                                          
                                          
                   SILOXANES ENVIRONMENTAL MONITORING ECA MEETING
      		TAKEN DECEMBER 12, 2013
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      
      

      In Attendance:
      Ward Penberthy Karluss Thomas
      Trent Doyle
      Kathy Plotcke
      Cathy Fehrenbacher
      Russell Mait
      Tala Henry
      Steve Anderson
      Mark Seltzer
      Charles Staples
      Nhan Nguyen
      Karen Eisenreich
      Debra McNett
      David Tobias
      Sara Pollack
      Allison Starmann
      Paul Lewis
      Brad Goodwin
      Paul DeLeo
      Raymond Ludwiszewski
      Tracy Guerrero
      Wendy Koch
      Karen Vail
      Joe Avcin
      Kristen Smith
      Noriko Shibuya
      Neil Patel
      Hugh Flack
      Lisa DuMars
      On the Phone:
      Gene Browning
      Betsy Carlton
      Sean Bursick
      Lynne Blake-Hedges
      Steve Reynolds
      
      		          *  *  *  *  *  *
      		MR. PENBERTHY:  Okay.  My name is Ward Penberthy.  I'm deputy director of the Chemical Control Division here at EPA.  Why don't we go around the room this way?  
      		MR. SELTZER:  I'm Mark Seltzer, attorney advisor in the Chemical Control Division.  
      		MR. STAPLES:  Charles Staples, a contractor -- an environmental science contractor with SEHSC.  
      		MS. PLOTCKE:  Kathy Plotcke with Dow Corning.  
      		MR. THOMAS:  Karluss Thomas with SEHSC.  
      		MR. DOYLE:  Trent Doyle with Keller Heckman, outside counsel to SEHSC.
      		MR. MAIT:   Russell Mait, Evonic.
      		MR. WEBB: Keith Webb,  (Inaudible) Chemical Corporation.
      		MS. DuMARS:  Lisa DuMars, Momentive.
      		MS. HENRY: Tala Henry, director of the Risk Assessment Division in OPPT.
      		MS. Fehrenbacher:   Cathy Fehrenbacher, chief of the Exposure Assessment Branch in the Economic Exposure and Technology Division, EPA.
      		MR. GOODWIN:   Brad Goodwin, AAAS Fellow in the Chemical Control Division.
      		MS. EISENREICH:  Karen Eisenreich, a toxicologist in the Risk Assessment Division.  
      		MS. POLLACK:  Sara Pollack, a toxicologist in the Risk Assessment Division.
      		MS. SELBY-MOHAMEDU:  Yvette Selby-Mohamedu, Associate Chief of the Exposure Assessment Branch.  
      		MR. TOBIAS:  David Tobias, Exposure Assessment Branch.
      		MR. DeLEO:   Paul DeLeo, American Cleaning Institute.
      		MR. LUDWISZEWSKI:   Raymond Ludwiszewski, Gibson Dunn.  
      		MS. McNETT:  Deborah McNett, Dow Corning.
      		MS. GUERRERO:   Tracy Guerrero, SEHSC.
      		MS. KOCH:  Wendy Koch consultant to Evonic.
      		MS. VAIL:  Karen Vail, SEHSC.
      		MR. NGUYEN:  Nhan Nguyen Branch Chief, Chemical Engineering Branch
      		MR. AVCIN:   Joe Avcin, engineer EPA.
      		MS. SMITH:  Kristen Smith,  Momentive.
      		MS. STARMANN:  Allison Starmann with SEHSC.
      		MS. SHIBUYA:   Noriko Shibuya, Shieseido.
      		MR. PATEL:  Neil Patel, Economics, Exposure and Technology Division, OPPT.
      		MR. ANDERSON:   Steve Anderson from EPA's Office of General Counsel.  
      		MR. PENBERTHY:  Okay.  Paul Lewis will be here shortly.  He's attending a high-level meeting on fracking, so another wonderful topic.  
      		So we should go on the phone and just hear who's on the phone.  Can people on the phone start identifying themselves?
      		MS. CARLTON:   This is Betsy Carlton, Bluestar Silicones.
      		MR. BROWNING:  This is Gene Browning, (inaudible) of America.
      		MR. BURSICK:  Sean Bursick, Proctor & Gamble.
      		MS. BLAKE-HEDGES:  Lynne Blake-Hedges, Office of Pollution Prevention and Toxics, EPA.
      		MS. RIZUTTO:  Pat Rizutto, Bloomberg BNA.
      		MR. REYNOLDS:   Dave Reynolds, inside EPA.
      		MR. GRIFFITH:   Patrick Griffith, National Association of Clean Water Agency.  
      		MR. PENBERTHY:  Is that everyone on the phone?  Okay.  So Karluss, you sent me the list of unresolved issues.  Are there any other issues besides these or --
      		MR. THOMAS:  There are a couple of -- there are a few things at the end that we'll want to talk about from the standpoint of editorial type changes or just comments to some of the language, but what I've tried to list here are what we would consider the major issues.  
      		MR. PENBERTHY:  Okay.  So everything  else should be relatively simply disposed of?
      		MR. THOMAS:  We certainly hope so.  
      		MR. PENBERTHY:  Apart from these, maybe?
      		MR. THOMAS:  Yes.  
      		MR. PENBERTHY:  Okay.  All right.  So why don't we start on the first one?
      		MR. THOMAS:  Sure.  And actually, before we get started, I just -- I think I wanted to thank EPA on behalf of SEHSC for continuing to be patient as we work through this.  
      		One of the things I also wanted to note with respect to the remaining issue and in terms of our viewpoint on those issues, we've actually started to have pretty substantial discussions with a number of contractors with respect to trying to identify some expertise that's going to actually do the work for us.  
      		And I just wanted you to be aware that -- a number of our positions with respect to these issues have been informed by those discussions, so a lot of practical implications from the standpoint of how we do the work, a lot of that feedback, has been informed by those discussions we've had with contractors.  
      		MR. PENBERTHY:  Okay, great.  You know, it's our goal to have a complete document finished at the end of the day today that we can all be satisfied with.  So that's our ultimate objective and we'll stay here as long as it takes, so --
      		MR. THOMAS:  Okay.  
      		MR. PENBERTHY:  Then all right.  Go ahead.  
      		MR. THOMAS:  So I'll just start walking through these one by one.  On the timing for the quality assurance plan and for the study plans, we're happy with the language that's in the current version of the document.  
      		The one thing I think we wanted to point out -- and I think it's very important -- there are going to be substantial timing implications if EPA does not approve these plans in the specified.  So for example, if EPA does not provide some feedback or ultimately approve the plans within the time frame that's laid out, we're looking at substantial delays in actually the program moving forward.  So we're talking six months, along those times, if we can't get the feedback from EPA within the 60 days, I think, that's allotted for that.  
      		MR. PENBERTHY:  Okay.  You did request that we  -  a time limit -- I'm trying to find where we expressed that.  What page did you say that was?  I think it's on Page 8.  
      		MR. THOMAS:  Section 9.  It says, "EPA shall approve the QAPP within 60 days of receipt if it meets the requirements of this ECA."  
      		So again, I think the language is acceptable.  I just wanted to highlight, again, that if we -- if there are delays associated with that feedback or if there is some misunderstanding with respect to whether the plan meets requirements, again, we just want it to be clear that there are going to be substantial delays associated with the program if we don't have those met.  
      		MR. PENBERTHY:  I'm trying to find exactly where -- what page that is.  
      		UNIDENTIFIED FEMALE:  Under study and right above testing, in that statement.  
      		MR. PENBERTHY:  Okay.  So we're happy with that?
      		MR. THOMAS:  Okay.  Yeah, happy with that.  The other thing, Number 2, Force Majeure, this is a topic, as you know, that's -- we've kind of gone back and forth over for quite some time.  After carefully reviewing the language in the text, we're comfortable with it.  So we're happy that the language with respect to Force Majeure is going to satisfy our needs, so I think we're good for that one.  
      		MR. PENBERTHY:  Okay.  Then I think we've basically took most of your language from the start, so --
      		MR. THOMAS:  Okay.  
      		MR. PENBERTHY:  -- good enough.  
      		MR. THOMAS:  So Number 3, the use of one lab for analytical analyses.  I think here in several places EPA has included language with respect to contract laboratory vendors, and in other places using only one laboratory.  I think here our request would be that the language be made consistent in terms of the language in the actual ECA document and the language that's in the test standards.  And I guess from the standpoint of consistency, our preference would be to maintain some flexibility.  
      		MR. PENBERTHY:  Okay.  Where is that type of reference?
      		MR. DOYLE:  In the body of the ECA, it would be at Section 9A, Page 7, on my copy.  
      		MR. PENBERTHY:  Okay, all right.
      		MR. DOYLE:  It's referenced there that if multiple commercial laboratories are actually used (inaudible).  It's referenced there talking about multiple labs.  There is only -- each of the test standards, there's actually -- it's specifying you shall use one lab, and we want to make sure that that gets modified to accommodate flexibility if, in fact -- I mean, obviously that's our intent, but just so we can make sure there's some flexibility there if we need a second lab.  
      		MR. PENBERTHY:  Well, let me explain what our concern there was.  You know, we know that these are difficult analyses to do and it's to the benefit of the quality of the day-to-day results that a single lab would be done.  And the way we drafted this, I think you'll notice that in each of the media test standards we wanted each of the -- all of the testing for each of the media to be in a single laboratory at least, but it's our preference that they all be tested at one lab.  So that's the way it's drafted right now.  
      		MS. PLOTCKE:  I mean, I think -- so the way language is that you have, it says, "The use of only one laboratory is most desired."  We actually agree with that completely.  That is our preference as well, but one of the things we are just trying to do is to put in contingencies; if something were to happen, that we would have some back-up.  
      		So we just want that flexibility, and then that and the test standards is a little more -- shall have one laboratory.  So we want to make sure that that flexibility of this language is really also consistent with what it says in the test standard.  
      		MR. DOYLE:  So if you look at section --
      		MS. PLOTCKE:  So we're of the same mindset.  
      		MR. DOYLE:  So Section 8A, it appears and it also appears in Section 9A of the ECA, and then if you look at how the language is worded there -- so Section 8A is, "Preferably all samples should be analyzed for D4 at one commercial testing laboratory..." -- 
      		MR. PENBERTHY:  Okay.  So that expresses our preference?  
      		MR. DOYLE:  Yes.  So that's -- that's exactly right.  We -- we're fine with that.  The only part about that -- and not to jump ahead about that provision right there -- is where we say one commercial testing laboratory -- it says, "...known to have appropriate expertise with D4 analyses..."  
      		In our waiving -- that whole "known to have appropriate expertise" part could just all be struck.  I mean, I don't -- I'm not sure known to who, and at this point in time the method of validation, the EPA doing the GLP, that's what's going to sort of establish that the lab is -- has appropriate expertise in doing analyses (inaudible) ahead of time.  I mean, we're obviously going to choose a vendor we think has appropriate expertise, but I just don't see that that really counts as much.  
      		So now if we --
      		MR. PENBERTHY:  Well, hold on, hold on, hold on:  Go ahead, Kathy.  
      		MS. FEHRENBACHER:  I thought that in prior discussions and, in fact, in the draft that the SEHSC submitted we had included language about working with the laboratory to make sure they had the required  expertise.  And that's where we're coming from with this language, known to have appropriate experience.  
      		MR. MAIT:  Well, let's do this:  We're planning on going through with whatever lab is selected to ensure that the methods and techniques are all validated as if they went in the lab like whether it's a company lab or not.  If that's what you mean by that, then it's going to be okay.  If prior knowledge before we select the lab, that's where the challenge comes in.  That's where Trent's concern comes from.  
      		MR. PENBERTHY:  So if we change the language from "known to have" to just say "that has appropriate expertise,"   wouldn't that essentially --
      		MR. MAIT:  As long as it -- is it preferred -- as long as it's considered from a timing issue that we're going to going to have the opportunity to give them that -- okay.  
      		MR. PENBERTHY:  I don't think that's necessarily --
      		MR. MAIT:  I don't want it to be an a priori thing.  It would be better if we're allowed to give them that validation time so that they know they can achieve what is expected in the test plans.  
      		MR. DOYLE:  We're certainly going to put them through the validation process just like we established in the test standards and so forth.  
      		MR. PENBERTHY:  So is it okay -- so one commercial testing laboratory that has appropriate experience?  
      		MS. PLOTCKE:  Can you say has or will acquire?  
      		MR. ANDERSON:  That has at the time of the testing.  
      		MS. PLOTCKE:  Oh, yes.  
      		MR. DOYLE:  That's what I was getting at, is the timing issue on that.  
      		MR. PENBERTHY:  Go ahead, Steve.  
      		MR. ANDERSON:  That has appropriate -- whatever it is -- experience at the time the testing occurs.  It sounds like that's the --
      		MS. PLOTCKE:  That's the -- yeah.  
      		MR. PENBERTHY:  That's the issue.  Okay.  Let me just read that sentence as I have it.  So I say, "Preferably all samples should be analyzed for D4 at one commercial laboratory that has appropriate expertise with the D4 analyses of the samples of the types collected in this testing program when the testing occurs."  Is that okay?  
      		MR. DOYLE:  Yes.  
      		MR. THOMAS:  Yes.  
      		MR. PENBERTHY:  Okay.  Now, you mentioned there's other places?  
      		MR. DOYLE:  Yes.  
      		MR. PENBERTHY:  Can we clean the other places up on this draft?  
      		MR. DOYLE:  Let's flip back to the test standards, so back at the Appendices.  
      		MR. PENBERTHY:  Okay.  So I assume we'll start at Appendix 4?  
      		MR. DOYLE:  Appendix 4.  Let's go to the section that says, "Analysis of influent and effluent samples for D4."           The very first sentence there says, "All influent and effluent samples and accompanying QA samples shall be analyzed for D4 at one commercial testing laboratory known to have appropriate expertise with D4 analyses to be conducted."  
      		MR. PENBERTHY:  Okay.  Here you'll notice that it's limited to influent and effluent samples; it's not all samples.  
      		MR. DOYLE:  I understand that.  The concern is, if in the middle of the program or somehow we need to, you know, have another lab be involved, that we want to make sure we have that flexibility.  I mean, obviously, our intent is to have one lab do everything.  That's what's intended.  
      		MR. PENBERTHY:  Does the saying change (inaudible)?  
