0511 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 2 REGION 5 3 4 __________________________________________________ 5 In the Matter of: 6 7 BEHNKE LUBRICANTS, INC., 8 MENOMONEE FALLS, WISCONSIN 9 Respondent, 10 11 Docket No; FIFRA-05-2007-0025. 12 __________________________________________________ 13 VOLUME III 14 4/2/08 15 16 17 Proceedings had and evidence taken, 18 beginning at 8:30 a.m., April 2, 2008, at the Waukesha 19 County Courthouse, 515 West Moreland Boulevard, Room 20 21 350, Waukesha, Wisconsin, before Ms. Barbara Gunning, 22 23 Administrative Law Judge, to whom the matter in 24 25 difference between the parties has been submitted. 0512 1 A P P E A R A N C E S 2 3 MS. BARBARA GUNNING, Administrative Law Judge 4 1200 Pennsylvania Avenue, N.W., 5 Washington, DC 20460 6 7 8 FOR THE COMPLAINANT: 9 U.S. EPA, Associate Regional Counsel, 10 Region 5, 77 West Jackson Boulevard, Chicago, Illinois 11 60604-3590, by MS. NIDHI O'MEARA, MR. JAMES J. CHA and 12 MR. ERIC H. OLSON. 13 14 15 FOR THE RESPONDENT: 16 MCILNAY & BUTTON, LTD., 1150 Washington 17 Street, Grafton, Wisconsin 53024-1916, by MR. BRUCE A. 18 MCILNAY. 19 20 21 22 23 24 25 0513 1 I N D E X 2 3 WITNESS EXAMINATION PAGE 4 Dr. Tajah Blackburn By Mr. Cha................. 514 5 By Mr. McIlnay............. 520 6 By Mr. Cha................. 537 7 By Mr. McIlnay............. 539 8 By Mr. Cha................. 542 9 Mr. Eric Peter By Mr. McIlnay............. 549 10 By Ms. O'Meara............. 640 11 By Mr. McIlnay............. 725 12 By Ms. O'Meara............. 733 13 Mr. Troy Paquette By Mr. McIlnay............. 738 14 15 16 E X H I B I T S 17 COMPLAINANT'S RECEIVED REJECTED 18 51...................................... 518 19 54...................................... 518 20 55...................................... 519 21 56...................................... 519 22 71..................................... 725 23 24 RESPONDENT'S RECEIVED REJECTED 25 69..................................... 640 0514 1 P R O C E E D I N G S 2 MR. CHA: We'll recall Dr. Blackburn. 3 JUDGE GUNNING: I'll just remind 4 Dr. Blackburn that you're still under oath. 5 THE WITNESS: Thank you. 6 MR. CHA: Thank you, Your Honor. 7 EXAMINATION 8 BY MR. CHA: 9 Q Dr. Blackburn, could you please turn to 10 Complainant's Exhibit 8c. It's in Volume I. 11 MR. CHA: Your Honor, may I approach 12 the witness? 13 JUDGE GUNNING: Yes. 14 MR. CHA: Thank you. 15 BY MR. CHA: 16 Q Dr. Blackburn, if you could just please take a 17 moment and look over that exhibit. 18 A Is there any page in particular? 19 Q Just generally, and then let me know when you're 20 finished. 21 A Okay. 22 Q Dr. Blackburn, is this another document which you 23 reviewed as part of your work in this case? 24 A Yes. 25 Q If you could turn specifically to the three pages 0515 1 that are Bates stamped EPA 0270271 and 272. Just 2 for the record, Dr. Blackburn, what product is 3 being discussed on these pages? 4 A POLY-Guard FG-2 on Page 0270, the same product on 5 0271, and the same product on the final 6 Page 0272. 7 Q Thank you, Doctor. Dr. Blackburn, in general 8 terms what information appears on these pages? 9 A It appears to be data that has been collected 10 over time for one particular test, and over a 11 period of time for the other tests as well. 12 Q Okay. Does the information on these pages 13 provide you with enough information to evaluate 14 the efficacy of the antimicrobial properties of 15 this product? 16 A No, it does not. 17 Q Okay. And why not? 18 A Based on the standards set by the agency, it's 19 silent, the data is silent on what test was 20 actually conducted to generate the data. It's 21 silent on the conduct, the study conduct, were 22 the necessary controls present, what the contact 23 time was for the products to be in contact with 24 the surface, exposure time, the actual test 25 organisms. There are multiple yeasts that exist, 0516 1 multiple molds that exist. Coli, in the 2 scientific arena we rarely refer to E. coli as 3 just coli. It has a scientific name requiring 4 both a genus name and a species name. And on the 5 other test as well, the Listeria is tested here, 6 but again it's silent as to where the source of 7 the strain was isolated from. The yeast and 8 mold, again, I don't know what yeast colonies, 9 what mold colonies they're referring to, what 10 test organisms were tested. And the test method 11 again is not present on any of these documents. 12 The study conduct is missing as well. 13 Q In your opinion, would you consider this data 14 that appears on these three pages to be reliable? 15 A No. 16 Q Just a few more questions, Dr. Blackburn. We 17 previously -- you previously identified certain 18 claims that Behnke's Micronox technology was 19 effective against, both gram-positive and 20 gram-negative bacteria. When a product makes 21 this kind of claim, why is an efficacy evaluation 22 important? 23 A That classification of gram-negative and 24 gram-positive tells scientists, tells end users, 25 tells the consumer briefly what organisms are 0517 1 going to be placed on the label, but it does not 2 provide enough information to detail which exact 3 organism is classified as gram-positive or 4 gram-negative and will be placed on the label. 5 So it's important that efficacy is conducted 6 against the actual organism that's claimed so 7 that the end user knows and the agency is 8 confident after reviewing the efficacy 9 evaluation, the data, that the product is indeed 10 efficacious and will provide the level of 11 performance that's expected. 12 Q And where a product makes claims that it's 13 effective against yeasts and molds, why is an 14 efficacy evaluation important? 15 A Well, there are some yeasts that we classify as 16 pathogenic, public health, and some molds that we 17 classify as public health and pathogenic, and 18 it's important to disclose which organisms were 19 tested on the label as a point of reference and 20 to insure that efficacy -- or the product will 21 perform at the level which it is intended to 22 perform. 23 Q Thank you, Doctor. 24 MR. CHA: Your Honor, I have no 25 further questions. I would move to admit 0518 1 Complainant's Exhibits 51, 54, 55 and 56 into 2 evidence. I'll repeat those, Your Honor. 3 Complainant's Exhibits 51, 54, 55 and 56. And 4 just to remind everyone, these were standard 5 operating procedures and guidelines for efficacy 6 evaluations. They're admitted strictly for the 7 purpose of providing background for the types of 8 guidance documents that Dr. Blackburn relies upon 9 in performing her work. Since she is offered as 10 an expert witness, those guidelines may assist 11 the trier of fact in evaluating her testimony. 12 MR. MCILNAY: Your Honor, if we could 13 just go through them quickly, refresh my 14 recollection. 51 was the first one? 15 MR. CHA: Correct. 16 MR. MCILNAY: No objection. 17 JUDGE GUNNING: Please mark 18 Exhibit 51 as received. 19 Now, 50 also has already been 20 received. 21 MR. CHA: The next one is 54. 22 MR. MCILNAY: 54. No objection, Your 23 Honor. 24 JUDGE GUNNING: Please mark 54 as 25 received. 0519 1 MR. CHA: 55 and 56 were the next 2 exhibits. 3 MR. MCILNAY: That's in the next 4 volume. 5 MR. CHA: I believe so, yes. 6 MR. MCILNAY: No objection to 55. 7 JUDGE GUNNING: All right. Please 8 mark 55 as received. 9 MR. MCILNAY: The next one is? 10 MR. CHA: 56. 11 MR. MCILNAY: No objection to 56. 12 JUDGE GUNNING: Okay. Please mark 56 13 as received. 14 MR. CHA: Thank you, Your Honor. 15 Again, no further questions at this 16 time. 17 JUDGE GUNNING: Okay. 18 MR. MCILNAY: If I might have just a 19 second, Your Honor. 20 JUDGE GUNNING: Yes. 21 MR. MCILNAY: This is a question I -- 22 Complainant's Exhibit 47, I don't have a note on 23 whether that was offered and received. That's 24 the doctor's curricula vitae. 25 MR. CHA: It has been received into 0520 1 evidence, I believe, pursuant to the joint 2 stipulation and motion to admit. 3 JUDGE GUNNING: That's what I also 4 have as identified. 5 EXAMINATION 6 BY MR. MCILNAY: 7 Q Good morning, Dr. Blackburn. 8 A Good morning. 9 Q I would like to start with your curricula vitae. 10 That would be Complainant's Exhibit 47 in Volume 11 2. 12 A I do not have a Volume 2. 13 MR. CHA: Your Honor, may I approach? 14 I believe I set it aside earlier. 15 JUDGE GUNNING: Yes. 16 MR. MCILNAY: I can do that. 17 BY MR. MCILNAY: 18 Q More specifically, Doctor, I want to ask some 19 questions about your position. I believe it 20 appears on EPA Page 902, under the heading 21 Additional Laboratory Experience. 22 A Okay. 23 Q Could you describe, again very briefly, what your 24 role was with Merico/Earthgrains? 25 A Yes. My role -- well, my title was Quality 0521 1 Assurance Inspector/Microbiologist, and it was my 2 responsibility to tour the facility to insure 3 that proper sanitization protocols had been 4 followed by measuring colony formations via plate 5 count, and using an IDEXX system, basically emits 6 light when certain colonies are being -- or when 7 bacteria is at a certain load. 8 Q Okay. And I'm not sure I understand 9 Merico/Earthgrains/Nestle Refrigerated Dough 10 Production Facility, did you actually work for 11 Nestle or was this a -- 12 A It's all three. It's all three. 13 Q So all three? 14 A Yes. Earthgrains was the overall heading. It 15 originally switched from Merico to Earthgrains, 16 and then we were contracted, we had contracted 17 with Nestle in order to generate their products 18 as well. 19 Q So Nestle was a customer, correct? 20 A Well, it was part of the production facility. 21 Q Okay. And the microbes you were testing for 22 would include Salmonella? 23 A Salmonella -- any potential pathogenic enteric 24 organism, Salmonella, E. coli, Listeria. It 25 would be a whole gamut of things, because you 0522 1 would also use certain selective agents or 2 identifying markers to determine what type of 3 microbes were potentially present. 4 Q Okay. And the reason that you did these 5 inspections and testing was for food safety 6 purposes, correct? 7 A Yes. 8 Q You didn't want those human pathogens to be in 9 the food that was produced, correct? 10 A Or animal pathogens, yes. 11 Q Or animal pathogens. Well, I take it cookie 12 dough was intended for human consumption. 13 A It is, but those pathogens can also be animal 14 pathogens as well, based on where they're 15 isolated from. 16 Q All right. I'm not familiar with the processing 17 in the plant. Were there lubricants used on the 18 machinery? 19 A I'm not sure. I never interfaced with the 20 lubricant part of it. That would be more for the 21 maintenance side of the plant production. 22 Q All right. You were asked some questions 23 regarding Exhibit 8c, I believe, just now. 24 A Okay. Uh-huh. 25 Q With regard to efficacy testing? 0523 1 A Okay. 2 Q In your position with Merico/Earthgrains, were 3 you consulted on purchasing of products used to 4 clean the plant? 5 A No, I was not. 6 Q Did you have any familiarity with how the 7 purchasing decisions were made? 8 A No. 9 Q And help me here. I don't want to -- relative to 10 receipt of your postgraduate degree, when were 11 you employed there? Was it after you received 12 your Ph.D.? 13 A No, it was after I received my BA. 14 Q Doctor, are you familiar with the acronym HACCP? 15 A I've heard of it, but I'm not -- 16 MR. CHA: I'm going to object, Your 17 Honor. This goes beyond the scope, and this 18 witness was not ever offered to talk about the 19 HACCP program of the USDA. 20 MR. MCILNAY: Your Honor, I'm getting 21 background information on the witness' 22 experience. 23 JUDGE GUNNING: I'll allow it. 24 THE WITNESS: No. 25 0524 1 BY MR. MCILNAY: 2 Q Did you have occasion in the course of your 3 employment with Merico/Earthgrains to review 4 products used in that plant for their efficacy in 5 eradicating or mitigating the microbes that were 6 of concern, Listeria, Salmonella, etc.? 7 A So your question is whether or not I conducted 8 efficacy evaluation on purchased products? 9 Q Did you review the efficacy data? 10 A No, I did not, not for the individual products, 11 no. 12 Q And did you do any efficacy testing with respect 13 to those products? 14 A No. 15 Q Were there occasions in which after your 16 inspection, the counts of E. coli, Listeria, the 17 various microbes that we've been discussing, were 18 higher than was acceptable within the plant? 19 A Yes, there were occasions. 20 Q What were the procedures that you followed when 21 that was discovered? 22 A Multiple procedures based on the standard 23 operating procedures that were in place. 24 Q And the standard operation procedures that were 25 in place was something that you helped co-author 0525 1 and edit, correct? 2 A Exactly, from a microbiological standpoint. 3 Q Help me. I don't have the standard operating 4 procedures in front of me, and I understand it's 5 been several years since you've done it. So I'm 6 going to try to be very specific. Did those 7 standard operating procedures include reviewing 8 the products being used in the plant to eradicate 9 or mitigate the microbes for their efficacy? 10 A The standard operating procedure document was 11 pretty extensive. My focus was not on that 12 aspect. 13 Q So your answer is, you don't know? 14 A That was not my focus, so I can't say whether or 15 not that statement was in there, what the 16 procedure was for that. That was not my focus in 17 contributing to the SOP in general. 18 Q You testified on direct examination that you've 19 had occasion to tour a bovine facility. How many 20 occasions have you? 21 A One bovine and one swine. 22 Q And what was the purpose of your visits? 23 A The purpose of my visit to the swine facility was 24 to obtain the pulmonary artery for endothelial 25 cell isolation. The purpose of my tour of the 0526 1 bovine facility was preparation for this case. 2 Q So the swine facility, you were actually going 3 to -- pulmonary artery would be lungs? 4 A It's actually the artery that's off of the lungs, 5 the most part, where the blood is pumped away 6 that's been oxygenated, pumped away from the 7 lungs for systemic circulation. 8 Q And for that purpose when you visited the plant, 9 did you tour the plant? 10 A Yes. 11 Q And how long ago was that, Doctor? 12 A That was back in the early 90's. 13 Q The bovine facility you said was in preparation 14 for this case? 15 A Yes. 16 Q When did you make that visit? 17 A In January, 2008. 18 Q And what plant did you visit? 19 A American Foods. 20 Q The Green Bay plant? 21 A Yes. 22 Q Did you meet with anyone from American Foods 23 while you were there? 24 A Yes. 25 Q Who did you speak with? 0527 1 A We toured the facility with Josh Rybicki, and I'm 2 not sure of the other participants. 3 Q You say, we toured the plant. Were there more 4 people there besides yourself that were visitors? 5 A Yes. 6 Q Who was with you? 7 A Part of the counsel. 8 Q I'm sorry. 9 A Part of the counsel. 10 Q Okay. Did you query anyone at American Foods 11 whether they do their own efficacy testing on 12 their greases or oils? 13 A No, I did not. 14 Q Did you have an opportunity to view the 15 production as it was in process? 16 A The production of -- 17 Q The -- whatever they produced there, beef? 18 A Yes. 19 Q Okay. And did you query anyone while you were 20 there as to how they used the Behnke Lubricants 21 that they purchased? 22 A They actually told us how they used them. 23 Q And do you recall what some of those applications 24 were? 25 A Yes. 0528 1 Q What do you recall? 2 A They spoke of the gears, the overhead gears, the 3 gears, I guess, associated in closed boxes. 4 Q Overhead gears. 5 A Or chains. 6 Q Or chains? 7 A Or hooks, or whatever, whatever is associated 8 with that. 9 Q Dr. Blackburn, there should be the binders that 10 have -- 11 A These? 12 Q Yes. These are Respondent's exhibits. And if 13 you would, could you please turn to Respondent's 14 Exhibit 53. Has Bates stamp number RS -- R-e-s-p 15 00079. Have you found that? 16 A Yes, I have. 17 Q In preparing for your testimony in this case, 18 have you had an opportunity, or were you asked to 19 review this document? 20 A Yes. 21 Q And so you've reviewed this document before? 22 A In preparation for this case, yes. 23 Q Yes. And among other things, this is an FDA 24 Guidance concerning antimicrobial food additives; 25 is that correct? 0529 1 A It is. 2 Q Okay. And having reviewed this document, can you 3 form an opinion as to whether or not someone 4 subject to these regulations would be required to 5 produce the kind of efficacy data that you would 6 find acceptable, as opposed to what you described 7 earlier? 8 MR. CHA: I'm going to object, Your 9 Honor. First of all, Dr. Blackburn didn't talk 10 about any FDA studies. And, second, Counsel is 11 assuming facts not in evidence. The question 12 assumes facts not in evidence, specifically that 13 assuming someone is subject to these regulations. 14 It's also vague. What does subject to the 15 regulations means. 16 JUDGE GUNNING: I'll allow the 17 question, but additional information will be 18 needed. 19 MR. MCILNAY: Absolutely. 20 BY MR. MCILNAY: 21 Q Let me back up. You are an expert witness, and 22 what I'm asking you is a hypothetical. And 23 perhaps it would be helpful if we were to turn to 24 Respondent 008. 25 MS. O'MEARA: Is that 80? 0530 1 MR. MCILNAY: Oh, I'm sorry. 88. 2 THE WITNESS: 88. 3 MR. MCILNAY: I withdraw that. I 4 withdraw that. 5 BY MR. MCILNAY: 6 Q What I'd like you to do, Doctor, is take a moment 7 and read sections J and D -- or J and K on 8 Page 87. Okay. First, I'd like to ask you a 9 couple of questions about sub J. This states, 10 however, there are a number of resources specific 11 to microbiological methods that the agency 12 recommends. FDA publishes an online version of 13 the Bacteriological Analytical Manual. Did you 14 have occasion to review the Bacteriological 15 Analytical Manual prior to today? 16 A No. 17 Q It states, Furthermore, FDA maintains a website 18 with numerous links to related resources on 19 microbiological methods. Did you have an 20 opportunity or occasion to review that 21 publication? 22 A No. 23 Q Lastly, it states, Also, FSIS -- and by the way, 24 do you know what that acronym stands for. 25 A Not directly, no. 0531 1 Q Maintains a Microbiology Laboratory Guidebook of 2 current protocols for analytical tests by FSIS in 3 its regulatory activity on meat, poultry and egg 4 products. These test procedures may be useful in 5 the experimental design of technical effect 6 studies. Did you have occasion to review that 7 document? 8 A No. 9 Q Turning now to sub K, could you read the first 10 sentence to yourself? 11 A Okay. 12 Q Okay. Are you familiar with the terminology 13 that's used, as an example, a five-log reduction 14 in the number of microbes targeted? 15 A Yes, I am. 16 Q And could you explain what that means? 17 A A log reduction is basically a 90 percent 18 reduction in the number of organisms that are 19 originally on a surface, etc. A five-log 20 reduction is considered -- for an example, if you 21 start with a million colonies, a five-log 22 reduction will result in ten colonies remaining. 23 Q And during your direct testimony you were asked 24 by counsel for the EPA why misleading claims, I 25 believe was the word, might be dangerous to the 0532 1 public. And you used the example of an E. coli 2 breakout at a daycare center. Do you recall 3 that? 4 A Yes. 5 Q And that somebody at the daycare center might go 6 buy a product that claimed to mitigate E. coli, 7 but if there were no efficacy testing, it might 8 not work, correct? 9 A Potentially. 10 Q Yes. Based on your experience with -- and I 11 apologize, I'll refer to it as the Nestle frozen 12 dough employment, how would you describe the 13 sophistication of that customer versus a daycare 14 center? 15 A What are you defining as sophistication? 16 Q Well, I'm going to withdraw the question. You 17 testified that you don't have the background in 18 the purchasing at that plant, so I'm just going 19 to withdraw the question. 20 In your years of experience, whether 21 with Nestle or the EPA or the -- and you have to 22 help me with this -- the food -- or I mean the 23 Health -- what's your other position? 24 A Public Health Service. 25 Q Public Health Service. Have you any past 0533 1 experience with specifically food producers who 2 do their own efficacy testing? 3 A I haven't had any personal experience via 4 literature search, etc., reading manuscripts or 5 whatever. I would suppose that you would do some 6 type of R&D when you're selecting products, but 7 they rely heavily, I know, on EPA-registered 8 products for use in the sanitization process. 9 Q In the sanitization process? 10 A Yes. 11 Q Okay. Let's talk about that a minute. You've 12 been here throughout this hearing, and you heard 13 Mr. Rybicki's testimony, correct? 14 A Yes, I did. 15 Q And I asked Mr. Rybicki about the sanitation 16 process, and he testified that that process would 17 take place post production, and the only 18 foodstuffs or animal parts that might be in there 19 would be waste. Do you recall that testimony? 20 A I don't recall him saying that the only thing in 21 it would be waste. No, I don't. 22 Q Well, based on your experience with Nestle, when 23 you would do the sanitation process, would there 24 be food product in the room? 25 A It may be some residual, they may be actually 0534 1 loading things, and it really depends. 2 MR. CHA: Your Honor, I don't know if 3 this is an objection. I just want to be clear 4 that terminology is correct. I believe that 5 Dr. Blackburn has used the word sanitization 6 process. Mr. McIlnay, unless I heard wrong, used 7 the word sanitation. And I believe those are two 8 separate words and have separate meanings, and it 9 could be important in this case. 10 MR. MCILNAY: If I did, I apologize. 11 Sanitization is what I meant. Thank you, 12 Counsel. And let the record reflect that was my 13 intent. 14 BY MR. MCILNAY: 15 Q And was that your understanding, if I did? 16 A Sanitization. 17 Q Yes. 18 A Yes. 19 Q Well, were the standard operating procedures, did 20 they cover the sanitization process? 21 A I'm positive they did, but I was not involved in 22 that aspect of the document. 23 Q All right. So as far as what the standard 24 operating procedures provided with regard to 25 foodstuffs in the facility during sanitization, 0535 1 you're not familiar with? 2 A I don't know what it detailed. 3 Q All right. Are you familiar with any of the 4 products that were used in the sanitization 5 process to disinfect or sanitize the facility? 6 A As I was employed there over maybe 10, 12 years 7 ago, I don't remember the exact products. No, I 8 don't. 9 Q Okay. Do you recall whether there was anything 10 in the standard operating procedure addressing 11 concern with the sanitization products becoming 12 part of food? 13 A I'm sure there was. But as I mentioned earlier, 14 I was only responsible for the microbiological 15 analysis, the test methods that took place in the 16 lab, and not the actual process that took place 17 on the production floor. 18 MR. McILNAY: One moment, Your Honor? 19 JUDGE GUNNING: Yes. 20 BY MR. MCILNAY: 21 Q In connection with your -- well, based on any of 22 your experience, whether with Nestle or with EPA, 23 do you have any knowledge of food processing 24 industry standards in terms of doing the type of 25 inspection and lab work that you did? 0536 1 A Yes, I know the levels for that. As I mentioned 2 before, I've conducted this maybe 10 to 12 years 3 ago, so what they are to present date, I'm not 4 sure of, no. 5 Q Okay. Based on your experience, can you tell the 6 Court whether or not what you -- the role you 7 played, whether that is common throughout the 8 industry, the food processing industry? 9 A The role that I played in what, as Quality 10 Assurance Inspector/Microbiologist? 11 Q Yes. 12 A Yes, I think that role is pretty consistent. 13 Q And, again, one of the purposes of your role was 14 to insure food safety? 15 A Food safety and the quality of the final product. 16 Q One last question. You testified yesterday, I 17 believe, that the microbes identified in some of 18 the literature, particularly Salmonella, E. coli, 19 and Listeria, were not deleterious to lubricants; 20 is that correct? 21 A Yes. 22 Q And by that I take it to mean that these are not 23 bacteria that would assist or lead to the 24 degradation, breakdown or odor of those products; 25 is that right? 0537 1 A No, I didn't reference odor. 2 Q Okay. All right. Let me ask about the breakdown 3 life cycle of the product. Let me turn it 4 around. What did you mean by that testimony? 5 A That those three organisms are not -- do not 6 break down the grease within itself. 7 Q Okay. And how do you know that? 8 A Literature. 9 Q All right. And was that literature reviewed in 10 preparation for this case? 11 A Yes, and as part of my studies as well. I mean, 12 you learn the characteristics of organisms, how 13 they perform in their environment and what they 14 typically -- what they break down, what they 15 metabolize. 16 MR. MCILNAY: Thank you. No further 17 questions. 18 JUDGE GUNNING: Thank you. 19 MR. CHA: Your Honor, I just have a 20 few brief questions on redirect. 21 EXAMINATION 22 BY MR. CHA: 23 Q Dr. Blackburn, if you could look back at 24 Respondent's Exhibit 53. First, just a general 25 question, Dr. Blackburn. How does Respondent's 0538 1 Exhibit 53, the FDA Guidance document, compare 2 with EPA's guidelines for conducting efficacy 3 evaluations? 4 A It's pretty silent on the -- what we do as an 5 agency. It doesn't make reference to the 6 different categories of disinfectants, sanitizers 7 that we use. It doesn't state which methods to 8 use. It gives you, I guess, a selection via the 9 manual choices. It doesn't give a set 10 performance standard. It does not give set 11 organisms which are to be tested. So it's silent 12 on a lot of things that the agency looks for in 13 its evaluation. 14 Q In your opinion, could this guidance document, 15 Respondent's Exhibit 53, serve as a substitute 16 for the EPA guidelines on efficacy evaluations? 17 A No. 18 Q Why not? 19 A Well, it's silent on methodology, it's silent on 20 test organisms, it's silent on requirements 21 regarding contact time, silent on log reduction. 22 It doesn't really go into the level of detail 23 that we require on -- that the agency requires. 24 And we require that level of detailed information 25 so that there is a basis, there's a standard, 0539 1 there's a measure which to compare products over 2 time. 3 MR. CHA: If I could have one moment, 4 Your Honor. 5 JUDGE GUNNING: Yes. 6 BY MR. CHA: 7 Q One final question, Dr. Blackburn. The EPA 8 requirements you've just outlined for efficacy 9 evaluations, is the EPA efficacy evaluation team 10 required to follow those guidelines and 11 requirements? 12 A Yes, we are. 13 MR. CHA: Thank you, Dr. Blackburn. 14 I have nothing further, Your Honor. 15 MR. MCILNAY: Could I ask that the 16 last question and answer be read back? 17 (The question and answer were read.) 18 EXAMINATION 19 BY MR. MCILNAY: 20 Q Doctor, could you turn to the USDA -- or the 21 USFDA proposed guidelines, and specifically 22 Page 86. Could you take a moment to read 23 subsection I? 24 MR. CHA: I'm going to raise an 25 objection. I think the Court had ordered that 0540 1 Respondent would be limited to what they 2 submitted in the record. And despite our request 3 for production of information, Respondent has 4 provided no evidence that there was any actual 5 review by anyone at the FDA regarding 6 Respondent's products. This is just a smoke 7 screen, with all due respect. So I'm objecting 8 on the grounds of relevance. 9 JUDGE GUNNING: Your argument will be 10 considered in the weight accorded the document. 11 I have one quick question. It's a Draft 12 Guidance. Does anyone know if this has been 13 finalized? 14 MR. MCILNAY: I am not absolutely 15 certain, Your Honor. The comment period has 16 expired. But the last I looked -- and I can't 17 tell you what that is -- I had not seen the 18 final. 19 JUDGE GUNNING: But this document was 20 admitted, it's my understanding, pursuant to the 21 stipulations? 22 MR. CHA: Yes, Your Honor. 23 JUDGE GUNNING: Okay. I'll allow the 24 question. 25 0541 1 BY MR. MCILNAY: 2 Q Doctor, could you look at the first sentence 3 under the heading, not the sentence itself, that 4 starts with, there are a number of unique 5 circumstances that might be considered when 6 designing a study to show an antimicrobial 7 additive's effect. And it goes on to describe 8 what some of those might be. In setting the EPA 9 efficacy guidelines, are there similar unique 10 circumstances such as that? 11 A There are unique circumstances with any test 12 method. 13 Q Would you read the first sentence under the 14 heading J, into the record, please? 15 A Okay. FDA recognizes it is impractical to design 16 a standard experimental protocol that addresses 17 all relevant safety issues for every 18 antimicrobial agent. 19 Q Do you have -- strike that. Do you know if 20 that's a true statement? 21 A I would like to know what safety issues they're, 22 you know, responding to, what the point -- what 23 their reference is. 24 Q Okay. In that regard then could you focus your 25 attention about a third of the way down under the 0542 1 paragraph under the heading K, What is FDA's 2 performance standard for a new antimicrobial food 3 additive? 4 A Okay. 5 Q Okay. Could you read the two sentences that 6 begin with, Given the variability, read that into 7 the record, please? 8 A Sure. Given the variability in the intended 9 technical effect of antimicrobial food additives 10 and types of food treated, FDA does not have a 11 single performance standard for antimicrobial 12 food additives. 13 Q And the next sentences? 14 A However, to prove that an additive achieves its 15 intended technical effect as an antimicrobial 16 agent, data from an efficacy study should 17 demonstrate that at a minimum there is a 18 measurable difference between the treated samples 19 and a negative control, the treatment absent the 20 active agent. 21 Q Thank you. 22 MR. MCILNAY: No further questions. 23 MR. CHA: Very quickly, Your Honor. 