19 Plus, I think it's also unclear -- the value of 

20 this exercise relative to its need for doing a risk 

21 assessment. 
80

1 MR. PENBERTHY: Yeah. I'll explain that 

2 to you. It's not directly related to the risk assessment, but 

3 it is related to the quality of the information generated by

4 the testing. 

5 And by that, I mean, if there is time 

6 separation between the duplicates of influent and effluent, 

7 it allows us to understand -- if there's a potential for an 

8 artificially low measured concentration or is this really

9 standard operating procedure. And if -- and a standard 

10 operating condition or even a steady-state situation. 

11 So the greater the time separation between 

12 when the samples are taken, it would give us some 

13 assurance, if the levels are comparable, that there's nothing 

14 precarious going on there. It's a typical situation. So that 

15 was the intent, to make it sort of a quality check. So we 

16 understand the residence is not going to be a long time, but 

17 we want to find the time dimension that gives us some 

18 assurance of the concern I just mentioned. 

19 MR. THOMAS: If the concern has to do 

20 with ensuring that the plants are operating within the range 

21 of what would be normal operating conditions, I think we 
81

1 talked previously about collecting a whole number of data 

2 for each plant that would be included in the site-specific 

3 sampling plans. And I think you would get information 

4 with respect to the --

5 MR. PENBERTHY: I don't understand 

6 that. 

7 MR. DOYLE: In Appendix 4, under 

8 establishment of appropriate time for sampling events. It 

9 starts off, "At each site, two sampling events will be 

10 undertaken that are scheduled to be a minimum of three 

11 months apart and during normal plant operations and 

12 weather conditions. Normal operating conditions will be 

13 established by consulting with the operator of each 

14 wastewater treatment plant, indirect and direct discharge 

15 facility. The criteria or means that are used by the 

16 facilities to determine normal operating conditions will be 

17 documented in the site-specific sampling plans." 

18 Confirmation will be obtained that the subject facility is 

19 operating under normal conditions prior to commencing 

20 sampling at a given location." 
82

1 The intent in having all of that in there was 

2 precisely to get at making sure we're sampling, when, in 

3 fact, these sites are operating under normal conditions. It 

4 just is a practical matter to have folks, you know, 

5 happening around multiple days and trying to meet --

6 MR. PENBERTHY: What page is this on? 

7 MR. DOYLE: That's on Page 22. We're 

8 concerned between residence time, there could be -- we 

9 can have weather issues come up, a whole host of things. 

10 And all of a sudden we're going to keep -- you know, 

11 you're going to invalidate your whole sort of sampling in a 

12 program there because you were going to be -- going to 

13 have such huge time gaps between the -- each individual 

14 sample potentially. 

15 It adds a lot of uncertainty to try to have 

16 multiple field crews out there working at all of these sites 

17 and getting the program to stay on schedule. To me, you 

18 know, if anything, is seems to introduce more variability

19 or uncertainty into the data as compared to, you know, 

20 cleaning it up. 
83

1 MR. MAIT: And I would offer that we, 

2 you know, look at, let's say, a theoretical 14 sites within 

3 the time window in order to achieve only environmental 

4 conditions that we have to satisfy and the types of 

5 facilities, and the geographic thing. This is quite a thing to 

6 choreograph to be sure we're meeting the window of 360 

7 days. 

8 MR. PENBERTHY: So your proposal is 

9 specifically in terms of the language of this?

10 MR. THOMAS: Is to strike the language 

11 that -- so the language would just be stricken at -- there 

12 would be a period after at each influent and effluent 

13 location, seven grab samples -- and then there's a 

14 parenthetical -- two quality assurance samples, and five 

15 D4 study samples will be taken, period. So the "...at least 

16 one wastewater treatment plant residence time apart, if 

17 practical" will be stricken. 

18 MR. PENBERTHY: Do you have the 

19 assurances you need in other parts of that document? 

20 MR. NGUYEN: We talking only a few 

21 samples, right. We're only taking it for (inaudible). We're 
84

1 not talking about the rest of the samples. We're talking 

2 about the --

3 MR. THOMAS: Right. The issue here is 

4 not -- the number of samples. So for example, if the 

5 residence time for a plant is two days and you're taking 

6 five samples, that's ten days. So suppose on Day 3 it starts 

7 raining and something happens where -- you know, and 

8 you've got 14 wastewater treatment plants to duplicate that 

9 at, we've only got 360 days to complete the program. 

10 There's concern that adding all of this time could 

11 substantially --

12 MR. NGUYEN: But you don't have a time 

13 dimension in there. I mean, you're just talking like two, 

14 three hours apart pretty much the same sample. 

15 MR. MAIT: Are you prepared to extend 

16 the period? If you want to go over 360 days, we could 

17 discuss that. 

18 MS. McNETT: We also only have 14 days'

19 stability for water samples too, so that needs to be kept in 

20 mind. QC samples need to travel with all of the samples 

21 back to the laboratory. 
85

1 MR. THOMAS: And it's also not clear -- I 

2 mean, Ward, what you just articulated was a need to have 

3 some assurance that the plant was operating within some 

4 normal range of operating conditions. I'm not clear how 

5 the time element plays into that. Because, again, Trent 

6 just articulated where in other parts of the document you're 

7 going to get all of that information. 

8 MR. PENBERTHY: Right. I guess if we 

9 saw a large difference between two samples taken a period 

10 of time apart, it would be an indication of what's going on, 

11 was it really -- was there an issue with how the plant is 

12 operating? 

13 MS. FEHRENBACHER: We do have this 

14 clause in here, if practical. Do you have -- I mean, is it 

15 possible to further define what you think is practical from 

16 your perspective?

17 MR. THOMAS: Well, I think if practical 

18 means it's going to mean we won't be able to meet our 

19 360-day time obligation, that it's impractical. 

20 MR. DOYLE: In reaching out to the 

21 vendors who we reached out to already, you know, to 
86

1 execute the program for us in the constraints that we've 

2 been operating under, I mean, it's -- and this is the 

3 feedback we received. It's an extremely aggressive -- I 

4 mean, that's the consistent feedback we've had from 

5 multiple well-respected vendors. They said, we're just 

6 worried about -- you know, if it's already extremely 

7 aggressive and adding something that -- in our way of 

8 thinking is really kind of unrelated to doing a risk 

9 assessment into the mix and you think about it -- even for 

10 the client's purposes he's not going out there sampling all 

11 of these multiple days apart --

12 MR. MAIT: From a strict project 

13 management standpoint, this introduces a high degree of 

14 project risk. You know, because we've got to go back to 

15 the same places twice. And the way this has been sort of 

16 organized, I mean, they're basically -- crews are going 

17 from one site, they do their work. Hopefully, hopefully, 

18 the weather cooperates, and then they're sort of scheduled 

19 one right after the other and choreographed with the 

20 laboratory. So you started adding this (inaudible) into 
87

1 there, the ability to control and manage the project from a 

2 time standpoint just goes out the window. 

3 MR. PENBERTHY: All right. So we're 

4 going to rely on the criteria means that are used by the 

5 facilities term operating conditions of the document. 

6 MR. DOYLE: I mean, that's what's done 

7 all the time for compliance purposes. 

8 MR. PENBERTHY: Okay, fair enough. 

9 Next item. 

10 MR. THOMAS: Okay. The location of 

11 surface water, sediment, and biota sampling. 