      		MR. DOYLE:  Yeah.  I think you mirror the language that you have in the body of the ECA, which is, "Preferably testing should be conducted in one lab," and Steve's qualifier at the end, too.  
      		MR. PENBERTHY:  So that was Section 8.  Okay.  So you would -- so we would delete this first sentence and replace it with the sentence we just constructed?  
      		MR. DOYLE:  Yes.  
      		MR. PENBERTHY:  Are you satisfied with that?  
      		MS. PLOTCKE:  Yeah, that's fine.  
      		MR. PENBERTHY:  Okay.  So we'll mirror the sentence on -- insert the sentence from Page 6.  
      		MR. DOYLE:  It's going to be essentially that same edit for each one of the other test standards.  
      		MR. PENBERTHY:  Okay.  Hold on, just let me just check.  I'll just circle that on each of them so I know.  
      		Okay.  So that would be on Page 30; that would be the same on Page 6?  Okay.  We'll keep going.  
      		Okay.  Again, on Page 35.  Page 35, the biosolids; Page 40, on sediment; Page 48, biota.  
      		Is that all of them?  
      		MR. DOYLE:  I think so.  
      		MR. PENBERTHY:  Okay.  Is this now resolved, this issue?  
      		MS. FEHRENBACHER:  So let me just confirm what we're saying here.  For -- our preference is to have all samples collected or analyzed for D4 at one commercial testing laboratory.  And then for each of the media, we did want to have samples for each media analyzed at one commercial laboratory?  
      		MR. DOYLE:  That's our intent as well.  However, we wanted to make sure there's that flexibility; if something goes awry and we need to bring another lab on board, that we can have that flexibility to do that.  
      		MR. MAIT:  We've had discussions.  We've had discussions with potential vendors and this question came up of -- there are potential situations where somebody can't perform and we want to be in a position that doesn't impact overall the whole program by not having somebody in the back seat that we can bring on board, revalidate, and to move forward so the program doesn't get delayed.  That's the thinking.  
      		MR. PENBERTHY:  So on Page 48, in lieu of that first sentence, we would strike the first sentence.  And on Page 48, if you strike that first sentence and say, "Preferably all samples should be analyzed for D4 at one commercial testing lab that has appropriate expertise with the D4 analysis of samples of the types collected in this testing program when the testing occurs."  That's okay?  
      		MR. DOYLE:  Right.  
      		MS. FEHRENBACHER:  So what would be a situation where you would need to use a second laboratory?  
      		MR. MAIT:  Some crazy act of God or something like that.  That's what we're --
      		MS. PLOTCKE:  Or if a laboratory closes down.  
      		MR. MAIT:  Or burns down.  
      		MS. PLOTCKE:  Goes out of business, you know.  
      		MS. FEHRENBACHER:  But you switch labs and you go back to all the samples?  
      		MS. PLOTCKE:  Yes.  
      		MR. DOYLE:  The intent is not to farm this out to a bunch of different labs.  The intent is to have all the analyses for all the different matrixes done at the same lab.
      		UNIDENTIFIED MALE:  Whether it's, you know, the initial lab that runs in the -- whatever kind of problem there is, we need to go to a backup lab.  
      		MR. PENBERTHY:  I think the way this was constructing it was -- our preference was to have all the samples from all the media in one lab.
      		MS. PLOTCKE:  Right.  
      		MR. PENBERTHY:  And then our requirement, when we drafted this, was at least each media have the same.  
      		MS. FEHRENBACHER:  That's right.  
      		MR. PENBERTHY:  So we are somewhat being somewhat more flexible.  
      		MS. FEHRENBACHER:  Yes, we are.  And I just wanted to make sure that we were okay with --
      		MS. PLOTCKE:   I mean, the intent is to have every sample, and so -- of all the same media analyzed at the same lab, but all samples.  So this is only contingency planning for a natural disaster kind of thing that, you know, we've asked the contractors to put in place just in case something, you know, unforeseen happens, but we don't expect that to happen.  We don't want that to happen.  Our intent is one laboratory does all the sample analysis for the whole program as well as each matrix.  
      		MR. MAIT:  So the point is, from the project managers ' standpoint we want to minimize the potential risk of not meeting its time schedule by not having a potential backup in the event that it was needed.  If it's never needed, we'll never use it.  
      		MS. HENRY:   But in particular for a specific media, if you're part way through and have to switch, you got to go back and do them all at the same lab.  
      		MR. DOYLE:  That's not what they're saying.  That's not really what they want to do.  
      		MS. HENRY:  Well, that's inconsistent.  If you can switch midstream, it's inconsistent with all samples that we will have.  
      		MR. DOYLE:  Preferably, all samples should be analyzed at one lab.  That's what our aim is to do.  If something happens -- you know, let's say we go through the whole first campaign, if you will, the whole first sampling event at all the sites, have them all analyzed, then we wait the three months between, as prescribed, go do the -- if something happens in those intermediate periods with the lab -- I don't know.  We can imagine a whole host of scenarios -- we want to make sure that we had the flexibility if we need to bring another lab up.  That goes to the validation that we can do that under this ECA.  That's really what it is.  It's just for -- we want to make sure we can make the project schedule.  
      		In that situation, we're not going to go back and repeat all the whole first-phase sampling because we were supposed to use a different lab.  The labs are going to have to have to go through validation, you know, the second lab.  I mean, that's -- you know, I mean, these are all out there.  
      		MR. PENBERTHY:  There are retained samples.  
      		MS. PLOTCKE:   Not on everything because they won't be of value if -- well, some of them from a stability standpoint.  I mean, this is really just, you know, that unforeseen kind of -- I mean, we've had some wild weather, tornados, hurricanes.  I mean, if the lab we happen to be at has something like that that totally shuts it down, we want a backup -- that's all -- but it's not our intent to go anywhere else once we start.  
      		MS. FEHRENBACHER:  I prefer that the language in the ECA specify the intent.  And it seems that we're all in agreement that the intent is that for each media we would prefer the samples to be analyzed at one laboratory, and then it sounds like you want to have a contingency in place in case you're not able to meet that --
      		MR. PENBERTHY:  So how about we change the language on -- that's on Page 6 and say -- instead of preferably to say, "All samples should be analyzed for D4 at
      one commercial laboratory that has appropriate expertise with D4 analysis of samples of the types collected in this program when the testing occurs unless there are unforeseen catastrophic circumstances," something along those lines.  Because that's -- see, "preferably" is somewhat flexible and what we're trying to do --
      		MR. DOYLE:  Exactly.  
      		MR. PENBERTHY:  Well, it's too flexible and what we're trying to do is limit it, that the -- be clear about when this would happen.  
      		MR. DOYLE:  I mean, to me -- there's a Force Majeure clause when you deal with a lot of these catastrophic kind of things.  Here we didn't -- honestly didn't think this was going to be that big of a deal.  We wanted to -- we expressed our intent.  
      		And there's a trust factor, but at the end of the day I think -- to me, if it says, "Preferably all samples should be analyzed for D4..." as stated, I mean, that's the preference.  That's our intent.  We've restated it multiple times.  It provides for that.  Obviously, if we're going to do something different midstream, I mean, everyone is going to be notified of that.  I mean, I don't -- I mean, to me, we could try to wordsmith this and -- to find all of these kind of contingency events, but to me that's an exercise of futility.  
      		MR. ANDERSON:  Or one option might be to sort of go along what you were thinking, having an "unless" clause at the end, but link it and say unless there's an event that would qualify under the Force Majeure provision at such and such.  
      		MR. PENBERTHY:  Would you be happy with that?  We'll just cross preferably, start it with all, and then unless there's a Force Majeure.  
      		MR. MAIT:  Yes, because that would be what we would be anticipating, obviously, under those conditions.  Even if that provision wasn't in there, the lab wasn't available, we would invoke Force Majeure and this time the schedule would be blown anyway and we'd be back renegotiating the time frame and so on.  
      		MS. STARMANN:  I'm sorry, I know I'm not at the table.  I'm not sure about Force Majeure -- if that would qualify for some of the lab situations that -- Force Majeure is somewhat narrowly defined in this agreement.  
      		UNIDENTIFIED FEMALE:  What's your name?  
      		MS. STARMANN:  Allison Starmann.  
      		MR. PENBERTHY:  Let's go back and take a look at what it is.  
      		MR. ANDERSON:  And there's also the regulation section, 790.68 where you have unforeseen circumstances.  
      		MS. STARMANN:  You'd have to be known in advance to qualify.  
      		MR. PENBERTHY:  I'm trying to find the Force Majeure section, what it says.  
      		So it's caused by circumstances beyond its control or control of -- any entity controlled by the signatory company.  So how is that limited?  
      		MR. DOYLE:  Well, I think my preference is to -- and the reason we stuck the provision in there in the first place and -- where we talk about the labs is so that we don't get into arguments about what does or doesn't qualify as Force Majeure.  I mean, that's the -- that --
      		MR. PENBERTHY:  Well, I guess what we do want to avoid is the situation where the lab says, oh, this is harder than we thought, we're going to charge you twice as much; and you say, well, that's too much, we want to go to a different lab, then we have to go through the program.  
      		MR. DOYLE:  That's not what was intended.  
      		MR. PENBERTHY:  I know that's not intended, but is that a scenario that could --
      		MS. PLOTCKE:   I think we put appropriate controls in place.  
      		MR. MAIT:  I think -- obviously, we've fairly well engaged the contractors and I think there's a clear understanding of expectation of what they have to do.  They've obviously looked at the preliminary test standards and so on.  So the idea of whether they can perform or not, I think it's well-understood that they can.  
      		It's a matter of achieving -- you know, as we've said, we're going to get them validated, so they should be able to be in a position to execute what -- again, we're concerned about things that are well beyond our control, but I'm not a lawyer here.  
      		MR. DOYLE:  I think we need to avoid getting -- we're trying to argue about what the contractor could or couldn't have controlled, which is literally -- comes up in the Force Majeure provision.  I mean, I think that goes beyond -- I mean, you know, we kind of stated we wanted the flexibility if it comes up.  We don't anticipate it coming up.  It's -- and that's why you put the provision in in the first place.  
      		I mean, at some point we've communicated what our intent is.  We've stated it multiple times.  It's on the record.  I mean, it's -- to me, if we leave the flexibility in there, that's consistent with accommodating our needs.  We've stated, you know, what we're going to do to accommodate, you know, what you prescribed.  
      		MR. SELTZER:  The only scenario you provided was if the lab were to flood or something along those lines, and that would fit within -- that would be encompassed in the Force Majeure section.  Are there other scenarios you're thinking might not and you're worried about --
      		MS. PLOTCKE:   Well, I think what Trent's point is is we can't control everything.  We can't control everything for them.  I mean, and so --
      		MR. DOYLE:  I mean, that lab may decide to, you know, go out of the business of providing, you know, this kind of, you know, analytical work.  I mean, we can't control -- maybe it gets sold.  Maybe they get bought, you know.  I mean, it's -- maybe, you know, all the staff, you know, will leave.  You know, there's just a whole host of things that could happen.  
      		UNIDENTIFIED MALE:  Breaks down and they can't fix it.  
      		MR. DOYLE:  Yeah, you know, they've got equipment that breaks down.  I mean, I don't want to get into this situation where we argue about whether that's Force Majeure or not.  I mean, that's not an efficient process for anybody.  We want to get the program done.  That's what we thought by doing this in the first place, was to get the program done.  
      		MS. FEHRENBACHER:  I think the reason that we're pretty strongly in favor of keeping the language that all samples for individual media be analyzed by one laboratory is for the data-quality issue.  
      		There's a small number of samples being collected and analyzed for media.  And if you split those samples among laboratories, then you're introducing variability -- inter-laboratory variability on top of the other potential areas of variability and uncertainty.  And because of the small number of samples, you need to maximize the data quality aspects.  And one way of doing that is to ensure that at a minimum each of the -- all of the samples for each media are analyzed by one laboratory.  
      		MS. PLOTCKE:   And that is our intent as well because we agree completely from a data-quality perspective.  And so that's the intent that we're going in with, that all of them would be analyzed at one laboratory.  If something were to happen and we had to use a backup laboratory, we would be sure that that laboratory was trained and validated and accounted for any potential variability.  
      		MS. FEHRENBACHER:  And again, would all of the samples be analyzed --
      		MS. PLOTCKE:   I mean, we wouldn't know what -- you know, if something happens in the middle of doing something and they -- we have to make that shift to go to the backup laboratory, but we would make sure that --
      		MR. SELTZER:  To cite the reg, 790.68 A2 III, it says, "Not technically feasible unforeseen circumstances such as lack of laboratory availability."  I mean, that sounds like that and a reg goes to right what you're talking about, any of the issues talking about is right there.  
      		MR. DOYLE:  It seems like that will be your right consistent with your --
      		MR. SELTZER:  And we can cite to that in addition to Force Majeure, if you want -- I think one of the previous --
      		MR. PENBERTHY:  So let's go back to where we were.  So if we start with -- delete the Preferably and say unless there is -- what was it?  
      		MR. SELTZER:  Unforeseen circumstances such as lack of laboratory availability.  
      		MR. PENBERTHY:  As defined --
      		MR. SELTZER:  As defined in 790.68 A2, III.  
      		MR. PENBERTHY:  If there is unforeseen -- give me the right words.  
      		MR. SELTZER:  Unforeseen circumstances such as lack of laboratory availability.  
      		MR. PENBERTHY:  Such as --
      		MR. SELTZER:  A lack of laboratory availability.  
      		MR. PENBERTHY:  As noted in section --
      		MR. SELTZER:  790.68 A2, III.  
      		MR. PENBERTHY:  Is that okay?  
      		MS. PLOTCKE:   Yes.  
      		MR. DOYLE:  Yes.  
      		MR. THOMAS:  Yes.  
      		MR. PENBERTHY:  Okay.  That's a reasonable outcome -- okay, fair enough.  So we'll change that all and that will be the sentence.  The next one was site specific sample times.  Could you explain what your issue is?  
      		MS. PLOTCKE:   Yeah.  Actually, I'm not sure we really have an issue there, so I think we'll probably find out that we just wanted to clarify.  It says, "Site characterization".   And we wanted to make sure that that's what we had referred to in the past, is we would evaluate the site, evaluate the biology of the site, and come up with the plan of what we would expect to be there.  
      		So as long as we're in agreement with that, then --
      		MR. PENBERTHY:  Okay.  Where is this in the text?  
      		MS. PLOTCKE:   This is --
      		MR. DOYLE:  Appendix 1 near the end of the appendix.  It's the last bullet point in the list.  It says, "Site characterization for benthic invertebrate and fish sampling, including species that are expected to be collected for analysis."  