24 EXAMINATION 25 0543 1 BY MR. CHA: 2 Q Dr. Blackburn, focusing on that -- those last 3 couple sentences that Mr. McIlnay asked you 4 about. Would, I guess for lack of a better word, 5 the standards set forth in those sentences, would 6 that satisfy EPA's requirement for efficacy 7 reviews? 8 A No. Their standard doesn't appear to be an 9 exact. It's says technical effect. I'm not 10 really sure what that references. It leaves a 11 lot to interpretation. 12 Q Thank you, Doctor. And do you notice that in 13 that first sentence it says, the data from the 14 efficacy study should demonstrate that, etc. Did 15 you note the word should? 16 A Yes, should demonstrate, uh-huh. 17 Q And if you could turn to the page near the 18 beginning of the document. It's Bates stamped at 19 the lower left corner Respondent RESP, 00081. 20 Now I'm going to read from the last paragraph, 21 the last full paragraph on that page. Do you see 22 where it says, FDA's guidance documents, 23 including this guidance, do not establish legally 24 enforceable responsibilities. Instead, guidances 25 describe the Agency's current thinking on a topic 0544 1 and should be viewed only as recommendations, 2 unless specific regulatory or statutory 3 requirements are cited. The use of the word 4 should in Agency guidances means that something 5 is suggested or recommended, but not required. 6 Do you see that paragraph? 7 A Yes. 8 MR. CHA: Thank you, Doctor. I have 9 nothing further. 10 MR. MCILNAY: Nothing further, Your 11 Honor. 12 JUDGE GUNNING: Does EPA reserve this 13 witness? 14 MR. CHA: While I doubt we will be 15 recalling Dr. Blackburn, I will reserve her for 16 the possibility. 17 JUDGE GUNNING: Okay. So thank you 18 very much for your testimony today, but 19 unfortunately you are not excused. 20 THE WITNESS: Thank you. 21 MR. CHA: Thank you, Your Honor. 22 JUDGE GUNNING: Yes. Now, does that 23 conclude EPA's case in chief? 24 MS. O'MEARA: Yes, Your Honor. I'm 25 sorry. At this time EPA rests. 0545 1 JUDGE GUNNING: Okay. Well, we've 2 done pretty well, I think. 3 Now, yesterday afternoon I offered 4 both parties the opportunity to sleep on the 5 possibility of settlement discussions. Once 6 again, the agency encourages such, even at the 7 late stage of the proceeding. I don't know if 8 you would like to do that. It's strictly up to 9 the parties, and I think this would be an ideal 10 time to do it if it's going to be done. 11 MR. MCILNAY: Your Honor, I would 12 first of all agree with your assessment of the 13 timing. And I would suggest it either way. I 14 was going to ask for a short recess to get 15 organized so that we can move through the 16 Respondent's case more efficiently. I have had 17 an opportunity to discuss my client's willingness 18 to explore the possibility, and we are certainly 19 willing to talk. 20 JUDGE GUNNING: EPA, would you like 21 to engage in those discussions? 22 MS. O'MEARA: Absolutely. We're 23 always willing to talk. 24 JUDGE GUNNING: Right now it's about 25 9:30. You need a little time to prepare. 0546 1 MR. MCILNAY: Correct. 2 JUDGE GUNNING: And I guess what we 3 could do is just monitor the situation. Is there 4 a room available that you could all go to, to 5 talk? 6 MR. MCILNAY: Go ahead. You're more 7 familiar than I am. 8 UNIDENTIFIED: Room 355. 9 JUDGE GUNNING: Okay. That would be 10 excellent. And those who are not directly 11 involved, I think it would be safe to say you 12 could take a half hour if you would like to, if 13 you're not directly involved in the discussions. 14 And if someone could at some point tell me where 15 you're at, at the end of the half hour. It's 16 going to take a little time in addition for you 17 to prepare. 18 MR. MCILNAY: Absolutely. 19 JUDGE GUNNING: Okay. 20 MR. MCILNAY: Thank you, Your Honor. 21 JUDGE GUNNING: Okay. Thank you. 22 (A recess was taken.) 23 JUDGE GUNNING: Is there someone who 24 wants to speak for the group? I assume there is 25 no settlement. 0547 1 MS. O'MEARA: There is not, but -- 2 and we are going to proceed, and I will let 3 Mr. McIlnay speak for himself -- but the door is 4 not shut. 5 MR. MCILNAY: That would be an 6 accurate representation. 7 JUDGE GUNNING: Okay. 8 MR. MCILNAY: And I apologize. I 9 just discovered that some documentation that I 10 thought Mr. Paquette was bringing with him to 11 assist me in my examination of my first witness 12 isn't here. I could proceed if I could get some 13 time with Mr. Peter to -- he will be our first 14 witness -- to discuss -- to get organized. 15 JUDGE GUNNING: So, in other words, 16 you need additional time at this point. 17 MR. MCILNAY: Right, but not for the 18 purposes of settlement. We've spent this time 19 trying to -- 20 JUDGE GUNNING: Right. Would 21 15 minutes do it? 22 MR. MCILNAY: Could I ask for -- 23 JUDGE GUNNING: Well, if we could -- 24 because we have taken a fair amount of time. My 25 concern is now we won't be able to finish by 0548 1 Friday. 2 MR. MCILNAY: I understand. We will 3 do our best, Your Honor. 4 JUDGE GUNNING: Okay. Well, in the 5 meantime, I would recommend again tomorrow 6 morning -- I don't know what is best for you all, 7 I find that sleeping on things sometimes can be 8 enlightening. And so I would recommend if you 9 want additional time tomorrow, I would be glad to 10 give you that. 11 MS. O'MEARA: That's great. Thank 12 you. 13 JUDGE GUNNING: So another 14 15 minutes. 15 MR. MCILNAY: Thank you, Your Honor. 16 In that regard I would just -- 17 JUDGE GUNNING: How about eleven. 18 MR. MCILNAY: I would invite 19 counsel -- I know this is not really relevant to 20 you guys, but it's been an hour commute. I have 21 decided to take a hotel room tonight, much closer 22 to the courthouse, so that I don't waste two 23 hours a day commuting here. So I could be here 24 before we commence at 8:30. 25 MS. O'MEARA: I have no problem 0549 1 showing up at 4 a.m. if you -- 2 MR. MCILNAY: That might be a bit 3 early. 4 JUDGE GUNNING: I won't be here, 5 though. You all can do that together. 6 MS. O'MEARA: You don't want to get 7 up at four? 8 JUDGE GUNNING: That's not in the job 9 description. 10 MS. O'MEARA: Tell me the time. I'll 11 be here. 12 MR. MCILNAY: Okay. 13 JUDGE GUNNING: Okay. That would be 14 excellent. 15 (A recess was taken.) 16 JUDGE GUNNING: 17 MR. MCILNAY: The Respondent calls as 18 its first witness Mr. Eric Peter. 19 ERIC PETER, called as a witness 20 herein, having been first duly sworn on oath, was 21 examined and testified as follows: 22 EXAMINATION 23 BY MR. MCILNAY: 24 Q Mr. Peter, I can tell already we're going to have 25 a problem if you don't use the mike. 0550 1 A I'll use the mike. 2 Q Okay. Thank you. And, again, if I tend to drop 3 my voice, let me know. Mr. Peter, would you 4 state your full name, please? 5 A Eric John Peter. 6 Q And would you spell your last name? 7 A P-E-T-E-R. 8 Q So it's not Peters? 9 A Correct. 10 Q And, Mr. Peter, where do you reside? 11 A Elm Grove, Wisconsin. 12 Q And could you very briefly tell the Court 13 something about your educational background? Do 14 you hold any higher educational degrees? 15 A No, I do not. 16 Q And have you -- did you attend any institutions 17 of post high school? 18 A I attended about a year and a half of 19 undergraduate studies in basically chemical 20 engineering, starting that. And after that, left 21 to join the family business. 22 Q And what is the family business, or what was the 23 family business? 24 A We market and produce lubricating oils and 25 greases for machinery and equipment. 0551 1 Q Does the family business have a name? 2 A Behnke Lubricants, Incorporated. 3 Q All right. And approximately when did you join 4 Behnke Lubricants? 5 A I joined initially doing about a year's worth of 6 work as a truck driver in 1972. Joined full-time 7 late '74, '75. 8 Q When you started your employment with Behnke 9 Lubricants on a full-time basis in 1974 or '75, 10 what position did you hold? 11 A I did some office, clerical, warehouse work, and 12 then graduated over to a sales position that had 13 opened up. 14 Q Okay. You already referred to it as a family 15 business. Who was your immediate supervisor when 16 you started? 17 A My father. 18 Q Thank you. And how long had your father been in 19 this business? 20 A He had acquired the business, along with my 21 maternal grandfather, in the early 60's. 22 Q Let's focus on '1974, '75. Can you tell the 23 Court what the business of Behnke Lubricants was 24 at that time? 25 A At what time? 0552 1 Q When you graduated from being a truck driver 2 to -- 3 A Okay. Pretty much similar to what it is today, 4 we marketed lubricants. A little bit different 5 in the fact that we did not manufacture as many 6 lubricants as we do today, but now we're pretty 7 much manufacturing most of what we sell in terms 8 of fluid lubricants. 9 Q When you use the terminology lubricants, what do 10 you mean? In other words, you know, are we 11 talking motor oil that I buy at the Mobil 12 station? 13 A Well, in broad terms, yes, anything that's used 14 to facilitate and reduce friction in moving parts 15 on machinery. 16 Q And you say on machinery. Is there a specific 17 market for Behnke's products? 18 A We address several different markets. Initially 19 we -- most of our market was heavy construction, 20 off-highway vehicles, trucking, some fleet 21 operations. And fairly early on we were involved 22 with food processing facilities, too, as 23 Wisconsin and Minnesota and Illinois are pretty 24 big food processing states. 25 Q Let me just -- in a more broad sense, since 0553 1 you've been with the company, have you, the 2 company, whether it's manufacturing or 3 distribute, marketed to the consumer market such 4 as motor oils that I might buy at the local 5 filling station? 6 A No. We did distribute at one time for some 7 branded product, namely like Valvoline or 8 something like that, in the 60's and early 70's. 9 But our line, the JAX line, is aimed almost -- 10 well, exclusively at commercial markets. 11 Q Let's talk about that a minute. JAX is a trade 12 name? 13 A Trademark. 14 Q And so the lubricants that you sell under the JAX 15 trademarks, those are lubricants that are Behnke 16 products; is that correct? 17 A Correct. 18 Q Now, you said during your testimony that early on 19 you were more of a distributor and less of a 20 manufacturer. I want to ask you now as we sit 21 here today, does Behnke still distribute 22 lubricants manufactured by others? 23 A Yes. We're not an integrated grease 24 manufacturer. We do a couple of items that are 25 smaller, technical, and specialty, but for the 0554 1 most part we contract for the grease 2 manufacturing. We do manufacture all of our 3 fluid products. 4 Q All of your -- 5 A Fluid products. 6 Q And I'm assuming that the Court's not familiar 7 with the lubricant industry. What is the 8 difference between fluid products and greases? 9 A Okay. Well, in essence a fluid lubricant would 10 be anything you can pour. Although, greases in 11 their lightest form can be poured also, generally 12 they're thickened with a thickener that enables 13 them to stay put in place in bearings and open 14 lubricant applications. 15 Q As we sit here today, approximately how large is 16 Behnke in terms of the number of employees it 17 has? 18 A Approximately fifty. 19 Q And where is Behnke located? 20 A We have our corporate headquarters in Menomonee 21 Falls, Wisconsin. And we have a satellite branch 22 in Sacramento, California, which is a warehouse 23 operation and a sales office. 24 Q Where does the manufacturing of the fluid 25 lubricants take place? 0555 1 A Menomonee Falls. 2 Q And I'm going to ask you a couple of different 3 market questions. First, by product line, you 4 made a distinction between food processing and 5 other applications. What are the other 6 applications? 7 A Other markets we serve? 8 Q Yes. 9 A I think I touched on it briefly, but anything 10 from industrial plants, to off-highway vehicles, 11 to fleets, to plants that produce fiberglass for 12 insulation or board products, for particleboard, 13 OSB. You know, pretty much anything that moves 14 needs lubrication, so we're pretty free-ranging. 15 The only things we do not get involved with 16 typically are metal working fluids and cutting 17 oils. 18 Q Then you referenced the food processing 19 marketplace. 20 A Yes. 21 Q What -- can you describe, tell the Court what 22 that market entails? 23 A That market entails providing lubricants for 24 processors of anything from fruit, vegetables, 25 nuts, meat, poultry, seafood products, and 0556 1 snacks, beverages. It's wide ranging. 2 Q Okay. Now, you are the company's representative 3 for purposes of these hearings. And in order to 4 move things along, you are familiar with the 5 products that are at issue in this case? 6 A Yes. 7 Q Excuse me? 8 A Yes. 9 Q Namely, the JAX POLY-Guard FG-2, JAX POLY-Guard 10 FG-LT, JAX HALO-Guard FG-2, JAX HALO-Guard FG-LT, 11 JAX Magna-Plate 74, and JAX MAGNA-Plate 78, those 12 are all products with which you're familiar? 13 A Yes. 14 Q Which of the markets that you just described, the 15 food industry and the nonfood industry, are these 16 products marketed to? 17 A All of those are marketed to the general food 18 industry. I mean, to the food industry 19 specifically, but in the wide-ranging sense that 20 I mentioned it. 21 Q Which would include beverage? 22 A Yeah, absolutely. 23 Q And do you, does Behnke market this outside the 24 food industry, any of the products that I just 25 named? 0557 1 A We don't. There really wouldn't be that much 2 appeal for them outside of the food industry 3 because they have a perceived value of not 4 performing quite as well, and generally they cost 5 about double the conventional lubricants. 6 Q And now I want to ask you to define your market 7 geographically. Where within the world does 8 Behnke sell these products? 9 A Well, the easiest way to break it down, is we 10 have direct markets that we service around our -- 11 both of our facilities in Sacramento and in the 12 Milwaukee area, ranging out for maybe a hundred 13 miles. 14 Outside of that, our sales are 15 through distribution. We have distributors 16 throughout this country. We have distribution in 17 Mexico and Canada, we have several in South 18 America. We have distributors in Europe, and 19 distributors in southeast Asia, we have a 20 distributor in China. So it's fairly far flung. 21 I would say the export portion is not a major 22 portion, but it's fairly wide-ranging. 23 Q I want to make sure my question was clear. I'm 24 restricting that to the six products that I just 25 read into the record that are at issue in this 0558 1 case. 2 A Uh-huh. 3 Q You understood that? 4 A I thought you were talking about the company in 5 general. 6 Q Okay. Let me ask you then, focusing on the JAX 7 POLY-Guard, all versions, the JAX HALO-Guard, the 8 two versions, and the JAX Magna-Plate, 9 geographically where are those sold or 10 distributed? 11 A Potentially they would be any of the places I 12 mentioned, depending on the market that those 13 distributors are addressing. 14 Q Now, I didn't ask this. Your current position 15 with Behnke is what? 16 A President. 17 Q And is there anyone, officer that you report to? 18 A No. 19 Q In fact, do you have any ownership in Behnke 20 Lubricants? 21 A I'm the majority owner. 22 Q I'm sorry? 23 A I am the majority owner. 24 Q Now, your testimony was that potentially these 25 products could be marketed in any of those 0559 1 geographic markets that you described. Actual 2 sales and distribution, what percentage of that 3 takes place within the United States? 4 A I don't have an exact number, but I would say our 5 export sales are less than 15 percent of our 6 sales. 7 Q Of these products? 8 A Of those products? Well, these products are a 9 small percentage of our overall sales. 10 Q That's why I'm asking. Maybe it would be easier 11 if we do it this way. A different market 12 question, defining your market. Of your gross 13 annual revenues, approximately what percentage is 14 made up from the food processing market as 15 opposed to the nonfood processing? 16 A Okay. It's been a growing industry for us for 17 many years, so it's a good industry. It's likely 18 over 50 percent of what we do now. 19 Q And you indicated that it has been growing. 20 Again, in the interest of time, I would like you 21 to be brief, but can you give us some history as 22 to how and when Behnke entered this food 23 processing market? 24 A I can give you a lot of history. 25 Q Well, try and hit the highlights. 0560 1 A Well, I think my affidavit explained it fairly 2 well but -- or my, you know -- the initial foray 3 into the food processing lubricant market came 4 because the FDA, USDA and the FSIS decided in the 5 early 60's that something had to be done to 6 address the fact that the lubricants being used 7 in these processing plants were not any different 8 than the lubricants that could be used anywhere 9 else in society. 10 Q Okay. Let me interrupt you for a moment. We 11 have a lot of acronyms. FDA and USDA might 12 be not -- everybody may know what those are. You 13 used another one, FSIS? 14 A Food Safety Inspection Service. 15 Q And do you know if that's associated with one of 16 the -- 17 A It's associated with the USDA. 18 Q I'm sorry I interrupted. So prior to this early 19 60's, food processors were using the same 20 lubricants you were selling? 21 A Pretty much so. And lubricants at that time were 22 even less stringently regulated because many 23 additives that they were using subsequently 24 became unusable, not only outside of the food 25 plant but outside, period. I mean, in the early 0561 1 60's -- I was born in the Eisenhower 2 administration -- so, I mean, I was around at 3 that point in time, but I don't recall when the 4 EPA came into function, but many additives used 5 at that time contained -- lead was a great 6 additive, things like that, that absolutely now 7 wouldn't be used in a food plant. And many of 8 the additives that were used then wouldn't even 9 be used outside of a food plant. 10 Q All right. So what changed? 11 A They made the determination that people were as a 12 result of these processing plants eating these 13 lubricants. There is pretty much no getting 14 around the fact that they are getting into the 15 food as the processing happens. So they said 16 this can't happen anymore the way it's happening. 17 We have to regulate the formulations of these 18 lubricants so that when this inevitable 19 consumption occurs, they will not be harmful in 20 any way. 21 So early on the FDA set up some 22 guidelines for the products that could be used as 23 raw material ingredients in food processing 24 lubricants. They did the toxicology studies and 25 all that and made up a definitive list of what we 0562 1 could use to formulate lubricants that were used 2 in food contact environments within the plant. 3 Q And today if I were to ask you where I might find 4 that list, what would be your answer? 5 A It's in the 21 CFR. 6 Q Do you have a specific section number? 7 A Well, the specific section number that points at 8 lubricants is 178.3570. But there are other 9 areas where we can use GRAS substances as well. 10 Q Another acronym. I know it's in the record, but 11 just to make it clear. What is GRAS? 12 A Generally Recognized As Safe. 13 Q Okay. In the process of this change -- and 14 you've been with the company now since 1974 on a 15 full-time basis -- have you seen an evolution in 16 this product market? 17 A In the market or the products themselves? 18 Q Well, tell me about the market first, tell the 19 Court, please. 20 A Well, the market has changed pretty much hand in 21 hand with the products, because the products 22 improve -- the market was very limited early on 23 because the limitations on what we could use 24 didn't make for the world's best lubricants. So 25 the plants that would use them, would only use 0563 1 them where they really felt they had to or where 2 the USDA inspectors mandated them, and everywhere 3 else they would use conventional lubricants 4 because of their performance value. 5 The use in other plants outside of 6 the auspices of USDA inspections did not really 7 get started until later in the 60's, early 70's, 8 because those plants were not inspected by any 9 other authority, possibly maybe some state 10 inspectors for some vegetable plants or things 11 like that, but it wasn't on the radar screen for 12 those people. 13 Q All right. And today, what do you find the 14 market to be? 15 A It continues to be a growing market. There are 16 still pockets of resistance from processors to 17 use some of these products. But the FDA book has 18 grown, more toxicology studies have been done, 19 more component manufacturers have submitted 20 components to FDA for evaluation, they've been 21 added to the list. The performance of the 22 lubricants has steadily improved, the markets 23 have grown. Contamination cases have forced some 24 of these processors to say, hey, we better look 25 at this and make sure that if we get in any 0564 1 contamination litigation we've got food-grade 2 lubricants in our processing equipment. 3 So it's continued to grow based on 4 the fact that the performance of the lubricants 5 has improved and the acceptance and knowledge of 6 the need to use these lubricants has improved. 7 Q Within the marketplace is there a generally 8 accepted understanding -- you used the term 9 food-grade. Is there a generally accepted 10 understanding of what food-grade refers to? 11 A By most people. But a lot of the processors need 12 an explanation of it. The term food-grade is 13 used to the lubricants initially that the USDA 14 defined as lubricants suitable for incidental 15 food contact. Shortly thereafter, in the early 16 60's, they changed that designation to AA. And 17 they had two classifications of lubricants at 18 that time. They had the AA list, which are the 19 lubricants I just described. And they had the BB 20 list, which are the lubricants that are basically 21 industrial in nature that would -- could be used 22 in the plant, but not in an area of food contact. 23 And then they basically had a 24 knockout list of any ingredients, if they were 25 used in lubricants, those lubricants couldn't 0565 1 come in the plant, period. The -- where was I 2 going with that? The food-grade lubricants were 3 regulated by the list. Everything had to be on 4 that list, the AA lubricants. The BB lubricants 5 were regulated more or less by exclusion. They 6 couldn't have these products in them. So we were 7 guided completely by the FDA guidelines in terms 8 of formulation for AA lubricants. BB lubricants 9 were guided by what we could not put in them. 10 Eventually -- I can just finish -- 11 that the AA designation was in the early 70's 12 changed to H1, and the BB designation was changed 13 to H2. 14 Q All right. And who's designation were those? 15 Who's terminology was that? 16 A USDA. 17 Q Let's focus on after the designation changes to 18 H1 and H2. Was there some procedure or process 19 that Behnke followed to get approval of its 20 products as compliant with H1 requirements? 21 A Yes. Each product had to be submitted to the 22 USDA for approval process, which involved filling 23 out some paperwork that included formulation 24 information, some paperwork that included some 25 identification information of the company, 0566 1 including a product label or facsimile of a 2 label, and including a four-ounce sample. And 3 that was prepared -- I prepared 50 to 100 of them 4 myself, and then sent the package off to USDA to 5 wait for their findings. 6 Q And -- 7 MS. O'MEARA: Your Honor, I'm sorry. 8 I just need clarification when this was. 9 BY MR. MCILNAY: 10 Q Yeah. I was just going to ask you that. 11 A When this was? This process happened from the 12 very start, from the very inception of the USDA 13 program, all the way up until they discontinued 14 the process in 1999. That was the process we 15 went through. 16 Q All right. And this submission process would 17 take place each time you had a new product 18 that -- 19 A Each time we had a new product or decided on a 20 formulation change to an existing product. 21 Q All right. And what, if anything, would happen 22 after you submitted it to the USDA vis-a-vis some 23 kind of registration or certification? 24 A If there were no issues with the labeling, I 25 mean, the commas were in the right places, the 0567 1 periods were in the right places, you would kind 2 of sit and wait, and wait for your approval 3 letter. And when the approval letter came back, 4 you had that as a document to take to the field 5 to use for the inspectors to verify that this was 6 an approved product at that level. And then also 7 it would be published in what they called the 8 White Book eventually to indicate that it was an 9 approved product. But the doctors and so forth, 10 the food inspectors in the field did not 11 necessarily have that White Book updated all the 12 time, so you had to have the letters, too. 13 Q When you say you had to have -- 14 A One had to have, we had to provide the letters to 15 the end user and their food safety people. 16 Q And would -- you testified earlier that you 17 transferred into sales after your initial time in 18 the clerical field. For how long were you in 19 sales? 20 A I'm still in sales. But direct field sales, ten 21 years. 22 Q And what time period? 23 A '75 to '85, '86. 24 Q And in that time period and in that capacity, did 25 you call on food processing plants? 0568 1 A Yes. 2 Q For the purpose of selling these products? 3 A Yes. 4 Q And during that period of time, did you sometimes 5 have occasion to interact directly with the USDA 6 inspectors in terms of showing the certification? 7 A Occasionally. But usually that was the purview 8 of the plant people. 9 Q Was it your experience that the plant people 10 required you to show certification? 11 A The USDA-inspected plants definitely had to have 12 it. These products could not enter the door 13 unless you had a certification letter or it was 14 listed in the White Book. It was a little less 15 stringent in plants that weren't under USDA 16 authority. 17 Q Did that change over time? 18 A It's become more stringent. The HACCP program 19 has made it pretty much of a mandate. They want 20 to make sure all those things are approved and 21 have a handle on everything coming in the plant. 22 But it's become more accepted and grown. I mean, 23 they want documentation. 24 Q Let me back up. We will come back to it later, 25 but just to make the record clear. You used 0569 1 another acronym, HACCP. What does that stand 2 for? 3 A HACCP, Hazard Analysis and Critical Control 4 Point, I believe it is. 5 Q All right. And we'll come back to that in more 6 detail. What I want to focus on right now is 7 your current marketing process, channels of 8 distribution and marketing for the food-grade 9 lubricant group. How does Behnke approach the 10 marketplace? 11 A Through direct sales contact, literature. 12 Q Well, here's what I -- you mentioned that you 13 have distributors. 14 A Correct. 15 Q Okay. Do you have paid salesmen, marketing 16 people that work directly for Behnke? 17 A Yes. 18 Q Okay. Can you distinguish between the 19 distributors and the direct salespeople for the 20 Court? How did they function? 21 A Well, we have a group of direct salespeople that 22 will make direct sales calls on to end users. We 23 also have a group of salespeople that will assist 24 our distributors in making direct sales calls 25 with end users. 0570 1 Q And who are you talking about when you talk about 2 end users? 3 A Consumers of the lubricants. And if you're 4 specific to those six, they would be food 5 processing concerns. 6 Q And -- well, let's go beyond the six. Do you 7 have other food-grade lubricants besides the six? 8 A Yes. 9 Q Okay. Food-grade lubricants, who are the end 10 users? 11 A Food processors, beverage processors. 12 Q All right. Does Behnke market those food-grade 13 products to anyone else? 14 A We don't market them to anyone else. The 15 marketing is pretty vertical-market-oriented to 16 the food processing industry. 17 Q Okay. I just want to make sure that's clear. 18 What do you mean by, it's pretty vertical? 19 A Well, I mean it's targeted at the food processing 20 industry. Again, I mentioned there isn't that 21 much reason for other people to want to use them 22 because they're lacking some of the goodies, so 23 to speak, that we can put in non food-grade 24 lubricants, and they cost more. 25 Q All right. I think I've asked this, but in 0571 1 the generic distinction between consumer market 2 and commercial or business-to-business market, is 3 there any consumer-oriented market for these 4 lubricants? 5 A There is no consumer market for them. No 6 consumer would go to any store and find any 7 food-grade H1 products. No one would want to 8 lubricant their car or their garage door opener 9 or their lawn mower. There's no reason to use 10 these other than in food processing plants. 11 Q So it's not sold in retail stores? 12 A No. You couldn't -- you couldn't -- not only 13 couldn't you find ours in retail stores. I think 14 you would be hard pressed to find any H1 type 15 lubricants anywhere in a retail outlet. People 16 wouldn't really even know what it is, to be 17 honest with you. 18 Q All right. I want to ask you a little bit about 19 your experience and background and whatnot with 20 these food-grade lubricants. How did you gain 21 your knowledge of food-grade lubricants? 22 Obviously, your work experience, but were there 23 other avenues where you learned about -- 24 A Well, work experience, we had a knowledge base. 25 I have some chemistry background. We have 0572 1 suppliers that provide knowledge in terms of 2 performance of products that can be used and 3 that. A lot of it early on was -- as far as 4 performance was concerned, was hit and miss 5 because of the limited list that we could choose 6 from to make these products. We put them 7 together and put them in the field, and then 8 hoped we could stick our head in the door the 9 next time we came back and that the machines 10 weren't laying on the floor. So, you know, there 11 was a lot of trial and error in putting these 12 things together with the list of ingredients that 13 we had. 14 Q And that's good. I should have asked a different 15 question, because that's not quite what I was 16 driving at. Your knowledge or understanding of 17 what was required for food-grade lubricants, and 18 specifically the H1 lubricants, what I'm getting 19 at is, were there industry associations that had 20 educational programs or that sort of thing? 