1

1 2 SI LOXANES ENVIRONMENTAL MONITORING ECA 3 MEETING 4 TAKEN DECEMBER 12 , 2013 5 6
7
8
9
10
11
12
13
14
15
16
172

1
2
3
4
5 In Attendance: 6 Ward Penberth y Karluss Thomas 7 Trent Do yl e 8 Kathy

Plotcke 9 Cathy

Fehrenbacher 10 Russell Mait 11 Tala Henry 12 Steve Anderson 13 Mark Seltzer 14 Charles Staples 15 Nhan Ngu yen 16 Karen Eisenreich 17 Debra McNett 18 David Tobias 193

Sara Pollack 1 Allison Starmann 2 Paul L ewis 3 Brad Goodwin 4 Paul DeLeo 5 Ray

mond Ludwiszewski 6 Tracy

Guerrero 7 Wendy

Koch 8 Karen Vail 9 Joe Avcin 10 Kristen Smith 11 Noriko Shibuy a 12 Neil Patel 13 Hugh Flack 14 Lisa DuMars 15 On the Phone: 16 Gene Browning 17 Bets y Carlton 18 Sean Bursick 19 Lynne Blake

- Hedges 20 Steve Rey

nolds 214

15 * * * * * * 1 MR. PENBERTHY: Okay . M y name is 2 Ward Penberth y. I'm deputy director of the Chemical 3 Control Division here at EPA. Why don't we go around 4 the room this way? 5 MR. SELTZER: I'm Mark Seltzer, attorney 6 advisor in the Chemical Control Division. 7 MR. STAPL ES: Charles Staples, a 8 contractor
-- an environmental science contractor with 9 SEHSC. 10 MS. PL OTCKE: Kathy Plotcke with Dow 11 Corning. 12 MR. THOMAS: Karluss Thomas with 13 SEHSC. 14 MR. DOYLE: Trent Doyle with Keller 15 Heckman, outside counsel to SEHSC. 16 MR. MAI T: Russell Mait, Evonic. 17 MR. WEBB: Keith Webb, (Inaudi ble) 18 Chemical Corporation. 19 MS. DuMARS: L isa DuMars, Momentive. 206 MS. HENRY: Tala Henry, director of the 1 Risk Assessment Division in OPPT. 2 MS. Fehrenbacher: Cathy Fehrenbacher, 3 chief of the Exposure Assessment Branch in the Economic 4 Exposure and Technology Division, EPA. 5 MR. GOODWI N: Brad Goodwin, AAAS 6 Fellow in the Chemical Control Division. 7 MS. EI SENREICH: Karen Eisenreich, a 8 toxicologist in the Risk Assessment Division. 9 MS. POLLACK: Sara Pollack, a 10 toxicologist in the Risk Assessment Division. 11 MS. SELBY

- MOHAMEDU: Yvette 12 Selby

- Mohamedu, Associate Chief of the Exposure 13 Assessment Branch. 14 MR. TOBIAS: David Tobias, Exposure 15 Assessment Branch. 16 MR. DeLEO: Paul DeLeo, American 17 Cleaning Institute. 18 MR. LUDWI SZEWSKI : Ray mond 19 Lu dwiszewski, Gibson Dunn. 207 MS. McNETT: Deborah McNett, Dow 1 Corning. 2 MS. GUERRERO: Tracy Guerrero, 3 SEHSC. 4 MS. KOCH: Wendy Koch consultant to 5 Evonic. 6 MS. VAIL: Karen Vail, SEHSC. 7 MR. NGUYEN: Nhan Ngu yen Branch 8 Chief, Chemical Engineering Bran ch 9 MR. AVCI N: Joe Avcin, engineer EPA. 10 MS. SMI TH: Kristen Smith, Momentive. 11 MS. STARMANN: Allison Starmann with 12 SEHSC. 13 MS. SHIBUYA: Noriko Shibuy a, 14 Shieseido. 15 MR. PATEL : Neil Patel, Economics, 16 Exposure and Technology Division, OPPT. 17 MR. ANDERSON: Steve Anderson from 18 EPA's Office of General Counsel. 198 MR. PENBERTHY: Okay . Paul Lewis 1 will be here shortl y. He's attending a high

- level meeting 2 on fracking, so another wonderful topic. 3 So we should go on the phone and just hear 4 who's on the phone. Can people on the phone start 5 identifying themselves? 6 MS. CARL TON: This is Bets y Carlton, 7 Bluestar Silicones. 8 MR. BROWNI NG: This is Gene 9 Browning, (inaudible) of America. 10 MR. BURSI CK: Sean Bursick, Proctor & 11 Gamble. 12 MS. BLAKE

- HE DGES: Ly nne Blake

13 Hedges, Office of Pollution Prevention and Toxics, EPA. 14 MS. RIZUTTO: Pat Rizutto, Bloomberg 15 BNA. 16 MR. REYNOLDS: Dave Rey nolds, inside 17 EPA. 18 MR. GRIFFITH: Patrick Griffith, 19 National Association of Clean Water Agency

. 209
MR. PENBERTHY: Is that everyone on 1 the phone? Okay . So Karluss, you sent me the list of 2 unresolved issues. Are there an y other issues besides 3 these or

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

-- 5 there are a few things at the end that we'll want to talk 6 about from the standpoint of editorial ty pe changes or just 7 comments to some of the language, but what I've tried to 8 list here are what we would consider the major issues. 9 MR. PENBERTHY: Okay . So every thing 10 else should be relativel y simply disposed of? 11 MR. THOMAS: We certainly hope so. 12 MR. PENBERTHY: Apart from these, 13 may

be? 14 MR. THOMAS: Yes. 15 MR. PENBERTHY: Okay . All right. So 16 why

don't we start on the first one? 17 MR. THOMAS: Sure. And actuall y, 18 before we get started, I just

-- I think I wanted to thank 19 EPA on behalf of SEHSC for continuing to be patient as 20 we work through this. 2110 One of the things I also wanted to note with 1 respect to the remaining issue and in terms of our 2 viewpoint on those issues, we've actually started to have 3 p retty

substantial discussions with a number of contractors 4 with respect to trying to identify some expertise that's 5 going to actually do the work for us. 6 And I just wanted you to be aware that

-- a 7 number of our positions with respect to these issues h ave 8 been informed b y those discussions, so a lot of practical 9 implications from the standpoint of how we do the work, a 10 lot of that feedback, has been informed b y those 11 discussions we've had with contractors. 12 MR. PENBERTHY: Okay , great. You 13 know, it' s our goal to have a complete document finished 14 at the end of the day today that we can all be satisfied 15 with. So that's our ultimate objective and we'll stay here 16 as long as it takes, so

-- 17 MR. THOMAS: Okay

. 18 MR. PENBERTHY: Then all right. Go 19 ahe ad. 2011 MR. THOMAS: So I'll just start walking 1 through these one b y one. On the timing for the quality 2 assurance plan and for the study plans, we're happy

with 3 the language that's in the current version of the document. 4 The one thing I think we wante d to point 5 out
-- and I think it's very important

-- there are going to 6 be substantial timing implications if EPA does not approve 7 these plans in the specified. So for example, if EPA does 8 not provide some feedback or ultimately approve the plans 9 within the time frame that's laid out, we're looking at 10 substantial delay s in actually the program moving forward. 11 So we're talking six months, along those times, if we can't 12 get the feedback from EPA within the 60 day s, I think, 13 that's allotted for that. 14 MR. PENBERTHY: Okay . You did 15 request that we

– a time limit

-- I'm tryi ng to find where 16 we expressed that. What page did you say that was? I 17 think it's on Page 8. 18 MR. THOMAS: Section 9. It say s, "EPA 19 shall approve the QAPP within 60 day s of receipt if it 20 meets the requirements of this ECA." 2112 So again, I think the language is acceptable. 1 I just wanted to highlight, again, that if we

-- if there are 2 delay s associated with that feedback or if there is some 3 misunderstanding with respect to whether th e plan meets 4 requirements, again, we just want it to be clear that there 5 are going to be substantial delay s associated with the 6 program if we don't have those met. 7 MR. PENBERTHY: I'm trying to find 8 exactly

where

-- what page that is. 9 UNIDENT IF IED FEMALE: Under study 10 and right above testing, in that statement. 11 MR. PENBERTHY: Okay . So we're 12 happy

with that? 13 MR. THOMAS: Okay . Yeah, happ y with 14 that. The other thing, Number 2, Force Majeure, this is a 15 topic, as you know, that's

-- we've kind of gone back and 16 forth over for quite some time. After carefully reviewing 17 the language in the text, we're comfortable with it. So 18 we're happ y that the language with respect to Force 19 Majeure is going to satisfy our needs, so I think we're 20 good for that one. 2113 MR. PENBERTHY: Okay . Then I think 1 we've basically took most of your language from the start, 2
so -- 3 MR. THOMAS: Okay

. 4 MR. PENBERTHY:
-- good enough. 5 MR. THOMAS: So Number 3, the use of 6 one lab for anal yt ical analy ses. I think here in several 7 places EPA has included language with respect to contract 8 laboratory

vendors, and in other places using onl y one 9 laboratory . I think here our request would be that the 10 language be made consistent in terms of the language in 11 the actual ECA document and the language that's in the 12 test standards. And I guess from the standpoint of 13 consistency , our preference would be to maintain some 14 flexibility

. 15 MR. PENBERTHY: Okay . Where is that 16 ty

pe of reference? 17 MR. DOYLE: In the body of the ECA, it 18 would be at Section 9A, Page 7, on m y cop y. 19 MR. PENBERTHY: Okay , all right. 2014 MR. DOYLE: It' s referenced there that if 1 multiple commercial laboratories are actually us ed 2 (inaudible). It's referenced there talking about multiple 3 labs. There is onl y -- each of the test standards, there's 4 actuall y -- it's specifying you shall use one lab, and we 5 want to make sure that that gets modified to accommodate 6 flexibility

if, in fact

-- I mean, obviously that's our intent, 7 but just so we can make sure there's some flexibility there 8 if we need a second lab. 9 MR. PENBERTHY: Well, let me explain 10 what our concern there was. You know, we know that 11 these are difficult anal ys es to d o and it's to the benefit of 12 the quality

of the day

- to
- day

results that a single lab would 13 be done. And the way we drafted this, Ithink you'll notice 14 that in each of the media test standards we wanted each of 15 the

-- all of the testing for each of the med ia to be in a 16 single laboratory at least, but it's our preference that they 17 all be tested at one lab. So that's the way it's drafted right 18
now. 19 MS. PL OTCKE: I mean, Ithink

-- so the 20 way

language is that you have, it say s, "The use of only 2115

one laboratory

is most desired." We actuall y agree with 1 that completely . That is our preference as well, but one of 2 the things we are just trying to do is to put in 3 contingencies; if something were to happen, that we would 4 have some back

- up. 5 So we just want th at flexibility , and then 6 that and the test standards is a little more

-- shall have one 7 laboratory . So we want to make sure that that flexibility 8 of this language is really also consistent with what it say s 9 in the test standard. 10 MR. DOYLE: So if you look at section

-- 11 MS. PL OTCKE: So we're of the same 12 mindset. 13 MR. DOYLE: So Section 8A, it appears 14 and it also appears in Section 9A of the ECA, and then if 15 yo u look at how the language is worded there

-- so Section 16 8A is, "Preferabl y all samples s hould be anal yz ed for D4 17 at one commercial testing laboratory ..."

-- 18 MR. PENBERTHY: Okay . So that 19 expresses our preference? 2016 MR. DOYLE: Yes. So that's

-- that's 1 exactly

right. We

-- we're fine with that. The only part 2 about that

-- and not to j ump ahead about that provision 3 right there

-- is where we say one commercial testing 4 laboratory

-- it say s, "...known to have appropriate 5 expertise with D4 anal ys es..." 6 In our waiving

-- that whole "known to 7 have appropriate expertise" part could just all be struck. I 8 mean, I don't

-- I'm not sure known to who, and at this 9 point in time the method of validation, the EPA doing the 10 GLP, that's what's going to sort of establish that the lab is

- 11

- has appropriate expertise in doing anal ys es (inaudible) 12 ahe ad of time. I mean, we're obviousl y going to choose a 13 vendor we think has appropriate expertise, but I just don't 14 see that that really counts as much. 15 So now if we

-- 16 MR. PENBERTHY: Well, hold on, hold 17 on, hold on: Go ahead, Kathy

. 18 MS. FEHRENB ACHER: Ithought that in 19 prior discussions and, in fact, in the draft that the SEHSC 20 submitted we had included language about working with 2117

the laboratory

to make sure they

had the required 1 expertise. And that's where we're coming from with this 2 language , known to have appropriate experience. 3 MR. MAI T: Well, let's do this: We're 4 planning on going through with whatever lab is selected to 5 ensure that the methods and techniques are all validated as 6 if they

went in the lab like whether it's a company la b or 7 not. I f that's what you mean by that, then it's going to be 8 okay . If prior knowledge before we select the lab, that's 9 where the challenge comes in. That's where Trent's 10 concern comes from. 11 MR. PENBERTHY: So if we change the 12 language from "known to have" to just say "that has 13 appropriate expertise," wouldn't that essentiall y -- 14 MR. MAI T: As long as it

-- is it preferred

- 15

- as long as it's considered from a timing issue that we're 16 going to going to have the opportunity to give them that

-- 17
o kay

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

-- 2018 MR. MAI T: I don't want it to be an a priori 1 thing. It would be better if we're allowed to give them that 2 validation time so that they know they

can achieve what is 3 expected in the test plans. 4 MR. DOYLE: We're certainly going to put 5 them through the validation process just like we 6 established in the test standards and so forth. 7 MR. PENBERTHY: So is it okay

-- so one 8 commercial testing laboratory that has appropriate 9 experience? 10 MS . PL OTCKE: Can you say has or will 11 acquire? 12 MR. ANDERSON: That has at the time of 13 the testing. 14 MS. PL OTCKE: Oh, y es. 15 MR. DOYLE: That's what Iwas getting at, 16 is the timing issue on that. 17 MR. PENBERTHY: Go ahead, Steve. 18 MR. ANDERSON: That has appropriate

-- 19 whatever it is

-- experience at the time the testing occurs. 20 It sounds like that's the

-- 2119 MS. PL OTCKE: That's the

-- ye ah. 1 MR. PENBERTHY: That's the issue. 2 Okay . Let me just read that sentence as I have it. So I 3 say , "Preferabl y all samples should be anal yz ed for D4 at 4 one commercial laboratory that has appropriate expertise 5 with the D4 anal ys es of the samples of the t ypes collected 6 in this testing program when the testing occurs." Is that 7 okay? 8 MR. DOYLE: Yes. 9 MR. THOMAS: Yes. 10 MR. PENBERTHY: Okay . Now, you 11 mentioned there's other places? 12 MR. DOYLE: Yes. 13 MR. PENBERTHY: Can we clean the 14 other places up on this draft? 15 MR. DOYLE: Let's flip back to the test 16 standards, so back at the Appendices. 17 MR. PENBERTHY: Okay . So I assume 18 we'll start at Appendix 4? 19 MR. DOYLE: Appendix 4. L et's go to the 20 section that say s, "Anal ysis of influent and effluent 2120

samples for D4." The very first sentence there say s, 1 "All influent an d effluent samples and accompanying QA 2 samples shall be anal yz ed for D4 at one commercial 3 testing laboratory known to have appropriate expertise 4 with D4 anal ys es to be conducted." 5 MR. PENBERTHY: Okay . Here you'll 6 notice that it's limited to influent and effluent samples; it's 7 not all samples. 8 MR. DOYLE: I understand that. The 9 concern is, if in the middle of the program or somehow we 10 need to, you know, have another lab be involved, that we 11 want to make sure we have that flexibility . I mean, 12 obvi ously , our intent is to have one lab do every thing. 13 That's what's intended. 14 MR. PENBERTHY: Does the saying 15 change (inaudible)? 16 MR. DOYLE: Yeah. I think you mirror 17 the language that you have in the body of the ECA, which 18 is, "Preferabl y testing should be conducted in one lab," 19 and Steve's qualifier at the end, too. 2021 MR. PENBERTHY: So that was Section 8. 1 Okay . So you would

