UNITED STATES ENVIRONMENTAL PROTECTION AGENCY SILOXANE TECHNICAL WORKING GROUP/POTW MONITORING

U.S. ENVIRONMENTAL PROTECTION AGENCY 1201 CONSTITUTION AVENUE, N.W. WASHINGTON, D.C. 20460

DECEMBER 6, 2012 1:35 P.M.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 2

1 APPEARANCES 2 Ward Penberthy, EPA 3 Cathy Fehrenbacher, EPA 4 Ellen Mihaich, ERR (contractor for Bluestar) 5 Paul DeLeo, American Cleaning Institute 6 Charles Staples, Attourney for SEHSC 7 Hugh Flack, Wacker Chemical 8 Gene Browning, Shinetsu Silicones 9 Betsy Carlton, Bluestar Silicones 10 Kevin West, Momentive 11 Lisa Dumars, Momentive 12 Russell Mait, Evonik 13 Kathy Plotzke, Dow Corning 14 Karluss Thomas, SEHSC 15 Marcus Aguilar, EPA 16 Paul Lewis, EPA 17 David Tobias, EPA 18 19 20 21 22 23 24 25Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 3

1 U.S. ENVIRONMENTAL PROTECTION AGENCY 2 SILOXANE TECHNICAL WORKING GROUP/POTW MONITORING 3 December 6, 2012 4 MR. PENBERTHY: We will take attendance. 5 MR. THOMAS: Okay. 6 MR. PENBERTHY: Karluss, why don't you 7 start? 8 MR. THOMAS: I'm Karluss Thomas with the 9 Silicone's Environmental Health and Safety Council. 10 MS. PLOTZKE: Kathy Plotzke with Dow 11 Corning. 12 MR. MAIT: Russell Mait, Evonik. 13 MS. DUMARS: Lisa Dumars, Momentive. 14 MR. WEST: Kevin West, Momentive. 15 MS. CARLTON: Betsy Carlton, Blue Star 16 Silicones. 17 MR. BROWNING: Gene Browning, 18 representing Shin-Etsu Silicones of America. 19 MR. FLACK: Hugh Flack, Wacker Chemical 20 Corporation. 21 MR. STAPLES: Charles Staples, with the 22 SEHSC. 23 MR. DELEO: Paul DeLeo, American 24 Cleaning Institute. 25 MS. MIHAICH: Ellen Mihaich, ER SquaredSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 4

1 for Blue Star. 2 MS. FEHRENBACHER: Cathy Fehrenbacher, 3 EPA. 4 MR. PENBERTHY: Ward Penberthy, EPA. 5 MR. TOBIAS: David Tobias, EPA. 6 MR. LEWIS: Paul Lewis, EPA. 7 MR. PENBERTHY: We'll go around the 8 room. 9 MR. BRUSHESKI: -- Bursheski (Phonetic) 10 with Dow Corning. 11 MS. BARKAS: Jessica Barkas, EPA. 12 MS. EISENREICH: Karen Eisenreich, EPA. 13 UNIDENTIFIED SPEAKER: --, EPA. 14 MR. AGUILAR: Marcus Aguilar, EPA. 15 MR. AVCIN: Joe Avcin, EPA. 16 UNIDENTIFIED SPEAKER: --, EPA. 17 MS. HOPKINS: -- Hopkins, EPA. 18 MS. BILL: Karen Bill, SEHSC. 19 MS. BURERA: Tracey Burera, SEHSC. 20 MR. CRAFT: -- Craft representing 21 Evonik. 22 MR. KOZERSKI: Gary Kozerski with Dow 23 Corning. 24 MR. ANDERESON: Steve Anderson, EPA. 25 MR. PENBERTHY: Could the people on theSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 5

1 phone identify themselves one by one. 2 UNIDENTIFIED SPEAKER: -- 3 MR. HILEY: This is Raymond Hiley with 4 Momentive Performance Materials. 5 MS. SMITH: This is Kristan Smith with 6 Momentive Performance Materials. 7 MS. MCNETT: Deborah McNett with Dow 8 Corning. 9 MR. POWELL: Greg Powell with Dow 10 Corning. 11 MR. JIN: Jason Jin, Dow Corning. 12 UNIDENTIFIED SPEAKER: -- 13 MR. GRIFFITH: Patrick Giffith with the 14 Los Angeles County Sanitation Districts. 15 MR. PENBERTHY: Has everyone on the 16 phone stated their name? 17 MR. KOGER: John Koger, Personal Care 18 Products Counsel. 19 UNIDENTIFIED SPEAKER: -- Personal Care 20 Products Counsel. 21 MR. PENBERTHY: Anyone else? Okay. 22 Paul, do you want to go through our how meetings are 23 typically run as usual? 24 MR. LEWIS: Sure, thank you, Ward. 25 Again, this is Paul Lewis from EPA Chemical Division.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 6

1 I want to welcome everyone today for this meeting 2 dealing with the Siloxane's ECA, and we have two hours 3 scheduled for this meeting. We are going to begin by 4 having a presentation on Objectives for EPA's 5 Objective for Siloxane Monitoring followed by 6 estimated costs of monitoring, EPA's plan for D4 risk 7 assessment, and give an opportunity for SEHSC 8 perspectives on D4 risk assessment. This meeting also 9 provides an opportunity like we have had for our other 10 ECA discussions for interested parties to identify 11 themselves and divide their input in terms of the 12 deliberations today, and then we will adjourn. 13 Like, this meeting similar to other 14 meetings, all of the materials that will be presented 15 today will be available at docket. So, we will make 16 that available for public inspection. Any questions 17 for me in terms of the format for our discussion today 18 before I turn it back to Ward to kind of kick-off our 19 discussion today. 20 MR. THOMAS: Just one quick question. 21 Is it okay if during the presentations if we have 22 questions we can ask informal questions during the 23 presentations, or would you prefer for us to wait 24 until afterwards. 25 MR. PENBERTHY: Interested parties canSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 7

1 ask questions, sure. 2 MR. THOMAS: Okay, thank you. 3 MR. PENBERTHY: Observers should 4 observe. 5 UNIDENTIFIED MALE: Could you move a 6 couple of those chairs away from the end of the table, 7 it is tough to see the screen? 8 MR. LEWIS: Sure, we can do that. Thank 9 you. Any other questions in terms of our meeting 10 today? 11 MR. AGUILAR: I just want to remind 12 everybody if you can please state your name before you 13 make a comment, that will really help with the 14 transcript making sure that it is accurate. I know 15 people do not remember every time, but if you could 16 please try and make sure you do that, that will really 17 help us out. 18 MR. LEWIS: Thank you, Marcus. 19 MR. PENBERTHY: And we have a few extra 20 copies of the presentation if you don't have one- that 21 we can pass around. 22 MR. AGUILAR: There is also a sign-in 23 sheet going around, so if you could -- you know, write 24 your name, who you are representing and then your 25 email address, that would also help us out as well.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 8

1 MR. LEWIS: Ward, do you want to take it 2 or leave it for Cathy? 3 MR. PENBERTHY: Uh, no Cathy is going to 4 make our first presentation. Any thoughts you would 5 like to say, before we start off? 6 MR. THOMAS: No, we do have a 7 presentation, we will make it available during the 8 course of the meeting. I apologize for not having it 9 sooner, but we will make that available, and we will 10 provide it to the document as well. The docket as 11 well. 12 MR. LEWIS: Thank you. 13 MR. PENBERTHY: Okay, Cathy. 14 MS. FEHRENBACHER: Okay. So, again, 15 this is Cathy Fehrenbacher from the EPA's office of 16 pollution prevention and toxics, and my presentation 17 is on the EPA objectives for the Siloxane 18 Environmental monitoring. There is a brief 19 presentation that I will be walking through. So, we 20 have been very clear in identifying our objectives for 21 the Siloxane Environmental Monitoring, and this really 22 goes back to some communications in writing -- most 23 notably, on December 20th, 2010, and then email as 24 well as in a follow-up letter of December 19, 2011. 25 There were informal pre-ECA process meetings, and weSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 9

1 have also been very clear on these objectives during 2 the ECA process. And, we excerpted text from these 3 written communications, and included it within the 4 slides for this presentation. So, from these early 5 communications, we identified for D4 and D5 6 environmental monitoring that the program is intended 7 to develop a better understanding of the sources and 8 pathways of environmental concentrations and 9 environmental media, and by biota associated with 10 industrial releases from manufacturing processing 11 formulation and high volume industrial or commercial 12 end users. We also clarified that the intent was to 13 include the full product life cycle from manufacturing 14 through processing formulation high volume industrial 15 or commercial end use and disposal. And, we 16 identified the proposed essential elements of the 17 monitoring program which would include representative, 18 municipal and on-site industrial waste water treatment 19 plant monitoring, concentrations and flow rates for 20 both influent and affluent biosolids and potential 21 migration from land application. We addressed site 22 selections stating that it should encompass a 23 representative range of on-site handling and treatment 24 practices for waste, discharge waters, nearby 25 population centers, and low and high-flow conditions.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 10

1 We stated that the sampling locations should include 2 points upstream and downstream progressively distant 3 from the point of discharge, and that we were 4 interested in examining surface waters, suspended 5 solids, bottom sediments, air, biosolids, benthic, and 6 aquatic organisms. 7 In terms of monitoring site selection 8 as I stated, the program -- yes, Karluss? 9 MR. THOMAS: One comment on the first 10 slide before you move on to the second one. I did 11 want to point out that you are right that this 12 information was communicated a couple of years ago, so 13 prior to our initiating formal ECA negotiation 14 process, but I did want to point out that our 15 understanding was that the scope of what is described 16 in this initial slide had been narrowed pretty 17 substantially based on subsequent discussions. I 18 would point out not only the conference calls that we 19 held this year, but the discussions that we had prior 20 to those conference calls in our view suggested that 21 the scope of the program had been narrowed to not only 22 exclude the product life cycle components, but also 23 probably the on-site industrial waste water component 24 as well. So, and it was our view that the scope had 25 been narrowed to focus exclusively on data that wouldSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 11

1 facilitate the development of an environmental risk 2 assessment, so that is essentially the basis for our 3 proposal. So, I just wanted to clarify that indeed 4 these things were communicated very early on in the 5 process, but our proposal was responsive to what we 6 thought was our most recent understanding of what the 7 scope of the program was -- which from out 8 understanding was much more narrow than what is 9 described here, and I think that some of the 10 subsequent communications between us and the EPA would 11 probably highlight that as well. 12 MR. PENBERTHY: Yes, I think you are 13 right, that we have changed some of our positions from 14 this, and I think there is a slide later on that lists 15 the major changes that we've made to be accommodating 16 to our mutual interest, so. 17 MS. FEHRENBACHER: Okay, so moving on, 18 the next slide as I said addresses the monitoring site 19 selection. Again, these are from the early 20 discussions. Representative watersheds and industrial 21 manufacturing processing and formulation sites. A 22 representative number of sites should be selected. We 23 had a lot of discussion about conceptual site models, 24 which characterize sources or and their releases for 25 all manufacturer, processor and formulator facilities.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 12

