### 202-234-4433 Neal R. Gross & Co., Inc. Page 1 UNITED STATES OF AMERICA

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ENVIRONMENTAL PROTECTION AGENCY (EPA)

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SILOXANE ECA NEGOTIATION

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WEDNESDAY JUNE 27, 2012

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The Siloxane Negotiation commenced, at 10:00 a.m., in Room 1117A, EPA East, 1201 Constitution Avenue, NW, Washington, D.C., Paul Lewis of the EPA, moderating.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 2 EPA PARTICIPANTS: PAUL LEWIS, Moderator JOE AVCIN JESSICA BARKAS JESSICA BELL KAREN EISENREICH CATHY FEHRENBACHER CORY JENSEN ROBERT JONES ANNE KIM NGAN NGUYEN WARD PENBERTHY MARK SELTZER TODD STEDEFORD DAVID TOBIAS

INTERESTED PARTIES:

AMERICAN CLEANING INSTITUTE Paul DeLeo BLUESTAR SILICONES USA CORP Betsy Carlton Jim Blum Ellen Mihaich DOW CORNING CORPORATION Kathleen Plotzke

EVONIK GOLDSCHMIDT CORPORATION Russell Mait NATIONAL ASSOCIATION OF CLEAN WATER AGENCIES Cynthia Finley MOMENTIVE MPM SILICONES, LLC. Lisa DuMars PERSONAL CARE PRODUCTS COUNCIL Thomas Myers SHIN-ETSU SILICONES OF AMERICA INC. Gene Browning SILICONE ENVIRONMENTAL HEALTH AND SAFETY COUNCIL OF NORTH AMERICA (SEHSC) Karluss Thomas WACKER CHEMICAL CORPORATION Hugh Flack Elaine Boyd

### 202-234-4433 Neal R. Gross & Co., Inc. Page 3 OBSERVERS:

SHISEIDO AMERICAS CORPORATION Akihiro Kinoshita Noriko Shibuya

ALSO PRESENT:

TRENT DOYLE, Keller Heckman TRACY GUERRERO, SEHSC RAY HILEY, Momentive JENNY HOPKINSON, Inside EPA

WENDY KOCH, Consultant to Evonik Goldschmidt GARY KOZERSKI, Dow Corning Corporation RAYMOND B. LUDWISZEWSKI, Gibson, Dunn &

Crutcher GEORGE MISKO, Keller Heckman PAT RIZZUTO, Chemicals Reporter BNA CHARLES STAPLES, Consultant for SEHSC

KEVIN WESS, Momentive

### 202-234-4433 Neal R. Gross & Co., Inc. Page 4 C-O-N-T-E-N-T-S

Call to Order 5 Paul Lewis EPA Introductions, Purpose, Goals, and 5, 12 Objectives Paul Lewis EPA

Ward Penberthy 16 EPA

Identification of Interested Parties 8

Industry Presentation 18, 76 Karluss Thomas SEHSC Opportunity for Interested Party 29, 60, 67 Comments 78

EPA's Response 30 Ward Penberthy EPA

Questions and Responses 31, 61, 72 Next Steps 78 Ward Penberthy EPA

Questions and Comments 80

### 202-234-4433 Neal R. Gross & Co., Inc. Page 5 1 P-R-O-C-E-E-D-I-N-G-S

2 10:06 a.m. 3 MR. LEWIS: I would like to 4 welcome everyone today to our public meeting 5 discussing an enforceable consent agreement 6 for two siloxanes. 7 I am Paul Lewis with the Office of 8 Pollution Prevention and Toxics, and I am 9 joined by my colleagues Ward Penberthy and 10 Cathy Fehrenbacher, in addition to several EPA 11 colleagues here who have helped us today 12 preparing for this meeting. I want to thank 13 them all in terms of their contributions in 14 preparing for our discussion. 15 I want to provide some background 16 in terms of topic today before we go into the 17 substantive part of the agenda. 18 On May 24th, 2012, the EPA 19 announced in The Federal Register holding a 20 public meeting today to negotiate an 21 Enforceable Consent Agreement, commonly called 22 an ECA, to collect certain environmental

### 202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 monitoring data on D4 and D5. 2 As background, EPA has concerns 3 about the environmental effects of D4 and D5, 4 two high-production volume chemicals with a 5 wide variety of industrial, commercial, and 6 consumer uses, including cleaning agents and 7 products, adhesives, personal care products, 8 paints, textiles, and manufacturing processes. 9 In addition, on June 1st, 2012, EPA identified 10 D4 as one of 18 additional work plan chemicals 11 for assessment during 2013-2014. 12 EPA has an evaluate poll submitted 13 by the Silicons Environmental, Health and 14 Safety Council, commonly known and we will be 15 discussing as SEHSC. And the agency believes 16 that proceeding with a negotiation of an ECA 17 is an efficient means for obtaining data to 18 help develop a better understanding of the 19 potential for environmental effects of these 20 chemicals. 21 The Federal Register notice 22 indicated that those interested in

### 202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 negotiations today will be given the status of 2 an interested party and were told to notify 3 the agency in The Federal Register by June 4 25th of this year. 5 The interested parties committed 6 to participate in the negotiation process. 7 That is going to be here today in the 8 substantive negotiation process. And other 9 members of the public may attend the 10 negotiation meetings as observers, but then 11 identify themselves, as the parties will not 12 be permitted to participate in the 13 negotiations. Eleven organizations have 14 notified the agency as interested parties in 15 the ECA negotiation. 16 I would like to request at this 17 time that each interested party identify 18 themselves and briefly explain their interest 19 in the ECA. I will be listing the interested 20 parties in alphabetical order, beginning with 21 the American Cleaning Institute. 22 Are you present?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 DR. DeLEO: Paul DeLeo of the 2 American Cleaning Institute. 3 MR. LEWIS: Could you speak into 4 the microphone?

5 DR. DeLEO: Sure. 6 MR. LEWIS: And while the American 7 Institute is coming to the table, let me just 8 remind everyone that this meeting is being 9 recorded and to please identify yourself and 10 speak into the microphone. 11 DR. DeLEO: Good morning. 12 I am Paul DeLeo with the American 13 Cleaning Institute. As part of our 14 membership, we have companies that are 15 suppliers of a variety of siloxane 16 ingredients, well, a number of industries. 17 And also, we have companies that formulate 18 cleaning products, and siloxanes are used, a 19 variety of siloxane materials used in cleaning 20 products. So, that is the nature of our 21 interest in being an interested party as part 22 of this process.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 MR. LEWIS: Thank you. 2 The next is Bluestar Silicones. 3 MS. CARLTON: Yes, I'm -- 4 MR. LEWIS: Bluestar Silicones, 5 please come to the table. Thank you. 6 MS. CARLTON: I'm Betsy Carlton. 7 I am with Bluestar Silicones. With me today, 8 also, is Ellen Mihaich and Jim Blum. Bluestar 9 Silicons is a member of SEHSC, and we have 10 actively participated in the development of 11 the proposal for the ECA. 12 MR. LEWIS: Next is Dow Corning 13 Corporation. 14 DR. PLOTZKE: Hi. This is 15 Kathleen Plotzke. I am the Director of our 16 Health and Environmental Sciences Group at Dow 17 Corning, and we are also a member of SEHSC. 18 MR. LEWIS: Evonik Goldschmidt? 19 MR. MAIT: Right here. 20 MR. LEWIS: Okay. 21 MR. MAIT: I am Russell Mait, 22 Director for Environmental Health, Safety, and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 Quality for Evonik Goldschmidt. Evonik 2 Goldschmidt is a processor of siloxanes. We

3 are also a member of SEHSC. 4 MR. LEWIS: Next is the National 5 Association of Clean Water Agencies. Please

6 come to the table. 7 MS. FINLEY: I am Cynthia Finley. 8 I am Director of Regulatory Affairs for NACWA, 9 the National Association of Clean Water 10 Agencies. We represent municipal waste water 11 treatment agencies. 12 MR. LEWIS: Momentive MPM 13 Silicones? 14 MS. DuMARS: Lisa DuMars, 15 Momentive Performance Materials. We are also 16 members of SEHSC and have sites in the U.S. as 17 manufacturers and processors. 18 MR. LEWIS: Next is the Personal 19 Care Products Council. 20 MR. MYERS: Hi. My name is Tom 21 Myers. I am the Associate General Counsel 22 with the Personal Care Products Council. Most

### 202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 of our members utilize siloxane in some form 2 or fashion, particularly the cosmetic 3 companies, which is why we have an interest in 4 the proceedings today. 5 MR. LEWIS: Thank you. 6 Next is Shin-Etsu Silicones. 7 MR. BROWNING: I am Gene Browning. 8 I am an independent consultant and I represent 9 Shin-Etsu Silicones of America, who are 10 importers, processors, and formulators of 11 these two chemicals. 12 MR. LEWIS: Thank you. 13 SEHSC? Please identify yourself.

