202-234-4433 Neal R. Gross & Co., Inc. Page 1 ENVIRONMENTAL PROTECTION AGENCY

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AMMONIA/UREA MEETING

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TUESDAY FEBRUARY 16, 2010

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The meeting was held at 1:00 p.m., in the Potomac Yards South Building at 2777

Crystal Drive, Arlington, Virginia, Director Joan Harrigan-Farrelly presiding.202-234-4433 Neal R. Gross & Co., Inc. Page 2 PRESENT: JOAN HARRIGAN-FARRELLY, Director, Antimicrobial Division, EPA DENNIS EDWARDS, Chief of Regulatory Branch 1, Antimicrobial Division, EPA PHIL ROSS, Office of General Counsel, EPA BILL JORDAN, Office of Pesticide Programs, EPA MELBA MORROW, Regulatory Branch 1, Antimicrobial Division, EPA HANNA SILBERBERG, ICL-IP America PAUL RAYMOND, Ashland KRISTINA WOODS, Ashland TOM KEENAN, Ashland GERI EDENS, MLA/Buckman MICHAEL BOUCHER, McKenna Long & Aldridge, representing Buckman DAVID BROOKMAN, Buckman THOMAS McNEEL, Buckman ROBERT COOPER, Buckman BILL PITCHER, Buckman CYNTHIA TAUB, Steptoe/Nalco MICHAEL ANCONA, Nalco STEVE LANDSMAN, Nalco BRYAN SILL, Nalco LAURA RICE, Nalco

E. STUART PASSANTINO, Nalco ELIZABETH BROWN, Steptoe/Nalco SETH GOLDBERG, Steptoe/Nalco KAREN HANSEN, Beveridge & Diamond JAMES BRADY, Ashland LINDA CHANEY, Ashland202-234-4433 Neal R. Gross & Co., Inc. Page 3 C-O-N-T-E-N-T-S

Call to Order and Welcome 6 Director Joan Harrigan-Farrelly Groundrules for the Meeting 7 Director Joan Harrigan-Farrelly Introductions 8 Presentation by Ashland Hercules 12

Karen Hansen 12, 33 James Brady 21 Linda Chaney 29 Presentation by Buckman 35 Michael Boucher 35, 51 David Brookman 48 Comments by Nalco 55 Seth Goldberg 55 Presentation by Nalco 58 Seth Goldberg 58, 73 E. Stuart Passantino 59

Elizabeth Brown 67 Questions from EPA 81, 141202-234-4433 Neal R. Gross & Co., Inc. Page 4 C-O-N-T-E-N-T-S (CONTINUED) Questions from the Companies of 115 Each Other

Ashland Hercules 115 Karen Hansen 115 Linda Chaney 117

Buckman 120 Michael Boucher 120, 122, 123 Response by Ashland 120 Karen Hansen Response by Nalco 121, 123 Seth Goldberg Nalco 124 Cynthia Taub 124, 125 Response by Buckman 124 Michael Boucher Response by Buckman 125 Tom McNeel Response by Buckman 126 Robert Cooper Response by Ashland 126 Linda Chaney Response by Ashland 127 Karen Hansen202-234-4433 Neal R. Gross & Co., Inc. Page 5

C-O-N-T-E-N-T-S (CONTINUED)