1 We also had a number of discussions about treatment 2 configurations of waste water treatment plants, 3 including activated sludge, lagoons, et cetera. We 4 stated that the population of the area connected to a 5 facility must be a consideration in the selection of 6 sites for both municipal and waste water treatment 7 plant sites and for the MPF sites. And, in addition, 8 geologic, geographic and climatic parameters must also 9 be considered. In addition to the characteristics of 10 the receiving water body and finally, that we should 11 be careful in selecting which POTW's would be chosen 12 for a given metropolitan area, as a large municipality 13 may have facilities of varying sizes. 14 Okay, and then moving on to the next 15 slide, which is focusing on biota monitoring. Biota 16 monitoring, in terms of EPA objectives must support 17 the evaluation of bio- accumulation and bio18 magnification in biota including at least three 19 replicate samples of specific species per site with 20 fish species selected to represent at least two 21 trophic levels or levels of aquatic food web, low and 22 high. And, additional benthic species and 23 environmental occurrence sampling. 24 MS. PLOTZKE: One question I have there, 25 Cathy maybe you'll get to it when you get to that lastSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 13

1 slide, on the biota type of monitoring, and how have 2 you factored in what's already available out there on 3 the food webs and what criteria have you used to say 4 that would apply to generating this type of 5 information? 6 MS. FEHRENBACHER: We have evaluated all 7 of the available data. 8 MS. PLOTZKE: Is there a set of criteria 9 that you're using to define what isn't already 10 available or what isn't known and what needs to be 11 known? I think that will be helpful in understanding 12 that. 13 MS. FEHRENBACHER: Okay. 14 MS. PLOTZKE: Maybe you will get to it 15 at that last slide. 16 MR. PENBERTHY: Maybe, I guess what's 17 unclear about the slide? 18 MR. THOMAS: Well, what specifically 19 about the available data would not allow you to make a 20 determination about bio-accumulation at this point? 21 What specific needs are there that aren't met with 22 existing data that would allow you to make a 23 determination here? 24 MR. PENBERTHY: I don't think we think 25 there is an adequate data set.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 14

1 MR. THOMAS: Are there specific 2 components in particular that you might point to in 3 terms of where the inadequacies are? 4 MR. PENBERTHY: There's just not enough 5 data to that. I don't know Karen, do you have 6 anything to add to that? 7 MS. ELZENREICH: Yes, this is Karen 8 Elzenreich, EPA. What we need is data that is going 9 to represent the industrial facilities here in the 10 U.S., much of the data is not for species found in 11 food webs. That is not all of the data, but what 12 we're asking for, a representative sampling of waste 13 water treatment plants here in the U.S. that represent 14 the manufacturing, that has overlooked the biota to be 15 represented as well. 16 MS. PLOTZKE: So, are you concerned that 17 the behavior of these chemicals in the biota and in 18 the food web would be different under those 19 circumstances compared to what we have already 20 generated? 21 MS. ELZENREICH: It could be potentially 22 different. 23 MS. PLOTZKE: Well, for us, it tries to 24 address, sort of the chemical/physical properties of 25 the materials from what's already known, but more onSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 15

1 that later then. 2 MS. FEHRENBACHER: Okay. Thank you. 3 And, then finally, in terms of the EPA objectives with 4 respect to existing monitoring data, the Agency made 5 it very clear that we would consider existing 6 monitoring data collected at sites inside and outside 7 the U.S. provided there is shown to have similar and 8 representative site characteristics. And, these 9 characteristics would include the water shed, the air 10 shed, the facility production releases of D4 and D5, 11 run-on and run-off potential, waste generation, 12 handling and disposal for on-site waste water 13 treatment facilities, on-site waste disposal unit -- 14 such as, waste piles, dumps, ponds, pits, land fills, 15 ditches, or land applied sledge areas. The site 16 climate, hydrology, geology, soil type, receiving 17 stream morphologies, sediment, flow-rate, nutrient 18 load, water chemistry, aquatic biota, on and around 19 the chosen manufacturing facilities. In addition, we 20 said that the submission of existing monitoring data 21 is encouraged to further enhance our understanding of 22 the behavior of D4 and D5 in the environment. 23 Although, the agency will have a high bar for a 24 substitution of foreign data for monitoring at U.S. 25 sites based on representativeness.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 16

1 MS. PLOTZKE: Kathy Plotzke, one other 2 question on that is, do you also, have you defined 3 criteria for accepting non-U.S. site data. Is there 4 any guidance that you would give us on what would be 5 acceptable as a non-U.S. site? 6 MS. FEHRENBACHER: Well, I think this is 7 fairly clear in terms of the criteria that we would 8 use to evaluate non-U.S. data. We are looking at 9 representativeness, and that there would be a high bar 10 for acceptance of non-U.S data. 11 MS. PLOTZKE: Well I guess that's 12 probably the part that's a little bit challenging to 13 understand as the high bar. I think we could lay out 14 the criteria around all of the sites that we have 15 already monitored or where there is monitoring data 16 where it meets a lot of these, but what's that 17 acceptance criteria? 18 MR. PENBERTHY: I think you just need to 19 make your case. 20 MS. PLOTZKE: Make the case? 21 MR. PENBERTHY: Right. 22 MS. FEHRENBACHER: I think we have made 23 it clear that we would welcome data that you have, and 24 we would evaluate whether it is representative of 25 U.S., and then we would use it accordingly. And,Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 17

1 these are the criteria that we would use in evaluating 2 the data. 3 MR. MAIT: But, you do not have any 4 quantitative type process here? 5 MS. FEHRENBACHER: Well, I mean in terms 6 of representativeness, there are -- we do not have 7 specific criteria, but we know how many MPF facilities 8 there are in the U.S. We know that the data 9 available, and we have information -- we have had 10 lengthy discussions about sample size and the numbers 11 of samples. So, those would also be additional 12 criteria that we would consider in determining how we 13 would and whether we would utilize the data in our 14 assessments. 15 MR. THOMAS: I think part of the 16 difficulty as well, Cathy, is that much of what is 17 described here has not been proposed for monitoring 18 even the U.S. site, so it is difficult to understand 19 from a quantitative perspective how would you compare 20 the representativeness of non-U.S. data to U.S. data 21 from the standpoint of these considerations when much 22 of this information won't even be known about the U.S. 23 sites. 24 MS. FEHRENBACHER: Well, I mean for 25 instance -- we have had some discussions -- some ofSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 18

1 the -- in fact, a lot of the data that is available 2 represents marine environments, and for the risk 3 assessment that we would be conducting, we would be 4 looking at fresh water environments, so that data is 5 not very relevant to the assessment that we would be 6 conducting. 7 MR. PENBERTHY: I think a monitoring 8 program if it was developed -- the ECA would have 9 provide some information relevant to this and to these 10 specifics that -- so that those circumstances of 11 monitoring were understood. 12 MS. FEHRENBACHER: Okay, so in terms of 13 the last slide, and Karluss you made a comment that 14 there have been modifications to the agencies 15 objectives, and we agree there have been modifications 16 to the EPA siloxane monitoring objectives during the 17 ECA negotiation. In fact, we have intended to focus 18 on the monitoring -- the minimum defensible monitoring 19 needed for risk assessment purposes, and so, we have 20 agreed to a smaller number of MPF monitoring sites, 21 fewer POTW monitoring sites, the deletion of air 22 monitoring, and the deletion of down-stream 23 monitoring. We have also limited the biota monitoring 24 to industrial sites. We believe that this is a bare 25 bones plan that allows for a scientific assessment,Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 19

1 and just in closing, again the Agency has been very 2 clear from the start on the elements of the monitoring 3 plan. We have again made modifications during the ECA 4 discussions and the formal negotiation to arrive at 5 what we believe is a minimum defensible approach for a 6 scientifically sound national risk assessment. 7 MR. THOMAS: So, now just for 8 clarification, when you say "fewer MPF monitoring 9 sites," our initial proposal was that the four direct 10 discharges be monitored. What has been beyond the 11 change there? 12 MR. PENBERTHY: Well- as you recall we 13 actually started at 41 and 42, and we dropped the 14 number right? Of the POTW's sorry. 15 MR. THOMAS: No, I am talking about at 16 the first point on the fewer MPF monitoring sites. 17 MR. PENBERTHY: Well, I think if you 18 look at our initial written communications- that were 19 a lot more expansive about the processing formulating 20 sites than we are. But defiantly yeah we've come -. 21 MR. THOMAS: Many of those maybe even 22 most of those we have no control over. I mean many of 23 the processors and formulators in particular are not 24 going to be SEHSC sites, so from the standpoint of a 25 universe of sites over which we have some control, weSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 20

1 have essentially offered all of the direct discharges. 2 MR. PENBERTHY: Right, and, so I've 3 recognized that and have targeted or went to focus on 4 the sites that you have control over. 5 MR. THOMAS: Okay. All right, I guess it 6 was just unclear how that was a change, but I just 7 want to -- overall, I think again if we go back to 8 what was originally communicated in the discussions 9 maybe a year or two ago, I think we would both agree 10 that there has been some narrowing of the scope such 11 that we provide a useful data set to support a risk 12 assessment. I think on that point we would agree. 13 And, I guess I would say from our standpoint, we have 14 modified our original proposal pretty substantially. 15 That first slide that you put up -- the excerpt taken 16 from the letter that we got from Dr. Doa a couple of 17 years ago was in response to a proposal that has not 18 been the focus of these discussions at all. But, that 19 I would say represents a substantial change from our 20 perspective. I think in addition, during the last 21 meeting we also offered to change the mix of waste 22 water treatment types as a result of some of the 23 concerns that have been expressed. So, I think from 24 our perspective, we would say that -- you know, we 25 have been flexible as well with respect to thoseSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 21

1 elements of the program that we think would need to be 2 changed to accommodate a risk assessment. 3 MR. PENBERTHY: Okay. 4 MR. GRIFFIN: This is Patrick Griffin 5 from Los Angeles County Sanitation Districts and 6 NACWA. I had a clarification question. You mentioned 7 in that slide that you guys deleted air monitoring. I 8 am not recalling that in any of the discussions then. 9 I know it was not a big factor any how; but, I think 10 in the drafts that they sent to you, there was one of 11 POTW that was planned for air monitoring and also in 12 the conceptual site model, it looked like the only 13 pathways for human exposure were by air. Can EPA 14 touch on that a little bit? 15 MR. PENBERTHY: I mean, I think over the 16 course of discussions, we have pretty much determined 17 that would not be our main focus; but, it was included 18 in our last proposal recognizing that folks like you 19 are participating with interested parties in the 20 process, so while that might be a concern of yours, it 21 is not necessarily one of ours. 22 MR. LEWIS: Other comments from people 23 on the phone, or around the room? Okay, Mr. Tobias, 24 do you want to talk about some estimated costs? 25 MR. TOBIAS: Sure.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 22

