0226 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 II 14 4/1/08 15 16 17 Proceedings had and evidence taken, 18 beginning at 8:30 a.m., April 1, 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. 0227 1 A P P E A R A N C E S 2 MS. BARBARA GUNNING, Administrative Law Judge 3 1200 Pennsylvania Avenue, N.W. 4 Washington, DC 20460 5 6 7 FOR THE COMPLAINANT: 8 U.S. EPA, Associate Regional Counsel, 9 Region 5, 77 West Jackson Boulevard, Chicago, Illinois 10 60604-3590, by MS. NIDHI O'MEARA, MR. JAMES J. CHA and 11 MR. ERIC H. OLSON. 12 13 14 FOR THE RESPONDENT: 15 McILNAY & BUTTON, LTD., 1150 Washington 16 Street, Grafton, Wisconsin 53024-1916, by, MR. BRUCE A. 17 McILNAY. 18 19 20 21 22 23 24 25 0228 1 I N D E X 2 WITNESS EXAMINATION PAGE 3 Mr. Dennis Edwards By Ms. O'Meara................ 234 4 By Mr. McIlnay................ 366 5 By Ms. O'Meara................ 421 6 By Mr. McIlnay................ 436 7 By Ms. O'Meara................ 439 8 Dr. Tajah Blackburn By Mr. Cha ................. 448 9 10 E X H I B I T S 11 COMPLAINANT'S DESCRIPTION RECEIVED REJECTED 12 18a..................................... 448 13 18b..................................... 448 14 18c..................................... 448 15 18d..................................... 448 16 18e..................................... 358 17 18f..................................... 358 18 19...................................... 331 19 20...................................... 347 20 21...................................... 360 21 24 ..................................... 266 22 50 ..................................... 321 23 24 RESPONDENT'S DESCRIPTION RECEIVED REJECTED 25 0229 1 P R O C E E D I N G S 2 JUDGE GUNNING: Good morning. Now, 3 yesterday we had discussed we were going on to 4 EPA's next witness. Any matters that have arisen 5 overnight? 6 MR. CHA: I don't know if it's fair 7 to say it arose overnight, but I just have one 8 preliminary matter that I wanted to put on the 9 record. 10 Apparently this past Sunday, 11 March 30th, counsel for Respondent sent an e-mail 12 to counsel for EPA which identified which 13 witnesses Respondent intended to call in its case 14 in chief. And I believe there were 17 witnesses 15 identified. I want to make a motion orally 16 regarding three of those witnesses. Three of the 17 witnesses were identified as William Barden, Bill 18 Bailes -- 19 MR. MCILNAY: Excuse me, Your Honor. 20 We could make this unnecessary. They're 21 withdrawn. 22 MR. CHA: They're withdrawn. 23 JUDGE GUNNING: Who was the third 24 then? 25 MR. CHA: It was Tracey Huebner. 0230 1 MR. MCILNAY: They're withdrawn. 2 MR. CHA: Then I have no motion to 3 make, Your Honor. 4 MR. MCILNAY: Indeed, as a 5 housekeeping matter, we went over our witness 6 list last evening. I haven't had a chance to 7 give my office -- they are printing a revised 8 witness list. Don't hold me to the exact number, 9 but I think it's down to five, six witnesses, 10 that I'll have here by noon. 11 MS. O'MEARA: Okay. Can we -- would 12 you mind if we got the list orally? I have a 13 list here, and I can just cross off names. 14 Is that okay, Your Honor? 15 JUDGE GUNNING: Yes. No problem. 16 MS. O'MEARA: While you're pulling 17 that up, if I could talk about a logistic matter, 18 which is, we moved this over here just so you can 19 hear the witness speak as well, instead of having 20 the witness' back turned to you. Would this work 21 better? 22 JUDGE GUNNING: No, this is fine. 23 And I think it may help the court reporter 24 immensely to have it in the witness box. 25 MS. O'MEARA: I mean from the podium, 0231 1 I was talking about the logistics of the podium, 2 the podium here as opposed to there, would -- 3 JUDGE GUNNING: Whatever works for 4 both of you. That's fine. If it doesn't block 5 your view. Because when someone's standing 6 there, it may block the view of the witness. You 7 mean keep it here? 8 MS. O'MEARA: Yes. 9 JUDGE GUNNING: Okay. As long as 10 when someone is standing -- 11 MS. O'MEARA: Yeah, logistically 12 James and I will keep moving back and forth. 