Questions from the Companies of EPA 129

Ashland Hercules 130

Karen Hansen 130

Buckman 135

Geri Edens 135

Nalco 136

Cynthia Taub 136

Seth Goldberg 139202-234-4433 Neal R. Gross & Co., Inc. Page 6 1 P-R-O-C-E-E-D-I-N-G-S 2 1:04 p.m. 3 DIRECTOR HARRIGAN-FARRELLY: Okay. 4 I think we are ready once again. 5 Welcome to EPA and to this meeting 6 to discuss ammonia and urea. 7 My name is Joan Harrigan-Farrelly. 8 I am the Director of the Antimicrobials 9 Division here in the Office of Pesticide 10 Programs. 11 We have provided this forum to 12 hear the issues raised in the petitions, the 13 letters and the emails that we have received 14 from the various companies. 15 As the agenda outlines, we will 16 have introductions of all parties in the room. 17 Then we will move into presentations, starting 18 with Ashland Hercules, then moving to Buckman, 19 followed by Nalco. 20 We will take a short break, and 21 then move into questions by the agency, 22 followed by questions from the parties.202-234-4433 Neal R. Gross & Co., Inc. Page 7 1 The agency has prepared some 2 questions for you, and you will have those in 3 writing as well. 4 Some of the ground rules. I 5 expect that this meeting, although covering a 6 very passionate topic to all of you, will be 7 conducted in a very respectful manner. We 8 will allow time for all the parties to make 9 their presentations, the time that is 10 allotted, no interruptions, et cetera. 11 In an effort to afford the 12 broadest of transparencies, this meeting is 13 being recorded, and we also have a 14 stenographer who is taking notes and minutes. 15 The minutes of the meeting will be placed in 16 the docket, once it is available. 17 Please remember to refrain from 18 discussing any CBI issues because, as I 19 mentioned, it is being recorded and it will 20 also be placed in the docket. 21 After the meeting, all parties 22 will have 30 days to submit any additional or202-234-4433 Neal R. Gross & Co., Inc. Page 8 1 supporting documentation or responses to 2 questions that you were asked, and if you did 3 not have an answer or documentation 4 immediately available. Once your 30 days are 5 up, the opening of the docket will be 6 announced, and everything will be placed in 7 the docket, including all the information that 8 we gathered from you previously. 9 If any time you should have any 10 unresolved issues after the 30 days, you are 11 free to make your comments to the docket with 12 the rest of whoever is interested in making 13 comments to the docket. 14 Those are my very brief ground 15 rules, and we will now go through 16 introductions. 17 MR. EDWARDS: I'm Dennis Edwards, 18 Chief of Regulatory Branch 1 in the 19 Antimicrobials Division. 20 MR. ROSS: I'm Phil Ross. I'm 21 with the EPA Office of General Counsel. 22 MR. JORDAN: I'm Bill Jordan. I202-234-4433 Neal R. Gross & Co., Inc. Page 9 1 work for the Office Director in the Office of 2 Pesticide Programs at EPA. 3 DR. MORROW: Melba Morrow, Special 4 Assistant to Dennis Edwards. 5 MS. SILBERBERG: Hanna Silberberg, 6 Regulatory Affairs Manager for ICL-IP America, 7 formerly known as Ameribrom, and the 8 registrant of an ammonium bromide-based 9 biocide pesticide technology and distributed 10 by Ashland Hercules. 11 MR. RAYMOND: Paul Raymond, 12 President of Ashland Hercules Water 13 Technologies. 14 MS. WOODS: I have a really loud 15 voice. I don't think I need a microphone. 16 I am Kristina Woods, in-house 17 Environmental Counsel for Ashland, 18 Incorporated, the parent corporation for 19 Hercules. 20 MR. KEENAN: Hi, I'm Tom Keenan. 21 I'm also with Ashland, and I'm Director of 22 Environmental Regulatory Affairs.202-234-4433 Neal R. Gross & Co., Inc. Page 10 1 MS. EDENS: I'm Geri Edens with 2 McKenna Long & Aldridge, on behalf of Buckman 3 Laboratories. 4 MR. BOUCHER: Michael Boucher. 5 I'm a partner in McKenna, also here on behalf 6 of Buckman. 7 DR. BROOKMAN: My name is Steve 8 Brookman. I am here on behalf of Buckman. 9 MR. McNEEL: Tom McNeel. I am the 10 principal scientist for Buckman Laboratories. 11 MR. COOPER: Hello. I'm Robert 12 Cooper. I'm the Global Market Development 13 Manager for New Technologies for Buckman 14 International. 15 MR. PITCHER: I'm Bill Pitcher, 16 General Counsel with Buckman. 17 MS. TAUB: Cynthia Taub, Steptoe & 18 Johnson, here in on behalf of Nalco. 19 MR. ROSS: Repeat, please. 20 MR. ANCONA: Michael Ancona, 21 Program Manager, Nalco Company. 22 MR. LANDSMAN: Steve Landsman,202-234-4433 Neal R. Gross & Co., Inc. Page 11 1 General Counsel for Nalco. 2 MR. ROSS: Can she repeat, please? 3 Yes, we couldn't hear you up here. 4 MS. TAUB: Cynthia Taub, Steptoe & 5 Johnson, and I'm here on behalf of Nalco. 6 MR. ROSS: Thank you. 7 MR. SILL: Bryan Sill, Assistant 8 General Counsel with Nalco Company. 9 MS. RICE: Laura Rice, Research 10 Scientist with Nalco Company. 11 MR. PASSANTINO: I'm Stuart 12 Passantino. I'm Global Strategic Business 13 Manager for Nalco Company. 14 DR. BROWN: Elizabeth Brown, 15 Steptoe & Johnson, on behalf of Nalco. 16 MR. GOLDBERG: Seth Goldberg with 17 Steptoe & Johnson, for Nalco. 18 MS. HANSEN: Karen Hansen with 19 Beveridge & Diamond, counsel for Ashland. 20 DR. BRADY: Jim Brady, Senior 21 Research Fellow for Ashland. 22 MS. CHANEY: And I'm Linda Chaney.202-234-4433 Neal R. Gross & Co., Inc. Page 12 1 I'm the Business Manager for the 2 Microbiological Control Product Line for North 3 America, and I also have global accountability 4 for the Spectrum XD3899 technology. 5 DIRECTOR HARRIGAN-FARRELLY: Okay. 6 I think we got everybody. I was trying to 7 write names down and figure out colors of ties 8 next to names, but I got lost in that. 9 So why don't we jump right into to 10 the presentations? We will ask Ashland 11 Hercules to go ahead and proceed. 12 MS. HANSEN: Well, thank you very 13 much. 14 Well, it looks like the PowerPoint 15 is coming up on both of the screens. With 16 that, we will go ahead and get started. 17 We first wanted to just thank EPA 18 for the opportunity to meet today. We think 19 that there are some important things that we 20 are all going to be talking about today. So 21 we appreciate the time to do that together. 22 I am going to take a few minutes202-234-4433 Neal R. Gross & Co., Inc. Page 13 1 to provide an overview of some of our remarks. 2 Then Dr. Brady and Linda Chaney will assist 3 with the rest of our presentation. 4 From our perspective, the 5 overarching context of this matter needs to be 6 kept in mind, although we are going to focus 7 on some specific claims that Nalco has made 8 today. 9 What we are talking about in this 10 matter are competitive products that are sold 11 by Ashland, Buckman, and Nalco to pulp and 12 paper mills in which all of these products are 13 being used by the mills as biocides. 14 Some important things to keep in 15 mind are that, of the three companies who are 16 represented here today, only two of the three 17 companies' products are registered under 18 FIFRA. Nalco has not registered its precursor 19 products, the ammonium sulfate and the urea 20 products, that we will be talking about today. 21 In addition, Nalco's five 22 registered sodium hypochlorite products are202-234-4433 Neal R. Gross & Co., Inc. Page 14 1 not registered for use with ammonia or urea or 2 any other chemicals that are used in the paper 3 mill setting. 4 Nalco has made a number of claims 5 in this process, but the primary claim that 6 they seem to be making is that their products 7 are not biocides, but, instead, are stabilizer 8 products. We are going to present information 9 today that refutes this claim, but it is 10 important to keep this overall FIFRA 11 compliance status of their two products in 12 mind as we run through these materials. 13 What are the key factors that EPA 14 should be looking at that demonstrate that 15 Nalco's two products are biocides? Well, 16 there is a legal analysis, and we are going to 17 spend a little bit of time talking about the 18 definition of biocide, and then, also, talking 19 about EPA's precedent for registering biocides 20 that are formed by in situ chemistry. 21 We are also going to share with 22 you a technical analysis of what the different202-234-4433 Neal R. Gross & Co., Inc. Page 15 1 chemical properties are between biocides and 2 stabilizers, and some of the technical 3 considerations and customer use information 4 that is important in answering that question. 5 Our conclusion, which we have 6 shared previously with the agency, is that 7 Nalco is selling two unregistered biocides, 8 and that this action violates FIFRA. 9 As we have requested consistently 10 in our submittals to EPA, we respectfully 11 request that EPA immediately stop the sales of 12 these products and pursue appropriately strong 13 enforcement action against Nalco. 14 What are the features of the 15 products that we are talking about? Again, 16 there are two unregistered products. Nalcon 17 60620 uses ammonium sulfate in combination 18 with sodium hypochlorite, while Nalcon 60615 19 reacts urea with sodium hypochlorite. In our 20 terminology that we have been using throughout 21 our communications and today, the precursor in 22 that formulation is the ammonium sulfate or202-234-4433 Neal R. Gross & Co., Inc. Page 16 1 the urea, and the reactant is the hypo. 2 Now these onsite chemical 3 reactions are occurring at the mills, and the 4 chemicals are mixed in an aqueous solution 5 before they are added to the processed water. 6 We want EPA to continue to ask, why are these 7 chemicals being reacted in this way and used 8 in this way? 9 Nalco has claimed that the 10 precursors, ammonium sulfate and urea, are not 11 biocidely active, but, instead, stabilize the 12 hypo. Our technical analysis is going to run 13 you through the reasons why this is not the 14 case, and why, instead, when these two 15 products are reacted together, they create 16 new, active biocides, not hypo. 17 In particular, Dr. Brady will talk 18 about why ammonium sulfate and urea, when 19 reacted together, do not stabilize hypo, but, 20 instead, react with it; that in each case, the 21 reaction creates new active biocidal 22 ingredients, and that it is these new202-234-4433 Neal R. Gross & Co., Inc. Page 17 1 ingredients, not the hypo, that are providing 2 the biocidal control in these two products. 3 The new actives that are formed 4 are chloramine in the case of ammonium sulfate 5 and urea -- excuse me -- ammonium sulfate and 6 hypo, and chlorourea in the case of urea and 7 hypo. We put on this slide instances in which 8 Nalco has publicly acknowledged to EPA and in 9 its patent materials that these two active 10 biocides are created by its products. We will 11 also show you that, in reality, the customers 12 at the mills are using both of these products 13 as biocides. 14 Now EPA works day-in and day-out 15 with the FIFRA and regulatory definition of 16 pesticide. We don't need to tell you what it 17 says. We would focus your attention, though, 18 on the fact that it does look at the purpose 19 and intent of the pesticide, of the product 20 being used, and it looks at actual and 21 constructed knowledge of both the seller and 22 the customer.202-234-4433 Neal R. Gross & Co., Inc. Page 18 1 And there's no question that 2 Nalco's two products are used in combination 3 with hypo to create new biocides. That also 4 falls within EPA's definition. 5 And under these well-established 6 tests, we believe that the objective evidence 7 shows that Nalco's two products are biocides. 8 Indeed, when Nalco first inquired about this 9 with the agency, and was told that combining 10 ammonium sulfate and hypo to treat water would 11 be considered pesticidal, instead of 12 registering their product, they challenged 13 EPA's registration of Buckman's competitive 14 product, which uses the very same chemistry. 15 They did that a month later. 16 And then, rather than registering 17 their product, they continued to sell the 18 ammonium sulfate product and, in the meantime, 19 introduced the new product that uses urea. 20 This is contrary to FIFRA, which requires 21 registration first and then sales, not the 22 other way around.202-234-4433 Neal R. Gross & Co., Inc. Page 19 1 EPA has a well-established 2 framework for regulating biocides that are 3 used onsite to create new actives using 4 precursors that by themselves are not 5 biocidal. The fact that the precursors alone 6 are not biocidal is irrelevant. You have to 7 look at how they are used. 8 And in fact, EPA has had a 9 longstanding framework for doing this. It did 10 it with the two competitive products here in 11 the framework that goes back 25 years. It has 12 been used by EPA to register precursor product 13 in situ biocide chemistries in a number of 14 other instances which are shown on this slide. 15 So this is not an unprecedented or novel 16 approach, contrary to what Nalco has argued. 17 In addition, Nalco has tried to 18 convince EPA that it is sufficient under FIFRA 19 for EPA to simply rely on the registration of 20 hypo, but that is not right. And it is not 21 right for at least three reasons. 22 First, hypo is not the biocidal202-234-4433 Neal R. Gross & Co., Inc. Page 20 1 active in their two products. So focusing on 2 hypo misses the point. 3 Second, most of the hypo labels 4 that are out there that EPA has approved 5 prohibit mixing with anything but water, and 6 especially not with ammonium salts or other 7 chemicals. 8 And third, the solution that they 9 are advancing, if EPA were to register only 10 hypo, would lead to a situation in which 11 anything could be combined with hypo and never 12 be reviewed by EPA. So they could take any 13 chemical, ammonium sulfate, urea, pick your 14 next chemical, and combine it without ever 15 talking to EPA about whether it creates a new 16 biocide. We don't think that is what EPA 17 intends, and we don't think that is what FIFRA 18 requires. 19 I am going to turn the floor over 20 now to Dr. Brady to provide a brief technical 21 analysis to underscore some of these 22 conclusions.202-234-4433 Neal R. Gross & Co., Inc. Page 21 1 Jim? 2 DR. BRADY: Thank you, Karen. 3 To kick off this discussion, we 4 are just going to talk a little about what a 5 stabilizer actually is. I am, then, going to 6 talk about some key characteristics that you 7 would use to determine whether or not a 8 material is a stabilizer or a biocide. 9 Those characteristics are the 10 position of the reaction equilibrium that is 11 involved with a specific system, the 12 reactivity of these chemicals. In other 13 words, what is actually participating in the 14 reaction? Where does the biocidal activity 15 come from? All of those are various metrics 16 that you can use to assess whether or not you 17 are dealing with a stabilizer or a biocide. 18 We are then going to look at the mass balance 19 to identify the primary biocide in these 20 systems. 21 All together, these various 22 metrics come down on the side that these202-234-4433 Neal R. Gross & Co., Inc. Page 22 1 materials are biocides, not stabilizers. Now, 2 according to the literature, a stabilizer is 3 a chemical that, reacted with an oxidant, will 4 allow reversion back to that parent oxidant 5 chemical. 6 For the chemistries that we are 7 talking about today, it is the reaction of 8 hypochlorous acid to form some product, and 9 then that product can revert back through a 10 hydrolysis reaction to reform hypo in situ. 11 Nalco, in fact, claims that sodium 12 hypochlorite or hypochlorous acid reforms when 13 reacted with ammonium sulfate. This type of 14 reversion reaction is precisely what is 15 required to preserve the status of the 16 hypochlorous acid as a dominant biocide in the 17 system. The technical analysis is going to 18 show that this simply is not the case. 19 In broad strokes, you can look at 20 the various metrics that I mentioned, the 21 reaction equilibrium, the reactivity, biocidal 22 activity. And if we work down the columns202-234-4433 Neal R. Gross & Co., Inc. Page 23 1 here, for a stabilizer, you have to have 2 reversion back to reactant, the reactant in 3 this case being the hypochlorous acid. 4 In terms of reactivity, you are 5 getting direct reaction from hypochlorous 6 acid. In terms of biocidal activity, the 7 biocidal activity derives from hypochlorous 8 acid. 9 On the other hand, if you are 10 dealing with a new biocide, in terms of the 11 product mass, that should dominate the system. 12 In terms of reactivity, that should be the 13 entity that actually reacts with the various 14 substrates that are in the system. That 15 should be the chemical entity from which the 16 biocidal activity is derived. 17 Here I have diagramed the three 18 basic reactions that we are talking about 19 here, hypochlorous acid plus either a 20 stabilizer, ammonia, or urea, yielding water 21 and products. 22 You can formally write an202-234-4433 Neal R. Gross & Co., Inc. Page 24 1 equilibrium expression for any of those 2 reactions. If you look at the various 3 equilibrium constants that you would calculate 4 for those various equilibrium expressions, if 5 the number is low, you are tending towards the 6 reactive side, the lefthand side. If that 7 number is really large, you are tending 8 towards the product side or the righthand 9 side. 10 Now, for a typical stabilizer, you 11 are going to have a fairly modest equilibrium 12 constant, something on the order of 10,000. 13 For ammonium sulfate, in the formation of 14 chloramines, you can actually go to the 15 literature and look at those various weight 16 constants and control that equilibrium 17 constant. It is going to be in the order of 18 10 to the 13th. 19 We computationally estimated from 20 free energies of formation that chlorourea, 21 equilibrium constant for that reaction, as 22 written, is of the order of 10 to the 134th.202-234-4433 Neal R. Gross & Co., Inc. Page 25 1 Now what that means operationally, look at the 2 last column. I am making an estimate here for 3 typical dosing levels, which is parts per 4 million of total active. The ratio of the 5 product, which is material on the righthand 6 side, divided by hypochlorous acid, in other 7 words, the parent oxidant in this system. It 8 is something of the order of one for a 9 stabilizer. 10 For chloramines, it is about 250. 11 For chlorourea, it is through the roof. I 12 mean, formally, as I have it written down 13 there, it is something like infinity. 