21 A Lubricants in general there were. But this is 22 such a vertical market that there really weren't. 23 I mean, we were limited to 21 CFR and putting our 24 concoctions together and seeing how they worked. 25 Q And in terms of that process, the putting your 0573 1 concoctions together, as you so eloquently put 2 it, where would that take place? Did you do your 3 R&D in-house or did you use -- 4 A Early on we would do some R&D in-house, but we 5 would work with the people that were doing the 6 compounding with us. 7 Q Can you stop and explain that a little bit? I've 8 been your attorney for a long time, and what you 9 take for granted, isn't always obvious to the 10 rest of us. What do you mean by compounding? 11 A It's an industry term for manufacturing 12 lubricants. 13 Q All right. 14 A It's the putting together of the ingredients in a 15 vessel to make a finished product. 16 Q All right. Let's describe that just a moment. 17 As a layperson, I visualize oil coming out of the 18 ground, getting refined, and, you know, we get 19 different grades of lubricants. What goes into a 20 typical food-grade lubricant, generically? I'm 21 not asking you to specify what -- 22 A You know, the process isn't that much different 23 than any lubricant that you're going to 24 manufacture. It's typically a base oil, and then 25 performance additives that may impart, you know, 0574 1 anti-rust properties, anti-wear properties, 2 oxidation inhibition, tacifiers, improvers like 3 that. 4 The difference being, that when 5 you're making a food-grade lubricant, you're 6 coming in with FDA-approved ingredients to put 7 those products together, whether it's a white oil 8 or the additives from the 21 CFR list. 9 Q White oil would be the base? 10 A White oil is one of the bases. But on more 11 sophisticated applications there are other -- the 12 synthetic-based oils that are also approved. 13 Q All right. And additives are the performance 14 enhancers? 15 A Correct. 16 Q All right. And the compounding is the process of 17 mixing those together? 18 A Correct. 19 Q All right. Now, you personally at some time in 20 your career had responsibility for the food-grade 21 food registration process that you discussed, the 22 provision of a sample and ingredient list and so 23 on. Do you continue to do that today? 24 A No. And the process has changed a little bit. 25 Q Good. You anticipated my next line of 0575 1 questioning. How has the process changed? 2 A In 1999 the process through the USDA ceased, and 3 the regulations were changed so that the burden 4 of proof of food-gradability shifted more or less 5 to the food plants themselves. So we had to 6 supply certification of some sort to these food 7 plants indicating that the products were composed 8 of items off the FDA component list. That did 9 not mean though, however, that anything on the 10 old list became obsolete. 11 Q Okay. Now, you said you had to provide 12 certification. Was that a market demand? 13 A I guess you could call it a market demand, but it 14 was a necessity for the plant to have it. 15 Q I understand. In other words, your customers 16 wouldn't buy from you if you couldn't show that? 17 A Correct, if you couldn't assure them. 18 Q And the ability to show that after the USDA 19 ceased its testing, what methods did you use to 20 confirm for your customers that this was 21 food-grade lubricant? 22 A We had an in-house letter that we had confirming 23 that, with the wording that stated that this was 24 in compliance with the former regulations, and 25 cited the FDA chapters that the ingredients 0576 1 complied with. 2 Q You said former regulations. 3 A Well, the former testing that was done by the 4 USDA. 5 Q All right. Was there any other way to certify to 6 the customer that your lubricant was food-grade? 7 A Not for the first couple years. There was no 8 other independent agency that wanted to do that. 9 We had talked a little bit among the industry 10 about what we would do to have a general, 11 standardized certification process. But there 12 was nothing at the time, until some independent 13 testing agencies offered to provide the service. 14 Q All right. And did that eventually happen? 15 A Yes. 16 Q Was there one or more agencies that became the 17 standard in the industry? 18 A Yes. Two agencies, nongovernment agencies, 19 decided to pursue it. One was Underwriters 20 Laboratory and the other one was NSF. 21 Q And what does NSF stand for? 22 A I don't think it stands for anything anymore, but 23 at one time I think it stood for National Safety 24 Foundation. 25 Q All right. And whether it was NSF or 0577 1 Underwriters Laboratory, what would these 2 organizations do? 3 A Well, they would provide a third-party 4 confirmation of what you were already confirming 5 in your letter, and be a nongovernment 6 replacement or private replacement for the 7 process that the USDA went through. 8 Unfortunately, the USDA did it for free, and 9 these people charged a fee. So -- 10 Q Was there a requirement that you go through one 11 of the -- 12 A No, there was no requirement, but the industry 13 gravitated to the NSF program because it was more 14 in line with what the USDA had done previously. 15 And, as a matter of fact, we worked with the NSF 16 when they started setting up this program. There 17 were a lot of phone calls between their document 18 manager and their people as to how these things 19 were handled and what were the protocols that 20 were used to make these things work. 21 Q And when you say we -- which you've done often 22 today -- you're talking about Behnke? 23 A Behnke Lubricants. 24 Q Now, you described how the USDA stopped its 25 testing, and you had previously used the acronym 0578 1 HACCP. Are the two related in some fashion? 2 A I think Troy Paquette could be a little more 3 familiar with that. But HACCP programs basically 4 started initiating when the USDA pulled back on a 5 lot of its testing. In the 90's it wasn't just 6 this program that was downsized. It was the 7 amount of inspectors in plants. There were a lot 8 of changes made in the late 90's to the USDA, 9 FSIS programs. 10 Q Now, I want you to focus on the current time 11 frame, all right. You mentioned that customers 12 who aren't in need of food-grade lubricants 13 aren't likely to buy them because they're more 14 expensive; is that correct, than non food-grade? 15 A You're going to have to rephrase that. 16 MR. MCILNAY: Could you read it back? 17 (The question was read.) 18 THE WITNESS: That's correct. 19 BY MR. MCILNAY: 20 Q And that holds true today; is that -- 21 A Correct. 22 Q As it did in the early days? 23 A Correct. 24 Q All right. And you have, as the company's 25 representative, been here for the testimony 0579 1 that's gone into the case so far, including the 2 testimony of Mr. Rybicki? 3 A Yes. 4 Q All right. You're familiar, are you, as the 5 president of Behnke Lubricants, with competitors' 6 pricing? 7 A Somewhat. 8 Q All right. You're being modest. 9 MS. O'MEARA: Objection, Your Honor. 10 I would ask that Counsel not testify on behalf of 11 Mr. Peter. He answered the question. 12 BY MR. MCILNAY: 13 Q Mr. Peter, let me be more specific. You heard 14 the testimony that Mr. Rybicki indicated that 15 your product was 20 to 30 percent more expensive 16 than what they had previously been using? 17 A Uh-huh, yes. 18 Q All right. Within the marketplace, I mean, how 19 many competitors do you have? Is this a big 20 market with lots of competition or are there few 21 participants? 22 A The lubricating market in general or the food 23 processing? 24 Q Food processing. 25 A It's a huge amount of competitors in general, and 0580 1 it's a fairly large amount of competitors in the 2 food processing arena for lubricants, many of 3 which have come on the scene in the last 10 to 4 15 years. 5 Q All right. With regard to those competitors 6 within the food-grade lubricant market, are you 7 familiar with the range of pricing? 8 A Yes. 9 Q All right. And from the low price to the high 10 price, what kind of percentage difference is 11 there? 12 MS. O'MEARA: Your Honor, I'm going 13 to object at this time. He's already testified 14 he's somewhat familiar with it. There's nothing 15 in the record to support this, so it lacks 16 foundation. 17 BY MR. MCILNAY: 18 Q Let me back up. Let me just ask. Do you know? 19 A Do I know? 20 JUDGE GUNNING: Hold on. Do you have 21 a response to -- 22 MR. MCILNAY: I'll withdraw that 23 question. 24 JUDGE GUNNING: Okay. 25 0581 1 BY MR. MCILNAY: 2 Q I will rephrase it to this. Do you know what the 3 price ranges are from high to low? 4 A Well -- 5 MS. O'MEARA: Your Honor, I'm going 6 to -- I'm sorry. I'm going to continue to make 7 that objection. Again, the testimony was he is 8 somewhat familiar. There is nothing in the 9 record, in any of the prehearing exchange 10 documents that shows what the range is. 11 Therefore, there is no foundation. 12 MR. MCILNAY: I'm asking if he knows. 13 JUDGE GUNNING: Right. I'll allow 14 the question. The relevancy at some point is 15 somewhat tangential, and so you may want to limit 16 the questions down this road. 17 MR. MCILNAY: I will. 18 JUDGE GUNNING: Okay. 19 THE WITNESS: I'm familiar with the 20 range. They could range -- 21 BY MR. MCILNAY: 22 Q You're familiar with it. 23 A Yes. 24 Q How? Why are you familiar? 25 A Well, it's a competitive marketplace. We have to 0582 1 know where we're priced to obtain business. 2 Q All right. And in general, what's the range? 3 A The range on food-grade products could be 4 anywhere from 10 or 15 percent below our prices 5 to 100 percent above our prices. 6 Q All right. Okay. We're here about Micronox. 7 Let's begin with, has Micronox always been a part 8 of Behnke's food-grade lubricants? 9 A No. 10 Q All right. When did the concept of Micronox 11 arise at Behnke? 12 A Can I back the calendar up a little bit? 13 Q Sure. 14 A Okay. As the FDA approved more raw material 15 ingredients that we could use in making 16 products -- 17 Q These are the additives? 18 A The additives, components is probably a better 19 term. We would test them and try to find out 20 better solutions. If a better rust inhibitor 21 came on the market -- maybe in the early 70's, we 22 had complaints that the rust inhibition wasn't 23 good on these products -- we would incorporate 24 that into the products, get a new approval, and 25 move on. 0583 1 And so the process of developing 2 these lubricants is very evolutionary, because 3 there is not an additive company, per se, that 4 formulates additives for the market. In other 5 industries that we service, you can call a 6 Lubrisol, which is an additive supplier, or an 7 Oranite or -- they've changed their names so 8 much -- but there are dozens of additive 9 companies that you can go to and get components 10 to make almost ready-made packages. You can drop 11 in this component and make a transmission fluid. 12 You can't do that with food-grade additives 13 because you have to pick and choose from what's 14 listed in the FDA guidelines. But as things 15 became more available, improvements could be 16 made, and we would address problems that we saw 17 in the field with these improvements that we 18 made. 19 Q I mean, was that evolution in part to respond to 20 customer concerns? 21 A I would say 95 percent of them are. 22 Q Now -- 23 A Or our concerns about making a better product. 24 Q Right. Now, Micronox, which is where we started 25 that, how did that -- and let's back up. 0584 1 Micronox is a registered trademark? 2 A Correct. 3 Q All right. When we talk about Micronox, could 4 you explain to the Court what that means in your 5 mind? 6 A Well, it basically means the antimicrobial 7 attribute that we have in our lubricants. 8 Q Is there a -- I'm searching for the right word -- 9 single formula for something called Micronox? 10 A No. 11 Q I'm sorry. Please speak up. 12 A No. No, there is not. 13 JUDGE GUNNING: I have a question at 14 this point on a practical matter. Are we getting 15 into any confidential business information? 16 MR. MCILNAY: Not as yet. 17 JUDGE GUNNING: Okay. 18 MR. MCILNAY: I will be sensitive to 19 that when and if we get there. 20 JUDGE GUNNING: If you have an 21 additional witness in the room, and I don't 22 know -- 23 MR. MCILNAY: He is one of our 24 experts, and when and if we get there, I will ask 25 the Court to admonish -- 0585 1 JUDGE GUNNING: I just wanted to make 2 sure we're cognizant of that. 3 MR. MCILNAY: Exactly. And I 4 appreciate that, as I'm sure Mr. Peter does as 5 well. 6 BY MR. MCILNAY: 7 Q How did -- strike that. Were you finished with 8 your description of Micronox? 9 A Sure. 10 Q How is it that Behnke pursued developing this 11 technology? 12 A It was a customer asking for some improved 13 performance in terms of microbial containment. 14 Q All right. Now, just to be sure, the particular 15 customer and the details of this, do you consider 16 that a confidential business? 17 A We didn't publish it in our literature, but I 18 don't consider it confidential. 19 Q All right. So you could discuss who the customer 20 was? 21 A Yes. 22 Q All right. Could you tell the Court who the 23 customer was? 24 A The initial customer that requested some improved 25 performance in this area was Kraft Food. 0586 1 Q And specifically do you recall the time frame? I 2 don't mean month and day but -- 3 A Roughly around 2000, maybe 2001. 4 Q Okay. And do you have personal knowledge of the 5 request? I mean, were you the party that they 6 approached, or how did the issue -- 7 A I was not personally the party they approached, 8 but I was aware of the request and our initiative 9 to see if we could help out. 10 Q All right. How did you learn about the request? 11 A It was probably from one of our salespeople or 12 from my technical director. 13 Q All right. In the process, Mr. Peter, of an 14 initiative, what role did you play? 15 A Pretty much strictly an oversight role. 16 Q All right. In the course of this, did you have 17 occasion to have direct contact or discussions 18 with anyone from Kraft? 19 A I personally don't recall. I may have had one or 20 two, but it was not my main focus. 21 Q Okay. Did you have an understanding from your 22 salesperson what -- was there a particular 23 application that you were trying to target? 24 A This particular application -- and I think that 25 one of the salespeople on the witness list might 0587 1 have been a little bit more involved, and also 2 Troy Paquette was -- 3 Q Understood. 4 A -- was a bearing. 5 MS. O'MEARA: Your Honor, I'm sorry. 6 I'm going to object. It sounds like this is 7 skirting on hearsay. I mean, we have people on 8 the witness list, Mr. Paquette, and I believe 9 others, that will be talking about this. Perhaps 10 that would be more appropriate. But I'm hearing 11 hearsay at this moment. 12 JUDGE GUNNING: As you well know, 13 under the administrative rules we don't strictly 14 follow the rules of evidence. That's not to say 15 we ignore them. The preferable is obviously the 16 person with the most direct knowledge. But given 17 this situation, I'll allow some questions. 18 MR. MCILNAY: I understand, and I 19 could make some arguments as to why this isn't 20 strictly hearsay, but -- 21 BY MR. MCILNAY: 22 Q For purposes of brevity and to get to lunch, can 23 you generally describe what your understanding 24 was? 25 A My understanding was that it was a large bearing 0588 1 in the processing of cream cheese. 2 Q All right. You mentioned your technical 3 director. Who is that? 4 A Troy Paquette. 5 Q And that was -- that person was the same 6 technical director back in 2001? 7 A Yes. 8 Q Did you as president of the company give any 9 direction to Mr. Paquette relative to this 10 customer request? 11 A No. Mr. Paquette is pretty familiar with our 12 formulation guidelines. 13 Q I understand that, but did you ask him to do 14 anything? 15 A See if he could solve the problem. 16 Q All right. And you basically then set 17 Mr. Paquette loose to -- 18 A Let's investigate. 19 Q -- to investigate it. All right. What happened 20 next in this process, as far as you know? You 21 set Mr. Paquette to investigate. 22 A Well, after his investigation and our 23 determination that we may have something that was 24 a solution; although, we don't do any efficacy 25 testing in-house, but we were familiar with the 0589 1 ingredient list and what was usable through 21 2 CFR, we put together a sample and said, would you 3 like to take a look at it and try it to see if it 4 helps with your problem. 5 Q And you say, would you like to take a look. 6 A You, Mr. Kraft. 7 Q So you supplied them with a sample? 8 A Yes. 9 Q All right. Ultimately, based on your knowledge 10 of the business and business records, did Kraft 11 purchase a product from you -- 12 A Ultimately they purchased, yes. 13 Q -- that addressed this concern? 14 A Yes. 15 Q At that point in time -- well, let me back up. 16 We've talked about a number of your products, six 17 of them most specifically. I take it those 18 aren't all interchangeable for different 19 applications? 20 A I wish they were. It would help with inventory. 21 Q All right. But they're not? 22 A No. 23 Q All right. For the Kraft project, was there a 24 specific or particular lubricant application that 25 has a name that you can put to it? 0590 1 A The lubricant itself? 2 Q Yes. 3 A For the Kraft application that we use the 4 POLY-Guard FG-2. 5 Q And POLY-Guard FG-2, for the record, that is a 6 fluid or a grease? 7 A That's a grease. 8 Q All right. I believe this is in the record, but 9 there is some outsourcing of manufacturing. Do 10 you manufacture the grease? 11 A We do not manufacture grease, no. 12 Q All right. So you subcontract that to somebody 13 else who uses your formula to produce that 14 product? 15 A Correct. 16 Q All right. 17 A But -- if I can throw a but in there. 18 Q Go ahead. 19 A We have in our laboratory grease equipment and 20 can do batch size -- you know, trial batch-size 21 formulation work there. 22 Q Okay. 23 A Because most of the formulas that we have 24 manufactured on the greases are -- virtually all 25 of them are our formulations. 0591 1 Q Okay. And, excuse me, after that I forgot -- 2 it's the HALO-Guard? 3 A POLY-Guard. 4 Q POLY-Guard FG-2. 5 A Correct. 6 Q What does the FG stand for in the name. 7 A Food-grade. 8 Q What does the 2 stand for? 9 A 2 refers to the NLGI grade, which stands for 10 National Lubricating Grease Institute, and has to 11 do with the penetration of the grease, basically 12 the hardness. 13 Q All right. And so Kraft started to purchase this 14 product with the new formulation? 15 A Correct. 16 Q Had you started calling it Micronox at that 17 point? 18 A No. 19 Q Did you have any other marketplace for it? I 20 mean, at that particular time, any other 21 customers? 22 A Well, POLY-Guard FG-2 had other marketplaces. 23 Q Right. Right. 24 A And so we decided to incorporate that technology 25 into POLY-Guard FG-2. 0592 1 Q All right. 2 MR. MCILNAY: Your Honor, I know 3 we've gone a little bit later the last couple of 4 days, but it is noon, and this would be a great 5 point to break, if we would come back at one. 6 JUDGE GUNNING: Okay. How long do 7 you anticipate with this witness overall? 8 MR. MCILNAY: Overall, maybe another 9 hour possibly. 10 JUDGE GUNNING: Okay. EPA, any 11 objection to breaking now for lunch? 12 MS. O'MEARA: Absolutely not. 13 JUDGE GUNNING: Okay. Very good. 14 MR. MCILNAY: Thank you. 15 JUDGE GUNNING: And we'll return here 16 at 1:00 o'clock. 17 MR. MCILNAY: That would be great. 18 (A recess was taken.) 19 JUDGE GUNNING: I'll just remind the 20 witness that you're still under oath. 21 THE WITNESS: Yes. 22 JUDGE GUNNING: Okay. 23 MR. MCILNAY: And may I ask the court 24 reporter to read back the last question and 25 answer. 0593 1 (The question and answer were read.) 2 BY MR. MCILNAY: 3 Q Mr. Peter, in the interest of keeping this 4 moving, could you turn to Complainant's 5 Exhibit 35? It should be in one of the white 6 binders. 7 MR. MCILNAY: May I approach? 8 JUDGE GUNNING: Yes. It's in Volume 9 2. 10 MS. O'MEARA: I'm sorry. What 11 exhibit, Counsel? 12 MR. MCILNAY: Complainant's 13 Exhibit 35. 14 MS. O'MEARA: Thank you. 15 MR. MCILNAY: If I'm not mistaken -- 16 I'm sorry. I don't show that is offered and 17 received but I could have just been -- 18 MS. O'MEARA: It was stipulated to. 19 MR. CHA: I believe that's correct. 20 MR. MCILNAY: That's probably why. 21 Okay. 22 JUDGE GUNNING: Okay. Respondent's 23 Exhibit 32 or Complainant's? 24 MR. MCILNAY: Complainant's. 25 JUDGE GUNNING: 32? 0594 1 MR. CHA: 35. 2 JUDGE GUNNING: 35. Okay. 3 BY MR. MCILNAY: 4 Q Mr. Peter, let me direct you specifically to EPA 5 0730. That's the little Bates stamp number at 6 the bottom of the page. Are you at that page? 7 A Yes, I am. 8 Q Okay. You generally recognize this as a 9 trademark application filed on behalf of Behnke 10 for the Micronox name? 11 A Yes. 12 Q Okay. And on the page that I reference, 730, 13 there is an indication that the first use of the 14 mark in commerce was October 19, 2001. 15 A Yes. 16 Q Is that consistent with your recollection as to 17 the time frame in which Behnke began to use the 18 term Micronox? 19 A Yes. 20 Q All right. Could you -- I know it's difficult, 21 but you're speaking very quietly -- if it's 22 possible to pull the mike closer to you. 23 I want to focus on the October 19, 24 2001, time frame. At that point in time, was 25 this technology incorporated in all of Behnke's 0595 1 food-grade lubricants? 2 A I don't think so. I don't remember. I think it 3 was somewhat later than that that we got it in 4 all of them. 5 Q All right. And just so the record is clear, when 6 I use food-grade, I am referring to H1 designated 7 lubricants? 8 A That's fine. 9 Q Okay. At any time since October 19, 2001, or at 10 any time from the beginning of time, has Behnke 11 used the technology that's referred to as 12 Micronox in any non H1 lubricants? 13 A No. 14 Q Now, Complainant's Exhibit 35, just above the 15 date there is a subheading for Goods and 16 Services. Do you see that? 17 A Yes. 18 Q And there's a statement that those Goods or 19 Services are antimicrobial additives for 20 industrial lubricants and greases. Do you see 21 that? 22 A Yes. 23 Q Okay. Is that your language, sir? 24 A Yes. 25 Q Okay. Now, I'd like to direct your attention to 0596 1 EPA 0734. What is that document, sir? 2 A Appears to be a label for a 400-pound drum. 3 Q Of what? 4 A JAX Proofer Chain Oil. 5 Q And what is Proofer Chain Oil? 6 A It's an oil -- 7 Q Let me ask you this. Is it a food-grade 8 lubricant? 9 A Yes. 10 Q And it indicates that on the label; is that 11 correct? 12 A Yes. 13 Q What is the next page, for the record, EPA 0735? 14 A It is a product data sheet for POLY-Guard 15 greases. 16 Q And generically, generally, what is a product 17 data sheet? 18 A It's a description of the product and its 19 inherent characteristics for sales purposes. 20 Q And you anticipated my next question. How is it 21 used? I understand it's for sales purposes, but 22 how is it used in your business? 23 A Basically to introduce the product to a potential 24 customer. 25 Q And do you do mass mailings of these or -- 0597 1 A No, I don't believe we've done mass mailings of 2 these at any time. 3 Q Page 0736, can you identify what that document 4 is? 5 A Again, it's a drum sticker for a 400-pound drum 6 container. 7 Q Is this the same as the prior? 8 A Appears to be the same label. 9 Q Okay. And 0737, what document is that? 10 A Another product data sheet. 11 Q I'm going to skip -- what product? 12 A POLY-Guard Greases. 13 Q Okay. You've been in the courtroom this entire 14 hearing, and you've seen a number of the product 15 data sheets blown up, and various witnesses asked 16 questions about concerns they might have about 17 statements made in those product data sheets. 18 A Yes. 19 Q And let's turn to EPA 0739. 20 A Okay. 21 Q Are you there? This is a POLY-Guard grease? 22 A Yes. 23 Q I want to direct your attention to the statement 24 in the upper left-hand corner above Benefits, 25 where it begins, Now, for the first time a 0598 1 food-grade lubricant. Do you see that? 2 A Yes. 3 Q All right. This was submitted to the Patent and 4 Trademark Office in 1991. Subsequent to that, 5 have your product data sheets changed? 6 A Yes. 7 Q Do your current product data sheets include that 8 language? 9 A They would not include that language, to the best 10 of my knowledge. 11 Q For any of the products at issue in this case? 12 A To the best of my knowledge, no. 13 Q And can you tell the Court why that is? 14 A Why they don't include that language? 15 Q Yes. 16 A Well, they don't include that language because of 17 the threat of the EPA action. 18 MS. O'MEARA: Objection, Your Honor, 19 as to the characterization of, threat. 20 MR. MCILNAY: Let me back up and 21 let's take it a step at a time. All right. 22 BY MR. MCILNAY: 23 Q At some point in time, subsequent to October 24 of 2001, did anyone approach you about a concern 25 they had with this language? 0599 1 MS. O'MEARA: Your Honor, I'm sorry. 2 Could the court reporter repeat that question? I 3 apologize. 4 (The question was read.) 5 MS. O'MEARA: Thank you. 6 THE WITNESS: I was approached with a 7 concern about the language on our labeling by 8 NSF. 9 BY MR. MCILNAY: 10 Q All right. And NSF is the nongovernmental 11 organization -- 12 A Correct. 13 Q -- doing the H1 certifications? 14 A Doing their H1 certification. 15 Q And do you recall approximately when Behnke was 16 first approached with a concern about labeling 17 relative to the H1 products? 18 A I would say it was probably sometime in 2003. 19 Q All right. And initially I want you to tell the 20 Court what the concern was that was conveyed to 21 you. 22 A The concern was conveyed to me that they thought 23 that this would be -- possibly run amuck of some 24 EPA pesticide concerns. 25 Q All right. And what, if anything, did you do in 0600 1 response to that contact? 2 A I asked them if we could meet and discuss that, 3 because we did not feel it did, based on the type 4 of product it was. 5 Q And before we get to the meeting, at that time, 6 approximately 2003, it was your understanding or 7 your belief that it didn't run amuck of -- 8 A It wasn't my belief. But we used FDA guidelines, 9 so the crossover to EPA was very limited when we 10 did our study of what we could say and what we 11 couldn't say. 12 Q What study are you referring to when you say, 13 what we could say and what we couldn't say? 14 A Well, back up a little bit. When we decided we 15 had what was a pretty neat technology here to 16 help food processors, we discussed it, and said, 17 is there a way to incorporate it in more 18 products, and is there a way to promote it as a 19 benefit to the processing plants? So we did our 20 own efficacy studies, and continue to do some -- 21 not in-house, but we sent those out -- and to 22 reconfirm that we had something that was actually 23 doing something. And then we did studies of the 24 FDA documentation to see what we thought we could 25 and couldn't say. 0601 1 Q When you say we -- 2 A Troy Paquette. We as a company, Troy Paquette 3 primarily, and I, doing some research on what we 4 may or may not say in terms of the ability of the 5 Micronox to help these plants control some 6 bacteria. 7 Q And I want to make it clear. You personally 8 participated in the review of that information? 9 A Yes. 10 Q All right. And is it fair to assume that within 11 Behnke you were the ultimate decision maker as to 12 what you were going to say and not say? 13 A Yes. 14 Q None of this could have occurred without your 15 prior approval? 16 A I would take responsibility for it, but things 17 happen that I'm not always aware of. But in this 18 case, I was aware of the language. 19 Q Okay. So that was the mind-set with which you 20 left, or you requested the meeting with NSF in 21 approximately 2003? 22 A No. And 2003 may not be an accurate date. It 23 may have been 2004, because the meeting we had 24 was in 2005. So there might not have been red 25 flags sent up on any of this stuff until 2004, 0602 1 because I don't think the lag time between when 2 we started having issues on the labeling was that 3 long before I requested a meeting with NSF. 4 Q Okay. Now, I want you to put yourself back in 5 2004. You used the term labeling. How did you 6 understand that term then? 7 A Well, customarily in the trade and with any 8 documentation that we sent in to USDA, FSIS for 9 approvals, when we sent a label, we sent 10 something very similar to what you showed in EPA 11 0738. It's what is applied to the container. 12 Q All right. Was it in your mind that it would 13 include the product data sheets? 14 A No. 15 Q So you requested a meeting with the NSF to better 16 understand what the concern was? 17 A Yes, because they had started to raise issues 18 with what we were claiming on our labels. 19 Q All right. And did such a meeting take place? 20 A Yes. 21 Q Approximately when? 22 A Approximately May 23, 2005. 23 Q All right. And where did the meeting take place? 24 A I personally was in Ann Arbor, Michigan, and Troy 25 Paquette was on the speaker phone back at our 0603 1 office. 2 Q All right. And was there somebody from NSF in 3 attendance? 4 A There were, I believe, four people in attendance. 5 Q All right. And do you remember who from NSF was 6 the person that was in authority, I guess? 7 A The person who was most concerned with this 8 situation was a Dr. Kenji Yano. 9 Q All right. And to avoid objections as to 10 hearsay, when you left the meeting, did you have 11 a better -- or did you have an understanding of 12 what NSF's concerns were at that point? 13 A I had an understanding, but we basically left the 14 meeting agreeing to disagree. 15 Q All right. Did you have further communication 16 with NSF concerning what you understood to be 17 labeling concerns? 18 A I don't remember. There may have been some 19 further communication. NSF had further 20 communication with us as a company. Whether I 21 had much more direct further communication, there 22 was some, limited, but nothing that sticks in my 23 mind like that particular meeting. 