      		MR. PENBERTHY:  Okay.  So all of these dots refer -- evolve from the sentence above them.  A detailed sampling plan shall be prepared for each site and included as part of the overall study plan submitted to EPA.  The sampling plans shall include...", and then all of those items?  
      		MS. PLOTCKE:   Mm-hmm.  
      		MR. PENBERTHY:  Okay.  So --
      		MR. STAPLES:  Our concern is some of us read it differently than others and that's -- we wanted to be sure that this particular part of the site characterization planning is not presampling, not pre-field work, but, in fact, it is conversations with local officials who are -- might be knowledgeable so that these -- we might be able to identify species that might be there, should be there.  We're going to try to collect, but not that we have done presampling, pre-field work.  
      		MR. PENBERTHY:  Okay.  Do you see -- I don't see -- they're not presampling, but they will ask questions.  
      		MS. PLOTCKE:   You're going to understand the biology and -- yeah, yeah.   
      		Okay.  We just wanted to make sure we were on that same page; that's all.  
      		MR. STAPLES:  Dramatically affects the schedule.  
      		MR. MAIT:  Strictly precautions, right?  
      		MS. PLOTCKE:   Yeah.  
      		MS. FEHRENBACHER:  And we appreciate you checking in with us.  
      		MS. PLOTCKE:   Yeah.  We just want to make sure.  
      		MS. FEHRENBACHER:  It's good for us to all be on the same page.  
      		MR. PENBERTHY:  Okay.  Number 5.  
      		MR. THOMAS:  Yes.  This is the selection criteria for the industrial POTWs.  This is Appendix 2.  There is a sentence here that relates to the D4 concentration at the POTWs.  It says, "D4 concentrations in the wastewater treatment plant influent shall be reasonably expected to be at least one part per billion."  
      		And I think that's going to be difficult from the standpoint of presampling.  We had not intended to do any presampling, so I think --
      		MR. PENBERTHY:  What we meant by "reasonably expected" is not sampling, but an engineering calculation, something along those lines.  I mean, what we're trying to get at here is there's reasonable assurance that there's actually D4 in the wastewaters.  
      		MR. THOMAS:  Sure, sure.  And I think the language prior to that sentence is sufficient to accomplish that.  It says, all wastewater treatment sites selected for monitoring must be currently processing wastewater from one or more industrial sites known to be a D4 processor or formulator as documented through industrial user surveys, or other readily available information.  We think that language is sufficient to --
      		MR. PENBERTHY:  I mean, processing wastewater doesn't mean it contains wastewater, so the sentence is a little bit weak in that processing wastewater -- you would have to at minimum say, containing D4.  
      		MR. THOMAS:  It says known to be a D4 processor.  
      		MR. PENBERTHY:  Yeah, but that doesn't mean the wastewater is -- actually contains D4.  I mean, the D4 processor might not have any water releases, D4 water releases.  
      		MR. THOMAS:  Right, but that's the whole point of the exercise.  
      		MR. MAIT:  But then there wouldn't be a discharger, it seems redundant.
      If they had no effluent -- they wouldn't --
      		MR. PENBERTHY:  My point is they could have effluent that doesn't have D4 in it.  We want to be sure that we're sampling facilities --
      		MR. MAIT:  But that is some of the dilemma, is there is no -- without presampling there's no way to confirm that position.  Well, that's an absolute, right?  If you know it, then somebody's actually analyzed it.  Otherwise, it's somebody's opinion that it's there.  
      		MR. PENBERTHY:  I mean, if it wasn't receiving D4 from a processing facility, then it would be basically an Appendix 3 facility, correct?
      		MR. THOMAS:  An Appendix 3 facility -- right, right, right.  
      		MR. PENBERTHY:  Well, that doesn't make sense to us.  So what is the assurance that there's actually going to be D4 in that wastewater?
      		MR. THOMAS:  Other than to go out and measure it, which is the whole point of the monitoring --
      		MR. PENBERTHY:  Well, can the facility operator tell you, yes, we released before?  
      		MR. MAIT:  Typically, the experience is with things like that, you would complete a survey for that -- when they're doing these types of investigations, basically, Categorical Standards of Manufacturing is the Agency here who tends to regulate.  
      		You do a survey.  You provide information to the operator of the facility that says, these are the types of processors I have, this is the materials processed, this is the type of, you know, pretreatment or whatever it is that we have, is it known to you or whatever.  
      		Because frankly, I'm not aware that -- the people who are going to be asking other than -- potentially the industrial folks who are in this room would know whether it's in the effluent or not, so we're stuck with -- the only way you really know is you pretest.  
      		MS. PLOTCKE:   They may know they process it, formulate it, but each of the systems that they have could be removing it.  They don't know that.  
      		MR. PENBERTHY:  So let's go back one step further.  So how are you going to identify these --
      		MR. MAIT:  The sites would be identified as we've discussed before.  There's certain categorical standards, you know, classifications, that are known to process materials like D4, and then --
      		MR. PENBERTHY:  (Inaudible).  
      		MR. MAIT:  Then you would then have -- as part of the recon on the POTW, we would work with -- through our contractor, work with that POT operator to go back to their dischargers to complete a survey, do you process with D4, are you manufacturing with D4, is it known to be in your effluent, is it suspected to be in your effluent.  That's typically what I see on these surveys.  
      		MR. PENBERTHY:  I think that's okay as long as -- but that's -- how do we put that in this text?
      		MR. THOMAS:  We got here through industrial user surveys, and that was what was just described.  
      		MS. PLOTCKE:   And it says, "as documented," so there will be -- those surveys would be on record.  
      		MR. PENBERTHY:  All right.  One thing we did -- I propose adding another sentence at that point, then it would be in the second sentence in the paragraph, after -- the first sentence would be, the Study Plan shall detail the factors that were used to select each of the sites for testing."  
      		And then we would want to add a sentence along the lines of, "The Study Plan shall provide an explanation of why D4 concentration in influent are expected to be above the surface water MDL specified in Appendix 5."  So we want to know there's actually a water release.  
      		MR. THOMAS:  We may not be able to know.  
      		MR. PENBERTHY:  Well, you would know if you did the survey, right?  
      		MR. THOMAS:  Well, just because there's a water release doesn't mean you'll be able to detect it or that it's going to be above the MDL.  I mean, that's --
      		MR. PENBERTHY:  Well, every facility that was tested in the Canadian said you had concentrations over --
      		MR. THOMAS:  Not in the surface water concentrations.  In fact, I remember --
      		MR. PENBERTHY:  Yeah.  Well, I'm talking about the influent.  
      		MR. DOYLE:  Well, the influent you'd have to --
      		MR. PENBERTHY:  Correct.  That's what I'm talking about.  I mean -- you follow?  
      		UNIDENTIFIED MALE:  It still (inaudible) presampling or not.   I mean, you know, we're not going to make representations about it.  
      		MR. THOMAS:  We would have to actually meet that.  I mean, certainly it sounds like you could reasonably expect that to be the case; but to confirm it, we'd have to go out and --
      		MR. PENBERTHY:  Well, that's what we said, reasonably expected.  
      		MR. THOMAS:  Right, but to make that -- to show that, you would actually have to go out and do the testing.  
      		MR. MAIT:  I mean, my personal view is if folks are processing it, they have discharge, things like that; whether they're pretreating or not, is there potentially a quantifiable amount?  Probably.  But absolutely?  You know, that's a pretty tall standard to take without actually doing the analysis.  
      		MR. THOMAS:  And that's what we're trying to avoid, the need to go out and do the presampling.  
      		MR. PENBERTHY:  Well, the intent is not presampling.  I mean, obviously, we're not -- we're trying to be sure that there's waste being treated.  And how do we assure that?  And you know, the paranoid person would say, well, you're just going to pick facilities that are closed systems and they have absolutely no chance of a water release, and that's not what we're interested in.  
      		MR. MAIT:  But if the survey is offered by the -- let's say for the POTW, the folks that are discharging to them, if they're completing the survey where they are asked, known to be present or suspected to be present, then you would be relying on their knowledge of their effluent.  
      		MR. PENBERTHY:  But I'm saying that that would be sufficient.  
      		MR. MAIT:  Okay.  Well, that's fine.  
      		MR. DOYLE:  We just can't -- I can't qualify that further by saying that that equates to being above the method detection line.  
      		MS. FEHRENBACHER:  So if we were to add after the wastewater influent shall reasonably be expected based on the industrial site -- the industrial user survey and other readily available information to be at least one parts per billion, would that --
      		MR. THOMAS:  The one part per billion is always going to be problematic because the only way to confirm that is to go out and measure it.  Everything you said up until the one part per billion, I think, is fine.  I mean, we certainly want to make sure we're testing facilities that process D4, but we can't attest to, on the front end, what the concentrations are going to be.  
      		MR. PENBERTHY:  So how about we say the waste -- a study that says that you want to do -- you say the wastewater influent shall reasonably be expected to contain D4?
      		MR. THOMAS:  Yes.
      		MR. NGUYEN:   Have a measurable amount.  
      		MR. PENBERTHY:  So we have the proposal the wastewater influent shall reasonably be expected to have a measurable amount of D4?  
      		MR. DOYLE:  I like the first one.  That's the whole point.  We don't know.  Based on these surveys, we're going to qualitatively determine that -- through the surveys, that the site releases wastewater to the POTW that has D4 in the effluent.  
      		MR. PENBERTHY:  Okay.  How did you just say it?  
      		MR. DOYLE:  Whether it's measurable, whether it's --
      		MR. PENBERTHY:  Well, let's put the words you just said into a reasonable sentence.  
      		MR. PENBERTHY:  Let's start with -- we've got our first sentence, "All wastewater sites selected for monitoring must be currently processing wastewater from one or more industrial sites known to be a D4 processor or formulator."  
      		MR. PENBERTHY:  And then we need the wastewater treatment plant influent --
      		MR. DOYLE:  Shall reasonably be expected to contain D4 based on -- as documented through industrial user surveys --
      		UNIDENTIFIED MALE:  Or other readily -- 
      		MR. DOYLE:  Or other readily available information.  I mean, maybe they've done (inaudible).  
      		MR. FLACK:  Well, you start the sentence with D4 concentrations, so you expect -- 
      		MR. PENBERTHY:  So let me get this.  "The wastewater treatment plant influent shall reasonably be expected to  contain D4 based on..." -- and is it this phrase up here, and industrial user surveys --
      		MR. DOYLE:  Or other readily available information, yes.  
      		MR. MAIT:  That would be the basis to inform us that we have a reasonable expectation that it be present.  
      		MR. DOYLE:  And this is going to be documented in the Study Plan, so it's going to all come through EPA.  You know, you're going to get to see sites, we pick the basis, we pick the sites.  This sets out the standard for everything.  
      		MR. MAIT:  So Ward, think of it this way.  If the surveys come back and the dischargers to the POTWs say, not expected to be present, obviously that's not --
      		UNIDENTIFIED MALE:  We would be putting it into a different category, would we not, just as you suggested?  
      		MR. PENBERTHY:  Are you okay with that, Nhan?  It all makes sense, the wastewater treatment plant --
      		MR. NGUYEN:  I think first to have some explanation -- a fair explanation of the Study Plan that explains why we expect that the concentration and wastewater contains D4.  Some kind of explanation --
      		MR. THOMAS:  And we'll certainly have some explanation for why we expect there to be D4 in the influent, and that would be because the folks that release to that wastewater treatment plant say they use D4.  
      		MR. MAIT:  And reasonably expect it to be present.  
      		MR. PENBERTHY:  All right.  So again, on the -- it says on the sentence, "The Study Plan shall detail the factors that were used to select each of the sites for testing," and then include an explanation of how -- and shall provide an explanation of why D4 is expected in the influent.  
      		All right.  So here's the proposal I got.  Can I read it to you?  Are you okay?
      		MR. THOMAS:  Mm-hmm.  
      		MR. PENBERTHY:  Okay.  So I'll go one more time with the sentence up on top just so we know what we're saying.  
      		"The wastewater treatment plant influent shall reasonably be expected to contain D4 based on industrial user surveys or other readily available information."  
      		And then in the paragraph below the dots, the first sentence, we'll extend it.  It will read, the Study Plan shall detail the factors that were used to select each of the sites for testing and shall provide an explanation of why D4 is expected in the influent."  
      		Okay.  So the next one -- does anyone need clarification on what we just said or are you going on to that?
      		MR. THOMAS:  So the next one is selection of non-industrial POTWs.  
      		MR. PENBERTHY:  Okay.  
      		MR. THOMAS:  And I think here --
      		MR. PENBERTHY:  This is Appendix 3, I take it?
      		MR. THOMAS:  This is Appendix 3, yes.  
      		MR. PENBERTHY:  Okay.  Here we're comfortable with the language.  I think we just wanted to acknowledge, I think, based on our previous recommendation, that the agency included some wording that we thought made the section more clear, in particular, the clause of Preferably no wastewater from D4 manufactured processors or formulators, but I think we're good with this section.  
      		MR. PENBERTHY:  Okay.  So it's a non-issue.  
      		MR. THOMAS:  The next one is number of analyses.  And I'm going to let our technical folks list them.  
      		MR. STAPLES:  Okay.  Mainly the things that were added in terms of number of samples were some extra QA samples, in other words, samples collected to be used for field spikes would be split and both the spiked and unspiked portions of those would be analyzed.  So that adds a considerable number of samples for QA purposes.  A total over the course of the program were roughly another 25 percent of the samples.  
      		Speaking with our analytical folks, it might provide some small additional positive QA concern, but it is an awful lot of samples.  We're not going to say no, but it -- we consider it a relatively large additional number of samples for a really small benefit.  
      		MR. PENBERTHY:  Well, you know, we had some difficulty with this issue, and I'll explain what our logic was.  Obviously, we have a limited number of samples and sites for you to pick, so we definitely want to have as much assurance that the samples that we actually do have taken are good samples.  And so the way you could do that is with good QA, QC or more samples.  You all are very insistent on fewer samples, and so that leaves us no choice in terms of boosting the QA so we know that the samples that are taken are good.  
      		MR. STAPLES:  Well, what we have defined, I think, will get you to the same spot.  Our analysts do say that this will provide a slight bit of additional positive benefit, not really necessary but --
      		MR. PENBERTHY:  So we're good?  
      		MS. PLOTCKE:   So we're fine, yeah. 