1 MR. LEWIS: Thank you. 2 MR. TOBIAS: Again, David Tobias from 3 the EPA, and we are going to be discussing some data 4 sources that we looked at to create cost estimates for 5 the monitoring programs. Next slide thanks. So, ther 6 are three main sources we have for creating cost 7 estimates for these programs -- the first one is just 8 to give an idea of how -- what the cost was for a 9 recent monitoring program that was completed by the 10 office of water, called the Target National Sewage 11 Sledge survey. The next step we did was to talk to 12 Environment Canada about the costs that they 13 encountered during their recent monitoring program for 14 Siloxanes at waste water treatment plants, and then 15 the last bullet point indicates that we also went to a 16 academic with the EPA proposal and asked for a cost 17 estimate or a quote from him for how much he thought 18 he would require to perform the EPA's monitoring 19 program. Thanks. 20 So, the office of water in 2006 and 21 2007, they went to 74 waste water treatment plants 22 spread across the country -- gathered only sewage 23 sledge samples, and they -- the stats, they are there 24 - the difference they had is they have one media they 25 are monitoring, only the sludge, but they areSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 23

1 interested in a much wider spectrum of possible 2 chemicals in those samples. The list is there, it is 3 pretty broad -- 145 total with chemicals coming -- 4 metals, hydrocarbons, flame retardants, 5 pharmaceuticals, steroids, and this would make their 6 plan more costly and complex for analytical efforts 7 per sample, and that is -- The important thing I think 8 about is that these were not performed by ORD, these 9 are not internal government research, but the EPA 10 awarded these in externally competitive bid contracts 11 to three outside labs, and this is the pretty 12 inclusive price is $1.3 million with all of the things 13 listed there -- labor, travel, sampling, handling, the 14 sample analysis report writing, and also the contract 15 management for that. And, there are many more details 16 that you can obtain from the results of the study on 17 the waters web page that is given at the bottom of the 18 slide. 19 MS. PLOTZKE: David, one quick question 20 -- do you know if they included a QAQC program as a 21 part of this, I did not get a chance to take a look at 22 their website. 23 MR. TOBIAS: I do not know the complete 24 details of it, but if you look at their documentation, 25 they do discuss -- they took duplicate samples andSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 24

1 they discussed how they performed the QAQC. 2 MR. PENBERTHY: An EPA monitoring 3 program would be required to do that. 4 MR. TOBIAS: Yes. Thank you. So, I 5 talked to a Meltran Alaee at Environment Canada who 6 was one of the leads for performing Canada's Siloxane 7 monitoring program, and I asked for him to give 8 estimates of what his labor costs would be for 9 different components of his monitoring program -- 10 including labor costs for travel, what his estimated - 11 - his analytical costs would have been per sample. 12 How much he had to pay for fixed costs -- for things 13 like isotope analytical standards, and lab supplies; 14 but, the big difference between this and the OW study 15 is this was performed in house at Environment Canada, 16 so he had access to probably lower labor costs similar 17 to a university that would be post-docs and graduate 18 students. So, I did not use any of his numbers for 19 what his labor costs were, and I discuss on the 20 subsequent slides what I did use instead for those 21 costs. 22 MS. PLOTZKE: Sorry, this is Kathy 23 again, and the question -- so, and for this would be 24 what type of samples that they collected? Was it just 25 influent, affluent?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 25

1 MR. TOBIAS: The? 2 MS. PLOTZKE: Because they did a number 3 of different programs, so I am not sure what this is. 4 MR. TOBIAS: This is the compository -- 5 the in fluent/affluent sediment and water and sediment 6 were the two that they did. 7 MS. PLOTZKE: Right. 8 MR. TOBIAS: You are rightthey did not 9 have biota in the Canadian program. 10 MS. PLOTZKE: Right, I just wanted to 11 make sure. 12 MR. TOBIAS: Yes. 13 MR. TOBIAS: Anyone else have questions 14 on this slide or anybody on the phone? Just to make 15 sure. Okay. So, what I used these numbers to create - 16 - I used a preliminary cost estimate for the two 17 proposals that are in discussion right now. The first 18 slide is for the SEHSC proposal. So, the SEHSC 19 proposal has nine sites and I multiplied the numbers 20 on the previous page for travel and labor costs that 21 Mehran gave for traveling and labor at those sites. 22 There are 55 samples in the current SEHSC program. I 23 used his numbers for laboratory supplies and the study 24 would be completed, and then I put in numbers for the 25 labor costs. Now, so I get the labor costs, I haveSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 26

1 eight workers for six working months at $15,000 per 2 month, and to get that number, there are two numbers 3 that it is very close to -- the $15,000 per month. 4 That is very close to what the EPA would pay for a 5 contract labor for an entire month, which is 6 approximately $100 an hour, or $16,000 a month; and, 7 it also is very close to what it comes out to be for 8 the cost, not the salary of a fully-loaded government 9 staff employee. It comes very close to $15,000 as 10 well. So, by taking together those numbers, you get 11 an SEHSC proposal estimated to cost around $800,000. 12 MS. PLOTZKE: And, this is Kathy Plotzke 13 again, I have a question on the 55 samples, what was 14 the basis for coming up with the 55 for the number of 15 samples for our proposal? 16 MR. TOBIAS: That was out of your plan. 17 You had four sites with the first -- your four sites 18 that were directly controlled by you, and then five 19 sites outside. So, for the four sites directly 20 controlled by you, I think there was -- was it 21 effluent, water, sediment and in fluent -- so, four 22 samples; and, then at the other sites there were -- 23 plus the fish -- and, at the other sites, I think -- 24 did you test three fish, I think? 25 MS. PLOTZKE: One fish, one benefit.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 27

1 MR. TOBIAS: One fish, one benefit. 2 MS. PLOTZKE: Yes. Okay, so, one sample 3 per 4 MR. TOBIAS: One of each. One of each 5 medium. 6 MS. PLOTZKE: -- per environmental 7 matrix? 8 MR. TOBIAS: Yes. 9 MS. PLOTZKE: Okay. That was my -- when 10 I am looking at this, and I see 55, that was not our 11 number, because we look at it -- we have based it on 12 our experience where we have already been doing 13 monitoring. Recently, when we just went out in Lake 14 Champlain 15 MR. TOBIAS: Uh-huh (indicating 16 affirmatively). 17 MS. PLOTZKE: -- we are collaborating 18 with the University of Vermont, and we had 720 samples 19 in total for a very similar sampling program. When we 20 have done a power analysis to look at what is the 21 adequate number as well as the inclusion of all of our 22 quality control field and analytical samples. So, 23 that to me I saw that big difference. I did not know 24 what the basis was. So, you were assuming one sample 25 collection for each matrix we put down?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 28

1 MR. TOBIAS: That was. 2 MS. PLOTZKE: Okay. 3 MR. TOBIAS: See, the problem is, we do 4 not have the details that the ECA completed at this 5 point, so -- you are not sure how many to put in, and 6 these numbers are saying how I do not remember us ever 7 discussing what that number would actually turn out to 8 be. 9 MS. PLOTZKE: Yes, and I think what we 10 had always indicated is, what we would do is the power 11 analysis, and we would determine those numbers. But, 12 this is based on our experience. 13 MR. TOBIAS: Okay. 14 MR. MAIT: Dave, Russell Mait . You 15 only considered how many sampling events? 16 MR. TOBIAS: This is one sampling event. 17 MR. MAIT: In my recollection, there was 18 two -- so, that only represents a single event. Is 19 that correct? 20 MR. TOBIAS: That's true. The sampling 21 number actually is for just one event. Go the next 22 one. So, I had to update the number of samples 23 analyzed here from due to a couple of different 24 estimates, and I will get to that -- that is the red 25 number -- but, this is for the EPA plan. The numberSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 29

1 of sites has changed -- there are 25 sites. The 2 number of samples changed, and we have had discussions 3 on this -- so, this number actually is also bringing 4 down the reduction in the number of biota, and to only 5 the industrial sites; and, the number that the -- what 6 is cut and pasted into the proposal unfortunately was 7 from a larger program that we had been discussing in 8 the past. The laboratory supplies and analytical 9 standards are just scaled up, and we have increased 10 the amount of labor costs that we see based upon the 11 increase in the number of sites. So, it is 12 proportional to what that would be, and the number 13 that comes out from that is about $2.1 million. 14 MR. DELEO: This is Paul DeLeo from the 15 American Cleaninng Institute. So, David, are you 16 saying you believe that program could be carried out 17 to your satisfaction by taking 148 samples? 18 MR. TOBIAS: I say that is what is 19 within our proposal. 20 MR. DELEO: Okay. 21 MR. TOBIAS: The ECA was not complete -- 22 to be honest, so, this is -- that is why I've also at 23 the top I had preliminary cost estimates for each one. 24 MS. FEHRENBACHER: Does that- may not 25 include QAQC samples?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 30

1 MR. TOBIAS: There could be other costs 2 that would come in. I agree with that. That is why on 3 each one I've been saying it is a preliminary cost 4 estimate. 5 MR. MAIT: David, Russell Mait. So, is 6 this a single sampling event, so it is comparitable to 7 the prior slide? 8 MR. TOBIAS: The samples would have to 9 be updated. I did not think that you would need 10 10 workers for 12 working months to do one sampling event 11 to be honest. But, the number of samples might be 12 incorrect for that purpose. 13 MR. LEWIS: And do they got idea on how 14 many months? 15 MR. TOBIAS: We were -- there is a lot 16 of conversation on how do so to establish how many 17 labor months you would need? Given that the plan is 18 not completed yet, so, the -- we did this based upon 19 the workers and the working months. I talked to the 20 Canadians about how many people were involved, how 21 many people ended up on their publications. Talked 22 with people in the EPA who have done environmental 23 monitoring projects to try to come up with an 24 estimate. So, the whole thing is in the context of a 25 preliminary cost estimate.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 31