12 MR. STAPLES: Okay. On the base 

13 subject of where samples are taken, the previous version 

14 of the ECA and the current version of the ECA both 

15 contain language specific to surface water that --

16 "Sampling for surface water shall be taken as reasonably

17 close to the effluent outfall provided adequate mixing has 

18 occurred." 

19 And we spent a lot of time in a previous 

20 meeting talking about what adequate mixing has occurred. 

21 And all the experts that we've talked to, that means the end 
88

1 of the mixing zone. That's a location that -- which you 

2 will be assured that effluent has reached all dimensions of 

3 the surface water and the sediment and, hence, the fish and 

4 biota. Now that's been entirely taken out, the concept of 

5 the mixing zone -- and it appears that you're now are 

6 focusing on the choice of sample collection from where 

7 the benthos are taken and working backwards from that. 

8 To us, that has an impractical nature in that 

9 effluent outfalls can hug the bottom and not mix with the 

10 water for some distance, but the nearest deposition zone 

11 may be before the end of the mixing zone. Similarly, 

12 effluents can hug the shoreline for a considerable distance 

13 before it mixes with -- fully mixes with the water and a 

14 deposition zone that may be nearer to the outfall and the 

15 end of the mixing zone may never receive effluent, so we 

16 cannot --

17 MR. PENBERTHY: So this is language in 

18 what, Appendix 8? 

19 MR. STAPLES: Everything is tied to 

20 Appendix 8 now. 
89

1 MR. PENBERTHY: I just want to make 

2 sure I locate the language. So there seems to be a question 

3 about what does provided adequate mixing of the 

4 discharge and receiving water has occurred mean. I know 

5 we're not really interested in getting into the whole mixing 

6 zone debate because we don't necessarily --

7 MR. STAPLES: We feel --

8 MR. PENBERTHY: Because I think that's 

9 a debatable criteria and what do you really mean by that. 

10 MR. STAPLES: Well, we feel we can 

11 give you assurance that influent has reached --

12 MR. PENBERTHY: How would you like 

13 this to read? 

14 MR. STAPLES: Say that again, please. 

15 MR. PENBERTHY: How would you you 

16 like this to read? 

17 MR. STAPLES: Back the way it read in 

18 the last version. 

19 MR. DOYLE: "At each site fish should be 

20 collected as close as reasonably possible to the discharge 

21 point provided adequate mixing of the discharge and 
90

1 receiving water has occurred. To satisfy this requirement 

2 fish shall be collected at the end of the mixing zone in 

3 locations where fish may be expected to be captured." 

4 MR. THOMAS: So we would use the 

5 language in the version previous to the one that was 

6 distributed a couple weeks ago. 

7 MR. PENBERTHY: Okay. And ours --

8 well, what you put in here was pretty much based on the 

9 Canadian approach, where they pretty much worked 

10 downstream from the outfall until they found enough 

11 benthic species in a sediment. 

12 MR. TOBIAS: They just found sediment, 

13 actually. They just wanted to find a spot with the 

14 sediment in the Canadian study. 

15 MR. PENBERTHY: Okay. Is the phrase 

16 "provided adequate mixing of the discharge", is that -- if 

17 we deleted that, does that --

18 MR. STAPLES: Actually, we thought that 

19 to be a useful concept in that we then interpret it as the end 

20 of the mixing zone. 
91

1 MR. MAIT: The strategy though conforms 

2 to at least -- with my experience with the water division 

3 here, it conforms to when you would do similar things or 

4 this kind of work. That's where you would be, that's the 

5 whole purpose of defining it anyway, that you have -- you 

6 know, the environmental impact being noted in an area 

7 where the effluent really resides. So you want to be sure 

8 that, you know, the species are there with what we're 

9 looking for. 

10 MR. STAPLES: And right now it does 

11 say, "Sampling shall begin at the outfall and proceed 

12 downstream until adequate benthic organism samples are 

13 collected." And we have no assurance that -- beginning at 

14 the outfall and proceeding downstream, where the effluent 

15 actually reaches the sediment. 

16 MR. PENBERTHY: Yeah. You have to 

17 keep going until you find it. 

18 MR. STAPLES: Keep finding what, D4? 

19 MR. PENBERTHY: No. You start at the 

20 outfall and work downstream in the sediment until you 

21 find enough benthic organisms. 
92

1 MR. STAPLES: With you we're not sure 

2 that D4 and -- effluent possibly containing D4 has been to 

3 that deposition zone unless we know the water is well 

4 mixed. 

5 MR. TOBIAS: I think by sitting where the 

6 outfall is you can tell where the effluent is going. You just 

7 described -- I mean, that's what the Canadians basically

8 did. They used knowledge of the sites to study where D4 -

9 - or best select, they thought, where the sediment. 

10 I guess the problem is that when I talk to 

11 the people at the regions of how mixing is defined, they

12 say each state is to define their own technique for deciding 

13 whether to use them if they want to, and some don't. And 

14 they can define it different ways, so I'm worried about 

15 giving different -- I don't know how -- what will come 

16 back after you go back and do these mixing zones. Will 

17 you come back with twenty miles and -- I don't know what 

18 the outcome would be. 

19 It seems like -- I wanted something that 

20 was more determined in the document. 
93

1 MR. DOYLE: And that's whether I think 

2 we didn't prescribe to use it in the EPA model to 

3 determine mixing zones, too. We didn't --

4 MR. TOBIAS: But there are many, and a 

5 state has to choose how to do it. That's what the people at 

6 the regions told us. I contacted people in Region 6 and 

7 other regions to ask what happened when you actually 

8 apply this -- because we devolve the program to the states 

9 -- and sometimes the states can choose not to accept the 

10 concept. It's state by state. 

11 MR. MAIT: Do you have a preferred 

12 technique for defining -- I mean, part of the problem is 

13 these operators of these POTWs have those defined areas. 

14 So we need to be mindful of them being concerned about 

15 creating a new sampling point for regulatory purposes, 

16 which is not located at this point. So I mean, that's why

17 we choose to pick, select an EPA model that's already

18 accepted if there's not one already defined. 

19 MR. STAPLES: Yeah, I guess I'm not 

20 certain as to what your hesitation is. Let's take your 

21 example. If the mixing zone is 20 miles downstream, in 
94

1 that twenty miles you have no assurance that the effluent 

2 has touched the sediment you're collecting. If you go to 

3 the end of the mixing zone, you have assurance that the 

4 surface water that's carrying the D4 has touched the 

5 sediment that you're going to sample. And we're hoping 

6 that these mixing zones are very close to the facilities. We 

7 don't know for sure. We've only seen aerial photos of 

8 them, but --

9 MR. TOBIAS: So you don't have any

10 sample numbers from either a site survey or even a study? 

11 MR. STAPLES: That will all be -- I 

12 believe that will all be presented in the Study Plan. Is that 

13 the intention? Yes. So all the preliminary work that once 

14 we get to the facilities and work with the facilities on what 

15 they know about the mixing zone, if they don't, then we've 

16 talked to several teams who use EPA modeling and do 

17 mixing zones to make a determination.

18 MR. LEWIS: Why do you focus on the 

19 end of the mixing zone? Why do you think of that 

20 location? 
95

1 MR. STAPLES: Because that's where the 

2 water body is well-mixed side to side, top to bottom. 

3 MS. FEHRENBACHER: Now, I think our 

4 concern is the consistency in interpreting the mixing zone 

5 and our assurance that samples that we -- that will be 

6 collected there will meet our needs. 