14 Now I have zero for hypochlorous 15 acid indicated there. That is what we 16 measure. We measure no hypo-free hypochlorous 17 acid with the chlorourea product. 18 If you start to look at 19 reactivity, the literature has a fair amount 20 of work in this area. Particularly, Dale 21 Margerum in the eighties looked at a lot of 22 aspects of chloramine chemistry. In202-234-4433 Neal R. Gross & Co., Inc. Page 26 1 particular, he looked at the specific 2 mechanism of chlorine transfer or oxidation 3 that monochloramine undergoes, and the best 4 thing to do is actually quote the authors of 5 that work. 6 The results indicate that direct 7 chlorine transfer occurs from NH3Cl+ as a very 8 active chlorinating agent. Hence, the 9 chlorine transfer is direct, as given by 10 equation 1, with a negligible amount occurring 11 by the hydrolysis pathway. 12 Now the hydrolysis pathway is the 13 pathway that would allow regeneration of 14 hypochlorous acid in situ. Basically, what 15 they are saying is it is all direct reaction 16 here. It does not go through a hypochlorous 17 intermediate for oxidation. 18 You can also look at the redox 19 potential of these various oxidants. The 20 redox potential of hypochlorous acid and 21 monochloramine are significantly different. 22 Again, this is in the open, technical202-234-4433 Neal R. Gross & Co., Inc. Page 27 1 literature. Let me just quote the major 2 finding. 3 This is a direct indication that 4 NH2/CL is a thermodynamically weaker oxidizing 5 agent than free chlorine. In other words, it 6 is a distinct entity that has different 7 oxidizing characteristics. 8 With respect to chlorourea, there 9 is less in the open literature. Although 10 there is sprinkled all about various 11 application of the N-haloureas as mild and 12 selective oxidizing agents, they have a 13 reactivity profile that is rather different 14 than hypochlorous acid. The punch line is it 15 is a different oxidant species. 16 The specific references are shown 17 here. It tends to be a very nice tool to 18 execute a selective oxidation of tryptophan 19 and tyrosine residues, as well as more classic 20 organic chemical oxidation. 21 We also prepared N-chlorourea from 22 a separate literature preparation that allows202-234-4433 Neal R. Gross & Co., Inc. Page 28 1 direct synthesis of N-chlorourea and its 2 purification. We looked at how that material 3 performed with respect to biocidal activity 4 against a combination of sodium hypochlorite, 5 caustic, and urea. At equal active dosing, 6 you get the same biocidal result. In other 7 words, the primary biocide here is 8 N-chlorourea. 9 Now, to come back to that table 10 that I started with, and you look at whether 11 or not these various metrics come down on the 12 side of these two materials being biocides or 13 stabilizers, in virtually all of those 14 categories it comes down on the side that 15 these are distinct chemical entities, and they 16 are biocides. 17 Now, if you look at the specific 18 example of monochloramine, it is kind of 19 midway in the equilibrium constant. You can 20 actually calculate how much, in principle, 21 hypochlorous acid would be there under given 22 conditions. Under typical use conditions,202-234-4433 Neal R. Gross & Co., Inc. Page 29 1 there's about a 250-fold excess of 2 monochloramine. 3 Now it had been previously 4 positive that hypochlorous acid is 25 to 100 5 times more potent biocide than monochloramine. 6 Well, you really need to look at the product 7 of the potency and the concentration to see 8 where you get your biocidal action. And even 9 in this case, the biocidal action of 10 monochloramine is going to dominate because it 11 is in such large excess. 12 I am now going to pass it on to 13 Linda Chaney to talk a bit about some in-field 14 data. 15 MS. CHANEY: Thank you, Jim. 16 I am going to review information 17 that shows how these products are applied and 18 how they are monitored in the marketplace. 19 Customers use Nalco's two products 20 as biocides. The paper mills that use either 21 Nalco, Buckman, and Ashland products all use 22 these products for the same purpose. That202-234-4433 Neal R. Gross & Co., Inc. Page 30 1 singular purpose is to control the growth of 2 microorganisms. 3 The following graphs use actual 4 mill operational data that show how mills use 5 these products all in the same way. Customers 6 measure total combined chlorine and the effect 7 on the biological activity as a gauge for the 8 performance of the biocidal programs. 9 It is important to note here that 10 customers do not measure free available 11 chlorine, and that is the biocidal species 12 that comes from application of hypo that would 13 be present if hypo were, in fact, the applied 14 active. 15 Free available chlorine is 16 extremely important to monitor and measure 17 because overdosage of that particular oxidant 18 results in overusage of other wet-end 19 chemicals. It is aggressive towards machine 20 clothing. It is also very corrosive to 21 metallurgies that are installed on the paper 22 machine.202-234-4433 Neal R. Gross & Co., Inc. Page 31 1 This chart shows the trend for 2 total combined chlorine from one of our 3 customer sites where they were originally 4 using ammonium bromide, our Spectrum XD3899 5 technology. It was then followed with Nalco's 6 unregistered ammonium sulfate and then their 7 unregistered urea programs. 8 Once again, you can see that the 9 trends only are for total combined chlorine. 10 No free chlorine is used as a monitoring tool 11 for their program, nor is it used it for our 12 program here. 13 Secondly, we would like to look at 14 the trends for both ATP and aerobic plate 15 counts for our registered Spectrum XD3899 16 ammonium bromide program that was, then, 17 followed, once again, by Nalco's unregistered 18 ammonium sulfate and their urea technologies. 19 You can see that, with time over 20 the course of a couple of years, that these 21 two monitoring tools are used as a primary 22 gauge to indicate biological fouling in the202-234-4433 Neal R. Gross & Co., Inc. Page 32 1 systems that are treated. 2 So, to summarize, the ammonium 3 sulfate and urea in Nalco's products are 4 combined with sodium hypochlorite to form new 5 and distinct biocidal active ingredients that 6 are separate completely from hypochlorous 7 acid. Chloramines are generated from the 8 combination of hypo with Nalcon 60620. 9 Chloroureas are generated from the combination 10 of sodium hypochlorite with Nalcon 60615. 11 That is, of course, urea. So they do not 12 stabilize hypo. 13 But, instead, chloramines are an 14 active and chemically-distinct biocide, as 15 Nalco has themselves acknowledged in its EPA 16 submittals, and chlorourea is an active and 17 chemically-distinct biocide, as Nalco has 18 acknowledged in its own patent application. 19 So, these NC2-generated biocides 20 could not be made without the precursor 21 products ammonium sulfate and urea. These 22 products are sold to and used by mills as202-234-4433 Neal R. Gross & Co., Inc. Page 33 1 biocides. 2 And with that, I will hand it back 3 over to Karen. 4 MS. HANSEN: The bottom line is 5 that the legal and technical analyses that we 6 have quickly summarized here today, along with 7 an examination and understanding of customer 8 use, give every indication that these two 9 products being marketed by Nalco are 10 pesticides under FIFRA and require 11 registration under FIFRA. 12 As we have said in our submittals 13 to EPA today, and again respectfully request, 14 we think the agency's next step ought to be to 15 remove these two unregistered biocides from 16 the marketplace in order to protect human 17 health and the environment. We don't know, 18 and EPA doesn't know, because these products 19 don't have FIFRA registration, and they don't 20 have FIFRA labels, and so the conditions in 21 which they are being used in the mills creates 22 uncertain risks.202-234-4433 Neal R. Gross & Co., Inc. Page 34 1 Furthermore, EPA should prohibit 2 the sale of these products unless and until 3 Nalco applies for registration and supplies 4 all of the data that EPA would normally 5 require and has required of the two competitor 6 companies to sell basically the very same 7 products to the very same industry for the 8 very same use. 9 And finally, we believe that this 10 is a situation in which EPA should exercise 11 its discretion to pursue appropriately-strong 12 enforcement action against Nalco. If you 13 don't do these things, you risk encouraging 14 other companies coming into the marketplace 15 with products first, engaging you about it 16 later, and waiting until a lengthy process has 17 been completed to come into compliance with 18 the law. We don't think that is the intent of 19 FIFRA, and we don't think that is the result 20 that EPA desires. 21 Thanks very much. 22 DIRECTOR HARRIGAN-FARRELLY: Thank202-234-4433 Neal R. Gross & Co., Inc. Page 35 1 you very much. You are right on time. Okay, 2 so we are off to a good start and on time. 3 I will bring it over to Buckman 4 Laboratories. 5 MR. BOUCHER: I want to change the 6 slides here. 7 While we are setting up the 8 slides, thanks for having me. Thanks for not 9 canceling it. 10 DIRECTOR HARRIGAN-FARRELLY: I'm 11 sorry. Not to interrupt you, but did we have 12 anyone who is going to be webcasting in? 13 MR. BOUCHER: No, not from -- 14 DIRECTOR HARRIGAN-FARRELLY: I 15 mean from the other companies. Okay. 16 MR. ROSS: Let's wait until your 17 thing goes up, and then we will time you from 18 then. 19 DIRECTOR HARRIGAN-FARRELLY: Yes. 20 MR. ROSS: That would be good if 21 you could go ahead and pass those out. I 22 would ask everyone to do that before they202-234-4433 Neal R. Gross & Co., Inc. Page 36 1 begin their presentation. 2 DIRECTOR HARRIGAN-FARRELLY: Just 3 pass that out. 4 MR. ROSS: Yes. 5 DIRECTOR HARRIGAN-FARRELLY: It 6 saves on time. 7 MR. BOUCHER: Thanks for having 8 the meeting. 9 I just want to add, before I 10 start, that there's nothing I am saying here 11 that is CBI. There is also nothing I am 12 saying here to today that isn't in the record 13 and hasn't been in the record for quite a 14 while. 15 Also, I just want to make it clear 16 that, from Buckman's perspective, we don't 17 consider coming here and giving this 18 presentation as a substitute for any of the 19 submissions that have been made or for the 20 administrative record that has already been 21 created in this case. We hope you will be on 22 top of that record or will be on top of that202-234-4433 Neal R. Gross & Co., Inc. Page 37 1 record shortly. 2 I am going to take a slightly 3 different approach to Karen. I would like to 4 talk a little bit about the chemistry, but I 5 would like to focus more on the legal issues. 6 This is not a typical case that 7 the Antimicrobials Division faces where you 8 haven't seen the chemical or you haven't seen 9 the technology, and you are trying to figure 10 out jurisdictional issues, what you are going 11 to do, and you take your sweet time doing it 12 because everybody is unregulated, and there 13 may be a ranking of seriousness of the safety 14 issues. 15 This is a case where you folks 16 have already decided that ammonia, when used 17 in a very specific way, is a pesticide. You 18 have already said that ammonia, when mixed 19 with bleach in process water at all the paper 20 mills, as part of a process to control 21 bacterial slime as a pesticide, has a very 22 precise use that you have registered.202-234-4433 Neal R. Gross & Co., Inc. Page 38 1 But you made that statement. We 2 didn't make it. Nalco didn't make it. Nalco 3 disagrees with it. Ashland didn't make it. 4 This is your decision that you have already 5 made, folks, when you registered a 6 manufacturing-use product, an end-use product. 7 Then, while you were looking at 8 this petition, and after you had already 9 temporarily authorized this continued sale of 10 unregistered ammonia, you went ahead and 11 amended the EUP to add a use site. So the 12 problem here is you are acting schizophrenic. 13 On the one hand, you grant the registrations. 14 On the other hand, you give an express 15 authorization to sell unregistered ammonia for 16 the currently-registered uses. It creates a 17 lot of problems. 18 First of all, there has been no 19 end in sight that we can see to the temporary 20 authorization, this letter that was issued in 21 February of 2008. The authorization was 22 supposed to last just as long as you were202-234-4433 Neal R. Gross & Co., Inc. Page 39 1 looking at things. To pick up on Karen's 2 point, that has really continued for quite a 3 while. This isn't really, I think, what 4 Congress or anything that you have in mind 5 when you are thinking about good regulation 6 under FIFRA. 7 Also, perversely, setting up the 8 registered products in direct competition with 9 the unregistered products has had the effect 10 of penalizing registrants who have to not only 11 bear costs, which are significant, but 12 certainly not earth-shattering, but you have 13 to operate under all of FIFRA's limitations, 14 the whole life cycle from production right 15 through to disposal and everything in between, 16 every time you change a label, every time you 17 make an advertisement, every time you make a 18 claim, every production report, every 6(a)(2) 19 report. It is a heavily-regulated industry. 20 Right now, we are in it, doing all 21 those things. Ashland is in it, doing all of 22 those things. And our competitors aren't.202-234-4433 Neal R. Gross & Co., Inc. Page 40 1 EPA is responsible for that situation. 2 Now we all sat around scratching 3 our heads trying to think, what exactly is so 4 difficult about this issue that for two years 5 EPA has been paralyzed and unable to figure 6 out what to do? So, we went through all the 7 typical rationales for regulating a substance. 8 Well, it can't be protection of 9 health because leaving unregistered ammonia on 10 the market doesn't do that. As Karen has 11 pointed out, there is no FIFRA labeling. So 12 the warning statements and precautioning 13 statements aren't required; they are not 14 regulated. The directions for use aren't 15 regulated. They can be changed at any time to 16 say anything they need to say. 17 Applicators are not legally 18 required to follow the labeling, even if it is 19 correct. You don't have any idea of what the 20 exposure risks to the applicators are, and you 21 don't know what the exposure risks to 22 consumers are from any residues in food202-234-4433 Neal R. Gross & Co., Inc. Page 41 1 packaging, the commodities pulp and paper 2 mills. 3 You know, one of the big issues in 4 this case is, what's coming out of this 5 process? Well, you don't know. You haven't 6 looked at it. And I would propose that not 7 knowing doesn't protect anything. 8 Similarly, in the environmental 9 area, again, there's a disagreement here about 10 exactly what the chemistry is of using 11 ammonia, whether it is registered or 12 unregistered. If you accept Nalco's theory, 13 I guess ammonia is coming out of this process 14 and then a hypochlorous acid or something. I 15 am not entirely sure. But if you believe our 16 theory and Ashland's theory, then chloramines 17 of some kind are probably being generated by 18 this process. 19 Both chemicals are toxic to 20 aquatic organisms. Nalco's own label says 21 don't use this product, this ammonia product, 22 if you are going to be discharging a water202-234-4433 Neal R. Gross & Co., Inc. Page 42 1 that contains fish. So, whatever it is that 2 is coming out of that process is a threat to 3 fish. Once again, you don't what that risk is 4 because you haven't looked at it. You are not 5 regulating it. 6 And finally, even if the problem 7 could be solved by some kind of precautionary 8 labeling, because there is no FIFRA 9 regulation, it may or may not be happening. 10 Who knows? 11 If you are interested in ensuring 12 FIFRA compliance, well, then, leaving an 13 unregistered ammonia on the market for a 14 couple of years isn't really helpful, either. 15 You have asked us some questions about 16 Section 152.15. We all work with that 17 regulation on a daily basis. You know, guys, 18 if you say that using ammonia with bleach in 19 process water in a pulp and paper mill is a 20 pesticidal use, then, by definition, any 21 direction for use that is like that is a 22 pesticidal claim. It is, by definition, a202-234-4433 Neal R. Gross & Co., Inc. Page 43 1 pesticidal claim. You don't have to say on 2 the bottle of the ammonia that it is a 3 microbiocide or that it kills wide. 4 In its directions for use, to mix 5 it with bleach and process water in a pulp and 6 paper mill, you have said that is a pesticidal 7 use, not us. So the unregistered ammonia is, 8 by definition, a pesticide. So keeping it on 9 the market violates Section 12, and an 10 authorization, whether temporary or otherwise, 11 also violates FIFRA. So, if you are 12 interested in stricter compliance, you are not 13 going to do well there, either. 14 And as I have emphasized already, 15 unregistered ammonia serves no obvious purpose 16 of FIFRA. You are getting no recordkeeping. 17 You are getting no 6(a)(2) reporting. You 18 have no idea if this product complies with the 19 registration standard, and there's no 20 regulation, production, composition, or any of 21 the other things you would typically be able 22 to look at, monitor, regulate, enforce202-234-4433 Neal R. Gross & Co., Inc. Page 44 1 against. You can't do that here because you 2 said the product could be on the market for 3 registered uses without any regulation. 4 And if your interest is in 5 protecting the integrity of your own 6 regulatory program, that doesn't make a lot of 7 sense, either, because you have set up the 8 competing, the registered and the unregistered 9 products in direct competition with one other. 10 You have done that at the expense only of the 11 registrants. It is not the unregistered 12 people who are suffering here. It is Ashland 13 and it is Buckman who are regulated. 14 You are creating confusion in the 15 marketplace. You are, arguably, undermining 16 respect for your own EPA decisions. As I 17 said, it is not us who registered ammonia; 18 it's you guys. 19 This dragging on of this is 20 damaging the reputation for fairness and the 21 science and the good administration of FIFRA. 