-- so we would delete this first 2 sentence and replace it with the sentence we just 3 constructed? 4 MR. DOYLE: Yes. 5 MR. PENBERTHY: Are you satisfied with 6 that? 7 MS. PL OTCKE: Yeah, that's fine. 8 MR. PENBERTHY: Okay . So we'll 9 mirror the sentence on

-- insert the sentence from Page 6. 10 MR. DOYLE: It' s going to be essentially 11 that same edit for each one of th e other test standards. 12 MR. PENBERTHY: Okay . Hold on, just 13 let me just check. I'll just circle that on each of them so I 14 know. 15 Okay . So that would be on Page 30; that 16 would be the same on Page 6? Okay . We'll keep going. 17 Okay . Again, on P age 35. Page 35, the 18 biosolids; Page 40, on sediment; Page 48, biota. 19 Is that all of them? 20 MR. DOYLE: I think so. 2122 MR. PENBERTHY: Okay . Is this now 1 resolved, this issue? 2 MS. FEHRENBACHER: So let me just 3 confirm what we're saying here. For

-- our preference is to 4 have all samples collected or anal yz ed for D4 at one 5 commercial testing laboratory . And then for each of the 6 media, we did want to have samples for each media 7
anal yz ed at one commercial laboratory? 8 MR. DOYLE: That's our intent as well. 9 However, we wanted to make sure there's that flexibility ; 10 if something goes awry and we need to bring another lab 11 on board, that we can have that flexibility to do that. 12 MR. MAI T: We've had discussions. 13 We've had discussions with potential vendors and this 14 question came up of

-- there are potential situations where 15 somebody

can't perform and we want to be in a position 16 that doesn't impact overall the whole program b y not 17 having somebody in the back seat that we can bring on 18 board, revalidate, and to move forward so the program 19 doesn't get delay ed. That's the thinking. 2023 MR. PENBERTHY: So on Page 48, in lieu 1 of that first sentence, we would strike the first sentence. 2 And on Page 48, if you strike that first sentence and say, 3 "Preferably

all samples should be anal yz ed for D4 at one 4 commercial testing lab that has appropriate expertise with 5 the D4 anal ys is of samples of the t ypes collected in this 6 testing program when th e testing occurs." That's okay? 7 MR. DOYLE: Right. 8 MS. FEHRENBACHER: So what would 9 be a situation where you would need to use a second 10 laboratory? 11 MR. MAI T: Some crazy act of God or 12 something like that. That's what we're

-- 13 MS. PL OTCKE: Or if a laboratory closes 14 down. 15 MR. MAI T: Or burns down. 16 MS. PL OTCKE: Goes out of business, you 17 know. 18 MS. FEHRENBACHER: But you switch 19 labs and you go back to all the samples? 20 MS. PL OTCKE: Yes. 2124 MR. DOYLE: The intent is not to farm this 1 out to a bunch of different labs. The intent is to have all 2 the anal ys es for all the different matrixes done at the same 3 lab. 4 UNIDENT IF IED MALE: Whether it's, 5 yo u know, the initial lab that runs in the

-- whatever kind 6 of problem there is, we need to go to a backup lab. 7 MR. PENBERTHY: I think the way this 8 was constructing it was

-- our preference was to have all 9 the samples from all the media in one lab. 10 MS. PL OTCKE: Right. 11 MR. PENBERTHY: And then our 12 requirement, when we drafted this, was at least each media 13 have the same. 14 MS. FEHRENBACHER: That's right. 15 MR. PENBERTHY: So we are somewhat 16 being somewhat more flexible. 17 MS. FEHRENBACHER: Yes, we are. 18 And I just wanted to make sure that we were okay with

-- 19 MS. PL OTCKE: I mean, the intent is to 20 have every

sample, and so

-- of all the same media 2125

anal yz ed at the same lab, but all samples. So this is only 1 contingency

planning for a natural disaster kind of thing 2 that, you know, we've asked the contractors to put in place 3 j ust in case something, you know, unforeseen happens, but 4 we don't expect that to happen. We don't want that to 5 happen. Our intent is one laboratory does all the sample 6 anal ys is for the whole program as well as each matrix. 7 MR. MAI T: So the point is, from the 8 project managers ' standpoint we want to minimize the 9 potential risk of not meeting its time schedule b y not 10 having a potential backup in the event that it was needed. 11 If it's never needed, we'll never use it. 12 MS. HENRY: But in particular for a 13 specific media, if you're part way through and have to 14 switch, you got to go back and do them all at the same lab. 15 MR. DOYLE: That's not what they 're 16 saying. That's not reall y what they want to do. 17 MS. HENRY: Well, that's inconsistent. If 18 yo u can switch midstream, it's inconsistent with all 19 samples that we will have. 2026 MR. DOYLE: Preferably , all samples 1 should be anal yz ed at one lab. That's what our aim is to 2 do. If something happens

-- you know, let's say we go 3 through the whole firs t campaign, if you will, the whole 4 first sampling event at all the sites, have them all analyzed, 5 then we wait the three months between, as prescribed, go 6 do the

-- if something happens in those intermediate 7 periods with the lab

-- I don't know. We can im agine a 8 whole host of scenarios

-- we want to make sure that we 9 had the flexibility if we need to bring another lab up. That 10 goes to the validation that we can do that under this ECA. 11 That's reall y what it is. It's just for

-- we want to make 12
sure we can make the project schedule. 13 In that situation, we're not going to go back 14 and repeat all the whole first

- phase sampling because we 15 were supposed to use a different lab. The labs are going to 16 have to have to go through validation, you know, the 17 second lab. I mean, that's

-- you know, I mean, these are 18 all out there. 19 MR. PENBERTHY: There are retained 20 samples. 2127 MS. PL OTCKE: Not on every thing 1 because they won't be of value if

-- well, some of them 2 from a stability standpoint. Imean, this is reall y just, you 3 know, that unforeseen kind of

-- I mean, we've had some 4 wild weather, tornados, hurricanes. I mean, if the lab we 5 happen to be at has something like that that totally shuts it 6 down, we want a backup

-- that's all

-- but it's not our 7 intent to go an ywh ere else once we start. 8 MS. FEHRENBACHER: Iprefer that the 9 language in the ECA specify the intent. An d it seems that 10 we're all in agreement that the intent is that for each media 11 we would prefer the samples to be anal yz ed at one 12 laboratory , and then it sounds like you want to have a 13 contingency in place in case you're not able to meet that

-- 14 MR. PENBER THY: So how about we 15 change the language on

-- that's on Page 6 and say

-- 16 instead of preferably to say , "All samples should be 17 anal yz ed for D4 at 18 one commercial laboratory that has appropriate expertise 19 with D4 anal ys is of samples of the ty pes collected in this 20 program when the testing occurs unless there are 2128

unforeseen catastrophic circumstances," something along 1 those lines. Because that's

-- see, "preferabl y" is 2 somewhat flexible and what we're trying to do

-- 3 MR. DOYLE: Exactl y. 4 MR. PENBERTHY: Well, it's too flexible 5 and what we're trying to do is limit it, that the

-- be clear 6 about when this would happen. 7 MR. DOYLE: I mean, to me
-- there's a 8 Force Majeure clause when you deal with a lot of these 9 catastrophic kind of things. Here we di dn't

-- honestly 10 didn't think this was going to be that big of a deal. We 11 wanted to

-- we expressed our intent. 12 And there's a trust factor, but at the end of 13 the day

Ithink

-- to me, if it say s, "Preferably all samples 14 should be anal yz ed for D4..." a s stated, I mean, that's the 15 preference. That's our intent. We've restated it multiple 16 times. It provides for that. Obviously , if we're going to do 17 something different midstream, I mean, everyone is going 18 to be notified of that. I mean, I don't

-- I m ean, to me, we 19 could try

to wordsmith this and

-- to find all of these kind 2029

of contingency

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

. 2 MR. ANDERSON: Or one option might be 3 to sort of go along what you were thinking, having an 4 "unless" clause at the end, but link it and say unless there's 5 an event that would qualify under the Force Majeure 6 provision at such and such. 7 MR. PENBERTHY: Would you be happy 8 with that? We'll just cross preferabl y, start it with all, and 9 then unless there's a Force M ajeure. 10 MR. MAI T: Yes, because that would be 11 what we would be anticipating, obviously , under those 12 conditions. Even if that provision wasn't in there, the lab 13 wasn't available, we would invoke Force Majeure and this 14 time the schedule would be blown any way and we'd be 15 back renegotiating the time frame and so on. 16 MS. STARMANN: I'm sorry , I know I'm 17 not at the table. I'm not sure about Force Majeure

-- if that 18 would qualify for some of the lab situations that

-- Force 19 Majeure is somewhat narrowly d efined in this agreement. 2030
UNIDENT IF IED FEMALE: What's your 1 name? 2 MS. STARMANN: Allison Starmann. 3 MR. PENBERTHY: Let's go back and take 4 a look at what it is. 5 MR. ANDERSON: And there's also the 6 regulation section, 790.68 where you have un foreseen 7 circumstances. 8 MS. STARMANN: You’d have to be 9 known in advance to qualify

. 10 MR. PENBERTHY: I'm trying to find the 11 Force Majeure section, what it say s. 12 So it's caused b y circumstances beyond its 13 control or control of

-- any entit y controlled b y the 14 signatory

company . So how is that limited? 15 MR. DOYLE: Well, I think my preference 16 is to

-- and the reason we stuck the provision in there in 17 the first place and

-- where we talk about the labs is so that 18 we don't get into arguments about what does or doesn't 19 qualify

as Force Majeure. Imean, that's the

-- that

-- 2031 MR. PENBERTHY: Well, Iguess what we 1 do want to avoid is the situation where the lab says, oh, 2 this is harder than we thought, we're going to charge you 3 twice as much; and you say , well, that's too much, we 4 want to go to a different lab, then we have to go through 5 the program. 6 MR. DOYLE: That's not what was 7 intended. 8 MR. PENBERTHY: I know that's not 9 intended, but is that a scenario that could

-- 10 MS. PL OTCKE: I think we put 11 appropriate controls in place. 12 MR. MAI T: I think

-- obviously , we've 13 fairl y well engaged the contractors and I think there's a 14 clear understanding of expectation of what they have to 15 do. They've obviously looked at the preliminary test 16 st andards and so on. So the idea of whether they can 17 perform or not, I think it's well

- understood that they can. 18 It 's a matter of achieving

-- you know, as 19 we've said, we're going to get them validated, so they 20 should be able to be in a position to exec ute what

-- again, 2132

we're concerned about things that are well beyond our 1 control, but I'm not a lawyer here. 2 MR. DOYLE: I think we need to avoid 3 getting

-- we're trying to argue about what the contractor 4 could or couldn't have controlled, which is lit erally

-- 5 comes up in the Force Majeure provision. Imean, Ithink 6 that goes beyond

-- I mean, you know, we kind of stated 7 we wanted the flexibility if it comes up. We don't 8 anticipate it coming up. It's

-- and that's wh y you put the 9 provision in in the first place. 10 I mean, at some point we've communicated 11 what our intent is. We've stated it multiple times. It's on 12 the record. I mean, it's

-- to me, if we leave the flexibility 13 in there, that's consistent with accommodating our needs. 14 We've stated , you know, what we're going to do to 15 accommodate, you know, what you prescribed. 16 MR. SELTZER: The only scenario you 17 provided was if the lab were to flood or something along 18 those lines, and that would fit within

-- that would be 19 encompassed in the Force Majeure section. Are there 2033

other scenarios you're thinking might not and you're 1
w orried about

-- 2 MS. PL OTCKE: Well, I think what 3 Trent's point is is we can't control every thing. We can't 4 control every thing for them. Imean, and so

-- 5 MR. DOYLE: I mean, that lab may decide 6 to, you know, go out of the business of providing, you 7 know, this kind of, you know, anal yt ical work. I mean, we 8 can't control

-- may be it gets sold. May

be they get bought, 9 yo u know. I mean, it's

-- may be, you know, all the staff, 10 yo u know, will leave. You know, there's just a whole host 11 of things that cou ld happen. 12 UNIDENT IF IED MALE: Breaks down 13 and they

can't fix it. 14 MR. DOYLE: Yeah, you know, they 've 15 got equipment that breaks down. Imean, I don't want to 16 get into this situation where we argue about whether that's 17 Force Majeure or not. I mean , that's not an efficient 18 process for an ybod y. We want to get the program done. 19 That's what we thought by doing this in the first place, was 20 to get the program done. 2134 MS. FEHRENBACHER: Ithink the 1 reason that we're prett y strongl y in favor of keeping the 2 language that all samples for individual media be anal yz ed 3 by

one laboratory

is for the data

- quality

issue. 4 There's a small number of samples being 5 collected and anal yz ed for media. And if you split those 6 samples among laboratories, then you're i ntroducing 7 variability

-- inter

- laboratory variability

on top of the other 8 potential areas of variability and uncertaint y. And because 9 of the small number of samples, you need to maximize the 10 data quality aspects. And one way

of doing that is to 11 ensure that at a minimum each of the

-- all of the samples 12 for each media are anal yzed by one laboratory

. 13 MS. PL OTCKE: And that is our intent as 14 well because we agree completely from a data

- quality 15 perspective. And so that's the intent that we're going in 16
w ith, that all of them would be anal yz ed at one laboratory

. 17 If something were to happen and we had to use a backup 18 laboratory , we would be sure that that laboratory was 19 trained and validated and accounted for an y potential 20 variability

. 2135 MS. FEHRENBACHER : And again, 1 would all of the samples be anal yz ed

-- 2 MS. PL OTCKE: I mean, we wouldn't 3 know what

-- you know, if something happens in the 4 middle of doing something and they

-- we have to make 5 that shift to go to the backup laboratory , but we would 6 make sure that

-- 7 MR. SELTZER: To cite the reg, 790.68 8 A2 III, it say s, "Not technically feasible unforeseen 9 circumstances such as lack of laboratory availability ." I 10 mean, that sounds like that and a reg goes to right what 11 yo u' re talking about, any of the issues talking about is 12 right there. 13 MR. DOYLE: It seems like that will be 14 yo ur right consistent with your -- 15 MR. SELTZER: And we can cite to that in 16 addition to Force Majeure, if you want
-- I think one of the 17 previous

-- 18 MR. PENBERTHY: So let 's go back to 19 where we were. So if we start with

-- delete the Preferabl y 20 and say

unless there is

-- what was it? 2136 MR. SELTZER: Unforeseen 1 circumstances such as lack of laboratory availability

. 2 MR. PENBERTHY: As defined

-- 3 MR. SELTZER: As defi ned in 790.68 A2, 4 III. 5 MR. PENBERTHY: If there is unforeseen 6

-- give me the right words. 7 MR. SELTZER: Unforeseen 8 circumstances such as lack of laboratory availability

. 9 MR. PENBERTHY: Such as

-- 10 MR. SELTZER: A lack of laboratory 11 availabili ty
. 12 MR. PENBERTHY: As noted in section

-- 13 MR. SELTZER: 790.68 A2, III. 14 MR. PENBERTHY: Is that okay ? 15 MS. PL OTCKE: Yes. 16 MR. DOYLE: Yes. 17 MR. THOMAS: Yes. 18 MR. PENBERTHY: Okay . That's a 19 reasonable outcome

-- okay , fair enough. So we'll change 20 that all and that will be the sentence. The next one was 2137

site specific sample times. Could you explain what your 1 issue is? 2 MS. PL OTCKE: Yeah. Actually , I 'm not 3 sure we reall y have an issue there, so I think we'll 4 probably

find out that we just wanted to clarify . It say s, 5 "Site characterization". And we wanted to make sure that 6 that's what we had referred to in the past, is we would 7 evaluate the site, evaluate the biology of the site, and come 8 up with the plan of what we would expect to be there. 9 So as long as we're in agreement with that, 10 then

-- 11 MR. PENBERTHY: Okay . Where is this 12 in the text? 13 MS. PL OTCKE: T his is

-- 14 MR. DOYLE: Appendix 1 near the end of 15 the appendix. It' s the last bullet point in the list. It say s, 16 "Site characterization for benthic invertebrate and fish 17 sampling, including species that are expected to be 18 collected for anal ys is." 19 MR . PENBERTHY: Okay . So all of these 20 dots refer