7 MR. PENBERTHY: So how about this? 

8 How about we just delete that first sentence and say 

9 benthic sampling shall be begin at the outfall and proceed 

10 downstream until adequate benthic organism samples are 

11 obtained? Would you be happy with that, and then just get 

12 rid of the mixing issue altogether? 

13 MR. TOBIAS: I don't know if I like that. 

14 MR. PENBERTHY: What's that? 

15 MR. STAPLES: That's less certain than 

16 before. 

17 UNIDENTIFIED FEMALE: Yeah. 

18 MR. TOBIAS: That's why the previous 

19 version of our standard started with where is the water 

20 well-mixed, because it's the water that's carried -- the 

21 effluent carried to the water and the water carries it to the 
96

1 sediment. And if we sample the water and fish from the 

2 place we know is well-mixed, we'll know that the 

3 sediment -- the nearest deposition zones will also have 

4 received effluent. 

5 MR. PENBERTHY: Yeah, but if you go to 

6 the end of the mixing zone, that's not going to be 

7 necessary, the location of your minimum concentration 

8 D4, which partitions to the sediment, right? That will be 

9 essentially your lowest concentration until the surface 

10 water at least, right? So if you did that at the end of the 

11 mixing zone, you would get the lowest possible level of 

12 the sediment, correct? 

13 MR. STAPLES: I have no idea. 

14 MS. PLOTCKE: Your highest 

15 concentrations, you're going to be in your deposition 

16 zones. So if that's what you're trying to target for the 

17 sediment, but what Charles is -- you're right, you might 

18 have a higher concentration coming out of an effluent, but 

19 that's not reflective of what's going to impact the biology, 

20 which is really the sediment. 
97

1 MR. PENBERTHY: Yeah, but the mixing 

2 zone is not what's really relevant. It's where D4 ends up.

3 MS. PLOTCKE: And that's your 

4 deposition zone. And that's where you're going to be in 

5 equilibrium in mixture within your water and biota and 

6 sediment. 

7 MR. STAPLES: The nearest deposition 

8 zone may be, for instance, halfway across the river but 

9 only ten feet downstream of the outfall, but it may never 

10 receive effluent. 

11 MS. PLOTCKE: So the real challenge is 

12 defining where it's well-mixed. Whether you call it --

13 whether you use models to do a mixing zone or you say

14 (inaudible). 

15 MR. PENBERTHY: Well, if it's well16 mixed, where is the maximum is more of the issue. 

17 MS. PLOTCKE: And that's really -- once 

18 you define where it's well-mixed and then look to your 

19 deposition zone, that's where your maximum is going to be 

20 in your sediment. But what you're concerned about is how 
98

1 well can you really characterize a mixing zone with all the 

2 different models and the inconsistencies in it. 

3 MR. STAPLES: And I guess my concern 

4 is more of collecting samples of water and sediment that I

5 have assurance of having effluent in them. 

6 MR. PENBERTHY: Can we go over again 

7 -- what's your suggestion again?

8 MR. THOMAS: To go back to the 

9 language in the previous version -- the previous draft. 

10 MR. PENBERTHY: No one would agree 

11 with that, so --

12 MS. PLOTCKE: I'm wondering if there's 

13 some qualifications we can put in there like we have with 

14 some of the others because I understand, yes, you're right 

15 there's multiple models that's being used. And what we're 

16 asking the contractor to do is do the best job they can of 

17 defining that mixing zone so we can achieve what Charles 

18 is saying we want to achieve, but we realize there could be 

19 some inconsistency. Maybe if we -- you know, are less 

20 practical -- they're going to do the best job they're going to 

21 to do. 
99

1 MR. PENBERTHY: We're just trying to 

2 get the -- to have something here that's reasonably 

3 understandable and clear. 

4 MS. PLOTCKE: And the other thing, 

5 again, this comes back to it will be documented as to sort 

6 of the reconnaissance up front of how that's going to be 

7 determined. 

8 MS. FEHRENBACHER: So I think -- I'm 

9 trying to identify the criteria that we're interested in, we 

10 want a well-mixed sediment, we want the maximum 

11 concentration, we want presence of biota, and we want 

12 water and sediment samples collected at that same area. 

13 And I think we're not confident that having generic 

14 language like mixing zone with different models and 

15 different interpretations will meet all of those criteria. 

16 And the language that we developed will meet those 

17 criteria and give us assurance that the samples that you're 

18 collecting will meet our needs. 

19 MR. STAPLES: And I respectfully 

20 disagree. We cannot predict. We cannot define where the 
100

1 maximum concentration will be unless we go out and hunt 

2 for it, and that's not what this program is about. 

3 MS. PLOTCKE: So let's look at the 

4 language. Maybe if we do that -- so you have at each site 

5 benthic organisms shall be collected as close as reasonably 

6 possible to the effluent outfall providing an adequate 

7 mixing of the discharge and receiving water has occurred. 

8 I think we all agree on that, right? Whether you call it a 

9 mixing zone, that's what we're trying to achieve. So we 

10 agree on that. 

11 I think the next part is the sampling shall 

12 begin at the outfall and proceed downstream -- that's, I 

13 think, where you're concerned. You could start sampling 

14 where you don't have well-mixing. So maybe it's the 

15 wording there that we have to change, that it occurs after 

16 we have identified what we believe is the well-mixed area. 

17 If you don't want to call it a mixing zone, I think it's fine. 

18 MR. MAIT: We can take the word out, I 

19 mean -- understood. 
101

1 MR. DOYLE: Well, as it stands right now 

2 -- because sort of how it stands, there's two sentences 

3 there. They seem to be inconsistent or too different. 

4 MR. LEWIS: Sampling shall begin where 

5 adequate mixing occurs. I mean, that's what you're 

6 basically looking at to compare with what you have in the 

7 previous sample? 

8 MS. FEHRENBACHER: Well, so maybe 

9 what we're talking about is modifying that first statement 

10 to include -- so I think what we want is adequate benthic 

11 organism sample mass, perhaps, incorporating somehow 

12 into that first statement. 

13 MR. DOYLE: Well, I think the first 

14 statement is good. It's the second statement that needs to 

15 be tweaked because the concern -- if you read the first 

16 statement, we perfectly agree with that. It says you're 

17 going to -- as close as reasonably possible providing 

18 adequate mixing has occurred. So that's exactly spot on 

19 with what we like to do. It's that second sentence where it 

20 says -- it's like notwithstanding what we just said, 

21 sampling shall begin at the outfall. 
102

1 MR. PENBERTHY: So how about this? 

2 Let go -- take the first sentence and then delete sampling --

3 continue that sentence into the second sentence, but delete 

4 sampling shall begin at the outfall and just say, and 

5 proceed until adequate benthic organism sample masses 

6 have been obtained. I'll just read the sentence. 

7 At each site, benthic organisms shall be 

8 collected as close as reasonably possible to the effluent 

9 outfall provided adequate mixing of the discharge and 

10 receiving water has occurred and proceed downstream 

11 until adequate benthic organism sampling masses are 

12 obtained. Is that --

13 MS. PLOTCKE: Yeah. 

14 MR. DOYLE: Yes. 

15 MR. THOMAS: Yes. 

16 MS. EISENREICH: So the question is that 

17 adequate is defined. 

18 MR. PENBERTHY: All right. So can we 

19 work on that now? 

20 MS. FEHRENBACHER: So wait, going 

21 back to what you said earlier, each one of the sampling 
103

1 plans will include for each site the specificities around 

2 this, how adequate mixing will be determined? 