13 JUDGE GUNNING: Okay. 14 MR. MCILNAY: That would be fine, 15 Your Honor. I thought about making a request -- 16 and I will, and Mr. Peter can say what he wants 17 to do. He was unhappy last evening that he can't 18 see the witness at all. I was curious as to 19 whether, given the number of seats here, if on 20 occasion the EPA wouldn't object if he sat in the 21 third row back here. 22 MS. O'MEARA: Not at all. 23 JUDGE GUNNING: Okay. In fact, I 24 would think the seat directly in back of you 25 would give a better view. 0232 1 MR. MCILNAY: Yeah, yeah. 2 Go through these -- you have the list 3 in the same order that I have here. 4 MS. O'MEARA: I'm fine. I'm pretty 5 familiar with it. 6 MR. MCILNAY: Eric Peter is a fact 7 witness. 8 MS. O'MEARA: Okay. 9 MR. MCILNAY: Carter Anderson is a 10 fact witness. Patty Riek, R-I-E-K, is a fact 11 witness. Mike Keller is a fact witness. James 12 Leroux, L-E-R-O-U-X. 13 THE COURT REPORTER: Do these mikes 14 work? 15 (Discussion off the record.) 16 MR. MCILNAY: Larry Cooper; Troy 17 Paquette, P-A-Q-U-E-T-T-E; Shaun, S-H-A-U-N, 18 Beauchamp, B-E-A-U-C-H-AM-P; and last is Charles 19 Goodale, G-O-O-D-A-L-E. 20 MS. O'MEARA: So is that a total of 21 nine witnesses? 22 MR. MCILNAY: Correct. 23 MS. O'MEARA: Okay. So just so I can 24 confirm, Mr. Rybicki is no longer on the list? 25 MR. MCILNAY: Correct. 0233 1 MS. O'MEARA: Mr. Durian is no longer 2 on the list? 3 MR. MCILNAY: Correct. 4 MS. O'MEARA: Mr. Hoffman is no 5 longer on the list? 6 MR. MCILNAY: Correct. 7 MS. O'MEARA: Mr. Nelson is no longer 8 on the list? 9 MR. MCILNAY: Correct. 10 MS. O'MEARA: Okay. Thank you. 11 MR. MCILNAY: And Eddie Chancellor 12 has been taken off. 13 MS. O'MEARA: Oh, yes. I had that. 14 I got that message yesterday. 15 MR. MCILNAY: Okay. 16 MS. O'MEARA: I'm sorry. Yes, 17 Chancellor. Now we know Huebner, Bailes and 18 Barden as well? 19 MR. MCILNAY: Correct. 20 MS. O'MEARA: And then Bradstreet 21 Pike & Brown were taken off yesterday. 22 MR. MCILNAY: Correct. 23 MS. O'MEARA: Thank you. 24 MR. MCILNAY: You're welcome. 25 JUDGE GUNNING: Anything further? 0234 1 Excellent. 2 MS. O'MEARA: May I proceed? 3 JUDGE GUNNING: Please. 4 MS. O'MEARA: U.S. EPA calls 5 Mr. Dennis Edwards to the stand, please. 6 DENNIS EDWARDS, called as a witness 7 herein, having been first duly sworn on oath, was 8 examined and testified as follows: 9 EXAMINATION 10 BY MS. O'MEARA: 11 Q Good morning, Mr. Edwards. Can you please state 12 your name and spell it for the record? 13 A Dennis Hill Edwards, Jr., D-E-N-N-I-S, H-I-L-L, 14 E-D-W-A-R-D-S, then J-R, period. 15 Q And can you tell the Court what city and state 16 you live in? 17 A I live in Springfield, Virginia. 18 Q And what is your occupation? 19 A I am Chief of Regulatory Management, Branch 1, in 20 the Antimicrobials Division in the Office of 21 Pesticide Programs at EPA. 22 Q How long have you worked with the EPA? 23 A I have worked a little over 32 years. 24 Q Were you asked to review the government's records 25 relating to the Behnke Lubricants case? 0235 1 A Yes, I was. 2 Q And you're aware that that case is focused on 3 five particular antimicrobial lubricants? 4 A Yes, I am. 5 Q And have you reviewed some of the labels on 6 Behnke's products for these five products? 7 A I have looked at the literature now for all of 8 them. 9 Q Have you reviewed the claims on the internet as 10 well? 11 A Yes. 12 Q Okay. And based on your review, do you have an 13 opinion as to whether JAX POLY-Guard FG-2 should 14 have been registered under FIFRA? 15 A Based on the claims on the labels and the 16 associated literature, the products should be 17 registered as pesticide products. 18 Q And is that your opinion for HALO-Guard FG-2 as 19 well? 20 A Yes. 21 Q And JAX Magna-Plate 74? 22 A Yes. 23 Q And HALO-Guard FG-LT? 24 A Yes. 25 Q And JAX Magna-Plate 78? 