-- evolve from the sentence above them. A 2138

detailed sampling plan shall be prepared for each site and 1 included as part of the overall study plan submitted to 2 EPA. The sampling plans shall include...", and th en all of 3 those items? 4 MS. PL OTCKE: Mm

- hmm. 5 MR. PENBERTHY: Okay . So

-- 6 MR. STAPL ES: Our concern is some of us 7 read it differentl y than others and that's

-- we wanted to be 8 sure that this particular part of the site characterization 9 planning is not presampling, not pre

- field work, but, in 10 fact, it is conversations with local officials who are

-- 11 might be knowledgeable so that these

-- we might be able 12 to identify

species that might be there, should be there. 13 We're going to try to collect, but not that we have done 14 presampling, pre

- field work. 15 MR. PENBERTHY: Okay . Do you see -- 16 I don't see

-- they 're not presampling, but they will ask 17 questions. 18 MS. PL OTCKE: You're going to 19 understand the biology and

-- yeah, ye ah. 2039 Okay . We ju st wanted to make sure we 1 were on that same page; that's all. 2 MR. STAPL ES: Dramatically affects the 3 schedule. 4 MR. MAI T: Strictly precautions, right? 5 MS. PL OTCKE: Yeah. 6 MS. FEHRENBACHER: And we 7 appreciate you checking in with us. 8 MS . PL OTCKE: Yeah. We just want to 9 make sure. 10 MS. FEHRENBACHER: It' s good for us 11 to all be on the same page. 12 MR. PENBERTHY: Okay . Number 5. 13 MR. THOMAS: Yes. This is the selection 14 criteria for the industrial POTWs. This is Appendix 2. 15 Th ere is a sentence here that relates to the D4 16 concentration at the POTWs. It say s, "D4 concentrations 17 in the wastewater treatment plant influent shall be 18 reasonabl y expected to be at least one part per billion." 1940 And I think that's going to be difficul t from 1 the standpoint of presampling. We had not intended to do 2 any

presampling, so I think

-- 3 MR. PENBERTHY: What we meant b y 4 "reasonabl y expected" is not sampling, but an engineering 5 calculation, something along those lines. I mean, what 6 we're tryin g to get at here is there's reasonable assurance 7 that there's actually D4 in the wastewaters. 8 MR. THOMAS: Sure, sure. And I think 9 the language prior to that sentence is sufficient to 10 accomplish that. It say s, all wastewater treatment sites 11 selected for monitoring must be currentl y processing 12 wastewater from one or more industrial sites known to be 13 a D4 processor or formulator as documented through 14 industrial user survey s, or other readily available 15 information. We think that language is sufficient t o -- 16 MR. PENBERTHY: I mean, processing 17 wastewater doesn't mean it contains wastewater, so the 18 sentence is a little bit weak in that processing wastewater

- 19

- you would have to at minimum say , containing D4. 2041 MR. THOMAS: It say s known to be a D4 1 proce ssor. 2 MR. PENBERTHY: Yeah, but that doesn't 3 mean the wastewater is

-- actuall y contains D4. I mean, 4 the D4 processor might not have an y water releases, D4 5 water releases. 6 MR. THOMAS: Right, but that's the whole 7 point of the exercise. 8 MR. MAI T: But then there wouldn't be a 9 discharger, it seems redundant. 10 If they

had no effluent

-- they

wouldn't

-- 11 MR. PENBERTHY: My point is they 12 could have effluent that doesn't have D4 in it. We want to 13 be sure that we're sampling facilities

-- 14 MR. MAI T: But that is some of the 15 dilemma, is there is no

-- without presampling there's no 16 way

to confirm that position. Well, that's an absolute, 17 right? I f you know it, then somebod y's actuall y analyzed 18 it. Otherwise, it's somebody 's opinion that it' s there. 1942 MR. PENBERTHY: I mean, if it wasn't 1 receiving D4 from a processing facility , then it would be 2 basically

an Appendix 3 facility , correct? 3 MR. THOMAS: An Appendix 3 facility

-- 4 right, right, right. 5 MR. PENBERTHY: Well, that doesn't 6 make sense to us. So what is the assurance that there's 7 actuall y going to be D4 in that wastewater? 8 MR. THOMAS: Other than to go out and 9 measure it, which is the whole point of the monitoring

-- 10 MR. PENBERTHY: Well, can the facility 11 operator tell you, y es, we released before? 12 MR. MAI T: Ty pically , the experience is 13 with things like that, you would complete a survey for that 14

-- when they 're doing these ty pes of investigations, 15 basically , Categorical Standards of Manufacturing is the 16 Agency

here who te nds to regulate. 17 You do a survey . You provide information 18 to the operator of the facility that say s, these are the ty pes 19 of processors I have, this is the materials processed, this is 2043

the ty pe of, you know, pretreatment or whatever it is that 1 we have, is it known to you or whatever. 2 Because frankl y, I'm not aware that

-- the 3 people who are going to be asking other than

-- potentially 4 the industrial folks who are in this room would know 5 whether it's in the effluent or not, so we're stuck with

-- the 6 only

way you really

know is you pretest. 7 MS. PL OTCKE: They may know they 8 process it, formulate it, but each of the s ys tems that they 9 have could be removing it. They don't know that. 10 MR. PENBERTHY: So let's go back one 11 step further. So how are yo u going to identify these

-- 12 MR. MAI T: The sites would be identified 13 as we've discussed before. There's certain categorical 14 standards, you know, classifications, that are known to 15 process materials like D4, and then

-- 16 MR. PENBERTHY: (Inaudible). 17 MR. MAI T: Then you would then have

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

-- 19 through our contractor, work with that POT operator to go 20 back to their dischargers to complete a survey , do you 2144

process with D4, are you manufacturing with D4, is it 1 known to be in your effluent, is it suspected to be in your 2 effluent. That's t ypically what I see on these surveys. 3 MR. PENBERTHY: I think that's okay as 4 long as

-- but that's

-- how do we put that in this text? 5 MR. THOMAS: We got here through 6 industrial user survey s, and that was what was just 7 described. 8 MS. PL OTCKE: And it say s, "as 9 documented," so there will be

-- those survey s would be 10 on record. 11 MR. PENBERTHY: All right. One thing 12 we did

-- I propose adding another sente nce at that point, 13 then it would be in the second sentence in the paragraph, 14 after

-- the first sentence would be, the Study Plan shall 15 detail the factors that were used to select each of the sites 16 for testing." 17 And then we would want to add a sentence 18 along the lines of, "The Study Plan shall provide an 19 explanation of why D4 concentration in influent are 20 expected to be above the surface water MDL specified in 2145

Appendix 5." So we want to know there's actually a water 1 release. 2 MR. THOMAS: We may not be able to 3 know. 4 MR. PENBERTHY: Well, you would 5 know if you did the survey , right? 6 MR. THOMAS: Well, just because there's 7 a water release doesn't mean you'll be able to detect it or 8 that it's going to be above the MDL. I mean, that's

-- 9 MR. P ENBERTHY: Well, every facility 10 that was tested in the Canadian said you had 11 concentrations over

-- 12 MR. THOMAS: Not in the surface water 13 concentrations. In fact, I remember

-- 14 MR. PENBERTHY: Yeah. Well, I'm 15 talking about the influent. 16 MR. DOYLE : Well, the influent you'd 17 have to

-- 18 MR. PENBERTHY: Correct. That's what 19 I'm talking about. I mean

-- you follow? 2046
UNIDENT IF IED MALE: It still 1 (inaudible) presampling or not. Imean, you know, we're 2 not going to make representations about it. 3 MR. THOMAS: We would have to 4 actuall y meet that. I mean, certainl y it sounds like you 5 could reasonably expect that to be the case; but to confirm 6 it, we'd have to go out and

-- 7 MR. PENBERTHY: Well, that's what we 8 said, reasonabl y expected. 9 MR. THOMAS: Right, but to make that

-- 10 to show that, you would actuall y have to go out and do the 11 testing. 12 MR. MAI T: I mean, m y personal view is if 13 folks are processing it, they have discharge, things like 14 that; whether they 're pretreating or not, is there potentially 15 a quantifiable amount? Probably . But absolutel y? You 16 know, that's a prett y tall standard to take without actually 17 doing the anal ys is. 18 MR. THOMAS: And that's what we're 19 trying to avoid, the need to go out and do the presampling. 2047 MR. PENBERTHY: Well, the intent is not 1 presampling. I mean, obviously , we're not

-- we're trying 2 to be sure that there's waste being treated. And how do we 3 assure that? And you know, the paranoid person would 4 say , well, you're just going to pick facilities that are closed 5 sy stems and they have absolutely

no chance of a water 6 release, and that's not what we're interested in. 7 MR. MAI T: But if the survey is offered b y 8 the

- - let's say for the POTW, the folks that are discharging 9 to them, if they 're completing the survey where they

are 10 asked, known to be present or suspected to be present, 11 then you would be rel yi ng on their knowledge of their 12 effluent. 13 MR. PENBERTHY: But I'm sa yi ng that 14 that would be sufficient. 15 MR. MAI T: Okay . Well, that's fine. 16 MR. DOYLE: We just can't

-- I can't 17 qualify

that further by

sayingthat that equates to being 18 above the method detection line. 19 MS. FEHRENBACHER: So if we were to 20 add after the wastewater influent shall reasonabl y be 2148

expected based on the industrial site

-- the industrial user 1 survey

and other readily

available information to be at 2 least one parts per billion, would that

-- 3 MR. THOMAS: The one part per billion is 4 alway s going to be problematic because the onl y way to 5 confirm that is to go out and measure it. Every thing you 6 said up until the one part per billion, I think, is fine. I 7 mean, we certainl y want to make sure we're testing 8 facilities that process D4, but we can't attest to, on the 9 front end, what the concentrations are going to be. 10 MR. PENBERTHY: So how about we say 11 the waste

-- a stud y that says that you want to do

-- you 12 say

the wastewater influent shall reasonabl y be expected 13 to contain D4? 14 MR. THOMAS: Yes. 15 MR. NGUYEN: Have a measurable 16 amount. 17 MR. PENBERTHY: So we have the 18 proposal the wastewater influent shall reasonably be 19 expected to have a measurable amount of D4? 2049 MR. DOYLE: I like the first one. That's 1 the whole point. We don't know. Based on these survey s, 2 we're going to qualitatively determine that

-- through the 3 survey s, that the site releases wastewater to the POTW 4 that has D4 in the effluent. 5 MR. PENBERTHY: Okay . How did you 6 just say

it? 7 MR. DOYLE: Whether it's measurable, 8 whether it's

-- 9 MR. PENBERTHY: Well, let's put the 10 words you just said into a reasonable sentence. 11 MR. PENBERTHY: Let's start with

-- 12 we've got our first sentence, "All wastewater sites selected 13 for monitoring must be currentl y pro cessing wastewater 14 from one or more industrial sites known to be a D4 15 processor or formulator." 16 MR. PENBERTHY: And then we need the 17 wastewater treatment plant influent

-- 18 MR. DOYLE: Shall reasonably be 19 expected to contain D4 based on

-- as document ed through 20 industrial user survey s -- 2150
UNIDENT IF IED MALE: Or other readily 1

-- 2 MR. DOYLE: Or other readily available 3 information. Imean, may be they 've done (inaudible). 4 MR. FLACK: Well, you start the sentence 5 with D4 concentrations, so you expe ct
-- 6 MR. PENBERTHY: So let me get this. 7 "The wastewater treatment plant influent shall reasonably 8 be expected to contain D4 based on..."

-- and is it this 9 phrase up here, and industrial user survey s -- 10 MR. DOYLE: Or other readily available 11 information, yes. 12 MR. MAI T: That would be the basis to 13 inform us that we have a reasonable expectation that it be 14 present. 15 MR. DOYLE: And this is going to be 16 documented in the Study Plan, so it's going to al l come 17 through EPA. You know, you're going to get to see sites, 18 we pick the basis, we pick the sites. This sets out the 19 standard for every thing. 2051 MR. MAI T: So Ward, think of it this way

. 1 If the survey s come back and the dischargers to the 2 POTWs say , not expected to be present, obviously that's 3 not
-- 4 UNIDENT IF IED MALE: We would be 5 putting it into a different category , would we not, just as 6 yo u suggested? 7 MR. PENBERTHY: Are you okay with 8 that, Nhan? It all makes sense, the wastewater treatment 9 plant

-- 10 MR. NGUYEN: I think first to have some 11 explanation

-- a fair explanation of the Study Plan that 12 explains why we expect that the concentration and 13 wastewater contains D4. Some kind of explanation

-- 14 MR. THOMAS: And we'll certainly have 15
som e explanation for why we expect there to be D4 in the 16 influent, and that would be because the folks that release 17 to that wastewater treatment plant say they use D4. 18 MR. MAI T: And reasonably expect it to be 19 present. 2052 MR. PENBERTHY: All right. So a gain, 1 on the

-- it say s on the sentence, "The Study Plan shall 2 detail the factors that were used to select each of the sites 3 for testing," and then include an explanation of how

-- and 4 shall provide an explanation of why D4 is expected in the 5 influent. 6 All right. So here's the proposal I got. Can 7 I read it to you? Are you okay? 8 MR. THOMAS: Mm

- hmm. 9 MR. PENBERTHY: Okay . So I'll go one 10 more time with the sentence up on top just so we know 11 what we're saying. 12 "The wastewater treatment plant i nfluent 13 shall reasonabl y be expected to contain D4 based on 14 industrial user survey s or other readily available 15 information." 16 And then in the paragraph below the dots, 17 the first sentence, we'll extend it. It will read, the Study 18 Plan shall detail the f actors that were used to select each of 19 the sites for testing and shall provide an explanation of 20 why

D4 is expected in the influent." 2153 Okay . So the next one

-- does an yone need 1 clarification on what we just said or are you going on to 2 that? 3 MR. THOM AS: So the next one is 4 selection of non

- industrial POTWs. 5 MR. PENBERTHY: Okay

. 6 MR. THOMAS: And Ithink here

-- 7 MR. PENBERTHY: This is Appendix 3, I 8 take it? 9 MR. THOMAS: This is Appendix 3, y es. 10 MR. PENBERTHY: Okay . Here we're 11 comfort able with the language. I think we just wanted to 12 acknowledge, I think, based on our previous 13 recommendation, that the agency included some wording 14 that we thought made the section more clear, in particular, 15 the clause of Preferabl y no wastewater from D4 16 manufactured processors or formulators, but I think we're 17 good with this section. 18 MR. PENBERTHY: Okay . So it's a non

19 issue. 2054 MR. THOMAS: The next one is number of 1 anal ys es. And I'm going to let our technical folks list 2 them. 3 MR. STAPL ES: Ok ay . Mainly the things 4 that were added in terms of number of samples were some 5 extra QA samples, in other words, samples collected to be 6 used for field spikes would be split and both the spiked 7 and unspiked portions of those would be anal yz ed. So that 8 add s a considerable number of samples for QA purposes. 9 A total over the course of the program were roughly 10 another 25 percent of the samples. 11 Speaking with our anal yt ical folks, it might 12 provide some small additional positive QA concern, but it 13 is an awf

ul lot of samples. We're not going to say no, but 14 it

-- we consider it a relatively large additional number of 15 samples for a reall y small benefit. 16 MR. PENBERTHY: Well, you know, we 17 had some difficult y with this issue, and I'll explain what 18 our logic was. Obviously , we have a limited number of 19 samples and sites for you to pick, so we definitel y want to 20 have as much assurance that the samples that we actually 2155

do have taken are good samples. And so the way you 1 could do that is with good QA, QC or more samples. You 2 all are very

insistent on fewer samples, and so that leaves 3 us no choice in terms of boosting the QA so we know that 4 the samples that are taken are good. 5 MR. STAPL ES: Well, what we have 6 defined, I think, will get you to the same spot. Our 7 anal ys ts do say that this will provide a slight bit of 8 additional positive benefit, not really necessary

but

-- 9 MR. PENBERTHY: So we're good? 10 MS. PL OTCKE: So we're fine, y eah. 11 MR. DOYLE: Yes. 12 MR. THOMAS: Yes. 13 MR. PENBERTHY: We're on Item 8? 14 MR. THOMAS: Yes. So this is the 15 method detection limit. I'll let Charles do that one as well. 16 MR. STAPL ES: And I'm just going to kind 17 of tee this up, but we have in the room Dr. Deb McNett 18 who is the