3 MS. PLOTCKE: Yeah. I mean, that's 

4 what our contractor will have to do. Now, we had 

5 originally specified determining mixing zones, but they 

6 will use some method in their reconnaissance to identify

7 where that adequate mixing occurs. 

8 MS. FEHRENBACHER: It can be slightly

9 different, at each site. 

10 MS. PLOTCKE: Yeah. 

11 MR. PENBERTHY: So can we add a 

12 sentence after --

13 MS. FEHRENBACHER: And we 

14 reviewed these ahead. 

15 MR. PENBERTHY: I propose that the 

16 study -- each site-specific sampling plan will --

17 MS. PLOTCKE: Document. 

18 MR. PENBERTHY: -- document the 

19 location of the point at which well-mixed -- the effluent 

20 and the stream are well-mixed? 
104

1 MS. PLOTCKE: Yeah, I mean, it's going 

2 to have that identified, but --

3 MR. PENBERTHY: Well, each Study Plan 

4 has a site sampling plan for each site, and each one of 

5 those site-specific sampling plans would identify where 

6 the effluent and receiving stream are well-mixed. 

7 Could you give us five minutes? (A recess 

8 was taken)

9 MR. PENBERTHY: All right. Good to

10 go. So here's what the -- language we propose. It's a lot 

11 of what we already discussed, so it should be at least fresh 

12 here. 

13 The sentence would read, "At each site 

14 benthic organism shall be collected as close as reasonably 

15 possible to the effluent outfall provided adequate mixing 

16 of the discharge and receiving water has occurred and 

17 where adequate benthic organism sample masses are 

18 obtained." 

19 We'll read it as a sentence similar to what I 

20 already mentioned. "Each site-specific sampling plan will 
105

1 identify where the effluent and receiving streams are well2 mixed and the method used to determine this." 

3 MR. DOYLE: That works. 

4 MS. PLOTCKE: Yeah, yeah. 

5 MR. PENBERTHY: Okay. Take off the 

6 (inaudible). 

7 MR. STAPLES: I'm not a lawyer, but is 

8 adequate and well the same thing? 

9 MR. PENBERTHY: Pardon me? 

10 MR. STAPLES: Are the words adequate 

11 and well-mixed -- mean the same thing? 

12 MR. PENBERTHY: Are adequately 

13 mixed, okay. Good point. You are a lawyer. You could 

14 work at EPA. No, that's a good catch. Thank you. 

15 Consistency in language is always helpful. 

16 MR. STAPLES: Would there been a 

17 continuing sentence then? 

18 MR. PENBERTHY: Yeah. "At each site 

19 fish, water, and sediment will also be collected at the same 

20 location." 
106

1 MR. STAPLES: And that same location is 

2 the place where it's adequately mixed? Is that understood? 

3 MR. PENBERTHY: The location is where 

4 you pick up benthic organisms. 

5 MR. STAPLES: That might be a 

6 kilometer long. Our intention would be to take it as close 

7 as possible to that first location of adequate mixing, water 

8 and fish and sediment. 

9 MR. DOYLE: In other words, the starting 

10 point of where you collect the benthic species would be 

11 the location where we would be collecting the fish and the 

12 --

13 MR. STAPLES: Surface water, fish --

14 MR. PENBERTHY: So just help me 

15 review here. If what it says is, "At each site fish, surface 

16 water and sediment shall also be collected at the same 

17 location," is that unclear? 

18 MR. STAPLES: As long as the same 

19 location is the -- that place where it's adequately mixed. 

20 MR. DOYLE: It's got to be done with the 

21 criteria. 
107

1 MS. FEHRENBACHER: Right. It used to 

2 be all of the criteria completely mixed and as close as 

3 reasonably possible to the effluent, sufficient benthic 

4 organisms sample masses and have --

5 MR. PENBERTHY: You know, if you 

6 want we can just say, at each site fish, surface water, and 

7 sediment shall be collected at the same location as benthic 

8 organisms (inaudible). 

9 MR. STAPLES: I'm just saying that 

10 benthic organisms may be collected over a long scattered 

11 range, and wouldn't it be -- our intention, I'm assuming, 

12 and your intention is we would collect water, sediment, 

13 and fish as close to the outfall as possible, so at where it's 

14 adequately mixed. 

15 MR. PENBERTHY: Well, you want them 

16 right where you picked up the benthic organisms. 

17 MR. STAPLES: The first benthic 

18 organisms. 

19 MS. PLOTCKE: I think it's fine saying --

20 I mean, it's going to be -- it can be potentially over a 
108

1 scattered location, but you're also -- I mean, that's still the 

2 same location you're going to collect. 

3 MR. DOYLE: It actually gives some 

4 flexibility. I think it's reasonable to take Ward’s, 

5 language. It's fine. 

6 MR. STAPLES: Okay. I just want to be 

7 sure we can tell a contractor where to sample. 

8 MS. EISENREICH: I do have a question. 

9 Why would you think that there's a possibility that it 

10 would take a kilometer to collect benthic organisms if it's 

11 already at a well-mixed place where there's -- you know, 

12 where it's going to be covered in the sediment? 

13 If you have sediment, you're going to have 

14 sediment curves and you would just -- in my mind, you 

15 would take a grab sample, and then obviously -- or likely 

16 you're not going to get enough for analysis. So you would 

17 move a little to the left or a little to the right, but you 

18 wouldn't have to necessarily go a kilometer down the 

19 stream. 

20 MR. STAPLES: We're very hopeful that 

21 that's the case. Dow Corning has considerable experience 
109

1 collecting benthic organisms. They're the hardest thing to 

2 collect in the field, so we want to have the flexibility. If 

3 you look at some of the receiving waters that we proposed 

4 in the documentation, they're pretty small and narrow. It 

5 might take some distance to get the mass we need to do 

6 the analyses. 

7 MR. PENBERTHY: Okay. So how about 

8 we just say --

9 MR. DOYLE: I think it's covered. 

10 MS. PLOTCKE: I think we've covered it. 

11 MR. THOMAS: It's fine. 

12 MS. HENRY: Again, we're doing all of 

13 this planning in the abstract and your plan, if it is a space 

14 like that where it's very small or whatever you can 

15 anticipate, I think you could describe that for our review. 

16 MS. PLOTCKE: Again, when you're 

17 doing all the reconnaissance up front, you're going to have 

18 ideas of what you're dealing with. 

19 MR. PENBERTHY: Okay. Next item. 

20 MR. THOMAS: We've got a couple more 

21 things in that same section. Okay. Go ahead, Charles. 
110

1 MR. STAPLES: These are hopefully

2 lesser. On Page 44 and 47 -- on Page 44, the third line 

3 above Figure 5, it talks about the retained samples retained 

4 in a refrigerator. This is a change from the last draft, 

5 which said that they'd be in a freezer. We are going to 

6 freeze them out in the field and hold it in the laboratory

7 until it’s used, so --

8 MR. PENBERTHY: But you want a 

9 freezer, retain in a freezer? 

10 MR. STAPLES: Unless there was some --

11 MR. PENBERTHY: I don't think so. 

12 MR. STAPLES: Okay. 

13 MR. PENBERTHY: That's fine. 

14 MR. STAPLES: That's also on Page 47. 

15 MR. PENBERTHY: Good catch. 

16 MR. STAPLES: The third line below 

17 Figure 6. 

18 MR. PENBERTHY: Okay. 

19 MR. STAPLES: And then the concept of 

20 using commercially-acquired benthic species as a 

21 surrogate field blank. In the previous version of the ECA, 
111

1 the test standards suggested employing the ground-up 

2 rainbow trout that we obtain from a known supplier, and 

3 they're known to have very low or no detectable D4 

4 concentrations. 