1 MS. PLOTZKE: And, again this is Kathy 2 Plotzke, but 148 is based on one sample per 3 environmental matrix and any inclusion of field or lab 4 QC's? 5 MR. TOBIAS: There is not QC-specify in 6 our plant right now, so it is not described here. 7 MS. PLOTZKE: That is one of the things 8 that we obviously have factored into ours. 9 MR. TOBIAS: Okay. 10 MS. PLOTZKE: And, that is a critical 11 component for these materials given their chemical 12 physical properties -- the volatility. We have seen 13 loss of these samples even transferred from the field. 14 Canada has seen it as well. So, having field QC's as 15 well as lab QC's is very critical for these materials. 16 MR. TOBIAS: That is true. I agree. 17 MS. FEHRENBACHER: Yes, we would 18 certainly agree with that, and I think the information 19 that David has presented does not include 20 consideration for QAQC's samples we - We do agree 21 with you that those samples and criteria are 22 important, and so that would increase the cost of the 23 estimates that were providing, but we don't believe it 24 would be appreciable cost. It would be an incremental 25 additional cost.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 32

1 MS. PLOTZKE: It is actually quite 2 substantial. I mean, we have been doing a number of 3 programs already, and a good portion of our samples 4 are field and lab QC's because of the unique 5 challenges from both a loss and a contamination sample 6 stability from transport to the field to the lab. It 7 is significant with these materials. The other thing 8 that we have seen and have factored in to our cost is 9 the pre-work for either going out to the site and 10 ensuring you have identified the appropriate areas to 11 sample from, how you are going to sample. That's been 12 critical to do a pre-field evaluation, and then the 13 other part is the analytical method validation with 14 which ever contract laboratories you would use. The 15 analytical labs -- the analytical methods for these 16 materials are quite challenging, and each lab has to 17 establish that they can conduct those type of analyses 18 per matrices in their laboratory. So, that has all 19 been factored into our cost. 20 MR. MAIT: Dave, Russell Mait. Just to 21 go back, if I do my math right just like I did on the 22 other side. 25 sites times 6 would give you 150, 23 would it not? 24 MR. TOBIAS: 25 times 6. It is not that 25 straight forward unfortunately, becauseSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 33

1 MR. MAIT: It appears to be. 2 MR. TOBIAS: The -- you want to get to 3 the -- are you worried about the 148 number right now? 4 MR. MAIT: Yes, I am trying to get to 5 148 because that is what you put down. 6 MR. TOBIAS: Unfortunately, there are 7 three fish at some of the sites, not at others. There 8 would be sludge monitoring at some of the sites, not 9 the others -- because, you said for your four direct 10 sites, the sludge has all been incinerated. Even in 11 your program you have differences in the meti -- I can 12 lay out how I multiplied out those numbers. If you'd 13 like. 14 MR. MAIT: But, at a very high level 15 like we are dealing right now, that is about what it 16 is? Isn't it? 17 MR. TOBIAS: So, you do not want me to 18 say 148, you want me to say 150. Is that it? 19 MR. MAIT: No, I am just trying to get 20 at how you got 148. 21 MR. TOBIAS: It is by taking whether 22 there are 23 MR. MAIT: I am just an engineer. I am 24 not a toxicologist. You guys are all smarter than me. 25 MR. TOBIAS: I am not a toxicologistSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 34

1 either, but it was by adding up the in fluent 2 affluent, sludge was going to be there, water, 3 sediment, and then perhaps up to three fish species 4 depending upon the site. I agree, but for the needs 5 of analysis at this level, it does not matter. 6 MR. MAIT: Okay. 7 MR. TOBIAS: Whether it is plus or minus 8 a few. 9 MR. MAIT: Okay. 10 MR. TOBIAS: I also have been trying to 11 emphasize this message. So, are there any more 12 comments on this slide? None? Anybody on the phone? 13 So, the EPA described its program to a 14 professor at SUNY Albany. We sent him the proposal 15 that we have been discussing with the requirements for 16 the number of samples, number of sampling events, the 17 different media, and we also were fortunate enough to 18 find someone who has performed previous work on 19 siloxanes and POTW's and consumer products. We asked 20 him how would a fair quote for what he would need to 21 do this work, and his quote for analytical work 22 travel, sample collection and labor, he gave a cost 23 estimate a little below $500,000 for the EPA proposal. 24 We did not ask him to do QCQA, but we think that for 25 someone in his position, he has pretty extensiveSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 35

1 experience with doing related work to monitoring 2 siloxanes. His work is actually already published as 3 well on those sectors, and as I point out in the 4 bottom one, he will have significantly lower labor 5 costs than would be possible in a govermentor contract 6 situation. Anybody have questions on that slide? 7 MS. PLOTZKE: This is my only comment, 8 this is Kathy again. From the university perspective, 9 again, we just had recent experience with the 10 University of Vermont, and these costs are not in line 11 with what they have put together for our program, so. 12 MR. TOBIAS: Okay. So, for the last 13 slide -- as just a summary of the relative sizes of 14 the different programs. The relative analytical 15 complexity they had, and their prices beginning with 16 the OW ( opposite water) water sewer sludge survey, 17 that should not be sediment. There are then also 18 explained the tables shows how that we have different 19 cost estimates based upon assignment candidate 20 experience, and costs or a quote from a university 21 researcher, but only for the EPA proposal. 22 MR. THOMAS: So, I guess just so 23 summarize, Dave, and thanks for putting this together. 24 I think it really helps us understand, you know, what 25 kind of motivated your thinking about cost. I guessSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 36

1 just in a macro way, based on what I think I am 2 hearing you say is that even your estimate of the 3 SEHSC proposal, assumes one sampling event, and I 4 think our proposal has two -- I think from our 5 perspective, that would have pretty substantial 6 implications on the estimated costs. The other thing 7 is the number of samples you have estimated to be 55, 8 I think by our own reckoning, it would be at least an 9 order of magnitude more than that. So, I think that 10 would certainly have a big impact on costs. But, I 11 guess just to sort of take a step back from costs, I 12 mean I just do want to be clear though that the basis 13 for our proposal has really not been on costs. I mean 14 what we really tried to focus on is how to develop a 15 program that is responsive to the agencies needs to 16 develop a risk assessment. So, I guess from my 17 perspective, it probably would not even be all that 18 constructive for us to have a protractive discussion 19 about costs, because what we really tried to do was 20 put together a program that allows you guys to 21 generate data for risk assessment. I think part of 22 the challenge has been -- clearly, there is somewhat 23 of a philosophical difference in terms of not only how 24 the program should be constructed, but what the focus 25 should be. The way we have laid out our program is asSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 37

1 a screening assessment, followed up by consideration 2 of risk management, if necessary. Now, it is my 3 understanding that is the way the agency typically has 4 gone about doing a risk assessment. You do a screening 5 level assessment based on worse case data, and that is 6 essentially what our proposal intends to provide. So, 7 I think if we can get past -- or we can come to some 8 agreement on the critical philosophical elements, or 9 at least come to some common understanding of -- how 10 do you construct a risk assessment, and what are going 11 to be the data needs to support that? I think we 12 probably would be much better off having that 13 discussion than having a discussion about costs 14 because to be totally honest, that is not going to be 15 a huge driver for us in terms of whether we are able 16 to come to an agreement on this. 17 MR. PENBERTHY: Fair enough. I mean the 18 only reason we've put this in is in some popular press 19 articles that circulated in the city say 50 million, 20 and we do not think that is anywhere near the right 21 number; and, so we just want to set the facts 22 straight. And, it may not be the numbers we say. 23 MR. THOMAS: Uh-huh (indicating 24 affirmatively). 25 MR. PENBERTHY: But, it is not $50Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 38

1 million. 2 MR. THOMAS: We do not have any control 3 over what numbers people report in the press. 4 MR. PENBERTHY: Well, they got the 5 number from somewhere, so 6 MR. TOBIAS: I just want to make a 7 couple of points for clarification. It is correct 8 that I misstated the number of samples that would be 9 in a twice performed monitoring program, but I think 10 the driver is labor costs. So, in this estimate, and 11 you can disagree with how I made the estimate -- I 12 agree. It's a very rough estimate, but we have not 13 received anything in the past for what your thinking 14 was for what these cost estimates would be. It is 15 really just during this discussion that you have 16 started to elaborate and discovered -- well, we have 17 not received any sort of breakdown or numbers at all 18 about what you view this as costing. So 19 MR. MAIT: Well, Dave -- Russell Mait, I 20 think what I recall from our prior meetings was, we 21 were not going to talk about costs, but we had planned 22 to talk about a sampling and monitoring plan once we 23 could get past what Karluss just mentioned -- which 24 was the philosophical approach of how to do this. 25 Once we can get there, then we can start getting down,Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 39

1 and I appreciate the level to which you got to -- 2 talking about those aspects, and I think that is where 3 again, we are sort of -- you know, at cross. We did 4 not get to that meeting. 5 MR. TOBIAS: I was just clarifying the 6 specific points. I am sorry. 7 MR. MAIT: I understand that, but what I 8 am getting at is that meeting did not take place. We 9 had talked about that, and I recall that from prior 10 meetings. We had talked about getting to that, and I 11 recall Paul, you even mentioning that. We have never 12 had that meeting. 13 MR. LEWIS: I think what we are trying 14 to do here is just put things in context knowing that 15 how we want to move forward on the ECA -- any other 16 questions on this? 17 MR. WEST: I have a question. Kevin 18 West from Momentive. Dave, do you know if this work 19 done by this gentleman from Albany has been published? 20 MR. TOBIAS: Yes. 21 MR. WEST: I just tried to find it 22 quickly and only got this I think form you yesterday, 23 and I did not find anything, and do you know if there 24 were volatile siloxanes that he has been looking at? 25 MR. TOBIAS: It is D4, D5, D6 that areSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 40

1 definitely part of the set. He also has some linear 2 siloxanes he is looking at, and different chain 3 lengths and cyclical components. He has a publication 4 for work from a waste water treatment plant and for 5 consumer products, and we can forward those if you 6 would like to see them. And, from discussions with 7 him, he has also done further work on waste water 8 treatment plants in other locations. 9 MS. PLOTZKE: And, this is Kathy Plotzke 10 again. Just a couple of things, I know we want to 11 move away from the costs and why we have not provided 12 the details, but one of the things that I clearly can 13 talk from is experience where we have been monitoring 14 for these materials for three years -- three plus 15 years already doing very similar programs. You made 16 the statement that the most critical factor is going 17 to be labor costs. It is not going to be labor costs. 18 It is going to be sample handling and analysis costs. 19 The analytical, the QC, the QA that goes into these 20 programs is huge, it really is because of the nature 21 of these materials. A recent publication just out, 22 where they have employed this, -- this type of QAQC 23 continues to demonstrate the value of that and all of 24 our publications do as well. 25 MR. LEWIS: So, let's move to the nextSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 41