14 MR. THOMAS: Yes. Hello. I am 15 Karluss Thomas, the Executive Director for the 16 Silicones Environmental Health and Safety 17 Council of North America. As you know, SEHSC 18 developed the proposal on behalf of its member 19 companies. 20 MR. LEWIS: Thank you. 21 Two more. Unilever? Is Unilever

22 here?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 (No response.) 2 Oh, Unilever is not here. Okay. 3 Wacker Chemical Company? 4 MR. FLACK: My name is Hugh Flack. 5 I am Director of Environmental Regulatory 6 Affairs for the Wacker Chemical Corporation. 7 Along with me is Elaine Boyd, who is serving 8 as Chair, as member of the SEHSC. 9 MR. LEWIS: Thank you. 10 Before I discuss the terms of the 11 ECA procedures, can we just go around the 12 table, now that we have interested parties 13 identified, and if you have not identified 14 yourself, please identify yourself and your 15 affiliation. 16 (Off mic introductions.) 17 I will use this microphone since I 18 have better clarity here. 19 I want to continue in terms of 20 discussing the ECA procedures. The ECA 21 procedure, it follows 40 CFR 790.22, which is 22 procedures for development of a consent

### 202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 agreement. It contains provisions to ensure 2 the public is accorded a chance to participate 3 in ECA negotiations and that the views of 4 interested parties are taken into account 5 during the negotiation process. 6 All negotiation materials for the 7 development of the ECA will be open to the 8 public, and minutes of today's and any 9 subsequent meetings that are needed will be 10 placed in the docket. In addition, as you 11 walked in today, you received several pieces 12 of information, the agenda, The Federal 13 Register notice announcing today's meeting. 14 Again, all this material will be placed in the 15 docket for public review and inspection. 16 The EPA will advise interested 17 parties and the public of meeting dates and 18 available meeting minutes, proposed consent 19 agreement, background documents, and other 20 materials distributed at negotiation meetings. 21 A negotiation schedule can be 22 established at today's meeting, but it cannot

### 202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 exceed a period of six months from today's 2 meeting. In other words, we need to complete 3 this ECA negotiation by December 27th, 2012. 4 If an ECA is not final within six

5 months and EPA does not choose to extend the 6 negotiation time period, negotiations will be 7 terminated and any unmet data needs may be 8 pursued via a test rule promulgated under TSCA 9 Section 4. 10 EPA will circulate a draft of the 11 ECA to all interested parties if the EPA 12 concludes that such a draft is likely to 13 achieve final agreement. EPA will enter into 14 consent agreements only where there is a 15 consensus among the agency, manufacturers and 16 processors agree to conduct responsible 17 testing, and all interested parties have 18 identified themselves. 19 Thirty days will be provided for 20 submitting comments or written objections to 21 the ECA. But, again, I want to emphasize that 22 this ECA must be completed within six months

### 202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 from today's meeting, again, December 27th,

2 2012. 3 Before I move on to the next phase 4 of the agenda, I just want to again review the 5 agenda that we have today. There will be a 6 presentation by SEHSC. We will provide an 7 opportunity for comments from interested 8 parties that are present here today. And 9 then, there will be an opportunity for EPA to 10 provide a response to both the presentation by 11 SEHSC and interested parties. Then, we will 12 have a general discussion here at this meeting 13 in terms of what we heard from the ECA and in 14 terms of means to develop consensus and, then, 15 in terms of next steps as part of our process, 16 as part of this negotiation over the next six

17 months. 18 I want to again remind everyone 19 that this meeting is recorded, to please 20 identify yourself when you speak and speak 21 into the microphone. 22 Thank you.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 Ward, do you have any comments? 2 MR. PENBERTHY: Yes. First of 3 all, I would like to thank SEHSC for their 4 proposal. I think that is a great step 5 forward. Obviously, we wouldn't have entered 6 into this whole process if we didn't think 7 there was a good possibility of a favorable

8 outcome. 9 So, I am looking forward to the 10 discussions. I hope we can wrap this up 11 fairly quickly in a couple of hours, right? 12 (Laughter.) 13 But, anyway, I guess Karluss, 14 SEHSC, is next on the agenda. You have 15 prepared a presentation, and so please go

16 ahead. 17 MR. THOMAS: All right. Thanks,

18 Ward. 19 On behalf of SEHSC, I would really 20 like to thank EPA for the opportunity to 21 provide this overview of the proposal. We 22 certainly would like to hope that, based on

### 202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 all of the hard work that has gone into this 2 effort, we certainly hope that we can come up 3 with a proposal that is mutually-acceptable

4 for both our members and EPA. 5 Can everybody hear me? No? Is 6 this better? Okay, is this better? No? The 7 green light is on. I will just talk really 8 loud. Can people hear me now? Okay. 9 What I am going to do is provide a 10 really brief overview of the proposal. I 11 think the detailed proposal was provided to 12 the EPA docket. In addition, there was a 13 written copy of the proposal on the table 14 outside. So, what I would like to do is just 15 sort of run through the high-level components 16 of the program. And it sounds like subsequent 17 to this, we are going to have a more full 18 discussion of all the details. 19 All right. Well, consistent with 20 EPA's stated goal for the program, and also 21 with Paul's remarks earlier, the real purpose 22 of the proposal was to provide additional

### 202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 information on the presence and the 2 concentrations of both D4 and D5 in the 3 environment, and on the sources of and 4 pathways to releases of environmental 5 concentrations of D4 and D5. 6 As the basis for the proposal, we 7 used a variety of different inputs. Firstly, 8 we used some generic conceptual site models 9 that were developed for D4 and D5. And I will 10 talk a little bit more about those in a few 11 moments. We also utilized existing monitoring 12 data for the materials, available science on 13 the environmental properties, the 14 physical/chemical parameters of D4 and D5, 15 also feedback that we received from the 16 agency. We also used some of the results of 17 consultations with an environmental consulting 18 firm, and we also used the existing 19 international monitoring program for D4 and D5 20 that industry has voluntarily entered into. 21 With respect to the conceptual 22 site models that I mentioned earlier, SEHSC

### 202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 contracted with an environmental consultant to 2 actually develop these conceptual site models. 3 The real basis for the conceptual site models 4 was facility release data that was generated 5 by SEHSC members for their facilities here in 6 the U.S. These estimates were prepared by 7 each member company, at their own expense I 8 might add. And those specific data, 9 aggregated by manufacturer, processor, and 10 formulator, were provided to the environmental 11 consultant to develop the conceptual site

12 models. 13 So, the consultant further 14 reviewed the data, and then they were 15 aggregated by facility type. This aggregation 16 was really important to be able to protect 17 proprietary facility process data and, also, 18 intellectual property.

19 One of the comments that we had 20 received earlier with respect to some of the 21 information was that the agency might be 22 interested in more specific facility release

### 202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 data from some of the specific facilities. I 2 just wanted to point out here that it would be 3 difficult, if not impossible, to provide those 4 data because of the proprietary nature of that 5 information. 6 With respect to the ultimate 7 results of what the conceptual site models 8 showed, essentially, we found that inhalation 9 exposure resulting from dispersion in air was 10 the primary pathway and primary release for 11 these materials. We also wanted to point out 12 that, because this pathway applies to only 13 human receptors, ecological receptors are 14 typically not evaluated for their inhalation 15 exposure risk. So, this particular pathway is 16 not a significant component of the proposal we 17 are going to talk about here today. 18 Also, it is important to note that 19 exposures via sediment, including direct 20 exposure for bottom-dwelling biota and 21 indirect exposure via the food chain to 22 ecological receptors represents the most

### 202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 important pathway to the environment for these 2 materials. 3 And I will just stop with this for 4 a real brief moment. I know this is almost 5 impossible for you guys to see at the back of 6 the room. But this is just the result of the 7 generic CSM4 industrial facilities. 8 I want to talk a little bit now 9 about some of the monitoring results that I 10 mentioned earlier that helped provide some of 11 the information that was used to develop the 12 proposal. I think it is really important to13 point out that detectable in terms of the non14 U.S.-based studies for which there is a fair 15 amount of data, detectable concentrations of 16 D4 and D5 are predominantly found in air, 17 wastewater treatment influents, sludge to a 18 lesser extent, sediments impacted by

19 wastewater effluents. There have also been 20 detectable concentrations of both D4 and D5 in 21 sediments that were variable and typically 22 associated with high-population areas.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 There are also some detectable 2 concentrations in the Arctic, but they were 3 generally very low and non-detect and only in 4 areas where there has been some human impact. 5 Both the Austrian wastewater treatment 6 monitoring results and the wastewater 7 treatment monitoring results from Oregon8 generally show that these materials are non9 detects and you don't find them. 10 In Japan, there were detectable 11 amounts of materials found in sediments, but 12 consistent with the data we have seen in 13 Canada and other areas, it is typically 14 associated with areas that are impacted by 15 industrial and municipal wastewater treatment. 16 And the Canadian influent and 17 effluent monitoring report, detectable 18 concentrations in effluent, but the scientific 19 review indicates that all D4 concentrations 20 and most D5 are below the limit of detection. 21 I think it is also worth pointing 22 out here that all of these data are very

### 202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 consistent with the ultimate results of the D5 2 water review in Canada, which concluded that 3 D5 did not pose a risk to the environment. 4 Here I think what we really wanted 5 to point out was that, with respect to all of 6 the manufacturing, processing, and formulation 7 facilities that are under SEHSC's control, the 8 focus of the proposal is really on direct 9 discharge sites for which SEHSC members have 10 control. There were four of those sites, all 11 four of which will be monitored as part of 12 this proposal. 13 Here I just wanted to briefly 14 summarize all of the MPF sites that are going 15 to be included in the monitoring program. We 16 have got one facility in Sisterville, West 17 Virginia, that is a Momentive facility that is 18 involved in D4 and D5 processing. There is a 19 Dow Corning facility in Kentucky that is 20 involved in manufacturing and formulation. 21 There is a Wacker facility in Adrian, 22 Michigan, that is involved in processing and

### 202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 formulation for both D4 and D5, and there is 2 an additional Momentive facility in Waterford, 3 New York, that is involved in manufacturing, 4 processing, and formulation. 5 With respect to the monitoring 6 parameters, the proposal is to monitor 7 effluent, surface water, sediment, fish, 8 benthic species, and there would be two 9 monitoring events for each facility. 10 And again, the basis for these 11 monitoring parameters was the fact that, 12 because the proposal was focused on 13 environmental releases, the thought is that 14 these parameters gave the most useful 15 information for that purpose.

16 Now I want to move to the 17 wastewater treatment plant, the municipal 18 wastewater treatment plant conceptual site 19 model. I won't spend a lot of time here. 20 What I will focus on is the thinking that went 21 into the development of the proposal for the 22 municipal wastewater treatment sites.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 So, the design considerations for 2 the wastewater treatment plant monitoring 3 proposal, initially, we developed and gained 4 agreement on a set of parameters that would be 5 used as the basis for site selection. I will 6 talk a little bit more about those parameters 7 in a few minutes. We ran EPA's EFAST model to 8 predict surface water concentration 9 distributions for municipal facilities.