5 Dow Corning has worked with that lab for 

6 a considerable time in obtaining those samples, and we 

7 have proposed using the ground-up fish tissue for both as 

8 surrogate blanks in the fish collection and in the benthic 

9 collection. You're now proposing really a new 

10 requirement of using commercial sources of benthic 

11 invertebrates, which Dow Corning has no experience with 

12 in terms of finding a supplier that's going to have D4-free 

13 invertebrates. 

14 MS. McNETT: Especially in sufficient 

15 quantities. 

16 MR. STAPLES: In sufficient quantities. 

17 Since the tissue will be ground and then placed in an 

18 identical kind of container and opened during processing, 

19 we'd prefer to use the --

20 MR. PENBERTHY: What page is this? 
112

1 MR. STAPLES: Page 45. I believe it's 

2 Page 45. 

3 MR. PENBERTHY: Right here. I got it, 

4 third paragraph. 

5 MR. STAPLES: Third paragraph. 

6 MR. PENBERTHY: I mean, my 

7 understanding of why we changed this is that there are 

8 commercial sources of benthic organisms. It could be just 

9 -- is that correct?

10 MR. THOMAS: I think the concern is 

11 about whether those could be assured that they're D4 free -

12 - and I think that's the challenge in finding -- at least that's 

13 been the experience. 

14 MS. PLOTCKE: Well, again, it's starting 

15 over. It's something new in ensuring that you find that 

16 source, you can get adequate source, we know this is 

17 something that works and is ready to go. 

18 MS. McNETT: We will work with our 

19 suppliers and make sure that they're not contaminating the 

20 fish. We can't be assured of that in a new supplier of 
113

1 benthic organisms that don't have scales on the outside to 

2 protect them from taking up some D4. 

3 MR. STAPLES: (Conferring with 

4 associates). 

5 MS. FEHRENBACHER: (Conferring with 

6 associates). 

7 MS. HENRY: (Conferring with 

8 associates). 

9 MS. McNETT: (Conferring with 

10 associates). 

11 MR. PENBERTHY: Everyone -- why 

12 don't you explain that that's fair, and then we'll try to work 

13 this? 

14 MS. POLLACK: Well, the question is 

15 what prompted it and why would you use organisms that --

16 regardless of whether they're free from D4 samples 

17 compared to other organisms that are different; so the idea 

18 of why would you compare apples to oranges? So there 

19 could be a way to -- if you have this supplier -- if they're 

20 ensuring there are no D4 samples in the rainbow trout, 

21 (inaudible) or suppliers. 
114

1 MS. POLLACK: To answer your first 

2 question, this is for QC out in the field to ensure there's no 

3 contamination, so it's not -- you know, we're not trying to 

4 compare apples and oranges. This is just a check on that. 

5 MR. PENBERTHY: It's different tissues. 

6 MS. PLOTCKE: It's different tissues, but 

7 it is still tissue that would allow you to capture. And it's 

8 actually one of the more efficient ones we've seen that will 

9 tell you whether you have contamination or not. If you 

10 could go out and potentially look at something that is very

11 similar from a matrix standpoint. 

12 So if you wanted to do that, then we can 

13 add six months onto the timeline because we'd have to re14 evaluate sources and ensure that that -- you could get that 

15 kind of sample and ensure that it's free of D4. So you 

16 could do that check in the field. It would take time. This 

17 is already proven. We use it all the time on every one of 

18 our samplings, and so does Norway and others as well, so 

19 --

20 MS. HENRY: You know, she's the expert 

21 at the whole smash it, extract it, (inaudible). So how 
115

1 similar is the mass on (inaudible) depending extraction 

2 and all? Is it virtually identical depending on the tissue? 

3 MS. PLOTCKE: Yes. 

4 MS. HENRY: So for any fish species and 

5 the benthic species, and even, I guess, like the bank that 

6 were done on, and all that, the extraction method is the 

7 same? 

8 MS. PLOTCKE: Yeah. 

9 MS. HENRY: If it was dry or something, 

10 grind it, extract it, and putting it --

11 MR. PENBERTHY: So basically, it 

12 becomes an issue of whether the tissue has the same 

13 absorption; is that correct? 

14 MS. PLOTCKE: It actually -- this would 

15 probably even have more. 

16 MS. HENRY: There's introduction in that 

17 D4 in that old process. 

18 MS. PLOTCKE: Yeah. It's just -- it's a 

19 check on the potential for contamination. 

20 MS. EISENREICH: Right. And we 

21 understand that. I mean, that's not the question. The 
116

1 question is whether fish tissue acts like worm tissue or 

2 invertebrate tissue. And if they would, you know, 

3 essentially through the process -- through the process of 

4 processing, accumulate the same way and the same rate 

5 and the same --

6 MS. PLOTCKE: I mean, it would be 

7 pretty similar. In fact, it could be probably even more, so 

8 that is why it's a nice way to actually check whether you 

9 have some potential source that's there. 

10 MS. EISENREICH: But how would you 

11 guarantee that, I guess, if you have not used the 

12 invertebrate? 

13 MS. PLOTCKE: You could look at the 

14 content, like the fat content of the tissue and --

15 MS. EISENREICH: So you would use a 

16 lipid? 

17 MS. PLOTCKE: It's a lipid, yeah. It's 

18 going to be driven by the lipid felicity of it. 

19 MR. PENBERTHY: All right. We'll go 

20 with the fish. So is that -- I need to know the specific 

21 changes. Just that one sentence? 
117

1 MS. EISENREICH: It's kind of 

2 (inaudible). 

3 MS. PLOTCKE: Yeah, throughout. 

4 MS. EISENREICH: Change the subject. 

5 MR. PENBERTHY: Well, wait a minute. 

6 This is the benthic. So basically what we use -- in the 

7 blank, we use rainbow trout, right? 

8 MR. STAPLES: Ground rainbow trout 

9 tissue just as done in fish. 

10 MR. PENBERTHY: Is it any other place 

11 besides that paragraph? 

12 MR. STAPLES: Is it in the figure? 

13 MS. EISENREICH: Yes, it's in the figure. 

14 MR. PENBERTHY: Okay. So we'll say

15 rainbow trout in the -- all the QA samples; is that correct? 

16 MS. HENRY: Just to be clear, you go out 

17 to some hatchery that you have already established has 

18 whatever food and all that jazz and they are pretty clean. 

19 You just grab from that every time. It really has nothing 

20 to do with the D4 at all. 

21 MS. PLOTCKE: Right. 
118

1 MR. PENBERTHY: So basically every

2 time you have ground benthic invertebrates in that QA 

3 paragraph, we'll change it to rainbow trout. 

4 MR. STAPLES: I see in at least two 

5 paragraphs that we were just working in, two separate 

6 paragraphs --

7 MR. PENBERTHY: Okay. Can you just 

8 point those out to me, so I know where you are. 

9 MR. STAPLES: On page 45. The second 

10 paragraph, "It should be noted..." -- middle sentence --

11 "...benthic invertebrate tissue from benthic organisms 

12 purchased." 

13 MR. PENBERTHY: And then the 

14 following paragraph, correct? 

15 MR. STAPLES: The following paragraph. 

16 MR. PENBERTHY: Anywhere else? 

17 MS. FEHRENBACHER: It's a couple 

18 times in that paragraph. 