24 Q All right. At some point after your meeting in 25 Ann Arbor, did Behnke take any action relative to 0604 1 its labeling because of the NSF issue? 2 A Yes, and I think we had taken some action even 3 before that because of some of the issues they 4 had raised. So we were starting to pare back the 5 claims that we made in the labeling. 6 Q Okay. And, again, at that point in time, when 7 you refer to labeling, your understanding -- 8 A It's on the package. 9 Q All right. So that didn't necessarily mean 10 that's when you pared back on collateral 11 literature? 12 A No, no. Because -- well, in the submissions that 13 we would make for these products, they would ask 14 for a label, and that's what would be sent to 15 them. So they wouldn't necessarily even have 16 seen collateral stuff either. And that's -- the 17 label is the label. 18 Q Okay. You have to be careful. I understand you 19 don't do this every day. When we go back at the 20 record, it's -- you are referring to they, but 21 who are you referring to? 22 A I'm sorry. NSF. 23 Q So as part of the standard H1 certification 24 process, you would submit labels to NSF? 25 A Correct. 0605 1 Q And that, at that point in time, is the only 2 documentation they had? 3 A Correct. 4 Q After you made the changes that you've 5 described -- paring back I think was the language 6 you used -- on the claims in the labels, were 7 there any additional issues raised by NSF? 8 A Well, I believe there were two or three issues 9 raised by NSF sequentially that caused us to 10 change the labeling and make changes. One of 11 them was changing our claims about killing what 12 we believed were microorganisms on food or in the 13 food to saying -- telling our people that all we 14 could say was that we're protecting our product. 15 In hindsight, that was not the best advice to be 16 given to us or for us to heed. 17 Q If you recall, at any point in time did NSF raise 18 a concern with collateral literature other than 19 the product label? 20 A Not that I'm aware of. 21 Q The Ann Arbor trip, was that your last meeting 22 with Dr. Kenji Yano? 23 A No. 24 Q Did you have a subsequent meeting with Dr. Yano? 25 A I met with Dr. Yano in the fall, in October 0606 1 of 2005. 2 Q And where did you meet? 3 A I met at a trade convention that I attended in 4 Orlando, Florida. 5 Q All right. Was the purpose of the trip to meet 6 with Dr. Yano? 7 A The purpose of the trip was to attend a trade 8 meeting, a portion of that trade meeting that was 9 being given by Dr. Yano and also Mr. Edwards 10 regarding food-grade lubricants and, you know, 11 antimicrobials. 12 Q So you chose to attend this without the specific 13 intent of meeting Dr. Yano? 14 A Without the specific intent. More the specific 15 intent of, to hear what they were going to say. 16 Q All right. And was this in the nature of a 17 conference then? 18 A In the nature of a conference and a presentation 19 at that conference. 20 Q And who was the sponsor of the conference? 21 A The group is called ILMA, it's Independent 22 Lubricant Manufacturers Association. 23 Q During that trip, did you have occasion to meet 24 individually with Dr. Yano? 25 A I met individually with Dr. Yano and also with 0607 1 Dr. Yano and Mr. Edwards. 2 Q At the same time? 3 A At the same time -- at one point at the same time 4 they were together, yes. 5 Q All right. And was that part of the conference, 6 or was that something that you gentlemen arranged 7 once you were down there? 8 A It was subsequent to the presentation. 9 Q All right. Is this a meeting you requested? 10 MS. O'MEARA: Your Honor, I'm going 11 to object. Just to make the record clear, this 12 certainly was not disclosed in any of Mr. Peter's 13 prehearing exchange summaries or the declaration 14 that was submitted. So this is the first time we 15 are hearing this, and it was never discussed with 16 us. 17 MR. MCILNAY: Your Honor, I guess 18 I -- if my interpretation of the prehearing 19 exchange is not consistent with the practice, and 20 I have done Rule 26 exchanges in federal court. 21 I believe we provided a summary of what we 22 anticipated he would testify to, including the 23 history of NSF issues and its use -- the use of 24 this product, the evolution of the use of this 25 product in the industry generally. My 0608 1 understanding is there are opportunities for 2 further discovery that weren't pursued. We would 3 submit that it's very relevant to especially the 4 issue of gravity. 5 MS. O'MEARA: Your Honor, if I may 6 just respond? 7 JUDGE GUNNING: Yes. 8 MS. O'MEARA: Thank you. I want to 9 draw a distinction between Rule 26 and what the 10 administrative practice here is and the fact that 11 discovery and deposition rules are very different 12 between the two. I'm looking at the summary 13 right now. It consists of nine lines. And I'm 14 looking at the declaration right now, and it does 15 not consist of this conversation. And I just 16 want the record to be clear that this is the 17 first time we're hearing it. 18 And I also take exception to the fact 19 that I was given an opportunity to get additional 20 discovery. We asked for discovery through a 21 voluntary process. We renewed it, and we renewed 22 it, and then we filed a motion to compel. And we 23 asked for any documentation, any communication 24 with the EPA, USDA, FDA and NSF, and did not get 25 this information. 0609 1 JUDGE GUNNING: Okay. The objection 2 is noted. 3 MS. O'MEARA: Thank you. 4 JUDGE GUNNING: But it is overruled. 5 MR. MCILNAY: Would you read the 6 question back? 7 (The question was read.) 8 THE WITNESS: It was a meeting that 9 resulted from me being present at the end of the 10 presentation and the fact that I knew Dr. Yano 11 from a previous meeting. 12 MS. O'MEARA: I'm sorry. I couldn't 13 hear you, Mr. Peter. 14 THE WITNESS: It was a meeting that 15 resulted from my being present after the 16 presentation and from my previous knowledge 17 and -- of knowing Dr. Yano. 18 BY MR. MCILNAY: 19 Q Approximately how long did the three of you meet? 20 A Less than an hour. 21 Q What was the topic of your conversation? 22 A Well, the topic of my conversation was their 23 continuing opinion that the antimicrobial 24 properties that would be imparted into food-grade 25 lubricants would have to be FIFRA registered. 0610 1 Q All right. And subsequent to that meeting, did 2 you take any action to address further concerns 3 regarding your labeling? 4 A Well, we had already gone through two or three 5 generations of labeling changes at that point in 6 time. My further concerns revolved around the 7 fact that we had EPA making decisions on 8 FDA-regulated products in what I thought was a 9 fairly arbitrary manner with no FDA involvement. 10 Q Did you just ignore those concerns that were 11 raised by -- 12 A No. We continued to research FDA and try and see 13 if there was a reason for us to continue to have 14 concern on this. 15 Q All right. Now, ultimately -- let me ask you to 16 turn to Complainant's Exhibit 37, I believe. And 17 more specifically -- 18 MR. MCILNAY: Am I wrong? Is there 19 more than one copy of this in the record? Is 20 there another -- 21 MS. O'MEARA: Yes, because it -- if I 22 may, Your Honor? 23 JUDGE GUNNING: Yes. 24 MS. O'MEARA: Because it was moved 25 from state to federal court, so we obtained both 0611 1 copies, not knowing what we were getting. 2 MR. MCILNAY: Okay. Actually if you 3 can help me, which one have we -- 36. 4 MS. O'MEARA: I have referred to the 5 complaint as 36, but it's the identical 6 complaint, I believe, that's in 37, just moved to 7 federal court. 8 MR. MCILNAY: I agree. 9 BY MR. MCILNAY: 10 Q For consistency purposes and because it's been 11 referred to in the record already, could you turn 12 to Exhibit 36 instead? 13 MS. O'MEARA: Mr. McIlnay, they both 14 have been stipulated to. 15 MR. MCILNAY: I understand. But I'm 16 just thinking somebody reading the transcript 17 doesn't have to look back. 18 MS. O'MEARA: That's fine. 19 BY MR. MCILNAY: 20 Q Mr. Peter, this is a copy of a court record in 21 the United States District Court for the Eastern 22 District of Wisconsin. And I want to direct your 23 attention most directly to EPA 0750, and that 24 single document entitled a Complaint runs up 25 through EPA 0760. Would you take a few moments 0612 1 to review that document silently to yourself. 2 Have you had a chance to review that 3 at least briefly? 4 A Briefly. 5 Q This is a lawsuit that was filed on behalf of 6 Behnke Lubricants? 7 A Correct. 8 Q Is it fair to assume that within Behnke, you were 9 the person who made the ultimate decision that 10 you were going to authorize your counsel to 11 proceed with this lawsuit? 12 A Yes. 13 Q And prior to the filing of the lawsuit, were you 14 given an opportunity to review this complaint? 15 A Yes. 16 Q Feel free to refer back to the allegations in the 17 complaint if you need to refresh your 18 recollection. But can you tell the Court -- 19 strike that. Your decision to file this 20 litigation, was it a business decision? 21 A Yes. 22 Q What motivated you to make the decision you did 23 to file this action? 24 A Well, during the time that NSF was requesting us 25 to make label changes, we complied early on 0613 1 without much fuss. As the label changes that 2 they were requesting got more and more 3 restrictive, we fussed a little bit. But in the 4 summer of 2005, they threatened to pull our 5 approvals if we didn't make the label changes 6 that they requested. 7 Q Was there a specific change that they requested 8 that was the straw that broke the -- 9 A Well, they had requested that we make the change 10 to more of the treated article language. And 11 then subsequent to that, they had requested and 12 demanded that we remove that language. And then 13 subsequent to that, they insisted we remove just 14 the word even Micronox. 15 Q And in that regard, can you review Paragraph 19 16 on Page 0756, which alleges that in or about 17 June, 2005, NSF -- pardon the characterization -- 18 pressed Behnke further and demanded that Behnke 19 remove all reference to Micronox in connection 20 with any products certified by NSF. Does that 21 refresh your recollection as to when that -- 22 A Yes. 23 Q -- occurred? 24 A Yes. 25 Q And -- 0614 1 MS. O'MEARA: I'm sorry. 2 Mr. McIlnay, what paragraph is that? 3 MR. MCILNAY: 19. 4 MS. O'MEARA: Thank you. 5 BY MR. MCILNAY: 6 Q If I can use a colloquialism, is that the straw 7 that broke the camel's back at that point? 8 A Yes, it was. 9 Q Up until that point in time -- well, let's go 10 back a moment, back to the EPA 0750. On the 11 first page there is a stamp over the caption 12 of -- happens to be this circuit court of January 13 13, 2006. Is that consistent with your 14 recollection as to when the suit was first filed? 15 A Yes. 16 Q Up until January 13, 2006, other than the meeting 17 that you previously described, discussed in 18 Florida where Mr. Edwards was present, had you 19 had any contact with anyone from EPA? 20 A No. 21 Q Let me ask you then to turn to Complainant's 22 Exhibit 2, which should be in Volume I. Would 23 you take a moment to review that? 24 A Okay. 25 Q What is exhibit Complainant's Exhibit 62 -- or I 0615 1 mean 2. 2 A Notice of Intent to File a Civil Administrative 3 Complaint against Behnke Lubricants. 4 Q And to whom is it addressed? 5 A Addressed to me. 6 Q What is the date? 7 A December 22, 2006. 8 Q And did you, in fact, receive a copy of that 9 document through the United States mail sometime 10 within the time period of December 22nd? 11 A Yes. 12 Q Let me ask you to turn one exhibit back to 13 exhibit, Complainant's CX 1. And specifically 14 could you refer to EPA Page 4. And, Mr. Peter, I 15 would like to direct your attention -- you can 16 read it silently to yourself -- the first 17 paragraph at the top of that page. Have you had 18 a chance to review that? 19 A Yes. 20 Q Okay. From the time of your brief meeting with 21 Mr. Edwards in Florida to October of 2006, had 22 you been contacted, or to your knowledge had 23 anyone at Behnke been contacted by the 24 Environmental Protection Agency relative to 25 Micronox? 0616 1 A No. 2 Q And what happened -- I understand you can read 3 this -- but what happened to the best of your 4 recollection at your meeting on August 11, 2006? 5 Who was present? 6 A I thought he was a representative of the 7 Wisconsin DNR. Through his testimony, it's 8 obvious he was with another agency, probably the 9 agricultural agency in Wisconsin. But we had a 10 meeting, and he just pretty much simply mentioned 11 that he had been requested to come in and collect 12 some information for EPA. 13 Q Okay. Did you have any particular conversation 14 as to -- 15 MS. O'MEARA: Excuse me, Your Honor. 16 Someone just walked into the courtroom, and if 17 this person is a witness, that they are to be 18 sequestered. So I just want to get some 19 clarification. 20 MR. MCILNAY: Sure. Actually she is 21 a secretary, paralegal in my office here to 22 deliver some documents. 23 MS. O'MEARA: Thank you. I just 24 wanted to make sure. I didn't know who it was. 25 MR. MCILNAY: For the record, Debbie 0617 1 Phfannerstill, P-H-F-A-N-N-E-R-S-T-I-L-L. 2 MS. O'MEARA: Thank you. 3 MR. MCILNAY: Was the question 4 answered? 5 (The question was read.) 6 BY MR. MCILNAY: 7 Q Let me withdraw that question. Do you recall who 8 you met with on August -- 9 A Yes. I don't recall his name at the moment. 10 Q Was it the gentleman that testified as the first 11 witness in this matter? 12 A Yes, it was. 13 Q At that point in time, did he discuss with you 14 concerns about labeling? 15 A I think at that point in time we had been 16 presented with this -- with his Wisconsin 17 Departmental Agricultural sheet that he had 18 provided us either on that visit or the previous 19 visit. 20 Q All right. I want to focus on your conversation 21 with him. Do you recall having a conversation? 22 A I recall having a brief conversation, but the 23 content of it -- 24 Q You don't recall the details? 25 A I don't recall too much. 0618 1 Q From October 11 -- August 11, 2006, to the date 2 of the correspondence identified as Complainant's 3 Exhibit 2, had you been contacted by anybody from 4 EPA? 5 A No. 6 Q All right. When you received Complainant's 7 Exhibit 2, what, if any, action did you take, 8 other than call me? 9 A That's pretty much it, I think, when something 10 like that shows up. 11 Q All right. Let me ask you. To direct your 12 attention to 0060, it's the second page of 13 Complainant's Exhibit 2. And specifically you 14 see the name and address for Mr. Bonace there? 15 A Yes. 16 Q I want to direct your attention to the last 17 sentence of the previous paragraph where it says, 18 if you wish to have a conference with the EPA. 19 Do you see that? 20 A Yes. 21 Q Did you take advantage of that invitation to have 22 a conference with the EPA? 23 A Yes, we did schedule a conference. 24 Q And do you recall approximately how long after 25 you received this letter your conference with the 0619 1 EPA took place? 2 A I believe it was in February. 3 Q Of -- 4 A Of 2006 -- or 2007. 5 Q Thank you. 6 A Okay. 7 Q And the conference took place at the EPA's 8 regional offices in Chicago? 9 A Correct. 10 Q All right. And in attendance were you, myself, 11 another attorney in my office, Mr. Paquette, 12 Attorney O'Meara and Mr. Bonace, correct? 13 A To the best of my recollection. 14 Q Walking into that meeting, did you have an 15 understanding as to what the terminology, 16 labeling, meant? 17 A I had my understanding. 18 Q What was your understanding prior to that 19 meeting? 20 A It was the label applied to any of our packaging. 21 Q All right. Is it fair to say that you were made 22 aware at the meeting that the EPA considered 23 collateral documentation in addition to strictly 24 the paper put on your -- 25 A I was made aware that their lasso was a lot 0620 1 bigger than what typical industry practices would 2 be. 3 Q All right. And after that meeting, did you take 4 any steps to address concerns about language in 5 collateral material? 6 A Yes, we did. 7 Q And I know that specific dates and so on may be 8 difficult to recall, but generally what action 9 did you take? 10 A Well, we tried to bring the labeling more in line 11 with what NSF's original recommendations were, or 12 the -- let me correct that. We tried to bring 13 the other documentation, product data sheets, so 14 forth, more in line with what NSF had requested 15 us to do in the early changes they had requested 16 on the labeling. 17 Q All right. Such as? 18 A Such as removing references to specific 19 pathogens, such as acting more in terms of that 20 we were protecting the lubricant itself instead 21 of, you know, pathogens on food, processed food. 22 I felt that I needed a clarification, having FDA 23 involved in this clarification process, and 24 hadn't gotten that, so quite personally I 25 resisted making Draconian changes to our product 0621 1 data sheets, but we did make changes. 2 Q What about the references to Listeria, 3 Salmonella, E. coli in the -- that had been in 4 the -- 5 A I believe most of that was purged. 6 Q Okay. Let me step back a moment because you kind 7 of alluded to this before, but what was the 8 rationale in your mind -- back up. Let me go 9 through the foundation. With regard to those 10 product data sheets, did you have the last say as 11 to the language that was actually put in those? 12 A For the most part they would cross my desk for 13 signoff. Sometimes in -- for expediency cases, 14 I'm not always available, and they don't, but 15 usually they would. 16 Q Let's be very specific with reference to E. coli, 17 Listeria and Salmonella. 18 A Yes. 19 Q You signed off on that language? 20 A Yes. 21 Q When you did that, what was your rationale for 22 referencing those particular organisms? 23 A You're backing the calendar up a little bit to 24 the point where we wanted to -- when we 25 discovered that we had something that not only 0622 1 meant FDA guidelines, but provided an additional 2 benefit, much like increased rust protection or 3 better anti-wear or something like that, that 4 would be a benefit to our end customers, met the 5 formulation guidelines, and we wanted to promote 6 it and use it as a sales tool. That's what we 7 were in business for, is to sell product. We -- 8 being Troy Paquette and I -- discussed the 9 ramifications of the labeling. Troy was somewhat 10 aware from his past employment of EPA and some of 11 the testing regarding -- I think at that point it 12 was chemical fertilizers or something like that, 13 and the extensive and extremely expensive 14 processes to go through to get those types of 15 approvals and the subsequent possible state 16 approvals, the different things that were needed. 17 So we took the tact that we would, at all costs, 18 do our best job to avoid language that would 19 implicate us in FIFRA labeling and try and stay 20 within the language that was given to us in the 21 FDA guidelines. 22 Q All right. Other than expense and time 23 consumption, and I think the other issue you 24 raised concerning Mr. Paquette was involving 25 individual states, did you have any other 0623 1 concerns about pursuing EPA registration of 2 either your lubricant products or any additives? 3 A We were very concerned that these being 4 food-grade products would then have to carry some 5 type of EPA registration number, insignia, logo 6 or something indicating that these products 7 contained an EPA pesticide. 8 Q I'm going to jump back to the meeting that we had 9 in February of 2007 with the EPA. Did you do 10 further investigation subsequent to that meeting 11 to consider registration under FIFRA of either 12 the additive or the lubricants themselves? 13 A Yes, we did. 14 MS. O'MEARA: I'm sorry. I need that 15 last part -- 16 JUDGE GUNNING: Right. And if you 17 could just not trail off at the end. 18 MR. MCILNAY: I'm sorry. 19 (The question was read.) 20 THE WITNESS: Yes, we did. 21 BY MR. MCILNAY: 22 Q Okay. Did you choose to pursue registration of 23 Micronox, an additive or the lubricant? 24 A No, we did not. 25 Q Why not? 0624 1 A Well, we felt that based on the food-grade, food 2 additive nature of the product that we were 3 putting out, it still would fall under the 4 auspices of FDA. We felt that if we had a label 5 on these products as would be required indicating 6 a pesticide was incorporated into the 7 formulation, it would be shooting ourselves in 8 our foot regarding marketing these products. 9 Q Now, did you take any action to investigate 10 whether or not your concern about shooting 11 yourself in the foot had any validity? 12 A Yes. We did a market study with our salespeople 13 to talk to customers to see if that was going to 14 be a concern. And it was a concern. 15 Q And as you understood the concern, what was it? 16 A Well, if I can use a hypothetical, we have a 17 contamination incident at a food processor, we 18 have litigation in process with the injured 19 parties, and the attorney notes that the 20 food-grade lubricants that they were using in the 21 processes were also containing an EPA-registered 22 pesticide, that's -- with the concerns of food 23 safety these days, it wasn't a risk they were 24 willing to take. 25 Q Okay. At the meeting in Chicago, were you made 0625 1 aware that a competitor, if I will -- well, 2 strike that. Do you know who Petro Canada is? 3 A Yes. 4 Q Are they a competitor in food-grade lubricant 5 market? 6 A Yes, they are. A recent competitor. 7 Q What? 8 A A recent competitor. 9 Q And were you made aware that they had had, in 10 fact, pursued registration of an additive known 11 as benzoic acid? 12 A I was made aware of that at the meeting in 13 Chicago. 14 Q All right. Even with that knowledge, you were 15 concerned about market acceptance of a product 16 containing EPA-registered pesticide? 17 A Yes. 18 Q Now, I know that you may not have all of the 19 details as to the timing, but as we sit here 20 today, to the best of your knowledge, does any of 21 Behnke's labeling as you understand it, product 22 labels that are currently being sold, newly 23 shipped, contain any claim to the antimicrobial 24 other than the name Micronox? 25 A I can't be absolutely certain that none of the 0626 1 labels as I understand them contain any reference 2 to the word antimicrobial. But beyond anything 3 much like that, I would not think there would be 4 much language beyond that, other than the word 5 Micronox. 6 Q Was it at least your intent and attempt to make 7 sure that was the only reference? 8 A Yes. 9 Q By the way, when the greases are manufactured by 10 another party, where does the labeling of the 11 greases take place? 12 A Typically at our facility. 13 Q All right. To the best of your knowledge, as you 14 sit here today, do any of your material data 15 sheets make any references to antimicrobial 16 properties, other than the name Micronox? 17 A To the best of my knowledge, no. And most of 18 them probably would not even mention the name 19 Micronox. 20 Q To the best of your knowledge, as you sit here 21 today, do any of your advertisements that are 22 paid advertising in media make reference to 23 antimicrobial properties in your food-grade 24 lubricants, other than maybe the name Micronox? 25 A No. 0627 1 Q They do not? 2 A They do not. 3 Q Okay. While we're on that subject, are you the 4 person at Behnke that makes the decisions as to 5 where print media advertising will be placed? 6 A Yes. 7 Q And other than print media advertising, does 8 Behnke engage in any other form of advertising, 9 television, radio, that sort of thing, regarding 10 its food-grade lubricants? 11 A No. 12 Q And let's take the period of time since you came 13 up with -- go ahead. 14 A I might correct that. We do attend trade shows, 15 so if that's considered advertising. 16 Q Let's deal with those separately. I'll come back 17 to those. Okay. The period of time, roughly 18 October of 2001, when you first used the term 19 Micronox in commerce according to the Patent and 20 Trademark application, to today's date, what 21 types of media have you placed ads in? 22 A Trade publications and trade shows. 23 Q Okay. And in particular, is there a particular 24 type of trade publications that you choose? 25 A Regarding food-grade products? 0628 1 Q Food-grade lubricants. 2 A Regarding food-grade lubricants, it would be food 3 processing type of -- types of publications. 4 Q Can you give us some examples of those? 5 A Food Engineering, I believe there is one called 6 Meat and Poultry. There are only a handful of 7 them that we utilize, but I don't know all their 8 names right now. 9 Q Okay. Now, are you also the person at Behnke 10 that's ultimately responsible for how your 11 advertising dollars, your advertising budget -- 12 A Yes. 13 Q -- is going to be used? Why do you choose those 14 particular publications? 15 A Well, because they're in the vertical market that 16 we're trying to sell the products into. 17 Q All right. Let's go back then to the trade 18 shows. And all of these questions deal with 19 food-grade lubricants. 20 A Okay. 21 Q Which as I stated earlier, means H1. 22 A Okay. 23 Q What -- from the period of roughly October, 2001 24 to today's date, what sorts of trade shows did 25 Behnke attend to promote those food-grade 0629 1 lubricants? 2 A They would be regional and/or national food 3 processing related trade shows, whether equipment 4 related or regional shows for affiliated 5 associations within those regions. 6 Q All right. And is it common for your 7 representatives to these trade shows to take 8 literature about Behnke's food-grade lubricants? 9 A Yes. 10 Q Since our meeting in Chicago in February of 2007 11 with the EPA, have you made any efforts to make 12 sure that that literature makes no references to 13 the antimicrobial properties, other than perhaps 14 the name Micronox? 15 A Well, again, we've made efforts to purge as much 16 of the offensive, to EPA, language out of there, 17 but I believe that there is probably still some 18 reference to the word antimicrobial. 19 Q All right. Finally, we've heard testimony 20 earlier in the case about the EPA's investigation 21 of JAX's web site. 22 A Uh-huh. 23 Q Is that a yes? 24 A Yes. Sorry. 25 Q Mr. Peter, who developed your web site? 0630 1 A I don't remember. 2 Q Okay. 3 A It's pretty old. We have a meeting next week to 4 update it. 5 Q All right. Who within Behnke, if anyone, is 6 responsible or has the ability to update the web 7 site? 8 A In the past, I did. I have another person in the 9 office who can make changes to it now. 10 Q Okay. And at what point in time did the other 11 person come on board? 12 A She's been able to make web page changes probably 13 for the last two to three years. 14 Q All right. Subsequent to the meeting with the 15 EPA in Chicago in February of 2007, did you 16 personally make any effort to make changes to 17 Behnke's web site? 18 A I may have either personally made efforts to make 19 those changes or personally directed that those 20 changes be made. 21 Q What was your intent in making those changes? 22 A To remove language that the EPA considered 23 offensive. 24 Q All right. Now, we heard testimony from 25 Mr. Bonace that as early as Monday of this 0631 1 week -- as late as Monday of this week, and he 2 read them into the record, certain statements 3 contained in portions of your web site. Do you 4 recall that? 5 A Yes, I recall. 6 Q And you don't disagree that those were there? 7 A No. 8 Q What did you do after you heard that on Monday? 9 A I left a voice mail Monday night, and went into 10 the office Tuesday morning and made sure they got 11 changed, because we missed them. 12 Q Let me ask you, did you direct your web site 13 person to specifically leave those claims on your 14 web site? 15 A No, I did not. 16 Q Was it your intent that all of the claims be 17 removed? 18 A Yes. 19 Q Subsequent to the meeting in Chicago, did you 20 make any attempt to retrieve literature that had 21 previously been distributed to customers or 22 potential customers that made claims that have 23 been complained about at the hearing today? 24 A No. 25 Q Why is that? 0632 1 A Because I felt like the ball was still up in the 2 air. We hadn't reached a decision regarding 3 where we stand on this. We have no opinion from 4 FDA. We have no opinion from -- we have EPA's 5 opinion, but we have no opinion from the agency 6 that governs our products. That's part of the 7 frustrating part of this whole process. 8 Q All right. You also market some products that 9 are private -- I mean, you manufacture products 10 that are private labeled? 11 A Yes. 12 Q And one of those private labels is FMC. Do I 13 have the name right? 14 A Correct. 15 Q And, for the record, can you describe what that 16 means when something is private labeled? 17 A Companies will have us relabel our products under 18 their name and their brand name so they may sell 19 them through their parts distribution or use them 20 on their equipment as the OEM build it, and then 21 recommend that those products of theirs be used 22 subsequently on their equipment in the field. 23 Q Okay. You used the term OAM. 24 A OEM. 25 Q OEM, what does that mean? 0633 1 A That means original equipment manufacturer. 2 Q Okay. So the concept is that to their consumers, 3 this appears to be their product, they've put 4 their label on it? 5 A Correct. 6 Q How much, if any, input does Behnke have into the 7 content of its private label customers, what they 8 put into their labels? 9 A We generally don't have any input, per se, but 10 we'll supply them with the labeling that we use. 11 Q All right. Do you actually put the labels on 12 their products in your plant? 13 A Yes. It goes out the door as their product. 14 Q All right. What steps, if any, did you take 15 subsequent to our meeting with EPA in February 16 of 2007, to address claims that might be made on 17 a private labeled product? 18 A With FMC, I didn't take any steps with their 19 labels because I don't necessarily control their 20 labels, but I told them about the concerns that 21 EPA had raised regarding Micronox and that they 22 may want to make -- I didn't even ask them to 23 make it. I said, be on call to hear if some 24 changes have to be made regarding those labels. 