      		MR. DOYLE:  Yes.  
      		MR. THOMAS:  Yes.  
      		MR. PENBERTHY:  We're on Item 8?
      		MR. THOMAS:  Yes.  So this is the method detection limit.  I'll let Charles do that one as well.  
      		MR. STAPLES:  And I'm just going to kind of tee this up, but we have in the room Dr. Deb McNett who is the -- one of the leading experts in terms of analyses of D4 in all media around the world.  And I say that truthfully because she is the person that's going to be basically in charge of training -- qualifying and training the laboratory that is selected for this, so as such she has considerable knowledge in terms of analytical methodologies.  
      		One of the challenges that we've had with explaining our position on method detection limits and so forth is that we can take a method that one lab uses and hand it to another laboratory, a very well-qualified laboratory, and they can adapt that method and start analyzing for D4.  But according to the experts at Dow Corning, they will also start to find background contamination issues that are different with -- Dow Corning's were different from any other laboratory.  
      		And that will just take some time, and so where we're at on the appropriate level of detection is that we can accept the higher -- we can accept the levels -- limit of quantizations
      you proposed for each of the media as long as we recognize and the tests reflect that those are the reportable limits for D4 analyses.  We're not sure -- Dow Corning is not confident and not sure that any lab on the pace that this program is going to be conducted at can reach the MDLs, that the MDLs times three to get your LOQ -- if that LOQ was agreed to be the point of departure, that is the reporting limit, then we can agree to those.  
      		MR. PENBERTHY:  And so basically you're going to -- you wouldn't report non-detects?  Is that what you're saying, you would only report when you actually detect above the LOQ?  
      		MR. STAPLES:  Anything below the LOQ is a non-detect.  
      		MR. PENBERTHY:  Is that conventional science?  
      		MS. PLOTCKE:   Maybe we can go back to the text in the actual ECA, Trent.  
      		MR. THOMAS:  --
      if you want to look at -- there's a couple different spots here.  We've got two locations really where this comes up -- or key locations.  
      		There's -- in Section 2 of the ECA, we talked about chemical subject of the ECA.  Do you remember we had talked about -- this is a little different than your normal test plan or ECA because it's not toxicology testing.  We've got -- here it says the ECA requires testing for the presence of D4 in specified wastewater treatment plant influent and effluent discharges, receiving streams, environmental matrices -- and here's the part we want to focus on -- at method detection limits specified in the test standards Appendices 4 through 8.  
      		And our key comment here is, we would take that method detection limit and replace that with limits of quantization specified in the test standards in Appendices 4 through 8.  
      		Then if you go back to the individual test standards, that's what Kathy was referring to in terms of -- that's where it's been set out how the limits of quantization are calculated.  And those were established based on a multiplication of the method detection limits that have been achieved in previous studies and multiply those -- originally we had -- if you recall, a practical quantification limit of five times the method detection limit.  
      		EPA has come back with a factor three times the method detection limit, and we're going to accept that as a limit of quantification.  I think the point that Charles made is we want to make certain, when the data are reported, it's going to be -- if it's above the limit of quantization, it's reported as such.  If it's below that, it would be essentially, as you rightly pointed out, Ward, it would be reported as less than the LOQ.  
      		MR. PENBERTHY:  Okay.  But that's not a conventional approach to monitoring, is it?  
      		MR. DOYLE:  I think that the challenge here is with the --
      		MR. PENBERTHY:  You usually report the data that you get, right?  So whatever you get is the number you get.  You wouldn't filter it.  
      		MR. DOYLE:  Remember, what we're going to qualify in these labs is to be able to achieve a limit of quantification of three times the -- because the method detection value that's being plugged in, that's from a prior study.  That's not a study that these labs have done.  That's from the prior studies that have been achieved.  And that's what's going to use -- we're willing to use various values that have been pulled from these various studies to calculate a limit of quantification.  
      		We're just not certain that -- from a time standpoint, we're going to be able to get a particular lab to achieve a method detection limit that equals what's specified there; hence, going with the limit of quantification.  I don't know if, Kathy, you have anything else to add.  
      		MS. PLOTCKE:   So I think we may want to maybe go and talk about this if we can.  
      		MR. PENBERTHY:  Sure.  
      		MS. PLOTCKE:   But I want to make sure that we understand your position before we do that.  
      		MS. EISENREICH:  I do have a question.  So you're saying that you would use -- so we have an MDL from your literature, from all the literature -- we used the highest values we can find from your reported MDLs.  So you're saying you're okay with using three times that as the limit -- the LOQs; however, LOQs are typically calculated three times whatever MDL is achieved in the study, so to set a specific number is inappropriate.  And I think our point with the MDL had -- the one I'm looking at happens to be from biota, so three and a half nonograms per gram, you would be less than that, up to -- your MDLs -- you should be able to achieve an MDL that's up to three nanograms per based on all literature that's out there, the MDLs that have been reported.  
      		MR. DOYLE:  I understand what you're saying, but --
      		MS. PLOTCKE:  Yeah.  What we're saying is the way those were achieved is -- there were a lot of special precautions taken in place, and that's why we were originally going with the practical.  But what we're saying is we'll go based on what the lab is able to achieve, which is what you just said.  You determine the MDL, and then the LOQ is three times that.  But it's what they're able to achieve, not something that's cited in literature where special precautions and --
      		MS. EISENREICH:  Right.  The reason why these MDLs are in here are to give a maximum analytical benchmark essentially, so we want to make sure that the -- the analytical ability of the lab reaches a certain point.  
      		MS. FEHRENBACHER:  And let me also ask some clarifying questions on the work that you're planning to do to get these analytical laboratories up to speed because I'm quite concerned about that.  You have quite of bit of expertise with these chemicals and the precautions that folks need to take such as don't wear -- or don't use products that contain siloxane compounds, so it seems to me you must have a list of those precautions, some of which should be fairly straightforward.  And I'm assuming that you're going to share that information.  
      		MS. PLOTCKE:   And we already have with our candidates, yes.  
      		MS. FEHRENBACHER:  And that you must have some assurance that the samples that they're going to be collecting and analyzing will be of high quality.  And I'm also assuming that you're planning to have your experts from Dow or other laboratories that have that expertise to work with the laboratories and share their knowledge so that they understand that precaution.  So what are some of the special precautions you think will be so difficult that other laboratories won't be able to meet MDLs that have been widely published in the literature.  
      		MS. PLOTCKE:   So for example, some of the things that we've done, we may have a dedicated clean hood.  You know, asking a laboratory to the -- to have a dedicated clean area when they're a commercial laboratory is just challenging to do.  
      		So we're a smaller laboratory.  We have the ability to do that, but a commercial laboratory -- certainly we have asked them to have as much of these precautions put in place as possible, but they are a commercial laboratory, so, you know, there's a lot that goes on at those commercial laboratories.  
      		This is what we do, so it's just that level -- or for us, it's what we do.  This is what we do, these are our analyses that we do, and -- but for them, they're a commercial laboratory.  They do a variety of things.  We can't ask them to shut down their entire lab and do only this project, so you have to -- but we've put all the training in place.  
      		They know the requirements.  They will actually be tested after they're trained to ensure that they don't have contaminations.  We put provisions in the agreements that they would have to sign indicating, if they have samples, what's the ramifications and the consequences of that?  
      		So we've laid all of that out for them and we will do that and they will have that training, but it's just a level that we can go to in our laboratories because we're small groups.  This is what we do.  This is, you know, what we do every day.  That can impact that, that level.  
      		MS. McNETT:  And we've spent a decade or more getting to that level and determining where the sources of contamination can come from.  For example, we've analyzed air in different laboratories even within our site, and we'll have laboratories that have air samples of -- that contain D4 14 times higher than another laboratory, and it takes time to identify where that source of contamination is.  And on a schedule that this program is on, we can't guarantee that we're going to contract a laboratory that's not used to that to be able to identify all of their sources of contamination that are possible.  
      		MR. PENBERTHY:  I think we've tried to be pretty generous here because we picked the high end of the ranges of all the MDLs of studies that you've done.  And you know, I would think that if you couldn't achieve the method detection limits that are specified here, you'd have to come forward with a modification explaining that, and then describing what the MDL is and see if we would approve the modification.  But I think the MDLs we've picked are pretty reasonable.  I mean, they're what's required, you know, for risk assessment purposes to have meaningful data.  
      		MS. PLOTCKE:  Deb, did you want to make a comment?  Go ahead.
      		MS. McNETT:  I'm just going to go from the 1985 EPA document describing practical quantification limits and it describes this issue, I think, very well in that a practical quantification limit is proposed as the lowest level achievable among laboratories within specified limits during routine laboratory operations.  
      		The PQL is significant because different laboratories will produce different MDLs even though they're using the same analytical procedure, same instruments, and same matrices.  
      		MR. PENBERTHY:  That's why we picked an (inaudible) that you've already demonstrated.  
      		MS. McNETT:  Not in all cases are they on the high end of the range.  
      		MR. PENBERTHY:  All the ones here say they are.  
      		MS. McNETT:  For example, sediment, we've had a study where we had 8.5 nanograms per gram.  And you're proposing 3.7 nanograms per gram in this version.  
      		MR. PENBERTHY:  We picked studies that you've had published and we picked MDLs at the high-end range.  
      		MS. McNETT:  Right.  
      		MR. TOBIAS:  It was from
      one study.  That study had multiple MDLs.  We took the highest one out of the study.  So within that one study, there was the one we cited 3.7.  There was also, I believe, .4, as the other one.  And the 3.7 actually they thought was inflated, and there's a long explanation of why they thought it was inflated.  
      		MS. McNETT:  But there's also another study reference that has 8.5 nanograms per gram.  And those were different time periods and different levels of expertise for us to identify the contamination potential, and in that case it was a particular sample of Nitrogen gas that was used in a concentration step.  But what I'm saying is we can't control for all the variables and points of contamination potential.  
      		MS. PLOTCKE:   Debbie, maybe it would be good to state what you think the language should be.  
      		MS. McNETT:  Okay.  
      		MS. PLOTCKE:   And then we go, and then if you guys need to talk about it --
      		MS. McNETT:  I need to find it here.  I'm on Page 48 -- sorry, Page 30.  And this is a paragraph that says, the MDL.  And I'm going to start with the second to the last sentence where it states, "During method development the Knoerr 2013 analytical method for D4 I achieved a matrix-specific MDL of 0.037 in micrograms per liter and which shall be achieved for surface water testing."  
      		And then it goes on to say, "The specific level of detection shall be based on the LOQ, which shall be three times the MDL."  
      		I'm proposing -- or we are proposing that shall be achieved for surface water testing in that -- the end of the second to the last sentence be removed.  
      		MR. PENBERTHY:  So if we did that how would we know the precision of the data that we were getting?  You know, what are you agreeing to?  How do we know what you're agreeing to?  
      		MS. McNETT:  We will agree to report any level above the limit of quantification at three times -- in this case three times 0.037, which is 0.11.  
      		MR. LEWIS:  And you want that to each environmental matrices?  
      		MS. McNETT:  Right, changing the number appropriately, but --
      		MR. PENBERTHY:  But how do we know the actual sensitivity test that you're performing?  
      		MS. McNETT:  But you are agreeing to 0.037?  
      		MS. PLOTCKE:   Times three.  
      		MR. PENBERTHY:  They're agreeing to three times the MDL, whatever the hell that might be.  If they're not trying hard, it might be 5.3 or something.  
      		MS. PLOTCKE:   No.  We're okay with actually the MDLs that are specified in there.  
      		MR. THOMAS:  Yeah, we're okay with that number.  
      		MS. PLOTCKE:   So it's three times that would be the limit of quantification or the level of quantification.  
      		MR. PENBERTHY:  But I mean, if you have that -- if you can -- why wouldn't you report levels between the MDL and the LOQ?  It doesn't make sense.  
      		MS. PLOTCKE:   Because it's below the limit of quantification.  
      		MR. STAPLES:  And recall all of the MDLs that you are proposing are Dow Corning concentrations that have been developed over -- with a skill base over the course of many years.  We're talking about having a couple of months to train a laboratory to do the best that they can.  
      		MS. FEHRENBACHER:  So just to make sure that we understand you're okay with the MDL values that we've included, but you're only proposing to report values above the LOQs and any value below an LOQ would be a non-detect, would be reported as a non-detect.  So we would never know --
      		MS. PLOTCKE:  Less than LOQ.  
      		MS. HENRY:  But if you're agreeing to the predefined MDL and three times that, it's a fixed number.  
      		MR. STAPLES:  0.11 micrograms per liter.  
      		MS. FEHRENBACHER:  But really below the LOQ, you have really no assurance that -- you know, you're really drastically limiting our assurance of the values that you're analyzing and the accuracy, the accuracy of those values.  
      		MR. PENBERTHY:  And you're filtering the raw before you send it to us -- out.  I just don't understand that.  
      		MS. PLOTCKE:   I mean, what you're really saying is because there's that level of uncertainty.  There's a greater level of uncertainty in that number, and so it's below that limit of quantification.  That's all you're really saying.  
      		MR. PENBERTHY:  Why don't you just explain that in your report and report the raw data?  I mean, that's typically what people do in science, don't they?  
      		MS. PLOTCKE:   You could see it in multiple ways.  
      		MS. FEHRENBACHER:  That's our standard practice, is to record -- record the raw data with the MDL and the LOQ and not the (inaudible).  
      		MR. STAPLES:   And I will just say this as a nonanalytical chemist, but based on my long dialogs with analytical chemists is that we don't think we can train a lab that's not analyzed D4 and all these matrices in the months that we have to do to reach the Dow Corning method.  
      		MR. PENBERTHY:  I mean, if that's the case, then what you should do is file for a modification that explains what --
      		MR. THOMAS:  Can we take 10 or 15 minutes to just kind of talk a little bit about this and maybe this would be a good time for a break anyway?  
      		MR. PENBERTHY:  Sure.  (A recess was taken)
      		MR. THOMAS:  One thing we thought would be helpful for clarification, can you give us some sense for how the agency typically treats data that's reported below the LOQ?  
      		MR. PENBERTHY:  Well
      typically we report the LOQ -- well, I'll give you my understanding and then let (inaudible) tell you.  I think typically we report all of the raw data and then in these kinds of reports we certainly define the MDL and define the LOQ, and then we will define what actually is meant by a nondetect.  And so we wouldn't be filtering data like this, typically in a sound science basis, it would be unusual -- I think it would be very hard for us to agree to that kind of thing.  