22 I think that just has the effect of reducing202-234-4433 Neal R. Gross & Co., Inc. Page 45 1 trust in EPA and respect for the FIFRA 2 program. 3 Typically, OPP is very careful not 4 to get into commercial disputes, avoiding 5 commercial disputes. Otherwise, things get 6 very nasty and complicated. I can respect 7 that. 8 But, again, if you are trying to 9 avoid level-playing-field issues, you have 10 really done quite the opposite here. Again, 11 you have set up registered and unregistered 12 ammonia in direct competition with one 13 another. 14 My clients aren't really so 15 concerned about the cost of complying with 16 FIFRA as the fact that everything they do has 17 a FIFRA compliance element to it. Many things 18 require prior notification to EPA, labels, 19 claims. Any kind of sales literature has to 20 be -- it is either enforceable by EPA; it has 21 to be notified to EPA. In many cases, it has 22 to be approved in advance by EPA.202-234-4433 Neal R. Gross & Co., Inc. Page 46 1 We can't just change our sales 2 literature or our processes or our product 3 chemistry on a dime to suit the market. We 4 are a heavily-regulated industry, and every 5 substantial change requires a lot of time and 6 effort. Our competitors don't have to do 7 that. If the customers don't like something, 8 they could just change the claims. If they 9 don't like the composition, they could just 10 change it. 11 Now, finally, maybe -- and this is 12 probably the most plausible reason -- you have 13 hesitated to do something because there are a 14 lot of chemistry issues here, and you are not 15 entirely sure if the registered and the 16 unregistered ammonia are the same or have 17 significant differences. That is fair. 18 There are a lot of things, though, 19 that I don't think are in dispute. I don't 20 think folks are disputing the active 21 ingredients that are in the products, the fact 22 that they are quite similar. The formulations202-234-4433 Neal R. Gross & Co., Inc. Page 47 1 are quite similar. The intended uses, users, 2 and use sites are all the same. The bacterial 3 slime to be controlled by using unregistered 4 ammonia and registered ammonia, it is the same 5 pest. Very similar directions for use, and 6 even pretty similar systems for using ammonia, 7 not identical, but pretty similar. 8 In our petition, we give you this 9 diagram and some pretty photographs and some 10 other things, and explained in detail how this 11 process works. But, basically, you are mixing 12 the hypochlorous acid and the sodium 13 hypochlorite and the ammonia in the process. 14 We can disagree about what comes out of the 15 process, but it doesn't look so different from 16 Nalco's process. I mean this is at least what 17 it was in late 2008. It might have changed. 18 It is a pretty similar process. They have to 19 add a caustic to increase the pH, whereas, we 20 formulate our ammonia in a way to make that 21 unnecessary. 22 This is a slightly more detailed202-234-4433 Neal R. Gross & Co., Inc. Page 48 1 process diagram, but, again, no real surprises 2 here, not big differences between the way 3 Buckman uses ammonia and the way that Nalco 4 uses ammonia. 5 But the disputes that do exist are 6 about the chemical output from these processes 7 that are going on in the pulp and paper mills. 8 And what are the claims, again, registered 9 ammonia? And I would like to spend a couple 10 of minutes to talk about this. I may turn the 11 microphone over. 12 But, basically, this is sort of 13 our view or, really, the scientific consensus 14 view on what happens with all these ammonia 15 processes, not just ours. 16 I am just going to let David 17 Brookman talk about them. 18 DR. BROOKMAN: Hi. I am Dave 19 Brookman, speaking for Buckman Laboratories. 20 What happens when you react 21 ammonia with hypochlorous acid has been known 22 for a long time. We have what we call a202-234-4433 Neal R. Gross & Co., Inc. Page 49 1 consensus view here. 2 The consensus view is not only the 3 scientific community, it is also EPA itself. 4 EPA has written the same reaction in its own 5 documentation. 6 So there is no question that 7 ammonia and hypochlorous acid react together 8 to make monochloramine. So, in the case of 9 Buckman, the reaction stops here because 10 Buckman knows how to control the aspects of 11 this reaction. That is not the case 12 necessarily for Nalco. We don't know what 13 their product is. Nobody knows what it is 14 because it has never been disclosed to EPA. 15 But, anyway, this means that there is a 16 possibility that other chloramines are present 17 in their product. 18 The graph on the bottom shows what 19 happens if you generate monochloramine in an 20 aqueous system, and a lot of that is stable 21 for a long time. But this means that, when 22 Buckman or Nalco carry out this reaction, they202-234-4433 Neal R. Gross & Co., Inc. Page 50 1 get monochloramine. They put it in the system 2 or the paper products, the paper streams that 3 are being treated, and it stays as 4 monochloramine. It will stay there for a long 5 time until it reacts out. 6 This is some advertising 7 information from Nalco. Nalco says that the 8 theories of comparing two ways of operating of 9 their process as a biocide, if you look 10 carefully, it says "cell cluster" up there at 11 the top and at the bottom. 12 Cell cluster is showing, we 13 believe, a pack of cell clusters, a biofilm, 14 by hypochlorous acid, at the top. Then, at 15 the bottom, how hypochlorous acid gets 16 together with what they call the stabilizer. 17 They show that the stabilizer 18 carries the hypochlorous acid into the cell, 19 where it associates back into hypochlorous 20 acid. We think this is not what happens. We 21 know of no information that suggests that this 22 actually happens. It is much more likely, we202-234-4433 Neal R. Gross & Co., Inc. Page 51 1 think, that monochloramine reacts by itself 2 inside the biofilm. 3 MR. BOUCHER: So there are two 4 competing views on the output of the process. 5 So you have a lot of information in front of 6 you. You will know what our view is; you know 7 what the consensus view is. You have gotten 8 some more information from Ashland today. So, 9 hopefully, you will have enough information 10 soon to make a decision of your own, after 11 hearing from the Nalco folks, what you think 12 is actually going on when ammonia is used. 13 Then there is the issue of what 14 kind of claims are at issue here. As I said, 15 it is Buckman's view that any product that 16 gives directions for use with chlorine in 17 process water in pulp and paper mills is, by 18 definition, a pesticide because of EPA's 19 registration actions. That might be different 20 in a case where they hadn't taken a 21 registration action, but they have. 22 We also have additional claims202-234-4433 Neal R. Gross & Co., Inc. Page 52 1 that aren't necessarily on the label, but are 2 they are in sales literature. One, oddly, is 3 you can see that sometimes they talk about the 4 use of 60620, which is the ammonia, in the 5 context of producing chloramine. So that is 6 not entirely consistent with the 7 stabilization. It is more consistent with our 8 view of the chemistry or the consensus view of 9 the chemistry. 10 I will let you examine these 11 slides at your own convenience, there's a 12 couple of them, and they are already in the 13 record. 14 Then, the second set of claims 15 that we have been able to collect that might 16 address some of your questions here, it seems 17 to us that there are claims that the 18 unregistered ammonia is used as part of a 19 biocidal system. That happens over and over 20 again. 21 Here, for example, shows the whole 22 product line at a time. Many of these202-234-4433 Neal R. Gross & Co., Inc. Page 53 1 products have been registered, and I guess the 2 registration just stopped -- you know started 3 stop happening with 60620, for some reason. 4 But, in any event, it is part of an oxidizing 5 biocide system. 6 More slides talk about comparing 7 different kinds of chemicals used in a biocide 8 system. You can read all of these on your 9 own, and they are in the record. 10 But it seems to us clearly 11 documented that Nalco's claim is that ammonia 12 is used in the context of a biocidal system. 13 So, the conclusion: since 14 registering ammonia several years ago, OPP has 15 not done anything concrete other than to 16 expressly authorize the competing sale of the 17 unregistered ammonia for the registered uses. 18 As far as we can tell, OPP hasn't obtained any 19 new information about ammonia since the end of 20 2008. Thus, you had early all the information 21 that you could have conceivably needed to 22 regulate unregistered ammonia since 2008 at202-234-4433 Neal R. Gross & Co., Inc. Page 54 1 the latest. 2 Therefore, like the Ashland folks, 3 we believe that the reasonable approach here 4 after two years of unregulated sale of ammonia 5 and plenty of time to register ammonia for 6 this use, it is time for EPA to stop the sale 7 of this unregistered ammonia, at least for the 8 currently-registered uses. If you want to 9 allow other uses of ammonia on the market, 10 that's fine. But it doesn't make any sense at 11 this point in time to permit the continued 12 sale of unregistered ammonia for uses that you 13 have already said are registered. 14 And after you've stopped the sale 15 of unregistered ammonia for the registered 16 uses, you can do whatever else you want. Take 17 as much time as you like. Do whatever else 18 you like. Do nothing more. It doesn't really 19 matter to us. 20 But it seems to us that you have 21 got to stop authorizing the continued sale of 22 the unregistered ammonia for the registered202-234-4433 Neal R. Gross & Co., Inc. Page 55 1 uses, because the status quo is unlawful and 2 it is unfairly harming the registered parties 3 in this. 4 Thank you. 5 DIRECTOR HARRIGAN-FARRELLY: Thank 6 you. 7 MR. GOLDBERG: Excuse me, Joan, 8 could I have a microphone, please? 9 MR. ROSS: Is this part of your 10 presentation? 11 MR. GOLDBERG: No, it is not. 12 At the outset, I just have to say 13 that Mr. Boucher -- 14 DIRECTOR HARRIGAN-FARRELLY: No, 15 no, no. No, no, when we are ready. No, no, 16 no. 17 MR. GOLDBERG: Wait just one 18 second. This is very important. 19 DIRECTOR HARRIGAN-FARRELLY: No, 20 no, no. You can include that in your -- I'm 21 sorry, sir. 22 MR. GOLDBERG: They have made a202-234-4433 Neal R. Gross & Co., Inc. Page 56 1 representation about -- 2 DIRECTOR HARRIGAN-FARRELLY: Well, 3 you can include that in your discussion. 4 MR. GOLDBERG: -- not including 5 the CBI, and he included our company's CBI. 6 DIRECTOR HARRIGAN-FARRELLY: Okay. 7 MR. GOLDBERG: And I kind of view 8 that as a point of order. Are you telling me 9 you are going to take my 25 minutes to make 10 the point? 11 MR. BOUCHER: You've made your 12 point of order in the submissions -- 13 MR. GOLDBERG: Excuse me. 14 MR. BOUCHER: When I am talking, 15 they are taking time -- 16 DIRECTOR HARRIGAN-FARRELLY: 17 Please. No. Both of you, we are going to 18 move on with the other presentation. 19 Sir. Thank you. 20 MR. BOUCHER: Are you starting 21 your presentation? 22 DIRECTOR HARRIGAN-FARRELLY: Thank202-234-4433 Neal R. Gross & Co., Inc. Page 57 1 you. 2 Mr. Boucher, Mr. Goldberg, we will 3 carry on with the other presentation. 4 MR. ROSS: Could you go ahead and 5 put up Nalco's slides, so we can begin timing 6 the presentation? 7 DIRECTOR HARRIGAN-FARRELLY: 8 During your question and answer, you can raise 9 it, if you wish. 10 MR. ROSS: Pass out anything you 11 have to pass out. 12 DR. BROWN: Now that is the second 13 of the two, and there is another one that goes 14 first. Not that one. 15 MR. ROSS: Does this have your 16 complete presentation? 17 DIRECTOR HARRIGAN-FARRELLY: Is 18 there a second one? 19 MR. ROSS: Is there a second one? 20 DR. BROWN: They are all together. 21 DIRECTOR HARRIGAN-FARRELLY: Oh, 22 okay.202-234-4433 Neal R. Gross & Co., Inc. Page 58 1 MR. ROSS: Thank you. 2 DR. BROWN: They are all together. 3 MR. ROSS: Are you ready to begin? 4 MR. GOLDBERG: Absolutely. Well, 5 at the outset, just let me reiterate that in 6 Nalco's view the following slides in Buckman's 7 presentation contain Nalco's confidential 8 business information. Nalco thinks this is a 9 very serious matter. Those slides are 12, 17, 10 18, 21, 22, 23, 24. In addition, slides 15, 11 17, and 25 contain information that is 12 distorted from Nalco presentations. 13 Nalco will proceed but requests 14 EPA not continue the publication of this 15 confidential business information, and hereby 16 submits that claim again. 17 With respect to the substance, 18 Nalco's view is perhaps a little bit different 19 than the other viewpoints. What we are going 20 to do today is talk a little bit about, first 21 of all, Nalco, the company, the OxiPRO system, 22 and how this integrated technology really202-234-4433 Neal R. Gross & Co., Inc. Page 59 1 provides a more effective control, using less 2 chemicals than competing systems. 3 I will review the agencywide 4 practice regarding adjuvants and Nalco's 5 practice and its marketing of the OxiPRO 6 system in the context of the adjuvant 7 precedent that exists within EPA. 8 And finally, we will talk a little 9 bit about all those pieces put together. 10 With that, I would like to 11 introduce our first speaker, Stuart 12 Passantino. Stuart is the Global Strategic 13 Business Manager for Water and Process 14 Services. Stu has been with Nalco for 17 15 years and is very familiar with the OxiPRO 16 system and how it came on the market. 17 Stu? 18 MR. PASSANTINO: Can everyone hear 19 me? Hello. 20 DIRECTOR HARRIGAN-FARRELLY: Not 21 yet. 22 MR. PASSANTINO: Hello. Hello.202-234-4433 Neal R. Gross & Co., Inc. Page 60 1 DIRECTOR HARRIGAN-FARRELLY: Yes. 2 MR. PASSANTINO: Good afternoon. 3 Thanks, Seth. 4 I am just going to spend about a 5 few minutes high level on who Nalco is to 6 really set the stage clear, and I am going to 7 spend a little time on what OxiPRO technology 8 is and what makes it successful. 9 So who is Nalco? Nalco has been 10 in operation for over 80 years. We are a 11 publicly-traded company on the New York Stock 12 Exchange, based in the western suburbs of 13 Chicago, Naperville, Illinois. We have over 14 11,000 employees, of which 7,000 are actually 15 in the field touching our customer. That 16 actually is unmatched in the competition that 17 we compete with. We are in more than 70,000 18 customer locations, operating in over 130 19 countries. 20 If you noticed our tagline, 21 Essentials for water, energy, and air, we are 22 very proud of our track record because that is202-234-4433 Neal R. Gross & Co., Inc. Page 61 1 exactly what we deliver to our customers. It 2 is what our customers asked us to do, bring 3 them innovation, differentiated service, and 4 differentiated technologies. 5 And we are very proud of our track 6 record from an environmental standpoint. We 7 are also very proud of what we have 8 accomplished over the last many years, some of 9 which I will just touch on briefly. 10 We helped one of our major 11 customers reduce over a billion gallons of 12 water a year annually at their operations by 13 deploying some of that innovative technology 14 that I just touched on. That is what Nalco is 15 all about. We just were awarded a DOE grant 16 to look at carbon dioxide capture. 17 So we are very proud of our focus. 18 We are very proud of our innovation, and we 19 are also very proud that we have been 20 recognized as part of that contribution to 21 industry by being a member of the Dow Jones 22 Sustainability Index member for the last202-234-4433 Neal R. Gross & Co., Inc. Page 62 1 couple of years, a very prestigious member. 2 Of the roughly 2800 companies that are on the 3 Stock Exchange, the Dow Jones Sustainability 4 Index is set aside for about 317 companies. 5 So what is OxiPRO and what makes 6 it successful, and why do our customers want 7 to buy it? Three components, and I think it 8 is important that we really set the stage here 9 for what OxiPRO is. 10 Yes, there is a chemistry 11 component. But, equally as important, there 12 is the proactive monitoring tools and the 13 onsite expertise that I just mentioned, the 14 7,000 people. There are 7,000 technical, 15 well-trained technical service employees that 16 are involved with our customer processes and 17 have real customer intimacy, to let us know 18 how to apply the technologies that we develop. 19 So the chemistry. Three 20 components. It is the EPA-registered sodium 21 hypochlorite. These chemistries have been 22 around, as you have heard, for many, many202-234-4433 Neal R. Gross & Co., Inc. Page 63 1 years. This isn't something that was just 2 developed. We use a pH buffer and a halogen 3 stabilizer. 4 Proactive monitoring tools gives 5 us real insight, real high monitoring, 24/7 6 monitoring of our customers' processes. 7 Could I have another microphone? 8 The second component is, as I was 9 mentioning, the proactive monitoring tools. 10 They give us 24/7 real-time monitoring of what 11 is going on in our customers' process from a 12 microbial activity and fouling standpoint. 13 And then, I have already touched 14 on the fact that those well-trained technical 15 experts take the data that the tools are 16 providing them, they interpret the data, and 17 they make the appropriate selections for how 18 to dose the chemistry. 19 What that allows us to do is 20 really, at the end of the day, use the minimum 21 amount of chemical required to meet our 22 customers' key parameters.202-234-4433 Neal R. Gross & Co., Inc. Page 64 1 You've actually already seen this 2 slide, strangely enough, and we can leave that 3 discussion for another day. But you can see 4 that we take the EPA-registered sodium 5 hypochlorite with the pH buffer through our 6 proprietary piece of equipment. We mix it. 7 We add the halogen stabilizer. We mix it 8 again. And we push it with carrier water into 9 our customers' process. Again, knowing where 10 to feed it, how to feed it, when to feed it is 11 very critical. 12 So what makes OxiPRO successful? 13 Well, it is the components. It is the three 14 components that I just mentioned. It is much 15 more than chemistry. 16 This is what our customers are 17 asking us to bring them. This is what our 18 customers are asking us to deliver and focus 19 on, which is innovation and differentiated 20 solutions. 