19 MR. PENBERTHY: Oh, yeah, definitely 

20 in that third paragraph. We'll do a search, and then we'll 

21 try to do our best on that. I just --
119

1 MR. STAPLES: Okay. And then the 

2 figure with that we talked about. 

3 MR. PENBERTHY: Okay. So are we 

4 finished that that intent? 

5 MR. STAPLES: No. There's one more 

6 thing. It's a minor thing on Page 46, last paragraph. 

7 MR. PENBERTHY: Mm-hmm. 

8 MR. THOMAS: The third line begins, 

9 "Three of the samples shall be divided into three parts." 

10 And this is a description -- this paragraph describes that 

11 fish are collected and basically packaged. The samples 

12 shall be divided into three parts. 

13 We understand that samples need to be split 

14 and lipid contents and so forth, but the way this is said is 

15 that this is basically done in the field. It is suggestive of 

16 being done if the field. In the field the fish will actually be 

17 bagged and frozen, and all the processing, dividing, and so 

18 forth occurs in the laboratory. 

19 MR. PENBERTHY: So how would you 

20 want this written? 
120

1 MR. STAPLES: So the second sentence 

2 could read something to the effect of for each of the two 

3 species, five individual fish or composited samples shall 

4 be prepared and frozen. In the laboratory fish samples are 

5 thawed, homogenized, and divided into three parts. 

6 MR. PENBERTHY: Okay. Hold on. 

7 Laboratory --

8 MR. STAPLES: I guess three of the fish 

9 samples shall be thawed, homogenized, and divided into 

10 three parts. 

11 MR. PENBERTHY: Thawed, 

12 homogenized, and divided into three parts, okay. 

13 MR. PENBERTHY: Does that meet your 

14 needs? 

15 MR. STAPLES: Yes. 

16 MR. PENBERTHY: Okay. 

17 MR. STAPLES: That was a minor 

18 methodological clarity. 

19 MR. PENBERTHY: Yes. I can appreciate 

20 that. That's good, attention to detail. 

21 MR. PENBERTHY: Are we done with 10?
121

1 MR. THOMAS: We are done with 10 

2 MR. PENBERTHY: Okay. Now onto 

3 Appendix 6. 

4 MR. THOMAS: Yes. Appendix 6, this is 

5 the location of biosolid sampling. I think we can be 

6 comfortable with the current language with one change. 

7 This has to do with the location of the biosolid sampling. 

8 UNIDENTIFIED MALE: Can I have the 

9 page?

10 MR. THOMAS: This is page -- what page 

11 is this? 

12 MR. PENBERTHY: It's Page 33. 

13 MR. THOMAS: Okay. The sentence 

14 starts, "At each site, the chosen location of biosolid 

15 sampling shall be immediately after dewatering before 

16 onsite storage and shallbe established in site-specific 

17 sampling plan." We would just add "as practicable". 

18 MR. PENBERTHY: Okay. That's fine. 

19 MR. THOMAS: All right. Analytical 

20 methods. 

21 MR. PENBERTHY: That's on twelve?
122

1 MR. THOMAS: Twelve, yes. 

2 MR. PENBERTHY: Oh, wow. 

3 MR. STAPLES: This is in a couple of 

4 places, so let me kind of generically explain the issue, and 

5 then we'll go to the specific text. In terms of handling and 

6 processing in the field the sediment and then extending 

7 that to the biosolid, which we can consider similar, we had 

8 originally cited approaches used by Powell 2009 

9 reference. You've changed that to Powell 2010 and 

10 changed the handling in the field. Now the handling in the 

11 field is you collect the sediment, put it in a jar, and cover it 

12 with water and seal it. 

13 It's been Dow Corning's experience that 

14 that actually introduces error, and so they've abandoned 

15 that, and so we would like to go back to the handling 

16 method, which is put the sediment -- collect the sediment 

17 with the dredge or whatever, put it in a bag, and put it in 

18 the sample, just as we had it in the previous text. That's 

19 also the method that is now in the Knoerr 2012 method. 

20 MR. PENBERTHY: Okay. Now, we 

21 changed the method. It was based on the MDL, correct? 
123

1 MR. TOBIAS: Well, it was just to the 

2 other study. I'm surprised you say it introduces greater 

3 error when it looks like they get better results in the paper. 

4 MS. PLOTCKE: It's a stability issue. It 

5 actually creates -- it's less stable. The samples are less 

6 stable that way. 

7 MR. TOBIAS: When you put them in a 

8 plastic baggy, they're more stable than when you put them 

9 in a glass --

10 MS. PLOTCKE: Jar with the water 

11 overlay. 

12 MR. TOBIAS: -- jar. Or without the water 

13 overlay. If you put it in a glass jar, is it the water you're 

14 saying or is it -- it just read funny to me that you think a 

15 plastic baggy would be better than a glass jar where you 

16 tie down the top, and then put tape over around it instead 

17 of a plastic bag --

18 MR. PENBERTHY: Could you show me 

19 the language we're talking about? 
124

1 MS. McNETT: We homogenize the 

2 sediment sample in a plastic bag and transfer is to a glass 

3 jar, but you do not lay water over it. 

4 MR. TOBIAS: Okay. So -- but why is the 

5 plastic bag important. That seems like an odd step to 

6 introduce, why not -- like in the paper, it seemed like the 

7 clearing path was just to put it in a glass cylinder. 

8 MS. McNETT: Because you have a very

9 large sample of sediment that you've taken from a core, I 

10 mean, relatively large that you have to homogenize it and 

11 get homogeneous samples that of the jar that are about this 

12 size. 

13 MR. TOBIAS: Sure. You use the plastic 

14 as an intermediate to do that? 

15 MS. McNETT: Yes. 

16 MR. TOBIAS: Okay. 

17 MS. McNETT: A plastic bag, you know, 

18 very briefly. It's not stored in there for an extended period 

19 of time. 

20 MR. TOBIAS: Okay. 
125

1 MS. McNETT: To mix up the sediment in 

2 the field without a whole lot of spatulas or anything. You 

3 can just squeeze it, and then take homogeneous sediment 

4 samples and place them in glass jars. 

5 MR. TOBIAS: Okay. 

6 MR. PENBERTHY: I need to know what 

7 to do --

8 MR. TOBIAS: They just want to change it 

9 back to how it was before, and the description of intent. 

10 MR. PENBERTHY: Yeah, but I don't 

11 know what that was. So we're on page 38, I take it, second 

12 paragraph from the bottom, correct? 

13 MR. DOYLE: Page 39, right? 

14 MR. STAPLES: I had it on page 39 

15 directly above Figure 4. 

16 MR. PENBERTHY: Okay. We'll follow 

17 what you want it to read. 2009? 

18 MR. STAPLES: The 2009 reference. 

19 MR. PENBERTHY: And then we'll have 

20 to add 2009 -- is that still in the references? It's not in the 

21 references. 
126

1 MS. McNETT: Do you want the last one 

2 you cited? I didn't hear what you said. That's what we 

3 used in the (inaudible) years. 

4 MR. STAPLES: Oh, okay, yes. The 

5 Powell 2009 reference is the method for sediment --

6 handling these sediments, which involves collection of it, 

7 placing the baggies, homogenizing it. That has been 

8 adapted to the Knoerr 2012 biosolids method. 

9 MR. PENBERTHY: Okay. So read to me 

10 that sentence, how it's supposed to read. You know, I'm 

11 up to sample collection, storage, and preparation will 

12 follow Powell 2009. What does it say after that? What 

13 should it state? 

14 MR. LEWIS: That's the prior language, it's 

15 a little bit more collaborative. 