0236 1 A Yes. 2 Q Mr. Edwards, what qualifies you to make such a 3 decision? 4 A One, the 32 years that I've spent at EPA where 5 I've reviewed not only the -- starting off, 6 looking at labels for these pesticide products, 7 but also being a product manager for 12 years, 8 and then being the branch chief for 12 years, 9 I've had the occasion to look at labeling 10 associated with a wide variety of pesticide 11 products. 12 Q Okay. Thank you. And if you thought for a 13 moment these antimicrobial products were not 14 subject to FIFRA registration, would you be here 15 today? 16 A No. 17 Q Okay. Let's talk about your career. I'd like to 18 find out a little bit of what you have done as a 19 civil servant. Did you join EPA right after you 20 completed your formal education? 21 A Yes, I did. 22 Q And what was your first job at the EPA? 23 A My first job was reviewing labels of products, 24 starting off looking at labels for new 25 registration applications and amendments, working 0237 1 my way up to reviewing new chemical applications, 2 looking at tolerance documents, writing tolerance 3 documents, experimental use permits, 24C's and 4 the more complex applications that we receive. 5 Q And what was your title in your first job? 6 A Biologist. 7 Q Okay. And how long were you in this position? 8 A For about eight years. 9 Q And in those eight years, how many times 10 approximately would you say you had to make a 11 decision regarding registration? 12 A I wrote letters for amendment new registration 13 applications during that time hundreds of times. 14 Q And this was regarding pesticides? 15 A This was always working with pesticides in one 16 way or the other. 17 Q And then were you promoted from that position? 18 A Yes. 19 Q To what position? 20 A I became a product manager of an insecticide 21 team. 22 Q Okay. And what were your duties as a product 23 manager? 24 A To supervise five people on the team, and then 25 the team handled, again, registration 0238 1 applications associated with a specific group of 2 active ingredients. 3 Q Okay. And how long were you in that position, 4 Mr. Edwards? 5 A Approximately 12 years. 6 Q And in that time frame how many times did you and 7 your staff make decisions regarding registration 8 of pesticides? And give me an approximate 9 number. 10 A Well, again, we received hundreds of applications 11 each year that we worked through to completion. 12 Q Okay. And then were you promoted again from that 13 position to your current position? 14 A Yes. 15 Q And what is your current position? 16 A It's chief of a regulatory branch in 17 Antimicrobials Division. 18 Q Thank you. How long have you been in that 19 position? 20 A Little over 12 years. 21 Q And can you, please, list out the branch's role, 22 the duties of your branch? 23 A Well, the branch has three teams, two regulatory 24 teams that handle registration applications 25 associated with a specific set of active 0239 1 ingredients, and an outreach team that houses a 2 communications officer and an ombudsman. 3 Q Okay. And as the branch chief of the regulatory 4 branch in the Antimicrobial Division, what is 5 your role in particular? 6 A My role is to oversee 13 people and to provide 7 advice and guidance on registration applications 8 that we receive, as well as working with the 9 outreach people and ombudsman in answering 10 questions that we get from the public, from the 11 city, from states, regions, and other parties. 12 Q All right. Does this branch handle antimicrobial 13 pesticides only? 14 A Yes. 15 Q And can you tell the Court what an antimicrobial 16 pesticide is? 17 A An antimicrobial pesticide is an application for 18 a pesticide product that's going to be applied to 19 an inanimate surface to control microorganisms. 20 Q And what are public health antimicrobial 21 pesticides? 22 A Public health pesticides, antimicrobial 23 pesticides, are pesticide products that are 24 intended to control pests that are infectious or 25 pathogenic to man. 0240 1 Q Can you give an example? 