      		MR. THOMAS:  But in terms of the subsequent analysis, does the -- do data above the LOQ get treated in the same manner as those that are below the LOQ?  You just report in all of the data and --
      		MR. PENBERTHY:  Right.  And then the arguments start, but the data speaks for themselves.  Why does -- what's the average?  What's a nondetect level?  But the data is there; it's present.  So we're going to need to have that.  I just don't think we could agree with your proposal where we would filter data and keep raw data out of the record of what's available.  
      		MR. THOMAS:  And I don't think that was the intent.  I think the idea was more to have some relative acknowledgement that the quality of those data are different.  Otherwise, there would be no point of having an LOQ.  
      		MR. PENBERTHY:  Right.  I understand that and we understand that there's difficulties -- maybe difficulty in meeting the MDLs, but we also know that Canada did a study and they met similar MDLs.  And so we know while this is a difficult issue -- it may be problematic -- it is something that's can be dealt with.  
      		And to the extent -- we can insert language into this ECA that says, we recognize achieving the MDL may be difficult and may require modification, if necessary.  But then if that was going to happen, we'd need to know precisely what has occurred and why (inaudible).  
      		MS. PLOTCKE:   You know, to be honest, our real concern is the ability of the labs to achieve these MDLs, and particularly in the time frame that we're dealing with.  As Deb said, we've been doing this for a decade, so we have a lot of learnings that -- yes, we will try to transfer as much as possible in the training and everything, but we are concerned.  
      		So we just want to make sure that there's a way to manage that concern.  So if there's a better way to do it by putting some language about -- what happens if they're not able to achieve it, then let's look at that.  
      		MR. PENBERTHY:  Right.  And we can add a sentence in here on the -- you know, along the lines of in the event the MDL for a specific media that's being measured couldn't be achieved, SEHSC will -- I don't know what the right verb is -- apply for a modification under the procedures and explain why EPA recognizes that this could be an issue.  
      		MR. DOYLE:  Conceptually, I understand (inaudible), but the key is we really want to make sure -- we'd like to capture, engage, recognition of the challenge of the issue.  So I think the language you used, I think, Ward, most recently when you said the agency recognizes that achieving these MDLs may present challenges.  
      		MR. PENBERTHY:  Okay.  So let me start putting a pen here.  
      		UNIDENTIFIED FEMALE:  Is that for Part 2?  
      		MR. PENBERTHY:  No.  I think we'll leave Part 2.  And this will be a sentence in each of the test standards 4 through 8, that EPA recognizes that laboratories may have difficulty obtaining -- achieving the as-specified MDL.  In this event -- what's the proper noun, test sponsors?  Test sponsors shall seek a modification -- shall seek an ECA
      modification as specified under -- 
      		MR. SELTZER:  40 C.F.R., 790.68.  
      		MR. ANDERSON:  Actually, I don't think it would be the principal test sponsor.  I think it would be the signatory company.  
      		MR. SELTZER:  You're right.  It's mutual companies.  We define it that way.  
      		MR. PENBERTHY:  Under 790.68.  And then we will repeat that in each -- repeat it in each of the test standards?
      		MR. THOMAS:  Yes.  
      		MS. PLOTCKE:   Do we want to specify the time or -- I mean, does it matter.  I mean, if we're not -- we will -- we can probably define the timing.  
      		MR. PENBERTHY:  If the scheduling gets off, you need to seek a modification.  
      		MS. PLOTCKE:   Anyway, so you're right.  Yeah, yeah, okay.  
      		MR. MAIT:  One leads to the other.  
      		MR. DOYLE:  The only challenge that I think would be the timing of the -- the timing of the modifications.  The 790.68 rule we have are prescriptive about the timing of submitting applications for schedule modifications.  
      		MR. PENBERTHY:  What's your concern?  
      		MR. DOYLE:  Well, I just want to make sure that the -- you know that -- depending upon -- I guess maybe it's a concern about nothing insomuch as depending upon when this happens in the process, whether we could meet the 60-day window, which, I guess, it shouldn't be a problem assuming these occur early on in the program, you know, during the validation portion, so maybe you think it's not a real concern.  I'm just looking at the timing provisions of 790.68.  
      		UNIDENTIFIED MALE:  Well, I think we're okay.  
      		MR. PENBERTHY:  I mean, this whole section agrees that it's sort of meant for the situation.  Do you have any input on this, on the 790?  
      		MR. DOYLE:  We're okay.  We just want to make sure that we thought through the timing.  I had to make sure that we weren't going to, you know, practically speaking, not have time to actually submit a request for modification.  
      		MR. MAIT:  The lab validation process is one of the first things we're going to (inaudible), so --
      		UNIDENTIFIED MALE:  Any bad news would be heard early.  
      		MR. THOMAS:  So I think we're Good on this one.  
      		MR. PENBERTHY:  60 days, right?  Okay, thank you.  
      		MR. THOMAS:  All right.  Thank you.  
      		So the next one was the collecting influent samples one residence time apart.  And this is Appendix -- this is either five or seven.  I think it's five.  The issue is the collection of influent and effluent samples for analysis of D4.  And the language specifies that the samples will be taken at least one wastewater treatment plant residence time apart, if practical.  
      		MR. DOYLE:  That's Appendix 4.  It's right before the Figure 1.  
      		MR. PENBERTHY:  Okay.  You understand that this is specific to influent and effluent, correct?  
      		MR. THOMAS:  Yes, correct, correct.  
      		MR. PENBERTHY:  Okay.  So what is the specific concern?
      		MR. THOMAS:  The specific concern is that the residence time at some POTWs could vary between hours and days.  And given the number of samples that need to be taken, you're talking -- you're substantially increasing the amount of time required to do sampling at each site, which is going to not allow us to achieve the 60-day goal.  
      		Plus, I think it's also unclear -- the value of this exercise relative to its need for doing a risk assessment.  
      		MR. PENBERTHY:  Yeah.  I'll explain that to you.  It's not directly related to the risk assessment, but it is related to the quality of the information generated by the testing.  
      		And by that, I mean, if there is time separation between the duplicates of influent and effluent, it allows us to understand -- if there's a potential for an artificially low measured concentration or is this really standard operating procedure.  And if -- and a standard operating condition or even a steady-state situation.  
      		So the greater the time separation between when the samples are taken, it would give us some assurance, if the levels are comparable, that there's nothing precarious going on there.  It's a typical situation.  So that was the intent, to make it sort of a quality check.  So we understand the residence is not going to be a long time, but we want to find the time dimension that gives us some assurance of the concern I just mentioned.  
      		MR. THOMAS:  If the concern has to do with ensuring that the plants are operating within the range of what would be normal operating conditions, I think we talked previously about collecting a whole number of data for each plant that would be included in the site-specific sampling plans.  And I think you would get information with respect to the --
      		MR. PENBERTHY:  I don't understand that.  
      		MR. DOYLE:  In Appendix 4, under establishment of appropriate time for sampling events.  It starts off, "At each site, two sampling events will be undertaken that are scheduled to be a minimum of three months apart and during normal plant operations and weather conditions.  Normal operating conditions will be established by consulting with the operator of each wastewater treatment plant, indirect and direct discharge facility.  The criteria or means that are used by the facilities to determine normal operating conditions will be documented in the site-specific sampling plans." Confirmation will be obtained that the subject facility is operating under normal conditions prior to commencing sampling at a given location."  
      		The intent in having all of that in there was precisely to get at making sure we're sampling, when, in fact, these sites are operating under normal conditions.  It just is a practical matter to have folks, you know, happening around multiple days and trying to meet --
      		MR. PENBERTHY:  What page is this on?  
      		MR. DOYLE:  That's on Page 22.  We're concerned between residence time, there could be -- we can have weather issues come up, a whole host of things.  And all of a sudden we're going to keep -- you know, you're going to invalidate your whole sort of sampling in a program there because you were going to be -- going to have such huge time gaps between the -- each individual sample potentially.  
      		It adds a lot of uncertainty to try to have multiple field crews out there working at all of these sites and getting the program to stay on schedule.  To me, you know, if anything, is seems to introduce more variability or uncertainty into the data as compared to, you know, cleaning it up.  
      		MR. MAIT:  And I would offer that we, you know, look at, let's say, a theoretical 14 sites within the time window in order to achieve only environmental conditions that we have to satisfy and the types of facilities, and the geographic thing.  This is quite a thing to choreograph to be sure we're meeting the window of 360 days.  
      		MR. PENBERTHY:  So your proposal is specifically in terms of the language of this?
      		MR. THOMAS:  Is to strike the language that -- so the language would just be stricken at -- there would be a period after at each influent and effluent location, seven grab samples -- and then there's a parenthetical -- two quality assurance samples, and five D4 study samples will be taken, period.  So the "...at least one wastewater treatment plant residence time apart, if practical" will be stricken.  
      		MR. PENBERTHY:  Do you have the assurances you need in other parts of that document?  
      		MR. NGUYEN:  We talking only a few samples, right.  We're only taking it for (inaudible).  We're not talking about the rest of the samples.  We're talking about the --
      		MR. THOMAS:  Right.  The issue here is not -- the number of samples.  So for example, if the residence time for a plant is two days and you're taking five samples, that's ten days.  So suppose on Day 3 it starts raining and something happens where -- you know, and you've got 14 wastewater treatment plants to duplicate that at, we've only got 360 days to complete the program.  There's concern that adding all of this time could substantially --
      		MR. NGUYEN:  But you don't have a time dimension in there.  I mean, you're just talking like two, three hours apart pretty much the same sample.  
      		MR. MAIT:  Are you prepared to extend the period?  If you want to go over 360 days, we could discuss that.  
      		MS. McNETT:  We also only have 14 days' stability for water samples too, so that needs to be kept in mind.  QC samples need to travel with all of the samples back to the laboratory.  
      		MR. THOMAS:  And it's also not clear -- I mean, Ward, what you just articulated was a need to have some assurance that the plant was operating within some normal range of operating conditions.  I'm not clear how the time element plays into that.  Because, again, Trent just articulated where in other parts of the document you're going to get all of that information.  
      		MR. PENBERTHY:  Right.  I guess if we saw a large difference between two samples taken a period of time apart, it would be an indication of what's going on, was it really -- was there an issue with how the plant is operating?  
      		MS. FEHRENBACHER:  We do have this clause in here, if practical.  Do you have -- I mean, is it possible to further define what you think is practical from your perspective?
      		MR. THOMAS:  Well, I think if practical means it's going to mean we won't be able to meet our 360-day time obligation, that it's impractical.  
      		MR. DOYLE:  In reaching out to the vendors who we reached out to already, you know, to execute the program for us in the constraints that we've been operating under, I mean, it's -- and this is the feedback we received.  It's an extremely aggressive -- I mean, that's the consistent feedback we've had from multiple well-respected vendors.  They said, we're just worried about -- you know, if it's already extremely aggressive and adding something that -- in our way of thinking is really kind of unrelated to doing a risk assessment into the mix and you think about it -- even for the client's purposes he's not going out there sampling all of these multiple days apart --
      		MR. MAIT:  From a strict project management standpoint, this introduces a high degree of project risk.  You know, because we've got to go back to the same places twice.  And the way this has been sort of organized, I mean, they're basically -- crews are going from one site, they do their work.  Hopefully, hopefully, the weather cooperates, and then they're sort of scheduled one right after the other and choreographed with the laboratory.  So you started adding this (inaudible) into there, the ability to control and manage the project from a time standpoint just goes out the window.  
      		MR. PENBERTHY:  All right.  So we're going to rely on the criteria means that are used by the facilities term operating conditions of the document.  
      		MR. DOYLE:  I mean, that's what's done all the time for compliance purposes.  
      		MR. PENBERTHY:  Okay, fair enough.  Next item.  
      		MR. THOMAS:  Okay.  The location of surface water, sediment, and biota sampling.  
      		MR. STAPLES:  Okay.  On the base subject of where samples are taken, the previous version of the ECA and the current version of the ECA both contain language specific to surface water that -- "Sampling for surface water shall be taken as reasonably close to the effluent outfall provided adequate mixing has occurred."  
      		And we spent a lot of time in a previous meeting talking about what adequate mixing has occurred.  And all the experts that we've talked to, that means the end of the mixing zone.  That's a location that -- which you will be assured that effluent has reached all dimensions of the surface water and the sediment and, hence, the fish and biota.  Now that's been entirely taken out, the concept of the mixing zone -- and it appears that you're now are focusing on the choice of sample collection from where the benthos are taken and working backwards from that.  
      		To us, that has an impractical nature in that effluent outfalls can hug the bottom and not mix with the water for some distance, but the nearest deposition zone may be before the end of the mixing zone.  Similarly, effluents can hug the shoreline for a considerable distance before it mixes with -- fully mixes with the water and a deposition zone that may be nearer to the outfall and the end of the mixing zone may never receive effluent, so we cannot --
      		MR. PENBERTHY:  So this is language in what, Appendix 8?  
      		MR. STAPLES:   Everything is tied to Appendix 8 now.  
      		MR. PENBERTHY:  I just want to make sure I locate the language.  So there seems to be a question about what does provided adequate mixing of the discharge and receiving water has occurred mean.  I know we're not really interested in getting into the whole mixing zone debate because we don't necessarily --
      		MR. STAPLES:  We feel --
      		MR. PENBERTHY:  Because I think that's a debatable criteria and what do you really mean by that.  
      		MR. STAPLES:   Well, we feel we can give you assurance that influent has reached --
      		MR. PENBERTHY:  How would you like this to read?  
      		MR. STAPLES:   Say that again, please.  
      		MR. PENBERTHY:  How would you you like this to read?  
      		MR. STAPLES:   Back the way it read in the last version.  
      		MR. DOYLE:  "At each site fish should be collected as close as reasonably possible to the discharge point provided adequate mixing of the discharge and receiving water has occurred.  To satisfy this requirement fish shall be collected at the end of the mixing zone in locations where fish may be expected to be captured."  
      		MR. THOMAS:  So we would use the language in the version previous to the one that was distributed a couple weeks ago.  
      		MR. PENBERTHY:  Okay.  And ours -- well, what you put in here was pretty much based on the Canadian approach, where they pretty much worked downstream from the outfall until they found enough benthic species in a sediment.  
      		MR. TOBIAS:  They just found sediment, actually.  They just wanted to find a spot with the sediment in the Canadian study.  