25 Q Did you advise FMC that you had received an EPA 0634 1 notice of intent to file an action? 2 A It has come up, and they are aware of it. 3 Q Do you have other private label customers besides 4 FMC? 5 A Yes. 6 Q Are any of them private label customers for the 7 H1 products? 8 A Some are. I would say FMC is the largest. 9 Q Have you notified other private label customers 10 of the fact that you received a notice of intent 11 to file a complaint regarding labeling issues? 12 A Likely not. 13 Q Have you kept it a secret? 14 A No. 15 Q Have you made a conscious effort to contact any 16 of those people to discuss labeling? 17 A No. 18 Q You also have a distribution network of 19 distributors. Are these parties employees of 20 JAX, employed by JAX? 21 A No. Our distributors are not employed by JAX, 22 no. 23 Q All right. Are they independent business people? 24 A Yes. 25 Q All right. What communications have you had with 0635 1 distributors concerning their continued use of 2 any literature that might be out there that had 3 claims that you were made aware of that -- 4 A Communication would have been similar to what I 5 may have told FMC, that there are some perceived 6 problems with the labeling, and that they should 7 stand by for a resolution. 8 Q All right. A good part of the EPA's case was 9 exhibits concerning visits that Mr. Bonace made 10 to your customers in March, generally, of 2007. 11 Do you recall that evidence and testimony? 12 A Yes. 13 Q All right. Subsequent to March of 2007, have any 14 of those customers that were described in those 15 materials ceased using your products? 16 MS. O'MEARA: Objection, Your Honor. 17 It's immaterial, irrelevant. 18 MR. MCILNAY: Your Honor, I think it 19 goes to the gravity of his state of mind and this 20 market acceptance issue. 21 JUDGE GUNNING: I'll allow it. The 22 probative value that it's accorded, of course, is 23 what is important, but I will allow the question. 24 THE WITNESS: Yes. 25 0636 1 BY MR. MCILNAY: 2 Q And in the interest of brevity, that was 3 Jennie-O's Turkey Store? 4 A Yes. 5 Q That was actually the company visited by the 6 Minnesota Department of Agriculture? 7 A Yes. 8 Q Have you had an opportunity since Monday evening 9 to either confirm for yourself or talk to your 10 web -- whatever title she has -- to see if she's 11 made those changes? 12 A No, I have not. 13 Q All right. In terms of the chemistry of your 14 products and the compliance of that chemistry mix 15 of specific food-grade H1 lubricants, is that 16 Mr. Paquette's responsibility? 17 A Primarily Mr. Paquette's responsibility. 18 Q Is it fair to say you rely on him to make the 19 determination that the product formula comply 20 with the FDA requirement for H1 certification? 21 A Yes, I rely on him, and also our document 22 submission person does a double-check. 23 Q All right. Let's go back then very briefly. You 24 discussed that after you had made the 25 determination to incorporate this technology in 0637 1 other food-grade lubricants, that you had sent 2 the products out for efficacy testing. 3 A Yes. 4 Q The labs that you used, have you used those labs 5 in the past? 6 A Yes. 7 Q And the data that came from that testing, you 8 maintained those data in-house? 9 A Yes. 10 Q Had a customer ever requested to see the data, to 11 your knowledge? 12 A Perhaps. 13 Q Had a customer requested the name and a contact 14 with the lab that actually did the testing -- 15 MS. O'MEARA: I'm going to object, 16 Your Honor. This is hearsay. 17 JUDGE GUNNING: Overruled. 18 BY MR. MCILNAY: 19 Q -- would you have provided it to them? 20 A Yes. 21 Q In fact, did any of your literature talk about 22 which labs had done the testing, if you recall? 23 A No. We had literature published at one point in 24 time that actually had the reports from the 25 laboratories photocopied on it, promotional 0638 1 material. 2 Q With the lab's -- 3 A With the lab's report incorporated into the 4 material. 5 Q I was going to ask, it's letterhead? 6 A Letterhead was on it, yes. 7 Q And when was that? 8 A I don't recall. But, of course, all this is 9 between 2002 and now, but within the last three 10 years. 11 Q Has there been one laboratory that was used or 12 more than one? 13 A Probably a better question for Troy Paquette, but 14 I believe only one. 15 Q That you engaged? 16 A I believe only one. 17 Q All right. I believe your testimony was that 18 Kraft did independent testing. That wasn't the 19 same testing that you referred to? 20 A Correct. 21 Q Are you aware of any other customers who have 22 done independent testing? 23 A I think there are numerous customers that have 24 done independent testing. 25 Q These are food processors? 0639 1 A Correct. 2 MR. MCILNAY: Your Honor, that's all 3 the questions I have for him on direct. 4 JUDGE GUNNING: Okay. How about we 5 take a five, ten-minute break before commencing 6 cross of this witness. 7 MS. O'MEARA: Thank you. 8 JUDGE GUNNING: Okay. 9 (A recess was taken.) 10 MR. MCILNAY: Your Honor, on my break 11 it occurred to me that I had overlooked one 12 document that I wanted to authenticate and offer 13 through this witness. And I spoke briefly with 14 Attorney O'Meara. I can do it from my seat here, 15 if I might. 16 BY MR. MCILNAY: 17 Q Mr. Peter, would you turn to, I believe it's 18 Exhibit 69 in the black books. Do you see that 19 exhibit? 20 A Yes. 21 Q Generally can you describe what is contained 22 within Respondent's Exhibit 69? 23 A It appears to be a series of product data sheets, 24 material data sheets, some trade publication 25 information, NSF approval letters, USDA approval 0640 1 letters, all relating to the products in 2 question. 3 Q And -- 4 MS. O'MEARA: Your Honor, if I may 5 interrupt for a second. I don't have any 6 objection if you want to get these into the 7 record. 8 MR. MCILNAY: Okay. We're just going 9 to offer them. 10 JUDGE GUNNING: Okay. So we're 11 talking Exhibit 69 in its entirety. 12 MR. MCILNAY: RX. 13 JUDGE GUNNING: Yes. Please mark as 14 received Respondent's Exhibit 69. 15 MR. MCILNAY: Thank you. 16 JUDGE GUNNING: Were there any other 17 exhibits? 18 MR. MCILNAY: Not with this witness, 19 Your Honor. 20 JUDGE GUNNING: Okay. 21 MS. O'MEARA: May I proceed? 22 JUDGE GUNNING: Yes. 23 MS. O'MEARA: Thank you. 24 EXAMINATION 25 0641 1 BY MS. O'MEARA: 2 Q Good afternoon, Mr. Peter. 3 A Good afternoon. 4 Q You testified about the lubricant, and its main 5 purpose was to lubricate equipment; isn't that 6 correct? 7 A Correct. 8 Q And you said that these food-grade lubricants 9 that we've been talking about actually cost 10 double the amount sometimes; is that correct? 11 A It's a good rough number. 12 Q Okay. But you said they're not perceived to work 13 as well as -- 14 A History would dictate they're not perceived to 15 work as well because they don't have the full 16 formula regulatory products available to them. 17 Q So they don't work as well as lubricants; is that 18 correct? 19 A Correct. 20 Q Okay. You also said that there's really been an 21 evolution over these lubricants; isn't that 22 correct? 23 A Correct. 24 Q So it's come kind of a long way, correct? 25 A Correct. 0642 1 Q And can you expect it to go even further in the 2 future? 3 A I would hope so. 4 Q Okay. It would certainly open up your market; 5 wouldn't it? 6 A I -- 7 Q You would hope so? 8 A If we're the ones that are the ones to push it 9 further. 10 Q Okay. Now, you expect it to get better. Could 11 you expect it to -- could you see -- you talked 12 about a hypothetical, I believe. Let me see if I 13 can find it. Well, I'll get to that in a second. 14 I suppose I'll find it. But you said you want to 15 see the market open up for these lubricants, 16 right? 17 A I'd like to see my market open up for these 18 lubricants. 19 Q Okay. And the lubricants that are food-grade; is 20 that correct? 21 A Yes. I'm not discriminatory, though. I'll have 22 it open up for any of these lubricants. 23 Q I can appreciate that, because you are a 24 business, and you're in the business of making 25 money, correct? 0643 1 A Right. 2 Q Okay. And you also said that you couldn't see a 3 use for these food-grade lubricants out of a food 4 processing facility; is that correct? 5 A I can't perceive a use why anyone would be 6 motivated to use them outside of a food 7 processing facility. 8 Q Okay. If someone was, though, would you sell it 9 to them? 10 A I have little or no control over where the end 11 user uses these products, so I would. 12 Q You have little or no control where it's used. 13 So it could be used in a nonfood form, correct? 14 A In theory. 15 Q In theory. Okay. Let me give you a 16 hypothetical. Let's say Hasbro Toy Company comes 17 to you and wants to have you enter into a $1 18 million contract for your lubricants, okay, 19 because they believe that this lubricant is 20 falling onto those toys, and those toys are being 21 chewed by children, and it will safeguard the 22 children. Would you engage in that contract with 23 them? 24 A It's a legitimate concern. 25 Q Okay. Would you engage in that contract with 0644 1 them? Would you then sell that lubricant, that 2 food-grade lubricant? They're willing to take 3 that risk to safeguard children. Would you sell 4 that food-grade lubricant to Hasbro? 5 A Yes, I would, sure. 6 Q Okay. And they would use it in a nonfood form, 7 and you couldn't control that; isn't that 8 correct? 9 A Correct. 10 Q Okay. And let me give you another example. You 11 said that they don't get sold in the retail 12 market. I bet you'd like to open up the retail 13 market; wouldn't you? 14 A No. I have no interest in retail. 15 Q You have no interest in selling your product in 16 another market? 17 A No. 18 Q Okay. 19 A Not retail. 20 Q Let me give you a hypothetical. Let's say pet 21 stores want to come to you and buy that product 22 because the wheels on their hamster wheels are 23 squeaking, and the hamsters are licking that 24 wheel. And this lubricant is food-grade. Would 25 you sell it to them? 0645 1 A I'll sell it to whoever wants to buy it. 2 Q Okay. All right. 3 A If they pay their bill. 4 Q If they pay the bill. Okay. Would you consider 5 a toy a food? 6 A Unless it's an edible toy, I wouldn't. 7 Q Okay. Just a plastic toy, would you consider 8 that food? 9 A I've never eaten one. 10 Q Okay. Good. How about this pen, is this food? 11 A I don't consider a pen food, no. 12 Q Okay. Let me give you another hypothetical. 13 This is a Skilcraft. If they came to you and 14 said, we want to use these in our manufacturing 15 facilities because we think the lubricant is 16 falling onto the production line, and we'd rather 17 have a food-grade lubricant instead. Because I 18 tend to chew my pens when I get nervous, so I 19 might consume it, and someone else might. Would 20 you sell it to them? 21 A Certainly. 22 Q Okay. You testified earlier about the fact that 23 you were developing a new lubricant to have these 24 antimicrobial properties, correct? 25 A Yes. 0646 1 Q Okay. And you said something about the fact that 2 there is trial and error involved; is that 3 correct? 4 A I don't know if I said that regarding the 5 antimicrobial properties, but I said that in 6 regard to developing products in general. 7 Q Okay. Well, thank you for clarifying that, 8 because that's what I'm trying to clarify. Was 9 there any trial and error involved in developing 10 the Micronox technology, which you said is 11 inherent in your lubricant? You did some mixing, 12 and I think the proper word that was used was 13 concoction. 14 A Well, there was an increased performance through 15 Micronox, but food-grade lubricants, not just JAX 16 food-grade lubricants, have for -- I know you're 17 new to this party -- have for 20 or 25 years been 18 mentioning that they have antimicrobial 19 properties. 20 Q I want to focus on your five products and the 21 development of the Micronox technology that we're 22 talking about. What I'm trying to find out is, 23 was there some trial and error that occurred? Or 24 perhaps if you think it's a question better asked 25 to Mr. Paquette, I'll reserve it until then. But 0647 1 you called it a concoction, and I'm just trying 2 to understand what that means. 3 A I don't think I referred to that particular thing 4 as a concoction. But in development of these 5 products, there is some work in the laboratory 6 before they go to the field. If that's trial and 7 error, yes, there are trial and error in terms of 8 formulating the products even within our own 9 facility. 10 Q Okay. Thank you. Once the Micronox formula was 11 developed, could it then be reliably replicated, 12 or was there still trial and error going on? 13 A It's reliably replicated. 14 Q Okay. And there's a specific formula for 15 Micronox technology that you can reliably 16 replicate to put into a lubricant? 17 A No, there is not a specific formula for Micronox 18 technology. The Micronox technology refers to 19 the enhanced antimicrobial characteristics of the 20 food-grade lubricants after we determine that 21 there was some FDA-approved ingredients that 22 would bump that performance up. 23 Q So did you have to add things into the lubricant 24 to develop that enhanced property that you then 25 call Micronox? 0648 1 A Add and/or rearrange. 2 Q Add or rearrange. But your company knew what you 3 were adding or rearranging to create that 4 additional property, correct, because you had a 5 lubricant, and then you reformulated that 6 lubricant, correct? 7 A Right. 8 Q Okay. So you could probably pinpoint exactly 9 what was put in there to make it enhanced as a 10 result of Micronox technology, correct? 11 A I probably could. 12 Q Okay. You mentioned earlier when you were 13 talking about white oils and synthetic-based 14 oils, you said something about anti -- you said 15 something about performance additives. Is the 16 antimicrobial property or the Micronox a 17 performance additive? 18 A No. 19 Q It is not. Okay. Or enhancer, rather, 20 performance enhancer? 21 A It's more of a benefit than a -- when we talk 22 about performance lubricants, we would talk more 23 about lubricated-related performance enhancement, 24 such as better wear protection or better rust 25 protection. 0649 1 Q So this was a benefit, and the other things are 2 enhancers? 3 A The other things are properties. Additives are 4 added to achieve better properties of the 5 lubricant. 6 Q But you called Micronox an -- Micronox 7 antimicrobial properties, right? Just trying to 8 understand the difference between -- 9 A We call Micronox, Micronox antimicrobial 10 technology. 11 Q Technology, okay. You also talked about when the 12 certification, the USDA involvement stopped back 13 in, I think, 1999, correct? 14 A Correct. 15 Q And you talked about NSF? 16 A Right. 17 Q Correct. And they began to charge a fee to do 18 what USDA used to do for free? 19 A Correct. 20 Q Okay. And you could self-certify, though, right? 21 A Correct. 22 Q Yeah. So -- and NSF is not a governmental 23 agency; is it? 24 A Correct. 25 Q So there's nobody overseeing NSF from the 0650 1 government, correct? 2 A Correct. 3 Q Okay. 4 A No. I'm making an assumption on that. I 5 don't know if there's -- 6 Q It's your belief. 7 A It's my belief. I know they have relationships 8 with government branches, such as EPA. 9 Q Okay. 10 A But whether they have government oversight, I -- 11 Q But it's your belief that -- 12 A It's my belief they would not. 13 Q Okay. Thank you. 14 A Otherwise, I couldn't sue them. 15 MS. O'MEARA: Bear with me. I have a 16 lot of notes to go through, Your Honor if that's 17 okay. 18 BY MS. O'MEARA: 19 Q You said something about -- Mr. McIlnay asked you 20 about, you know, whether you control what's on 21 the labels and what's going on in your company, 22 correct? 23 A Correct. 24 Q And you said that you take responsibility for 25 what's going on in your company, correct? 0651 1 A Correct. 2 Q Okay. I just want to clarify. I know we're 3 talking about five JAX lubricants, but you have a 4 whole line of JAX lubricants, correct? 5 A Correct. 6 Q How many products would you say are in that line? 7 A Perhaps 300. 8 Q 300. And do they all contain Micronox? 9 A No. 10 Q How many of them contain Micronox? 11 A Micronox would be limited to the food-grade 12 products. 13 Q Okay. How many of your JAX -- okay. I see what 14 you're saying. How many of your food-grade 15 products -- how many food-grade products do you 16 have in your JAX line? 17 A I believe one of our publications says we have 18 165 NSF-approved products. 19 Q So you have 165 NSF H1 approved products? 20 A No. That would include HS products. So -- well, 21 maybe that is H1 products. It's well over 100. 22 It's under 200. 23 Q How many do you have that aren't NSF approved but 24 still are H1? 25 A There may be a handful. 0652 1 Q Okay. So let's just call it over 165 products. 2 And do they all contain Micronox technology? 3 A I would say virtually all. Perhaps not every 4 single one, but virtually all. 5 Q And do you market all of them in the same manner? 6 A No. They're all marketed to different submarkets 7 of the vertical food machinery market. 8 Q Do you make antimicrobial claims regarding all of 9 these 165-plus products? 10 A I don't believe we do with all of them, no. 11 Q Okay. How about -- I understand you didn't 12 understand what labeling meant, as EPA defines 13 it. How about labeling claims, the actual label 14 that is affixed on the product, do you make the 15 claims on the labels of the product. 16 A Well, I explained any labeling claims that we 17 have now would be limited to the word Micronox 18 and perhaps the word antimicrobial. 19 Q So you still use the word antimicrobial and 20 perhaps the word Micronox on all 165 products? 21 A I couldn't answer that. 22 Q Would it be over 50? 23 A It would be over 50 percent. 24 Q Okay. So that's over 82 and a half. Would it be 25 over 100? 0653 1 A I don't know. 2 Q Would it be over 120? 3 A I don't know. 4 MR. MCILNAY: I'm sorry. I can't 5 hear your answers. 6 Would you read back the last two 7 answers? 8 (The questions and answers were 9 read.) 10 MR. MCILNAY: Thank you. 11 BY MS. O'MEARA: 12 Q But you admit you're responsible for all of them, 13 right, because you just said you're responsible 14 for what's going on in your company, correct? 15 A Yes. 16 Q Well, let's talk about -- you testified earlier 17 about the fact that you researched some of the 18 EPA regulations and guidance and statutes, or you 19 researched to see if you were in compliance with 20 EPA? 21 A We did not want to be listed under FIFRA. 22 Q You did not want to be listed under FIFRA? 23 A We did not want to be. 24 Q Okay. So did you keep that in mind when you did 25 research? 0654 1 A Yes, we did. 2 Q Okay. And let's talk about labeling first. Did 3 you research our regulations and statute? 4 A I did limited research. Mr. Paquette would have 5 done more. 6 Q Okay. But you said you did some research with 7 him? 8 A Yes. 9 MS. O'MEARA: May I approach the 10 witness? 11 JUDGE GUNNING: Yes. 12 MS. O'MEARA: Thank you. I'm going 13 to hand him, Mr. Peter, the FIFRA statute, Your 14 Honor. And I'm at -- bear with me because it's 15 going to be tricky sometimes -- under the 16 definition section, 136, subsection P, which is 17 entitled Label and Labeling. 18 MR. MCILNAY: When you say 136, 19 that's the USC citation? 20 MS. O'MEARA: Yes. 21 BY MS. O'MEARA: 22 Q Right here, P. Could you read out loud to the 23 Court what the definition of label and labeling 24 is, please? 25 A Label and Labeling. Label, the term label means 0655 1 the written, printed or graphic matter on or 2 attached to the pesticide or device or any of its 3 containers or wrappers. Labeling, the term 4 labeling means all labels and other -- and all 5 other written, printed or graphic matter -- 6 Q Okay. 7 A -- accompanying the pesticide or device at any 8 time. 9 Q Okay. Thank you. Now I'm going to show you our 10 FIFRA regulations. Are you familiar with these? 11 A Not that form, but we may have it. 12 Q Okay. I'm going to direct you to 40 CFR 152.15, 13 which is pesticide products required to be 14 registered under subsection A. And could you 15 read that for the Court, please? 16 A Could you point which section? 17 Q I'm sorry. Right here, subsection A, if you 18 would read that whole section, please? 19 A A person who distributes or sells a substance 20 claims, states or implies by labeling or 21 otherwise. 22 Q Okay. Thank you. And I'd ask anyone who is 23 turning to this -- I'll turn to it for 24 Mr. Peter -- 40 CFR 168.22 A. And I'll turn to 25 that page for you. First I'd ask you, if you 0656 1 could please, just read the title of the section 2 under 40 CFR 168.22? 3 A Advertising of unregistered pesticides, 4 unregistered uses of registered pesticides and 5 FIFRA Section 24 C registrations. 6 Q Okay. Thank you. And then if you could read to 7 the Court the last sentence in this paragraph, 8 starting with EPA? 9 A 3, EPA interprets these provisions as extending 10 to advertisements in any advertising medium to 11 which pesticide users or the general public have 12 access. 13 Q Okay. Thank you. Do you have a better 14 understanding now, Mr. Peter, of what labeling 15 means under FIFRA? 16 A In regard to pesticides, I do. 17 Q With regard to pesticides. Do you understand 18 that that means the advertising material as well, 19 such as the written material you saw yesterday? 20 A With regard to pesticides. 21 Q Okay. And do you understand that means marketing 22 materials as well? 23 A With regard to pesticides. 24 Q And do you understand it also means any internet 25 claims as well? 0657 1 A With regard to pesticides. 2 Q And any claims that might be made by your 3 salespeople, do you understand that's what it 4 means as well? 5 A I have been made to understand that through this 6 hearing. 7 Q Now, you testified that you were contacted by NSF 8 about the labeling on your products, correct? 9 A Correct. 10 Q At that time, did you try to understand what 11 labeling meant in the context of U.S. EPA? 12 A No. 13 Q No. Okay. They approached you. You weren't 14 sure. So I'm going to ask you to turn to 15 Complainant's Exhibit 36, please. Complainant's 16 Exhibit 36. I'll direct you to EPA number 755, 17 Paragraph 18. 18 A 755? 19 Q Yes. 20 MS. O'MEARA: May I approach the 21 witness, Your Honor? 22 JUDGE GUNNING: Yes. 23 MS. O'MEARA: Thank you. 24 BY MS. O'MEARA: 25 Q Paragraph 18. And if you -- would you just 0658 1 review that first sentence, please? 2 A In 2003, NSF contacted Behnke and informed it 3 that NSF considered that references to some 4 antimicrobial properties of Micronox in 5 association with products certified by NSF were 6 improper. 7 Q Thank you. That's good. So now are you clear 8 that it was 2003, not 2004 when NSF began to -- 9 A Yes. 10 Q -- throw up red flags for you? 11 A Well, I was unclear whether it was 2003 or 2004. 12 Q Okay. I just want to make sure we're clear on 13 the date. 14 A Right. 15 Q And you said that you -- after they contacted you 16 in 2003 and told you that there was a concern, 17 they thought that your lubricants might be EPA -- 18 need EPA registration, you said you met with 19 them, correct? 20 A Correct. 21 Q Or you discussed it with them. Correct? 22 A In 2003? 23 Q Yes. 24 A I don't recall having a discussion in 2003 with 25 them. 0659 1 Q Okay. So after NSF asked -- told you, made you 2 aware of the fact that you might be subject to 3 FIFRA requirements under U.S. EPA in 2003, did 4 you meet with them? 5 A I did not meet with them until 2005, and there 6 was no mention of FIFRA from EPA at that point in 7 time. 8 Q Okay. 9 A I mean, from NSF at that time. 10 Q From NSF. 11 A Correct. 12 Q Okay. But they told you they were concerned with 13 the labeling, right? 14 A Correct. 15 Q Okay. And they said it was improper, the 16 labeling, that was their concern? 17 A They had said it was improper on, it looks like, 18 several occasions before that, too. So, yeah, 19 that was their concern. 20 Q All right. Did they tell you why they thought it 21 was improper? 22 A They thought that the claims may -- 23 Q Well, without looking at that, Mr. Peter. Or 24 maybe I can restate the question. Did you ask 25 them why they thought it was improper? 0660 1 A I don't recall having that conversation. 2 Q Okay. Thank you. Did you ever at that time, in 3 2003, try to talk to the EPA? 4 A No. 5 Q Okay. I'm sorry. I didn't hear you. 6 A No. 7 Q But your testimony was that was a red flag to 8 you, and you said 2003 -- I mean, 2004, but we've 9 clarified that it's 2003, that at this point this 10 was a red flag to you. That was your testimony, 11 correct? 12 A The word red flag? 13 Q Yes. You don't recall that? 14 A No. 15 Q You said at that time you began to do some 16 research, though, correct to determine what the 17 problem was? 18 A We had done some research with the FDA guidelines 19 from the beginning. 20 Q When did you start to do research with EPA 21 requirements? 22 A We did not consider ourselves an EPA-regulated 23 product, so we did not do a lot of EPA research. 24 Q You didn't do a lot of EPA -- 25 A We were governed by FDA, and continue to be 0661 1 governed by FDA. 2 Q Okay. The NSF program that certifies your 3 lubricants, is it a nonfood -- is the program 4 called Nonfood Compounds Registration Program? 5 A Perhaps that's what NSF called it, but that's a 6 similar name to what USDA had for it, too. 7 Q And as part of that program, NSF refers to 8 nonfood products, including lubricants that have 9 incidental contact with food, correct? 10 A That's how they've always been referred to. 11 Q Okay. I think it was in 2002 about when NSF 12 began to certify your lubricants under its 13 nonfood program, correct? 14 A If not earlier. 15 Q Okay. Can you read Paragraph 17. You have that 16 page open. We're talking about labeling. I want 17 to get some clarification. So if you could read 18 Paragraph 17 into the record, please? 19 A Subsequent to receiving the NSF certifications 20 and listing in the White Book, Behnke undertook 21 substantial advertising, both in print media and 22 on its web site, stating that the products were 23 NSF certified. In addition, Behnke truthfully 24 stated in the media and on its web site that the 25 products contained the Micronox antimicrobial 0662 1 additive. 2 Q Okay. So you did start advertising back then, 3 correct? 4 A Back then -- 5 Q Back in, I think it said -- 6 A There's no date reference in that paragraph. 7 Q Yes. In Paragraph 16 it says, starting in 2002 8 the label for the food-grade lubricants submitted 9 to NSF for certification disclosed that the 10 lubricants contained the Micronox additive. The 11 labels were submitted to NSF, and NSF knew from 12 2002 onward that Behnke Lubricants which -- that 13 the Behnke food-grade lubricants, which NSF 14 certified, contained the Micronox additive. 15 Subsequent to receiving the NSF 16 certification, starting in 17, then you began the 17 advertising, correct? 18 A Correct. 19 Q Okay. And at that time you advertised that they 20 controlled E. coli, Salmonella, and Listeria, 21 correct? 22 A Correct. 23 Q And in 2003 when NSF contacted you, did they ask 24 you to remove the references to Salmonella 25 Listeria and E. coli? 0663 1 A I believe so. I don't know if I was the one they 2 directly contacted or if it was Troy Paquette or 3 Patty Riek. 4 Q Okay. 5 A But there were requests to remove references to 6 those. 7 Q Okay. But you're familiar with this lawsuit, 8 right? You probably reviewed it -- 9 A Oh, sure. 10 Q -- before it was filed? Why don't you read 11 Paragraph 18, starting with the third sentence, 12 In 2002, for example. Go ahead and read that 13 sentence. 14 A In 2002, for example, it had approved the label 15 for a Behnke lubricant, BDF Gling-Lube, a product 16 NSF had certified which stated, enhanced with 17 Micronox for exceptional knockdown performance 18 against Salmonella, Listeria and E. coli, but in 19 2003 demanded that the label be changed to state 20 that the product contains Micronox to provide 21 antimicrobial protection for this product. 22 Behnke made the change demanded by NSF. 23 Q Okay. Thank you. So they asked you to remove 24 the E. coli, Salmonella and Listeria at that 25 time? 0664 1 A Correct. 2 Q Okay. And did you remove it from all your 3 material? 4 A We removed it from the label that was submitted 5 to NSF. 6 Q But not the advertising and the marketing? 7 A No. 8 Q Okay. In early of 2005 is it correct that NSF 9 asked you to remove from your web site and print 10 materials reference to Micronox having 11 antimicrobial properties in association with any 12 food-grade lubricants? 13 A Yes. 14 Q So they told you to take it out of your 15 advertising and your print materials, as well as 16 your labeling in 2005? 17 A Yes. 18 Q They did? Okay. At that time did you begin to 19 wonder why they did that? Did you then look at 20 any EPA regulations to figure out if labeling 21 meant advertising and marketing? 22 A We may have discussed it with Troy Paquette. But 23 at that time, again, this is a nongovernment 24 organization ordering us around regarding their 25 registration process. 0665 1 Q Sure. Oh, I totally understand. Did you call 2 the EPA? 3 A We did not feel our products were EPA products. 4 Q So you didn't call the EPA; is that correct? 5 A We did not call the EPA. 6 Q You did not seek any advice from them; is that 7 correct? 8 A Nor did we receive a call from the EPA. 9 Q The question was, did you call the EPA? 10 A I answered the question. We did not call the 11 EPA. 12 Q And I would appreciate if you would just answer 13 my questions. Thank you. 14 Could you please turn to EPA 756, 15 please, to Paragraph 21. It's just another page 16 over. 17 A Okay. 18 Q Mr. Peter, could you read that paragraph out 19 loud? 20 A NSF went further and demanded that Behnke seek 21 approval from the United States Environmental 22 Protection Agency to register the Micronox 23 product with the EPA as pesticide and to label 24 and identify the Micronox product as a pesticide. 25 Q Did that prompt you to call the EPA and inquire? 0666 1 A No. We still felt that we were an FDA product. 