-- one of the leading experts in t erms of 19 anal ys es of D4 in all media around the world. And Isay 20 that truthfully because she is the person that's going to be 2156

basically in charge of training

-- qualifying and training 1 the laboratory that is selected for this, so as such she has 2 considerab le knowledge in terms of anal yt ical 3 methodologies. 4 One of the challenges that we've had with 5 explaining our position on method detection limits and so 6 forth is that we can take a method that one lab uses and 7 hand it to another laboratory , a very well

- qualified 8 laboratory , and they can adapt that method and start 9 anal yz ing for D4. But according to the experts at Dow 10 Corning, they will also start to find background 11 contamination issues that are different with

-- Dow 12 Corning's were different from an y othe r laboratory

. 13 And that will just take some time, and so 14 where we're at on the appropriate level of detection is that 15 we can accept the higher

-- we can accept the levels

-- 16 limit of quantizations 17 yo u proposed for each of the media as long as we 18 recogni ze and the tests reflect that those are the reportable 19 limits for D4 analy ses. We're not sure

-- Dow Corning is 20 not confident and not sure that an y lab on the pace that this 2157

program is going to be conducted at can reach the MDL s, 1 that the MDL s times three to get your LOQ

-- if that L OQ 2 was agreed to be the point of departure, that is the 3 reporting limit, then we can agree to those. 4 MR. PENBERTHY: And so basically 5 yo u' re going to

-- you wouldn't report non

- detects? I s that 6 what you're saying, you woul d only report when you 7 actuall y detect above the LOQ? 8 MR. STAPL ES: Any thing below the LOQ 9 is a non

- detect. 10 MR. PENBERTHY: Is that conventional 11 science? 12 MS. PL OTCKE: May be we can go back 13 to the text in the actual ECA, Trent. 14 MR. THOMAS:

-- 15 if you want to look at

-- there's a couple different spots 16 here. We've got two locations really where this comes up 17

-- or key

locations. 18 There's

-- in Section 2 of the ECA, we 19 talked about chemical subject of the ECA. Do yo u 20 remember we had talke d about

-- this is a little different 2158

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

testing. We've got

-- here it say s the ECA 2 requires testing for the presence of D4 in specified 3 wastewater treatment plant influent and effluent 4 discharges , receiving streams, environmental matrices

-- 5 and here's the part we want to focus on

-- at method 6 detection limits specified in the test standards Appendices 7 4 through 8. 8 And our key comment here is, we would 9 take that method detection limit and repl ace that with 10 limits of quantization specified in the test standards in 11 Appendices 4 through 8. 12 Then if you go back to the individual test 13 standards, that's what Kathy was referring to in terms of

-- 14 that's where it's been set out how the limits of quantization 15 are calculated. And those were established based on a 16 multiplication of the method detection limits that have 17 been achieved in previous studies and multiply those

-- 18 originall y we had

-- if you recall, a practical quantification 19 limit of five ti mes the method detection limit. 2059 EPA has come back with a factor three 1 times the method detection limit, and we're going to accept 2 that as a limit of quantification. I think the point that 3 Charles made is we want to make certain, when the data 4 are repo rted, it's going to be

-- if it's above the limit of 5 quantization, it's reported as such. If it's below that, it 6 would be essentiall y, as you rightl y pointed out, Ward, it 7 would be reported as less than the LOQ. 8 MR. PENBERTHY: Okay . But that's not a 9 conventional approach to monitoring, is it? 10 MR. DOYLE: I think that the challenge 11 here is with the

-- 12 MR. PENBERTHY: You usually report 13 the data that you get, right? So whatever you get is the 14 number you get. You wouldn't filter it. 15 MR. DOYLE: Remember, what we're 16 going to qualify in these labs is to be able to achieve a 17 limit of quantification of three times the

-- because the 18 method detection value that's being plugged in, that's from 19 a prior stud y. That's not a study that these labs have done. 20 That's from the prior studies that have been achieved. And 2160

that's what's going to use

-- we're willing to use various 1 values that have been pulled from these various studies to 2 calculate a limit of quantification. 3 We're just not certain that

- - from a time 4 standpoint, we're going to be able to get a particular lab to 5 achieve a method detection limit that equals what's 6 specified there; hence, going with the limit of 7 quantification. I don't know if, Kath y, you have anything 8 else to add. 9 MS. PL OTCKE: So Ithink we may want 10 to may

be go and talk about this if we can. 11 MR. PENBERTHY: Sure. 12 MS. PL OTCKE: But I want to make sure 13 that we understand your position before we do that. 14 MS. EI SENREICH: I do have a question. 15 So you're saying that you would use

-- so we have an 16 MDLfrom your literature, from all the literature

-- we 17 used the highest values we can find from your reported 18 MDL s. So you're saying you're okay with using three 19 times that as the limit

-- the LOQs; however, LOQs are 20 ty

picall y calculated three times whatever MDL is achieved 2161

in the study , so to set a specific number is inappropriate. 1 And I think our point with the MDLhad

-- the one I'm 2 looking at happens to be fr om biota, so three and a half 3 nonograms per gram, yo u would be less than that, up to

-- 4 yo ur MDL s -- you should be able to achieve an MDL 5 that's up to three nanograms per based on all literature 6 that's out there, the MDLs that have been reported. 7 MR. D OYLE: I understand what you're 8 saying, but

-- 9 MS. PL OTCKE: Yeah. What we're saying 10 is the way

those were achieved is

-- there were a lot of 11 special precautions taken in place, and that's wh y we were 12 originall y going with the practical. But what we're saying 13 is we'll go based on what the lab is able to achieve, which 14 is what you just said. You determine the MDL, and then 15 the L OQ is three times that. But it's what they 're able to 16 achieve, not something that's cited in literature where 17 special precauti ons and

-- 18 MS. EI SENREICH: Right. The reason 19 why

these MDLs are in here are to give a maximum 20 anal yt ical benchmark essentially , so we want to make sure 2162

that the

-- the anal yt ical ability of the lab reaches a certain 1 point. 2 MS. FEHRENBACHER: And le t me also 3 ask some clarifying questions on the work that you're 4 planning to do to get these anal yt ical laboratories up to 5 speed because I'm quite concerned about that. You have 6 quite of bit of expertise with these chemicals and the 7 precautions that folks need to take such as don't wear

-- or 8 don't use products that contain siloxane compounds, so it 9 seems to me you must have a list of those precautions, 10 some of which should be fairl y straightforward. And I'm 11 assuming that you're going to share that information. 12 MS. PL OTCKE: And we already have 13 with our candidates, yes. 14 MS. FEHRENBACHER: And that you 15 must have some assurance that the samples that they 're 16 going to be collecting and anal yz ing will be of high 17 quality . And I'm also assuming that you' re planning to 18 have your experts from Dow or other laboratories that 19 have that expertise to work with the laboratories and share 20 their knowledge so that they understand that precaution. 2163

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

icult that other laboratories won't be able to meet 2 MDL s that have been widely published in the literature. 3 MS. PL OTCKE: So for example, some of 4 the things that we've done, we may have a dedicated clean 5 hood. You know, asking a laboratory to the

-- to have a 6 dedicated clean area when they 're a commercial laboratory 7 is just challenging to do. 8 So we're a smaller laboratory . We have the 9 ability

to do that, but a commercial laboratory

-- certainl y 10 we have asked them to have as much of these precauti ons 11 put in place as possible, but they are a commercial 12 laboratory , so, you know, there's a lot that goes on at those 13 commercial laboratories. 14 This is what we do, so it's just that level

-- 15 or for us, it's what we do. This is what we do, these are 16
our anal ys es that we do, and

-- but for them, they 're a 17 commercial laboratory . They do a variet y of things. We 18 can't ask them to shut down their entire lab and do only 19 this project, so you have to

-- but we've put all the training 20 in place. 2164 They know th e requirements. They will 1 actuall y be tested after they're trained to ensure that they 2 don't have contaminations. We put provisions in the 3 agreements that they would have to sign indicating, if they 4 have samples, what's the ramifications and the 5 conseque nces of that? 6 So we've laid all of that out for them and 7 we will do that and they will have that training, but it's just 8 a level that we can go to in our laboratories because we're 9 small groups. This is what we do. This is, you know, 10 what we do every day . That can impact that, that level. 11 MS. McNETT: And we've spent a decade 12 or more getting to that level and determining where the 13 sources of contamination can come from. For example, 14 we've anal yz ed air in different laboratories even within our 15 si te, and we'll have laboratories that have air samples of

-- 16 that contain D4 14 times higher than another laboratory , 17 and it takes time to identify where that source of 18 contamination is. And on a schedule that this program is 19 on, we can't guarantee that we 're going to contract a 2065

laboratory

that's not used to that to be able to identify all 1 of their sources of contamination that are possible. 2 MR. PENBERTHY: I think we've tried to 3 be prett y generous here because we picked the high end of 4 the ranges of al l the MDLs of studies that you've done. 5 And you know, I would think that if you couldn't achieve 6 the method detection limits that are specified here, you'd 7 have to come forward with a modification explaining that, 8 and then describing what the MDLis and s ee if we would 9 approve the modification. But I think the MDLs we've 10 picked are prett y reasonable. Imean, they 're what's 11 required, you know, for risk assessment purposes to have 12 meaningful data. 13 MS. PL OTCKE: Deb, did you want to 14 make a comment? Go ahead. 15 MS. McNETT: I'm just going to go from 16 the 1985 EPA document describing practical 17 quantification limits and it describes this issue, Ithink, 18 very

well in that a practical quantification limit is 19 proposed as the lowest level achievable among 2066

labor atories within specified limits during routine 1 laboratory

operations. 2 The PQLis significant because different 3 laboratories will produce different MDL s even though 4 they 're using the same analy tical procedure, same 5 instruments, and same matrices. 6 MR . PENBERTHY: That's wh y we picked 7 an (inaudible) that you've already demonstrated. 8 MS. McNETT: Not in all cases are they on 9 the high end of the range. 10 MR. PENBERTHY: All the ones here say 11 they

are. 12 MS. McNETT: For example, sediment, 13 we've h ad a study where we had 8.5 nanograms per gram. 14 And you're proposing 3.7 nanograms per gram in this 15 version. 16 MR. PENBERTHY: We picked studies 17 that you've had published and we picked MDLs at the 18 high

- end range. 19 MS. McNETT: Right. 20 MR. TOBIAS: It was from 2167

one study . That study

had multiple MDL s. We took the 1 highest one out of the study . So within that one study , 2 there was the one we cited 3.7. There was also, I believe, 3 .4, as the other one. And the 3.7 actuall y the y thought was 4 inflated, and there's a long explanation of wh y they 5 thought it was inflated. 6 MS. McNETT: But there's also another 7 study

reference that has 8.5 nanograms per gram. And 8 those were different time periods and different levels of 9 expertise for us to identify the c ontamination potential, 10 and in that case it was a particular sample of Nitrogen gas 11 that was used in a concentration step. But what I'm saying 12 is we can't control for all the variables and points of 13 contamination potential. 14 MS. PL OTCKE: Debbie, may b e it would 15 be good to state what yo u think the language should be. 16 MS. McNETT: Okay

. 17 MS. PL OTCKE: And then we go, and 18 then if you guy s need to talk about it

-- 19 MS. McNETT : Ineed to find it here. I'm 20 on Page 48

-- sorry , Page 30. And this is a paragraph that 2168

say s, the MDL. And I'm going to start with the second to 1 the last sentence where it states, "During method 2 development the Knoerr 2013 anal yt ical method for D4 I 3
a chieved a matrix

- specific MDL of 0.037 in micrograms 4 per liter and which shall be achieved for surface water 5 testing." 6 And then it goes on to say, "The specific 7 level of detection shall be based on the LOQ, which shall 8 be three times the MDL." 9 I'm proposing

-- or we are proposing that 10 shall be achieved for surface water testing in that

-- the 11 end of the second to the last sentence be removed. 12 MR. PENBERTHY: So if we did that how 13 would we know the precision of the data that we were 14 getting? You know, what are you agreeing to? How do 15 we know what you're agreeing to? 16 MS. McNETT: We will agree to report an y 17 level above the limit of quantification at three times

-- in 18 this case three times 0.037, which is 0.11. 19 MR. LEWI S: And you want that to each 20 environmental matrices? 2169 MS. McNETT: Right, changing the 1 number appropriatel y, but

-- 2 MR. PENBERTHY: But how do we know 3 the actual sensitivity test that you're performing? 4 MS. McNETT: But you are agreeing to 5 0.037? 6 MS. PL OTCKE: Times three. 7 MR. PENBERTHY: They 're agreeing to 8 three times the MDL, whatever the hell that might be. If 9 they 're not trying hard, it might be 5.3 or something. 10 MS. PL OTCKE: No. We're okay with 11 actuall y the MDLs that are specified in there. 12 MR. THOMAS: Yeah, we're okay with 13 that number. 14 MS. PL OTCKE: So it's three times that 15 would be the limit of quantification or the level of 16 quantification. 17 MR. PENBERTHY: But Imean, if you 18 have that

-- if you can -- why wouldn't you report leve ls 19 between the MDL and the LOQ? It doesn't make sense. 2070 MS. PL OTCKE: Because it's below the 1 limit of quantification. 2 MR. STAPL ES: And recall all of the 3 MDL s that you are proposing are Dow Corning 4 concentrations that have been developed over

-- w ith a 5 skill base over the course of many y ears. We're talking 6 about having a couple of months to train a laboratory to do 7 the best that they can. 8 MS. FEHRENBACHER: So just to make 9 sure that we understand you're okay with the MDL values 10 that we've inc luded, but you' re onl y proposing to report 11 values above the LOQs and any value below an LOQ 12 would be a non

- detect, would be reported as a non

- detect. 13 So we would never know

-- 14 MS. PL OTCKE: Less than LOQ. 15 MS. HENRY: But if you're agreeing to the 16 pr edefined MDL and three times that, it's a fixed number. 17 MR. STAPL ES: 0.11 micrograms per liter. 18 MS. FEHRENBACHER: But really below 19 the L OQ, you have really no assurance that

-- you know, 20 yo u' re really drasticall y limiting our assurance of the 2171

val ues that you're anal yz ing and the accuracy , the 1 accuracy

of those values. 2 MR. PENBERTHY: And you’re filtering 3 the raw before yo u send it to us

-- out. Ijust don't 4 understand that. 5 MS. PL OTCKE: I mean, what you're 6 reall y sa yi ng is because there 's that level of uncertainty

. 7 There's a greater level of uncertaint y in that number, and 8 so it's below that limit of quantification. That's all you' re 9 reall y sa yi ng. 10 MR. PENBERTHY: Why don't you just 11 explain that in your report and report the raw data? I 12 mean, that's ty pically what people do in science, don't 13 they? 14 MS. PL OTCKE: You could see it in 15 multiple way s. 16 MS. FEHRENBACHER: That's our 17 standard practice, is to record

-- record the raw data with 18 the MDLand the LOQ and not the (inaudible). 19 MR. STAPL ES: And I will just say this as 20 a nonanal yt ical chemist, but based on my long dialogs 2172

with analy

tical chem ists is that we don't think we can train 1 a lab that's not anal yz ed D4 and all these matrices in the 2 months that we have to do to reach the Dow Corning 3 method. 4 MR. PENBERTHY: I mean, if that's the 5 case, then what you should do is file for a modificatio n 6 that explains what

-- 7 MR. THOMAS: Can we take 10 or 15 8 minutes to just kind of talk a little bit about this and may be 9 this would be a good time for a break an ywa y? 10 MR. PENBERTHY: Sure. (A recess was 11 taken) 12 MR. THOMAS: One thing we thought 13
wou ld be helpful for clarification, can you give us some 14 sense for how the agency ty picall y treats data that's 15 reported below the LOQ? 16 MR. PENBERTHY: Well 17 ty

picall y we report the LOQ

-- well, I'll give you my 18 understanding and then let (inaudible) tell you. I think 19 ty

picall y we report all of the raw data and then in these 20 kinds of reports we certainly define the MDL and define 2173

the L OQ, and then we will define what actually is meant 1 by

a nondetect. And so we wouldn’t be filtering data like 2 this, ty

picall y in a sound science basis, it would be unusual 3

-- I think it would be very hard for us to agree to that kind 4 of thing. 5 MR. THOMAS: But in terms of the 6 subsequent anal ys is, does the