10 We also ran the ISTREEM model to 11 predict the geographic distribution of those 12 surface water concentrations. We looked more 13 closely into the detailed ISTREEM datasets, 14 and this was from the EPA Needs Survey, to 15 begin the monitoring site selection process. 16 From that, we developed a preliminary list of 17 potential monitoring sites and, then, reviewed 18 a number of the recent monitoring studies, 19 which I alluded to earlier, to provide some 20 additional insight. 21 Following that, we looked at 22 approximately 14,000 sewage treatment plants

### 202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 in the U.S., and these were from the EPA 2004 2 Needs Survey. We examined data onsite to 3 produce a smaller list of sites that could be 4 evaluated in more detail. And then, that list 5 was sorted by treatment type.6 We targeted sites in high7 population areas with low dilution. There was 8 also consideration given to sites that covered 9 a geographic range with an emphasis on 10 watersheds with high-population density. We 11 used that to predict influent and effluent 12 concentrations and examined those with the 13 higher concentrations in effluent. Those were 14 given the highest priority. 15 So, the specific factors that we 16 agreed would be the focus of the proposal, and 17 the proposal includes monitoring for five 18 sites. The first site would be an activated 19 sludge site with high population/low dilution 20 that was capped. And that would allow some 21 monitoring of air at that particular site. 22 The second site would be an activated sludge

### 202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 site with high population/low dilution. The 2 third site would be an oxidated ditch, high 3 population/low dilution. The fourth site 4 would be a trickling-filter site with high 5 population/low dilution. And then, the final 6 site would be a lagoon, high population/low 7 dilution. Again, the focus on high population 8 and low dilution for many of these sites is, 9 again, to target environmental releases. 10 With respect to the monitoring 11 parameters for each site, the proposal 12 includes monitoring for influent, effluent, 13 surface water, biosolids, sediment, fish, 14 benthic species, air, again, at the first 15 site, and then, also, there would be two 16 monitoring events consistent with the number 17 of monitoring events for the manufacturing, 18 processing, and formulation sites. 19 So, again, we haven't identified 20 the specific sites that would correspond to 21 all of those five site characteristics. So, 22 the final steps for this particular part of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 the proposal would include reviewing municipal 2 wastewater treatment plant NPDES permits, 3 looking at industrial inputs, compliance 4 issues, changes in facility structure, and so 5 forth, to get a better sense for specific 6 facilities that meet those characteristics 7 that I talked about a little while ago. 8 We would also, obviously, 9 determine which sites are capped/covered, do 10 things like checking Google Earth and 11 contacting the plant operators; also, look at 12 additional information like historical 13 effluent concentrations, annual flow, 14 temperature, pH, and so forth. And then, 15 finally, conduct the site visits and, then, 16 obtain letter-of-cooperation access for the 17 specific sites that we would envision 18 monitoring. 19 So, that is sort of the high-level 20 summary of the proposal. Again, the details 21 were in the information that was in the 22 docket; also, provided outside in a written

### 202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 format. 2 And with that, I would be happy to 3 take any questions. 4 MR. LEWIS: Thank you, Karluss. 5 We appreciate the steps forward that you and 6 your organization have done in terms of 7 presenting this ECA. 8 Before we go into the questions, I 9 want to at least -- and we will have that 10 opportunity in general discussion -- I want to 11 give an opportunity for the interested parties 12 to have any comments about the presentation 13 that we heard this morning. 14 And again, thank you for your 15 discussion. 16 Are there any comments from 17 interested parties based on what we heard this 18 morning? If so, please identify yourself, the 19 organization you are with. 20 (No response.) 21 Just checking, any interested 22 party comments?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 (No response.) 2 Okay. Hearing none, now are there 3 any questions in terms of the presentation? 4 In terms of questions, let's start with 5 questions of clarification. 6 (No response.) 7 Okay. Hearing none on that, also, 8 very clear presentation. Thank you, Karluss. 9 Ward, I am going to give the 10 microphone over to you now in terms of moving 11 forward in terms of our EPA response and 12 discussion in terms of our negotiation.

13 MR. PENBERTHY: Just as some 14 background, just continuing with what we have 15 already mentioned, D4 is one of our 2013-2014 16 work plan chemicals. When it is designated 17 like that, what that means is we plan to do or 18 develop a risk assessment for D4 in that 19 particular time period. 20 Obviously, what we want is a risk 21 assessment that has some high-quality data 22 that supports a robust assessment. And

### 202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 clearly, if we can be assured that the data 2 developed in this ECA was representative of 3 sort of a national picture of D4 releases, 4 that would be very important to us. So, that 5 is basically our major objective in this ECA 6 discussion, is to develop the dataset to help

7 that. 8 As Paul mentioned, our concerns 9 are largely ecological in nature. And so, 10 that is clearly the focus of your proposal and 11 what we are interested in. 12 I guess I did have a few questions 13 about the presentation. In the summary of14 past monitoring data, when you mentioned non15 detects, was there a detection -- it wasn't 16 clear what the detection levels were in those 17 data. And so, I guess that is one basic 18 question. 19 MR. THOMAS: Yes, I would invite 20 our technical experts to answer that question. 21 I think Kathy, in particular, could answer

22 that much better than I could.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 DR. PLOTZKE: It actually depends 2 upon the site and who was doing it. So, what 3 Karluss summarized is really an overview of 4 everything that is available from our 5 environmental monitoring program as well as

6 others. There has been a number of other 7 individuals and organizations doing 8 monitoring. So, I would say maybe the lowest 9 sort of detection limit that we have been able 10 to achieve in sediment, for example, low 11 nanogram per gram in sediment. 12 And sediment has been primarily 13 the focus. Typically, when you are collecting 14 water and analyzing it, you are not finding 15 it. There's a lot of challenges really with 16 the water analysis. So, sediment has been the 17 primary focus. 18 MR. PENBERTHY: Okay. I guess, 19 broadly speaking, when you get down to just 20 the number of sites tested, I think we want to 21 develop an understanding of, again, how those 22 data would be representative of a national

### 202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 picture. I am not sure that, while I 2 understand the four direct discharge sites -- 3 so, those are sites, manufacturing sites, and 4 may be also processing and formulating sites 5 that have their own water treatment. Is that 6 how that is supposed to be? 7 MR. THOMAS: Well, we didn't 8 really get into whether each of those sites 9 had their own treatment or not. Again, that 10 would be sort of proprietary information. 11 That is why we developed the conceptual site 12 models. But, again, I think what we would 13 focus on is we are essentially monitoring all 14 of the direct discharge sites over which SEHSC

15 has some control. 16 MR. PENBERTHY: So, what does 17 direct discharge precisely mean, I guess is

18 what I am -- 19 DR. PLOTZKE: Maybe I can add. I 20 think we can say that these have waste onsite 21 or offsite, even wastewater treatment plant 22 facilities associated with these sites. The

### 202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 direct aspect of it is really that it is being 2 released to surface water versus going through 3 any other municipal wastewater treatment 4 plant. 5 MR. PENBERTHY: Okay. Okay. So, 6 is that all the SEHSC sites that are direct

7 releases? 8 DR. PLOTZKE: That is correct, 9 yes. 10 MR. PENBERTHY: Okay. Okay. Now 11 I am also unclear -- I think you mentioned 12 before previously there are 13 SEHSC sites. 13 Are some of those sites covered in the POTWs 14 that are being sampled? 15 MR. THOMAS: The specific POTW 16 sites have not been identified yet. But I 17 think even in that range of parameters that we 18 identified, there is certainly the possibility 19 that some of those specific sites could have 20 releases from manufacturing facilities or 21 processing facilities, including SEHSC member 22 facilities. But, again, those specific sites

### 202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 have not been identified yet. What we have 2 laid out here are the considerations or the 3 characteristics for the sites that we would be 4 looking for.

5 DR. PLOTZKE: And one of the 6 criteria that we did provide to the consultant 7 to look at, identifying the specific sites, is 8 to look at the location of those other sites 9 beyond the direct discharge. So, we are 10 including in that identification of the five 11 municipal wastewater treatment plant sites. 12 So, we don't know what that looks like yet 13 because we haven't done that part of it yet, 14 but that will be one of the criteria to look 15 for our indirect discharge sites and where 16 they discharge to. It is actually in the 17 proposal, but that is how we will do that. 18 MR. PENBERTHY: Okay. And for the 19 remaining nine sites, SEHSC sites, is there a 20 rationale for why they wouldn't be monitored

21 as well? 22 MR. THOMAS: Well, again, the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 focus was on environmental releases. So, the 2 thought was that those sites have releases to 3 municipal wastewater treatment plants. So, 4 they wouldn't likely have significant 5 environmental releases. 6 MR. PENBERTHY: So, how do you

7 know that? 8 DR. PLOTZKE: Yes, maybe I can add 9 to that. So, if you look at the additional 10 sites, you either have some that just have no 11 release, particularly to the water 12 environment, which is really the focus here 13 when you look at the conceptual site models -- 14 MR. PENBERTHY: Right.

15 DR. PLOTZKE: -- of the 16 facilities. 17 What it identified as the one 18 complete pathway for ecological receptors was

19 release to water. 20 MR. PENBERTHY: Right. 21 DR. PLOTZKE: So, what we looked 22 at is that we have some sites there that don't

### 202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 even have release to water. Or, if they are 2 released to water, it is through/into a 3 municipal wastewater treatment, which 4 obviously we have seen significant removal of 5 these materials before; then, it is discharged 6 into surface water. 7 So, what we tried to focus on is 8 really the areas for the direct sites, 9 obviously, that would have direct release to 10 surface water. And then, we have the 11 municipal wastewater treatment as part of the 12 program to cover what is beyond that. 13 MR. PENBERTHY: Okay. Well, I 14 understand why you wouldn't sample sites that 15 have no release of water to a POTW, but I am 16 not sure I understand why you wouldn't sample 17 the site, the influent to a POTW, and then, 18 possibly, the effluent and the sediment 19 associated with those POTWs. 20 DR. PLOTZKE: And again, once we 21 define those five sites there, that is one of 22 our criteria that we have outlined, that we

### 202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 will look for the location of our other sites 2 that have that indirect discharge, which, 3 then, in the municipal wastewater treatment 4 plant we have proposed we would sample the 5 influent. So, it would really capture that. 6 MR. THOMAS: So, the influent to 7 municipal wastewater treatment plants from 8 sites that aren't covered in this program 9 would not have any environmental release. So, 10 I think what Kathy is --

11 MR. PENBERTHY: I don't understand 12 that because a POTW has a certain efficiency, 13 right? So, it will have a release. 14 MR. THOMAS: Well, what goes into 15 the wastewater treatment plant won't have any 16 releases. Once it gets there, it is going to 17 get treated. So, the part of the program that 18 is designed to look at municipal wastewater 19 treatment plants, you are going to get 20 influent to those treatment plants; you are 21 going to get effluent; you are going to get 22 biosolids, surface water, and all those other

### 202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 things. 2 MR. PENBERTHY: Okay. Well, I 3 think I made my point, but -- 4 DR. PLOTZKE: Yes, it won't have a 5 direct release because it goes through the 6 municipal wastewater treatment plant. 7 MR. PENBERTHY: All right. 8 MR. DOYLE: Trent Doyle with