16 MR. TOBIAS: Placed in a plastic bag? Is 

17 that what you --

18 MR. STAPLES: With each sample being 

19 placed --

20 MS. McNETT: Placed in a plastic bag, 

21 homogenized, and transferred to a glass jar. 
127

1 MR. STAPLES: We actually had it as 

2 three sentences, but --

3 MR. PENBERTHY: Okay. I'm going to 

4 read it back to you. Okay. This is what I have: "Sample 

5 collections stored in preparation will follow Powell 2009 

6 with each sample being placed in a plastic bag, 

7 homogenized, and placed directly into a glass jar 

8 covered..." -- shall I delete covered with water? 

9 MS. PLOTCKE: Yes, please. 

10 MR. PENBERTHY: And then capped? 

11 MS. PLOTCKE: Yes, it will be capped. 

12 MR. PENBERTHY: Okay. And then we'll 

13 have to add 2009 Powell to the reference list because it's 

14 not there now. 

15 MR. STAPLES: You still have the 

16 previous version. 

17 MR. PENBERTHY: So is that Number 12 

18 we're done with? 

19 MR. STAPLES: Well, does that also 

20 translate into biosolids? 
128

1 MR. PENBERTHY: Does that correct 

2 everything? Is there any other place I need to change? 

3 MR. LEWIS: And that's Powell and 

4 Woodburn? 

5 MR. STAPLES: Powell and Woodburn 

6 2009, yes. 

7 MR. LEWIS: That's what I thought it was, 

8 yes. 

9 MR. PENBERTHY: Okay. Where else 

10 does this need to --

11 MR. LEWIS: It is in Appendix 6 as well, 6 

12 and 7. 

13 MR. PENBERTHY: Appendix 6. So I've 

14 got to say reference language -- okay. 

15 MR. STAPLES: Did you find the location

16 for that? 

17 MR. PENBERTHY: Is it Page 34? Is that 

18 right? 

19 MR. DOYLE: That where I have it, on 

20 Page 34. 
129

1 MR. PENBERTHY: Okay. Tell me 

2 exactly what needs to be changed. 

3 MR. DOYLE: So that's where I have the 

4 policy that Powell 2010 and Woodburn 2009. 

5 MR. PENBERTHY: I don't see it here. 

6 MR. DOYLE: It's right here. During each 

7 sampling event biosolids at a given site, all quality 

8 assurance sampling prepared and D4 samples been 

9 prepared as described in Powell. Should we change 

10 Powell and Woodburn 2009? That's right above the 

11 Figure 3. 

12 MR. PENBERTHY: Okay. So I'll just --

13 for my purposes, I'll just say, "See Page 39." 

14 MR. TOBIAS: And this one didn't have 

15 (inaudible) of a plastic bag in there. 

16 MR. PENBERTHY: Well, is this going to 

17 be exactly as its --

18 MR. TOBIAS: In one of the Appendices it 

19 was explicitly put in; in the other, it wasn't. 
130

1 MR. PENBERTHY: Okay. Well, let's 

2 eliminate the confusion here. Is this sentence going to 

3 read exactly like Page 39 or not? 

4 MR. STAPLES: It could be as simple a 

5 change as changing from Powell 2010 to Powell 2009. 

6 MR. PENBERTHY: Okay. We'll do that. 

7 Fair enough. 

8 MS. McNETT: That's fine. 

9 MR. PENBERTHY: Well, what we have 

10 now is we're just going to change Powell 2009 on Page 34 

11 to Powell and Woodburn 2009. 

12 MS. McNETT: That's fine. 

13 MR. PENBERTHY: Okay. Do we have 

14 the reference there in that? Okay. Are we there?

15 MR. THOMAS: A couple more things. 

16 We're finished on that one. 

17 MR. PENBERTHY: We're finished with 

18 12?

19 MR. THOMAS: Yes, we've finished 12. 

20 MR. PENBERTHY: Okay. 
131

1 MR. THOMAS: Thirteen, selection of fish 

2 species. We can agree to the current text with one 

3 addition. We're on Appendix 8, Page 46. 

4 The sentence reads, "Biota samples shall 

5 include benthic species collected in sediment of the two 

6 receiving water bodies and two species of fish." We 

7 would add "if practicable of different trophic guilds in the

8 receiving water body." 

9 MR. PENBERTHY: Okay. This is in the 

10 third paragraph?

11 MR. THOMAS: My page numbers might 

12 be different than --

13 MS. PLOTCKE: Yeah. 

14 MR. THOMAS: No, it's already there. 

15 Okay, then we're good. 

16 MR. PENBERTHY: Okay. We don't need 

17 a change there? 

18 MS. PLOTCKE: No. 

19 MR. THOMAS: No it's already there. 

20 MR. PENBERTHY: That's what I thought. 
132

1 MR. LEWIS: It's on Page 46 at the third 

2 paragraph, "Two species of fish from different trophic 

3 guilds, collected in sufficient mass such that individual or 

4 composite samples can be prepared for analysis of D4, 

5 shall be selected." 

6 MR. PENBERTHY: No, no, no, keep 

7 going. Do we need a change or not?

8 MR. THOMAS: Well, we've got some 

9 versions where it's there and -- it's there, right? 

10 MR. STAPLES: The second place where 

11 this is discussed is on Page 46 of that standard, and it does 

12 not have the words, "if practicable". 

13 MR. THOMAS: Yeah. We want to add it 

14 to do test standards. 

15 MR. PENBERTHY: Okay. Where does it 

16 first show up? 

17 MR. STAPLES: The first page of that 

18 standard, requirements for sampling biota. 

19 MR. PENBERTHY: Okay. 

20 MR. DOYLE: It's okay there. It will be 

21 consistent with those places. 
133

1 MR. PENBERTHY: Okay, I got it all 

2 right. 

3 MR. THOMAS: So just a couple of other 

4 things I want to note. These aren't related necessarily for 

5 the language of the ECA. One -- and we talked about this 

6 before -- with respect to the draft order, we'd very much 

7 appreciate having an opportunity to take a look at it prior 

8 to the publication, in particular, the language associated 

9 with D4 and how it's characterized and so forth. 

10 MR. PENBERTHY: Okay. Hold on. So 

11 this is the notice of availability of the ECA. You know it 

12 would be highly unusual for EPA to coauthor --

13 MR. THOMAS: We're not asking to 

14 coauthor. We'd just like to take a look at it. 

15 MR. DOYLE: The premises for the 

16 concern, Ward, is when the original federal register came 

17 out announcing the whole ECA negotiation process, 

18 whether it was descriptions of D4 or D5, we had some 

19 concerns about how the chemicals were characterized 

20 there in terms of representing potential hazards and so 
134

1 forth. And that's why we want to make sure -- we were 

2 curious about --

3 MR. PENBERTHY: Well, tell me what 

4 you were concerned about. I mean, you're talking about 

5 the notice of selecting a -- seeking interested parties? 

6 MR. THOMAS: The description -- let me -

7 - I mean, I would have to look at the notice. 

8 MR. PENBERTHY: I mean, basically that 

9 expressed EPA's opinion. It doesn't express your opinion. 

10 I mean, I don't think we would necessarily extend any --

11 well, first of all, the notice of availability is a pretty benign 

12 thing. It's just this is D4. This is what we're doing. This 

13 is the tests that have been agreed to. 