-- do data above the L OQ 7 get treated in the same manner as those that are below the 8 LOQ? You just report in all of the data and

-- 9 MR. PENBERTHY: Right. And then the 10 arguments start, but the data speaks for themselves. Why 11 does

-- what's the average? What's a nondetect level? But 12 the data is there; it's present. So we're going to need to 13 have that. I just don't think we could agree with your 14 proposal where we would filter data and keep raw data out 15 of the record of what's available. 16 MR. THOMAS: And Idon't think that was 17 the intent. Ithink the idea was more to have some relative 18 acknowledgement that the quality of those data are 19 different. Otherwise, there would be no point of having an 20 LOQ. 2174 MR. PENBERTHY: Right. Iunderstand 1 that and we understand that there's difficulties

-- may be 2 difficulty

in meeti ng the MDL s, but we also know that 3 Canada did a study and they met similar MDL s. And so 4 we know while this is a difficult issue

-- it may be 5 problematic

-- it is something that's can be dealt with. 6 And to the extent

-- we can insert language 7 into this ECA that say s, we recognize achieving the MDL 8 may

be difficult and may require modification, if 9 necessary . But then if that was going to happen, we'd 10 need to know precisel y what has occurred and wh y 11 (inaudible). 12 MS. PL OTCKE: You know, to be honest, 13 our real concern is the ability of the labs to achieve these 14 MDL s, and particularly in the time frame that we're 15 dealing with. As Deb said, we've been doing this for a 16 decade, so we have a lot of learnings that

-- ye s, we will 17 try

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

thing, but we are concerned. 19 So we just want to make sure that there's a 20 way

to manage that concern. So if there's a better way to 2175

do it by putting some language about

-- what happens if 1 they 're not able to achieve it , then let's look at that. 2 MR. PENBERTHY: Right. And we can 3 add a sentence in here on the

-- you know, along the lines 4 of in the event the MDL for a specific media that's being 5 measured couldn't be achieved, SEHSC will

-- I don't 6 know what the right verb is

-- appl y for a modification 7 under the procedures and explain why EPA recognizes 8 that this could be an issue. 9 MR. DOYLE: Conceptually , I understand 10 (inaudible), but the key is we really

want to make sure

-- 11 we'd like to capture, engage, recogni tion of the challenge 12 of the issue. So Ithink the language you used, I think, 13 Ward, most recentl y when you said the agency recognizes 14 that achieving these MDLs may present challenges. 15 MR. PENBERTHY: Okay . So let me start 16 putting a pen here. 17 UNI DENT IF IED FEMALE: Is that for 18 Part 2? 19 MR. PENBERTHY: No. Ithink we'll 20 leave Part 2. And this will be a sentence in each of the test 2176

standards 4 through 8, that EPA recognizes that 1 laboratories may have difficulty

obtaining

-- achieving the 2
as - spec ified MDL. In this event

-- what's the proper noun, 3 test sponsors? Test sponsors shall seek a modification

-- 4 shall seek an ECA 5 modification as specified under

-- 6 MR. SELTZER: 40 C.F.R., 790.68. 7 MR. ANDERSON: Actually , I don't think 8 it would be the principal test sponsor. Ithink it would be 9 the signatory company . 10 MR. SELTZER: You're right. It's mutual 11 companies. We define it that way

. 12 MR. PENBERTHY: Under 790.68. And 13 then we will repeat that in each

-- repeat it in each of the 14 test standards? 15 MR. THOMAS: Yes. 16 MS. PL OTCKE: Do we want to specify 17 the time or

-- I mean, does it matter. I mean, if we're not

-- 18 we will

-- we can probably define the timing. 19 MR. PENBERTHY: If the scheduling gets 20 off, you need to seek a modifi cation. 2177 MS. PL OTCKE: Any

way , so you're right. 1 Yeah, ye ah, okay

. 2 MR. MAI T: One leads to the other. 3 MR. DOYLE: The onl y challenge that I 4 think would be the timing of the

-- the timing of the 5 modifications. The 790.68 rule we have are prescriptive 6 about the timing of submitting applications for schedule 7 modifications. 8 MR. PENBERTHY: What's your con cern? 9 MR. DOYLE: Well, I just want to make 10 sure that the

-- you know that

-- depending upon

-- I guess 11 may

be it's a concern about nothing insomuch as depending 12 upon when this happens in the process, whether we could 13 meet the 60

- day window, which, I gu ess, it shouldn't be a 14 problem assuming these occur earl y on in the program, 15 yo u know, during the validation portion, so may be you 16 think it's not a real concern. I'm just looking at the timing 17 provisions of 790.68. 18 UNIDENT IF IED MALE: Well, Ithink 19
we 're okay

. 2078 MR. PENBERTHY: I mean, this whole 1 section agrees that it's sort of meant for the situation. Do 2 yo u have an y input on this, on the 790? 3 MR. DOYLE: We're okay . We just want 4 to make sure that we thought through the timing. I had to 5 make sure that we weren't going to, you know, practically 6 speaking, not have time to actuall y submit a request for 7 modification. 8 MR. MAI T: The lab validation process is 9 one of the first things we're going to (inaudible), so

-- 10 UNIDENT IF IED MALE: Any ba d news 11 would be heard early

. 12 MR. THOMAS: So Ithink we're Good on 13 this one. 14 MR. PENBERTHY: 60 day s, right? Okay , 15 thank you. 16 MR. THOMAS: All right. Thank you. 17 So the next one was the collecting influent 18 samples one residence time apart. And this is Appendix

-- 19 this is either five or seven. Ithink it's five. The issue is 20 the collection of influent and effluent samples for anal ys is 2179

of D4. And the language specifies that the samples will be 1 taken at least one wastewater treatment plant residence 2 time apart, if practical. 3 MR. DOYLE: That's Appendix 4. It's 4 right before the Figure 1. 5 MR. PENBERTHY: Okay . You 6 understand that this is specific to influent and effluent, 7 correct? 8 MR. THOMAS: Yes, correct, correct. 9 MR. PENB ERTHY: Okay . So what is the 10 specific concern? 11 MR. THOMAS: The specific concern is 12 that the residence time at some POTWs could vary 13 between hours and day s. And given the number of 14 samples that need to be taken, you're talking

-- yo u're 15 substantially i ncreasing the amount of time required to do 16 sampling at each site, which is going to not allow us to 17 achieve the 60

- day goal. 18 Plus, Ithink it's also unclear

-- the value of 19 this exercise relative to its need for doing a risk 20 assessment. 2180
MR. PENBER THY: Yeah. I'll explain that 1 to you. It's not directly related to the risk assessment, but 2 it is related to the quality of the information generated by 3 the testing. 4 And by that, I mean, if there is time 5 separation between the duplicates of influent and effluent, 6 it allows us to understand

-- if there's a potential for an 7 artificially

low measured concentration or is this really 8 standard operating procedure. And if

-- and a standard 9 operating condition or even a steady - state situation. 10 So the gre ater the time separation between 11 when the samples are taken, it would give us some 12 assurance, if the levels are comparable, that there's nothing 13 precarious going on there. It' s a t ypical situation. So that 14 was the intent, to make it sort of a quality che ck. So we 15 understand the residence is not going to be a long time, but 16 we want to find the time dimension that gives us some 17 assurance of the concern I just mentioned. 18 MR. THOMAS: I f the concern has to do 19 with ensuring that the plants are operating w ithin the range 20 of what would be normal operating conditions, I think we 2181

talked previousl y about collecting a whole number of data 1 for each plant that would be included in the site

- specific 2 sampling plans. And I think you would get information 3 with respec t to the

-- 4 MR. PENBERTHY: I don't understand 5 that. 6 MR. DOYLE: In Appendix 4, under 7 establishment of appropriate time for sampling events. It 8 starts off, "At each site, two sampling events will be 9 undertaken that are scheduled to be a minimum of three 10 months apart and during normal plant operations and 11 weather conditions. Normal operating conditions will be 12 established by consulting with the operator of each 13 wastewater treatment plant, indirect and direct discharge 14 facility . The criteria or means that are used b y the 15 facilities to determine normal operating conditions will be 16 documented in the site

- specific sampling plans." 17 Confirmation will be obtained that the subject facility is 18 operating under normal conditions prior to commencing 19 sampling at a given location." 2082 The intent in having all of that in there was 1 precisel y to get at making sure we're sampling, when, in 2 fact, these sites are operating under normal conditions. It 3 just is a practical matter to have folks, you know, 4 happening around multiple day s and trying to meet

-- 5 MR. PENBERTHY: What page is this on? 6 MR. DOYLE: That's on Page 22. We're 7 concerned between residence time, there could be

-- we 8 can have weather issues come up, a whole host of things. 9 And all of a sudden we're going to keep

-- you know, 10 yo u' re going to invalidate your whole sort of sampli ng in a 11 program there because you were going to be

-- going to 12 have such huge time gaps between the

-- each individual 13 sample potentially

. 14 It adds a lot of uncertainty to try to have 15 multiple field crews out there working at all of these sites 16 and gett ing the program to stay on schedule. To me, you 17 know, if an ything, is seems to introduce more variability 18 or uncertainty into the data as compared to, you know, 19 cleaning it up. 2083 MR. MAI T: And I would offer that we, 1 yo u know, look at, let's say , a theo retical 14 sites within 2 the time window in order to achieve onl y environmental 3 conditions that we have to satisfy and the ty

pes of 4 facilities, and the geographic thing. This is quite a thing to 5 choreograph to be sure we're meeting the window of 360 6 day s. 7 MR. PENBERTHY: So your proposal is 8 specificall y in terms of the language of this? 9 MR. THOMAS: I s to strike the language 10 that

-- so the language would just be stricken at

-- there 11 would be a period after at each influent and effluent 12 location, seven grab samples

-- and then there's a 13 parenthetical

-- two quality assurance samples, and five 14 D4 study

samples will be taken, period. So the "...at least 15 one wastewater treatment plant residence time apart, if 16 practical" will be stricken. 17 MR. PENBERTHY : Do you have the 18
assurances you need in other parts of that document? 19 MR. NGUYEN: We talking onl y a few 20 samples, right. We're only taking it for (inaudible). We're 2184

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

-- 2 MR. THOMAS : Right. The issue here is 3 not
-- the number of samples. So for example, if the 4 residence time for a plant is two day s and you're taking 5 five samples, that's ten day s. So suppose on Day 3 it starts 6 raining and something happens where

-- you know, and 7 you' ve got 14 wastewater treatment plants to duplicate that 8 at, we've onl y got 360 days to complete the program. 9 There's concern that adding all of this time could 10 substantially

-- 11 MR. NGUYEN: But yo u don't have a time 12 dimension in there. I mean, you'r e just talking like two, 13 three hours apart pretty much the same sample. 14 MR. MAI T: Are you prepared to extend 15 the period? If you want to go over 360 days, we could 16 discuss that. 17 MS. McNETT: We also only have 14 day s' 18 stability

for water samples t oo, so that needs to be kept in 19 mind. QC samples need to travel with all of the samples 20 back to the laboratory

. 2185 MR. THOMAS: And it's also not clear

-- I 1 mean, Ward, what you just articulated was a need to have 2 some assurance that the plant was operat ing within some 3 normal range of operating conditions. I'm not clear how 4 the time element play s into that. Because, again, Trent 5 just articulated where in other parts of the document you're 6 going to get all of that information. 7 MR. PENBERTHY: Right. I guess if we 8 saw a large difference between two samples taken a period 9 of time apart, it would be an indication of what's going on, 10 was it reall y -- was there an issue with how the plant is 11 operating? 12 MS. FEHRENBACHER: We do have this 13 clause in here , if practical. Do you have

-- I mean, is it 14 possible to further define what you think is practical from 15 yo ur perspective? 16 MR. THOMAS: Well, Ithink if practical 17 means it's going to mean we won't be able to meet our 18 360

- day

time obligation, that it's i mpractical. 19 MR. DOYLE: In reaching out to the 20 vendors who we reached out to already, you know, to 2186

execute the program for us in the constraints that we've 1 been operating under, I mean, it's

-- and this is the 2 feedback we received. It's an extremely a ggressive

-- I 3 mean, that's the consistent feedback we've had from 4 multiple well

- respected vendors. They said, we're just 5 worried about

-- you know, if it's already extremely 6 aggressive and adding something that

-- in our way of 7 thinking is reall y kind of unrelated to doing a risk 8 assessment into the mix and you think about it

-- even for 9 the client's purposes he's not going out there sampling all 10 of these multiple day s apart
-- 11 MR. MAI T: From a strict project 12 management standpoint, this introduces a hi gh degree of 13 project risk. You know, because we've got to go back to 14 the same places twice. And the way this has been sort of 15 organized, I mean, they 're basicall y -- crews are going 16 from one site, they do their work. Hopefully , hopefully , 17 the weather co operates, and then they 're sort of scheduled 18 one right after the other and choreographed with the 19 laboratory . So you started adding this (inaudible) into 2087

there, the abilit y to control and manage the project from a 1 time standpoint just goes out the window. 2 MR. PENBERTHY: All right. So we're 3 going to rel y on the criteria means that are used b y the 4 facilities term operating conditions of the document. 5 MR. DOYLE: I mean, that's what's done 6 all the time for compliance purposes. 7 MR. PENBERTHY: Ok ay , fair enough. 8 Next item. 9 MR. THOMAS: Okay . The location of 10 surface water, sediment, and biota sampling. 11 MR. STAPL ES: Okay . On the base 12 subject of where samples are taken, the previous version 13 of the ECA and the current version of the ECA bo th 14 contain language specific to surface water that

-- 15 "Sampling for surface water shall be taken as reasonably 16 close to the effluent outfall provided adequate mixing has 17 occurred." 18 And we spent a lot of time in a previous 19 meeting talking about what ade quate mixing has occurred. 20 And all the experts that we've talked to, that means the end 2188

of the mixing zone. That's a location that

-- which you 1 will be assured that effluent has reached all dimensions of 2 the surface water and the sediment and, hence, the fish and 3 biota. Now that's been entirely taken out, the concept of 4 the mixing zone

-- and it appears that you're now are 5 focusing on the choice of sample collection from where 6 the benthos are taken and working backwards from that. 7 To us, that has an impractical nature in that 8 effluent outfalls can hug the bottom and not mix with the 9 water for some distance, but the nearest deposition zone 10 may

be before the end of the mixing zone. Similarly , 11 effluents can hug the shoreline for a considerable distance 12 before it mixes with

-- fully mixes with the water and a 13 deposition zone that may be nearer to the outfall and the 14 end of the mixing zone may never receive effluent, so we 15 cannot
-- 16 MR. PENBERTHY: So this is language in 17 what, Appendix 8? 18 MR. STAPL ES : Every thing is tied to 19 Appendix 8 now. 2089 MR. PENBERTHY: I just want to make 1 sure I locate the language. So there seems to be a question 2 about what does provided adequate mixing of the 3 discharge and receiving water has occurred mean. I know 4 we're no t reall y interested in getting into the whole mixing 5 zone debate because we don't necessarily

-- 6 MR. STAPL ES: We feel

-- 7 MR. PENBERTHY: Because I think that's 8 a debatable criteria and what do you really mean by that. 9 MR. STAPL ES: Well, we feel we can 10 give you assurance that influent has reached

-- 11 MR. PENBERTHY: How would you like 12 this to read? 13 MR. STAPL ES: Say that again, please. 14 MR. PENBERTHY: How would you you 15 like this to read? 16 MR. STAPL ES: Back the way it read in 17 the las t version. 18 MR. DOYLE: "At each site fish should be 19 collected as close as reasonably possible to the discharge 20 point provided adequate mixing of the discharge and 2190

receiving water has occurred. To satisfy this requirement 1 fish shall be collected at the end of the mixing zone in 2 locations where fish may be expected to be captured." 3 MR. THOMAS: So we would use the 4 language in the version previous to the one that was 5 distributed a couple weeks ago. 6 MR. PENBERTHY: Okay . And ours