9 Keller Heckman. 10 To your point, in the proposal we 11 did put in our wastewater treatment plan, we 12 did say that the site where we plan to do the 13 air monitoring, that that would be a site that 14 receives processed wastewater from one of the 15 indirect discharges. So, that was a way to 16 assure that one of those five sites at least 17 would be covered from one of the main effluent 18 processing locations. 19 MR. PENBERTHY: I guess my concern 20 with that is that we don't know that that 21 would be necessarily representative of the 22 other sites. So, that is just another concern

### 202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 that we will have. 2 Now, moving on, and maybe we will 3 just do the sites that the program is first 4 addressing. You know, there are over 20,000 5 POTWs in the United States. And so, we are 6 just awfully concerned that sampling of five 7 of them won't really give us data that is 8 robust enough to do a risk assessment as we 9 plan to do. 10 So, we are concerned with just, do 11 you have a representative of sorts? Does it 12 cover the various treatment methods, the 13 various sizes, the various flow rates? Is the 14 sample pool going to be big enough to make a 15 reasoned evaluation in terms of reasons and, 16 then, hence, risks from basically five sites, 17 five POTWs? 18 Particularly, setting aside that 19 the manufacturing and processing and 20 formulating sites that are straight to the 21 POTW, I mean, those are almost a special case 22 in our view. And then, you just have the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 regular discharge through municipal effluent

2 or flow of POTW that we are also concerned 3 with. So, that is another issue. 4 I am not sure if five sites is -- 5 I mean, I guess the question would be, how do 6 you think we could or you could argue that 7 that data would be representative and cover 8 the circumstance we find ourselves in at EPA? 9 MR. THOMAS: Well, I guess I would 10 point to two things. One, the focus, again, 11 is on environmental releases. We do have some 12 other data that helps give us a basis for sort 13 of refining this proposal. 14 I would point to the wastewater 15 treatment plant studies that have already been 16 done, the one in the U.S., the one that was 17 run in Oregon. There was also one that I 18 mentioned earlier that was done in Austria. 19 We also have some results from monitoring 20 activities in Canada. And all of those have 21 shown pretty consistently that it is very 22 difficult to find these materials at the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 technical levels. 2 So, what we have focused the 3 proposal on is those characteristics that are 4 most likely to allow you to be able to find 5 the materials in detectable concentrations. 6 Those specific considerations are those that 7 have high population and low dilution. So, 8 the proposal is almost disproportionately 9 oriented to those sites with those 10 characteristics because we believe that is 11 where you most likely are going to be able to 12 find it. 13 And again, where those studies 14 have been done, it has been virtually 15 impossible to find it. If you look at the 16 data in Oregon, those results are available. 17 Certain of the data in Canada, that 18 information has been published. I can give 19 you copies of that, if you are interested. 20 And I am not sure about the Austrian results. 21 But, again, they have all 22 consistently shown that it is very difficult

### 202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 to find these materials. So, again, what we 2 focused on are those considerations that give 3 you the greatest possibility of finding it in 4 measurable concentrations. And we do believe 5 five sites allows you to do that.

6 DR. PLOTZKE: I can comment on the 7 treatment type as well and how we looked at 8 that. As Karluss indicated, a lot of this is

9 also based on all of the data that we have to 10 date, which is quite extensive on these 11 materials from a monitoring perspective. 12 So, in addition to this program 13 here, we have a Voluntary Product Stewardship 14 Initiative that includes one other site in the 15 United States as well as a site in Canada, 16 that it would be very similar to other sites 17 in the U.S. 18 In looking at the distribution of 19 wastewater treatment plants in the U.S., 20 predominantly, over 80 percent are activated 21 sludge. So, that is why we weighted it 22 heavier to the activated sludge between our

### 202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 Voluntary Product Stewardship Initiative and 2 this, and then looked at the other ones, which 3 are much smaller from a representative of the 4 United States. 5 MS. FEHRENBACHER: Cathy 6 Fehrenbacher with the Exposure Assessment

7 Branch at EPA. 8 Is there an analysis that you have 9 prepared that looks at the over 20,000 POTWs 10 and your determination that five sites would 11 be appropriate to represent? It sounds like 12 you are looking to represent the upper end of 13 those POTWs. Is there an analysis that you 14 have done that you could provide to us? 15 DR. PLOTZKE: What we have really 16 is the EPA database, is really the breakdown 17 of the different types of treatment plants 18 across the United States. So, basically, that 19 is what we did. The consultant pulled that 20 out for us, showed us that breakdown over the 21 different types. And you can clearly see the 22 activated sludge is really over 80 percent

### 202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 representing that. And so, that is why we 2 focused on the activated sludge within our 3 Voluntary Product Stewardship Initiative as 4 well as this program. 5 MS. FEHRENBACHER: So, is there an 6 analysis that you have prepared? 7 MR. THOMAS: You mean an analysis 8 of treatment type for municipal wastewater 9 treatment plants? 10 MS. FEHRENBACHER: An analysis 11 that you have developed that is the basis for 12 selecting five sites as being representative 13 of the high-end POTW treatment plants. We 14 know that there are over 20,000 facilities in 15 the U.S., and five seems to be a very small 16 number, based on other studies that the agency

17 has done. 18 DR. PLOTZKE: And if you look at 19 the report that was prepared for us by the 20 consultant, which we did supply, basically, 21 they came up with a sampling of five 22 representative sites from the different

### 202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 treatment types. 2 In addition, again, what we have 3 done, combined with our monitoring program, is 4 developed models that model the different 5 wastewater treatment plant sites. What the 6 modeling really does show is you are not going 7 to get a lot of variation really in what you 8 are going to see. It is dependent upon the 9 removal rates, which you can factor in. So, 10 we have even taken some of the models, for 11 example, and added lagoons into those models. 12 We revised them ourselves. So, in addition to 13 the monitoring, we are also using the models, 14 then, to validate and cross-check what we are 15 finding. 16 MR. LEWIS: As part of this 17 conversation in terms of number of sites, do 18 interested parties have any comments about the 19 discussion that we are hearing so far? 20 Yes, please identify yourself. 21 MS. FINLEY: This is Cynthia 22 Finley with NACWA.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 I won't state any opinion right 2 now about whether five POTWs is a good number 3 to sample or not. But I just wanted to 4 explain a little bit about the number of POTWs 5 in the U.S. 6 The number we usually cite is 7 about 16,000 POTWs, but the vast majority of 8 those are very, very small. So, it is kind of 9 important to understand the distribution there 10 when you are looking at that overall number of 11 POTWs. So, I will be interested in taking a 12 closer look at the analysis that was done in 13 coming up with the five, but I just wanted to 14 put that in perspective a little bit when you 15 are looking at that, that most of these are 16 very small treatment plants. 17 MR. LEWIS: Could you provide that 18 information to us in terms of what you have 19 available? 20 MS. FINLEY: I'm sorry? I

21 couldn't hear. 22 MR. LEWIS: An analysis in terms

### 202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 of 15,000 and how you characterized that most 2 of them are very small? Do you have anything 3 that you can provide to us that could provide

4 some -- 5 MS. FINLEY: All of the data is in 6 the Clean Watershed Needs Survey -- 7 MR. LEWIS: Okay. 8 MS. FINLEY: -- that EPA produces. 9 I could do an analysis, come up with the 10 numbers. I don't have any numbers offhand 11 right now. 12 MR. LEWIS: Okay. Great. Thank 13 you.

14 Other comments from other 15 interested parties? 16 (No response.)

17 No? 18 Ward, you want to continue? 19 MR. PENBERTHY: Sure. Okay. 20 So, I guess we have discussed the 21 manufacturing, processing, formulating sites, 22 the POTW sites. I guess in your proposal, the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 way I understand it, you are basically testing 2 the effluent and the sediment and the 3 receiving water; is that correct?

4 MR. THOMAS: For the wastewater 5 treatment plant portion?

6 MR. PENBERTHY: Correct. 7 MR. THOMAS: Yes, we are testing 8 the influent, effluent, surface water, 9 biosolids, sediment, fish, benthic species, 10 air at the first site, and, then, also, there 11 are two monitoring events. 12 MR. PENBERTHY: Okay. So, 13 influent, surface water. So, effluent is not

14 there? 15 MR. THOMAS: Yes, effluent we had. 16 MR. PENBERTHY: Oh, okay. Sorry, 17 sorry. All right. 18 I guess, why did you exclude the 19 testing of the sludge from the -- 20 DR. PLOTZKE: Biosolids. 21 MR. PENBERTHY: Oh, you have 22 biosolids?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 DR. PLOTZKE: Yes. 2 MR. PENBERTHY: Okay, okay. I 3 didn't see that. Okay. 4 All right. So, that seems fairly 5 complete by our reckoning. 6 Now that is for the POTWs. Is it 7 the same for the four SEHSC sites? There is 8 no influent to your treatment facility, right?

9 MR. THOMAS: Correct.

10 MR. PENBERTHY: And there are no 11 biosolids there? 12 MR. THOMAS: Well, again, the 13 focus here was to prioritize those that would 14 have environmental releases. So, the 15 biosolids and the influent would not have 16 environmental releases. 17 MR. PENBERTHY: Well, if they are 18 in the biosolids and, then, you have got land 19 applied, you don't see that as a release 20 possibility?

21 DR. PLOTZKE: Not from the 22 manufacturing, processing, and formulator, but

### 202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 that is why we did include the biosolids from 2 the municipal. 3 MR. PENBERTHY: Okay. Now, if you 4 do the biosolids from the municipal facility, 5 you know, the logical next step would be to do 6 the soil at the application site. 7 DR. PLOTZKE: And if you go to the 8 conceptual site model -- and I know this is 9 really hard to see -- but, again, what we 10 focused on really was the complete pathway. 11 So, if you could see this diagram, what you 12 would see is that, once you do the sludge 13 amendment of the soil, you get degradation in 14 the soil or volatilization to the air. So, it 15 becomes an incomplete pathway. So, that is 16 what the consultant determined based on the 17 dataset that we have available on these 18 materials, that that ends up being an 19 incomplete pathway to ecological receptors. 20 MR. PENBERTHY: So, there is an 21 analysis that supports that? 22 DR. PLOTZKE: There is quite a bit

### 202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 of data out there, yes. It is published, 2 peer-review published, on the degradation in 3 soil. 4 MR. PENBERTHY: Okay. 5 DR. PLOTZKE: On the behavior of 6 these materials, then, in soil. 7 MR. PENBERTHY: Okay. We will be 8 interested in that, I'm sure. 9 On the SEHSC sites, there is no 10 air monitoring, right? Is that because it is 11 not a capped wastewater treatment? Or what is 12 the rationale there? 13 MR. THOMAS: That, and, also, the 14 point that we made earlier, that those would 15 not be important for ecological receptors, and 16 the degradation pathways, similar to what 17 Kathy described for soil, would also be the 18 case for air. 19 MR. PENBERTHY: Thank you. 20 MR. LEWIS: Cathy, anything to

21 add?