21 We take the treatment program. We 22 have the capability of understanding what the202-234-4433 Neal R. Gross & Co., Inc. Page 65 1 appropriate chemistries there are to feed; as 2 I have mentioned, what, when, how much, and 3 where. We take the monitoring tools, which 4 provide us real-time, 24/7 information. We 5 take the technical service reps, as well as 6 our R&D, to interpret that data. 7 MR. ROSS: Sorry. Can I just ask 8 you a question, so that we are all singing out 9 of the same book here at least? 10 MR. PASSANTINO: Sure. 11 MR. ROSS: By halogen stabilizer, 12 is that what you are using to refer to ammonia 13 today? Is that the term you're using -- 14 MR. PASSANTINO: Yes. 15 MR. ROSS: -- to refer to ammonia? 16 MR. PASSANTINO: Yes. 17 MR. ROSS: So, where we see 18 "halogen stabilizer", we should sort of say 19 that is where you are saying ammonia fits in? 20 MR. PASSANTINO: That's correct. 21 MR. ROSS: Thank you. 22 MR. PASSANTINO: You are welcome.202-234-4433 Neal R. Gross & Co., Inc. Page 66 1 And then we link it back to what 2 our customers really want. And what they 3 really want is a paper machine system to run 4 efficiently and effectively, using the least 5 amount of chemicals possible. That helps them 6 with their environmental footprint, and that 7 is what Nalco delivers. And that is what 8 makes OxiPRO successful, and that is why our 9 customers are very anxious to buy this 10 technology. 11 So, with that, I will turn it over 12 to Elizabeth. 13 MR. GOLDBERG: Elizabeth Brown is 14 our next speaker. Elizabeth is a PhD 15 entomologist. She's worked in the area of 16 pesticides for decades. She has worked in the 17 ag chem area as well as in the antimicrobial 18 area, and has really mastered the sort of 19 regime surrounding the handling of adjuvants 20 by EPA in the States. That is mostly what she 21 will be speaking to. 22 Elizabeth?202-234-4433 Neal R. Gross & Co., Inc. Page 67 1 DR. BROWN: Thank you. 2 When EPA first registered the 3 separately-added ammonia products, it raised 4 significant regulatory concerns to us for both 5 a procedural and a substantive basis. That is 6 why we filed the request with EPA to 7 reconsider those registrations, because they 8 appear to dramatically expand the scope of 9 FIFRA to a whole new range of products that 10 never previously had been considered. 11 I am going to briefly talk about 12 four different areas. One is that EPA has 13 long acknowledged that pesticides do not 14 include separately-added adjuvants. It is not 15 within their scope. That halogen stabilizers 16 not precursors -- and again, there is a lot of 17 history of EPA's work on this, and it is not 18 consistent with registration of both products. 19 None of the stabilizers, whether it is 20 halogens or any other active ingredient, are 21 pesticidal. 22 And finally, the regulatory202-234-4433 Neal R. Gross & Co., Inc. Page 68 1 framework and implications across the entire 2 pesticide program really do need to be 3 considered. 4 EPA has made it very clear that it 5 has no authority to regulate separately-added 6 adjuvants. They are not subject to 7 registration under FIFRA. 8 This was actually most recently 9 reiterated just this last December in relation 10 to the glyphosate re-registration review final 11 work plan, where when asked, in response to a 12 question about will they look at adjuvants 13 used with that product, the EPA said, no, only 14 those that are an intrinsic part of the actual 15 formulation itself. 16 There are a lot of different inert 17 ingredients in pesticide products. These are 18 not active. These are all inert ingredients 19 which are known to be used or the inside of 20 pesticide products. If these were added 21 separately, however, they still would not be 22 active. They would be separately-added202-234-4433 Neal R. Gross & Co., Inc. Page 69 1 adjuvants, not subject to regulation under 2 FIFRA. 3 There are a lot of states that do 4 register -- actually, about five states, I 5 believe that actually require adjuvant 6 registration. And if you go and look to see 7 what they have registered, you will see 8 registrations for all of these kinds of 9 products and many, many others. 10 Let's talk for a minute about 11 ammonium sulfate as an adjuvant. Ammonium 12 sulfate is a well-known adjuvant in crops. I 13 am going to pass around two separate examples 14 of adjuvant labels for ammonium sulfate that 15 are used in agriculture. 16 While they call these things water 17 conditioners, it is also very clear that it 18 results in a reaction between the herbicide 19 and the ammonium ion, forming the ion of amine 20 salt of the pesticide. 21 These labels claim that they 22 enhance and extend the performance. They202-234-4433 Neal R. Gross & Co., Inc. Page 70 1 prevent degradation. They prevent tie-up. 2 If you look at California, which 3 is one of the states that actually registers 4 adjuvants, there are over 36 different ammonia 5 sulfate products that are registered as 6 adjuvants in California for crop use. 7 In fact, the use of separately8 added stabilizers is no different for 9 industrial or drinking water use than it is 10 for any other use. EPA has not ever 11 identified that you really do need to register 12 those. They have never identified, despite 13 well knowing that chloramine is used in 14 drinking water, that that required 15 registration. Even though EPA is required by 16 law to register drinking water disinfectants, 17 they have not required either chloramine or 18 any ammonia stabilizer that is used to produce 19 the chloramine to be registered for that, nor 20 do they require the directions for use. 21 There has never been an example 22 that we have found where EPA has clearly202-234-4433 Neal R. Gross & Co., Inc. Page 71 1 identified or said that any of these 2 separately-added adjuvants, regardless of 3 their purpose, are precursors to pesticidal 4 active ingredients. 5 Even where you are going to making 6 an amine form, whether it is a halogen in 7 drinking water or somewhere else, you have 8 never identified that it is necessary to 9 register the adjuvant, the stabilizer that is 10 used to do it, even though you are well-aware 11 that it exists, and have been aware that it 12 exists for a long time. In fact, you have 13 addressed the known presence through the 14 registration of the chlorine source, which we 15 believe is appropriate. 16 Where you have registered a 17 precursor, such as sodium chlorite or ammonium 18 bromide, the activator, even if it is 19 mentioned on the label, does not require EPA 20 registration as a pesticide. It must be used. 21 It is required, but it is not registered as a 22 pesticide itself.202-234-4433 Neal R. Gross & Co., Inc. Page 72 1 This is similar to the use of 2 dimethylhydantoin, cyanuric acid, or the many, 3 many other ammonia-based compounds. None of 4 them are biocidal. In fact, even if they were 5 present as part of an antimicrobial pesticide 6 product, they would be judged as inert because 7 they have no independent pesticidal activity. 8 All right. The existing 9 registrations we believe were granted in 10 violation of both state statute and 11 regulation. The ammonia, as it is identified 12 on the product, is apparently not what is 13 actually in the product. 14 But, furthermore, the required 15 publication of receipt and decision and 16 supporting documents were not provided. And 17 since there was no timely opportunity for 18 public comment prior to registration, Nalco 19 has had to come in after the fact to provide 20 the types of public comments and the 21 additional information that we believe the 22 agency needed to consider.202-234-4433 Neal R. Gross & Co., Inc. Page 73 1 Finally, we believe that the 2 implication of any decision that adjuvants or 3 any subset must be required as pesticides 4 really does have an impact that goes across 5 the entire pesticide program. It is not 6 restricted to any single area. 7 Thank you. 8 MR. GOLDBERG: So that brings us 9 to what do we hope EPA will take a look at. 10 First, I think, from the company's 11 perspective, it is important that the EPA 12 recognize Nalco is committed to 13 sustainability, to innovation, and to 14 regulatory compliance; that this technology 15 really has resulted in better control, less 16 chemical use. And therefore, it has been very 17 popular with customers. In fact, undoubtedly, 18 the reason the other companies are raising 19 issues here is because in the marketplace 20 Nalco has been fairly successful. 21 Nalco very much favors a 22 transparent process. We thought that the202-234-4433 Neal R. Gross & Co., Inc. Page 74 1 docket would be open by now. We are 2 disappointed that it is not. We hope that EPA 3 will open a public docket and provide everyone 4 with an interest in this with an opportunity 5 to participate. 6 We feel as though it is very 7 important that the agency get that input 8 before it makes a decision, so that you can 9 really have a complete perspective on the 10 impact of the decision from everyone who might 11 be affected by it. 12 Nalco did a whole lot of due 13 diligence before embarking on the OxiPRO 14 system. Now this was in the early 2000 15 period. 16 But, as I listened this morning, 17 there was at the time absolutely no evidence 18 that EPA would require registration of 19 separately-added nitrogen sources that would 20 be used with registered chlorine. As 21 Elizabeth just said, virtually the same 22 technology is used in drinking water. In202-234-4433 Neal R. Gross & Co., Inc. Page 75 1 drinking water and, indeed, in industrial 2 water treatment, and amount of chlorine was 3 addressed as part of the rep. 4 There are many, many different 5 categories of adjuvants that react with the 6 pesticide, stabilizers, safeners, 7 intensifiers, catalysts, synergists. All of 8 them react. 9 So far as we know, EPA has never 10 taken a look at what the reaction products are 11 and tried to say, oh, we need to pay attention 12 to those as separately-added or as new active 13 ingredients. 14 And what is interesting about all 15 of these adjuvants is that all of them claim 16 that they make the pesticide work better. 17 That is exactly what Nalco claims about the 18 non-pesticidal parts of the OxiPRO system. 19 The nitrogen source, be it ammonia or urea, 20 and, indeed, the pH balancing that it does. 21 All those do is make the pesticide, the 22 chorine work better, and those are perfectly-202-234-4433 Neal R. Gross & Co., Inc. Page 76 1 acceptable claims for adjuvants, if you look 2 across the broad spectrum of adjuvants that 3 are sold and are regularly used today. 4 So, how does Nalco's system fit 5 within this regime? The Nalco system is, 6 basically, a tank rinse. It contains a 7 registered pesticide, sodium hypochlorite. It 8 contains an adjuvant, a halogen stabilizer, 9 and a pH adjustment. The active ingredient is 10 registered. It is used in a manner that is 11 consistent with the label. The adjuvant in 12 those states that require adjuvant 13 registration is recognized by the state as an 14 adjuvant and registered as an adjuvant. 15 So there is no question but that 16 the biocidal activity comes from the 17 registered ingredient, and it is basically a 18 typical tank rinse. The stabilizer simply 19 serves to get the chlorine to where it is 20 needed to kill microorganisms and not have it 21 be consumed earlier in the process with 22 organic matter that doesn't need to be202-234-4433 Neal R. Gross & Co., Inc. Page 77 1 controlled. 2 And again, the claims that Nalco 3 makes for its system are simply that the 4 system is effective. The system contains a 5 biocide. There should be no problem with a 6 claim about its separately-added ingredients 7 that are added separately to the biocide. 8 Now, in Nalco's view, this is 9 where the inquiry ought to end. This really 10 is completely consistent with the broad 11 precedent that governs not only drinking 12 water, but also the use of adjuvants across 13 the broad spectrum of agricultural uses. 14 While today's presentation about 15 the chemistry was impressive, the question is, 16 has anyone ever done that for any separately17 added adjuvant, to determine what the reaction 18 products are for any of these other materials? 19 I think that I would submit that the answer is 20 no. 21 Now, even if one accepts that 22 monochloramine is an active ingredient, there,202-234-4433 Neal R. Gross & Co., Inc. Page 78 1 nevertheless, are two problems with what 2 Buckman and Ashland are advocating here. The 3 first is that all of those systems that we 4 have been able to identify have the source of 5 the active ingredient, the source of the 6 active moiety, as the registered ingredient. 7 So, in the case of a system based on 8 monochloramine, it would be the chlorine 9 source that would have to be registered. And 10 that is exactly what Nalco has registered and 11 uses. 12 That is why, in registering 13 Buckman's ammonia product, EPA has departed 14 from decades of its own precedent of 15 registering the contributor of the active 16 moiety where there are precursor systems. 17 The other problem is that, if EPA 18 were to accept what Ashland and Buckman are 19 saying, you would need to evaluate all of the 20 reaction products of all of these different 21 kinds of separately-added inerts to determine 22 whether any of them was a new active202-234-4433 Neal R. Gross & Co., Inc. Page 79 1 ingredient. Now that is a Herculean task. It 2 would cause dramatic marketplace disruptions, 3 and it is not necessary in this situation. 4 So, you know, where Nalco comes 5 out on this is that, as a matter of merits, 6 what Nalco is doing is appropriate; that EPA, 7 perhaps because it didn't have complete 8 information, perhaps because all of the 9 information now available wasn't put in front 10 of it at the time it registered Buckman's 11 ammonia product, that that registration was 12 improvidently granted and should be canceled. 13 Nalco also believes EPA should 14 issue a clear statement that separately-added 15 adjuvants, including stabilizers for halogen16 based compounds, whether that be in drinking 17 water, swimming pools, or industrial water 18 treatment, all of those are separately-added 19 adjuvants and don't require registration. 20 Finally, in the event that EPA 21 really doesn't want to get to adherence, there 22 is the procedural point. There is no dispute202-234-4433 Neal R. Gross & Co., Inc. Page 80 1 that the Buckman registration was issued 2 without compliance with EPA's own procedures. 3 The precedent that you all established in 4 canceling the Bayer herbicide product based on 5 the New York court decision dictates that you 6 do the same thing here. 7 If you were to restart the process 8 and have public comment before issuing the 9 registration, as you were lawfully required to 10 do, we would not be in this situation today, 11 and I daresay you would make a different 12 decision. 13 Interestingly, that, too, won't 14 disturb the current situation in the 15 marketplace. We are not asking to take 16 anybody off the market. What we are saying 17 is, effectively, withdraw the improvidently18 granted registration and then evaluate, if you 19 are going to start looking at in-situ 20 generated biocides, evaluate them through a 21 public process and make a decision. 22 Thank you.202-234-4433 Neal R. Gross & Co., Inc. Page 81 1 DIRECTOR HARRIGAN-FARRELLY: Thank 2 you all. 3 Okay, we will take a 15-minute 4 break and be back. 5 You guys have been here probably 6 so often, you know where everything is. But 7 there's a little coffee shop across the 8 bridge. The restroom for men is down the 9 hall, and for women it is you go through here 10 and down the hall. You will find it. 11 Thank you, and I will see you back 12 in a few minutes. 13 (Whereupon, the above-entitled 14 matter went off the record at 2:25 p.m. and 15 resumed at 2:42 p.m.) 16 DIRECTOR HARRIGAN-FARRELLY: Okay. 17 Why don't we go ahead and get started? 18 As I mentioned, EPA had some 19 questions, and I believe you all have a copy 20 of those. I will turn it over to Bill Jordan, 21 and he is going to kick it off. 22 We have changed the microphones.202-234-4433 Neal R. Gross & Co., Inc. Page 82 1 So we don't have as many, but, hopefully, 2 these work better than the ones we had before. 3 So we will just have to share. 4 MR. JORDAN: Thank you, Joan. 5 I am Bill Jordan, and I am 6 relative newcomer and veteran to this. I 7 actually used to work once upon a time in the 8 Antimicrobials Division back in 2008 and heard 9 about this issue at that time. Then I left 10 AD, confident that I would never have to deal 11 with it again, and I was wrong, obviously. I 12 came back, was drawn into this discussion in 13 the last few weeks. 14 So, in preparation for this 15 meeting, I met and talked with my colleagues 16 in the Office of General Counsel and the 17 Antimicrobials Division, and we collectively 18 drafted a series of questions which we have 19 distributed to you. I am going to take a 20 moment or two and kind of set the table, 21 talking about what we are interested in 22 understanding and thinking through, and then202-234-4433 Neal R. Gross & Co., Inc. Page 83 1 pose some questions to representatives of the 2 company. 3 The first thing to say is that it 4 seems to us fairly obvious that the threshold 5 question is whether the products being 6 distributed, sold and distributed, by Buckman 7 and Ashland Hercules and Nalco should be 8 treated as pesticides. And therefore, if they 9 are pesticides, whether they should be 10 registered under FIFRA or not. 11 So the first question that you see 12 on the page, on the handout, draws your 13 attention to the applicable section of the 14 regulations supporting CFR 152.15 and some of 15 the text of that particular regulation, 16 then, poses questions about how that 17 regulatory text applies in the context of 18 these specific products. I am going to be 19 asking a couple of questions in a moment to 20 get into the details of how you see that 21 regulation fitting or not fitting with the 22 facts of these products.202-234-4433 Neal R. Gross & Co., Inc. Page 84 1 The second big area is one that I 2 guess I want to talk a little bit about as 3 well and set the table for it. We recognize, 4 simply by the number of people here 5 representing the companies, and how well6 dressed you all are, that this has big 7 financial stakes for the folks involved. We 8 are mindful of that. 9 But I will tell you that, for us 10 at EPA, one of the more important 11 considerations in doing our jobs here, and we 12 think really the thrust of FIFRA, is to focus 13 on protection of human health and the 14 environment. 