2 Q Did it prompt you to research the statute and 3 regulations related to EPA just to make sure -- 4 A Yes. 5 Q -- that you were just FDA? 6 A Yes. 7 Q You did? 8 A Yes. 9 Q Okay. And did you do that personally? 10 A Mr. Paquette did it. I believe Mr. McIlnay 11 assisted us to a certain extent, and I did also. 12 Q But ultimately you were responsible for whatever 13 the outcome was, correct? 14 A Ultimately, I'm responsible. 15 Q Okay. Do you know if Mr. Paquette called the 16 EPA? 17 A I do not know. 18 Q Did you tell him to call the EPA? 19 A I did not. 20 Q Okay. Now, you say that in response to NSF 21 requests you removed references to antimicrobial 22 properties that have Micronox from the web site 23 and the print materials; is that correct? I'm 24 just asking. I don't think the answer is in that 25 book. 0667 1 A No, we did not remove references to Micronox and 2 antimicrobial from the print materials. We 3 removed them from the labels. 4 Q Okay. I'm going to refer you to Paragraph 18, 5 which is one page back. Can you read -- I'll 6 show you -- if I may approach the witness? 7 JUDGE GUNNING: Yes. 8 BY MS. O'MEARA: 9 Q -- the sentence. Starting with, In early 2005, 10 would you please read that into the record? 11 A In early 2005, NSF then demanded that Behnke 12 remove from its web site and print materials 13 certain references to Micronox having 14 antimicrobial properties, even though in 2003 it 15 had dictated to Behnke that that terminology be 16 used. In response to this demand, Behnke removed 17 from its web site and print materials those 18 references to the antimicrobial properties of 19 Micronox in association with any food-grade 20 lubricant certified by NSF. In NSF's -- 21 Q Thank you. That's good. So they asked you to 22 remove it from the advertising and the web site, 23 but you only removed it from the labeling; is 24 that correct? 25 A Our document manager did some removing that I may 0668 1 not have been aware of, but there was removing of 2 certain levels. You have to understand this went 3 through a metamorphosis of what they were saying 4 was allowed. And so there were levels that were 5 removed to satisfy the requests ongoing. 6 Q So, but I'm just trying to understand what this 7 document says. It says that you removed them 8 because they requested it. Did you remove it 9 from advertising and the web site? 10 A By 2005 I think most of it had been removed. 11 Q And that's antimicrobial claims and E. Coli, and 12 Salmonella and Listeria? 13 A Likely references to the pathogens. 14 Q Okay. 15 A Again, the fact that we said Micronox or 16 antimicrobial, we did not feel put us under FIFRA 17 because of our FDA -- 18 Q So you didn't remove references to antimicrobial 19 properties and the word Micronox, correct? 20 A I don't believe we did across the board. 21 Q But in this document that you reviewed and then 22 filed a lawsuit, it says, in response to this 23 demand, Behnke removed from its web site and 24 print materials those references to antimicrobial 25 properties of Micronox in association with any 0669 1 food-grade lubricants. Can you explain what that 2 means then? It says you removed it. Is that 3 incorrect, or are you stating something incorrect 4 right now? 5 A No. But properties, we may have interpreted 6 properties to mean references to the pathogens 7 that we were aimed at. 8 Q Okay. You may have. Okay. You said Behnke just 9 didn't want to register the product with EPA, 10 correct, the lubricants with EPA? 11 A We wanted to stay out of that bailiwick. 12 Q Okay. And was this because EPA controls and 13 restricts the use of these registered products? 14 Is that why you didn't want EPA to have 15 jurisdiction over you? 16 A We didn't want our products associated with EPA 17 pesticides, our food-grade products. 18 Q If you could listen to my question and see if 19 maybe we can answer that one. Did you not want 20 EPA to have jurisdiction over you because EPA 21 controls and restricts the use of your registered 22 product -- of any registered product? Did you 23 not want EPA involvement because they control and 24 restrict -- would control and restrict your 25 lubricant? 0670 1 A Decisions were financial in nature because -- 2 Q Could you try to answer the question? 3 A The question is rather obtuse. 4 Q Okay. Well, why -- 5 JUDGE GUNNING: There's a double 6 negative. Perhaps if you could -- 7 BY MS. O'MEARA: 8 Q Why don't I just refer you to EPA 756, 9 Paragraph 22. 10 JUDGE GUNNING: What was the number 11 again? 12 MS. O'MEARA: EPA 756, and 13 Paragraph 22. Still in the same NSF document. 14 JUDGE GUNNING: Okay. 15 BY MS. O'MEARA: 16 Q Actually, why don't you -- can you read 17 Paragraph 22, Mr. Peter? 18 A Certainly. 19 Q Thank you. 20 A Were Behnke to identify the Micronox product as a 21 pesticide, the Micronox product would no longer 22 be accepted by producers and packager of food 23 products intended for human consumption. This is 24 so because of EPA restrictions and controls on 25 the use of pesticides by such producers and 0671 1 packagers. If Behnke were to identify the 2 Micronox product as a pesticide, as demanded by 3 NSF, Behnke would lose its competitive advantage 4 provided by the Micronox product. Such a loss 5 would be to the direct benefit of Behnke's 6 competitors in the food-grade lubricant market. 7 Q Okay. Thank you. Now, does that help you answer 8 the question that I asked you? Is it that you 9 did not want EPA involved because they restrict 10 how your lubricants are to be used? 11 A No. 12 Q Okay. But that's what it states in that 13 paragraph, correct? 14 MR. MCILNAY: States in one sentence? 15 BY MS. O'MEARA: 16 Q In one sentence. You're right that it is in one 17 sentence in that paragraph. Let me read it to 18 you. I have to read the first sentence just to 19 give it context. Were Behnke to identify the 20 Micronox product as a pesticide, the Micronox 21 product would no longer be accepted by producers 22 and packagers of food products intended for human 23 consumption. This is so because of EPA 24 restrictions and controls on the use of 25 pesticides by such producers and packagers. 0672 1 Okay. Why don't we move on. So you 2 didn't want to lose your competitive edge over 3 your competitors, correct? 4 A Correct. 5 Q And you perceived the fact that EPA would be 6 involved as a loss of your competitive edge? 7 A Correct. 8 Q Now, can your competitors -- are your competitors 9 making any of these kind of claims? Because you 10 said earlier that they also have antimicrobial 11 properties in their lubricants, right? 12 A Correct. 13 Q Are any of your competitors making these types of 14 claims, other than MICROL, that you know of? 15 A They have in the past. 16 Q Okay. Are any of your competitors making these 17 types of claims right now? 18 A I think some are. 19 Q Some are. Okay. The ones that aren't, they're 20 following the rules, and they understand the EPA 21 rules; isn't that correct? 22 MR. MCILNAY: Objection, calls for 23 speculation. 24 JUDGE GUNNING: Sustained. 25 MS. O'MEARA: Okay. 0673 1 BY MS. O'MEARA: 2 Q Isn't it true that even though NSF told you that 3 you should seek registration with EPA, you still 4 didn't contact EPA; is that correct? 5 A That's correct. 6 Q And, in fact, you waited until we contacted you 7 in 2000 -- in December of 2006; isn't that 8 correct? 9 A Correct. 10 Q Was that a business decision? 11 A Yes. 12 Q Okay. Were you just waiting for EPA to come 13 contact you? 14 A I was hoping that eventuality would not take 15 place. 16 Q But you were willing to take that risk, correct? 17 A I was willing to take that risk. 18 Q And that eventuality occurred on August 3, 2006, 19 when Mr. Saatkamp showed up at your facility; is 20 that correct? 21 A No. 22 Q It didn't. It wasn't until December 22, 2006? 23 A Correct. 24 Q Okay. So when Mr. Saatkamp came to your facility 25 and spoke with you, as well as Mr. Paquette and 0674 1 Ms. Riek, I believe, and told you that they were 2 looking at your lubricants to see if they were in 3 compliance with EPA, did you call EPA at that 4 time? 5 A No. 6 Q No. So you were still making a business decision 7 not to make that phone call; is that correct? 8 A Correct. 9 Q Okay. Now, there was some reference to the fact 10 that you stopped using even the trade name 11 Micronox. Have you stopped using the trade name 12 Micronox? 13 A No, we have not. 14 Q Okay. But in the -- do you approve all the 15 documents that Mr. McIlnay filed with the Court 16 with respect to this lawsuit? 17 A That's a pretty general statement. I don't know 18 that I reviewed every document Mr. McIlnay 19 submitted. 20 Q Okay. 21 MR. MCILNAY: It also assumes 22 Mr. McIlnay filed it. 23 MS. O'MEARA: I can show you that he 24 did. 25 JUDGE GUNNING: Okay. How about we 0675 1 stay with the cross. 2 MS. O'MEARA: Okay. 3 BY MS. O'MEARA: 4 Q Are you aware that Mr. McIlnay stated in one of 5 the documents in this case that the words 6 Micronox were removed entirely? 7 A In what context? 8 Q In the context of your labeling, advertising, and 9 marketing? 10 MR. MCILNAY: I'm sorry. Maybe I 11 misunderstood. We're talking about the case 12 we're here on today? 13 MS. O'MEARA: Yes. 14 BY MS. O'MEARA: 15 Q It's in Behnke's response to the motion for 16 accelerated decision. Are you aware that Behnke 17 states in that response that you removed the word 18 Micronox from all of your labeling, advertising, 19 and marketing in 2007? 20 A The word, Micronox, no, I'm not aware of that. 21 Q Okay. Are you aware that it also states that you 22 only used the word Micronox in one place in 2006. 23 And perhaps that means one advertising media. 24 I'm not sure. Are you aware of that? 25 A No. 0676 1 Q Now, you said that back in -- let's just get this 2 clear. When did you -- 3 MR. MCILNAY: Was there an answer to 4 the last question? I didn't hear it. 5 THE WITNESS: I said, no. 6 MR. MCILNAY: Okay. 7 BY MS. O'MEARA: 8 Q When did you remove the words E. coli, 9 Salmonella, and Listeria? Was that back in 2003 10 when NSF asked you to? 11 A I think so. 12 Q You think so? 13 A Again, I didn't do the direct removal of it, 14 so -- 15 Q But you were ultimately responsible for it, as 16 you previously stated, right? 17 A Right. 18 Q Okay. And you saw our exhibits that we went 19 through in the last couple of days, and you saw 20 those words were in those exhibits as well, 21 E. coli, Salmonella, and Listeria? 22 A Correct. 23 Q And we found them at the facility in 2006, at 24 Menomonee Falls facility, Behnke facility in 2006 25 in the literature, E. coli, Salmonella and 0677 1 Listeria, correct? 2 A In literature, you may have found it in 3 literature. 4 Q In the advertising? 5 A In literature. 6 Q All right. After EPA met with you and told you 7 that the public health claims, the E. coli, 8 Salmonella and Listeria were problematic, did you 9 remove it? 10 A We made an attempt to. 11 Q But you're not sure if you removed all of it; is 12 that what you're saying? 13 A I didn't review every document. 14 Q Okay. And you heard Mr. Bonace testify that he 15 found it as recent as this Monday, E. coli, 16 Listeria and Salmonella? 17 A Right. 18 Q So -- and ultimately, again, you're responsible 19 for Behnke, right? 20 A Correct. 21 Q And so it was still on web sites, correct? 22 A He pointed it out. Yes, it was. 23 Q Can you turn to Respondent's Exhibit 54, please. 24 Mr. Peter, I was referring to Respondent's 25 Exhibit 54. 0678 1 A Oh Respondent's exhibit. I'm sorry. 2 Q Let me get this out of your way a little bit. 3 A Thank you. 4 Q You're welcome. And can you turn to Page 14 of 5 that exhibit. I don't have the Bates version 6 with me right now. 7 MR. MCILNAY: Which document? 8 MS. O'MEARA: Respondent Exhibit 54, 9 Page 14. 10 BY MS. O'MEARA: 11 Q And this is one of the documents you submitted, 12 Behnke submitted for that lawsuit, correct? 13 A Correct. 14 Q Okay. And is there still reference to E. coli 15 and Salmonella and Listeria in this document? 16 A Yes, there is. 17 Q Okay. And can you turn to Respondent's Exhibit 18 65. And can you tell the Court what that is, 19 please? 20 A 65? 21 Q Yes. 22 A It looks like a declaration of Tracey Huebner. 23 Q Okay. And attached to that there is some 24 literature, correct? 25 A Correct. 0679 1 Q And let's just turn to the one that refers to the 2 advertising that was being done in 2007. 3 A Uh-huh. 4 Q Is the word Micronox still being used in 2007 5 there in some of the advertising? 6 A Yes. 7 MR. MCILNAY: May I -- where it 8 starts with the exhibit sticker C, is that the 9 page you're on? 10 MS. O'MEARA: I'm on my own -- yes, 11 exhibit sticker C. 12 MR. MCILNAY: So that's Respondent 13 00172. 14 MS. O'MEARA: Thank you. The version 15 that I have is -- I can't read it, but I have my 16 own photocopied version without the Bates numbers 17 on it. 18 BY MS. O'MEARA: 19 Q So is there anywhere in there that it still 20 refers to the word Micronox? 21 A Which document are we talking about? 22 Q It starts with Exhibit C. 23 A I don't see any reference to Micronox. 24 Q Okay. I'll show you a version that's readable. 25 I think a lot of them are blacked out, or 0680 1 overphotocopied. 2 Now, just so I'm clear, this Exhibit 3 C represents the advertising and labeling -- or 4 actually just the advertising and marketing 5 relating to 2007; is that correct? 6 A I don't know the extent of Exhibit C. 7 Q Okay. I'm going to direct your attention to 8 Paragraph 6 of the declaration, which states, 9 Attached hereto as Exhibit C is schedule for all 10 media placements for Behnke advertising during 11 the calendar year 20007. Okay? And, Attached to 12 the schedule are copies of the advertisements 13 identified in the 2007 schedule. 14 So, now turning you to Exhibit C, 15 I'll just show you the paper, since I don't know 16 if you can read yours there. This one is marked 17 Xterminate bacteria. Let me see if I can help 18 you find it, we can find what page number it is. 19 It's Respondent 00181. 20 MS. O'MEARA: Your Honor I have a 21 copy that is legible. I think yours is probably 22 very dark. 23 JUDGE GUNNING: Right. 24 MS. O'MEARA: I had to pull it from 25 the actual filing that we received when the 0681 1 response to the motion for accelerated decision 2 was filed. 3 MR. MCILNAY: We're looking for 4 another copy now. 5 MS. O'MEARA: Okay. 6 BY MS. O'MEARA: 7 Q Mr. Peter, if you could just read all of the 8 literature that's stated below Xterminate 9 bacteria? 10 A Was your question whether this ran in 2007? 11 Q Yes. 12 A Initially, it did not. 13 Q It did not. But in the declaration it states -- 14 A They may be misarranged, but this ad has not run 15 for years. 16 Q Okay. But that's what it says in the 17 declaration; is that correct? 18 A It's in error. 19 Q Okay. 20 JUDGE GUNNING: Now, for completeness 21 of the record, I would like to have that exhibit 22 attached to this exhibit, at least for the court 23 reporter. 24 MS. O'MEARA: Okay. 25 MR. MCILNAY: We could probably even 0682 1 supply -- substitute the entire document. The 2 Huebner declaration that is being referred to was 3 filed as well in -- as part of Respondent's 4 response to the motion for an accelerated 5 decision. I'm looking at that document now. 6 It's a much, much cleaner, better copy. And if 7 the Court would like, we could substitute that 8 whole document. 9 JUDGE GUNNING: Whatever -- EPA, what 10 is your preference? 11 MS. O'MEARA: That would be fine. 12 JUDGE GUNNING: Okay. 13 MS. O'MEARA: Happy to help do that, 14 make sure it's correct. 15 MR. MCILNAY: Okay. We don't need to 16 do it now. 17 MS. O'MEARA: No, no, no. I 18 understand that. 19 JUDGE GUNNING: Yes. 20 MS. O'MEARA: So we can make sure it 21 is in fact what it is. 22 BY MS. O'MEARA: 23 Q But this does talk about Xterminate bacteria, 24 correct? 25 A Yes. 0683 1 Q And it was represented that it was in the 2 advertising in the year 2007, correct? 3 A It was represented as such, but that's incorrect. 4 Q And it talks about E. coli, Salmonella, and 5 Listeria, correct? 6 A Yes. 7 Q And the next page -- two pages later -- probably 8 you can't see it, so I'll show it to you -- 9 that's also a document that is in Complainant's 10 Exhibit C? 11 A Yes. 12 Q And it talk about E. Coli, Salmonella and 13 Listeria as well? 14 A Yes. 15 Q And Micronox? 16 A Yes. 17 Q Is this incorrectly placed in there as well? 18 A Yes. 19 JUDGE GUNNING: Now, what document is 20 that? What's it look like? 21 MS. O'MEARA: It's two pages later, 22 Your Honor. 23 JUDGE GUNNING: Does it say Page 40. 24 MS. O'MEARA: Yes. 25 JUDGE GUNNING: And it's dated 0684 1 January, 2005. 2 MS. O'MEARA: Yes. 3 JUDGE GUNNING: Okay. So it's my 4 understanding that after Respondent gets a 5 cleaner copy, we will substitute that for that 6 currently in the record. Okay. 7 BY MS. O'MEARA: 8 Q Now, Exhibit B in that document, you probably 9 can't read it as well. 10 MS. O'MEARA: Perhaps Counsel can 11 help me. 12 MR. MCILNAY: If it's helpful -- I 13 know you're not looking at the numbered ones -- 14 if it's helpful -- 15 MS. O'MEARA: It that one -- what is 16 that one right there? 17 MR. MCILNAY: That was the last one 18 before Exhibit B. 19 JUDGE GUNNING: Bates Stamp 166? 20 MS. O'MEARA: Your Honor, if I may 21 approach, I can show you what it looks like. 22 MR. MCILNAY: Yes. 23 MS. O'MEARA: Xperience counts. 24 JUDGE GUNNING: Okay. 25 MR. MCILNAY: It is Bates 0685 1 stamped 166. 2 BY MS. O'MEARA: 3 Q If you could go to Bates Stamp 166 then, and I'm 4 going to show you a copy that is actually 5 legible, but I'm going to read to you before I 6 show it to you. It says at the very bottom, JAX 7 Micronox antimicrobial additive, the only one to 8 provide significant microbial knockdown 9 performance in food-grade lubricants. Is that 10 something that ran in 2006? 11 A I believe maybe 2005. It's looks like there was 12 a similar one to that here that said in '06, took 13 off Micronox. 14 Q Oh, I see. So this is not representative of what 15 happened in 2006, even though it -- 16 A It's probably '05. 17 Q -- even though it states it's in 2006. Okay. 18 MR. MCILNAY: Well, I object, Your 19 Honor. That wasn't his testimony. 20 Could you read back what his answer 21 was? 22 (The answer was read.) 23 MR. MCILNAY: Okay. I'll pursue it 24 on redirect. 25 0686 1 BY MS. O'MEARA: 2 Q Now, let's talk about this meeting you went to in 3 Florida. Do you remember talking about that? 4 A Yes. 5 Q Okay. What was the meeting for? 6 A It was a trade group, annual meeting. 7 Q What was your purpose of that meeting when you 8 scheduled to go there? 9 A My purpose was, knowing that I had conflicting 10 opinions with NSF on registration, I wanted to 11 hear what they were going to say and present to 12 other members of our trade association. 13 Q Who was presenting at that meeting? 14 A Dr. Yano was presenting, Mr. Edwards was 15 presenting. 16 Q Okay. Did you set up a meeting with them ahead 17 of time? 18 A No. 19 Q How many people were at that meeting, do you 20 recall? 21 A Attending that particular presentation? 22 Q Yes. 23 A It was not heavily attended. There may have been 24 30 attendees. 25 Q Okay. Was it a full room? 0687 1 A No. 2 Q Okay. And did you listen to Mr. Edwards' 3 presentation? 4 A Yes. 5 Q Did he know you were in the audience? 6 A I had not met Mr. Edwards before that. 7 Q Okay. And did you listen to Mr. Yano's 8 presentation? 9 A Yes. 10 Q Did he know you were in the audience? 11 A Yes. 12 Q Okay. Had you met him before? 13 A May of 2005 in Ann Arbor. 14 Q Was that the only time you met him? 15 A Mr. Yano? 16 Q Yes. 17 A To the best of my recollection. 18 Q Okay. 19 A Dr. Yano. 20 Q Now, after the meeting -- by the way, what was 21 Mr. Edwards talking about? Do you recall? 22 A Well, I would equate it to a sales presentation 23 for -- trying to get registrations for treated 24 articles. 25 Q Okay. So he was talking about the treated 0688 1 article exemption. You're aware he doesn't work 2 on any sort of a commission to get people to 3 register? 4 A That's what was rather alarming. 5 MR. MCILNAY: I'm sorry. What? 6 THE WITNESS: I said, that's what was 7 alarming about it. 8 BY MS. O'MEARA: 9 Q And he didn't require you to come to that 10 meeting; did he? 11 A No, but of all -- 12 Q If you could try to answer -- 13 MS. O'MEARA: Your Honor, if I could 14 ask -- 15 THE WITNESS: Okay. No, he did not. 16 MS. O'MEARA: If I could ask you to 17 direct the witness to please answer my questions, 18 that would be helpful. 19 JUDGE GUNNING: If you can just limit 20 your answer, and then anything else can be picked 21 up on redirect. 22 BY MS. O'MEARA: 23 Q Okay. So he didn't require you to come to that 24 meeting, did he? 25 A No. 0689 1 Q And did you talk to any other people in the room? 2 A Maybe just a social greeting. 3 Q Okay. But it's reasonable to expect that all 4 those people were interested in the treated 5 article exemption, correct? 6 A No, it's -- no. 7 Q Yes or no? 8 A No. 9 Q No. Oh, okay. Were you interested in the 10 treated article exemption that day? 11 A I was interested in what Mr. Edwards and Dr. Yano 12 were going to have to say. 13 Q Were you hoping to hear something so that you 14 wouldn't have to register your product? 15 A No. 16 Q So you spoke with Mr. Yano and Mr. Edwards 17 afterwards; is that correct? 18 A I spoke with Dr. Yano and Mr. Edwards afterwards. 19 Q I apologize, Dr. Yano. Did a lot of people go up 20 and talk to him afterwards? I would imagine they 21 did. 22 A No. 23 Q Were you the only one? 24 A No. 25 Q How many others, would you say? 0690 1 A A handful. 2 Q Okay. So about 20 percent of the people, right, 3 roughly? 4 A Roughly three or four. 5 Q I'm sorry. I thought a handful was five. Okay. 6 Did you have to wait in line to talk to him? 7 A I don't recall. There was a typical gathering 8 after the presentation. 9 Q Okay. Were people talking to Mr. Edwards in one 10 area and Dr. Yano in another? 11 A I don't recall. 12 Q What was Dr. Yano presenting about; do you recall 13 that? 14 A Yes, they were trying to sell a program of 15 registration of antimicrobial products. 16 Q Okay. But you don't recall that when you spoke 17 with Dr. Yano and Mr. Edwards if they were in 18 different places -- how did you get them 19 together? Do you remember that? 20 A Outside the meeting room we gathered, and 21 Dr. Yano introduced me to Mr. Edwards and -- 22 Q Okay. Was anybody else present? 23 A I believe there was another person from NSF 24 present with Dr. Yano. 25 Q Were any of the participants of the meeting 0691 1 present at that time? 2 A No. 3 Q Okay. Did you show Mr. Edwards at that time -- 4 did you introduce yourself? 5 A Yes. 6 Q There were a lot of people that day, correct? 7 A Correct. 8 Q Yeah. Did you show Mr. Edwards any of your 9 literature that day? 10 A No. 11 Q Any of your marketing claims? 12 A No. 13 Q Any of your internet web sites? 14 A No. 15 Q Any of your labeling? 16 A No. 17 Q Did you try to set up a meeting with him to do 18 that? 19 A No. 20 Q Because it was a business decision, correct? 21 A Correct. And because I had none of those 22 materials with me. 23 Q Okay. But you knew you were going there to talk 24 to Dr. Yano and Mr. Edwards to find out about the 25 treated article exemption, right? 0692 1 A I did not know I was going there to talk to them. 2 I know I was going there to listen to what they 3 had to say. 4 Q Did you go there to make sure you were in 5 compliance with FIFRA or if you were subject to 6 FIFRA? 7 A No. I was going there to understand their 8 interpretation of FIFRA and trying -- 9 Q As it applies to you? 10 A -- and trying to fold it into our understanding 11 of the FDA regulations. 12 Q Okay. But you didn't bring any of the material 13 to seek any advice from Mr. Edwards, correct? 14 A No. 15 Q Did you try to set up a meeting with him later 16 on, perhaps when he got back to the office so you 17 could provide him the materials? 18 A No. 19 Q Did you ask him specifically if you should 20 register your product? 21 A I did not ask. He offered his opinion. 22 Q But you didn't give him all the information he 23 needed, correct? 24 A I didn't give him information, no. 25 MR. MCILNAY: I didn't hear. I'm 0693 1 sorry. Could you speak up? 2 JUDGE GUNNING: Do you want that read 3 back? 4 MR. MCILNAY: Yes, please. 5 JUDGE GUNNING: Just the answer? 6 MR. MCILNAY: The answer is fine. 7 (The answer was read.) 8 MR. MCILNAY: Thank you. 9 BY MS. O'MEARA: 10 Q And you didn't send him any information regarding 11 labeling, advertising or marketing, correct? 12 A No. 13 Q Another business decision, right? 14 A Correct. 15 Q Did you continue to do research after that when 16 you got back to the office with Mr. Paquette? 17 A We were doing ongoing research. 18 Q With respect to EPA? 19 A With respect to our labeling. 20 Q With respect to EPA? 21 A EPA documents were in and among the FDA documents 22 that we had. 23 Q Did you do any research to determine if you had 24 to register your products under FIFRA with EPA? 25 A We had done extensive research to determine 0694 1 whether we had to register our products under 2 FIFRA with EPA. It was ongoing. 3 Q Now, you said, when Mr. McIlnay asked you about 4 what you did to address the labeling concerns, 5 that had been red flagged for you by NSF after 6 this meeting, you said you felt that EPA was 7 making FDA -- I don't remember exactly -- but 8 making decisions about FDA products that were 9 arbitrary in manner, correct? 10 A I may have. 11 Q Okay. Was that based on your conversation with 12 Mr. Edwards? Because you were talking about it 13 right after you talked about the meeting, or 14 right when you were talking about the meeting. 15 A I don't believe so. 16 Q So what did you believe -- how did you believe 17 EPA was arbitrary? Based on what conversation 18 did you determine that we were being arbitrary. 19 Was there a conversation with EPA that led you to 20 that conclusion that we were arbitrary? 21 A It likely was the conversation that Dr. 22 Edwards -- I mean, that Mr. Edwards had with 23 Dr. Yano down there. 24 Q So you didn't like what he had to say is what I 25 can glean from that, correct? 0695 1 A I disagreed with what he had to say. 2 Q I see. And you said it was a business decision 3 to file the litigation you did against NSF, 4 correct? 5 A Correct. 6 Q And it was a business decision then to ignore 7 EPA; is that correct? 8 A EPA had not contacted us yet. 9 Q But you hadn't contacted them, correct? 10 A Correct. 11 Q And you knew that there was some issue, correct? 12 A Not from EPA, I did not. 13 Q NSF -- didn't you just say that NSF told you that 14 you might have to register your EPA lubricants, 15 correct? 16 A EPA may have had an issue with NSF, but to the 17 best of my knowledge, EPA at that point had no 18 issue with us. 19 Q I understand that EPA didn't contact you. What 20 I'm trying to find out is, did you have some 21 knowledge through NSF that perhaps EPA would have 22 jurisdiction over your lubricants? 23 A We -- 24 Q Yes or no? 25 A If you're leading me with that question, I can't 0696 1 answer it the way you asked it. 2 Q It's a yes or no question. 3 A It's not a yes or no question. 4 JUDGE GUNNING: Okay. I think at 5 this stage we have addressed the issue, and 6 please move on. 7 MS. O'MEARA: Okay. 8 BY MS. O'MEARA: 9 Q Do you understand what the treated article 10 exemption is? 11 A More or less. 12 Q Do you understand if you comply with the treated 13 article exemption, you're not required to put a 14 logo or an insignia, as you state, on the product 15 that states the EPA establishment number or the 16 EPA registration number? 17 A If that's the case, I'm now aware of it. 18 Q You weren't aware of it before? 19 A I may or may not have been. 20 Q But you did some research relating to this issue, 21 correct? 22 A Some. 23 Q Now, on August 11, 2006, you met with 24 Mr. Saatkamp, correct, when he came to the 25 Menomonee Falls facility? 0697 1 A Correct. 2 Q And that was the Wisconsin Department of 3 Agriculture inspector? 4 A Correct. 5 Q Did you understand that he was doing an 6 inspection on behalf of EPA? 7 A I understand he was picking up some materials on 8 behalf of EPA. 9 Q Did you ask him anything about your labeling, 10 advertising, and marketing? 11 A No. 12 Q Another business decision? 13 A I didn't think he had anything to offer. So, 14 yes. 15 Q Yes. Was that the answer, yes? 16 A Yes. 17 Q After Mr. Saatkamp came on August 11th, the 18 question that Mr. McIlnay asked you was, did 19 anyone contact you from the EPA after that 20 inspection. Did anyone contact you from EPA? I 21 think your answer was, no. I'm just trying to 22 make sure I understood that. 23 A No. The first contact was the intent to file 24 a -- 25 Q Did you contact the EPA at that point? 0698 1 A Well, I contacted Mr. McIlnay, and we responded 2 to the letter. 3 Q Okay. So you waited for our letter to come, 4 correct? 5 A I didn't anticipate a letter coming, but it 6 arrived. 7 Q You were hoping it wouldn't come, correct? 8 A Nobody wants the EPA to come calling. 9 Q All right. It was a daunting letter, I imagine, 10 yes, to get the EPA sending you a letter; is that 11 correct? 12 A I'm not easily daunted. 13 Q Okay. But as you said, you don't want EPA coming 14 to call on you, correct? 15 A Correct. 16 Q And it was at that point then you contacted EPA, 17 correct? 18 A Correct. 19 Q And we made you aware at our meeting in February 20 of 2007 that labeling means more than just the 21 physical label on the container. It means the 22 advertising and the marketing and the claims, 23 correct? 24 A Correct. 25 Q You mentioned earlier that NSF asked you to 0699 1 change your labels, as you understood it, labels. 2 And you said something about the fact that you 3 changed your labels to protect the preservative 4 at that time, as opposed to protect the food; is 5 that correct? 6 MR. MCILNAY: Protect the lubricant. 7 THE WITNESS: Preserve the lubricant. 8 BY MS. O'MEARA: 9 Q I'm sorry. Preserve the lubricant, as opposed to 10 protect the food; is that correct? 11 A Correct. 12 Q Do you have any labels in the record that show 13 that there were, at any time, any advertising 14 that stated that the lubricant with the Micronox 15 antimicrobial technology was intended to protect 16 any food, any processed food? 17 A I don't know. 18 Q You don't know if there is any such label? 