-- 7 well, what you put in here was pretty much based on the 8 Canadian approach, where they prett y much worked 9 downstream from the outfall until they found enough 10 benthic species in a sediment. 11 MR. TOBIAS: They just found sediment, 12 actuall y. They just wanted to find a s pot with the 13 sediment in the Canadian study

. 14 MR. PENBERTHY: Okay . Is the phrase 15 "provided adequate mixing of the discharge", is that

-- if 16 we deleted that, does that

-- 17 MR. STAPL ES: Actually , we thought that 18 to be a useful concept in that we then interpret it as the end 19 of the mixing zone. 2091 MR. MAI T: The strategy though conforms 1 to at least

-- with my experience with the water division 2 here, it conforms to when you would do similar things or 3 this kind of work. That's where you would be, that' s the 4 whole purpose of defining it an yw ay , that you have

-- you 5 know, the environmental impact being noted in an area 6 where the effluent really resides. So you want to be sure 7 that, you know, the species are there with what we're 8 looking for. 9 MR. STAP LES: And right now it does 10 say , "Sampling shall begin at the outfall and proceed 11 downstream until adequate benthic organism samples are 12 collected." And we have no assurance that

-- beginning at 13 the outfall and proceeding downstream, where the effluent 14 actuall y reaches the sediment. 15 MR. PENBERTHY: Yeah. You have to 16 keep going until you find it. 17 MR. STAPL ES: Keep finding what, D4? 18 MR. PENBERTHY: No. You start at the 19 outfall and work downstream in the sediment until you 20 find enough benthi c organisms. 2192 MR. STAPL ES: With you we're not sure 1 that D4 and

-- effluent possibly containing D4 has been to 2 that deposition zone unless we know the water is well 3 mixed. 4 MR. TOBIAS: I think by sitting where the 5 outfall is you can tell where the effluent is going. You just 6 described

-- I mean, that's what the Canadians basically 7 did. They

used knowledge of the sites to study where D4

- 8

- or best select, they thought, where the sediment. 9 I guess the problem is that when I talk to 10 the people at the regions of how mixing is defined, they 11 say

each state is to define their own technique for deciding 12 whether to use them if they want to, and some don't. And 13 they

can define it different way s, so I'm worried about 14 giving different

-- I don't know how

- - what will come 15 back after you go back and do these mixing zones. Will 16 yo u come back with twenty miles and

-- I don't know what 17 the outcome would be. 18 It seems like

-- I wanted something that 19 was more determined in the document. 2093 MR. DOYLE: And th at's whether I think 1 we didn't prescribe to use it in the EPA model to 2 determine mixing zones, too. We didn't

-- 3 MR. TOBIAS: But there are man y, and a 4 state has to choose how to do it. That's what the people at 5 the regions told us. Icontacted people in Region 6 and 6 other regions to ask what happened when you actually 7 apply

this

-- because we devolve the program to the states 8

-- and sometimes the states can choose not to accept the 9 concept. It's state b y state. 10 MR. MAI T: Do you have a preferred 11 technique for defining

-- I mean, part of the problem is 12 these operators of these POTWs have those defined areas. 13 So we need to be mindful of them being concerned about 14 creating a new sampling point for regulatory purposes, 15 which is not located at this po int. So Imean, that's why 16 we choose to pick, select an EPA model that's already 17 accepted if there's not one already defined. 18 MR. STAPL ES: Yeah, I guess I'm not 19 certain as to what your hesitation is. L et's take yo ur 20 example. I f the mixing zone is 2 0 miles downstream, in 2194

that twenty

miles you have no assurance that the effluent 1 has touched the sediment you're collecting. If you go to 2 the end of the mixing zone, you have assurance that the 3 surface water that's carrying the D4 has touched the 4 sediment that you're going to sample. And we're hoping 5 that these mixing zones are very close to the facilities. We 6 don't know for sure. We've only seen aerial photos of 7 them, but

-- 8 MR. TOBIAS: So you don't have any 9 sample numbers from either a site survey or even a study? 10 MR. STAPL ES: That will all be

-- I 11 believe that will all be presented in the Study Plan. I s that 12 the intention? Yes. So all the preliminary work that once 13 we get to the facilities and work with the facilities on what 14 they

know abo ut the mixing zone, if they don't, then we've 15 talked to several teams who use EPA modeling and do 16 mixing zones to make a determination. 17 MR. LEWI S: Why do you focus on the 18 end of the mixing zone? Why do you think of that 19 location? 2095 MR. STAPL ES: Because that's where the 1 water bod y is well

- mixed side to side, top to bottom. 2 MS. FEHRENBACHER: Now, I think our 3 concern is the consistency in interpreting the mixing zone 4 and our assurance that samples that we

-- that will be 5 collecte d there will meet our needs. 6 MR. PENBERTHY: So how about this? 7 How about we just delete that first sentence and say 8 benthic sampling shall be begin at the outfall and proceed 9 downstream until adequate benthic organism samples are 10 obtained? Would you be happy with that, and then just get 11 rid of the mixing issue altogether? 12 MR. TOBIAS: I don't know if I like that. 13 MR. PENBERTHY: What's that? 14 MR. STAPL ES: That's less certain than 15 before. 16 UNIDENT IF IED FEMALE: Yeah. 17 MR. TOBIAS: T hat's why the previous 18 version of our standard started with where is the water 19 well

- mixed, because it's the water that's carried

-- the 20 effluent carried to the water and the water carries it to the 2196

sediment. And if we sample the water and fish from the 1 pl ace we know is well

- mixed, we'll know that the 2 sediment

-- the nearest deposition zones will also have 3 received effluent. 4 MR. PENBERTHY: Yeah, but if you go to 5 the end of the mixing zone, that's not going to be 6 necessary , the location of your minimum concentration 7 D4, which partitions to the sediment, right? That will be 8 essentially

your lowest concentration until the surface 9 water at least, right? So if you did that at the end of the 10 mixing zone, you would get the lowest possible level of 11 the sedime nt, correct? 12 MR. STAPL ES: I have no idea. 13 MS. PL OTCKE: Your highest 14 concentrations, you're going to be in your deposition 15 zones. So if that's what you're trying to target for the 16 sediment, but what Charles is

-- you're right, you might 17 have a higher concentration coming out of an effluent, but 18 that's not reflective of what's going to impact the biology , 19 which is reall y the sediment. 2097 MR. PENBERTHY: Yeah, but the mixing 1 zone is not what's really relevant. It's where D4 ends up. 2 MS. PL OTCKE: And that's your 3 deposition zone. And that's where you're going to be in 4 equilibrium in mixture within your water and biota and 5 sediment. 6 MR. STAPL ES: The nearest deposition 7 zone may

be, for instance, halfway across the river but 8 only

ten feet d ownstream of the outfall, but it may never 9 receive effluent. 10 MS. PL OTCKE: So the real challenge is 11 defining where it's well

- mixed. Whether you call it

-- 12 whether you use models to do a mixing zone or you say 13 (inaudible). 14 MR. PENBERTHY: Well, if it's well

15 mixed, where is the maximum is more of the issue. 16 MS. PL OTCKE: And that's reall y -- once 17 yo u define where it's well

- mixed and then look to your 18 deposition zone, that's where your maximum is going to be 19 in your sediment. But what you're co ncerned about is how 2098

well can you reall y characterize a mixing zone with all the 1 different models and the inconsistencies in it. 2 MR. STAPL ES: And I guess my concern 3 is more of collecting samples of water and sediment that I 4 have assurance of having ef fluent in them. 5 MR. PENBERTHY: Can we go over again 6

-- what's your suggestion again? 7 MR. THOMAS: To go back to the 8 language in the previous version

-- the previous draft. 9 MR. PENBERTHY: No one would agree 10 with that, so

-- 11 MS. PL OTCKE: I'm wondering if there's 12 some qualifications we can put in there like we have with 13 some of the others because I understand, ye s, you're right 14 there's multiple models that's being used. And what we're 15 asking the contractor to do is do the best job they can of 16 defining that mixing zone so we can achieve what Charles 17 is saying we want to achieve, but we realize there could be 18 some inconsistency . May be if we

-- you know, are less 19 practical

-- they 're going to do the best job they 're going to 20 to do. 2199
MR. PENBER THY: We're just trying to 1 get the

-- to have something here that's reasonabl y 2 understandable and clear. 3 MS. PL OTCKE: And the other thing, 4 again, this comes back to it will be documented as to sort 5 of the reconnaissance up front of how that's going t o be 6 determined. 7 MS. FEHRENBACHER: So Ithink

-- I'm 8 trying to identify the criteria that we're interested in, we 9 want a well

- mixed sediment, we want the maximum 10 concentration, we want presence of biota, and we want 11 water and sediment samples collecte d at that same area. 12 And I think we're not confident that having generic 13 language like mixing zone with different models and 14 different interpretations will meet all of those criteria. 15 And the language that we developed will meet those 16 criteria and give u s assurance that the samples that you're 17 collecting will meet our needs. 18 MR. STAPL ES: And I respectfull y 19 disagree. We cannot predict. We cannot define where the 20100

maximum concentration will be unless we go out and hunt 1 for it, and that's not what thi s program is about. 2 MS. PL OTCKE: So let's look at the 3 language. May be if we do that

-- so you have at each site 4 benthic organisms shall be collected as close as reasonably 5 possible to the effluent outfall providing an adequate 6 mixing of the discharg e and receiving water has occurred. 7 I think we all agree on that, right? Whether you call it a 8 mixing zone, that's what we're trying to achieve. So we 9 agree on that. 10 I think the next part is the sampling shall 11 begin at the outfall and proceed downstream -- that's, I 12 think, where you're concerned. You could start sampling 13 where you don't have well

- mixing. So may be it's the 14 wording there that we have to change, that it occurs after 15 we have identified what we believe is the well

- mixed area. 16 If you do n' t want to call it a mixing zone, Ithink it's fine. 17 MR. MAI T: We can take the word out, I 18
mean -- understood. 19101 MR. DOYLE: Well, as it stands right now 1

-- because sort of how it stands, there's two sentences 2 there. They

seem to be inconsistent or too different. 3 MR. LEWI S: Sampling shall begin where 4 adequate mixing occurs. Imean, that's what you're 5 basically looking at to compare with what you have in the 6 previous sample? 7 MS. FEHRENBACHER: Well, so may be 8 what we're talking about is modifying that first statement 9 to include

-- so I think what we want is adequate benthic 10 organism sample mass, perhaps, inco rporating somehow 11 into that first statement. 12 MR. DOYLE: Well, I think the first 13 statement is good. It's the second statement that needs to 14 be tweaked because the concern

-- if you read the first 15 statement, we perfectly agree with that. It say s you'r e 16 going to

-- as close as reasonably possible providing 17 adequate mixing has occurred. So that's exactly spot on 18 with what we like to do. It's that second sentence where it 19 say s -- it's like notwithstanding what we just said, 20 sampling shall begin at the o utfall. 21102 MR. PENBERTHY: So how about this? 1 Let go
-- take the first sentence and then delete sampling

-- 2 continue that sentence into the second sentence, but delete 3 sampling shall begin at the outfall and just say , and 4 proceed until adequate benthic o rganism sample masses 5 have been obtained. I'll just read the sentence. 6 At each site, benthic organisms shall be 7 collected as close as reasonably possible to the effluent 8 outfall provided adequate mixing of the discharge and 9 receiving water has occurre d and proceed downstream 10 until adequate benthic organism sampling masses are 11 obtained. Is that

-- 12 MS. PL OTCKE: Yeah. 13 MR. DOYLE: Yes. 14 MR. THOMAS: Yes. 15 MS. EI SENREICH: So the question is that 16 adequate is defined. 17 MR. PENBERTHY: All ri ght. So can we 18 work on that now? 19 MS. FEHRENBACHER: So wait, going 20 back to what you said earlier, each one of the sampling 21103

plans will include for each site the specificities around 1 this, how adequate mixing will be determined? 2 MS. PL OTCKE: Yeah. I mean, that's 3 what our contractor will have to do. Now, we had 4 originall y specified determining mixing zones, but they 5 will use some method in their reconnaissance to identify 6 where that adequate mixing occurs. 7 MS. FEHRENBACHER: It can be slightly 8 different, at each site. 9 MS. PL OTCKE: Yeah. 10 MR. PENBERTHY: So can we add a 11 sentence after

-- 12 MS. FEHRENBACHER: And we 13 reviewed these ahead. 14 MR. PENBERTHY: I propose that the 15 study

-- each site

- specific sampling plan will

-- 16 MS. PL OTCKE: Document. 17 MR. PENBERTHY:
-- document the 18 location of the point at which well

- mixed

-- the effluent 19 and the stream are well

- mixed? 20104 MS. PL OTCKE: Yeah, I mean, it's going 1 to have that identified, but

-- 2 MR. PENBERTHY: Well, each Study Plan 3 h as a site sampling plan for each site, and each one of 4 those site

- specific sampling plans would identify where 5 the effluent and receiving stream are well

- mixed. 6 Could you give us five minutes? (A recess 7 was taken) 8 MR. PENBERTHY: All right. Good to 9 go. So here's what the

-- language we propose. It 's a lot 10 of what we alread y discussed, so it should be at least fresh 11 here. 12 The sentence would read, "At each site 13 benthic organism shall be collected as close as reasonably 14 possible to the effluent o utfall provided adequate mixing 15 of the discharge and receiving water has occurred and 16 where adequate benthic organism sample masses are 17 obtained." 18 We'll read it as a sentence similar to what I 19 alread y mentioned. "Each site

- specific sampling plan will 20105

identify where the effluent and receiving streams are well

1 mixed and the method used to determine this." 2 MR. DOYLE: That works. 3 MS. PL OTCKE: Yeah, y eah. 4 MR. PENBERTHY: Okay . Take off the 5 (inaudible). 6 MR. STAPL ES: I'm not a lawy er, but is 7 adequate and well the same thing? 8 MR. PENBERTHY: Pardon me? 9 MR. STAPL ES: Are the words adequate 10 and well

- mixed

-- mean the same thing? 11 MR. PENBERTHY: Are adequatel y 12 mixed, okay . Good point. You are a lawyer. You could 13 work at EPA. No, that's a good catch. Thank you. 14 Consistency in language is alway s helpful. 15 MR. STAPL ES: Would there been a 16 continuing sentence then? 17 MR. PENBERTHY: Yeah. "At each site 18 fish, water, and sediment will also be collected at the same 19 location." 20106 MR. STAPL ES: And that same location is 1 the place where it's adequately mixed? I s that understood? 2 MR. PENBERTHY: The location is where 3 yo u pick up benthic organisms. 4 MR. STAPL ES: That might be a 5 kilome ter long. Our intention would be to take it as close 6 as possible to that first location of adequate mixing, water 7 and fish and sediment. 8 MR. DOYLE: In other words, the starting 9 point of where you collect the benthic species would be 10 the location wher e we would be collecting the fish and the 11

-- 12 MR. STAPL ES: Surface water, fish

-- 13 MR. PENBERTHY: So just help me 14 review here. If what it says is, "At each site fish, surface 15 water and sediment shall also be collected at the same 16 location," is that unclear? 17 MR. STAPL ES: As long as the same 18 location is the

-- that place where it's adequately mixed. 19 MR. DOYLE: It' s got to be done with the 20 criteria. 21107 MS. FEHRENBACHER: Right. It used to 1 be all of the criteria completely mixed and as close as 2 reasonabl y possible to the effluent, sufficient benthic 3 organisms sample masses and have

-- 4 MR. PENBERTHY: You know, if you 5 want we can just say , at each site fish, surface water, and 6 sediment shall be collected at the same location as benthic 7 organi sms (inaudible). 8 MR. STAPL ES: I'm just saying that 9 benthic organisms may be collected over a long scattered 10 range, and wouldn't it be