15 So the second question really 16 addresses, what are the human health and 17 environmental implications from our decision 18 to register or not to register these products? 19 The third question that I want to 20 talk about is related to something that 21 several of the presentations -- a couple of 22 the presentations -- referred to, and that is202-234-4433 Neal R. Gross & Co., Inc. Page 85 1 the broader implications beyond the specific 2 circumstances of the debate about the 3 registration status of these ammonia products 4 used in the pulp and paper/board industries. 5 Mr. Goldberg's comments addressed 6 that a lot, but I would be interested and we 7 will be asking you in the time here to talk 8 about the implications beyond simply this 9 context, whether it be other substances or 10 other applications of this technology, and 11 what distinctions, if any, can be drawn across 12 these different situations. 13 Questions 4 and 5 really relate to 14 more specific focus on these particular 15 products, and particularly on urea product, 16 which we understand is being sold by Nalco, 17 and whether it is essentially in the same 18 status or should be treated in the same way as 19 an ammonia product or whether it should be 20 treated differently. 21 So, with that as an introduction, 22 let me start off by asking, and mindful of the202-234-4433 Neal R. Gross & Co., Inc. Page 86 1 time, asking you to be brief in your 2 responses, whether there are meaningful 3 differences between the claims being made for 4 the Ashland Hercules and Buckman products 5 versus the Nalco products in terms of the 6 pesticidal activity. 7 Let me ask Mr. Goldberg to speak, 8 or one of your colleagues to speak, to that 9 question, and then turn to the representatives 10 of the other companies. 11 MR. GOLDBERG: Well, I think that 12 my own view of this is that the claims that 13 Nalco makes for the OxiPRO system are to 14 control microorganisms and foul in pulp and 15 paper mills. In terms of claims, Nalco is 16 very clear, and its customers are very clear, 17 that the registered sodium hypochlorite is the 18 active component to the system, that the pH 19 adjuster and the adjuvant, nitrogen source, 20 are non-active components. 21 We do claim that the system is 22 effective, that the system allows the use of202-234-4433 Neal R. Gross & Co., Inc. Page 87 1 fewer chemicals and results in better control, 2 but don't make any claims directly for 3 anything other than the registered sodium 4 hypochlorite. 5 MR. JORDAN: Okay, thanks. 6 Ms. Hansen? 7 MS. HANSEN: Thank you. 8 What I would say in response to 9 that is that, as our presentation 10 demonstrated, the hypo is not the active in 11 that product. Nalco spent some time 12 explaining the technologies that are 13 implemented. 14 The technologies that the three 15 companies employ in the field are all very 16 similar. There is a physical apparatus. 17 There is a chemical reaction. There are 18 employees of each of the three companies that 19 are at the mill. 20 To say that their claim of 21 biocidal control is only over the system begs 22 the question of what the biocidal active is202-234-4433 Neal R. Gross & Co., Inc. Page 88 1 and how it is being deployed. 2 MR. JORDAN: So you are asserting 3 that, by making claims for the system, they 4 are making claims for all the ingredients in 5 the product, in the system, and those that are 6 regarded -- and I want to make sure I am 7 getting it correctly -- those that exert a 8 pesticidal effect are, in fact, pesticides? 9 Would that be fair? 10 MS. HANSEN: What Mr. Goldberg 11 just said is that they understand, that Nalco 12 understands, and that the customers understand 13 that hypo is the active, and they look at the 14 hypo label, and that is sufficient under FIFRA 15 to provide for regulatory control and safety 16 for this process. 17 And what we are saying is that is 18 not the active, hypo. To understand what is 19 actually happening, you have to look at what 20 happens with that chemical reaction and what 21 is delivered to the water system. 22 MR. JORDAN: Thank you.202-234-4433 Neal R. Gross & Co., Inc. Page 89 1 MR. ROSS: And you would make the 2 same characterization about your product? 3 MS. HANSEN: Absolutely. And 4 Buckman's. 5 MR. JORDAN: Mr. Boucher, do you 6 have anything to add? 7 MR. BOUCHER: Yes. Our position 8 is that, despite Nalco's extensive due 9 diligence on this subject, that, actually, 10 sodium bromide has been registered for over a 11 decade for use with bleach to disinfect water 12 in pulp and paper mills. So there is 13 absolutely nothing new about the registration 14 of ammonia in this case. This actually 15 continues in a precedent that you established 16 a long time ago. 17 Two, bleach isn't registered for 18 use with ammonia in pulp and paper mills. So 19 there is no registered product for this use. 20 Therefore, even if the source of the biocide 21 were the bleach, the product is being used 22 inconsistent with its labeling in pulp and202-234-4433 Neal R. Gross & Co., Inc. Page 90 1 paper mills to disinfect water. 2 Third of all, we have, hopefully, 3 produced -- 4 MR. JORDAN: I was asking about 5 claims. Can you get at that, please? 6 MR. BOUCHER: Yes. Well, the 7 claims are that the ammonia should be used in 8 connection, under 152, Subsection (a)(1), that 9 the substance, ammonia, in combination with 10 bleach, can be used as a pesticide in pulp and 11 paper mills to reduce bacterial slime. 12 MR. JORDAN: So there are specific 13 claims that you see being made for Nalco's 14 product? 15 MR. BOUCHER: It is all in the 16 record. I mean I can't, you know -- 17 MR. JORDAN: Okay, thanks. 18 DR. MORROW: I have heard the term 19 adjuvant used quite extensively during the 20 presentations. I would like to get a working 21 definition of the term in the context of a 22 chemical reaction because I was always under202-234-4433 Neal R. Gross & Co., Inc. Page 91 1 the impression that an adjuvant is not used in 2 a chemical reaction, typically not used in a 3 chemical reaction, to form a new product or a 4 new chemical. 5 DR. BROWN: This is Elizabeth 6 Brown. 7 There are varying definitions of 8 what adjuvants are and are not. An adjuvant 9 is something that is added, and that is the 10 extent of it. It does not further describe 11 what the adjuvant does. 12 There are several different 13 versions of adjuvants, and you can look 14 particularly to the ag industry for this. 15 There are some ASTM methods or ASTM 16 definitions which are not fully acceptable to 17 the full ag industry. 18 CPDA has some. They are highly 19 variable. It is not consistent. 20 But there are adjuvants which 21 react. There are adjuvants which are termed 22 stabilizers. There are adjuvants which are202-234-4433 Neal R. Gross & Co., Inc. Page 92 1 also termed water conditioners. There are 2 adjuvants that are called safeners. There is 3 a wide variety of them, but the term adjuvant 4 is something simply that is added. 5 MS. HANSEN: This is Karen Hansen 6 on behalf of Ashland. 7 That is simply inaccurate. EPA 8 has a definition of adjuvant. It is in 40 CFR 9 Section 153.125(a)(2). It defines an adjuvant 10 as a compound which functions simply to 11 enhance or prolong the activity of an active 12 ingredient by physical action, not by chemical 13 reaction. 14 MR. ROSS: I would like to ask a 15 question based on, albeit I know this is 16 contested material, but I would like you to 17 turn to page 18 of the Buckman presentation, 18 please. 19 Now, just to make sure that we 20 have our terminology correct here, when you 21 add ammonia to hypochlorine or whatever 22 chlorine you have there, you end up with202-234-4433 Neal R. Gross & Co., Inc. Page 93 1 chloramine? Is that correct? 2 I am asking Nalco these questions. 3 MS. RICE: Laura for Nalco. 4 And, yes, that is correct. They 5 are forming different types of chloramines. 6 MR. ROSS: Okay. So, basically, 7 under the heading that says, Ammonia Makes 8 Chloramines, you are talking about comparative 9 features of chloramines here? Is that 10 correct? 11 MS. RICE: That is correct, based 12 on the different hydrolysis rates. 13 MR. ROSS: Okay. And, then, there 14 are at least two areas where -- well, there's 15 moderate quick kill and there's enhanced quick 16 kill and then there's enhanced control of 17 filamentous bacteria. All those, to me, seem 18 to be bacterial or microorganism control 19 claims, is that correct? 20 MS. RICE: In the context of the 21 presentation, the purpose of this slide was to 22 highlight the differences in stabilization202-234-4433 Neal R. Gross & Co., Inc. Page 94 1 rates and how the effect is impacted by the 2 type of stabilizer, and whether you are using 3 an inorganic or an organic stabilizer. 4 So it was to highlight that the 5 different programs persist differently in the 6 process to provide a different effect. So, in 7 the context of the presentation, the slide was 8 used to highlight those subtle differences. 9 MR. ROSS: Okay. So, are you 10 saying that you equate the term chloramine, 11 which appears to be a separate substance, with 12 stabilized chlorine? 13 MS. RICE: Chloramine is the 14 stabilized intermediate. 15 MR. ROSS: Stabilized 16 intermediate? Maybe you need to refresh my 17 memory as to -- you start with chlorine. You 18 add ammonia. You get to either chloramine or 19 stabilized chlorine. And then, what do you 20 end up with? 21 MS. RICE: The chloramine is a way 22 to deliver the chlorine biocide into the202-234-4433 Neal R. Gross & Co., Inc. Page 95 1 process. And because of the differences, the 2 very subtle differences in the persistence of 3 these organic versus inorganic chlorinated 4 forms, it has an impact on the overall 5 performance of the chlorine biocide. 6 MR. ROSS: Okay. I would invite 7 either Buckman or Ashland to jump in here in 8 a technical way, please. 9 MS. TAUB: Can I just clarify one 10 thing on this slide we were looking at? 11 MR. ROSS: Could you identify 12 yourself? 13 MS. TAUB: Sure. Cynthia Taub, 14 Steptoe & Johnson. 15 MR. ROSS: Yes. 16 MS. TAUB: I just point out that 17 this Ammonia Makes Chloramine that is there is 18 what Buckman added. This is not part of 19 Nalco's material, that heading up there that 20 you pointed to. 21 MR. ROSS: Ammonia Makes 22 Chloramine?202-234-4433 Neal R. Gross & Co., Inc. Page 96 1 MS. TAUB: That's theirs. They 2 added that. 3 MR. ROSS: Okay, but we have 4 also -- 5 MS. TAUB: No, no, I just wanted 6 to make sure you understood that. 7 MR. ROSS: Right, but the 8 equivalencies are still there. Okay. 9 Why don't you all sort of -- yes, 10 and then we will move on after a minute or 11 less. 12 DR. BRADY: Okay. This is Jim 13 Brady from Ashland. 14 If you go back to the literature 15 examples I gave, when you form the 16 monochloramine, you change the redox 17 potential. That is why it persists. You are 18 in a chlorine demand setting, so you, 19 basically, tune down the reactivity of that 20 system by making the new chemical entity. 21 That is why you see those 22 differing characteristics of enhanced202-234-4433 Neal R. Gross & Co., Inc. Page 97 1 persistence, and so on, which are 2 characteristics we like to design in. But you 3 make a new chemical entity. 4 MR. ROSS: A new chemical. 5 What about urea? 6 DR. BRADY: And that is also true 7 of ureas and then chlorourea. 8 DR. BROOKMAN: And it doesn't make 9 chloramines. 10 DR. BRADY: And yes, chemically, 11 that is not a chloramine. 12 MR. RAYMOND: What is it? 13 DR. BRADY: It is a chlorourea. 14 MR. RAYMOND: Okay. 15 MR. BRADY: A chlorobromide. 16 DIRECTOR HARRIGAN-FARRELLY: I'm 17 sorry. Can we just go back, so you can 18 identify who you are, please? 19 MR. RAYMOND: I'm sorry. Paul 20 Raymond with Ashland Hercules. 21 I just wanted to clarify because 22 there's really two systems represented on the202-234-4433 Neal R. Gross & Co., Inc. Page 98 1 slide you are asking about. One is the one 2 with the ammonia source, which is the 6620, 3 and the other is the 6615, which is actually 4 urea. 5 MR. ROSS: That is very helpful. 6 MR. RAYMOND: So let's make sure 7 we understand we are actually dealing with two 8 different unique compounds. 9 DIRECTOR HARRIGAN-FARRELLY: Thank 10 you. 11 DR. BROOKMAN: This is Dave 12 Brookman, speaking for Buckman. 13 When ammonia reacts with 14 hypochlorous acid, it makes chloramine. There 15 is just no question of that. There's a 16 chemical reaction that occurs. 17 When the chloramine reacts as a 18 biocide, it is not clear at all what happens. 19 It is possible that the chlorine material, the 20 active chlorine reacts directly. But if that 21 is the case, it is pretty unlikely that the 22 carrier, the material that they are calling202-234-4433 Neal R. Gross & Co., Inc. Page 99 1 the adjuvant, is released as such. So that is 2 a point. 3 MR. JORDAN: Let me jump in here. 4 I want to get, in the time that we have 5 allotted here on the agenda, to the next 6 question, which has to do with the potential 7 impacts on human health and environmental 8 risks. 9 I am interested in having folks 10 respond to what documentation indicates that 11 the use of the Nalco products poses any 12 different human health or environmental risk 13 compared to the products that are already 14 being marketed by Buckman and Ashland. 15 So, Ms. Hansen? 16 MS. HANSEN: Thank you. This is 17 Karen Hansen, on behalf of Ashland. I am 18 going to ask Paul Raymond to address that on 19 behalf of Ashland. 20 That is one of the primary reasons 21 that we initially engaged with the agency on 22 this, and we are quite concerned about the202-234-4433 Neal R. Gross & Co., Inc. Page 100 1 safety because our employees work in the same 2 mills where Nalco's products are deployed. 3 So, Paul, maybe you could describe 4 some of the actions that Ashland took in 5 response to that. 6 MR. RAYMOND: Sure, sure. Thank 7 you. 8 The main reason I'm here, 9 actually, of course, there's financial issues 10 involved, but the main reason I am here is for 11 product stewardship and for the safety aspects 12 of this. 13 As it emerged that these products 14 were on the market, you were, of course, very 15 familiar with how biocides are sold and 16 registered in the marketplace. We 17 investigated how Nalco was commercializing 18 these products. Actually, with the 6620, we 19 were very surprised to find that they had not 20 registered it, and we couldn't find any limits 21 of how they could apply it, what are the feed 22 rates, what are the feed ratios, et cetera.202-234-4433 Neal R. Gross & Co., Inc. Page 101 1 So that immediately caused us some concern. 2 Then, the 6615 became available on 3 the market, and we found that, to our 4 discovery, it was even a unique, completely 5 unique chemistry in the new compound, which, 6 obviously, raised even graver concerns. 7 As precautions, we implemented, 8 asked our employees to remove themselves from 9 where these chemicals were being applied and 10 tried to limit the contact with the process 11 water because it is simply unknown what the 12 possible hazards might be to these compounds. 13 DIRECTOR HARRIGAN-FARRELLY: How 14 were they being applied? 15 MR. RAYMOND: I'm sorry? 16 DIRECTOR HARRIGAN-FARRELLY: I'm 17 sorry. Joan Harrigan-Farrelly. 18 How were the products being 19 applied? 20 MR. RAYMOND: Well, they are all 21 being applied in exactly the same way. So 22 they are formulated in a more concentrated202-234-4433 Neal R. Gross & Co., Inc. Page 102 1 solution that is, then, added to process water 2 in paper mills, and to kill microbiological 3 species. 4 MR. JORDAN: It sounds as though 5 you are voicing questions, but do you have any 6 incidents that are attributable where people 7 have been hurt or where there have been fish 8 kills or any other examples like that? Or do 9 you have any risk assessments that you would 10 point to that would indicate different risks? 11 MR. RAYMOND: Again, in a broad 12 sense, we are really doing it from a 13 precautionary perspective. 14 MR. JORDAN: Okay. 15 MR. RAYMOND: But I could ask 16 Linda or Jim for some specific examples. 17 DR. BRADY: Yes, this is Jim Brady 18 again from Ashland. Let me just jump in. 19 First of all, there is virtually 20 no toxicological data for chlorourea that we 21 were able to find. 22 The other item, getting more to202-234-4433 Neal R. Gross & Co., Inc. Page 103 1 the safety issue, we did have a report from 2 some of our people in an analytical lab that 3 they work alongside Nalco people where one of 4 their workers was pulling a sample, brought it 5 into the lab, put it on the bench, asked our 6 worker, "Do you smell that?" 7 And he didn't smell anything, but 8 he looked around, and the container that the 9 Nalco worker had just brought in was, the word 10 he used was "smoking". Really, it was 11 something was coming off. No one really knows 12 what it was. 13 MR. JORDAN: Okay. Any thoughts 14 from Nalco on the question of whether there 15 are different risks? 16 MR. GOLDBERG: The short answer is 17 no. In the first place, the question that you 18 ask has to do with the use of ammonia. 19 Ammonia and urea both are widely-used, 20 separately-added adjuvants. 21 Again, you know, the plant that 22 supplies drinking water to this building uses202-234-4433 Neal R. Gross & Co., Inc. Page 104 1 ammonia to push chloramines through the 2 system, and it uses a registered source of 3 chlorine, whether it is chlorine gas or sodium 4 hypochlorite. Those risks are exactly the 5 same as the risks that all three companies' 6 chemistries pose. There are no differences. 7 We can't be expected to respond to 8 sort of ad hominem sort of claims about 9 smoking containers here. 10 MR. JORDAN: And I don't expect 11 you to do that. 12 Mr. Boucher? 13 MR. BOUCHER: I would add 14 something that isn't ad hominem. It is a 15 concern that you have raised. 16 If you look in Appendix D of our 17 September 2008 petition, we have a sales 18 documentation for a trial that was conducted 19 by Nalco at one of its customer sites. They 20 recommend use in a machine silo at a rate of 21 12 parts per million as total chlorine and in 22 a shower water chest at 10 parts per million202-234-4433 Neal R. Gross & Co., Inc. Page 105 1 as total chlorine. 