22 MS. FEHRENBACHER: You have

### 202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 mentioned both times analyses that the 2 environmental consultant has conducted for 3 you. Have you submitted those to the agency?

4 MR. THOMAS: Yes. That was 5 submitted back in, I think it was, the end of 6 January. Yes, it was January 31st there was 7 a submission to the agency that included the 8 detailed report from the environmental 9 consultant. I think it was almost 80 pages, 10 but it includes a lot of the information that 11 you are mentioning, Cathy. 12 MS. FEHRENBACHER: We would like 13 to further explore the benthic species and any 14 proposed biota sampling. Could you provide 15 additional information on what you are 16 proposing there and how that might be 17 representative to support a national risk

18 assessment?

19 DR. PLOTZKE: And the actual 20 specifics haven't been identified yet because 21 that will be site-dependent. So, what we have 22 learned from monitoring with these materials

### 202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 and going to different sites already is that 2 it is very site-dependent conditions, whether 3 those type of things, as to what type of 4 species. So, it would be a representative 5 species of the site that we identify. We 6 would do that research ahead of time and 7 understand what the most appropriate benthic 8 species would be. 9 MS. FEHRENBACHER: And is there a 10 specific number of species that you are 11 proposing to monitor for?

12 DR. PLOTZKE: It would be a 13 representative benthic species like per site, 14 and, then, say, a top predator, forage type of 15 fish at the site as well. But the details 16 really would be developed per site, once we 17 identify those sites. 18 But, as an example as to what we 19 included in our submission, it is a sampling 20 plan that we are doing under the Voluntary 21 Product Stewardship Initiative that gives 22 quite a bit of detail on numbers and how that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 is determined. 2 MS. FEHRENBACHER: So, it is one 3 benthic species and one top predator, is what 4 you are proposing? And was that also included 5 in the January 31st deliverable? Or is

6 that -- 7 DR. PLOTZKE: That was included in 8 our proposal.

9 MS. FEHRENBACHER: In the 10 proposal? 11 DR. PLOTZKE: Yes, in the ECA and 12 in the appendix there is the sampling plans 13 and protocols that we used with the Voluntary 14 Product Stewardship Initiative, and it would

15 be modeled after that. 16 MS. FEHRENBACHER: Okay. And how 17 many sites are you proposing to conduct the 18 sampling at?

19 DR. PLOTZKE: It would be 20 associated with the five municipal wastewater 21 treatment plant sites, in addition to what we 22 are doing under the Voluntary Product

### 202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 Stewardship Initiative, which includes one 2 additional site in the United States, plus, 3 again, Canada, which would be very similar to 4 sites in the U.S. as well, and the direct 5 sites as well. It would be focused on -- the 6 direct sites would be per each direct site. 7 MS. FEHRENBACHER: Okay. So, that 8 would be a total of nine sites that you are 9 proposing with the indirect and the five

10 POTWs? 11 DR. PLOTZKE: Combined. And plus, 12 in addition to our Voluntary Product 13 Stewardship, which has four sites total. 14 MS. FEHRENBACHER: Okay. And have 15 you also provided the details of the Voluntary 16 Product Stewardship Program to us? 17 DR. PLOTZKE: Yes, that is in the 18 appendix as well of our submission. 19 MS. FEHRENBACHER: Okay. Okay. 20 We will take a look at that. 21 And you think that that 22 combination of sites would be representative?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 57 1 DR. PLOTZKE: Yes, and combined 2 with the dataset that we already have. So, we 3 already have pretty extensive monitoring on 4 biota with some of our programs as well that 5 is being prepared for peer-review publication 6 and has been presented around the world. 7 MS. FEHRENBACHER: Okay. And in 8 terms of the trophic levels that you are 9 proposing, could you provide some additional 10 rationale on why you think a single benthic 11 and a single higher trophic level is 12 sufficient to understand the bioaccumulation 13 for these compounds? 14 DR. PLOTZKE: And again, that 15 builds on the program that we have done 16 previously. So, we have done pretty extensive 17 biomagnification/trophic magnification 18 studies, Lake Pepin in Minnesota as well as 19 Oslo Fjord in Norway, to look at the behavior 20 within the tropic levels. We have that 21 understanding already. So, this would be, 22 basically, representing what we found in those

### 202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 trophic-level studies. 2 And the benthic organism really is 3 the focus because we know the highest 4 concentrations that you might find out there 5 in the environment really would be found in 6 the sediment. As well as, even if you look at 7 what we have done in Canada, we have completed 8 a risk assessment on sediment organisms and 9 have shown that there is no risk associated 10 with the concentrations that are being found 11 in environments that are probably very similar 12 to the United States. 13 MR. THOMAS: And, Cathy, the other 14 thing I would point out with bioaccumulation, 15 in particular, that was looked at in detail 16 and very comprehensively as part of the D5 17 water review, those three independent 18 scientists who are widely considered experts 19 on the top have concluded that D5 is not 20 bioaccumulative. 21 MS. FEHRENBACHER: Okay. So, you 22 think that the biota that you are proposing

### 202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 will provide a sufficient understanding of the 2 distribution within the food web?

3 DR. PLOTZKE: Yes. 4 MS. FEHRENBACHER: And you are 5 planning to build from the Lake Pepin and the 6 other work that was done in Canada?

7 DR. PLOTZKE: Yes. 8 MS. FEHRENBACHER: Okay. And are 9 you proposing -- you mentioned that the 10 sampling would be site-dependent. So, would 11 there be an initial characterization to 12 identify the representative species that would 13 be subject to monitoring? 14 DR. PLOTZKE: Yes, that is what we 15 have done with every one of our sites. 16 MS. FEHRENBACHER: Okay. I think

17 that -- 18 MR. PENBERTHY: I guess in the 19 proposals there is mentioned two sampling 20 events per site, I guess. What does that 21 exactly mean, and how do you time and choose 22 the events, and all that?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 DR. PLOTZKE: And we call it two 2 monitoring events. They could be spaced a 3 year apart, but they might not be. We will 4 also factor that in as we look at the 5 selection sites. 6 So, depending upon the geographic 7 locations, if we were to want to take one site 8 and sample during one season versus another, 9 then we might incorporate it that way. Or we 10 could space it just a year apart. So, that 11 will be factored into the design of the 12 selection of the sites. 13 And we do know right now from the 14 work that has been done in Canada already 15 looking at seasonality that there is not much 16 of an impact. But that would allow us to have 17 some flexibility if we wanted to incorporate

18 that. 19 MR. LEWIS: Interested parties at 20 this time, do you have any comments on what 21 you have heard so far as part of the 22 discussions this morning?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 (No response.) 2 Seeing none, Cathy, anything you

3 want to add?

4 MS. FEHRENBACHER: Yes. For the 5 biota monitoring that has been done, do you 6 recall the concentrations that have been 7 measured in those samples? 8 DR. PLOTZKE: I probably would 9 have to look that up, the specific 10 concentrations. But we selected sites like, 11 for example, Lake Pepin and Oslo Fjord because

12 we knew we would have detectable 13 concentrations. So, we wanted to ensure that 14 we had measurable concentration in biota, so

15 that we could look across the food web. 16 MS. FEHRENBACHER: Okay. And in 17 terms of characterization of the Lake Pepin 18 site, how do you characterize that in terms of 19 looking at the U.S. overall? Is it 20 representative? Is it a high-end kind of an 21 environment in terms of other environments 22 where you might find biota present in the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 U.S.? 2 DR. PLOTZKE: Yes. If you look at 3 sort of what feeds into Lake Pepin -- and we 4 have done quite a bit of characterization of 5 it because we had additional monitoring there 6 previously. But the City of Minneapolis, 7 really, and a number of wastewater treatment 8 plants feed into that portion into Lake Pepin, 9 which is really a part of the Mississippi. 10 So, it is pretty representative of the United

11 States. 12 MS. FEHRENBACHER: Okay. Thanks 13 for those clarifications on your proposal. 14 MR. LEWIS: Ward, other comments 15 you might have? 16 MR. PENBERTHY: You know, 17 obviously, when you get to the manufacturing, 18 processing, and formulating sites, we are 19 concerned that the gamut is not covered. I 20 guess, are there, of the 13 sites, specific 21 sites, there are specific sites, as I 22 understand it, that don't have releases to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 water or releases to other factors that would 2 basically mean their releases would be of 3 lesser interest. I mean, I am just trying to 4 understand how many of those, how many sites 5 are there that fit that kind of criteria. 6 MR. THOMAS: Which criteria now?

7 MR. PENBERTHY: That don't have 8 any releases to water or, you know, there are 9 circumstances of their releases that make them 10 not necessarily pertinent to the analysis that 11 we are trying to do. 12 MR. MAIT: Russell Mait with 13 Evonik. 14 Ward, I want to clarify, you are 15 asking are these facilities discharge 16 facilities?

17 MR. PENBERTHY: To water. 18 MR. MAIT: To water? My 19 recollection, there may be one or two, but not 20 the majority. 21 MR. PENBERTHY: (Off mic comment) 22 MR. MAIT: Well, these facilities

### 202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 that are not included in the four, they all 2 discharge to a POTW. So, the industrial 3 effluent from those facilities is going to a 4 POTW. So, as we explained before, those could 5 be captured in the five municipal sites 6 because those are obviously POTWs that are

7 true for effluent.