19 A I don't know. 20 Q Because you said something to the effect that you 21 took NSF's advice, and it seemed to imply that 22 you had labeling claims that were different 23 before. Is that -- am I assuming an incorrect 24 assumption? Did you have different labeling 25 claims? 0700 1 A We did change labels, under the threat of 2 revocation of our letters. 3 Q Did you change them from claims that it was 4 effective against E. coli, Salmonella, and 5 Listeria? 6 A We tried to change them to comply with what they 7 were requesting. 8 MR. MCILNAY: Mr. Peter, answer her 9 question, please. 10 THE WITNESS: The question again? 11 BY MS. O'MEARA: 12 Q Did you change the labels to remove claims that 13 it was effective against E. coli, Salmonella, and 14 Listeria? 15 A To the best of my knowledge, that was one of the 16 claims they wanted removed. 17 Q Were there any claims, prior to changing them 18 because NSF asked you to, that said that the 19 lubricant's Micronox antimicrobial technology was 20 targeting food, processed food? 21 A I don't know. Possibly, but I do not know. 22 Q But we don't have any of those today, correct? 23 A No, but we don't target food. We target food 24 pathogens. You target food pathogens, not food. 25 Okay. 0701 1 Q And you're aware that the general public 2 understands that E. coli, Salmonella, and 3 Listeria are food pathogens, correct? 4 A There's been enough publicity. 5 Q Yeah. And you put these types of claims in there 6 to distinguish your lubricants from your 7 competitor's, correct? 8 A Correct. 9 Q And you thought that that would actually help 10 with your sales, correct? 11 A Correct. 12 Q Buy yet you are concerned that if your lubricants 13 are called pesticides, that that will change your 14 sales, make them decrease; is that correct? 15 A Correct. 16 Q And wasn't the testimony that Jennie-O -- first 17 of all, let me just clarify one thing about 18 Jennie-O. You testified that Jennie-O -- that 19 somebody came to Jennie-O, and Jennie-O then 20 switched their use of your lubricants to Petro 21 Canada's Microl lubricant, correct? 22 A That's what I've been told, correct. 23 Q That's what you've been told? 24 A Correct. 25 Q Okay. And I think the question was when 0702 1 Mr. Bonace did all the investigations, are you 2 aware that Mr. Bonace did not come to Jennie-O 3 Turkey Store? 4 A Yes. 5 Q It was a different inspector, in fact, not one 6 from U.S. EPA. Are you aware of that? 7 A Yes. 8 Q Okay. Let's go back to Jennie-O then. Your 9 declaration states that Jennie-O switched from 10 your product from Micronox to MICROL. Petro 11 Canada's product, correct? 12 A Neither of those are products. 13 Q I'm sorry. To the lubricant, your lubricant 14 containing Micronox, and they switched to Petro 15 Canada's lubricant, which is also food-grade 16 lubricant, containing MICROL, correct? 17 MR. MCILNAY: I'm going to object. 18 THE WITNESS: Correct. 19 MR. MCILNAY: Well, you've answered. 20 The record will show what his direct testimony 21 was. I don't believe there was any preference to 22 Petro Canada and MICROL on direct, but the record 23 will show. 24 BY MS. O'MEARA: 25 Q I can help clarify the record. Does your 0703 1 declaration state that as result of EPA's 2 investigation Jennie-O started to use -- switched 3 over to Petro Canada's MICROL product instead of 4 Behnke's lubricants with Micronox in it? 5 A I don't know if those are the exact words. 6 Q I imagine they're not. But just generally 7 speaking, is that what your declaration states. 8 A Generally speaking, yes. 9 Q Okay. And you're aware that the MICROL product, 10 MICROL additive that's in Petro Canada's 11 lubricant, food-grade lubricant, is registered 12 with the EPA, correct? 13 A Yes. 14 Q Okay. So their sales aren't suffering because 15 they registered their lubricant, correct? 16 MR. MCILNAY: Object, calls for him 17 to speculate as to their sales suffering. We 18 know about -- 19 JUDGE GUNNING: Sustained. 20 MS. O'MEARA: I'll withdraw the 21 question. 22 BY MS. O'MEARA: 23 Q Your customers chose to go to somebody that had a 24 registered product, correct? 25 MR. MCILNAY: One customer. 0704 1 Objection, Your Honor. 2 BY MS. O'MEARA: 3 Q Your customer, Jennie-O, chose to go to a 4 lubricant that had a registered additive in it, 5 correct, with EPA? 6 A Correct. 7 Q I'm sorry. Your answer? 8 A Correct. 9 Q Thank you. 10 A I can't know their motivation, but that's 11 correct. 12 MR. MCILNAY: Your Honor, could -- 13 you answered the question. 14 BY MS. O'MEARA: 15 Q Now, you testified on direct examination that EPA 16 approvals were long and expensive. Did you mean 17 the EPA registration process? 18 A Correct. 19 Q Is that why you won't register your product, your 20 lubricants? 21 A No. 22 Q Is it part of the reason why you won't register 23 your lubricants? 24 A It may play a small part. 25 Q So another business decision, correct? 0705 1 A Correct. 2 Q You said that you did a market study with respect 3 to determining if your customers would buy your 4 product if it was registered with EPA; is that 5 correct? 6 A Correct. 7 Q Is that market study present in the record today? 8 A No. It was -- no. 9 Q You also talked about your concern with 10 litigation that might occur if food-grade 11 lubricant had EPA pesticides in it, identified 12 EPA pesticides in it, correct? 13 A Correct. 14 Q Have you considered the ramifications of telling 15 your customers that your lubricant can substitute 16 sanitization processes? 17 A Yes, we have considered that. 18 Q Is that a bigger risk then? 19 A We considered it and made a point to remove that 20 reference. 21 Q Okay. So you weighed your risks, and you decided 22 the risk of litigation that might occur if the 23 food-grade lubricant had a pesticide number on it 24 outweighed the risk of complying with EPA FIFRA 25 regulations; is that correct? 0706 1 A The risk of litigation I was referring to was not 2 my risk of litigation. It was my customers' risk 3 of litigation. 4 Q Okay. I just want to clarify this, because you 5 testified that you tried to remove some of the 6 claims. Did you try to remove them off the 7 internet as well, the antimicrobial claims? 8 A The entire internet? 9 Q No, your web site. 10 A Our web site. I tried to remove them off our web 11 site, yes. 12 Q And you're aware now that you weren't successful 13 in that attempt? 14 A I'm aware. Hopefully, we are successful as of 15 today. 16 JUDGE GUNNING: At this stage my 17 suggestion is that he take a very short break, 18 and that would allow counsel to consolidate any 19 additional questions on cross, so that we can 20 bring this to a quick close. 21 MS. O'MEARA: Okay. 22 (A recess was taken.) 23 JUDGE GUNNING: Hopefully we'll be 24 able to get this down a little bit on cross. 25 MS. O'MEARA: I will try, yes. 0707 1 JUDGE GUNNING: Thank you. 2 MS. O'MEARA: Thank you. 3 BY MS. O'MEARA: 4 Q Mr. Peter, if we could talk about your 5 distributors for a moment. Is FMC one of your 6 distributors -- or they're a private label. I'm 7 sorry. 8 A Private label customer. 9 Q Let's talk about private label for a second. 10 They're a private label customer. Do you supply 11 them with advertising? 12 A No. 13 Q You don't supply them with your advertising 14 material? 15 A We supply -- we supply them with our product data 16 sheets and other information, so if that's what 17 you meant by the question, yes, they would have 18 access to ours. 19 Q Okay. And are you aware -- 20 JUDGE GUNNING: If everyone could 21 keep their voices up a little. 22 BY MS. O'MEARA: 23 Q Are you aware that on the internet they, too, are 24 making the same sorts of claims as Behnke is? 25 A Yes, I'm aware. 0708 1 Q And you said that they're on call, waiting to 2 hear from you about what changes they may have to 3 make, correct? 4 A Correct. 5 Q I'm just curious. Are you waiting for this 6 decision to -- what is the -- what event will 7 occur before you tell them to make a change? 8 A A decision on whether the EPA has jurisdiction 9 over our products. 10 Q Are you waiting -- you said earlier that you're 11 waiting for a decision. But you couldn't come to 12 EPA about it, correct? 13 A We are an FDA-regulated item, have been for 47 14 years. 15 Q Okay. So you -- 16 A So the FDA is my controlling agency. It's the 17 agency that I go to for information. 18 Q I understand. Are you waiting for FDA to tell 19 you when or if you have to register your products 20 with EPA? 21 A I would love to hear something from FDA. 22 Q And you realize, though, they don't have any 23 jurisdiction over understanding -- as we do, over 24 the EPA regulations and statute, correct? And 25 they don't have the authority to make that 0709 1 decision, correct? 2 A I disagree. But -- 3 Q You also said that you have a number of 4 distributors, correct? 5 A Correct. 6 Q And they're also on call waiting to hear from 7 you, correct? 8 A Our branded distributors that sell JAX brand? 9 Those that know or know that we have this action 10 pending are on call, right. 11 Q Have you told everybody, all your -- how many 12 distributors do you have, Mr. Peter? 13 A I don't know the number. 14 Q Over 10? 15 A Yes. 16 Q Over 20? 17 A Over 50. 18 Q Over 50. And have you contacted all your 19 distributors about this? 20 A No. 21 Q Now, you said there were some laboratory tests 22 that were done, the underlying data of these 23 charts. Are those in the record today? 24 A I don't know. 25 Q Were you asked to supply those for the purpose of 0710 1 this? 2 A I don't know. 3 Q You don't know. You said -- strike that. 4 MS. O'MEARA: May I have a moment? 5 JUDGE GUNNING: Yes. 6 MS. O'MEARA: Thank you. 7 Thank you, Your Honor. 8 BY MS. O'MEARA: 9 Q Now, you said earlier that your lubricants with 10 the Micronox technology were intended to target 11 food pathogens; is that correct? 12 A Correct. 13 Q Are you still stating today that they're intended 14 to target them on food? 15 A Correct. 16 Q Only on processed food? 17 A Only on processed food? That's correct. 18 Q Could it be on raw food as well, raw agricultural 19 commodities as well? 20 MR. MCILNAY: Objection, Your Honor, 21 to the extent that that calls for a legal 22 conclusion. As Your Honor and Counsel -- 23 MS. O'MEARA: I'll restate it. 24 MR. MCILNAY: RAC's are a term of 25 art. 0711 1 BY MS. O'MEARA: 2 Q Could it be targeting, let's just say, fruit that 3 hasn't been washed, organisms on fruit that 4 hasn't been washed? 5 A I don't know how it would get on fruit that 6 hasn't been washed. 7 Q How about nuts, we talked about nuts. Could it 8 be targeting nuts that are still in their shell, 9 going through a conveyor belt with a lubrication 10 above? 11 A I don't know what the pathogens would be on the 12 nuts. 13 Q But you would sell that lubricant to a facility 14 that perhaps would be handling that scenario that 15 I just described, correct? 16 A Yes. 17 Q Are you stating today -- I just want to clarify 18 because I can get rid of a bunch of questions if 19 I get the answer I'm looking for -- that the 20 lubricant is not a food, a processed food? 21 A No. 22 Q I'm sorry. Let me clarify the question. Is the 23 lubricant, are you claiming that the lubricant is 24 a processed food? 25 A That lubricant itself is a processed food? 0712 1 Q Yes. 2 A No. 3 Q So you wouldn't eat the lubricant, correct? 4 A Not intentionally. 5 Q Not intentionally. You wouldn't put it on a 6 cracker and eat it, would you? 7 A Not intentionally. 8 Q In fact, what the target is about is killing the 9 microorganism in the lubricant itself so it 10 doesn't cause cross-contamination, correct? 11 A I don't think that's an accurate description. 12 Q Would it be accurate to say that you call a 13 lubricant a hot spot? 14 A A lubricant a hot spot? I don't know if that's 15 an accurate description. 16 Q Mr. Peter, did you write your declaration? 17 A I wrote the first draft. 18 Q Okay. Can you turn to your declaration. I'm 19 sorry, let's find out what exhibit that is, 20 Respondent's Exhibit. I'm sorry, I have it here. 21 Respondent's Exhibit 61. I'm sorry. And if you 22 could turn to Paragraph 16, which is Page 5 of 23 your declaration, please. Can you read the last 24 sentence in Paragraph 16, please? 25 A Our customer asked whether Behnke could formulate 0713 1 a food-grade H1 lubricant that could reduce the 2 risks of such cross-contamination, thus 3 eliminating the lubricant as a hot spot for 4 microbial contamination under the processor's 5 HACCP evaluation process. 6 Q Okay. So let me ask you the question again. Do 7 you believe that the lubricant is a hot spot for 8 organisms such as E. coli, Salmonella, and 9 Listeria? 10 A I believe that's poorly worded. I don't believe 11 the lubricant can be a hot spot. 12 JUDGE GUNNING: Okay. I'm having 13 a -- there is some noise in the background, so 14 it's a little hard to -- what paragraph are you 15 in? 16 MS. O'MEARA: Paragraph 16 on Page 5 17 of Complainant's Exhibit 61, Your Honor. 18 JUDGE GUNNING: And if we could have 19 the court reporter read back the question and 20 answer, please. 21 (The question and answer were read.) 22 JUDGE GUNNING: Thank you. 23 BY MS. O'MEARA: 24 Q Is the Micronox technology in the lubricant to 25 kill E. coli, Salmonella, and Listeria within the 0714 1 lubricant itself? 2 A No. 3 Q Is the Micronox technology in the lubricant to 4 minimize cross-contamination? 5 A Cross-contamination in terms of when the 6 lubricant becomes deposited on the food product, 7 yes. 8 Q So would the Micronox technology kill the 9 E. coli, the Salmonella, or control it, the 10 E. Coli, Salmonella or Listeria, when the 11 bacteria gets into the lubricant, because that's 12 where the technology is? 13 A Would it -- yes. 14 Q So kill it on contact in the lubricant, correct? 15 A I don't know the capabilities of, on contact, 16 but -- 17 Q It would kill it in the lubricant, correct? 18 A Eventually it would not survive in the lubricant 19 either. 20 Q Okay. So that when the lubricant drips down onto 21 the food, for example, it doesn't have a colony 22 growth of these E. coli, Salmonella and Listeria 23 bacteria in it, correct? 24 A Correct. 25 Q You said that you -- that the Micronox technology 0715 1 was not in the lubricant to preserve itself; is 2 that correct? 3 A Correct. 4 Q But some of your advertising, you will admit, 5 says that it is in there to preserve itself, 6 correct? 7 A Correct. 8 Q Would you also admit that in the NSF lawsuit -- 9 well, let's turn to it. It's again Complainant's 10 Exhibit 36. I'd ask you to turn to Page 2 of 11 that which is EPA 751. EPA 751. 12 Could you read into the record, 13 please, starting, The Micronox product, which is 14 the third full sentence, please. 15 MR. MCILNAY: Of which paragraph? 16 MS. O'MEARA: Paragraph 5 on page EPA 17 0751. 18 THE WITNESS: The Micronox product 19 has antimicrobial properties which no competing 20 product contain. These properties extend the 21 useful lives of the food-grade lubricants 22 containing Micronox. It does this by retarding 23 bacterial growth in the lubricant, which 24 bacterial growth otherwise would degrade the 25 lubricants and make them potential harbors for 0716 1 bacteria. 2 BY MS. O'MEARA: 3 Q Thank you. So is that not correct? 4 A That's not correct. 5 Q And your advertising isn't correct either, 6 correct, that says that the lubricant is there to 7 preserve itself -- I mean, sorry -- the Micronox 8 in the lubricant is there to preserve the 9 lubricant itself? 10 A It's incorrect that the microbes will degrade the 11 lubricant. 12 Q Okay. I understand that. Is it correct that the 13 Micronox technology was intended to kill the 14 E. coli and Salmonella and Listeria in the 15 lubricants? 16 A It will do that, but that's not what it was 17 intended for. 18 Q Is it correct that some of your advertising 19 literature says that it will do that? 20 A Yes. 21 Q Okay. Have you submitted any efficacy testing to 22 EPA? 23 A No. 24 Q Have you submitted any efficacy testing to any 25 governmental agency? 0717 1 A No, not to the best of my knowledge. 2 Q Have you submitted any efficacy testing for the 3 Micronox technology to FDA? 4 A No. 5 Q And these lubricants are actually intended to be 6 on the equipment, correct, to help moving parts, 7 correct? 8 A Intended to lubricate the equipment, correct. 9 Q Okay. Do you tell any of your salespeople to 10 market your products by telling them that -- let 11 me restate that. Do you train your salespeople 12 with respect to Micronox technology? 13 A Not personally. 14 Q But ultimately you're responsible for it, 15 correct? 16 A Yes. 17 Q Do you know if in the training they're told to 18 tell their customers that the lubricant should be 19 listed as an ingredient because it's going to be 20 in food? 21 A No. 22 Q You don't know or -- 23 A No. 24 Q -- they don't? 25 A No. 0718 1 Q Do they tell your customers to list the -- 2 A That wasn't your question. 3 Q All right. Well, I'll ask another one. Do your 4 salespeople tell your customers to list the 5 lubricant as an ingredient in the processed food? 6 A I would think it would be likely they would not. 7 Q Okay. But -- okay. In fact, the FDA regulations 8 don't allow Behnke to add the lubricants into the 9 food directly; do they? 10 A Correct. 11 Q And the lubricants with Micronox technology are 12 not designed to be applied onto or added into the 13 food under FDA, correct? 14 A Correct. 15 Q Do you know if any of your customers actually 16 list them as ingredients in their food? 17 A I sincerely doubt it. 18 Q Okay. 19 MR. MCILNAY: Her question was, do 20 you know. 21 THE WITNESS: I do not know. 22 BY MS. O'MEARA: 23 Q Do you know if anybody lists them on the 24 nutrition labels? 25 A I do not know. 0719 1 Q Do you doubt it? 2 A I doubt it. 3 Q In fact, the lubricants are not actually intended 4 to become a component of the food, correct? 5 A Not intended, but they do. 6 Q Trace amounts of it, correct? 7 A Sometimes not trace amounts. 8 Q Okay. But that's not the intent, correct? 9 A That's not the intent. 10 Q Thank you. And the lubricants aren't intended to 11 have any sort of technical effect on food, are 12 they? 13 A No. 14 Q And they're not intended to actually get into the 15 food, correct? 16 A Not intended to. 17 Q Okay. None of your advertising or marketing 18 literature advises your potential customers to 19 list the lubricants as food, as ingredients in 20 food, correct? 21 A Correct. 22 Q And none of your advertising or marketing or 23 labeling literature tells your potential 24 customers that deadly organisms like E. coli, 25 Salmonella and Listeria will be killed upon 0720 1 contact on food, right, when the Micronox hits 2 it? 3 A I do not believe currently it should say any of 4 that. 5 MS. O'MEARA: I'm trying to move 6 through this, Your Honor. 7 BY MS. O'MEARA: 8 Q Probably be a bad business decision to advertise 9 the lubricants as a possible ingredient in 10 processed food, correct? 11 A I'm not a food processor, so I can't answer that. 12 Q Is the Micronox antimicrobial technology an 13 integral part of the lubricant? 14 A Yes. 15 MS. O'MEARA: Can I have a moment, 16 please? 17 JUDGE GUNNING: Yes. 18 MS. O'MEARA: Thank you. 19 BY MS. O'MEARA: 20 Q Mr. Peter, just going back to FMC for a second. 21 Are you aware that they still advertise their 22 products to have Micronox antimicrobial 23 properties that controls E. coli, Salmonella and 24 Listeria? 25 A Yes. 0721 1 Q Okay. 2 MS. O'MEARA: Your Honor, at this 3 time I ask to move Complainant's Exhibit 71 into 4 the record. It is all the advertising relating 5 to FMC. 6 MR. MCILNAY: I'm sorry. I 7 haven't -- 8 MS. O'MEARA: Complainant's 9 Exhibit 71. 10 MR. MCILNAY: I understand. 11 Your Honor, I'm going to strenuously 12 object to the relevancy of these exhibits. First 13 of all, the subject of this complaint are my 14 client's claims in its literature and in its own 15 documentation, number one. 16 Number two, even if it were to go to 17 the issue of gravity, Your Honor, it's clearly 18 been testified to that this is advertising 19 submitted by someone who is not here to discuss 20 why and for what purpose they chose to put this 21 in their advertising; although, Mr. Peter did 22 testify that they're aware of this action. I 23 just don't see any relevancy whatsoever to issues 24 in this matter that's before you today. 25 MS. O'MEARA: May I respond, Your 0722 1 Honor? 2 JUDGE GUNNING: Yes. 3 MS. O'MEARA: Your Honor, I think 4 they're relevant for a number of reasons. One, 5 is we've determined that Behnke private labeled 6 for FMC. 7 Two, is that we've determined that in 8 the advertising materials that I'm trying to move 9 into evidence the word Micronox is used, which is 10 a proprietary trademark of Behnke, so there's a 11 clear connection. 12 And, three, is that if you look at -- 13 and in the interest of brevity I didn't go 14 through this, but if you compare the two claims, 15 they're identical. And so I would submit that 16 this is just an extension of what we're talking 17 about here today, Behnke and the claims that are 18 being made. 19 JUDGE GUNNING: Okay. What I'm going 20 to do is sustain the objection, but allow you to 21 ask additional questions concerning the exhibit. 22 And also if you would like to make a very brief 23 offer of proof. 24 MS. O'MEARA: Sure, I can do that. 25 JUDGE GUNNING: I think this was -- 0723 1 you just did that, but if you would like to enter 2 that into the record. 3 MS. O'MEARA: Yes, I will make an 4 offer of proof for Complainant's Exhibit 71. 5 Your Honor, if Mr. Peter were to 6 testify, I would ask him to look through this 7 material and he would tell Your Honor that on EPA 8 1541, which is for a product called Formula 410 9 XLT, the language there states, incorporates new, 10 proprietary antimicrobial additive technology 11 Micronox for enhanced protection against a wide 12 variety of microbial agents, including yeasts, 13 molds, gram-positive and gram-negative bacteria. 14 A first in food-grade lubricant, Micronox 15 provides significant knockdown performance and 16 has proven especially effective against Listeria, 17 and then its correct scientific name -- I won't 18 attempt it -- E. coli, and its correct scientific 19 name, and Salmonella, and its correct scientific 20 name, on constant and over extended lubrication 21 intervals. 22 I would then have him turn to page 23 EPA 1543 for a product called Formula 10 Aerosol, 24 and have him read the language, and it would be 25 essentially the same language. 0724 1 I would then direct him to EPA 1545 2 for Formula 10 and have him read that language, 3 and the language would be essentially the same. 4 And then 1547 for a product entitled 5 Formula 322, and the language would be 6 substantially the same. 7 I would then ask him -- I'm sorry -- 8 and I would direct him to EPA 1549 and have him 9 read the second paragraph on, how does it work. 10 Actually, let me read this one. Formula 410 11 Phylax -- which has a trademark on it -- 12 incorporates new proprietary antimicrobial 13 additive technology for enhanced antimicrobial 14 protection against a wide variety of microbial 15 agents, including yeasts, molds, gram-positive 16 and gram-negative bacteria. A first in 17 food-grade lubricant, the antimicrobial additive 18 provides significant knockdown and ongoing growth 19 retardant performance in the lubricant and has 20 proven especially effective against Listeria, and 21 then the scientific name, E. coli, and then the 22 scientific name, and Salmonella, and then the 23 scientific name, on contact and over extended 24 lubrication intervals. 25 I would then ask him if that language 0725 1 is similar to much of the language we've already 2 discussed regarding the Behnke Lubricants, the 3 five lubricants we've been talking about. And 4 although I can't answer for him, it is similar or 5 identical at times. 6 JUDGE GUNNING: Okay. Thank you. 7 So Claimant's's Exhibit No. 71 is 8 marked as rejected. And that offer of proof has 9 been offered by Counsel. 10 MS. O'MEARA: Thank you. 11 JUDGE GUNNING: Thank you. 12 MS. O'MEARA: May I have one minute 13 Your Honor, please? 14 JUDGE GUNNING: Yes. 15 MS. O'MEARA: I have no further 16 questions at this time. 17 JUDGE GUNNING: Thank you. 18 I'd really like to conclude with this 19 witness this evening. I'm sure you would 20 appreciate it also. 21 THE WITNESS: I would. 22 MS. O'MEARA: Thank you, Your Honor. 23 JUDGE GUNNING: You're welcome. 24 EXAMINATION 25 BY MR. MCILNAY: 0726 1 Q Mr. Peter, you were asked a number of questions 2 by Attorney O'Meara about whether or not you 3 would sell your lubricants, for example, to a toy 4 company that might be concerned that the 5 lubricant dripping on the toy would have a human 6 pathogen, and maybe a kid would put the toy in 7 his mouth. Are you willing to limit your label 8 to say that the antimicrobials are good only for 9 processed foods? 10 A Yes. 11 Q Now, in that regard Attorney O'Meara asked you if 12 there were any documents or labels in the record 13 that stated that the purpose of MICROL -- or 14 Micronox, my apologies; maybe we do have a 15 trademark infringement -- Micronox, was targeting 16 food. Do you recall that question from Attorney 17 O'Meara? 18 A Yes. 19 Q All right. Now, we spent hours in two days going 20 through all of the materials that made reference 21 to Listeria, Salmonella, and E. coli. Do you 22 agree with Dr. Blackburn's testimony that those 23 are not deleterious to the lubricant itself? 24 A Yes. 25 Q And why did you choose those? 0727 1 A We chose those because those are the typical food 2 pathogens that our customers are most concerned 3 with, and those were the ones that we wanted to 4 prove that we had some effectiveness against, and 5 those were the ones that we felt, since they were 6 on or in food, we would be in line with the FDA 7 guidelines of protecting against pathogens in or 8 on food. 9 Q This is your -- I'm holding up a copy of the code 10 of Federal Regulation 21, part 170. Is this your 11 book? 12 A Yes. 13 Q Okay. When I say yours, I mean it's owned by 14 Behnke, correct? 15 A Yes. 16 Q Okay. I apologize, but I know on direct 17 examination you did not indicate that you'd 18 received a law degree; is that correct? 19 A Correct. 20 Q And did you -- I don't know if you can do this 21 anymore -- did you study in any state to pass the 22 bar without a law degree? 23 A No. 24 Q Have you specifically studied 21 CFR for its 25 definition of processed foods? 0728 1 A Not in -- no, not in any great detail. 2 Q So your opinion that the lubricant, even that 3 lubricant that might become part of the food 4 incidentally, that it's not processed food. That 5 testimony is your lay understanding; is that 6 accurate? 7 A Correct. 8 Q Could you turn to Claimant's Exhibit 36. That's 9 the Complaint. Attorney O'Meara asked you 10 something about Paragraph 22 of Exhibit 36. I 11 did not write down -- it's Paragraph 22 of the 12 Complaint contained in that, and it will take me 13 just a moment to find the EPA number. 14 MS. O'MEARA: Are you looking for the 15 EPA number for Paragraph 22? 16 MR. MCILNAY: Yes, of the Complaint. 17 MS. O'MEARA: It EPA 0756. 18 MR. MCILNAY: Thank you. 19 MS. O'MEARA: You're welcome. 20 BY MR. MCILNAY: 21 Q Have you found that page? 22 A Yes. 23 Q Okay. Do you recall the question, you were asked 24 about that? 25 A There have been a lot of questions. 0729 1 Q Okay. Well, I want to focus your attention on 2 the sentence that says, This is so because EPA 3 restrictions and controls on the use of 4 pesticides by such producers and packagers. Do 5 you see that sentence? 6 A Yes. 7 Q Did you draft that sentence or did the attorney 8 that signed this pleading draft that sentence? 9 A The attorney did. 10 Q Okay. If I substituted the acronym FDA for EPA 11 in that sentence, in its context, were Behnke to 12 identify the Micronox product as a pesticide, the 13 Micronox product would no longer be accepted by 14 producers and packagers of food products intended 15 for human consumption. This is so because FDA 16 restrictions and controls on the use of 17 pesticides by such producers and packagers. 18 Would you agree with that statement? 19 MS. O'MEARA: Your Honor, I'm going 20 to object. I don't see the relevance. 21 MR. MCILNAY: Well, she was trying to 22 suggest that he didn't want to comply with the 23 EPA because they would have control at that point 24 in time. I'm suggesting this is a typo. 25 JUDGE GUNNING: Okay. 0730 1 BY MR. MCILNAY: 2 Q Would that make more sense to you, sir? 3 JUDGE GUNNING: I'll allow the 4 question. 5 MR. MCILNAY: What? 6 JUDGE GUNNING: There was an 7 objection, so I'll allow the question. 8 MR. MCILNAY: Do you need it read 9 back? 10 THE WITNESS: I don't know if there 11 was a question. Go ahead. 12 (The question was read.) 13 THE WITNESS: I don't understand the 14 question, but the problem I have is with the word 15 pesticide. 16 BY MR. MCILNAY: 17 Q Okay. Let me rephrase the question. If the 18 paragraph, those first two sentences were to 19 read, were Behnke to identify the Micronox 20 product as a pesticide, the Micronox product 21 would no longer be accepted by producers and 22 packagers of food products intended for human 23 consumption. This is so because FDA restrictions 24 and controls on the use of pesticides by such 25 producers and packagers. As I amended it, 0731 1 substituting FDA for EPA, would that make more 2 sense to you? And if it doesn't, that's a fair 3 answer. 4 A It doesn't make more sense but -- 5 Q Okay. Fair enough. While you made that -- while 6 you're there. -- strike that. 7 Mr. Peter, you were asked by Attorney 8 O'Meara whether your advertising indicating that 9 Micronox was intended to serve as a preservative 10 or protect the product itself was not a true 11 statement. And I think your answer was, yes. 12 Why did you include that statement in the 13 advertising? 14 A That was the statement wording that came from 15 NSF, that they -- one of the stages that they 16 said that was their preferred wording. 17 Q Was it your intent to deceive your customers? 18 A No. 19 Q In your dealings with NSF, are you aware of 20 communications occurring between EPA and NSF 21 personnel concerning specifically Micronox? 22 A Yes. 23 Q And how are -- 24 MS. O'MEARA: Objection, Your Honor. 