2 And if you look in Exhibit E of 3 our petition, the registration of Busan 1215 4 that you approved, you have directions for use 5 that say maximum of 5 parts per million 6 measured as total chlorine in the water. So 7 that is twice the rate you found was 8 appropriate for the product that you looked at 9 and that you registered. 10 MR. JORDAN: Okay. Thanks. 11 Ms. Hansen, briefly. 12 MS. HANSEN: Just briefly, the 13 point, I think, that is being made here is 14 that, in the absence of registration, which 15 means review by you all, these risks are 16 uncertain, and you are uniquely in the 17 position to enforce FIFRA's requirement to 18 protect public safety. That is what we are 19 asking you to do. 20 DIRECTOR HARRIGAN-FARRELLY: Okay. 21 Let's try to move on. 22 MR. JORDAN: Okay. The last line202-234-4433 Neal R. Gross & Co., Inc. Page 106 1 of questioning has to do with the broader 2 precedential significance of deciding either 3 that these ammonia products need registration 4 or do not registration. 5 I heard Mr. Goldberg argue that 6 this is just the tip of the iceberg, so to 7 speak. I would be interested, Mr. Boucher, if 8 you have any thoughts or, Ms. Hansen, on that 9 subject. 10 MR. BOUCHER: Sure. Well, first 11 of all, I would like point everyone to Denny 12 Edwards' November 18, 2009 letter, where it 13 says the agency is not reevaluating its 14 position with regard to adjuvant stabilizers, 15 et cetera. The agency is addressing solely 16 issues connected with the sale, distribution, 17 and use of ammonia and potentially urea 18 products in the pulp and paper/board industry. 19 So, I understood that the issue 20 that was being considered here, or being 21 decided here, was fairly limited; it had 22 nothing to do with drinking water.202-234-4433 Neal R. Gross & Co., Inc. Page 107 1 Also, in terms of precedence, I 2 have already pointed out sodium bromide has 3 been registered for use with bleach to 4 disinfect water for at least a decade, and I 5 believe longer. 6 So registering ammonia was no kind 7 of precedent. Registering urea is no kind of 8 precedent. 9 You are up to at least three 10 technology systems now where you are 11 registering and you are doing this. I would 12 say the precedent has been established, and 13 there's more of a disruption to reverse that 14 trend at this point. 15 The whole industry is here in the 16 room. This cascade of products that are going 17 to have be registered in the ag business, it 18 is just not going to happen. The whole 19 industry is here. 20 And you are being asked to make a 21 decision about how to regulate this kind of 22 technology in this limited industry. You've202-234-4433 Neal R. Gross & Co., Inc. Page 108 1 got all the players in the room. 2 MR. JORDAN: Thank you. 3 So you see no inconsistencies, 4 then, between what EPA has done with regard to 5 the technologies that identified where we have 6 required registration and the technologies, 7 the categories of adjuvants that Mr. Goldberg 8 has described? You see no inconsistency 9 between those two approaches? 10 MR. BOUCHER: Well, the problem 11 with calling ammonia an adjuvant is that it 12 ends all argumentation. 13 MR. JORDAN: I understand that. 14 MR. BOUCHER: So I can't respond 15 to that. 16 MR. JORDAN: But how would you 17 distinguish the situations where EPA has 18 required registration and the ones, the 19 product lines where EPA has not, what 20 distinction? 21 MR. BOUCHER: I am not familiar 22 enough with the record to respond to that.202-234-4433 Neal R. Gross & Co., Inc. Page 109 1 MR. JORDAN: Ms. Hansen? 2 MS. HANSEN: I would point out in 3 our materials -- and I didn't go into this in 4 my discussion because of the limited time -- 5 but there are a number of other industrial 6 biocides that are created onsite with 7 precursor chemicals being reacted, including 8 some of Nalco's own registration. So we don't 9 think this is something new that EPA did with 10 the Ameribrom registration, starting in 2003. 11 That registration itself followed others that 12 EPA had regulated in the very same way. 13 I also think, and we have said 14 this in our comments, I think the notion that 15 this decision on Nalco's two specific products 16 is going to wreak havoc in the drinking water 17 industry or in the agricultural industry is 18 nonsense. 19 The notion that ammonia added in a 20 chemical reaction in an industrial plant is 21 the same as ammonium sulfate that may be used 22 in a completely different way in an202-234-4433 Neal R. Gross & Co., Inc. Page 110 1 agricultural product, and might well in that 2 context qualify as an adjuvant, it is just 3 totally irrelevant to what we are talking 4 about here. And I think it is designed as a 5 device to try to distract the agency from the 6 issue at hand. 7 MR. GOLDBERG: May I? 8 MR. JORDAN: Mr. Goldberg, 9 briefly, and then, my colleague, Mr. Ross, has 10 a question. 11 MR. GOLDBERG: Thank you. Just a 12 couple of points. 13 With respect to these precursor 14 systems, Mr. Boucher mentioned sodium bromide. 15 This goes back to the point that we made 16 earlier. Each of those systems, the piece 17 that contributes the active moiety is 18 registered, including Ashland's system. But 19 ammonia and urea, they simply don't contribute 20 an active moiety. Therefore, they shouldn't 21 be registered. 22 The way to approach that, if you202-234-4433 Neal R. Gross & Co., Inc. Page 111 1 wanted to register it as a precursor and 2 consider monochloramine, which never has been 3 listed as an active ingredient, as an active, 4 would be to register the chlorine piece. That 5 is the first part. 6 The second thing is simply that, 7 if one looks at the role that ammonium sulfate 8 plays in glyphosate, you know, and I am very 9 disappointed, I must say, that no one from RD 10 is here, and I certainly hope you will discuss 11 this with your colleagues on the ag side. 12 But there are chemical reactions. 13 This stabilization is the result of the 14 interaction. As Elizabeth Brown pointed out, 15 it forms the amine salt of glyphosate that is 16 more stable. 17 So the notion that there's any way 18 to kind of put a ring around this and say, 19 well, it's only for pulp and paper, I just 20 think is not sustainable. I really believe 21 strongly that that's the reason that input 22 from stakeholders, whether they are companies,202-234-4433 Neal R. Gross & Co., Inc. Page 112 1 whether they are users, whether they are 2 environmental groups, needs to be sought. 3 DIRECTOR HARRIGAN-FARRELLY: So a 4 quick question. 5 Joan Harrigan-Farrelly. 6 But is it not to the pulp and 7 paper industry that the product is currently 8 being marketed solely, your product? 9 MR. GOLDBERG: The OxiPRO system 10 is marketed to the pulp and paper industry 11 only. as I understand it. Is that correct? 12 Yes. 13 MR. ROSS: Yes, I just have a 14 request. Joan had mentioned that we will be 15 asking you to provide any followup to this 16 meeting within 30 days. 17 As part of that followup, and I 18 think you could provide this to us sooner, 19 actually, because I am only asking for 20 existing materials, I think within, say, five 21 days of this meeting, we would appreciate 22 receiving from each of the parties the202-234-4433 Neal R. Gross & Co., Inc. Page 113 1 marketing materials for all the products that 2 they believe are implicated in their product 3 lines in this matter. And I am talking about 4 ammonia and urea, and I am talking about 5 registered and unregistered. 6 So we would like copies of the 7 labels for each of those products that are 8 implicated, whether they are registered or 9 not, and we would like copies of the current 10 marketing materials for each of those 11 products. And we would like that within five 12 days because we want what exists now. And I 13 want to be real clear about that. 14 MR. GOLDBERG: And that includes 15 the registered and unregistered components of 16 all products? 17 MR. ROSS: That is correct. 18 MR. GOLDBERG: That is the 19 activators of our competitors' products? 20 MR. ROSS: That is correct. That 21 is correct. And again, we want existing 22 materials. We don't want any alterations to202-234-4433 Neal R. Gross & Co., Inc. Page 114 1 any materials. We want what exists right now. 2 MR. PASSANTINO: Just a checking 3 question, if you will allow me. 4 Stuart Passantino with Nalco. 5 MR. ROSS: Sure. 6 MR. PASSANTINO: Each individual 7 company will submit their own marketing 8 information, correct? 9 DIRECTOR HARRIGAN-FARRELLY: 10 Correct. 11 MR. ROSS: That is correct. That 12 is correct. 13 MR. PASSANTINO: Not each others'? 14 MR. ROSS: Right, right. Yes. 15 (Laughter.) 16 Well, who knows? We can't stop 17 you from doing that. 18 And, you know, obviously, if there 19 are any players out there that you are aware 20 of who have similar products that may be 21 crossing some line, as you perceive it, we 22 would be interested in that material as well.202-234-4433 Neal R. Gross & Co., Inc. Page 115 1 Okay? 2 And again, within five days, 3 please submit that to Dennis Edwards. Is that 4 right, Dennis? Okay. 5 And I'm Phil Ross, by the way. 6 DIRECTOR HARRIGAN-FARRELLY: Thank 7 you. Thank you, Mr. Jordan. Thank you, Mr. 8 Ross. Thank you, Dr. Morrow. 9 I think that concludes the 10 questions that we have for EPA, that EPA had 11 for you. So we will move forward with 12 questions that you may have for each other. 13 So I think we can kick this off, 14 also, if we wish, in an alphabetical manner, 15 and start with Ashland. 16 MS. HANSEN: Thank you. We are 17 happy to go first. 18 This is Karen Hanson again, on 19 behalf of Ashland. 20 We don't really have any questions 21 for the other parties. We would like to take 22 our five minutes to make a couple of points202-234-4433 Neal R. Gross & Co., Inc. Page 116 1 that I think need to be made here. 2 The first is very simple, which is 3 that, if you take out of Nalco's presentation 4 materials today the references to urea as an 5 adjuvant, which I believe we have already 6 commented on, they have said nothing here 7 today to you to explain the product chemistry 8 of urea when reacted with hypo. 9 They have done nothing to respond 10 on the merits to the extensive information 11 that is in the record already about the 12 unregistered urea product. It suggests that 13 there is something that they don't want you to 14 know about that product. 15 So, our understanding from the 16 agency is that they have not talked to you 17 about that product. I appreciate your request 18 that they submit information to you about that 19 product. I think that will lend to your 20 understanding, and I am glad you are going to 21 do that. 22 The other thing that we wanted to202-234-4433 Neal R. Gross & Co., Inc. Page 117 1 put on the record here has to do with the 2 safety issues that you were inquiring about 3 and, again, this idea that Nalco is promoting 4 that the registration of hypo is sufficient to 5 address FIFRA registration of these products. 6 I would like to turn it over to 7 Linda to just share with you very briefly a 8 comparison of two of the labels that will just 9 highlight for you the problem with relying on 10 hypo. 11 Linda? 12 MS. CHANEY: Okay, thank you. 13 This is Linda Chaney again. 14 What I would like to do is go 15 ahead and pass around to the group copies of 16 three labels, the first being Nalco's own 17 registered sodium hypochlorite that is 18 approved for use in the pulp and paper 19 industry. I am going to read from the 20 physical and chemical hazard section on this 21 particular label, so that you have some 22 insight as to what their own guidance is.202-234-4433 Neal R. Gross & Co., Inc. Page 118 1 Secondly, I would like to read 2 from our Spectrum XD3899. That is the 3 registered ammonium bromide product, and 4 specifically highlight the dosage limits that 5 are dictated, of course, by the EPA, and then 6 compare that with Nalco's unregistered 7 ammonium sulfate product. So that you get a 8 feel for the differences in the control that 9 comes with the registration process, and 10 potential safety hazards that could follow. 11 So, to begin, the Nalcon 60735, in 12 the physical and chemical hazard section has 13 described the following. It is described as 14 a strong oxidizing agent. "Mix only with 15 water according to label directions." Then, 16 further, it states that, "Mixing this product 17 with gross filth or with ammonia, acids, 18 detergents, or other chemicals will release 19 hazardous gases irritating to the eyes, lungs, 20 and mucous membranes." So, clearly, there is 21 the potential for a hazardous situation to be 22 created when ammonia is combined with hypo.202-234-4433 Neal R. Gross & Co., Inc. Page 119 1 Next, under the directions for use 2 section for our XD3899 label, it states that 3 Spectrum XD3899 is to be used only in 4 conjunction with, No. 1, an oxidant such as 5 sodium hypochlorite, typically 12.5 percent, 6 to produce Spectrum XD3899 biocide and, two, 7 the Spectrum XD3899 feed delivery system. 8 Okay? So, it specifically calls out that you 9 have to use specific equipment and that only 10 approved personnel must manage that particular 11 system. 12 It also, furthermore, states that 13 there are dosage limits of .3 to 10 parts per 14 million concentration. That is dictated, of 15 course, by EPA. 16 The directions for use on the 17 Nalcon product state that 60620, as a 18 stabilizer, can be mixed with a source of 19 active chlorine prior to paper machine waters. 20 The stabilizer is pre-blended with active 21 chlorine source. The mixture should, then, be 22 added to process water streams immediately202-234-4433 Neal R. Gross & Co., Inc. Page 120 1 prior to the point of sufficient mixing. 2 Optimal stabilization, the stabilizer, to 3 activate chlorine at a molar ratio between 1 4 and 1 and 2 to 1. 5 There's no specific directions on 6 how much they can use, where they can use it, 7 the specific feed equipment that is required 8 to ensure that the correct -- 9 MR. ROSS: Thank you. 10 DIRECTOR HARRIGAN-FARRELLY: Okay, 11 Buckman. 12 MR. BOUCHER: Thanks. I just have 13 a couple of questions. 14 We have heard today from Nalco 15 that the use of ammonia with EPA-registered 16 sodium hypochlorite produces chloramines and 17 that the pesticide in the process is EPA18 registered sodium hypochlorite. My question 19 would be, for either Nalco or Ashland, is 20 anybody aware of a registered sodium 21 hypochlorite product that is registered for 22 use with ammonia to produce chloramines in a202-234-4433 Neal R. Gross & Co., Inc. Page 121 1 pulp and paper mill? 2 MS. HANSEN: Very briefly, this is 3 Karen Hansen for Ashland. 4 We have looked at over 300 5 registered hypo labels, including five of 6 Nalco's, and none of them provide for mixing 7 with ammonia or urea for pulp and paper uses. 8 MR. GOLDBERG: May I? 9 I think the answer to your 10 question is that all sources, all registered 11 sodium hypochlorite that does not expressly in 12 the directions for use prohibit mixing with 13 ammonia allows the use of ammonia. That is 14 the way pesticide labels have been read and 15 interpreted. 16 You can't go enforce against a 17 user, you know, of a registered sodium 18 hypochlorite who is not doing anything 19 inconsistent with the label. So, frankly, our 20 answer is that our products are suitable for 21 that use. 22 Now, yes, there is some202-234-4433 Neal R. Gross & Co., Inc. Page 122 1 responsibility on the users to get the safety 2 record. That is why Nalco has its own 3 personnel doing this. 4 That is why, with the exception 5 of, again, anecdotal issues, there aren't 6 incidents, and there haven't been incidents 7 with respect to the use of registered chlorine 8 and unregistered ammonia in drinking water 9 plants across the country. There have been, 10 interestingly, incidents with respect to 11 registered sodium chlorate, which is a 12 precursor to chlorine dioxide. Because those 13 generators are, in fact, fairly unstable. 14 The fact of registration and the 15 fact that there are label directions hasn't 16 prevented those. So I think there's no 17 question from a label perspective the current 18 bleach labels allow the use that is being made 19 of the registered material. 20 MR. BOUCHER: Okay. Also, just 21 returning to Nalco's presentation slide 1, 2, 22 3, 4, entitled, "OxiPRO Mixing Strategy", I202-234-4433 Neal R. Gross & Co., Inc. Page 123 1 invite either Ashland or Nalco, or both, to 2 tell me why this diagram describes a tank mix, 3 as that term is understood in the agricultural 4 chemical industry. 5 I'm sorry, it is the fourth one in 6 the Nalco presentation. 7 MR. GOLDBERG: For Nalco, we view 8 that as the same as a tank mix because what 9 you are doing is mixing a pesticide with other 10 non-pesticidal materials to meet the need of 11 the consumer. In this case, that is the paper 12 mill. 13 What we do is blend those 14 ingredients, just as a farmer goes to the 15 co-op and says, "I want some herbicide and I 16 want some fertilizer to get the weeds growing 17 strong, to knock them down better with a 18 herbicide, and I need a sticking agent or a pH 19 adjuster or, indeed, a UV inhibitor." That is 20 exactly the same. 21 MR. BOUCHER: Can you point out 22 where the tank is here?202-234-4433 Neal R. Gross & Co., Inc. Page 124 1 MR. GOLDBERG: The mix, as you can 2 see -- is that a sort of rhetorical question? 3 MR. BOUCHER: No, it is a factual 4 question. Where is the tank? 5 MR. GOLDBERG: There is in-line 6 mixing in the application equipment. 7 MR. BOUCHER: I'm done, Phil. 8 MR. ROSS: Thanks. 9 DIRECTOR HARRIGAN-FARRELLY: Thank 10 you. 11 MR. ROSS: Nalco? 12 MS. TAUB: Cynthia Taub, Steptoe & 13 Johnson for Nalco. 14 We just have a couple of 15 questions, one quick clarification I wanted to 16 ask -- it comes from Buckman -- about your 17 registered ammonia products. 18 I understand from your written 19 submissions that the material in the products 20 is ammonium sulfate, but the label says 21 ammonia. I just wondered why there is that 22 discrepancy.202-234-4433 Neal R. Gross & Co., Inc. Page 125 1 MR. BOUCHER: I'm sorry, are you 2 asking us to give you information, our 3 confidential statement of formula, on the 4 record? 