-- our intention, I'm assuming, 11 and your intention is we would collect water, sediment, 12 and fish as close to the out fall as possible, so at where it's 13 adequatel y mixed. 14 MR. PENBERTHY: Well, you want them 15 right where you picked up the benthic organisms. 16 MR. STAPL ES: The first benthic 17 organisms. 18 MS. PL OTCKE: I think it's fine saying

-- 19 I mean, it's going to be

-- it can be potentially over a 20108

scattered location, but you're also

-- I mean, that's still the 1 same location you're going to collect. 2 MR. DOYLE: It actually gives some 3 flexibility . I think it's reasonable to take Ward’s, 4 language. It's fine. 5 MR. STAPL ES: Okay . I just want to be 6 sure we can tell a contractor where to sample. 7 MS. EI SENREICH: I do have a question. 8 Why

would you think that there's a possibility that it 9 would take a kilometer to collect benthic organisms if it's 10 alread y at a well

- mixed place where there's

-- you know, 11 where it's going to be covered in the sediment? 12 If you have sediment, you're going to have 13 sediment curves and you would just

-- in my mind, you 14 would take a grab sample, and then obviously

-- or likel y 15 yo u' re not going to get enough for anal ys is. So you would 16 move a little to the left or a little to the right, but you 17 wouldn't have to necessarily go a kilometer down the 18 stream. 19 MR. STAPL ES: We're very hopeful that 20 that's the case. Dow Corning ha s considerable experience 21109

collecting benthic organisms. They 're the hardest thing to 1 collect in the field, so we want to have the flexibility . If 2 yo u look at some of the receiving waters that we proposed 3 in the documentation, they're prett y small and nar row. It 4 might take some distance to get the mass we need to do 5 the anal ys es. 6 MR. PENBERTHY: Okay . So how about 7 we just say

-- 8 MR. DOYLE: I think it's covered. 9 MS. PL OTCKE: I think we've covered it. 10 MR. THOMAS: It' s fine. 11 MS. HENRY: Again, we're doing all of 12 this planning in the abstract and your plan, if it is a space 13 like that where it's very small or whatever you can 14 anticipate, I think you could describe that for our review. 15 MS. PL OTCKE: Again, when you're 16 doing all the reconnaissance up front, you're going to have 17 ideas of what you're dealing with. 18 MR. PENBERTHY: Okay . Next item. 19 MR. THOMAS: We've got a couple more 20 things in that same section. Okay . Go ahead, Charles. 21110 MR. STAPL ES: These are ho pefully 1 lesser. On Page 44 and 47

-- on Page 44, the third line 2 above Figure 5, it talks about the retained samples retained 3 in a refrigerator. This is a change from the last draft, 4 which said that they 'd be in a freezer. We are going to 5 freeze them out in the field and hold it in the laboratory 6 until it’s used, so

-- 7 MR. PENBERTHY: But you want a 8 freezer, retain in a freezer? 9 MR. STAPL ES: Unless there was some

-- 10 MR. PENBERTHY: I don't think so. 11 MR. STAPL ES: Okay

. 12 MR. PENBERTHY: T hat's fine. 13 MR. STAPL ES: That's also on Page 47. 14 MR. PENBERTHY: Good catch. 15 MR. STAPL ES: The third line below 16 Figure 6. 17 MR. PENBERTHY: Okay

. 18 MR. STAPL ES: And then the concept of 19 using commerciall y - acquired benthic species as a 20
s urrogate field blank. In the previous version of the ECA, 21111

the test standards suggested employing the ground

- up 1 rainbow trout that we obtain from a known supplier, and 2 they 're known to have very low or no detectable D4 3 concentrations. 4 Dow Corning has w orked with that lab for 5 a considerable time in obtaining those samples, and we 6 have proposed using the ground

- up fish tissue for both as 7 surrogate blanks in the fish collection and in the benthic 8 collection. You're now proposing reall y a new 9 requirement o f using commercial sources of benthic 10 invertebrates, which Dow Corning has no experience with 11 in terms of finding a supplier that's going to have D4

- free 12 invertebrates. 13 MS. McNETT: Especially in sufficient 14 quantities. 15 MR. STAPL ES: In sufficient quantities. 16 Since the tissue will be ground and then placed in an 17 identical kind of container and opened during processing, 18 we'd prefer to use the

-- 19 MR. PENBERTHY: What page is this? 20112 MR. STAPL ES: Page 45. Ibelieve it's 1 Page 45. 2 MR. PENBERT HY: Right here. I got it, 3 third paragraph. 4 MR. STAPL ES: Third paragraph. 5 MR. PENBERTHY: I mean, m y 6 understanding of wh y we changed this is that there are 7 commercial sources of benthic organisms. It could be just 8

-- is that correct? 9 MR. THOMAS : Ithink the concern is 10 about whether those could be assured that they 're D4 free

- 11

- and I think that's the challenge in finding

-- at least that's 12 been the experience. 13 MS. PL OTCKE: Well, again, it's starting 14 over. It's something new in ensuring that you find that 15 source, you can get adequate source, we know this is 16 something that works and is ready to go. 17 MS. McNETT : We will work with our 18 suppliers and make sure that they 're not contaminating the 19 fish. We can't be assured of that in a new supplier of 20113

benthic organisms that don't have scales on the outside to 1 protect them from taking up some D4. 2 MR. STAPL ES: (C onferring with 3 associates). 4 MS. FEHRENBACHER: (Conferring with 5 associates). 6 MS. HENRY: (Conferring with 7 associates). 8 MS. McNETT: (Conferring with 9 associates). 10 MR. PENBERTHY: Everyone -- wh y 11 don't you explain that that's fair, and then w e'll try to work 12 this? 13 MS. POLLACK: Well, the question is 14 what prompted it and why would you use organisms that

-- 15 regardless of whether they're free from D4 samples 16 compared to other organisms that are different; so the idea 17 of wh y would you compare apples to oranges? So there 18 could be a way to
-- if yo u have this supplier

-- if they 're 19 ensuring there are no D4 samples in the rainbow trout, 20 (inaudible) or suppliers. 21114 MS. POLLACK: To answer your first 1 question, this is for QC out in the field to en sure there's no 2 contamination, so it's not

-- you know, we're not trying to 3 compare apples and oranges. This is just a check on that. 4 MR. PENBERTHY: It' s different tissues. 5 MS. PL OTCKE: It' s different tissues, but 6 it is still tissue that would allow you to capture. And it's 7 actuall y one of the more efficient ones we've seen that will 8 tell you whether you have contamination or not. If you 9 could go out and potentially look at something that is very 10 similar from a matrix standpoint. 11 So if you wanted to do that, then we can 12 add six months onto the timeline because we'd have to re

13 evaluate sources and ensure that that

-- you could get that 14 kind of sample and ensure that it's free of D4. So you 15 could do that check in the field. It would take ti me. This 16 is alread y proven. We use it all the time on every one of 17 our samplings, and so does Norway and others as well, so 18

-- 19 MS. HENRY: You know, she's the expert 20 at the whole smash it, extract it, (inaudible). So how 21115

similar is the mass on (inaud ible) depending extraction 1 and all? I s it virtually identical depending on the tissue? 2 MS. PL OTCKE: Yes. 3 MS. HENRY: So for any fish species and 4 the benthic species, and even, I guess, like the bank that 5 were done on, and all that, the extracti on method is the 6 same? 7 MS. PL OTCKE: Yeah. 8 MS. HENRY: I f it was dry or something, 9 grind it, extract it, and putting it

-- 10 MR. PENBERTHY: So basically , it 11 becomes an issue of whether the tissue has the same 12 absorption; is that correct? 13 MS . PL OTCKE: It actually

-- this would 14 probably

even have more. 15 MS. HENRY: There's introduction in that 16 D4 in that old process. 17 MS. PL OTCKE: Yeah. It's just

-- it's a 18 check on the potential for contamination. 19 MS. EI SENREICH: Right. And we 20 understand that. I mean, that's not the question. The 21116

question is whether fish tissue acts like worm tissue or 1 invertebrate tissue. And if they would, you know, 2 essentially

through the process

-- through the process of 3 processing, accumulate the same way and the same rate 4 and the same

-- 5 MS. PL OTCKE: I mean, it would be 6 pretty

similar. In fact, it could be probabl y even more, so 7 that is why

it's a nice way

to actually

check whether you 8 have some potential source that's there. 9 MS. EI SENREICH: But how would you 10 guarantee that, I guess, if you have not used the 11 invertebrate? 12 MS. PL OTCKE: You could look at the 13 content, like the fat content of the tissue and

-- 14 MS. EI SENREICH: So you would use a 15 lipid? 16 MS. PL OTCKE: It' s a lipid, y eah. It 's 17 going to be driven b y the lipid felicity of it. 18 MR. PENBERTHY: All right. We'll go 19 with the fish. So is that

-- I need to know the specific 20 changes. Just that one sentence? 21117 MS. EI SENREICH: It's kind of 1 (inaudible). 2 MS. PL OTCKE: Yeah, throughout. 3 MS. EI SENREICH: Change the subject. 4 MR. PENBERTHY: Well, wait a minute. 5 This is the benthic. So basically what we use

-- in the 6 blank, we use rainbow trout, right? 7 MR. STAPL ES: Ground rainbow trout 8 tissue just as done in fish. 9 MR. PENBERTHY: Is it any other place 10 besides that paragraph? 11 MR. STAPL ES: Is it in the figure? 12 MS. EI SENREICH: Yes, it's in the figure. 13 MR. PENBERTHY: Okay . So we'll say 14 rainbow trout in the

-- all the QA samples ; is that correct? 15 MS. HENRY: Just to be clear, you go out 16 to some hatchery that you have already

established has 17 whatever food and all that jazz and they are prett y clean. 18 You just grab from that every time. It really

has nothing 19 to do with the D4 at all. 20 MS. PL OTCKE: Right. 21118 MR. PENBERTHY: So basically every 1 time you have ground benthic invertebrates in that QA 2 paragraph, we'll change it to rainbow trout. 3 MR. STAPL ES: I see in at least two 4 paragraphs that we were just working in, two separate 5 paragraphs

-- 6 MR. PENBERTHY: Okay . Can yo u just 7 point those out to me, so I know where you are. 8 MR. STAPL ES: On page 45. The second 9 paragraph, "It should be noted..."

-- middle sentence

-- 10 "...benthic invertebrate tissue from benthic organisms 11 purchased." 12 MR. PENBERTHY: And then the 13 following paragraph, correct? 14 MR. STAPL ES: The following paragraph. 15 MR. PENBERTHY: Any where else? 16 MS. FEHRENBACHER: It' s a couple 17 times in that paragraph. 18 MR. PENBERTHY: Oh, y eah, definitel y 19 in that third paragraph. We'll do a search, and then we'll 20 try

to do our best on that. Ijust

-- 21119 MR. STAPL ES: Okay . And then the 1 figure with that we talked about. 2 MR. PENBERTHY: Okay . So are we 3 finished that that intent? 4 MR. ST APLES: No. There's one more 5 thing. It's a minor thing on Page 46, last paragraph. 6 MR. PENBERTHY: Mm
- hmm. 7 MR. THOMAS: The third line begins, 8 "Three of the samples shall be divided into three parts." 9 And this is a description

-- this paragraph describes that 10 fish are collected and basically packaged. The samples 11 shall be divided into three parts. 12 We understand that samples need to be split 13 and lipid contents and so forth, but the way this is said is 14 that this is basically done in the field . It is suggestive of 15 being done if the field. In the field the fish will actually be 16 bagged and frozen, and all the processing, dividing, and so 17 forth occurs in the laboratory

. 18 MR. PENBERTHY: So how would you 19 want this written? 20120 MR. STAPL ES: S o the second sentence 1 could read something to the effect of for each of the two 2 species, five individual fish or composited samples shall 3 be prepared and frozen. In the laboratory fish samples are 4 thawed, homogenized, and divided into three parts. 5 MR. PENBERTHY: Okay . Hold on. 6 Laboratory

-- 7 MR. STAPL ES: I guess three of the fish 8 samples shall be thawed, homogenized, and divided into 9 three parts. 10 MR. PENBERTHY: Thawed, 11 homogenized, and divided into three parts, okay

. 12 MR. PENBERTHY: Does that meet your 13 needs? 14 MR. STAPL ES: Yes. 15 MR. PENBERTHY: Okay

. 16 MR. STAPL ES: That was a minor 17 methodological clarit y. 18 MR. PENBERTHY: Yes. Ican appreciate 19 that. That's good, attention to detail. 20 MR. PENBERTHY: Are we done with 10? 21121 MR. THOMAS: We are done with 10 1 MR. PENBERTHY: Okay . Now onto 2 Appendix 6. 3 MR. THOMAS: Yes. Appendix 6, this is 4 the location of biosolid sampling. I think we can be 5 comfortable with the current language with one change. 6 This has to do with the location of the biosolid sampling. 7 UNIDENT IF IED MALE: Can Ihave the 8 page? 9 MR. THOMAS: This is page

-- what page 10 is this? 11 MR. PENBERTHY: It' s Page 33. 12 MR. THOMAS: Okay . The sentence 13 starts, "At each site, the ch osen location of biosolid 14 sampling shall be immediately after dewatering before 15 onsite storage and shallbe established in site

- specific 16 sampling plan." We would just add "as practicable". 17 MR. PENBERTHY: Okay . That's fine. 18 MR. THOMAS: All right. Analy tical 19 methods. 20 MR. PENBERTHY: That's on twelve? 21122 MR. THOMAS: Twelve, y es. 1 MR. PENBERTHY: Oh, wow. 2 MR. STAPL ES: This is in a couple of 3 places, so let me kind of generically explain the issue, and 4 then we'll go to the specific text. Interms of handling and 5 processing in the field the sediment and then extending 6 that to the biosolid, which we can consider similar, we had 7 originall y cited approaches used b y Powell 2009 8 reference. You've changed that to Powell 2010 and 9 changed the han dling in the field. Now the handling in the 10 field is you collect the sediment, put it in a jar, and cover it 11 with water and seal it. 12 It 's been Dow Corning's experience that 13 that actually introduces error, and so they 've abandoned 14 that, and so we would like to go back to the handling 15 method, which is put the sediment

-- collect the sediment 16 with the dredge or whatever, put it in a bag, and put it in 17 the sample, just as we had it in the previous text. That's 18 also the method that is now in the Knoerr 201 2 method. 19 MR. PENBERTHY: Okay . Now, we 20 changed the method. It was based on the MDL, correct? 21123 MR. TOBIAS: Well, it was just to the 1 other study . I'm surprised you say it introduces greater 2 error when it looks like they get better results in the paper. 3 MS. PL OTCKE: It' s a stability issue. It 4 actuall y creates
-- it's less stable. The samples are less 5 stable that way

. 6 MR. TOBIAS: When you put them in a 7 plastic baggy , they 're more stable than when you put them 8 in a glass

-- 9 MS. PL OTCKE : Jar with the water 10 overlay

. 11 MR. TOBIAS:

-- jar. Or without the water 12 overlay . If yo u put it in a glass jar, is it the water you're 13 saying or is it

-- it just read funny to me that you think a 14 plastic baggy would be better than a glass jar where you 15 tie down the top, and then put tape over around it instead 16 of a plastic bag

-- 17 MR. PENBERTHY: Could you show me 18 the language we're talking about? 19124 MS. McNETT : We homogenize the 1 sediment sample in a plastic bag and transfer is to a glass 2 jar, but you do not lay water over it. 3 MR. TOBIAS: Okay . So

-- but why is the 4 plastic bag important. That seems like an odd step to 5 introduce, wh y not
-- like in the pa per, it seemed like the 6 clearing path was just to put it in a glass cylinder. 7 MS. McNETT: Because you have a very 8 large sample of sediment that you've taken from a core, I 9 mean, relativel y large that you have to homogenize it and 10 get homogeneous sampl es that of the jar that are about this 11 size. 12 MR. TOBIAS: Sure. You use the plastic 13 as an intermediate to do that? 14 MS. McNETT: Yes. 15 MR. TOBIAS: Okay

. 16 MS. McNETT: A plastic bag, you know, 17 very

briefl y. It 's not stored in there for an ex tended period 18 of time. 19 MR. TOBIAS: Okay

. 20125 MS. McNETT: To mix up the sediment in 1 the field without a whole lot of spatulas or an ything. You 2 can just squeeze it, and then take homogeneous sediment 3 samples and place them in glass jars. 4 MR. TOBIA S: Okay

. 5 MR. PENBERTHY: I need to know what 6 to do

-- 7 MR. TOBIAS: They just want to change it 8 back to how it was before, and the description of intent. 9 MR. PENBERTHY: Yeah, but Idon't 10 know what that was. So we're on page 38, I take it, secon d 11 paragraph from the bottom, correct? 12 MR. DOYLE: Page 39, right? 13 MR. STAPL ES: I had it on page 39 14 directly

above Figure 4. 15 MR. PENBERTHY: Okay . We'll follow 16 what you want it to read. 2009? 17 MR. STAPL ES: The 2009 reference. 18 MR. PENBERTHY: And then we'll have 19 to add 2009

-- is that still in the references? It' s not in the 20 references. 21126 MS. McNETT: Do you want the last one 1 yo u cited? Ididn't hear what you said. That's what we 2 used in the (inaudible) ye ars. 3 MR. STAPL ES: Oh, okay , y es. The 4 Powell 2009 reference is the method for sediment

-- 5 handling these sediments, which involves collection of it, 6 placing the baggies, homogenizing it. That has been 7 adapted to the Knoerr 2012 biosolids method. 8 MR. PENBERTHY: Okay

. So read to me 9 that sentence, how it's supposed to read. You know, I'm 10 up to sample collection, storage, and preparation will 11 follow Powell 2009. What does it say after that? What 12 should it state? 13 MR. LEWI S: That's the prior language, it's 14 a little bit more collaborative. 15 MR. TOBIAS: Placed in a plastic bag? I s 16 that what you -- 17 MR. STAPL ES: With each sample being 18 placed

-- 19 MS. McNETT: Placed in a plastic bag, 20 homogenized, and transferred to a glass jar. 21127 MR. STAPL ES: We actually had it as 1 three sentences, but

-- 2 MR. PENBERTHY: Okay . I'm going to 3 read it back to you. Okay. This is what I have: "Sample 4 collections stored in preparation will follow Powell 2009 5 with each sample being placed in a plastic bag, 6 homogenized, and place d directly into a glass jar 7 covered..."