25 There is no foundation for that. 0732 1 BY MR. MCILNAY: 2 Q Well, how are you aware of it? 3 JUDGE GUNNING: Okay. 4 THE WITNESS: I'm aware of it because 5 of a series of communications with Dr. Yano about 6 the word Micronox. 7 BY MR. MCILNAY: 8 Q And specifically did Dr. Yano provide you with 9 copies of communications he had with EPA? 10 A Yes. 11 MS. O'MEARA: Objection, Your Honor. 12 There is no foundation for that. It's not in the 13 record. 14 MR. MCILNAY: Well, it's not in the 15 record as an exhibit, but I think he can testify 16 to it. 17 JUDGE GUNNING: To his personal 18 knowledge, I'll allow the question. 19 MR. MCILNAY: Okay. 20 BY MR. MCILNAY: 21 Q Just so the record is crystal clear. I think the 22 question was, after you received the 23 December 2006 notice of intent to file, that's 24 when you contacted the EPA? 25 A Yes. 0733 1 Q And my question is, did you, Eric Peter, 2 individually contact the EPA at that point? 3 A I don't remember. I think you probably did. 4 Q To your personal knowledge, to your personal 5 knowledge, has any nonfood processor approached 6 Behnke and requested to buy any of your 7 food-grade lubricants? 8 JUDGE GUNNING: I can't hear. 9 BY MR. MCILNAY: 10 Q And requested to purchase your nonfood-grade 11 lubricants? 12 A A nonfood processor requested to purchase our 13 nonfood-grade lubricants? 14 Q I'm sorry. A nonfood processor requested to 15 purchase your food-grade lubricants, your H1 16 lubricants? 17 A To my personal knowledge, I don't know. 18 Q You don't know? 19 A I don't know. 20 MR. MCILNAY: Thank you. 21 MS. O'MEARA: Just a couple of 22 redirect. I promise. 23 EXAMINATION 24 BY MS. O'MEARA: 25 Q Mr. Peter, you were asked if you were willing to 0734 1 limit your label to only food -- to only 2 customers that are food processors. Is there 3 anything on your label currently or at the time 4 that you sold the products previously that limit 5 the label? 6 A Not in such language. 7 Q Do your labels in any way limit to just food 8 processors? 9 A Well, our labels are directed at food processing 10 equipment completely. 11 Q Now, Mr. McIlnay showed you the FDA regulations 12 that Behnke owns. Does Behnke own a set of EPA 13 regulations like this one? 14 A I am not aware that we do, but -- 15 Q 40 CFR 150 through -- 16 A -- Mr. Paquette may know. 17 Q Are you aware that the definition of on or in 18 processed food is not in the FDA regulations? 19 A I'm aware it's in some federal document. 20 Q Do you know if it's in the FDA regulations? 21 A On or in processed food? 22 Q Correct. 23 A I don't know. 24 Q And the letters between EPA and Dr. Yano, do you 25 have those today? 0735 1 A I have perhaps e-mail copies of correspondence 2 between Dr. Yano and EPA, but I don't have them 3 with me today. 4 Q Okay. One last question. I just want to clarify 5 the confusion over Paragraph 22, whether it meant 6 to say EPA or FDA. If you could look at 7 Paragraph 21. It's Complainant's Exhibit 36, EPA 8 756. And just because I know everybody wants to 9 get home, I will read it to you. It says, NSF 10 went further and demanded that Behnke seek 11 approval from the United States Environmental 12 Protection Agency, and in parentheses, EPA, to 13 register the Micronox product with EPA as a 14 pesticide and to label and identify the Micronox 15 product as a pesticide. Do you see that? 16 A Yes. 17 Q And then the next paragraph then carries on, on 18 that discussion and says, this is so because of 19 EPA restrictions. Do you see that? 20 A Yes. 21 Q Okay. 22 MS. O'MEARA: No further questions. 23 Thank you. 24 MR. MCILNAY: Nothing further, Your 25 Honor. 0736 1 JUDGE GUNNING: Okay. Does Counsel 2 wish to preserve this witness? 3 MR. MCILNAY: Yes, Your Honor. 4 JUDGE GUNNING: Okay. Your testimony 5 is taken today, but you are not excused. Okay. 6 Thank you very much. 7 Now, logistically, how many more 8 witnesses? 9 MR. MCILNAY: Your Honor, my next 10 witness would be Mr. Paquette. We clearly will 11 not finish his direct, but I am quite willing to 12 get started, go until 6:00 o'clock. I will want 13 to consult with my co-counsel and my client 14 tonight after the testimony. At the close of 15 their case, I may even further whittle -- 16 MS. O'MEARA: I'm sorry. I can't 17 hear you. 18 MR. MCILNAY: I may even further 19 whittle down our witness list. 20 JUDGE GUNNING: Okay. Because the 21 caveat is tomorrow and Friday, we must be out of 22 here by 5:00 o'clock, which means 4:30 probably. 23 We have to pack up. 24 MR. MCILNAY: Right. For that 25 reason, I would suggest that perhaps we get 0737 1 started with Mr. Paquette and go until six. 2 JUDGE GUNNING: Okay. That would be 3 fine. 4 MS. O'MEARA: I have no objection, 5 Your Honor. 6 MR. MCILNAY: I could use two or 7 three minutes. 8 JUDGE GUNNING: Okay. Let's take 9 five minutes. 10 (A recess was taken.) 11 MR. MCILNAY: While I'm pulling up 12 documents, I would like to put a couple of offers 13 on the record. One, being that should EPA desire 14 the production of the correspondence that's still 15 in Mr. Peter's possession between Dr. Yano and 16 the EPA, we'd be happy to produce it. And I 17 would also offer to EPA that we would offer any 18 of the efficacy study data that they would desire 19 to have. We would be willing to give that to our 20 customers, and we would be willing to give it to 21 the EPA. 22 MR. CHA: Your Honor, I appreciate 23 the offer, but with all due respect, it's a 24 little late. I mean, unless we're going to keep 25 this hearing record open and retain the 0738 1 possibility of reconvening for a day or day and a 2 half, I don't see the value of that. 3 As far as the efficacy data goes, 4 this -- with all due respect, this is the wrong 5 forum. This is not the time or the place for 6 Behnke Lubricants to try to prove the efficacy. 7 That should be done with the Antimicrobials 8 Division in the Office of Pesticides Programs of 9 the U.S. EPA. That's the appropriate forum. To 10 review efficacy you need scientists, you need 11 scientists in a lab under scientific conditions. 12 You can't reproduce that in a courtroom. 13 JUDGE GUNNING: Yeah, inasmuch as 14 they were not part of the prehearing exchange, I 15 think it would be inappropriate to admit them 16 into the record. 17 MR. MCILNAY: Well, I'm merely making 18 the offer to provide it to them. They may do 19 with it what they wish. 20 JUDGE GUNNING: Okay. 21 MS. O'MEARA: Your Honor, if I could 22 just follow up on the efficacy issue. I think 23 Mr. Edwards testified that the results of the 24 efficacy testing are not the crux of this case. 25 The crux of this case is -- are the advertising, 0739 1 marketing, and labeling claims. So I would like 2 to remain focused on that. 3 MR. MCILNAY: I would agree. 4 I would call Mr. Paquette. 5 TROY PAQUETTE, called as a witness 6 herein, having been first duly sworn on oath, was 7 examined and testified as follows: 8 EXAMINATION 9 BY MR. MCILNAY: 10 Q Could you state your full name for the record and 11 spell your last name, please. 12 A Troy Francis Paquette, P-A-Q-U-E-T-T-E. 13 Q And, Mr. Paquette, where do you currently reside? 14 A Hartland, Wisconsin. 15 Q And, Mr. Paquette, do you hold any post high 16 school degrees of higher education? 17 A I have a bachelor of science from the University 18 of Wisconsin, Superior, with a double major in 19 chemistry and physics. 20 Q And when did you graduate from -- when did you 21 receive your degree? 22 A 1989. 23 Q And subsequent to 1989, did you take any further 24 courses of study, such as postgraduate work? 25 A I don't have any postgraduate work. 0740 1 Q None at all? 2 A None. 3 Q Okay. Vocationally, what did you do upon 4 graduating from the University of Wisconsin, 5 Superior? 6 A I spent four years teaching at a college 7 preparatory school, and then went to work in the 8 lubricant industry for a company named Amsoil for 9 about six years and a bit, and then joined Behnke 10 Lubricants a little over nine years ago. 11 Q Let's go back just a moment. Do you recall 12 approximately what year you started in the first 13 lubricant position? 14 A '93. 15 Q And I think you said the company's name was 16 Amsoil? 17 A Amsoil. 18 Q All right. What was your position at Amsoil? 19 A I started out in the quality control program, and 20 then graduated to chief chemist, and then 21 technical director. 22 Q And to speed things up a little bit, Amsoil is a 23 producer of synthetic lubricants? 24 A Correct. 25 Q So you started then with Behnke Lubricants in 0741 1 approximately what year? 2 A January of '99. 3 Q And what was your title when you were hired? 4 A Technical director. 5 Q What is your title -- are you still employed at 6 Behnke lubricants? 7 A I am still employed at Behnke Lubricants. 8 Q And what is your title now? 9 A I am the technical director. 10 Q And as technical director, let's focus on 2001 to 11 present, what are your duties and 12 responsibilities? 13 A Several. I oversee our quality control for 14 product production, I am responsible for our 15 product development, I oversee our used oil 16 analysis laboratory, and I also conduct our 17 competitor analysis. 18 MS. O'MEARA: I'm sorry. Can you 19 read back the last portion, just the last. 20 (The answer was read.) 21 BY MR. MCILNAY: 22 Q I'm sure that most of the focus will be on new 23 product development. However, what is the used 24 oil -- 25 A Used oil analysis. 0742 1 Q -- analysis? 2 A It's testing of samples of soil provided by 3 customers to determine whether or not the oil has 4 reached its useful life or whether or not we have 5 problems with the equipment. 6 Q And your competitor analysis, what does that 7 involve? 8 A We test quite a few of our competitor products 9 that we come up against out in the market, both 10 from a performance standpoint to ascertain where 11 we are as far as where we are in the industry for 12 performance. 13 Q All right. Both of the testing you do on used 14 oil and competitor analysis, where does that 15 testing take place? 16 A That testing is conducted in our laboratory at 17 Behnke Lubricants. 18 Q And that's located at -- 19 A In Menomonee Falls. 20 Q -- Menomonee Falls. Could you wait until I 21 finish my question? 22 A I certainly can. 23 Q I'm sure everybody is anxious to get out of here, 24 including you. 25 Your responsibilities for new product 0743 1 development, could you describe, at least at 2 first generally, for the Court, what you do? 3 A When we're looking at doing product development 4 work, a lot of it is dependent on what's the 5 stimulus for looking at it. Whether it's a new 6 piece of equipment may have come to market, it 7 may be a competitor's product all of a sudden got 8 a lot better, it may be that we've had customers 9 request either higher viscosity or lower 10 viscosity, essentially thicker or thinner oil, 11 ascertaining whether or not we've got good water 12 demulsibility. 13 Q Okay. And new product development brings to mind 14 that you come out with a brand new product, might 15 have a new product name, and so on. I'm just 16 curious, does it also include improvements to 17 existing products? 18 A That's part of the product development process. 19 Again, you know, whether it's a new product or a 20 reformulation, both are product development. 21 Q All right. And we heard some testimony from 22 Mr. Peter about compounding the lubricants. Do 23 you recall that? 24 A Yes. 25 Q All right. When a lubricant is compounded, at 0744 1 least in Behnke's plant, are there formulas or 2 something that the plant is given to know what 3 ingredients go in what product? 4 A Yes, correct. 5 Q All right. Does it fall under your auspices to 6 come up with those formulas for your products? 7 A I do the development work, or laboratory staff 8 may do the hands-on work, depending. Typically 9 we do, Mr. Peter and I do, review of the product 10 line annually -- 11 Q All right. 12 A -- to review product. 13 Q Okay. I want to focus on the technical, how do 14 the people on the production floor know what to 15 put in a HALO-Guard? 16 A The product formulations are controlled in a 17 database, of which our production personnel have 18 access to generate what we call a batch ticket. 19 And on the batch tickets, essentially it's a 20 recipe, for simplification, and it would list the 21 ingredients that would be going into that 22 particular product. And with the database they 23 would essentially set the amount that they want 24 to produce. Let's say it's 1,000 gallons or 25 5,000 gallons. And when they enter that into the 0745 1 database, it generates the quantities that need 2 to be placed into the blend kettle or the 3 reactor. 4 Q Okay. So a very simple term, they don't need to 5 calculate, if I want to make a double batch of 6 pancakes, what is two cups compared to -- 7 A We calculate that for you. 8 Q All right. And within Behnke, this is what I'm 9 trying to get at, is it your responsibility 10 ultimately to determine that those recipes are 11 what you want them to be? 12 A Correct. 13 Q Okay. Other than postgraduate work or college, 14 or even in your undergraduate, have you had 15 occasion to get education through industry 16 groups, seminars, that sort of thing? 17 A Yes. I'm a member of the Society of Tribologists 18 and Lubrication Engineers. 19 Q And a Tribologist would be somebody -- 20 A Tribology is the study -- 21 Q Please let me finish my question. It will be 22 much easier for Phyllis and the record. 23 A Okay. 24 Q You anticipated my question. A Tribologist is 25 somebody who deals in tribology. Could you tell 0746 1 the Court what tribology is? 2 A Simplest term, tribology is the study of friction 3 or movement between bodies. 4 Q All right. And as a member of that organization, 5 you have opportunities for continuing education? 6 A Correct. 7 Q Mr. Paquette, I want to focus, quickly get down 8 to the meat of this matter. Are you familiar 9 with 21 CFR 178.3570? 10 A Yes. 11 Q Is that a relevant code section to you? 12 A I'm sorry. Was that relevant or irrelevant? 13 Q Is it relevant? 14 A It's a relevant section, yes. 15 Q Okay. Why? 16 A The 178.3570 under the 21 CFR is where the 17 materials that I'm allowed to use for the 18 development and for the manufacture of H1 19 lubricants are defined. 20 Q And within Behnke, is it your responsibility to 21 confirm or make sure that your recipes for H1 22 lubricants fall within the confines of that 23 regulation? 24 A Within 21 CFR, because there are other sections 25 that are utilized. 0747 1 Q I understand. But -- 2 A That is correct. 3 Q As to that section, what I'm really asking you 4 is, at Behnke who, who is responsible for making 5 sure that the recipes fit within the section? 6 A It's my responsibility, sir. 7 Q All right. And from your testimony, I take it 8 that that particular section, but perhaps others, 9 they relate to the H1 lubricants? 10 A Correct. 11 Q Do they relate to any other lubricants? 12 A They specifically are addressing the incidental 13 food contact lubricants. 14 Q All right. Quickly, because in the interest of 15 time, we've heard testimony H1 lubricants is a 16 designation for the incidental food contact 17 lubricants? 18 A Correct. 19 Q Are there other designations, for example, H2? 20 A Yes. 21 Q Is that an incidental food contact lubricant 22 designation? 23 A No, it is not. 24 Q All right. So with regard to an H2 lubricant, do 25 you have to concern yourself with 21 CFR 178 -- 0748 1 you know the rest of it? 2 A No. 3 Q All right. Now, we heard Mr. Peter talk about 4 concocting new products and formulas. Are you 5 the person at Behnke that worked on the 6 development of what is now referred to as 7 Micronox technology? 8 A Yes, I am. 9 Q And you testified that with regard to your 10 product development, your new product 11 development, that there might be different 12 incentives for when you take on that task, for 13 example, a new piece of equipment, or a 14 competitor's product has improved. What was the 15 impetus for your work on what ultimately became 16 known as Micronox? 17 A A request was made of one of our salesmen from a 18 gentleman at Kraft with a question on whether or 19 not there was anything we could do to improve the 20 lubricant's ability to combat some pathogens. 21 Q And were they specific with regard to the 22 pathogens? 23 A Yes, they were. 24 Q And do you recall what those pathogens were? 25 A The pathogens of discussion were Listeria, 0749 1 E. coli and Salmonella. 2 Q And do you recall who the customer was? 3 A Kraft Foods. 4 Q All right. Did you, Mr. Paquette, set out to see 5 if you could do that? 6 A Yes, I did. 7 Q And can you tell the Court what it is you did? 8 A There's been various food additives that are 9 allowed under the 21 CFR that are GRAS, Generally 10 Recognized As Safe, that are food antimicrobials, 11 food additive antimicrobials. And we worked with 12 several different components there to see if we 13 could come up with something that would give us a 14 win. 15 Q All right. And let me make sure that I 16 understand your testimony and that the record is 17 clear. The initial go at this, you used 18 additives to the oil or to the lubricant that 19 were also GRAS? 20 A Correct. 21 Q And you referred to GRAS as food additives? 22 A Correct. 23 Q All right. Let me ask kind of a general 24 question, and then I want to come back to Kraft 25 and be more precise. We've heard testimony 0750 1 throughout this hearing that Micronox technology 2 is used in a broad range of H1 lubricants. Is 3 that consistent with your knowledge? 4 A That's correct. 5 Q Is the Micronox technology in all of those 6 lubricants identical with regard to the GRAS 7 additive that's used? 8 A No. They can't be. 9 Q Okay. They can't be, why? 10 A We've got some issues with solubility in oil. 11 Some of them are -- some of the components are 12 solids, so we can use certain ones, for example, 13 in grease where we have a thickener system that 14 provides media to support it. Some of them 15 aren't basically soluble in oil, so we can't 16 dissolve them down into a fluid component in the 17 lubricant. So it's a balancing act, and it's 18 very product dependent. 19 Q All right. Are these GRAS additives ever used 20 for purposes other than antimicrobial properties 21 in any of your lubricants? 22 MS. O'MEARA: Your Honor, I'm sorry. 23 May I ask that the court reporter read that 24 question back. 25 (The question was read.) 0751 1 THE WITNESS: Not the GRAS 2 components, no. 3 BY MR. MCILNAY: 4 Q We heard testimony from Mr. Edwards about active 5 ingredients and inert ingredients. Did you hear 6 that? 7 A Yes, I did. 8 Q And did you have an understanding of the 9 difference between active and inert ingredients? 10 A Yes, I do. 11 Q All right. Within the lubricants, without 12 identifying specific components, the active 13 ingredients that provide the antimicrobial 14 properties in the lubricants, are they the GRAS 15 additives? 16 A The GRAS additives are components of the active 17 ingredients, yes. 18 Q All right. Just so I understand, so the GRAS 19 ingredients are combined with something else to 20 create the active ingredients? 21 A The GRAS components are active ingredients in the 22 formulations. 23 Q All right. Are there other active ingredients in 24 the -- 25 A Yes, there is. 0752 1 Q Okay. And I take it from your answer, they're 2 not GRAS? 3 A They are approved under the 3570. 4 Q What is 3570? 5 A The 21 CFR 178.3570. 6 Q Okay. And that section refers to food additives 7 that are safe for human consumption, 7530? 8 A 3570 are specific to additives allowed for 9 incidental food contact lubricants. 10 Q Thank you. So in the Kraft case do you recall 11 which lubricant they were using? 12 A The initial product we did work with was on the 13 POLY-Guard FG-2. 14 Q And the POLY-Guard FG-2, is that a grease or a 15 fluid? 16 A It's a grease. 17 Q And you undertook to experiment with finding a 18 formula that you thought would be effective for 19 their express need, correct? 20 A Correct. 21 Q Did you, Troy Paquette, do any of your own 22 testing on the finished product to determine 23 whether or not it was effective in addressing 24 Kraft's concerns? 25 A We did not do any testing in-house. We did our 0753 1 testing with an independent laboratory. 2 Q Okay. And the independent laboratory that you 3 used, who is that? 4 A Sommer, S-O-M-M-E-R, Frey, F-R-E-Y. 5 Q And where is Sommer Frey located? 6 A In Milwaukee. 7 Q Have you used that laboratory in the past? 8 A Yes, we have. 9 Q All right. Is that the only testing that was 10 done on the initial product that had the 11 technology which is now referred to as Micronox? 12 A That was our initial work prior to providing 13 samples to Kraft for their own testing. 14 Q All right. And just so we get the time frame 15 down, do you remember approximately when this 16 work took place? 17 A It's either late '99 or early 2000. 18 Q And Behnke, as I understand it, you had the 19 Sommer Frey test done. Did you retain the data 20 from those tests? 21 MS. O'MEARA: Your Honor, I'm going 22 to object at this point. We don't have this 23 Sommer Frey data in the record, so I'm not sure 24 if there is an appropriate foundation or what the 25 relevance at this point is. 0754 1 MR. MCILNAY: I'm simply asking 2 whether or not -- 3 MS. O'MEARA: Your Honor, just to 4 add, I also feel it's prejudicial because we 5 don't have an opportunity to review it, and that 6 was the whole purpose of the prehearing exchange. 7 MR. MCILNAY: Well, Your Honor, until 8 Mr. Edwards testified as to the requirements for 9 retaining data with nonhuman pathogen claims, but 10 still a requirement that they retain the data, I 11 didn't know data retention was going to be a 12 matter of issue in this case. It's a simple 13 question, yes or no. Did they retain -- 14 JUDGE GUNNING: Was this information 15 requested? 16 MS. O'MEARA: Yes. 17 JUDGE GUNNING: And do you have 18 anything that reflects that? 19 MS. O'MEARA: Yes. Yes. 20 MR. CHA: It will take a minute to 21 find the file, Your Honor. 22 MR. MCILNAY: For the record, I'm 23 accepting their representation. 24 JUDGE GUNNING: Okay. 25 MR. MCILNAY: It's not necessary. 0755 1 MR. CHA: I'm sorry, Your Honor. 2 What? 3 JUDGE GUNNING: There is a 4 stipulation that that was requested. And that 5 was part of the voluntary disclosure? 6 MS. O'MEARA: And the motion to 7 compel, I believe. Right? 8 MR. CHA: I believe so, Your Honor. 9 JUDGE GUNNING: Okay. Under those 10 conditions, I will have to strike references to 11 that. 12 MR. MCILNAY: All right. 13 BY MR. MCILNAY: 14 Q Mr. Paquette, you did supply a sample of what you 15 came up with to Kraft? 16 A Correct. 17 Q And ultimately did Kraft begin to purchase the 18 product with the technology that you had 19 developed? 20 A Yes, they did. 21 Q If you recall, between the time you gave them the 22 sample and the time they started to place orders 23 for actual use in their plant, how much time 24 expired? 25 A I don't know that information. I do know that we 0756 1 sent them several different sets of samples so 2 they could prolong their testing, but I don't 3 know when the first date of their purchase would 4 be. 5 Q Okay. Roughly do you know over what kind of time 6 period they were given additional samples for 7 further testing? 8 A Roughly a six-month time frame. 9 Q All right. And you simply don't know then when 10 they placed their first commercial order for 11 purposes other than testing? 12 A Correct. 13 Q Once the -- I'm sorry. It was POLY-Guard FG? 14 A FG-2, correct. 15 Q FG-2. Once Kraft finished its testing with that, 16 was the technology used for Kraft added to 17 POLY-Guard FG-2 on a regular basis? 18 A Yes. 19 Q All right. So the formula in the database was 20 changed to make that -- those changes to the 21 POLY-Guard FG-2 consistent from there on out? 22 A Correct. 23 Q From that time to today, has the formula for the 24 POLY-Guard FG-2 changed at all? 25 MS. O'MEARA: Objection, Your Honor. 0757 1 I don't see the relevance of that at all. 2 MR. MCILNAY: If I could finish my 3 question -- with regard to Micronox technology? 4 JUDGE GUNNING: I'll allow the 5 question. 6 Do you want it reread? 7 THE WITNESS: I think I know. No, it 8 has not. 9 BY MR. MCILNAY: 10 Q All right. Was the technology referred to as 11 Micronox then? 12 A No, it was not. 13 Q All right. Obviously, further work was done on 14 what's now known as the Micronox technology 15 because we've had days of hearing about all the 16 different products in which that technology now 17 resides. We have six products at issue in this 18 case. The first one happens to be the JAX 19 POLY-Guard FG-2. We've covered that. POLY-Guard 20 FG-LT, that would be a fluid lubricant? 21 A That is also a grease. 22 Q Oh, I'm sorry. POLY-Guard FG-2 is a grease? Is 23 that a yes? 24 A Correct. 25 Q You need to verbalize your answers. POLY-Guard 0758 1 FG-LT is a grease as well? 2 A Correct. 3 Q JAX HALO-Guard FG-2, that is a grease? 4 A Correct. 5 Q And JAX HALO-Guard FG-LT is a grease; is that 6 correct? 7 A Correct. 8 Q JAX Magna-Plate 74, what kind of product is that? 9 A It's an oil. 10 Q And JAX Magna-Plate 78, what kind of product is 11 that? 12 A Also an oil. 13 Q Okay. Are the -- just quickly, the JAX 14 Magna-Plate 74 versus the 78, what is the 15 significance of the numeric designations 16 following the name? 17 A They're product designations, but they are 18 different product applications. 19 Q All right. The Micronox technology has since 20 2001, since the Kraft project, been extended to 21 the JAX Magna-Plate 74 and the JAX Magna-Plate 22 78? 23 A Correct. 24 Q Do you use the same GRAS ingredients in those 25 products as you did in the POLY-Guard? 0759 1 A No, we do not. 2 Q And the reason for that is what you testified to 3 earlier, that you have issues with solubility, 4 etc.? 5 A That's correct. 6 Q Approximately when, approximately -- I understand 7 you may not know exactly when. Let me back up. 8 Let me go through this chronology. JAX 9 POLY-Guard FG-LT, that now contains a version of 10 the Micronox technology? 11 A Correct. 12 Q Is it identical to the original technology in the 13 JAX POLY-Guard FG-2? 14 A Yes, it is. 15 Q JAX HALO-Guard FG-2, does that now contain the 16 Micronox technology? 17 A Yes, it does. 18 Q And is it identical to the JAX POLY-Guard FG-2 19 technology? 20 A The Micronox components are identical. 21 Q Okay. And that's what I meant by my question. 22 And if I forget to ask that, that's -- for the 23 rest of these questions about the products, 24 that's what I'm referring to. And the JAX 25 HALO-Guard FG-LT, the Micronox technology has 0760 1 been incorporated into that product? 2 A Correct. 3 Q And that Micronox technology, is it identical to 4 the original Micronox technology incorporated in 5 the JAX POLY-Guard FG-2? 6 A Yes. 7 Q Okay. Do you have a recollection of 8 approximately when the Micronox technology was 9 added to the JAX POLY-Guard FG-LT, JAX HALO-Guard 10 FG-2, and JAX HALO-Guard FG-LT? 11 A I can't remember when it was added to the 12 POLY-Guard FG-LT, but it would have been added 13 shortly after when the HALO-Guard LT and FG-2 14 were coming to market. 15 Q Were those new products then, beyond the addition 16 of Micronox? 17 A The HALO-Guard products were developed after, 18 subsequent to Micronox. 19 Q All right. So the HALO-Guard products came to 20 market, and then the JAX POLY-Guard FG-LT, to 21 your recollection, that came -- the addition of 22 Micronox to it came later? 23 A The addition to the POLY-Guard was prior to the 24 HALO-Guard. 25 Q Okay. Now, you testified that JAX Magna-Plate, 0761 1 because that's an oil versus a grease, has a 2 different technology to achieve what is 3 generically referred to as the Micronox 4 technology. Do you recall approximately when 5 that new formulation for oils was put together? 6 A My best recollection is the process occurred 7 probably six to nine months after the grease work 8 was developed. 9 Q All right. As far as the categories of 10 lubricants that are H1 that are manufactured 11 and/or sold by JAX, can they all be divided into 12 either a grease or an oil, or is there some third 13 category of H1 lubricants? 14 A There could be a third category, but it's not 15 pertinent to the Micronox discussion. So whether 16 you want me to go there or not, I don't know. 17 Q Well, so that -- I don't need to know it, but let 18 me ask you. It doesn't use the Micronox 19 technology -- 20 A Correct. 21 Q -- this third category. So the H1 lubricants 22 that utilize the Micronox technology as you've 23 defined it, are either oils or they're greases? 24 A Correct. 25 Q Okay. Are all of the greases identical as far as 0762 1 the Micronox technology is concerned? 2 A All of the greases utilize the same Micronox 3 technology. 4 Q Same question with regard to the oils. Do all of 5 the oils utilize the same Micronox technology? 6 A No. 7 Q All right. 8 MR. MCILNAY: I don't know that we 9 need to get into it. It is six, Your Honor. 10 This would be a good time. 11 JUDGE GUNNING: Well, this would be, 12 exactly. 13 Now, there was a request for tomorrow 14 morning. Is that off the table, on the table, 15 8:00? 16 MR. MCILNAY: My thought was this, 17 that I'll -- because I'm staying closer, I'll be 18 here when the building opens at 7:30. And I'm 19 happy to meet with you when you get here. 20 MS. O'MEARA: At what time? 21 MR. MCILNAY: 8:00. 22 MS. O'MEARA: That would be fine. 23 JUDGE GUNNING: And we wouldn't start 24 before 8:30. 25 MS. O'MEARA: Okay. I mean, I want 0763 1 to keep everybody on schedule. 2 MR. MCILNAY: Absolutely. 3 JUDGE GUNNING: Right. Tomorrow 4 we'll get started at 8:30. 5 MR. MCILNAY: And if this isn't open, 6 I'll wait outside. Very good. 7 Thank you, Your Honor. 8 JUDGE GUNNING: And don't forget the 9 CBI, make sure that's taken care of. 10 MR. MCILNAY: Yes. The CBI, that's 11 the manila folder, manila envelope. 12 (The proceeding was adjourned at 6:00 13 p.m.) 14 15 16 17 18 19 20 21 22 23 24 25 0764 1 STATE OF WISCONSIN ) 2 ) SS 3 COUNTY OF MILWAUKEE ) 4 5 I, PHYLLIS M. KAPARIS, do hereby certify that I 6 reported the foregoing proceedings at the time and place 7 specified in the title page of said transcript and that 8 the foregoing is a full, true and correct transcription 9 of my stenographic notes thereof. 10 11 12 ___________________________ 13 PHYLLIS M. KAPARIS 14 Court Reporter 15 16 17 18 19 20 21 22 23 24 25