      		MR. PENBERTHY:  Okay.  Is the phrase "provided adequate mixing of the discharge", is that -- if we deleted that, does that --
      		MR. STAPLES:   Actually, we thought that to be a useful concept in that we then interpret it as the end of the mixing zone.  
      		MR. MAIT:  The strategy though conforms to at least -- with my experience with the water division here, it conforms to when you would do similar things or this kind of work.  That's where you would be, that's the whole purpose of defining it anyway, that you have -- you know, the environmental impact being noted in an area where the effluent really resides.  So you want to be sure that, you know, the species are there with what we're looking for.  
      		MR. STAPLES:   And right now it does say, "Sampling shall begin at the outfall and proceed downstream until adequate benthic organism samples are collected."   And we have no assurance that -- beginning at the outfall and proceeding downstream, where the effluent actually reaches the sediment.  
      		MR. PENBERTHY:  Yeah.  You have to keep going until you find it.  
      		MR. STAPLES:   Keep finding what, D4?  
      		MR. PENBERTHY:  No.  You start at the outfall and work downstream in the sediment until you find enough benthic organisms.  
      		MR. STAPLES:   With you we're not sure that D4 and -- effluent possibly containing D4 has been to that deposition zone unless we know the water is well mixed.  
      		MR. TOBIAS:  I think by sitting where the outfall is you can tell where the effluent is going.  You just described -- I mean, that's what the Canadians basically did. They used knowledge of the sites to study where D4 -- or best select, they thought, where the sediment.  
      		I guess the problem is that when I talk to the people at the regions of how mixing is defined, they say each state is to define their own technique for deciding whether to use them if they want to, and some don't.  And they can define it different ways, so I'm worried about giving different -- I don't know how -- what will come back after you go back and do these mixing zones.  Will you come back with twenty miles and -- I don't know what the outcome would be.  
      		It seems like -- I wanted something that was more determined in the document.  
      		MR. DOYLE:  And that's whether I think we didn't prescribe to use it in the EPA model to determine mixing zones, too.  We didn't --
      		MR. TOBIAS:  But there are many, and a state has to choose how to do it.  That's what the people at the regions told us.  I contacted people in Region 6 and other regions to ask what happened when you actually apply this -- because we devolve the program to the states -- and sometimes the states can choose not to accept the concept.  It's state by state.  
      		MR. MAIT:  Do you have a preferred technique for defining -- I mean, part of the problem is these operators of these POTWs have those defined areas.  So we need to be mindful of them being concerned about creating a new sampling point for regulatory purposes, which is not located at this point.  So I mean, that's why we choose to pick, select an EPA model that's already accepted if there's not one already defined.  
      		MR. STAPLES:  Yeah, I guess I'm not certain as to what your hesitation is.  Let's take your example.  If the mixing zone is 20 miles downstream, in that twenty miles you have no assurance that the effluent has touched the sediment you're collecting.  If you go to the end of the mixing zone, you have assurance that the surface water that's carrying the D4 has touched the sediment that you're going to sample.  And we're hoping that these mixing zones are very close to the facilities.  We don't know for sure.  We've only seen aerial photos of them, but --
      		MR. TOBIAS:  So you don't have any sample numbers from either a site survey or even a study?  
      		MR. STAPLES:   That will all be -- I believe that will all be presented in the Study Plan.  Is that the intention?  Yes.  So all the preliminary work that once we get to the facilities and work with the facilities on what they know about the mixing zone, if they don't, then we've talked to several teams who use EPA modeling and do mixing zones to make a determination.
      		MR. LEWIS:  Why do you focus on the end of the mixing zone?  Why do you think of that location?  
      		MR. STAPLES:   Because that's where the water body is well-mixed side to side, top to bottom.  
      		MS. FEHRENBACHER:  Now, I think our concern is the consistency in interpreting the mixing zone and our assurance that samples that we -- that will be collected there will meet our needs.  
      		MR. PENBERTHY:  So how about this?  How about we just delete that first sentence and say benthic sampling shall be begin at the outfall and proceed downstream until adequate benthic organism samples are obtained?  Would you be happy with that, and then just get rid of the mixing issue altogether?  
      		MR. TOBIAS:  I don't know if I like that.  
      		MR. PENBERTHY:  What's that?  
      		MR. STAPLES:   That's less certain than before.  
      		UNIDENTIFIED FEMALE:  Yeah.  
      		MR. TOBIAS:  That's why the previous version of our standard started with where is the water well-mixed, because it's the water that's carried -- the effluent carried to the water and the water carries it to the sediment.  And if we sample the water and fish from the place we know is well-mixed, we'll know that the sediment -- the nearest deposition zones will also have received effluent.  
      		MR. PENBERTHY:  Yeah, but if you go to the end of the mixing zone, that's not going to be necessary, the location of your minimum concentration D4, which partitions to the sediment, right?  That will be essentially your lowest concentration until the surface water at least, right?  So if you did that at the end of the mixing zone, you would get the lowest possible level of the sediment, correct?  
      		MR. STAPLES:   I have no idea.  
      		MS. PLOTCKE:   Your highest concentrations, you're going to be in your deposition zones.  So if that's what you're trying to target for the sediment, but what Charles is -- you're right, you might have a higher concentration coming out of an effluent, but that's not reflective of what's going to impact the biology, which is really the sediment.  
      		MR. PENBERTHY:  Yeah, but the mixing zone is not what's really relevant.  It's where D4 ends up.
      		MS. PLOTCKE:   And that's your deposition zone.  And that's where you're going to be in equilibrium in mixture within your water and biota and sediment.  
      		MR. STAPLES:   The nearest deposition zone may be, for instance, halfway across the river but only ten feet downstream of the outfall, but it may never receive effluent.  
      		MS. PLOTCKE:   So the real challenge is defining where it's well-mixed.  Whether you call it -- whether you use models to do a mixing zone or you say (inaudible).  
      		MR. PENBERTHY:  Well, if it's well-mixed, where is the maximum is more of the issue.  
      		MS. PLOTCKE:   And that's really -- once you define where it's well-mixed and then look to your deposition zone, that's where your maximum is going to be in your sediment.  But what you're concerned about is how well can you really characterize a mixing zone with all the different models and the inconsistencies in it.  
      		MR. STAPLES:  And I guess my concern is more of collecting samples of water and sediment that I have assurance of having effluent in them.  
      		MR. PENBERTHY:  Can we go over again -- what's your suggestion again?
      		MR. THOMAS:  To go back to the language in the previous version -- the previous draft.  
      		MR. PENBERTHY:  No one would agree with that, so --
      		MS. PLOTCKE:   I'm wondering if there's some qualifications we can put in there like we have with some of the others because I understand, yes, you're right there's multiple models that's being used.  And what we're asking the contractor to do is do the best job they can of defining that mixing zone so we can achieve what Charles is saying we want to achieve, but we realize there could be some inconsistency.  Maybe if we -- you know, are less practical -- they're going to do the best job they're going to to do.  
      		MR. PENBERTHY:  We're just trying to get the -- to have something here that's reasonably understandable and clear.  
      		MS. PLOTCKE:   And the other thing, again, this comes back to it will be documented as to sort of the reconnaissance up front of how that's going to be determined.  
      		MS. FEHRENBACHER:  So I think -- I'm trying to identify the criteria that we're interested in, we want a well-mixed sediment, we want the maximum concentration, we want presence of biota, and we want water and sediment samples collected at that same area.  And I think we're not confident that having generic language like mixing zone with different models and different interpretations will meet all of those criteria.  And the language that we developed will meet those criteria and give us assurance that the samples that you're collecting will meet our needs.  
      		MR. STAPLES:   And I respectfully disagree.  We cannot predict.  We cannot define where the maximum concentration will be unless we go out and hunt for it, and that's not what this program is about.  
      		MS. PLOTCKE:   So let's look at the language.  Maybe if we do that -- so you have at each site benthic organisms shall be collected as close as reasonably possible to the effluent outfall providing an adequate mixing of the discharge and receiving water has occurred.  I think we all agree on that, right?  Whether you call it a mixing zone, that's what we're trying to achieve.  So we agree on that.  
      		I think the next part is the sampling shall begin at the outfall and proceed downstream -- that's, I think, where you're concerned.  You could start sampling where you don't have well-mixing.  So maybe it's the wording there that we have to change, that it occurs after we have identified what we believe is the well-mixed area.  If you don't want to call it a mixing zone, I think it's fine.  
      		MR. MAIT:  We can take the word out, I mean -- understood.  
      		MR. DOYLE:  Well, as it stands right now -- because sort of how it stands, there's two sentences there.  They seem to be inconsistent or too different.  
      		MR. LEWIS:  Sampling shall begin where adequate mixing occurs.  I mean, that's what you're basically looking at to compare with what you have in the previous sample?  
      		MS. FEHRENBACHER:  Well, so maybe what we're talking about is modifying that first statement to include -- so I think what we want is adequate benthic organism sample mass, perhaps, incorporating somehow into that first statement.  
      		MR. DOYLE:  Well, I think the first statement is good.  It's the second statement that needs to be tweaked because the concern -- if you read the first statement, we perfectly agree with that.  It says you're going to -- as close as reasonably possible providing adequate mixing has occurred.  So that's exactly spot on with what we like to do.  It's that second sentence where it says -- it's like notwithstanding what we just said, sampling shall begin at the outfall.  
      		MR. PENBERTHY:  So how about this?  Let go -- take the first sentence and then delete sampling -- continue that sentence into the second sentence, but delete sampling shall begin at the outfall and just say, and proceed until adequate benthic organism sample masses have been obtained.  I'll just read the sentence.  
      		At each site, benthic organisms shall be collected as close as reasonably possible to the effluent outfall provided adequate mixing of the discharge and receiving water has occurred and proceed downstream until adequate benthic organism sampling masses are obtained.  Is that --
      		MS. PLOTCKE:  Yeah.  
      		MR. DOYLE:  Yes.  
      		MR. THOMAS:  Yes.  
      		MS. EISENREICH:  So the question is that adequate is defined.  
      		MR. PENBERTHY:  All right.  So can we work on that now?  
      		MS. FEHRENBACHER:  So wait, going back to what you said earlier, each one of the sampling plans will include for each site the specificities around this, how adequate mixing will be determined?  
      		MS. PLOTCKE:   Yeah.  I mean, that's what our contractor will have to do.  Now, we had originally specified determining mixing zones, but they will use some method in their reconnaissance to identify where that adequate mixing occurs.  
      		MS. FEHRENBACHER:  It can be slightly different, at each site.  
      		MS. PLOTCKE:   Yeah.  
      		MR. PENBERTHY:  So can we add a sentence after --
      		MS. FEHRENBACHER:  And we reviewed these ahead.  
      		MR. PENBERTHY:  I propose that the study -- each site-specific sampling plan will --
      		MS. PLOTCKE:   Document.  
      		MR. PENBERTHY:  -- document the location of the point at which well-mixed -- the effluent and the stream are well-mixed?  
      		MS. PLOTCKE:  Yeah, I mean, it's going to have that identified, but --
      		MR. PENBERTHY:  Well, each Study Plan has a site sampling plan for each site, and each one of those site-specific sampling plans would identify where the effluent and receiving stream are well-mixed.  
      		Could you give us five minutes?  (A recess was taken)
      		MR. PENBERTHY:  All right.  Good to go.  So here's what the -- language we propose.  It's a lot of what we already discussed, so it should be at least fresh here.  
      		The sentence would read, "At each site benthic organism shall be collected as close as reasonably possible to the effluent outfall provided adequate mixing of the discharge and receiving water has occurred and where adequate benthic organism sample masses are obtained."  
      		We'll read it as a sentence similar to what I already mentioned.  "Each site-specific sampling plan will identify where the effluent and receiving streams are well-mixed and the method used to determine this."  
      		MR. DOYLE:  That works.  
      		MS. PLOTCKE:   Yeah, yeah.  
      		MR. PENBERTHY:  Okay.  Take off the (inaudible).  
      		MR. STAPLES:   I'm not a lawyer, but is adequate and well the same thing?  
      		MR. PENBERTHY:  Pardon me?  
      		MR. STAPLES:   Are the words adequate and well-mixed -- mean the same thing?  
      		MR. PENBERTHY:  Are adequately mixed, okay.  Good point.  You are a lawyer.  You could work at EPA.  No, that's a good catch.  Thank you.  Consistency in language is always helpful.  
      		MR. STAPLES:   Would there been a continuing sentence then?  
      		MR. PENBERTHY:  Yeah.  "At each site fish, water, and sediment will also be collected at the same location."  
      		MR. STAPLES:   And that same location is the place where it's adequately mixed?  Is that understood?  
      		MR. PENBERTHY:  The location is where you pick up benthic organisms.  
      		MR. STAPLES:   That might be a kilometer long.  Our intention would be to take it as close as possible to that first location of adequate mixing, water and fish and sediment.  
      		MR. DOYLE:  In other words, the starting point of where you collect the benthic species would be the location where we would be collecting the fish and the --
      		MR. STAPLES:  Surface water, fish --
      		MR. PENBERTHY:  So just help me review here.  If what it says is, "At each site fish, surface water and sediment shall also be collected at the same location,"  is that unclear?  
      		MR. STAPLES:   As long as the same location is the -- that place where it's adequately mixed.  
      		MR. DOYLE:  It's got to be done with the criteria.  
      		MS. FEHRENBACHER:  Right.  It used to be all of the criteria completely mixed and as close as reasonably possible to the effluent, sufficient benthic organisms sample masses and have --
      		MR. PENBERTHY:  You know, if you want we can just say, at each site fish, surface water, and sediment shall be collected at the same location as benthic organisms (inaudible).  
      		MR. STAPLES:   I'm just saying that benthic organisms may be collected over a long scattered range, and wouldn't it be -- our intention, I'm assuming, and your intention is we would collect water, sediment, and fish as close to the outfall as possible, so at where it's adequately mixed.  
      		MR. PENBERTHY:  Well, you want them right where you picked up the benthic organisms.  
      		MR. STAPLES:   The first benthic organisms.  
      		MS. PLOTCKE:   I think it's fine saying -- I mean, it's going to be -- it can be potentially over a scattered location, but you're also -- I mean, that's still the same location you're going to collect.  
      		MR. DOYLE:  It actually gives some flexibility.  I think it's reasonable to take Ward's, language.  It's fine.  
      		MR. STAPLES:   Okay.  I just want to be sure we can tell a contractor where to sample.  
      		MS. EISENREICH:  I do have a question.  Why would you think that there's a possibility that it would take a kilometer to collect benthic organisms if it's already at a well-mixed place where there's -- you know, where it's going to be covered in the sediment?  