-- shall I delete covered with water? 8 MS. PL OTCKE: Yes, please. 9 MR. PENBERTHY: And then capped? 10 MS. PL OTCKE: Yes, it will be capped. 11 MR. PENBERTHY: Okay . And then we'll 12 have to add 2009 Powell to the reference list because it's 13 not there now. 14 MR. STAPL ES: You still have the 15 previous version. 16 MR. PENBERTHY: So is that Number 12 17 we're done with? 18 MR. STAPL ES: Well, does th at also 19 translate into biosolids? 20128 MR. PENBERTHY: Does that correct 1 every

thing? I s there any

other place I need to change? 2 MR. LEWI S: And that's Powell and 3 Woodburn? 4 MR. STAPL ES: Powell and Woodburn 5 2009, y es. 6 MR. LEWI S: That's what I thought it was, 7 ye s. 8 MR. PENBERTHY: Okay . Where else 9 does this need to

-- 10 MR. LEWI S: It is in Appendix 6 as well, 6 11 and 7. 12 MR. PENBERTHY: Appendix 6. So I've 13 got to say

reference language

-- okay

. 14 MR. STAPL ES: Did you find the location 15 for that? 16 MR. PENBERTHY: Is it Page 34? I s that 17 right? 18 MR. DOYLE: That where I have it, on 19 Page 34. 20129 MR. PENBERTHY: Okay . Tell me 1 exactly

what needs to be changed. 2 MR. DOYLE: So that's where I have the 3 policy

that Powell 2010 and Woodb urn 2009. 4 MR. PENBERTHY: I don't see it here. 5 MR. DOYLE: It' s right here. During each 6 sampling event biosolids at a given site, all quality 7 assurance sampling prepared and D4 samples been 8 prepared as described in Powell. Should we change 9 Powell and Woodburn 2009? That's right above the 10 Figure 3. 11 MR. PENBERTHY: Okay . So I'll just

-- 12 for my

purposes, I'll just say , "See Page 39." 13 MR. TOBIAS: And this one didn't have 14 (inaudible) of a plastic bag in there. 15 MR. PENBERTHY: Well, is th is going to 16 be exactly

as its

-- 17 MR. TOBIAS: In one of the Appendices it 18 was explicitly put in; in the other, it wasn't. 19130 MR. PENBERTHY: Okay . Well, let's 1 eliminate the confusion here. Is this sentence going to 2 read exactl y like Page 39 or not? 3 MR. STAPL ES: It could be as simple a 4 change as changing from Powell 2010 to Powell 2009. 5 MR. PENBERTHY: Okay . We'll do that. 6 Fair enough. 7 MS. McNETT: That's fine. 8 MR. PENBERTHY: Well, what we have 9 now is we're just going to change Powell 2009 on Page 34 10 to Powell and Woodburn 2009. 11 MS. McNETT: That's fine. 12 MR. PENBERTHY: Okay . Do we have 13 the reference there in that? Okay . Are we there? 14 MR. THOMAS: A couple more things. 15 We're finished on that one. 16 MR. PENBERTHY: We're finished with 17 12? 18 MR. THOMAS: Yes, we've finished 12. 19 MR. PENBERTHY: Okay

. 20131 MR. THOMAS: Thirteen, selection of fish 1 species. We can agree to the current text with one 2 addition. We're on Appendix 8, Page 46. 3 The sentence reads, "Biota samples shall 4 include benthic species collected in sediment of the two 5 receiving water bodies and two species of fish." We 6 would add "if practicable of different trophic guilds in the 7 receiving water body. " 8 MR. PENBERTHY: Okay . This is in the 9 third paragraph? 10 MR. THOMAS: My page numbers might 11 be different than

-- 12 MS. PL OTCKE: Yeah. 13 MR. THOMAS: No, it's alread y there. 14 Okay , then we're good. 15 MR. PENBERTHY: Okay

. We don't need 16 a change there? 17 MS. PL OTCKE: No. 18 MR. THOMAS: No it's alread y there. 19 MR. PENBERTHY: That's what I thought. 20132
MR. LEWI S: It's on Page 46 at the third 1 paragraph, "Two species of fish from different trophic 2 guilds, collected in sufficient mass such that individual or 3 composite samples can be prepared for analy sis of D4, 4 shall be selected." 5 MR. PENBERTHY: No, no, no, keep 6 going. Do we need a change or not? 7 MR. THOMAS: Well, we've got some 8 versions where it's there and

-- it's there, right? 9 MR. STAPL ES: The second place where 10 this is discussed is on Page 46 of that standard, and it does 11 not have the words, "if practicable". 12 MR. THOMAS: Yeah. We want to add it 13 to do test standards. 14 MR. PENBERTHY: Okay . Whe re does it 15 first show up? 16 MR. STAPL ES: The first page of that 17 standard, requirements for sampling biota. 18 MR. PENBERTHY: Okay

. 19 MR. DOYLE: It' s okay there. It will be 20 consistent with those places. 21133 MR. PENBERTHY: Okay , Igot it all 1 right

. 2 MR. THOMAS: So just a couple of other 3 things I want to note. These aren't related necessarily for 4 the language of the ECA. One

-- and we talked about this 5 before

-- with respect to the draft order, we'd very much 6 appreciate having an opportunity to take a look at it prior 7 to the publication, in particular, the language associated 8 with D4 and how it's characterized and so forth. 9 MR. PENBERTHY: Okay . Hold on. So 10 this is the notice of availability of the ECA. You know it 11 would be highl y unusual for EPA to coauthor

-- 12 MR. THOMAS: We're not asking to 13 coauthor. We'd just like to take a look at it. 14 MR. DOYLE: The premises for the 15 concern, Ward, is when the original federal register came 16 out announcing the whole ECA negotiation process, 17 whether i t was descriptions of D4 or D5, we had some 18 concerns about how the chemicals were characterized 19 there in terms of representing potential hazards and so 20134

forth. And that's wh y we want to make sure

-- we were 1 curious about

-- 2 MR. PENBERTHY: Well, tell me what 3 yo u were concerned about. Imean, you're talking about 4 the notice of selecting a

-- seeking interested parties? 5 MR. THOMAS: The description

-- let me

- 6

- I mean, I would have to look at the notice. 7 MR. PENBERTHY: I mean, basically that 8 expre ssed EPA's opinion. It doesn't express your opinion. 9 I mean, I don't think we would necessarily extend any

-- 10 well, first of all, the notice of availabilit y is a pretty benign 11 thing. It's just this is D4. This is what we're doing. This 12 is the tests th at have been agreed to. 13 MR. DOYLE: Yes. 14 MR. PENBERTHY: It' s not interpreted. 15 MR. DOYLE: And that's the key

-- 16 MR. PENBERTHY: But it explains why 17 we're doing this. And I'll have our federal register notice 18 they 're going to have to, you kn ow, go into that. If you 19 can tell me what your issues are, I might be able to think 20 about it, but I'm not going to

-- 21135 MR. THOMAS: Where D4 was described 1 and D5 as highl y persistent in sediment and highl y bio

2 accumulative benthic and aquatic species. I think the 3 highl y bio

- accumulative is

-- in particular, we will argue 4 that that might not

-- that's probably not supported by

the 5 facts. So these are the t ypes of things we're talking about 6 with respect to how the

-- 7 MR. PENBERTHY: Just tell me where the 8

-- so I'm going to go back and

-- I'll talk with the people 9 here about those issues, but I'm

-- we're going to express 10 our true beliefs, so if you're worried about the high

-- 11 obviously

the D5 is going to come out. 12 MR. THOMAS: No, no, right. But both 13 from being characterized as highl y persistent, and then 14 they

were highl y bio

- accumulative in aquatic species. 15 MS. PL OTCKE: It's more a 16 statement of that it is that versus it's being predicted to be 17 that. A lot of the field studies actu all y counterdict [sic] 18 that, so it's more what is reall y accurate of the current limit 19 standard of science. 20136 MR. PENBERTHY: Highly persistent and 1 highl y -- 2 MS. PL OTCKE: Predicted to be highl y 3 persistent and highl y bio

- accumulative, but they 're not 4 alway s highly bio

- accumulative when you go and actuall y 5 do studies, especiall y dependent upon the method that you 6 use and the way

-- where the science is today

. 7 MR. PENBERTHY: Your concerns are? 8 MR. THOMAS: That was the primary 9
concern. 10 MR. P ENBERTHY: Okay . We'll take that 11 under advisement. In the notice we're going to say what 12 we think, and we might add a reference if it's not there that 13 we need to support our assertion. Okay

. 14 MR. DOYLE: I guess the last item we had 15 was in each of th e test standards box

-- so Appendices 4, 16 5, 6, and 8. Let me get specific language for you. There 17
was -- where the references are made to the anal yt ical 18 methods, there's

-- we had previously stated

-- and let me 19 see if I can actually find that specific e xample

-- that they 20 would be adapted from whatever the citation. 21137 MR. PENBERTHY: How often was 1 Knoerr
-- adapted from Knoerr? 2 MR. DOYLE: For example

-- and we 3 wanted that retained in there. The concern is if that's

-- 4 MR. PENBERTHY: Where? Can we look 5 at
-- I want to look at Appendix 4. This is drafted, but this 6 is just word processing. Let's see if I can find 4. 7 MR. STAPL ES: 1 page 25. 8 MR. PENBERTHY: Yeah, how would you 9 like that changed? 10 MR. DOYLE: Yes, it should be

-- let's see 11

-- the commercial

-- this is the sentence that begins the 12 commercial laboratory , so it's the third sentence in the last 13 paragraph. 14 MR. PENBERTHY: Okay

. 15 MR. DOYLE: The commercial laboratory 16 will validate a method for the anal ys is of D4 in the 17 influent and effluentthat shall be adapted from the 18 anal yt ical methods specified in Knoerr. 19 MR. PENBERTHY: I assume that's okay? 20138
MR. LEWI S: You want that throughout 1 the document, okay

. 2 MR. DOYLE: And that's consistent with 3 my

version. 4 MR. PENBERTHY: Okay . So that's going 5 to have to then be in all Appendices

-- all

-- 4 through 8, 6 right? Okay . An ything else? 7 MR. THOMAS: Nothing else, other than I 8 hope there's some cookies left for you gu ys at the party

. 9 MR. PENBERTHY: Well, I'm greatly 10 relieved we're going to be coming to a final conclusion. 11 May

be we should go over the next steps. 12 MR. THOMAS: Absolutely

. 13 MR. PENBERTHY: Okay . He lp me out 14 here. I'm getting off track here, but, obviously , we have 15 some editing to do, so that will take a few day s to get the 16 language right. 17 At that point we will send that out to all the 18 interested parties for a 30

- day period. They

can comment 19

-- and I assume since most of the interested parties that 20 have been engaged are not stand

- up comments. One thing 21139

I will need from you three very shortl y is the name and 1 addresses of the signatories, so I would like to put that in 2 before we send it out for the 30

- day period. 3 So assuming, you know, in the C.F.R. 4 there's a definition of what constitutes a legitimate 5 comment, but Ican't imagine there would be any thing 6 substantial from the people in this room because that's 7 what we've been talking about. Al though, you know, just 8 like you have to get your bosses to sign off, we have to get 9 ours. So Ican understand what evolves out of that. 10 Hopefull y, an ything like that will be extremely minor. 11 At that point, after we get through the 30

- 12 day

period, we'l l have a final draft that will go to the

-- for 13 signatures. I think ty pically the way this has happened, 14 there's been a kind of signature page for each of the 15 signatory

companies. It's been a long time since we've 16 done this, but usually that goes out. 17 There's two copies, original, for the 18 signature

-- the first go out, come back, and everybody 19 gets a formal

-- and maybe even multiples since there's so 20 many

companies involved, but everyone gets an original. 21140

We would write this notice of availability , which describes 1 what's been agreed to, basically lay s out the schedule, and 2 references these today , and then we get started. 3 MR. SELTZER: There will need to be 4 additional extension period, 60 day s again. And that's 5 going to start on the

-- the 26th i s what you said is 6 currentl y scheduled period fixed to expire. 7 MR. PENBERTHY: So it's been m y 8 experience that sometimes rustling up signatures can take 9 a week, longer than you imagine, so hopefull y we can get 10 that done within a month or so after the 3 0 day s. 11 MR. THOMAS: Okay . Another thing 12 we're going to want to do at some point is identify a small 13 sort of technical team from EPA that could work with the 14 small technical team from our side to make quick 15 decisions in the field where the need arises or if there are 16 questions with respect to

-- like some of the things that 17 came up today like how do you collect the samples and so 18 forth and how do you ensure mixing. 19 A lot of those things are likely to come up, 20 and we're going to need som e people that can be 21141

available to make, you know, reasonably fast decisions 1 where the need arises. 2 MR. PENBERTHY: Okay . We can 3 arrange for that. 4 MR. STAPL ES: Especially on the Study 5 Plan up front. Before we get into the field even, there's 6 goi ng to have to be some

-- 7 MR. PENBERTHY: Back and forth, I 8 understand. 9 MR. STAPL ES: To get them done 10 quickly

. 11 MR. PENBERTHY: I mean, if we're all 12 clear about expectations and what's being done, it makes it 13 go easier. 14 Any problems with that? So that's basicall y 15 the (inaudible). It's been a wonderful almost three y ears. 16 But the one thing good about it is it looks like we're on a 17 positive trajectory and we'll have an (inaudible), so that's 18 very

important. I know that's wh y every body in th is room 19 comes to work, to have a success in this. 20 MR. THOMAS: Absolutely

. 21142 MR. PENBERTHY: So thanks so much. 1 Is there an ything else we need to talk about? 2 MR. THOMAS: Nothing from me. 3 Any

body else? No. So thank you. 4 MS. PL OTCKE: Thank you. 5 MR. PENBERTHY: Great. So Iexpect 6 something in the (inaudible) probabl y within a week. 7 MR. THOMAS: Okay

. 8 MR. PENBERTHY: Happy holiday s. 9 (Hearing adjourned) 10 11 12 13 14 15 16 17 18 19 20 21