5 MS. TAUB: I'm trying to 6 understand a little bit more about your 7 product. 8 MR. BOUCHER: My understanding -- 9 and you guys can answer this -- but my 10 understanding is that the product is a mixture 11 of things. 12 MR. McNEEL: Tom McNeel with 13 Buckman Laboratories. 14 If the product was only ammonium 15 sulfate and water, then it would be true that 16 it should say ammonium sulfate. It does, in 17 fact, contain more than one form of ammonia, 18 and we are recognizing the fact that the 19 active ingredient in the product is ammonia. 20 So the label states the total amount of 21 ammonia there and not just ammonium sulfate. 22 Should it have said ammonium sulfate, that202-234-4433 Neal R. Gross & Co., Inc. Page 126 1 would have been incorrect. 2 MS. TAUB: Another quick question 3 for Buckman. 4 Is the sodium hypochlorite used 5 with Buckman's products registered? 6 MR. COOPER: Certainly, in all 7 cases wherever we sell Busan 1215, we take two 8 approaches with that. The customer is either 9 required to purchase from us our own EPA10 registered sodium hypochlorite bleach or in 11 all communication with the customer it is 12 stipulated that they must purchase a 13 registered sodium hypochlorite bleach from 14 another supplier. 15 MS. TAUB: Thank you. 16 I have that same question for 17 Ashland. 18 MS. CHANEY: Hi. This is Linda 19 Chaney. 20 We have a different understanding 21 of the implication with use of a registered, 22 let's say ammonium bromide product, with a202-234-4433 Neal R. Gross & Co., Inc. Page 127 1 registered sodium hypochlorite product because 2 on both labels for both products there will be 3 explicit directions for use. 4 So, our Spectrum XD3899 label 5 explains clearly how that product is to be 6 used in combination with hypo. If you had a 7 situation where there were two products, two 8 registered products, each with its own 9 directions for use, applied together to form 10 an NC2-generated product, which label is 11 binding? That is the conflict that we see 12 with that situation. 13 Our label for 3899 explains 14 clearly, as I said earlier, how the product is 15 to be combined with hypo. And we see a 16 potential conflict if we were to use 17 registered hypo with a registered ammonium 18 bromide. 19 MR. GOLDBERG: So you use 20 unregistered hypo? 21 MS. CHANEY: Yes, we do. 22 MS. HANSEN: The only other thing202-234-4433 Neal R. Gross & Co., Inc. Page 128 1 I would add to that is that, when -- and you 2 can see this from reviewing the registration 3 jackets for the ammonium bromide product and 4 for Buckman's product, which is, because those 5 registrations included EPA's explicit 6 recognition that those products, those 7 chemicals were reacted to produce chloramines, 8 the whole endpoint of that was a labeling 9 process that took into account the fact that 10 those precursor products are combined with 11 hypo. 12 So, the use of the ammonium 13 bromide and ammonium sulfate in the Buckman 14 and Ameribrom products, the Ameribrom being 15 marketed by Ashland, in combination with hypo, 16 has been fully vetted by the agency as part of 17 those registration processes, and the same is 18 not true for Nalco's products. 19 DR. BROWN: We're done. Thank 20 you. 21 MR. ROSS: Thank you. 22 DIRECTOR HARRIGAN-FARRELLY: Thank202-234-4433 Neal R. Gross & Co., Inc. Page 129 1 you. 2 Okay. All right. Okay, I think 3 we have come to the point where we have heard 4 from all of the parties. I think it was a 5 very good discussion. I learned a lot. So, 6 hopefully, you all learned a lot from each 7 other as well. 8 We will now open up, so that you 9 can ask us your questions directly, and each 10 company gets five minutes. We will try to be 11 as brief as possible and answer your questions 12 to the best of our knowledge as quickly as 13 possible as well. 14 MR. ROSS: Can I just mention a 15 groundrule or two? 16 DIRECTOR HARRIGAN-FARRELLY: Sure. 17 MR. ROSS: Okay. I believe we 18 said at the beginning of this meeting that 19 this was not a decision meeting. So, we will 20 not entertain any questions regarding where we 21 are headed, what we are thinking, and those 22 kinds of questions, nor will we entertain any202-234-4433 Neal R. Gross & Co., Inc. Page 130 1 questions regarding our reactions to anything 2 that has been said here today. The same goes 3 for legal theories and things like that. 4 So, with that, with those as 5 groundrules, whatever questions you have for 6 us that fit within those groundrules, ask 7 away. 8 Ashland? 9 MS. HANSEN: How did you like us, 10 though? 11 (Laughter.) 12 This is Karen Hansen, on behalf of 13 Ashland. I won't ask you any of the questions 14 that you don't want to answer today. 15 But you have outlined a process 16 for us to provide additional comments to you 17 within 30 days. One question I think we 18 probably all have is that that supersedes this 19 60-day comment period for the three parties in 20 this room that was originally laid out. In 21 other words, we should comment within 30 days, 22 and then anything else will go on the public202-234-4433 Neal R. Gross & Co., Inc. Page 131 1 docket? 2 DIRECTOR HARRIGAN-FARRELLY: Yes. 3 MS. HANSEN: Okay. 4 MR. ROSS: Right, and that comment 5 period is going to be subsumed in the public 6 comment period. 7 DIRECTOR HARRIGAN-FARRELLY: Yes. 8 MS. HANSEN: Okay. I appreciate 9 that. 10 MR. ROSS: For efficiency and 11 process. 12 MS. HANSEN: I appreciate that. 13 And we, for all the reasons that 14 we have highlighted today and previously in 15 our communications, we are very interested in 16 a prompt and decisive action by the agency. 17 Obviously, we would like for you to do the 18 things that we have requested, but there's a 19 great deal of confusion in the marketplace. 20 The two companies here who have registered 21 their products are at a disadvantage because 22 Nalco is able to sell its products without the202-234-4433 Neal R. Gross & Co., Inc. Page 132 1 cost and the procedures that Buckman's counsel 2 was describing. 3 So I know you need to take into 4 consideration the things you have heard here, 5 and are going to continue to hear, but you 6 have a lot of information in front of you 7 already. Our question is, when can we expect 8 the agency to make some definitive decisions 9 on the issue of Nalco's two unregistered 10 products? 11 DIRECTOR HARRIGAN-FARRELLY: 12 That's one of the questions we weren't going 13 to answer. 14 MS. HANSEN: The question was just 15 when. Do you have any sense of your 16 timeframe? 17 MR. ROSS: We have set out a 18 process. We have asked you to get us some 19 stuff within five days. We have asked you to 20 give us some additional information within 30 21 days. 22 Once we have that material, a202-234-4433 Neal R. Gross & Co., Inc. Page 133 1 docket will be opened and there will be 2 commenced a public comment period, public 3 review and comment period, which we will 4 specify. Our plan is to issue a Federal 5 Register notice announcing that. 6 During that time period, any 7 additional comments or information that any of 8 the parties want to give us will be properly 9 addressed to the agency through the docket and 10 not any other means. 11 I can't give you a timeframe 12 specifically and won't want to commit to one 13 today. But you have the information that we 14 have at this point. 15 MS. HANSEN: Okay. I appreciate 16 that. 17 One last question, I guess, also, 18 procedural, from us: in the 30 days that you 19 are asking for the parties represented here 20 today to provide comments, is your expectation 21 that the parties will respond to everything 22 that is already on the record?202-234-4433 Neal R. Gross & Co., Inc. Page 134 1 DIRECTOR HARRIGAN-FARRELLY: No. 2 MS. HANSEN: Obviously, not what 3 is going to come in in the public docket 4 comment period, but to the things that have 5 already been exchanged between the parties? 6 MR. ROSS: Our expectation is one 7 thing; what you all do is another probably. 8 But we would like you to respond to anything 9 that you believe is hanging up in the air as 10 a result of today's meeting. We have been 11 papered already on this matter. 12 DIRECTOR HARRIGAN-FARRELLY: Let 13 me clarify. When we initially talked about 14 what we expected just in terms of submissions, 15 we wanted, if something needed to be clarified 16 or if there was a statement made and you had 17 supporting documentation, and you wanted to 18 submit that, or if you had other information 19 that you thought would shed light, but not to 20 respond to every -- we don't want a rebuttal 21 on everything, at least I don't, on 22 everything.202-234-4433 Neal R. Gross & Co., Inc. Page 135 1 So it is just additional, 2 supplemental clarification is what we are 3 looking for. 4 MR. ROSS: We are not asking for 5 orders of magnitude of more paper. 6 DIRECTOR HARRIGAN-FARRELLY: No. 7 MS. HANSEN: I understand that. 8 DIRECTOR HARRIGAN-FARRELLY: Thank 9 you. 10 MS. HANSEN: I think you said we 11 have one minute left. I want to ask Paul -- 12 MR. ROSS: You've got 20 seconds. 13 MS. HANSEN: -- if there is 14 anything else that you would like to ask the 15 agency in 15 seconds or less. 16 MR. RAYMOND: I think I'm fine. 17 MS. HANSEN: Okay. Thank you. 18 DIRECTOR HARRIGAN-FARRELLY: Thank 19 you. 20 Buckman? 21 MS. EDENS: This is Geri Edens on 22 behalf of Buckman.202-234-4433 Neal R. Gross & Co., Inc. Page 136 1 Just one point of clarification. 2 Are you indicating a 30-day public comment 3 period? 4 DIRECTOR HARRIGAN-FARRELLY: We 5 have not yet decided if it will be 30 or 60 6 days. We are betwixt and between on that. 7 But, yes, we haven't yet decided. 8 MR. ROSS: Is that it? 9 MS. EDENS: That's it. 10 MR. ROSS: Okay. 11 DIRECTOR HARRIGAN-FARRELLY: 12 Nalco? 13 MR. ROSS: And Nalco? 14 MS. TAUB: Cynthia Taub, Steptoe & 15 Johnson. 16 I have just a couple of questions. 17 With regard to Ashland's 18 submission, there was significant material 19 that was redacted. So, Nalco has not actually 20 seen the bulk of their arguments, even though 21 it was ostensibly about Nalco's product. I 22 wondered if the agency has made a decision202-234-4433 Neal R. Gross & Co., Inc. Page 137 1 about how they are going to handle that. We 2 had asked that that material be excluded from 3 the record unless Nalco was given access to 4 it. 5 MR. ROSS: We haven't decided that 6 yet. We will examine that issue. It might be 7 helpful if Ashland were to give us some 8 indication of what remains within their claim, 9 given what was presented today. There may be 10 an intersection of some of that information. 11 I am not asking you to specify it. 12 Maybe you want to clarify that within the 30- 13 day period. 14 MS. TAUB: Okay. But just as a 15 matter of fairness -- 16 MR. ROSS: I understand your 17 question, and I expected it to be asked today. 18 MS. TAUB: Okay. Great. Thank 19 you. 20 MR. ROSS: Did you have any other 21 questions? 22 MS. TAUB: I do.202-234-4433 Neal R. Gross & Co., Inc. Page 138 1 MR. ROSS: Okay. 2 MS. TAUB: In terms of the public 3 docket, I just want to confirm that the 4 material that Buckman has submitted that is 5 Nalco's CBI will not go into the public 6 docket. 7 MR. ROSS: That is also an issue 8 that we are going to consider. 9 MS. TAUB: Okay. I hope that is a 10 pretty easy issue for you. I mean if it's 11 CBI, it should -- 12 MR. ROSS: We will consider it, 13 but we will also consider the need for 14 substantiation and clearance as well. 15 MS. TAUB: Okay. We would be 16 happy to substantiate it. 17 MR. ROSS: All of that is on the 18 table. 19 MS. TAUB: Okay. 20 MR. BOUCHER: Phil, are you 21 suggesting that you are going to make a 22 decision and you would, therefore, want202-234-4433 Neal R. Gross & Co., Inc. Page 139 1 legal -- 2 MR. ROSS: Why don't we wait until 3 they're finished? 4 MR. BOUCHER: Okay. Sorry. 5 MR. ROSS: Yes. I think their 6 time is still running. 7 DIRECTOR HARRIGAN-FARRELLY: Yes. 8 MR. ROSS: Does Nalco have any 9 other questions? You have four minutes, three 10 minutes. 11 MS. TAUB: Thank you. 12 MR. GOLDBERG: Actually, one other 13 question. It is a process question. 14 MR. ROSS: Sure. 15 MR. GOLDBERG: Have you or will 16 you consult with the Office of Drinking Water 17 and the Registration Division within OPP 18 regarding this decision? 19 MR. ROSS: We intend to do the 20 consultation that we deem necessary, and we 21 note your suggestions, and they're not novel 22 suggestions.202-234-4433 Neal R. Gross & Co., Inc. Page 140 1 And the answer is yes. 2 (Laughter.) 3 Yes. Yes, we will and, yes, we 4 have. 5 DIRECTOR HARRIGAN-FARRELLY: Yes, 6 we have and, yes, we will. 7 (Laughter.) 8 MR. ROSS: Okay? To the extent, 9 yes. 10 DIRECTOR HARRIGAN-FARRELLY: I'm 11 not going to let two lawyers talk to each 12 other. 13 (Laughter.) 14 Any other questions from Nalco? 15 MR. GOLDBERG: No. 16 DIRECTOR HARRIGAN-FARRELLY: Okay. 17 MR. ROSS: Is this a clarifying 18 question from Buckman? 19 MR. BOUCHER: No, I know what I am 20 going to do. 21 MR. ROSS: Pardon me? 22 MR. BOUCHER: I'll sit down.202-234-4433 Neal R. Gross & Co., Inc. Page 141 1 MR. ROSS: No questions? 2 DIRECTOR HARRIGAN-FARRELLY: Okay. 3 Well, any other questions from EPA? Melba? 4 DR. MORROW: No. I had one, but I 5 will hold it. 6 DIRECTOR HARRIGAN-FARRELLY: Are 7 you sure? It's burning? Speak now. They're 8 all here. 9 DR. MORROW: Speak now? Okay. 10 This one goes back to a question 11 that I probably should have asked earlier, 12 when we had time, but we ran out. 13 If I'm hearing -- and it is back 14 to the adjuvant issue -- that the adjuvant is 15 just added, and that the chloramine is equal 16 to chlorine -- that's what I'm hearing from 17 you guys, right? Nalco? 18 MR. GOLDBERG: Well, yes. 19 DR. MORROW: The chloramine is 20 equal to chlorine, more or less? Then, urea, 21 if it has the same function in the formation 22 of chlorourea, then, basically, you are saying202-234-4433 Neal R. Gross & Co., Inc. Page 142 1 that all three of these things are essentially 2 the same? 3 MR. GOLDBERG: Laura, perhaps you 4 can respond to that? 5 MS. RICE: This is Laura Rice. 6 So what we are saying is that, 7 essentially, there are different stabilizers 8 that we are classifying as adjuvants that 9 react with the chlorine, and it is the 10 chlorine that is providing the antimicrobial 11 effect in the process. That chlorine can be 12 combined with the different adjuvants, aka 13 stabilizers, to provide varying oxidizing 14 power, which impacts the persistence of that 15 chlorine biocide in the process. 16 DR. MORROW: I just needed 17 clarification that the adjuvants were not 18 doing anything. 19 DIRECTOR HARRIGAN-FARRELLY: Did 20 someone else have a -- 21 MS. HANSEN: Well, this is Karen 22 Hansen.202-234-4433 Neal R. Gross & Co., Inc. Page 143 1 DR. MORROW: Does someone else 2 want to clarify? 3 MS. HANSEN: Yes, I only want to 4 respond because you were looking at Ashland. 5 DR. MORROW: No, I wasn't looking 6 at you. 7 MS. HANSEN: Oh, okay. 8 DR. MORROW: I'm sorry. 9 MS. HANSEN: That's not our 10 position, just for the record. 11 DR. MORROW: Yes. 12 DIRECTOR HARRIGAN-FARRELLY: 13 Melba, were you -- 14 DR. MORROW: I'm done. 15 DIRECTOR HARRIGAN-FARRELLY: Dr. 16 Morrow, are you okay? 17 DR. MORROW: Yes. I'm done. 18 DIRECTOR HARRIGAN-FARRELLY: Okay. 19 Well, I think that brings us to the conclusion 20 of today's summit, I'll call it. 21 (Laughter.) 22 I know this has been a long and202-234-4433 Neal R. Gross & Co., Inc. Page 144 1 frustrating experience for all of you. I came 2 into it in the middle or towards the end; I am 3 not sure which part. I am thinking the end. 4 Well, I know it is the end. That is for sure. 5 (Laughter.) 6 We will do our very best to work 7 as expeditiously on this as possible. I know 8 it has been, as I said, a long and tedious 9 process. 10 So, what will follow next, once 11 again, to sum up, is within five days we would 12 like to see marketing publications, whatever 13 it is you have, whether it is your websites or 14 brochures or anything. 15 MR. ROSS: Calendar days. 16 DIRECTOR HARRIGAN-FARRELLY: Five 17 calendar days. 18 MR. ROSS: Calendar days. 19 DIRECTOR HARRIGAN-FARRELLY: Okay, 20 five calendar days. 21 And within 30 days, if you have -- 22 you don't have to -- but if you have202-234-4433 Neal R. Gross & Co., Inc. Page 145 1 additional information you wish to submit, you 2 have 30 days -- is that calendar days? 3 MR. ROSS: Yes. 4 DIRECTOR HARRIGAN-FARRELLY: You 5 have 30 calendar days to submit that 6 information to us. 7 Once we get that information, we 8 will announce by Federal Register that we are 9 opening up the docket, and we will, then, 10 place within the docket all the information 11 that we received from you, going back now -- 12 I won't say how long -- for a while. To me, 13 it seems a lifetime, and I only just started 14 this process, but it seems forever. 15 So we will submit all that 16 information, of course, without the CBI that 17 we spoke about in several correspondences 18 before. 19 MR. ROSS: After we process 20 through the CBI. 21 DIRECTOR HARRIGAN-FARRELLY: Yes, 22 and we will reprocess through the CBI because202-234-4433 Neal R. Gross & Co., Inc. Page 146 1 we thought we had already done that. So we 2 will process that again. 3 What will also be submitted in the 4 docket is the presentations that were made 5 today, a summary of -- not a summary -- the 6 minutes of the meeting that was held today. 7 You will also all receive a copy of the 8 transcript of the meeting today. 9 And after the public comment, and 10 I am not sure, as I said, whether we are going 11 to do a 30- or 60-day public comment for that 12 process, we will, then, close that process and 13 begin to finalize our decisionmaking at that 14 time. 15 I think that summarizes where we 16 are. 17 I thank you all. I know it was 18 difficult trying to get this meeting set up 19 and established. I thank you all for being 20 able to make it here. 21 I thank you for being courteous 22 and kind to each other.202-234-4433 Neal R. Gross & Co., Inc. Page 147 1 And I know you all, like us, are 2 looking forward to a speedy decision on this. 3 Thank you. 4 (Whereupon, the above-entitled 5 matter went off the record at 3:47 p.m.) 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22202-234-4433 Neal R. Gross & Co., Inc. Page 148 A able43:21 52:15

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