2 A E.coli, Listeria, Salmonella. 3 Q And why are antimicrobial pesticides especially 4 important? 5 A Antimicrobial pesticides are important because 6 they are -- from EPA's role, they're applied to 7 inanimate surfaces to control organisms that you 8 normally cannot see. And if you do see them, 9 then that means that you've got a severe problem. 10 But typically you do not see what you're 11 intending to control. 12 Q And how does EPA address that issue? 13 A For public health we ask for efficacy data to 14 support the fact that they either work or don't 15 work. And they have to work before we -- they 16 have to demonstrate that they work before we 17 would register the product. 18 Q All right. And can you give an example of some 19 public health claims? 20 A Again, a claim to control E.coli, Salmonella, 21 Listeria, you know, common cold virus. 22 Q Okay. Let's talk about the registration process 23 if we can. What types of pesticide registrations 24 does your branch handle? 25 A We handle everything from new chemical 0241 1 applications, which would be for a new active 2 ingredient that's not contained in any currently 3 registered product; new uses which would be the 4 use that is new for an old active ingredient, a 5 use that has not been registered before; we 6 handle new product registration applications; we 7 handle amendments; tolerance applications; 8 experimental use permits; and to a limited extent 9 24(c), which are applications submitted by the 10 states. 11 Q And when you say additive -- I'm sorry -- an 12 active ingredient, what do you mean? 13 A Active ingredient is the substance that is 14 providing the efficacy for that pesticide 15 product. 16 Q Okay. And prior to the application process, what 17 types of decisions might you have to make with a 18 potential registrant? 19 A Depending on the complexity of the product that 20 may be submitted, we encourage a preregistration 21 meeting where the company would, either by 22 conference call, or actually come in and meet 23 with us to discuss the type of application that 24 they would be submitting and provide certain 25 information to us to determine what kind of 0242 1 requirements that they're going to need to meet. 2 Q What kind of information would you be looking for 3 in these preregistration meetings? 4 A We would want to see a label for the product that 5 they're proposing to register that mimics what 6 they would actually come in with, which would be 7 set up with a signal word, an ingredient 8 statement that would tell us what's actually in 9 it from an active ingredient standpoint, and the 10 percentage. We would want to see the 11 precautionary labeling that would be proposed, 12 both the hazards to humans in terms of what 13 precautions a user would need to take, we would 14 look at any environmental hazards, physical 15 chemical hazards. Then we'd look at the use 16 direction, where is it going to be applied, how 17 it's going to be applied, when it's going to be 18 applied. The contact time and the organism 19 claims, claims being use claims as well as 20 marketing claims. 21 Q Let's talk a moment about the ingredient list you 22 just mentioned. Why do you need the ingredient 23 list? Why is that so important? 24 A Well, the ingredient list -- when I talk about 25 ingredient list, I said active ingredient, but we 0243 1 actually would want to see the entire formula of 2 the product that they're attempting to register. 3 The active ingredient is providing the efficacy 4 for the product, but the inert ingredients in the 5 product are just as important from a toxicity 6 standpoint. 