8 MR. PENBERTHY: In some of our 9 previous discussions, there were, I think, at 10 least my notes here said we talked about or 11 there was a suggestion that 39 sites might be 12 appropriate in previous discussions. Is that 13 still -- why was there such a dropoff, I 14 guess? 15 DR. PLOTZKE: Well, what we had 16 proposed originally was that we would use a 17 screening approach to identifying probably 18 five sites, coming down to five sites, but 19 that we would screen only sediment, to then 20 look at the concentration and then identify 21 the top five sites. 22 MR. PENBERTHY: So, you would

### 202-234-4433 Neal R. Gross & Co., Inc. Page 65 1 screen the sediment of -- 2 DR. PLOTZKE: Thirty-nine sites. 3 MR. PENBERTHY: And then, from 4 that, pick your five? 5 DR. PLOTZKE: Five. 6 MR. PENBERTHY: Is that still the 7 plan or is that -- 8 DR. PLOTZKE: No. No, because we 9 were told that wasn't acceptable. 10 MR. PENBERTHY: Okay. 11 DR. PLOTZKE: And I think, too, 12 when you look at the dataset that we do have 13 from both our monitoring and the modeling that 14 we have done, and modeling really even for the 15 wastewater treatment plant, I think the five 16 really are representative of what you find.17 And then, it will show you from the mass18 balance kind of perspective, with the 19 different media that you are going to monitor, 20 that will be very similar to what we found 21 elsewhere in the world. 22 MR. PENBERTHY: Okay. So, I mean,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 I think we have made pretty clear that all the 2 13 sites that have either a direct release to 3 water or a release to POTW we are interested 4 in having those monitored. Okay. 5 And also, we still have to figure 6 out between us and work out what the right 7 number of POTW sites is because I don't think 8 -- well, I will defer to our exposure 9 assessors, but I don't think that we would be 10 -- well, I think we would have a hard time 11 defending a risk assessment just based on five 12 POTWs. That is my thinking right now, not 13 examining sort of the more detailed rationale 14 of why that might work or not. 15 MR. THOMAS: So, Ward, just to 16 clarify so that I am clear, what we have 17 included in the proposal is monitoring for 18 those four of our member sites that have 19 direct discharges to surface waters. So, what 20 you are suggesting is you would want to have 21 all member facilities included in the 22 monitoring proposal regardless of whether they

### 202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 are water direct discharges or not? Even if 2 they are discharges to a municipal wastewater 3 treatment facility, you would like to see 4 those monitored as well?

5 MR. PENBERTHY: Correct. 6 MR. LEWIS: At this time, 7 interested parties, any comments about what we

8 have heard so far? 9 Yes, please identify yourself. 10 MS. FINLEY: Hi. This is Cynthia 11 Finley with NACWA again. 12 I can provide just some other 13 comments about POTWs that I think might be 14 useful, if that is all right. And again, no 15 opinion right now about the number of POTWs 16 that are included. 17 The manufacturing facilities that 18 discharge POTWs, they can be regulated by 19 POTWs themselves through the pretreatment 20 program. All POTWs of a certain size must 21 have a pretreatment program in place, and 22 there are certain priority pollutants that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 they must consider in the pretreatment 2 program. And then, they are also able to 3 establish local limits for anything that they

4 need to. 5 So, in effect, industrial 6 dischargers can be controlled by POTWs, 7 discharges into the POTW itself. The problem 8 that POTWs have is that they can't control 9 discharges from domestic sources. So, 10 siloxanes or other chemicals that are heavily 11 used in consumer products make their way into 12 the sewer system and to the treatment plant. 13 So, concern for POTWs is not just 14 from industrial or manufacturing facilities. 15 It is what comes from people's homes and 16 businesses as well. 17 So, just in considering what POTWs 18 should be sampled or how many should be 19 sampled, it is something to consider. It is 20 not just industrial. It is consumer product

21 use also. 22 And going back to my previous

### 202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 comment about numbers of POTWs, one number I 2 do have off the top of my head is that NACWA 3 represents almost 300 municipal wastewater 4 treatment agencies. The populations served 5 range from very small, 1700 people, all the 6 way up to the very largest in the country, 7 which is 8.5 million people. So, that kind of 8 gives you a feel for how big the range can be 9 of the size of POTWs.

10 And our 300 members do cover the 11 majority of the sewered population in the U.S. 12 So, if you consider that 300 is covering most 13 of the sewage that goes to POTWs versus 16,000 14 or 20,000, whatever number you are using, that 15 gives you some perspective. 16 MR. LEWIS: So, at least the 17 comments that you have made now and previously 18 in terms of the number of POTWs, and what you 19 have heard in discussions at EPA and industry, 20 do you have any reaction as an interested 21 party about what the number of POTWs should

22 be?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 MS. FINLEY: I am not prepared at 2 this point to make any kind of statement on 3 the number. Those are just things to 4 consider, I think, when looking at that 5 number. So, again, I would like to look more 6 at the analysis that has been done to date and 7 give it some more consideration. 8 MR. LEWIS: Okay. Thank you. 9 MR. PENBERTHY: Do you have any 10 insight into what specific design features of 11 POTWs should be considered when establishing 12 a sampling plan or selection plan for 13 monitoring? 14 MS. FINLEY: That is something 15 that I would like to get some input from our 16 members about. Because there are so many 17 different configurations of POTWs, it is hard 18 to generalize overall. So, that is something 19 else that should be considered in the number, 20 is the different types of treatment. And that 21 is listed a bit in what is considered right 22 now in the five. But determining if that is

### 202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 representative or not will be important, I 2 think. 3 MR. LEWIS: Cathy, anything else 4 you have?

5 MS. FEHRENBACHER: In terms of the 6 biota monitoring, we have looked at the 7 previous work. We do believe that more 8 substantial biota monitoring would be needed 9 for a nationally-representative assessment. 10 And so, I think we would definitely be looking 11 at more substantial biota monitoring to 12 understand that situation within the U.S. 13 MR. THOMAS: Could you provide a 14 few more details with respect to specifically 15 what you would like to see?

16 MS. FEHRENBACHER: Yes. Yes. We 17 would like to include the direct and indirect 18 sites as well as the POTW sites. 19 MR. THOMAS: Well, with respect to 20 the biota monitoring in particular.

21 MS. FEHRENBACHER: Yes. Yes. 22 Benthic and aquatic.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 DR. PLOTZKE: Let me just clarify. 2 So, you are suggesting that, in addition to 3 the direct sites, that we do biota monitoring 4 at the indirect sites? Yet, they are not 5 discharging to a surface water. So, we are 6 going to be doing biota monitoring at the 7 municipal wastewater treatment plant. But 8 there would be really no location to do biota 9 monitoring with the indirect. 10 MS. FEHRENBACHER: So, there 11 aren't any releases to water at the indirect 12 sites?

13 DR. PLOTZKE: Not to surface 14 water. The only release to surface water is 15 at our direct discharge sites. 16 MS. FEHRENBACHER: Okay.

17 DR. PLOTZKE: The rest of them 18 will go through municipal wastewater

19 treatment. 20 MS. FEHRENBACHER: Okay. And in 21 terms of the biota that we are interested in, 22 we are looking at benthic invertebrates,

### 202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 algae, aquatic invertebrates, and both high 2 and low trophic fish. 3 DR. PLOTZKE: And that is pretty 4 much what we have done in our other programs. 5 To do, basically, a food-web type of study, 6 you need to have pretty good understanding of 7 the environment, which we will do that looking 8 at the benthic and the top-level fish in these 9 different sites, but you also need to have 10 access to the different types of species. 11 Like, for example, with Lake 12 Pepin, we had to work with the DNR. It 13 becomes a much more complicated program, and 14 we do feel that what we have done in Lake 15 Pepin and Oslo Fjord really represent that. 16 MS. FEHRENBACHER: Okay. Well, 17 thanks for sharing that. I appreciate the 18 additional clarification. 19 MR. LEWIS: So, what we have 20 accomplished so far is in terms of we have 21 heard the presentation from SEHSC, and thank 22 you for that, and some comments from

### 202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 interested parties, and in terms of dialog 2 with EPA. 3 What I would like to do now is to 4 take a break. It is now 11:20. And I would 5 like to reconvene at 11:35, to give people 6 time in terms of digesting what we have heard 7 right now. And let's reconvene at 11:35. 8 Thank you. 9 (Whereupon, the above-entitled

10 matter went off the record at 11:20 a.m. and 11 resumed at 11:39 a.m.) 12 MR. LEWIS: I would like to

13 reconvene. 14 During the recess, we had an 15 opportunity in terms of digesting what we 16 heard today. Before EPA has a response, 17 Karluss, do you have anything else you want to 18 add? Or, interested parties, anything else to

19 add? 20 MR. THOMAS: Yes. Thank you. 21 Before we get started again, I 22 just wanted to circle back to, if I could, the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 original purpose of the exercise, at least as 2 we envisioned it. 3 I think, Paul, you made some 4 remarks at the beginning of the meeting to 5 kind of review what the proposal intended to 6 provide. And I think what we developed was 7 consistent with what the agency had originally 8 provided us in terms of guidance on what you 9 guys were attempting to accomplish. I just 10 wanted to revisit that, just to make sure that 11 it is still, indeed, the goal before we have 12 further discussion. 13 So, what we thought we were 14 attempting to develop was a proposal that 15 would provide additional information on the 16 presence and concentration of D4 and D5 in the 17 environment and on resources of and pathways 18 to the environmental concentrations of D4 and

19 D5. 20 So, if that is, indeed, still the 21 goal of this effort, I really just wanted to 22 highlight again that, when we developed the

### 202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 conceptual site models, the idea was to have 2 models that you could use to simulate 3 representative facilities in the country with 4 respect to environmental releases of D4 and 5 D5. Because, again, if what we are attempting 6 to do is to provide exposure data, 7 environmental exposure data, to support a risk 8 assessment, we believe these models were 9 developed for that purpose. 10 So, our intent was never to 11 monitor every individual facility. The goal 12 was to monitor a representative sampling of 13 the facilities that allows you to validate, if 14 you will, the conceptual site models that were 15 generated to support aggregating facilities. 16 So, again, I go back to the MPF 17 sites. We focused on those with direct 18 discharges to surface waters because those, 19 again, were the focus for environmental

20 releases. 21 Now those facilities that are 22 releasing to the POTWs, those are going to be

### 202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 picked up, or facilities that are similar to 2 those are going to be picked up, with the 3 wastewater treatment plant monitoring because 4 those would not likely be any different from 5 any other facility that released processed