14 MR. DOYLE: Yes. 

15 MR. PENBERTHY: It's not interpreted. 

16 MR. DOYLE: And that's the key --

17 MR. PENBERTHY: But it explains why

18 we're doing this. And I'll have our federal register notice 

19 they're going to have to, you know, go into that. If you 

20 can tell me what your issues are, I might be able to think 

21 about it, but I'm not going to --
135

1 MR. THOMAS: Where D4 was described 

2 and D5 as highly persistent in sediment and highly bio3 accumulative benthic and aquatic species. I think the 

4 highly bio-accumulative is -- in particular, we will argue 

5 that that might not -- that's probably not supported by the 

6 facts. So these are the types of things we're talking about 

7 with respect to how the --

8 MR. PENBERTHY: Just tell me where the 

9 -- so I'm going to go back and -- I'll talk with the people 

10 here about those issues, but I'm -- we're going to express 

11 our true beliefs, so if you're worried about the high --

12 obviously the D5 is going to come out. 

13 MR. THOMAS: No, no, right. But both 

14 from being characterized as highly persistent, and then 

15 they were highly bio-accumulative in aquatic species. 

16 MS. PLOTCKE: It's more a 

17 statement of that it is that versus it's being predicted to be 

18 that. A lot of the field studies actually counterdict [sic] 

19 that, so it's more what is really accurate of the current limit 

20 standard of science. 
136

1 MR. PENBERTHY: Highly persistent and 

2 highly --

3 MS. PLOTCKE: Predicted to be highly 

4 persistent and highly bio-accumulative, but they're not 

5 always highly bio-accumulative when you go and actually 

6 do studies, especially dependent upon the method that you 

7 use and the way -- where the science is today. 

8 MR. PENBERTHY: Your concerns are? 

9 MR. THOMAS: That was the primary

10 concern. 

11 MR. PENBERTHY: Okay. We'll take that 

12 under advisement. In the notice we're going to say what 

13 we think, and we might add a reference if it's not there that 

14 we need to support our assertion. Okay. 

15 MR. DOYLE: I guess the last item we had 

16 was in each of the test standards box -- so Appendices 4, 

17 5, 6, and 8. Let me get specific language for you. There 

18 was -- where the references are made to the analytical 

19 methods, there's -- we had previously stated -- and let me 

20 see if I can actually find that specific example -- that they

21 would be adapted from whatever the citation. 
137

1 MR. PENBERTHY: How often was 

2 Knoerr -- adapted from Knoerr? 

3 MR. DOYLE: For example -- and we 

4 wanted that retained in there. The concern is if that's --

5 MR. PENBERTHY: Where? Can we look 

6 at -- I want to look at Appendix 4. This is drafted, but this 

7 is just word processing. Let's see if I can find 4. 

8 MR. STAPLES: 1 page 25. 

9 MR. PENBERTHY: Yeah, how would you 

10 like that changed? 

11 MR. DOYLE: Yes, it should be -- let's see 

12 -- the commercial -- this is the sentence that begins the 

13 commercial laboratory, so it's the third sentence in the last 

14 paragraph. 

15 MR. PENBERTHY: Okay. 

16 MR. DOYLE: The commercial laboratory

17 will validate a method for the analysis of D4 in the 

18 influent and effluentthat shall be adapted from the 

19 analytical methods specified in Knoerr. 

20 MR. PENBERTHY: I assume that's okay? 
138

1 MR. LEWIS: You want that throughout 

2 the document, okay. 

3 MR. DOYLE: And that's consistent with 

4 my version. 

5 MR. PENBERTHY: Okay. So that's going 

6 to have to then be in all Appendices -- all -- 4 through 8, 

7 right? Okay. Anything else?

8 MR. THOMAS: Nothing else, other than I 

9 hope there's some cookies left for you guys at the party. 

10 MR. PENBERTHY: Well, I'm greatly

11 relieved we're going to be coming to a final conclusion. 

12 Maybe we should go over the next steps. 

13 MR. THOMAS: Absolutely. 

14 MR. PENBERTHY: Okay. Help me out 

15 here. I'm getting off track here, but, obviously, we have 

16 some editing to do, so that will take a few days to get the 

17 language right. 

18 At that point we will send that out to all the 

19 interested parties for a 30-day period. They can comment 

20 -- and I assume since most of the interested parties that 

21 have been engaged are not stand-up comments. One thing 
139

1 I will need from you three very shortly is the name and 

2 addresses of the signatories, so I would like to put that in 

3 before we send it out for the 30-day period. 

4 So assuming, you know, in the C.F.R. 

5 there's a definition of what constitutes a legitimate 

6 comment, but I can't imagine there would be anything 

7 substantial from the people in this room because that's 

8 what we've been talking about. Although, you know, just 

9 like you have to get your bosses to sign off, we have to get 

10 ours. So I can understand what evolves out of that. 

11 Hopefully, anything like that will be extremely minor. 

12 At that point, after we get through the 30-

13 day period, we'll have a final draft that will go to the -- for 

14 signatures. I think typically the way this has happened, 

15 there's been a kind of signature page for each of the 

16 signatory companies. It's been a long time since we've 

17 done this, but usually that goes out. 

18 There's two copies, original, for the 

19 signature -- the first go out, come back, and everybody

20 gets a formal -- and maybe even multiples since there's so 

21 many companies involved, but everyone gets an original. 
140

1 We would write this notice of availability, which describes 

2 what's been agreed to, basically lays out the schedule, and 

3 references these today, and then we get started. 

4 MR. SELTZER: There will need to be 

5 additional extension period, 60 days again. And that's 

6 going to start on the -- the 26th is what you said is 

7 currently scheduled period fixed to expire. 

8 MR. PENBERTHY: So it's been my 

9 experience that sometimes rustling up signatures can take 

10 a week, longer than you imagine, so hopefully we can get 

11 that done within a month or so after the 30 days. 

12 MR. THOMAS: Okay. Another thing 

13 we're going to want to do at some point is identify a small 

14 sort of technical team from EPA that could work with the 

15 small technical team from our side to make quick 

16 decisions in the field where the need arises or if there are 

17 questions with respect to -- like some of the things that 

18 came up today like how do you collect the samples and so 

19 forth and how do you ensure mixing. 

20 A lot of those things are likely to come up, 

21 and we're going to need some people that can be 
141

1 available to make, you know, reasonably fast decisions 

2 where the need arises. 

3 MR. PENBERTHY: Okay. We can 

4 arrange for that. 

5 MR. STAPLES: Especially on the Study

6 Plan up front. Before we get into the field even, there's 

7 going to have to be some --

8 MR. PENBERTHY: Back and forth, I 

9 understand. 

10 MR. STAPLES: To get them done 

11 quickly. 

12 MR. PENBERTHY: I mean, if we're all 

13 clear about expectations and what's being done, it makes it 

14 go easier. 

15 Any problems with that? So that's basically 

16 the (inaudible). It's been a wonderful almost three years. 

17 But the one thing good about it is it looks like we're on a 

18 positive trajectory and we'll have an (inaudible), so that's 

19 very important. I know that's why everybody in this room 

20 comes to work, to have a success in this. 

21 MR. THOMAS: Absolutely. 
142

1 MR. PENBERTHY: So thanks so much. 

2 Is there anything else we need to talk about?

3 MR. THOMAS: Nothing from me. 

4 Anybody else? No. So thank you. 

5 MS. PLOTCKE: Thank you. 

6 MR. PENBERTHY: Great. So I expect 

7 something in the (inaudible) probably within a week. 

8 MR. THOMAS: Okay. 

9 MR. PENBERTHY: Happy holidays. 

10 (Hearing adjourned)

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