1 presentation and Karluss and others kind of spoke 2 about in terms of what the purpose is for this. We 3 want to at least talk now and move to the next phase 4 of the EPA's plans for D4 risk assessment, because 5 that is really what the value is of what we are trying 6 to accomplish here. So, let me turn the floor over to 7 Ward in terms of laying out our plans for the D4 risk 8 assessment. 9 MR. PENBERTHY: You know, recently, in a 10 comprehensive approach to enhance our existing 11 chemicals program, the EPA recently identified a work 12 plan of 83 chemicals for assessment under TSCA. 13 Basically, we focused our selection of these chemicals 14 based on a number of factors -- their potential 15 concern to children's health, their neurotoxic effects 16 if there are carcinogens, if they are persistent in 17 our body cumulative and toxic. They are used in 18 consumer products or children's products and detected 19 in a biomonitoring programs. Initially, we identified 20 seven chemicals of the 83 for a risk assessment in 21 2012, and my understanding at current is that those 22 assessments will be forthcoming before the end of the 23 year. On June 1st of this year we had -- EPA 24 identified another 18 chemicals for assessment during 25 the 2013/2014 period. D4 was one of those chemicals.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 42

1 And, if you want to have more details about our 2 enhanced existing chemicals and how these criteria 3 were applied, there is elaborate explanation on our 4 website and under our existing chemicals program. 5 D4 was included as a chemical for 6 assessment in the work plan because it is a high 7 production volume chemical. It is persistent, it is 8 biocumulative. There is potential for reproductive 9 toxicity. It certainly has some aquatic toxicity. It 10 is used in consumer products, and this is information 11 reported to IUR our CDR now. It is present in 12 biomonitoring, blood, breast milk and aquatic species. 13 It has been found in indoor environments, sediment and 14 surface water. As an aside, of course, there is this 15 ECA activity going on, so that provides an additional 16 focus to D4, and then there is an IRIS of assessment 17 going to start in 2013, and those typically stretch on 18 charged for a number of years. 19 MS. PLOTZKE: Ward, just one quick 20 question on some of the data sources, do you have 21 references for 22 MR. PENBERTHY: Yes, that is on our 23 website. They are all listed there in a document. 24 MS. PLOTZKE: For like -- for example, 25 the biomonitoring, where that has been recorded?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 43

1 MR. PENBERTHY: Correct, that would be 2 there. If you can't find it, after you take a look, I 3 can get you in touch with the people that did that 4 work. Obviously, the ECA has a lot of relevance to 5 our plan -- work plan risk assessment. Obviously, it 6 would provide valuable monitoring data which would 7 contribute to an exposure assessment, and it would 8 certainly reduce the uncertainty, and we think if it 9 was designed well, you know -- at this point, we 10 believe that the SEHSC proposal of four direct 11 discharge site and five POTW's would be insufficient 12 to develop an informed national exposure assessment, 13 and pursuing such limited monitoring strategy would 14 result in anecdotal data which would likely not reduce 15 uncertainty associated with the understanding of 16 concentrations of D4 in environmental media and if 17 pursued, our concern the way it might be an efficient 18 use of both our resources and your resources. We 19 believe our proposal that we have put forth is -- 20 would be a much more -- have much higher quality data 21 set and something that we could use effectively and in 22 a risk assessment. 23 I guess in the event that we cannot 24 conclude an ECA, and obviously, we have plans for the 25 risk assessment, and so this is a logical question isSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 44

1 -- okay, what if things do not work out, what would 2 happen? And, we would still pursue our risk 3 assessment. We would consider all available 4 information in the existing limited monitoring and 5 released data. We would use release estimating 6 methods that we often use in say for instance -- our 7 new chemicals program. We would use models to 8 estimate environmental concentrations, and also by 9 accumulation and persistence. We think that we need to 10 do some scientific work in the interim to enhance 11 those modeling, because siloxanes are some unique 12 chemicals in terms of their properties and their 13 ability to be modeled. We would take into account the 14 substantial information that we have already received 15 under a previous Dow agreement. SEHSC has also given 16 us some conceptual site model information, and there 17 is a number of assessment efforts that have gone on in 18 other countries -- for instance, the UK and Canada. 19 In addition to this, there is other ways that we can 20 supplement the information available to us, or we have 21 talked about a possible test rule. There is other 22 applicable sections of TSCA that could be applied -- 23 Section 8A, Section 8D, Section 11. We have heard 24 there is a lot of monitoring data. There has been 25 intimations of past monitoring going on at industrialSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 45

1 facilities and past assessments, and so we think we 2 could secure access to that if we had to, or if we 3 chose that as a logical course of action. There are 4 also other statutes and other programs at EPA that 5 would allow us potentially to get some relevant 6 information, and to the extent that makes sence we 7 would use those as well. 8 This is not -- we have made no plans at 9 all in regard to any of this, so this is a projection 10 of what we would do. It is just a laying out of the 11 possibilities that confront in the absence of a 12 monitoring program in our need to complete a risk 13 assessment. So, that is what we have. 14 MR. THOMAS: Now, most of our 15 discussions have focused on the risk assessment for 16 D4, could you clarify what the plans are for the D5 17 data? 18 MR. PENBERTHY: It would be D4. D5 19 would not be assessed in the work plan. 20 MR. THOMAS: Okay. So, is it essential 21 that data for D5 be generated as a part of this 22 program? 23 MR. PENBERTHY: The monitoring program? 24 MR. THOMAS: Yes. 25 MR. PENBERTHY: You know, this has beenSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 46

1 something that we have talked about around the edges a 2 little bit. Our concerns with D5 are much, much less 3 than with D4. There is some debate in circles about 4 the true hazards of D5, and there are some studies 5 ongoing in Europe that may clarify that. So, right 6 now, our main focus is D4. I mean, I think our 7 thinking and including D5 in the monitoring program is 8 that many of these sites, these are -- they had a both 9 D4 and D5, and while we are at it, getting information 10 on D5 would not be at least sort of a conceptual 11 level, not much of an enormous added increment to 12 this. So, that is our thinking. 13 MR. THOMAS: If most of the outstanding 14 questions regarding D5 are related to the hazard, 15 would you expect environmental monitoring data to help 16 clarify any of those? 17 MR. PENBERTHY: Could help. Could help. 18 MR. THOMAS: But, you are not planning a 19 formal risk assessment for D5 as you are with D4? 20 MR. PENBERTHY: Not at this time. That 21 is not a guarantee that that will never happen; but, 22 it is not scheduled for the 2013/2014 time period. 23 The focus of our activity in assessment activity would 24 be D4. 25 MR. THOMAS: Okay, Yes, I guess,Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 47

1 notwithstanding the outcome of this exercise, I think 2 we would certainly encourage the Agency, whether data 3 is generated as a part of this effort or not, to use 4 as much of the available information as possible. I 5 would say in particular the D5 water review in Canada 6 provides a lot of good information on doing risk 7 assessment for D5. I think by extension, there are 8 some things you could learn about doing a risk 9 assessment for D4 if in particular, if you look at 10 the fact that D4 is probably more rapidly degraded, 11 more readily metabolized than D5, that certainly might 12 provide some guidance with respect to some of the 13 elements of a risk assessment for D4. So, the overall 14 encouragement is just to use as much of that data as 15 possible, because we certainly will use it -- most of 16 it, if not all of it has got to be extremly relevant 17 for any assessment done here in the U.S. 18 MR. PENBERTHY: Okay. Thanks for the 19 coaching. 20 MR. LEWIS: Other questions, comments on 21 the presentation. Especially those on the phone? 22 MS. PLOTZKE: Just one -- Kathy one more 23 question. So you talked about the use of models and 24 that you acknowledged that there would need to be some 25 update around some of those models to be adopted orSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 48

1 adapted for siloxanes, and also inclusion of more 2 relevant, more current, accurate physical chemical 3 property data too, would that be the way you would 4 approach it, if available? 5 MR. PENBERTHY: I think so. 6 MS. PLOTZKE: Provided? 7 MR. PENBERTHY: This is not my field, 8 but, yes. 9 MS. PLOTZKE: All right, so really 10 everything that is out there right now that we have 11 provided to you in inclusion, there is recently 12 published models by Don MacKay, all of that would be 13 used. 14 MS. FEHRENBACHER: We would consider it, 15 and we would determine whether it made sense for us to 16 use those in our assessment. 17 MR. PENBERTHY: And, generally in all 18 of the risk assessments that are planned, prior to the 19 plan, have a peer review component included in them, 20 so that would happen. 21 MR. THOMAS: And, would the timing for 22 the assessment for D4, would you expect it to be 23 impacted by the extent to which we move forward this 24 program? 25 MR. PENBERTHY: I think if we could comeSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 49

1 together and get an ECA, that if there was that level 2 of agreement, that would be pretty compelling argument 3 to assess the time to allow that information to be 4 considered in the risk assessment. 5 MR. THOMAS: We do have a brief 6 presentation. As well -- I apologize for not having 7 sent it earlier. We have got copies available as 8 well, I think. 9 MR. AGUILAR: If you could just after 10 the meeting if you could provide a copy for us so that 11 we can post it to the public dockett. That would be 12 great. 13 MR. THOMAS: Okay. 14 MS. PLOTZKE: Yes, it is pretty small 15 print so I think that would be easier. 16 MR. THOMAS: All right, well, I guess 17 similar to the slides that were presented by Dave, we 18 just wanted to share a couple of thoughts and 19 perspectives from our perspective in terms of some of 20 the critical elements that go into thinking about how 21 to develop a risk assessment for these materials, and 22 then also just some -- Kathy is going to go through 23 some general observations in terms of a more deep dive 24 into the science. And, I spoke about a lot of these 25 things earlier as we were going through the EPASiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 50

1 slides, and you guys feel free to stop me as I go 2 through these if there are any questions for 3 clarification and so forth. But, again, I just want 4 to emphasize that, you know, our commitment to this 5 program is really on the basis of science and 6 developing the data to support a risk assessment. I 7 would also add that this will not be the first time 8 that we have generated environmental monitoring data 9 to support a risk assessment. We have done this in 10 Canada, we have done this is Europe, so we are 11 certainly willing to do it as well in the U.S. We 12 think it's a part of our commitment to environmental 13 stewardship. I just wanted to point out here some of 14 the specific things that kind of go into that making. 15 Again, I will emphasize that the number of sites is 16 not the primary driver for the proposal. I know a lot 17 of our discussions have kind of gotten into this 18 number of sites versus that number of sites. Again, 19 what we try to lay out is a proposal that gives you 20 the scientific rigor to do a risk assessment, and we 21 think there are several things that we try to provide 22 the agency with that provides compelling information 23 that our proposal accomplishes that. One, is the 24 facility release estimates that were developed right 25 before we developed the conceptual site models, and ISiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 51