6 wastewater to a POTW. 7 So, I just wanted to kind of go 8 back to that, to just reconfirm that what we 9 are trying to do is generate data that would 10 be useful for a risk assessment, and a part of 11 that is going to be validating these 12 conceptual site models around the 13 environmental pathways that are going to be 14 important for that assessment. 15 Is that still the case? 16 MR. LEWIS: Yes, it is, and I 17 think EPA will provide more clarification in 18 terms of what they heard today. And I like 19 your point in terms of how we are going to be 20 using the data in terms of for risk 21 assessment, and the model concept per se. We 22 could have further discussion about that.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 Before I turn to EPA, interested 2 parties, do you have anything else to add 3 based on what you heard this morning? 4 (No response.) 5 Seeing none, I will turn to EPA in 6 terms of your thoughts in terms of next steps 7 on what you heard for the past hour. 8 MR. PENBERTHY: I think, 9 obviously, we have difficulties with the POTW 10 issue. I am not sure we can just talk through

11 that here. 12 So, one thing that I would like to 13 propose, and see if the group is interested in 14 this, is to put together a technical group to 15 develop a sampling plan for POTWs that would 16 have a basis in a science that is acceptable 17 to all the participants because this is a 18 consensus process. So, we need to be sure 19 that anything that we pursue satisfies the 20 needs of everyone participating. 21 You know, I think I have made 22 pretty clear that we are concerned that five

### 202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 is not enough. And I understand you have a 2 rationale for that which you laid out in a 3 document in January. We have got to go back 4 and look at that in more detail. 5 But I think it would help if we 6 could get some of our scientists at EPA and 7 SEHSC and from the POTW groups, in particular, 8 to work on that issue about what is the right 9 number of POTWs to sample, why, what are the 10 factors, and how they should be selected. And 11 so, that would be a proposal I would make as 12 a next step. 13 I am not so sure our differences 14 on biota to be monitored are so much different 15 at this point. Maybe we can hold that. Maybe 16 a similar approach for that might be 17 necessary, but I think that is a little bit 18 more of a simpler issue to deal with. And 19 maybe we can do that subsequently. 20 I guess, Karluss, getting back to 21 your purpose, I think the purpose reads right 22 as long as you recognize where you are going

### 202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 to use that data for risk assessment. And so, 2 when we do that, I think that adds a layer of3 robustness. So, it is more than our worst4 case analysis. It is more than an anecdotal 5 collection of data. It is something that is 6 meaningful and representative that meets our 7 needs for risk assessment. 8 And I think when we talk about the 9 direct dischargers and the dischargers to 10 POTWs from your facilities, I think as long as 11 the POTWs selected for monitoring include 12 those facilities, I think that should take 13 care of itself. 14 So, I guess that would be my idea 15 for a next step, is really work on the POTW 16 issue because I think that is the most 17 significant difference that we have. 18 MR. MAIT: Russell Mait. I do 19 have a question for you. 20 When you talk about the indirect 21 discharges to POTWs, my question to you is, 22 the formulators and processors, must they only

### 202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 be from our member group to be representative? 2 MR. PENBERTHY: No. No, not at

3 all. 4 MR. MAIT: So, if we could 5 identify other facilities that are processors 6 and formulators of siloxanes, that would 7 validate, that would be sufficient as well?

8 MR. PENBERTHY: Correct. 9 MR. MAIT: Okay. 10 MR. PENBERTHY: That is sort of 11 the vector that we want to address, is the 12 formulators and processors and what their 13 contributions typically are to a POTW and what 14 is their influent and effluent and sediment 15 levels that they potentially contribute to

16 near those. 17 MR. MAIT: Okay. Thank you. 18 MR. LEWIS: What we would like to 19 have is, if you will, a work group that would 20 convene relatively quickly with interested 21 parties. Cynthia, we would like to have you 22 as part of this or a person from your

### 202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 organization to be part of this, since you 2 provided some helpful comments; from SEHSC, 3 and also, obviously, EPA. 4 We want to convene quickly; let's 5 say in the next two weeks to have this work 6 group to meet, but to come to the meeting 7 being prepared for a discussion to bring 8 information to have a discussion based on what 9 Ward just said right now. And then, from 10 there, for the working group, if you will, to 11 present to this entire body here in another 12 subsequent public meeting. 13 Does that seem acceptable to 14 everyone here? Interested parties? SEHSC? 15 MR. THOMAS: And just to clarify, 16 the purpose of the smaller team is essentially 17 to develop an acceptable proposal for the 18 POTW-monitoring portion of the program? 19 MR. LEWIS: Right. It is not in 20 terms of developing an acceptable ECA. It is 21 basically to tee the issue up for this entire 22 body to discuss and develop consensus on.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 MR. THOMAS: Okay. 2 MR. LEWIS: Microphone, please. 3 MR. DOYLE: The work product, if 4 you will, from this work group would be what 5 exactly?6 MR. LEWIS: So, in terms of non7 POTWs, the sampling strategy, basically, where 8 we have differences now in this room. But I 9 think it will be best if we get this group 10 together and the technical experts to actually 11 talk about the issues and to develop, if you 12 will, an approach that this work group would 13 find acceptable, and then to present it to 14 this entire body here. 15 MR. DOYLE: So, the work group16 would be essentially developing a mini17 proposal, so to speak, that would be 18 substituted for the original proposal we have? 19 So, it would be a proposal, and then it would 20 be brought back to the wider group? 21 MR. LEWIS: That is correct. 22 MR. DOYLE: And from there, set up

### 202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 a strawman, if you will, to try to or -- 2 MR. LEWIS: Right. Because I 3 think what we are having here is a very 4 helpful discussion with this interested party, 5 but I think it is best -- let's take a sidebar 6 conversation, if you will, a working group 7 discussion with technical experts to sort this 8 issue out, and then return to this entire 9 group here. 10 DR. PLOTZKE: What might be 11 helpful maybe is if we identify, what are the 12 key elements do you want this subgroup to work

13 on? 14 MR. LEWIS: Okay. 15 DR. PLOTZKE: So, I think that is 16 what Trent was kind of getting at. Is it a 17 replacement of what we have already proposed 18 or is it really more detail, specifics around 19 it? 20 MR. LEWIS: I think it is probably 21 a combination of both. 22 Ward, do you want to add?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 MR. PENBERTHY: Yes. I mean, I 2 think what we need is a science-based 3 rationale that covers what is a correct number 4 of sites, POTWs to sample. What are the 5 factors that should be considered in selecting 6 the sites? Does it cover the range of 7 different treatment configurations and 8 influent circumstances? And so, basically, 9 work out a plan that could be more generally 10 and comfortably agreed to. 11 MR. THOMAS: And if I understand 12 you correctly, what you are asking the subteam 13 to do is to go back and look at the scientific 14 rationale for the wastewater treatment 15 component of the program, but also to 16 potentially develop a modified version that 17 might be more acceptable. And if that is, 18 indeed, the case, we are certainly willing to 19 participate in those discussions, but I guess 20 I would have to say, on behalf of SEHSC, we 21 wouldn't be able to commit our members to that 22 until there was a full vetting of that

### 202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 proposal among the upper management of our 2 member companies. 3 I am sure you guys will understand 4 that all of our members are multinational 5 corporations. And some of the folks that need 6 to ultimately sign off on the proposal aren't 7 in this room. 8 So, we are happy to participate in 9 those discussions. And if that ultimately 10 results in a revised version of what we have 11 already presented, then that is something that12 would have to get further agreement and buy13 off on from the upper management levels of our 14 member companies. 15 MR. PENBERTHY: Right. Exactly. 16 We have the same circumstance here, that we 17 would have to vet anything that we would agree 18 to in this room first. 19 But, yes. No, it is just a 20 smaller group to really get down to the 21 details on the why's and how's. 22 MR. LEWIS: Right. I think what

### 202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 Ward is saying is true, in that in terms of 2 what the work group would present, and how we 3 would modify the ECA, it would have to be 4 vetted in terms of respective organizations. 5 But I think what we are trying to 6 accomplish here in the next few weeks is, now 7 that we understand some of the issues, let's 8 bring the scientific experts from respective 9 organizations to look at the correct number of 10 sites, the factors to consider, and have a 11 substantive discussion to present back here. 12 MR. DOYLE: Procedurally, Paul, 13 then, as far as how that fits into the 14 framework of the ECA negotiation process, 15 given the constraints that are in the EPA 16 regulations on negotiating meetings being open 17 to the public, and so forth, that would be, 18 essentially, then, official, if you will, 19 negotiation meetings with minutes and 20 interested parties, you know, and ultimately 21 published? 22 MR. LEWIS: It will be more of a

### 202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 working group meeting. And then, from there, 2 that type of discussion would be presented at 3 a full public meeting. So, you could look at 4 this more as a work group discussion. It 5 won't be in terms of a public setting per se. 6 But what will be decided or deliberated on and 7 agreed on at the work group meeting, the 8 entire public will have opportunity here. 9 Does that answer your question? 10 Other questions, comments? Yes, 11 please. 12 MS. BOYD: I figure I had better 13 ask this question right now because I am 14 thinking about timing and about your initial 15 statements, that you want everything completed 16 by a certain date, and that we know how long 17 it takes for things to come back with

18 comments. 19 So, if we are talking about a 20 working group meeting in two weeks, and then 21 coming back for a public meeting to discuss 22 the results of that working group, in between

### 202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 the working group and the public meeting there 2 has to be discussion among the members' 3 leadership as to whether that revision is 4 acceptable. And there could be two weeks' 5 timeframe in there. So, we could be talking, 6 adding the numbers up, six weeks. 7 So, is the clock starting or being

8 extended? 9 MR. LEWIS: I will go to your 10 first question directly. The clock has 11 started. So, where we are right now, we want 12 to be, to be complete within six months. 13 And in terms of knowing what a 14 schedule is, we want to have this work group 15 discussion and to complete the discussion in 16 two weeks. So, the clock has begun, and we 17 need to complete this. We are not 18 anticipating an extension at this time. 19 Another question? 20 MS. CARLTON: This is Betsy 21 Carlton from Bluestar Silicons. 22 I am one of those international

### 202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 companies. 2 MR. LEWIS: Can anyone pass the 3 microphone down? 4 MS. CARLTON: Is this one not 5 working? 6 MR. LEWIS: Thank you. 7 MS. CARLTON: Okay. Thank you. 8 This is Betsy Carlton from 9 Bluestar Silicons.10 And I am one of those vastly11 international companies. I am not convinced 12 that two weeks is sufficient time to run 13 through what we need to do before we get to 14 that meeting. I just wondered why you picked 15 two weeks as the potential meeting time. This 16 is sort of a difficult challenge. 17 MR. LEWIS: Why we chose two 18 weeks, again, in terms of what many people 19 have said, we are aware in terms of the 20 timeline. It is a compressed timeline. And 21 we feel, at least in terms of getting the 22 subgroup of scientists to at least talk about

### 202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 it in two weeks could be accomplished. 2 Again, it is not for an issue to 3 be vetted and approved at that time by the 4 entire audience here. It is to have a 5 substantive scientific deliberation on the 6 issues to eventually bring back to the entire 7 group. You will have an opportunity, when you 8 hear the working group presentation, to react, 9 comment, respond to that. 10 So, we want to be conscious in 11 terms of trying to complete this within six 12 months, and we feel that two weeks is enough 13 time to get people together and start thinking 14 about these issues that have been available in 15 the public docket for some time. So, these 16 people are at least aware in terms of what the 17 issues are right now.