      		If you have sediment, you're going to have sediment curves and you would just -- in my mind, you would take a grab sample, and then obviously -- or likely you're not going to get enough for analysis.  So you would move a little to the left or a little to the right, but you wouldn't have to necessarily go a kilometer down the stream. 
      		MR. STAPLES:   We're very hopeful that that's the case.  Dow Corning has considerable experience collecting benthic organisms.  They're the hardest thing to collect in the field, so we want to have the flexibility.  If you look at some of the receiving waters that we proposed in the documentation, they're pretty small and narrow.  It might take some distance to get the mass we need to do the analyses.  
      		MR. PENBERTHY:  Okay.  So how about we just say --
      		MR. DOYLE:  I think it's covered.  
      		MS. PLOTCKE:   I think we've covered it.  
      		MR. THOMAS:  It's fine.  
      		MS. HENRY:   Again, we're doing all of this planning in the abstract and your plan, if it is a space like that where it's very small or whatever you can anticipate, I think you could describe that for our review.  
      		MS. PLOTCKE:   Again, when you're doing all the reconnaissance up front, you're going to have ideas of what you're dealing with.  
      		MR. PENBERTHY:  Okay.  Next item.  
      		MR. THOMAS:  We've got a couple more things in that same section.  Okay.  Go ahead, Charles.  
      		MR. STAPLES:   These are hopefully lesser.  On Page 44 and 47 -- on Page 44, the third line above Figure 5, it talks about the retained samples retained in a refrigerator.  This is a change from the last draft, which said that they'd be in a freezer.  We are going to freeze them out in the field and hold it in the laboratory until it's used, so --
      		MR. PENBERTHY:  But you want a freezer, retain in a freezer?  
      		MR. STAPLES:   Unless there was some --
      		MR. PENBERTHY:  I don't think so.  
      		MR. STAPLES:   Okay.  
      		MR. PENBERTHY:  That's fine.  
      		MR. STAPLES:   That's also on Page 47.  
      		MR. PENBERTHY:  Good catch.  
      		MR. STAPLES:   The third line below Figure 6.  
      		MR. PENBERTHY:  Okay.  
      		MR. STAPLES:   And then the concept of using commercially-acquired benthic species as a surrogate field blank.  In the previous version of the ECA, the test standards suggested employing the ground-up rainbow trout that we obtain from a known supplier, and they're known to have very low or no detectable D4 concentrations.  
      		Dow Corning has worked with that lab for a considerable time in obtaining those samples, and we have proposed using the ground-up fish tissue for both as surrogate blanks in the fish collection and in the benthic collection.  You're now proposing really a new requirement of using commercial sources of benthic invertebrates, which Dow Corning has no experience with in terms of finding a supplier that's going to have D4-free invertebrates.  
      		MS. McNETT:  Especially in sufficient quantities.  
      		MR. STAPLES:   In sufficient quantities.  Since the tissue will be ground and then placed in an identical kind of container and opened during processing, we'd prefer to use the --
      		MR. PENBERTHY:  What page is this?  
      		MR. STAPLES:   Page 45.  I believe it's Page 45.  
      		MR. PENBERTHY:  Right here.  I got it, third paragraph.  
      		MR. STAPLES: Third paragraph.  
      		MR. PENBERTHY:  I mean, my understanding of why we changed this is that there are commercial sources of benthic organisms.  It could be just -- is that correct?
      		MR. THOMAS:  I think the concern is about whether those could be assured that they're D4 free -- and I think that's the challenge in finding -- at least that's been the experience.  
      		MS. PLOTCKE:   Well, again, it's starting over.  It's something new in ensuring that you find that source, you can get adequate source, we know this is something that works and is ready to go.  
      		MS. McNETT:  We will work with our suppliers and make sure that they're not contaminating the fish.  We can't be assured of that in a new supplier of benthic organisms that don't have scales on the outside to protect them from taking up some D4.  
      		MR. STAPLES:  (Conferring with associates).  
      		MS. FEHRENBACHER:  (Conferring with associates).  
      		MS. HENRY:  (Conferring with associates).  
      		MS. McNETT:  (Conferring with associates).  
      		MR. PENBERTHY:  Everyone -- why don't you explain that that's fair, and then we'll try to work this?  
      		MS. POLLACK:  Well, the question is what prompted it and why would you use organisms that -- regardless of whether they're free from D4 samples compared to other organisms that are different; so the idea of why would you compare apples to oranges?  So there could be a way to -- if you have this supplier -- if they're ensuring there are no D4 samples in the rainbow trout, (inaudible) or suppliers. 
      		MS. POLLACK:  To answer your first question, this is for QC out in the field to ensure there's no contamination, so it's not -- you know, we're not trying to compare apples and oranges.  This is just a check on that.  
      		MR. PENBERTHY:  It's different tissues.  
      		MS. PLOTCKE:   It's different tissues, but it is still tissue that would allow you to capture.  And it's actually one of the more efficient ones we've seen that will tell you whether you have contamination or not.  If you could go out and potentially look at something that is very similar from a matrix standpoint.  
      		So if you wanted to do that, then we can add six months onto the timeline because we'd have to re-evaluate sources and ensure that that -- you could get that kind of sample and ensure that it's free of D4.  So you could do that check in the field.  It would take time.  This is already proven.  We use it all the time on every one of our samplings, and so does Norway and others as well, so --
      		MS. HENRY:   You know, she's the expert at the whole smash it, extract it, (inaudible).  So how similar is the mass on (inaudible) depending extraction and all?  Is it virtually identical depending on the tissue?  
      		MS. PLOTCKE:   Yes.  
      		MS. HENRY:   So for any fish species and the benthic species, and even, I guess, like the bank that were done on, and all that, the extraction method is the same?  
      		MS. PLOTCKE:   Yeah.  
      		MS. HENRY:   If it was dry or something, grind it, extract it, and putting it --
      		MR. PENBERTHY:  So basically, it becomes an issue of whether the tissue has the same absorption; is that correct?  
      		 MS. PLOTCKE:  It actually -- this would probably even have more.  
      		MS. HENRY:   There's introduction in that D4 in that old process.  
      		MS. PLOTCKE:  Yeah.  It's just -- it's a check on the potential for contamination.  
      		MS. EISENREICH:  Right.  And we understand that.  I mean, that's not the question.  The question is whether fish tissue acts like worm tissue or invertebrate tissue.  And if they would, you know, essentially through the process -- through the process of processing, accumulate the same way and the same rate and the same --
      		MS. PLOTCKE:   I mean, it would be pretty similar.  In fact, it could be probably even more, so that is why it's a nice way to actually check whether you have some potential source that's there.  
      		MS. EISENREICH:  But how would you guarantee that, I guess, if you have not used the invertebrate?  
      		MS. PLOTCKE:   You could look at the content, like the fat content of the tissue and --
      		MS. EISENREICH:  So you would use a lipid?  
      		MS. PLOTCKE:   It's a lipid, yeah.  It's going to be driven by the lipid felicity of it.  
      		MR. PENBERTHY:  All right.  We'll go with the fish.  So is that -- I need to know the specific changes.  Just that one sentence?  
      		MS. EISENREICH:  It's kind of (inaudible).  
      		MS. PLOTCKE:   Yeah, throughout.  
      		MS. EISENREICH:  Change the subject.  
      		MR. PENBERTHY:  Well, wait a minute.  This is the benthic.  So basically what we use -- in the blank, we use rainbow trout, right?  
      		MR. STAPLES:   Ground rainbow trout tissue just as done in fish.  
      		MR. PENBERTHY:  Is it any other place besides that paragraph?  
      		MR. STAPLES:   Is it in the figure?  
      		MS. EISENREICH:  Yes, it's in the figure.  
      		MR. PENBERTHY:  Okay.  So we'll say rainbow trout in the -- all the QA samples; is that correct?  
      		MS. HENRY:   Just to be clear, you go out to some hatchery that you have already established has whatever food and all that jazz and they are pretty clean.  You just grab from that every time.  It really has nothing to do with the D4 at all.  
      		MS. PLOTCKE:   Right.  
      		MR. PENBERTHY:  So basically every time you have ground benthic invertebrates in that QA paragraph, we'll change it to rainbow trout.  
      		MR. STAPLES:   I see in at least two paragraphs that we were just working in, two separate paragraphs --
      		MR. PENBERTHY:  Okay.  Can you just point those out to me, so I know where you are.  
      		MR. STAPLES:   On page 45.  The second paragraph, "It should be noted..." -- middle sentence -- "...benthic invertebrate tissue from benthic organisms purchased."  
      		MR. PENBERTHY:  And then the following paragraph, correct?  
      		MR. STAPLES:   The following paragraph.  
      		MR. PENBERTHY:  Anywhere else?  
      		MS. FEHRENBACHER:  It's a couple times in that paragraph.  
      		MR. PENBERTHY:  Oh, yeah, definitely in that third paragraph.  We'll do a search, and then we'll try to do our best on that.  I just --
      		MR. STAPLES:   Okay.  And then the figure with that we talked about.  
      		MR. PENBERTHY:  Okay.  So are we finished that that intent?  
      		MR. STAPLES:   No.  There's one more thing.  It's a minor thing on Page 46, last paragraph.  
      		MR. PENBERTHY:  Mm-hmm.  
      		MR. THOMAS:  The third line begins, "Three of the samples shall be divided into three parts."  And this is a description -- this paragraph describes that fish are collected and basically packaged.  The samples shall be divided into three parts.  
      		We understand that samples need to be split and lipid contents and so forth, but the way this is said is that this is basically done in the field.  It is suggestive of being done if the field.  In the field the fish will actually be bagged and frozen, and all the processing, dividing, and so forth occurs in the laboratory.  
      		MR. PENBERTHY:  So how would you want this written?  
      		MR. STAPLES:   So the second sentence could read something to the effect of for each of the two species, five individual fish or composited samples shall be prepared and frozen.  In the laboratory fish samples are thawed, homogenized, and divided into three parts.  
      		MR. PENBERTHY:  Okay.  Hold on.  Laboratory --
      		MR. STAPLES:   I guess three of the fish samples shall be thawed, homogenized, and divided into three parts.  
      		MR. PENBERTHY:  Thawed, homogenized, and divided into three parts, okay.  
      		MR. PENBERTHY:  Does that meet your needs?  
      		MR. STAPLES:   Yes.  
      		MR. PENBERTHY:  Okay.  
      		MR. STAPLES:   That was a minor methodological clarity.  
      		MR. PENBERTHY:  Yes.  I can appreciate that.  That's good, attention to detail.  
      		MR. PENBERTHY:  Are we done with 10?
      		MR. THOMAS:  We are done with 10  
      		MR. PENBERTHY:  Okay.  Now onto Appendix 6.  
      		MR. THOMAS:  Yes.  Appendix 6, this is the location of biosolid sampling.  I think we can be comfortable with the current language with one change.  This has to do with the location of the biosolid sampling.  
      		UNIDENTIFIED MALE:  Can I have the page?
      		MR. THOMAS:  This is page -- what page is this?  
      		MR. PENBERTHY:  It's Page 33.  
      		MR. THOMAS:  Okay.  The sentence starts, "At each site, the chosen location of biosolid sampling shall be immediately after dewatering before onsite storage and shallbe established in site-specific sampling plan."  We would just add "as practicable".  
      		MR. PENBERTHY:  Okay.  That's fine.  
      		MR. THOMAS:  All right.  Analytical methods.  
      		MR. PENBERTHY:  That's on twelve?
      		MR. THOMAS:  Twelve, yes.  
      		MR. PENBERTHY:  Oh, wow.  
      		MR. STAPLES:   This is in a couple of places, so let me kind of generically explain the issue, and then we'll go to the specific text.  In terms of handling and processing in the field the sediment and then extending that to the biosolid, which we can consider similar, we had originally cited approaches used by Powell 2009 reference.  You've changed that to Powell 2010 and changed the handling in the field.  Now the handling in the field is you collect the sediment, put it in a jar, and cover it with water and seal it.  
      		It's been Dow Corning's experience that that actually introduces error, and so they've abandoned that, and so we would like to go back to the handling method, which is put the sediment -- collect the sediment with the dredge or whatever, put it in a bag, and put it in the sample, just as we had it in the previous text.  That's also the method that is now in the Knoerr 2012 method.  
      		MR. PENBERTHY:  Okay.  Now, we changed the method.  It was based on the MDL, correct?  
      		MR. TOBIAS:  Well, it was just to the other study.  I'm surprised you say it introduces greater error when it looks like they get better results in the paper.  
      		MS. PLOTCKE:   It's a stability issue.  It actually creates -- it's less stable.  The samples are less stable that way.  
      		MR. TOBIAS:  When you put them in a plastic baggy, they're more stable than when you put them in a glass --
      		MS. PLOTCKE:   Jar with the water overlay.  
      		MR. TOBIAS:  -- jar.  Or without the water overlay.  If you put it in a glass jar, is it the water you're saying or is it -- it just read funny to me that you think a plastic baggy would be better than a glass jar where you tie down the top, and then put tape over around it instead of a plastic bag --
      		MR. PENBERTHY:  Could you show me the language we're talking about?  
      		MS. McNETT:  We homogenize the sediment sample in a plastic bag and transfer is to a glass jar, but you do not lay water over it.  
      		MR. TOBIAS:  Okay.  So -- but why is the plastic bag important.  That seems like an odd step to introduce, why not -- like in the paper, it seemed like the clearing path was just to put it in a glass cylinder.  
      		MS. McNETT:  Because you have a very large sample of sediment that you've taken from a core, I mean, relatively large that you have to homogenize it and get homogeneous samples that of the jar that are about this size.  
      		MR. TOBIAS:  Sure.  You use the plastic as an intermediate to do that?  
      		MS. McNETT:  Yes.  
      		MR. TOBIAS:  Okay.  
      		MS. McNETT:  A plastic bag, you know, very briefly.  It's not stored in there for an extended period of time.  
      		MR. TOBIAS:  Okay.  
      		MS. McNETT:  To mix up the sediment in the field without a whole lot of spatulas or anything.  You can just squeeze it, and then take homogeneous sediment samples and place them in glass jars.  
      		MR. TOBIAS:  Okay.  
      		MR. PENBERTHY:  I need to know what to do --
      		MR. TOBIAS:  They just want to change it back to how it was before, and the description of intent.  