1 will add there that was not a trivial exercise. I 2 would say the industry is probably already well over a 3 $1 million in terms of commitment to what we have 4 already put into just the generation of the proposal 5 that we have on the table. We also generated the 6 facility release estimates, which again -- you guys 7 might not remember this, but I remember it well 8 because we spent a lot of time over the holidays -- 9 either last year or the year before, generating that 10 information. We also have employed environmental 11 consultants, environmental engineering consultants 12 that not only helped us develop the conceptual site 13 models, the monitoring program, but they also helped 14 provide a pretty detailed scientific justification for 15 our proposal, and we just wanted to highlight that as 16 well. 17 Some of the things that we talked about 18 before that Kathy talked about earlier in terms of 19 cost, we thought based on the limited amount of 20 information that we had with respect to the agencies 21 cost estimate, you may have missed, and I think we 22 have now been able to confirm among us that some of 23 the things that were missed were the QAQC which could 24 have a serious impact on the cost of the lab and -- 25 the lab and field quality control samples are going toSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 52

1 be essential for controlling for loss and 2 contamination. And, also, for assurance and 3 stability. And sample integrity and validation is 4 obviously also important, but we are very committed to 5 working with the agency to help inform our collective 6 understanding of the costs associated with the 7 development of these proposals. We certainly won't 8 say we have all of the answers, but certainly having 9 done it a couple of times in the past, we have got 10 some of them. Let me go to the next slide. 11 And, I think just kind of generally, a 12 more broad point that I think might be relevant not 13 only for this program but with others the agency might 14 be considering. Any of these methodologies that might 15 be used for assessing risk should really be consistent 16 for new and existing chemicals. We believe that would 17 get you a greater transparency and would foster 18 cooperation, and would really be a much greater 19 incentive for product innovation. You know, any time 20 we do not have the full set of information with 21 respect to how assessments are going to be carried out 22 and what the ultimate use of the data is going to be 23 from the standpoint of risk management, it hurts from 24 the standpoint of product innovation. Question, Dave? 25 MS. FEHRENBACHER: It would just beSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 53

1 helpful for you to elaborate on your suggestion that 2 methods should be consistent for new and existing 3 chemicals. 4 MR. THOMAS: The assessment 5 methodologies? 6 MS. FEHRENBACHER: Well, you say methods 7 for assessing risk should be consistent for new and 8 existing chemicals. Could you please elaborate on 9 that? 10 MR. THOMAS: So, the risk assessment 11 process that you would undertake to evaluate a new 12 chemical, it would be very important that also be the 13 same process that you would use for existing 14 chemicals. 15 MR. PENBERTHY: Well, they cannot be, 16 because there is different regulatory standards. 17 Sorry, one hazard may present an unreasonable risk 18 standard in chemicals, and one hazard will present. 19 So, accordingly existing chemicals, that qualitity the 20 data, the rigor assessment of the assessment is 21 generally has to be much greater. 22 MR. THOMAS: Well 23 MR. PENBERTHY: And, that is not because 24 I want it that way, that is what the statute says. 25 MR. THOMAS: Right, and that is a legalSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 54

1 distinction more than a scientific distinction, so we 2 should probably not spend a lot of time on this. This 3 was just sort of a general point, but I certainly 4 understand. 5 MR. PENBERTHY: Okay. 6 MS. PLOTZKE: I think it was Cathy that 7 just said the more we understand what you want, what 8 the process is, the easier it is for us whether it is 9 sitting here today working on a proposal or for the 10 future. That is what I think Karluss is trying to 11 say. 12 MR. THOMAS: And, again, I just wanted 13 to recap where we are at least in terms of our 14 understanding of the proposal that we have made and 15 modifications that have been made based on the 16 discussions we have had over the past several months. 17 For the POTW portion of our proposal, we had 18 identified -- we had suggested five sites be 19 monitored. Four activated sludge sites had initially 20 been three, but I think based on our last discussion, 21 we had suggested that a fourth site would also be an 22 activated sludge. I think based on the discussions, 23 our understanding was that EPA was suggesting that we 24 not monitor air at any other sites, so that is why the 25 air has been stricken. With respect to the monitoringSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 55

1 parameters, and you guys correct me if I am wrong, but 2 based on our last discussion, we had initially 3 proposed enfluent/affluent surface water, bio solid, 4 sediment, and then the biota fish and benthic species. 5 But, our impression was that based on the last 6 discussion, there was some interest in not having 7 those be monitored as the POTW's and then there would 8 be two monitoring events. 9 MS. ELZENREICH: We did not ask for 10 monitoring at the POTW sites, but we did ask for 11 monitoring at the indirect discharge sites, so it 12 totaled nine sites with an indirect discharge sites. 13 MR. THOMAS: You are talking biota 14 monitoring? 15 MS. PLOTZKE: Yes, biota monitoring 16 MR. THOMAS: Right, well, we're going 17 to get to the manufacturing process and formulators 18 next. I just wanted to clarify that this is agreeable 19 in terms of where the existence-- 20 MS. ELZENREICH: At the POTW sites we 21 did not ask at the previous meeting for biota 22 monitoring. 23 MR. THOMAS: Okay. 24 MS. PLOTZKE: Just one clarification, 25 Karluss, on site four we changed that from activatedSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 56

1 sludge it actually should be -- so it's three 2 activated sludge and two of those, that was what we 3 had proposed the last time we were together. 4 MR. THOMAS: Okay. All right. Thanks 5 a lot. So this is what our proposal had been for the 6 indirect dischargers, so all of the sites under SCHSC 7 control, all the direct discharge sites would be 8 monitored. The monitoring parameters would be 9 efficent at surface water, sediment, fish, the benthic 10 species, and there would be two monitoring events. All 11 right. Next slide. And again, this sort of gets at 12 some of the discussions that we had earlier, Paul, 13 which you alluded to in terms of overall philosophical 14 approach and none of these statements are intended to 15 be inflammatory or provocative. I mean, what we're 16 essentially trying to do is lay out what we believe 17 are the correct philosophical elements for a risk 18 assessment program and what we believe is also the 19 agency's previous guidance in terms of how these 20 things should be done. The -- we thought that the EPA 21 proposal presumes some D4/D5 risk management without 22 having conducted a risk assessment first. The reason 23 for that was because there was some discussion of 24 trying to just make some distinction between those 25 environmental concentrations that would beSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 57

1 attributable to residential sources versus those that 2 would be attributable to industrial sources. We 3 thought that exercise was probably more appropriate 4 for risk management than risk assessment. There was 5 also some discussion last time of some interest in 6 getting waste water treatment and even potential 7 facility efficiency information for treatment 8 efficiencies. We thought that also was outside the 9 scope of what would typically think of as a risk 10 assessment, so again, that statement that you were 11 starting to think about risk management without having 12 thought about risk assessment first was driven by some 13 of the comments that we heard from the last discussion 14 and we just wanted to be clear that our understanding 15 is risk-based decision- making is a two-tier process 16 where the potential environmental risk associated with 17 the material are systematically evaluated through an 18 assessment followed by a separate process for risk 19 management and that risk management should only be 20 considered after a risk is identified. And again, I 21 will highlight the experience in Canada where these 22 things have been studied pretty thoroughly and they 23 went so far as to say not only is there not a risk 24 now, but there will not be one in the future, at least 25 for D5. The nature and magnitude of the risk shouldSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 58

1 inform the risk management activities including 2 selection of the most practical risk management 3 instrument and I know I'm preaching the choir a lot 4 with this. I think we would all agree on that, but we 5 think a practically designed and efficient monitoring 6 proposal facilitates a determination first of -- 7 whether risk management is needed before implementing 8 the risk management instrument. What we also don't 9 believe; sufficient scientific justification has been 10 provided for conducting a national exposure assessment 11 prior to doing the risk assessment. We do believe 12 that a worst-case risk assessment would be sufficient 13 for what we're doing here. We think the data that 14 would be provided by this program would allow you to 15 do a screening level risk assessment and that would be 16 very consistent with the way the agency has typically 17 handled these matters and there is really no need at 18 this point for a national exposure assessment. And the 19 rest of these points just sort of further emphasize 20 that we think a screening level risk assessment is 21 sufficient and the four POTWs and five direct 22 discharge sites, we think, is going to provide a very 23 sufficient data set for doing a screening risk 24 assessment for D4 and D5. Questions before we move 25 onto the next one? All right. Next slide. Also justSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 59

1 wanted to comment briefly on the notion that we've 2 seen in some of the previous documentation that data 3 from SCHSC member and direct discharge facilities 4 might provide data that would be helpful in getting a 5 more complete understanding of the full universe of 6 processors and formulators for these materials. We 7 don't think that's necessarily the case. Certainly, we 8 could not represent that our processors and 9 formulators are representative of the potentially tens 10 of thousands of others that are in the country nor do 11 we feel that information is needed again for risk 12 assessment. Again, that gets at more the risk 13 management elements. Those facilities are not 14 discharging material to the environment. They're 15 discharging material to a municipal POTW in most, if 16 not all cases, and that is already a part of the 17 program, so we don't think that's going to provide any 18 value from the standpoint of supporting a screening 19 level risk assessment. And again, we've touched on 20 this, this last point, many times throughout all of 21 these discussions. The whole idea that available 22 monitoring data really should be considered for 23 informing the development of this program here in the 24 U.S. We feel like it would really be doing the agency 25 a disservice to dismiss those data out-of-hand becauseSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 60

1 it's our, you know, experience that there's a lot of 2 similarities that the treatment practices in Canada 3 are not so dissimilar from those in the U.S that we 4 think it would warrant not using those data at all. 5 And again, some of the monitoring conclusions or 6 results that we've seen in other countries and in 7 Europe in particular, we think would be helpful here, 8 so I won't go through all of these bullets, but I 9 think that's the overall gist of where we're going 10 with this. Questions before we move onto the next one? 11 All right. I'm going to let Kathy take it from here. 12 MS. PLOTZKE: And I just have a couple 13 of slides, I think you asked for our perspective on 14 the risk assessment on D4. I intend to cover both D4 15 and D5 in one here, but basically I think what we have 16 said all along is we've been conducting research on 17 these materials, so we have quite a bit of research 18 including monitoring data on the environmental effects 19 of D4 and D5 really, in the environment and there's a 20 lot that we have learned, as well, of the chemical 21 physical properties of these materials. We continue 22 to apply that in every new program that we have and 23 what's really critical is these basic physical/ 24 chemical characteristics and their relationship to 25 those physical / chemical characteristics in theSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 61