18 DR. PLOTZKE: Can I ask a 19 clarifying question, too?

20 MR. LEWIS: Sure. 21 DR. PLOTZKE: So, are you thinking 22 for this work group a face-to-face?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 MR. LEWIS: A conference call 2 could work also. Since it sounds like we have 3 international people or not all are here in 4 D.C., we can have a teleconference in terms of 5 working that out. 6 Again, it will be a relatively 7 small group, but a group that would have the 8 proper technical expertise to have this type 9 of discussion. 10 MR. THOMAS: Would it be possible, 11 I think, to help us identify the most 12 appropriate folks to join that discussion? 13 Would it be possible for us to ask the agency 14 to provide a brief agenda for this meeting and 15 some statement for what the expectation is in 16 terms of what we would like to accomplish? I 17 think that would really help us identify the 18 right folks to participate, if we know what we 19 are going to talk about and what we are hoping 20 to accomplish. 21 MR. LEWIS: Okay. I think that is 22 fine.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 In terms of having more structure, 2 I think it will be helpful for all us in terms 3 of what we want to accomplish here in kind of 4 laying out the questions that we want to have 5 the work group to react to. I think that will 6 be very helpful. Good. 7 Ward or Cathy, anything you want 8 to add in terms of what was just presented

9 now? 10 (No response.) 11 So, we will get the agenda out in 12 the next few days in terms of questions about 13 the structure. I think everyone is in 14 agreement here it is a tight timeline, and the 15 more focused that we can be, the greater sense 16 of accomplishment and output. 17 MR. THOMAS: And in terms of steps 18 following that smaller work group meeting, are19 there any thoughts around when the next face20 to-face meeting would be of the larger group 21 or what the potential timing for that might

22 be?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 MR. LEWIS: I think probably two 2 weeks after that would be appropriate to have 3 the next meeting with all the participants

4 that are noted here. 5 MR. THOMAS: So, end of July? 6 MR. LEWIS: End of July, right. 7 Because, again, we are all conscious in terms 8 of that six-month time period. I can't stress 9 it enough, that we want to have a sense of 10 accomplishment. We made great strides here 11 today. There is more work that has to be 12 done. We appreciate in terms of what your 13 team has presented and in terms of interested 14 party comments, but we need to make sure we 15 get this done by the end of December. 16 I would deal with you directly in 17 terms of who your person you want to have 18 represented. 19 Cynthia, I would contact you 20 directly in terms of that area. 21 And are there other interested 22 parties that might want to participate?

### 202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 MS. CARLTON: I really hate to be 2 a pain. This is Betsy Carlton again from 3 Bluestar Silicons. 4 Expecting me to get input back 5 from Europe two weeks after that meeting is a 6 dream, a total dream. 7 MR. PENBERTHY: I think we all 8 realize this is a difficult proposition, but 9 I think by the end of July we should have a 10 better idea of where we stand, right, and if 11 things are achievable or not. And then, we 12 want to make progress towards reaching an 13 agreement. And so, I am not prepared to give 14 up on it right now, and I don't think 15 stretching out the timeline is going to help. 16 So, I think we need to have the press of a 17 deadline to make progress here. 18 MR. THOMAS: And I think, just to 19 kind of further amplify Betsy's point, I mean, 20 again, I think we would certainly be willing 21 to participate in discussions. But as long as 22 there is no explicit expectation that any of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 our members are going to absolutely agree to 2 specific elements of changes beyond what has 3 already been proposed, we couldn't commit to 4 that in two weeks and maybe not in four weeks, 5 but certainly we will participate in the 6 discussions. We will make a point to try to

7 take back all the feedback from these calls to 8 the companies in a timely manner. 9 But, again, there can't be any 10 expectation that we are going to necessarily 11 be able to commit to anything specifically 12 that results from these discussions until 13 after we get full buy-in from all of our 14 members. At this point, unfortunately, we 15 won't be able to put a timing on that. I 16 think that is what Betsy is trying to 17 communicate. 18 MR. LEWIS: Right. And, Betsy, I 19 appreciate, in terms of being from an 20 international company, how do you basically 21 reach out to your members. 22 You know, what we want to try to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 have is some clear expectations and clear 2 outcomes. So, I think we all agree upon that. 3 And knowing that there may be some 4 complications that may not be able to be 5 fulfilled by mid-July, but let's try, at least 6 try, in terms of making success in that area. 7 MR. FLACK: Hugh Flack from

8 Wacker. 9 You are going to be generating an 10 agenda for this meeting. Would it be possible 11 for you to list the participants you would 12 propose, so that we can properly man and staff 13 our own -- you know, so that we can address 14 all the appropriate issues? 15 MS. FEHRENBACHER: But I think it 16 would be helpful, at least from the agency's 17 perspective, to know if Wacker and any of the 18 other interested parties would be interested 19 in working on this technical work group. 20 So, could we ask who might be 21 interested among the interested parties? 22 MR. MAIT: Russell Mait from

### 202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 Evonik. 2 We are one of the interested 3 parties, but we are also a member of SEHSC. 4 So, in the interest to sort of tee-off of what 5 Betsy was saying, to move this along -- I work 6 for a German company. So, it would be better 7 for me to have somebody in this meeting in two 8 weeks as a participant. 9 So, if you want to advance this 10 faster, it would be better for me to have a 11 rep in the meeting. Therefore, I have a 12 better conduit back to my folks back in 13 Europe. 14 So, from my standpoint, Evonik 15 would like to participate.

16 MR. LEWIS: Are there other 17 interested parties that would like to 18 participate? 19 DR. PLOTZKE: Well, this is Kathy 20 Plotzke from Dow Corning. 21 And, yes, we would like to 22 participate.

### 202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 MR. LEWIS: Okay. Other 2 interested parties? 3 MS. CARLTON: Bluestar will be 4 doing our best to participate.

5 MR. LEWIS: Good. 6 MR. FLACK: Wacker Chemical 7 Corporation would like to participate. 8 MR. LEWIS: Okay. Great. 9 DR. DeLEO: American Cleaning 10 Institute. 11 MR. LEWIS: Okay. 12 MS. DuMARS: Momentive will also

13 send someone. 14 MR. LEWIS: So, based on hearing 15 from the interested parties when we went 16 around, it sounds like all of the parties, if 17 we kind of go one-by-one, would be interested. 18 So, we can work on an agenda. We 19 will work in terms of scheduling. We will 20 have it be a teleconference. So, that way, 21 people don't need to travel back to D.C. And 22 we will scope out in terms of what we want to

### 202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 accomplish. 2 So, it sounds like what we are 3 going to have is SEHSC, interested party 4 representative, and also EPA representative. 5 And again, the focus here is 6 having a scientific discussion as a work group 7 to address these issues, knowing full well 8 that this type of discussion from a working 9 group perspective will be brought back to this 10 entire core here for discussion and 11 deliberation. 12 Any questions? 13 (No response.) 14 Seeing none, Ward, do you want to 15 continue?

16 MR. PENBERTHY: No. 17 MR. LEWIS: Before we adjourn, are 18 there any additional comments, questions about 19 next steps?

20 Yes? 21 Pass the microphone down. 22 MS. MIHAICH: Hi. This is Ellen

### 202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 Mihaich with Bluestar Silicons. 2 It is probably a naive question, 3 and I should know the answer to this, but we 4 were talking about the January 31st submission 5 that has a lot of the detail on what the 6 consultant -- and I am looking at Kathy right 7 now -- the consultant did. Wouldn't that be 8 very important for everyone on this work group 9 to make sure that they have read and provided 10 to others? I don't believe that made it into 11 The Federal Register, or did it? 12 MR. PENBERTHY: I believe it did. 13 This is January 31st.

14 MS. FEHRENBACHER: It was the 15 January 31st submission, yes. 16 MR. LEWIS: Great. So, we will 17 make it available not only to the group here, 18 but also make it available in the docket. 19 Other questions, comments before 20 we adjourn? 21 (No response.) 22 So, our next step is in terms of

### 202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 having a work group meeting. We will have a 2 representative from each interested party. We 3 are looking at having that in about two weeks, 4 and we will be communicating with you in terms 5 of optimal time. It will be a teleconference. 6 And like what we said, we will be having a 7 focused agenda in terms of what the 8 expectations are of the questions and issues

9 that we want to have resolved. 10 MR. DOYLE: What is the timeline 11 for the minutes? 12 MR. LEWIS: The minutes, our 13 contractor would have the transcripts 14 available in about two weeks and, then, from 15 there, it requires some editing. So, I would 16 say in about three weeks. 17 Right. So, the minutes will be 18 available. Actually, it is a transcript that 19 will be available publicly. So, we will make 20 that available. 21 Cathy, anything else to add? 22 MS. FEHRENBACHER: I don't think

### 202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 so. 2 MR. LEWIS: Okay. Ward, anything

3 else to add?

4 MR. PENBERTHY: No. 5 MR. LEWIS: Well, again, I want to 6 thank everyone for joining us today. I think 7 we had a very engaging and fruitful 8 discussion. 9 I want to again thank industry and 10 your team, EPA, interested parties, for being 11 here. And we are looking forward to our next 12 discussion as a working group in terms of 13 addressing some of the issues we were 14 discussing this morning. 15 Thank you. 16 (Whereupon, the above-entitled 17 matter went off the record at 12:07 p.m.)

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53:9NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W. (202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com C E R T I F I C A T E

This is to certify that the foregoing transcript

In the matter of:

Before:

Date:

Place:

was duly recorded and accurately transcribed under my direction; further, that said transcript is a true and accurate record of the proceedings.

----------------------- Court Reporter 117

Siloxane ECA Negotiation

EPA

06-27-12

Washington, DC