      		MR. PENBERTHY:  Yeah, but I don't know what that was.  So we're on page 38, I take it, second paragraph from the bottom, correct?  
      		MR. DOYLE:  Page 39, right?  
      		MR. STAPLES:   I had it on page 39 directly above Figure 4.  
      		MR. PENBERTHY:  Okay.  We'll follow what you want it to read.  2009?  
      		MR. STAPLES:   The 2009 reference.  
      		MR. PENBERTHY:  And then we'll have to add 2009 -- is that still in the references?  It's not in the references.  
      		MS. McNETT:  Do you want the last one you cited?  I didn't hear what you said.  That's what we used in the (inaudible) years.  
      		MR. STAPLES:   Oh, okay, yes.  The Powell 2009 reference is the method for sediment -- handling these sediments, which involves collection of it, placing the baggies, homogenizing it.  That has been adapted to the Knoerr 2012 biosolids method.  
      		MR. PENBERTHY:  Okay.  So read to me that sentence, how it's supposed to read.  You know, I'm up to sample collection, storage, and preparation will follow Powell 2009.  What does it say after that?  What should it state?  
      		MR. LEWIS:  That's the prior language, it's a little bit more collaborative.  
      		MR. TOBIAS:  Placed in a plastic bag?  Is that what you --
      		MR. STAPLES:   With each sample being placed --
      		MS. McNETT:  Placed in a plastic bag, homogenized, and transferred to a glass jar.  
      		MR. STAPLES:   We actually had it as three sentences, but --
      		MR. PENBERTHY:  Okay.  I'm going to read it back to you.  Okay.  This is what I have:  "Sample collections stored in preparation will follow Powell 2009 with each sample being placed in a plastic bag, homogenized, and placed directly into a glass jar covered..." -- shall I delete covered with water?  
      		MS. PLOTCKE:   Yes, please.  
      		MR. PENBERTHY:  And then capped?  
      		MS. PLOTCKE:   Yes, it will be capped.  
      		MR. PENBERTHY:  Okay.  And then we'll have to add 2009 Powell to the reference list because it's not there now.  
      		MR. STAPLES:  You still have the previous version.  
      		MR. PENBERTHY:  So is that Number 12 we're done with? 
      		MR. STAPLES:   Well, does that also translate into biosolids?  
      		MR. PENBERTHY:  Does that correct everything?  Is there any other place I need to change?  
      		MR. LEWIS:  And that's Powell and Woodburn?  
      		MR. STAPLES:   Powell and Woodburn 2009, yes.  
      		MR. LEWIS:  That's what I thought it was, yes.  
      		MR. PENBERTHY:  Okay.  Where else does this need to --
      		MR. LEWIS:  It is in Appendix 6 as well, 6 and 7.  
      		MR. PENBERTHY:  Appendix 6.  So I've got to say reference language -- okay.  
      		MR. STAPLES:   Did you find the location for that?  
      		MR. PENBERTHY:  Is it Page 34?  Is that right?  
      		MR. DOYLE:  That where I have it, on Page 34.  
      		MR. PENBERTHY:  Okay.  Tell me exactly what needs to be changed. 
      		MR. DOYLE:  So that's where I have the policy that Powell 2010 and Woodburn 2009.  
      		MR. PENBERTHY:  I don't see it here.  
      		MR. DOYLE:  It's right here.  During each sampling event biosolids at a given site, all quality assurance sampling prepared and D4 samples been prepared as described in Powell.  Should we change Powell and Woodburn 2009?  That's right above the Figure 3.  
      		MR. PENBERTHY:  Okay.  So I'll just -- for my purposes, I'll just say, "See Page 39."  
      		MR. TOBIAS:  And this one didn't have (inaudible) of a plastic bag in there.  
      		MR. PENBERTHY:  Well, is this going to be exactly as its --
      		MR. TOBIAS:  In one of the Appendices it was explicitly put in; in the other, it wasn't.  
      		MR. PENBERTHY:  Okay.  Well, let's eliminate the confusion here.  Is this sentence going to read exactly like Page 39 or not?  
      		MR. STAPLES:   It could be as simple a change as changing from Powell 2010 to Powell 2009.  
      		MR. PENBERTHY:  Okay.  We'll do that.  Fair enough.  
      		MS. McNETT:  That's fine.  
      		MR. PENBERTHY:  Well, what we have now is we're just going to change Powell 2009 on Page 34 to Powell and Woodburn 2009.  
      		MS. McNETT:  That's fine.  
      		MR. PENBERTHY:  Okay.  Do we have the reference there in that?  Okay.  Are we there?
      		MR. THOMAS:  A couple more things.  We're finished on that one.  
      		MR. PENBERTHY:  We're finished with 12?
      		MR. THOMAS:  Yes, we've finished 12.  
      		MR. PENBERTHY:  Okay.  
      		MR. THOMAS:  Thirteen, selection of fish species.  We can agree to the current text with one addition.  We're on Appendix 8, Page 46.  
      		The sentence reads, "Biota samples shall include benthic species collected in sediment of the two receiving water bodies and two species of fish."  We would add "if practicable of different trophic guilds in the receiving water body."  
      		MR. PENBERTHY:  Okay.  This is in the third paragraph?
      		MR. THOMAS:  My page numbers might be different than --
      		MS. PLOTCKE:   Yeah.  
      		MR. THOMAS:  No, it's already there.  Okay, then we're good.  
      		MR. PENBERTHY:  Okay.  We don't need a change there?  
      		MS. PLOTCKE:   No.  
      		MR. THOMAS:  No it's already there.  
      		MR. PENBERTHY:  That's what I thought.  
      		MR. LEWIS:  It's on Page 46 at the third paragraph, "Two species of fish from different trophic guilds, collected in sufficient mass such that individual or composite samples can be prepared for analysis of D4, shall be selected."  
      		MR. PENBERTHY:  No, no, no, keep going.  Do we need a change or not?
      		MR. THOMAS:  Well, we've got some versions where it's there and -- it's there, right?  
      		MR. STAPLES:   The second place where this is discussed is on Page 46 of that standard, and it does not have the words, "if practicable".  
      		MR. THOMAS:  Yeah.  We want to add it to do test standards.  
      		MR. PENBERTHY:  Okay.  Where does it first show up?  
      		MR. STAPLES:   The first page of that standard, requirements for sampling biota.  
      		MR. PENBERTHY:  Okay.  
      		MR. DOYLE:  It's okay there.  It will be consistent with those places.  
      		MR. PENBERTHY:  Okay, I got it all right.  
      		MR. THOMAS:  So just a couple of other things I want to note.  These aren't related necessarily for the language of the ECA.  One -- and we talked about this before -- with respect to the draft order, we'd very much appreciate having an opportunity to take a look at it prior to the publication, in particular, the language associated with D4 and how it's characterized and so forth.  
      		MR. PENBERTHY:  Okay.  Hold on.  So this is the notice of availability of the ECA.  You know it would be highly unusual for EPA to coauthor --
      		MR. THOMAS:  We're not asking to coauthor.  We'd just like to take a look at it.  
      		MR. DOYLE:  The premises for the concern, Ward, is when the original federal register came out announcing the whole ECA negotiation process, whether it was descriptions of D4 or D5, we had some concerns about how the chemicals were characterized there in terms of representing potential hazards and so forth.  And that's why we want to make sure -- we were curious about --
      		MR. PENBERTHY:  Well, tell me what you were concerned about.  I mean, you're talking about the notice of selecting a -- seeking interested parties?  
      		MR. THOMAS:  The description -- let me -- I mean, I would have to look at the notice.  
      		MR. PENBERTHY:  I mean, basically that expressed EPA's opinion.  It doesn't express your opinion.  I mean, I don't think we would necessarily extend any -- well, first of all, the notice of availability is a pretty benign thing.  It's just this is D4.  This is what we're doing.  This is the tests that have been agreed to.  
      		MR. DOYLE:  Yes.  
      		MR. PENBERTHY:  It's not interpreted.  
      		MR. DOYLE:  And that's the key --
      		MR. PENBERTHY:  But it explains why we're doing this.  And I'll have our federal register notice they're going to have to, you know, go into that.  If you can tell me what your issues are, I might be able to think about it, but I'm not going to -- 
      		MR. THOMAS:  Where D4 was described and D5 as highly persistent in sediment and highly bio-accumulative benthic and aquatic species.  I think the highly bio-accumulative is -- in particular, we will argue that that might not -- that's probably not supported by the facts.  So these are the types of things we're talking about with respect to how the --
      		MR. PENBERTHY:  Just tell me where the -- so I'm going to go back and -- I'll talk with the people here about those issues, but I'm -- we're going to express our true beliefs, so if you're worried about the high -- obviously the D5 is going to come out.  
      		MR. THOMAS:  No, no, right.  But both from being characterized as highly persistent, and then they were highly bio-accumulative in aquatic species.  
      		          MS. PLOTCKE:  It's more a statement of that it is that versus it's being predicted to be that.  A lot of the field studies actually counterdict [sic] that, so it's more what is really accurate of the current limit standard of science.  
      		MR. PENBERTHY:  Highly persistent and highly --
      		MS. PLOTCKE:   Predicted to be highly persistent and highly bio-accumulative, but they're not always highly bio-accumulative when you go and actually do studies, especially dependent upon the method that you use and the way -- where the science is today.  
      		MR. PENBERTHY:  Your concerns are?  
      		MR. THOMAS:  That was the primary concern.  
      		MR. PENBERTHY:  Okay.  We'll take that under advisement.  In the notice we're going to say what we think, and we might add a reference if it's not there that we need to support our assertion.  Okay.  
      		MR. DOYLE:  I guess the last item we had was in each of the test standards box -- so Appendices 4, 5, 6, and 8.  Let me get specific language for you.  There was -- where the references are made to the analytical methods, there's -- we had previously stated -- and let me see if I can actually find that specific example -- that they would be adapted from whatever the citation.  
      		MR. PENBERTHY:  How often was Knoerr -- adapted from Knoerr?  
      		MR. DOYLE:  For example -- and we wanted that retained in there.  The concern is if that's --
      		MR. PENBERTHY:  Where?  Can we look at -- I want to look at Appendix 4.  This is drafted, but this is just word processing.  Let's see if I can find 4.  
      		MR. STAPLES:  1 page 25.  
      		MR. PENBERTHY:  Yeah, how would you like that changed?  
      		MR. DOYLE:  Yes, it should be -- let's see -- the commercial -- this is the sentence that begins the commercial laboratory, so it's the third sentence in the last paragraph.  
      		MR. PENBERTHY:  Okay.  
      		MR. DOYLE:  The commercial laboratory will validate a method for the analysis of D4 in the influent and effluentthat shall be adapted from the analytical methods specified in Knoerr.  
      		MR. PENBERTHY:  I assume that's okay?  
      		MR. LEWIS:  You want that throughout the document, okay.  
      		MR. DOYLE:  And that's consistent with my version.  
      		MR. PENBERTHY:  Okay.  So that's going to have to then be in all Appendices -- all -- 4 through 8, right?  Okay.  Anything else?
      		MR. THOMAS:  Nothing else, other than I hope there's some cookies left for you guys at the party.  
      		MR. PENBERTHY:  Well, I'm greatly relieved we're going to be coming to a final conclusion.  Maybe we should go over the next steps.  
      		MR. THOMAS:  Absolutely.  
      		MR. PENBERTHY:  Okay.  Help me out here.  I'm getting off track here, but, obviously, we have some editing to do, so that will take a few days to get the language right.  
      		At that point we will send that out to all the interested parties for a 30-day period.  They can comment -- and I assume since most of the interested parties that have been engaged are not stand-up comments.  One thing I will need from you three very shortly is the name and addresses of the signatories, so I would like to put that in before we send it out for the 30-day period.  
      		So assuming, you know, in the C.F.R. there's a definition of what constitutes a legitimate comment, but I can't imagine there would be anything substantial from the people in this room because that's what we've been talking about.  Although, you know, just like you have to get your bosses to sign off, we have to get ours.  So I can understand what evolves out of that.  Hopefully, anything like that will be extremely minor.  
      		At that point, after we get through the 30-day period, we'll have a final draft that will go to the -- for signatures.  I think typically the way this has happened, there's been a kind of signature page for each of the signatory companies.  It's been a long time since we've done this, but usually that goes out.  
      		There's two copies, original, for the signature -- the first go out, come back, and everybody gets a formal -- and maybe even multiples since there's so many companies involved, but everyone gets an original.  We would write this notice of availability, which describes what's been agreed to, basically lays out the schedule, and references these today, and then we get started.  
      		MR. SELTZER:  There will need to be additional extension period, 60 days again.  And that's going to start on the -- the 26th is what you said is currently scheduled period fixed to expire.  
      		MR. PENBERTHY:  So it's been my experience that sometimes rustling up signatures can take a week, longer than you imagine, so hopefully we can get that done within a month or so after the 30 days.  
      		MR. THOMAS:  Okay.  Another thing we're going to want to do at some point is identify a small sort of technical team from EPA that could work with the small technical team from our side to make quick decisions in the field where the need arises or if there are questions with respect to -- like some of the things that came up today like how do you collect the samples and so forth and how do you ensure mixing.  
      		A lot of those things are likely to come up, and we're going to             need some people that can be available to make, you know, reasonably fast decisions where the need arises.  
      		MR. PENBERTHY:  Okay.  We can arrange for that.  
      		MR. STAPLES:   Especially on the Study Plan up front.  Before we get into the field even, there's going to have to be some -- 
      		MR. PENBERTHY:  Back and forth, I understand.  
      		MR. STAPLES:   To get them done quickly.  
      		MR. PENBERTHY:  I mean, if we're all clear about expectations and what's being done, it makes it go easier.  
      		Any problems with that?  So that's basically the (inaudible).  It's been a wonderful almost three years.  But the one thing good about it is it looks like we're on a positive trajectory and we'll have an (inaudible), so that's very important.  I know that's why everybody in this room comes to work, to have a success in this.  
      		MR. THOMAS:  Absolutely.  
      		MR. PENBERTHY:  So thanks so much.  Is there anything else we need to talk about?
      		MR. THOMAS:  Nothing from me.  Anybody else?  No.  So thank you.  
      		MS. PLOTCKE:   Thank you.  
      		MR. PENBERTHY:  Great.  So I expect something in the (inaudible) probably within a week.  
      		MR. THOMAS:  Okay.  
      		MR. PENBERTHY:  Happy holidays.  (Hearing adjourned)
      
      
      
      
      
      
      
      
      
      
      