1 environment. It's understanding that and that's what 2 helps you to design a monitoring program is the 3 relationship between your chemicals and the behavior 4 in the environment. Some of the key ones and we've 5 talked about it here as a group as well, the binding 6 to organic carbon. We know that these materials find 7 organic carbon, so understanding the area that you're 8 monitoring and understanding the, basically, the type 9 and the level of organic carbon is critical. We know 10 that for these materials, lipid content of the 11 organisms, another thing, we have a program underway 12 right now that you can look at the impact of different 13 lipids and the impact on numbers around 14 bioaccumulation. This basically has allowed the EPA 15 and other regulators of other countries to really 16 utilize the toxicity threshold data from around the 17 world to develop their own water and sediment quality 18 criteria, so if you understand those fundamental 19 properties around your chemical and apply that to the 20 areas that you're monitoring, whether it be in the 21 U.S. or outside of the U.S., you really can understand 22 the behavior of these materials. And there is no 23 scientific reason why D4 and D5 really should be 24 treated differently. What's key is understanding 25 their differences, their uniqueness, and applying itSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 62

1 really then to these programs and that's what we've 2 done with our learnings. These two chemicals are not 3 toxic at concentrations below their solubility which 4 means they're not toxic at the maximum concentrations 5 that could exist in the environment. This was a 6 significant effort that we went forward with under the 7 Canadian D5 order review, but we've also applied it to 8 D4 and we've also sought outside expertise to review 9 it is, where you look at what is the solubility of 10 these materials in each environmental compartment and 11 what's the maximum you could achieve and then compare 12 that to the concentrations that you're finding out 13 there in the environment for these chemicals. The 14 worst-case scenario from an-- (WHEREUPON, the 15 conference was briefly interrupted by on-hold music 16 playing on phone speaker. Non-related dialogue not 17 transcribed.) So I think and this comes back to what 18 Karluss was saying about why, you know, we proposed 19 what we did originally from the monitoring program is 20 that with our knowledge that we have already, we 21 believe the worst-case scenario for understanding the 22 risk and the potential risks associated with D4 is 23 already understood, so we already understand what 24 those maximum concentrations are or could be. We 25 already understand with all of the monitoring that weSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 63

1 have done how different properties out there in the 2 environment, whether it be in the U.S., whether it be 3 in Canada, whether it be in Olso Fjord, will impact 4 those concentrations. So we can already do that and 5 predict it all through the program that we did, so the 6 United States really just validates this, that 7 understanding already. If you go to the next slide. 8 And we know that D4 and D5 behave differently than 9 other compounds that are similar in molecular weight 10 and size and again, this comes back to this 11 understanding of these unique characteristics and 12 these characteristics do result in unique 13 distributions in the environment and explain their 14 lack of toxicity and risk. So with the experts that 15 we've engaged through the D5 order review and through 16 other programs, all of them have started out looking 17 at this data set and wondering what that end result 18 and then they understand these unique characteristics 19 they come to the same conclusions that we do, that 20 there is no risk. That these concentrations are not 21 going to be at levels greater than their solubility 22 and you're not going to find them at concentrations in 23 the environment that's going to present a risk to 24 biota. We know that they partition the air no matter 25 where they're discharged in the environment. The airSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 64

1 compartment may readily degrade, so that's why 2 everybody has quickly moved away from the air 3 compartment and moved into the aquatic and the 4 sediment compartment. Given the 30-plus years of use 5 for these chemicals, I think it's safe to assume that 6 they're relative -- that they're at a relative steady 7 state in the environment and other, all the experts 8 that we have in the D5 order review concluded that as 9 well and that even if they were not, they cannot 10 accumulate at concentrations in aquatic systems that 11 are above their solubility. This was really key for 12 the D5 order review when the experts got to that point 13 of seeing that, that's where they were very quickly 14 able to say there's not going to be a risk associated 15 with these materials no matter what testing we've done 16 in the laboratory. In addition, the degradation of 17 these compounds in aquatic eco-systems and the 18 metabolism within the organisms, all data sets that we 19 have generated and provided and have published further 20 prevent concentrations that would present a risk and 21 one comment, D4 versus D5, in a recent review we've 22 had of D4, you get even more metabolism and faster 23 degradation of D4, so that's even a greater impact for 24 D4 than it is for D5. Talk about the partitioning to 25 the organic carbon and that's why it does lead toSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 65

1 sometimes elevated concentrations in sediment and that 2 the sediment really is the compartment of greatest 3 exposure for these materials, so I think everybody who 4 has started out evaluating these materials moved 5 through that, moved away from there, moved to the 6 aquatic compartment, and it's very consistent with our 7 conceptual site models that we've put together looking 8 at which compartments are the compartments of real 9 concern here and it comes down to sediments and 10 looking at the microorganisms. But again, then what's 11 critical is taking that next step, what those 12 concentrations are going to be and whether or not 13 they're going to present any risk and that's exactly 14 what we've done with the Canadian work as well as 15 we've now done with the D4. We've conducted a 16 probabilistic risk assessment. We've provided that to 17 you and what we demonstrate is we have significant 18 margins of safety around the concentrations that you 19 find in the sediment when you monitor for these 20 materials compared to where you see any effects in the 21 laboratory and it really is related to these unique 22 characteristics that govern and determine its 23 solubility in sediment. So I think that's the two 24 slides I have. 25 MR. LEWIS: Questions? Comments?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 66

1 MR. PENBERTHY: It sounds like we'll 2 have a lot to talk about when we put together our risk 3 assessment. 4 MR. TOBIAS: If there's anybody on the 5 phone, they're not going to be able to ask a question. 6 MR. LEWIS: You might make a comment 7 not to be put on hold again because it sounds like 8 they're back on the phone. 9 MR. TOBIAS: Yeah. I think they heard 10 you. 11 MS. PLOTZKE: So I guess one last 12 comment to kind of summarize on the risk assessment, 13 too. I've referred to it in here. Obviously, we've 14 worked with a number of experts for the D5 board of 15 review, but we've also recently reached out to get 16 third-party review on D4 as well, so we're in the 17 process of finalizing that work and we'd be willing to 18 share it. 19 MR. PENBERTHY: Great, okay, thank you. 20 MR. LEWIS: Any comments for SEHSC on 21 their presentation? I see none. Let me open the floor 22 up now to any interested parties that are either on 23 the phone or in the room here if they want to provide 24 commentary on what they've been hearing this 25 afternoon. Yes? Please identify yourself.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 67

1 MR. DELEO: Paul DeLeo, American 2 Cleaning Institute. I have a comment about something 3 mentioned early in the discussion today with regard to 4 data availability for food webs in the U.S. We've 5 seen an epidemic of countries moving away from using 6 data from multiple geographies and requesting data 7 only from their specific countries, so China is going 8 down that road. Very recently, we understand that 9 Japan is going down that road where they're only 10 accepting data for species in their respective 11 countries, abandoning massive environmental safety 12 databases. The U.S. Government has been a strong 13 advocate in international forums for mutual acceptance 14 of data and, you know, we believe that's consistent 15 with the desires for minimizing animal testing and 16 just good stewardship of chemicals. We think it's the 17 best policy for industry and for the U.S. Citizen, so 18 I'm hoping that the comment that was made earlier 19 about the need for U.S. -- data on U.S.-specific 20 species isn't a policy move by the U.S. Government 21 away from what has been a very forceful international 22 stance on mutual acceptance of data. 23 MS. EISENREICH: This is Karen 24 Eisenreich, EPA. I want to clarify that I didn't say 25 that we're not going to review that. In thisSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 68

1 instance, we do have it and we are using it. It just 2 may not be the best representation, especially when 3 you're talking about saltwater species versus 4 freshwater species. They're completely different. 5 Completely different environments, different 6 behaviors, so I didn't say that we wouldn't use or 7 consider the data. 8 MR. LEWIS: I think the comment that 9 Karen mentioned right now what we've been saying for 10 our past few meetings in terms of looking at other 11 data sources. Looking at Environment Canada, for 12 example. And look at the applicability of how it can 13 be applied here I think, so your comment now is 14 aligning with what we've been saying since the spring 15 for these ECA discussions. 16 MS. PLOTZKE: Yes, and I guess I'll 17 just, this is Kathy, just add on to that because 18 there's been some reference about marine and certainly 19 we've done a food web study in Oslo Fjord. We've also 20 done a food web study in Lake Pepin. We've done food 21 web studies in Lake Ontario. We've done one just 22 recently in Tokyo Bay, so I know that is marine. But 23 we also just completed one in Lake Champlain in 24 Vermont in the United States this fall. So we are 25 doing, you know, food web studies within the UnitedSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 69

1 States on, with freshwater species and a lot of our 2 biota monitoring is with freshwater species. 3 MR. LEWIS: Ward, do you want to now 4 discuss other comments? 5 MR. PENBERTHY: I don't have any other 6 comments, really, at this point. I know we're winding 7 down to at least the regulatory limit for our 8 discussions, so I'm hopeful that there'll be some 9 modification to the positions over the next week or 10 two, but we'll see. 11 MR. LEWIS: Anything more from anyone 12 else? 13 MR. THOMAS: Well, just so in terms of 14 next steps, in terms of process, what's your 15 expectation in terms of what happens now? 16 MR. PENBERTHY: Well, we still have a 17 couple weeks to go, so we can't obviously -- we'll 18 brief upon chair we'll tell people the circumstances 19 as we have done before and at the end of the six-month 20 period, the decision will be made. 21 MS. FEHRENBACHER: It does appear that 22 the SEHSC position has not changed since the last 23 meeting and I think that's. 24 MR. PENBERTHY: -- that's what we'd be 25 telling people.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 70

1 MS. FEHRENBACHER: -- that's really 2 important -- 3 MR. PENBERTHY: Unless we hear 4 differently. 5 MS. FEHRENBACHER: -- for us to know. 6 MR. THOMAS: Well, again, the SEHSC 7 position was moderated I think during, our last 8 meeting when we talked about the mix of sites. I think 9 the fundamental underpinning of our proposal is, 10 again, going to be how you do a risk assessment. I 11 guess our view is that the agency has made little move 12 as well with respect to philosophical approach to this 13 monitoring program. We think the discussion merits 14 more than just considering numbers of sites and so 15 forth. I mean, I think the real substantive basis for 16 the program should be what you're trying to accomplish 17 and I guess if we could come to some mutual agreement 18 in terms of how we do that, I think that's what will 19 precipitate any potential changes in the proposal. 20 MR. PENBERTHY: We are not going to 21 start the activity with a worst-case assessment. 22 That's, that would lead to multiple recycles on 23 assessments that would go on decades. We have a plan 24 for doing a risk assessment in 2014 and it's going to 25 be assessment that would hopefully support aSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 71

1 regulatory action if necessary. That's the guidance 2 that we're operating under and have been given. So to 3 the extent that we can't get to a proposal for a 4 monitoring agreement that would support that 5 objective, then it's hard to see how this ends up. 6 MR. THOMAS: So you think the -- doing 7 an assessment the way the agency has typically done it 8 would require a process that went on for decades? 9 MR. PENBERTHY: Well, if we get into an 10 ECA for a limited number of studies for anecdotal 11 data, that would take several years to accomplish, 12 clearly, then we'd do an evaluation and then we would 13 go through another protracted process like this to 14 develop yet another ECA to get more detailed 15 information if, in fact, there was a concern. That 16 would go on for another several years and so the 17 timeline just doesn't look profitable. We just want to 18 do a good job. Do it as scientifically valid, 19 defensible, that's what allows us to make a decent 20 evaluation. That's just not a maybe maybe-not type 21 judgment. 22 MS. CARLTON: One questions in response 23 to that comment. This is Betsy Carlton from Bluestar 24 Silicones. The most recent evaluation where we have a 25 final decision has been from Canada resulting from theSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 72

1 Board of Review. They indicated that there was no risk 2 now nor any anticipated in the future. 3 MR. PENBERTHY: Is that D4 or D5? 4 MS. CARLTON: This is for D5. 5 MR. PENBERTHY: Well, okay, but we're 6 interested in D4 and my understanding is that they 7 have a mandatory pollution prevention requirement for 8 D4, so obviously there are concerns in Canada for D4. 9 MS. CARLTON: Okay, well that was-- 10 MR. PENBERTHY: So now we have 11 concerns. Their concerns support ours more than 12 anything, so that would tell me that we just-- 13 MS. CARLTON: Yeah, my question was 14 going to be what's your basis for your concern and 15 you've just answered that question before I asked it, 16 so thank you. 17 MR. PENBERTHY: Okay, good. 18 MR. THOMAS: Would you guys be opposed 19 to a brief break and then we come back and wrap-up? 20 MR. PENBERTHY: Sure. 21 MR. LEWIS: Five minutes. 22 (WHEREUPON, a brief recess was taken.) 23 MR. LEWIS: This is Paul Lewis and let 24 us re-continue or continue our discussion. Karluss, I 25 know you wanted a break to caucus with your group andSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 73

1 anything that you want to share with us at this time? 2 MR. THOMAS: Well, I just want to get, 3 if you guys would indulge us for a minute, could we 4 just clarify what the most recent version of the 5 agency's proposal is and in particular the indirect 6 discharge piece and what you intend to gain from that? 7 MR. LEWIS: Ward? 8 MR. PENBERTHY: The indirect discharge 9 piece, let me just rehash this so I have it straight 10 in my own head. There are SEHSC facilities, some are 11 manufacturing, some are processing, some are 12 formulating, some are all three, some are a 13 combination. But they discharge to POTWs. So we 14 think it's important to have those sites monitored. I 15 think, our estimate, there was, as I recall, five 16 sites that have water discharge some and we want your 17 confirmation because some of those sites don't 18 actually have a discharge to a POTW. I think there's 19 nine total sites. And of those nine, five have a 20 water discharge to a POTW. We would need confirmation 21 about that. That's our best understanding from our 22 discussions, so we would want all of those monitored 23 as well. 24 MR. THOMAS: And, and, and I don't 25 remember the exact numbers, but for those thatSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 74

1 discharge to a POTW, so those that we are calling 2 indirect dischargers as opposed to those that are 3 direct dischargers which we fully agree to have 4 monitored, just to clarify again, what's the value of 5 having those sites monitored from a risk assessment 6 perspective? 7 MR. PENBERTHY: Well, it's a -- I mean, 8 it's just a different circumstance, right? 9 MR. THOMAS: Well, but there's no 10 environmental release, so I don't see how it informs a 11 risk assessment if you're discharging to a POTW. 12 MR. PENBERTHY: You're releasing to a 13 POTW, right? 14 MR. THOMAS: Correct. 15 MR. PENBERTHY: TRI calls that a 16 release, right? And then something else happens to 17 it. It's treated, right? 18 MR. THOMAS: Correct. 19 MR. PENBERHTY: Okay. So that's what 20 we want to understand. 21 MS. PLOTZKE: It's treated at the POTW. 22 MR. PENBERTHY: Correct. 23 MS. PLOTZKE: So there's no, there is 24 no release to a direct environmental compartment. 25 MS. FEHRENBACHER: There's a pipe.Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 75

1 MS. PLOTZKE: There's a pipe, so when 2 we talk about biota-- 3 MR. PENBERTHY: Look are you saying that 4 100 percent of it that goes to the POTW is treated and 5 nothing goes out the effluent of the POTW? 6 MR. THOMAS: Well, whatever comes out, 7 you can monitor the POTW to know what comes out. You 8 don't need to monitor what comes out of the facility 9 to know what comes out of the POTW. 10 MS. PLOTZKE: You can't monitor the 11 indirect site to know exactly what's coming out of the 12 POTW. 13 MR. PENBERTHY: We want to understand 14 what's going in and what's coming out because then you 15 get to understand how that POTW is actually operating 16 and its effectiveness. 17 MR. THOMAS: And I think you understand 18 the point, we won't continue to debate it, but I think 19 the philosophical differences, we don't believe the 20 releases going into that POTW are of any consequence 21 from an environmental release perspective. You're 22 absolutely right, well, you may be right in your 23 suggestion that not all of it is treated. We don't 24 know that, but we feel like you can figure that out if 25 you monitor the POTW. You don't need to know whatSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 76

1 goes into the POTW to get a sense for what the 2 potential environmental releases are, so again, I 3 think that's just a -- we'll just agree that there's a 4 philosophical difference there with respect to our 5 approach for this risk assessment. 6 MS. FEHRENBACHER: I would also like to 7 comment that one of your suggestions was to maintain 8 consistency between new chemical and existing chemical 9 assessments and this is, indeed, the way that we 10 perform an assessment for both new chemicals and 11 existing chemicals where there are industrial 12 manufacturing, processing, and formulating releases 13 from facilities. We assess those releases through 14 discharge to the environment and treatment. That is 15 our standard process. 16 MR. THOMAS: Well, I guess I was going 17 to make-- 18 MS. FEHRENBACHER: And it's consistent 19 with what you asked us to do. 20 MR. THOMAS: I guess I would make a 21 distinction between regulatory reporting requirements 22 and what's necessary for a risk assessment. So while 23 that may be true, what you just mentioned in terms of 24 reporting requirements, I'm not sure that's 25 necessarily consistent with what you'd use for a riskSiloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 77

1 assessment. 2 MS. FEHRENBACHER: No, that's not 3 reporting requirements. I was describing the approach 4 that we use for generating an assessment of exposure. 5 MS. PLOTZKE: But it's a calculated 6 exposure. It's not a monitoring program. 7 MR. PENBERTHY: It doesn't have to be 8 if we have data. We would use it. 9 MS. FEHRENBACHER: And the reason that 10 we were so interested in obtaining release information 11 from you on all of the member facilities. 12 MR. PENBERTHY: So you need to know the 13 number or you can't do an assessment. 14 MR. THOMAS: Right, I guess again, we 15 would suggest that you could sufficiently understand 16 the loadings for monitoring around the POTWs because 17 that's where the release into the environment occurs 18 potentially. 19 MR. PENBERTHY: Okay. But you 20 understand where we're getting at, we just disagree. 21 MR. THOMAS: The other clarification I 22 wanted to make was around D5 and the agency's goals 23 with respect to what the agency is going to do with 24 the D5 data. Is there a view that the D5 data is as 25 essential as the D4 data?Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 78

1 MR. PENBERTHY: No. 2 MR. THOMAS: All right. I think that's 3 all of the questions that I have. Do others around the 4 table or on the phone have questions? 5 MR. LEWIS: Any questions from the 6 phone? Any final comments from the agency? 7 MR. PENBERTHY: No. I'm okay. 8 MR. LEWIS: Are we talking to our 9 management and letting them know in terms of where we 10 are in the discussion today? I think we all recognize 11 and appreciate in terms of that there's only a few 12 weeks remaining in terms of this process. So we want 13 to make sure that they're aware of this and I know 14 Karluss and your parties are also aware of that and 15 we'll go from there. 16 MR. THOMAS: Okay. Well, thank you 17 again for the time for this meeting. Thanks again for 18 the previous meetings. I know some of the 19 conversations have been difficult, but I do want to, 20 again, express our commitment to moving forward with 21 this. One final comment, I guess I'm just kind of 22 curious. Notwithstanding data that is generated for 23 this program or not, would the agency use data that 24 came in for a risk assessment just in general? If you 25 got data in that would inform a risk assessment for D4Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 79

1 or D5 or any thing else outside of the context of a 2 program like this, would the agency use that 3 information for the work plan assessments? 4 MR. PENBERTHY: Well, we would 5 certainly consider it. I don't know if we would use 6 it, but certainly we would pay attention to it. 7 MR. THOMAS: Okay. 8 MR. PENBERTHY: I would say thank you 9 for all of your participation. I know you've put a 10 lot of time and effort into all of this, so thanks for 11 meeting with us today. It's been very enlightening, 12 the whole process. Thank you. 13 (WHEREUPON, the Meeting was concluded 14 at 3:23 p.m.) 15 16 17 18 19 20 21 22 23 24 25Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 80

1 STIPULATION 2 3 The foregoing matter was taken on the date, and 4 at the time and place set out on the title page 5 hereof. 6 7 It was requested that the matter be taken by the 8 reporter and that the same be reduced to typewritten 9 form. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 81

1 CERTIFICATE OF REPORTER AND FOR SECURE ENCRYPTED 2 SIGNATURE AND DELIVERY OF CERTIFIED TRANSCRIPT 3 I, JASON ALAN LEES , Notary Public, do hereby 4 certify that the forgoing matter was reported by 5 stenographic and/or mechanical means, that same was 6 reduced to written form, that the transcript prepared 7 by me or under my direction, is a true and accurate 8 record of same to the best of my knowledge and 9 ability; that there is no relation nor employment by 10 any attorney or counsel employed by the parties 11 hereto, nor financial or otherwise interest in the 12 action filed or its outcome. 13 This transcript and certificate have been 14 digitally signed and securely delivered through our 15 encryption server, Brainloop. 16 All securely delivered documents are logged in a 17 tamper-proof audit trail to eliminate the use of 18 screen capture tools. 19 IN WITNESS HEREOF, I have here into set my hand 20 and delivered through encrypted server this 18th day 21 of December, 2012. 22 23 /s/JASON ALAN LEES 24 COURT REPORTER / NOTARY 25 My Commission Expires: October 2, 2016Siloxane Technical Working Group December 6, 2012 CCR # 16194-7 Page 82

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