7 Q Okay. 8 A For example, if a product contains four percent 9 methanol or greater, that would automatically 10 jump that product into a tox category of danger 11 and require the skull and crossbones and the word 12 poison to go on the label. You wouldn't need any 13 additional data to support that. We already have 14 data in our files. So the inerts, while they 15 could influence the efficacy, they certainly have 16 an effect often on the toxicity also. 17 Q And you mentioned that you also needed the 18 percentages. Why are those important? 19 A Yes. The percentage active is important because 20 we would look and make a determination, based on 21 the active ingredient, if that product had been 22 registered before at that percentage, or if it 23 were higher, look at the use dilution, and then 24 determine if we would consider that to be a 25 significant increase in exposure. 0244 1 If it's an increase in exposure to 2 the active ingredient, then we would likely send 3 it to one of our science branches for further 4 assessment. Again, insuring that there wouldn't 5 be unreasonable adverse effects on either the 6 applicator or the person that might be, depending 7 on the use, occupying the area treated after it's 8 been treated. 9 Q Okay. Let's talk about the draft label for a 10 second. Why would you need the draft label? 11 A Again, we want to know what the product is that 12 they're intending to market, what it looks like, 13 where it's going to be used, how it's going to be 14 used, because all that's important in determining 15 what kind of data requirements that might be 16 required to support that product. 17 Q Are you also looking at marketing claims on that 18 label? 19 A Yes. 20 Q Why is that important? 21 A Marketing claims again are going to influence the 22 type of data that we would expect to be submitted 23 with the application. And we also have in our 24 regulations a section in Part 156 in 40 CFR that 25 talks about false and misleading statements. So 0245 1 we want to make sure that their company is not 2 pushing the envelope in a sense and making claims 3 that go beyond, what we would consider to be 4 either false or misleading to the user of the 5 product. 6 Q Okay. Do you ask at this preregistration meeting 7 for any advertising literature related to the 8 product? 9 A We would ask the company to provide any and all 10 information that they're going to distribute with 11 the product. Sometimes we get it, sometimes we 12 don't. We tell them that any literature 13 associated with the product is considered to be 14 labeling. So if they don't provide it, then 15 they're told that that literature must be 16 consistent with the label that we accept. 17 Q Is there some regulation that guides you in 18 needing that information? 19 A Well, again, in 156 10 there is information 20 outlined as to what's considered to be a label, 21 and we have consistently interpreted, both 22 through the regulations and in pesticide 23 registration notices, that a label includes not 24 only associated literature, but even web site 25 material, magazines, newspapers -- 0246 1 Q Okay. 2 A -- TV ads. All that is considered to be part of 3 the label. 4 Q Okay. Now, I think you might have gone through 5 this, but you mentioned new chemicals, and that 6 if you had a registration application, if you 7 could just list out for us, for a new chemical, 8 could you tell us what types of information or 9 data requirements you would need for that new 10 chemical? 11 A Well, again, a new chemical for us is that the 12 product contains an active ingredient that's not 13 in any currently registered product. It may have 14 been previously registered -- 15 Q Okay. 16 A -- or it may be brand new. But the key is that 17 it doesn't contain -- it's not currently in any 18 current registered product. We ask for chemistry 19 data on the active ingredient. We have -- 20 depending on the use pattern, our toxicology data 21 is tiered. The tier one is a basic six-pack of 22 acute studies for that active ingredient. It's a 23 developmental toxicity study for the active 24 ingredient. It's a 90-day subchronic study, 25 typically by the oral route. But if the dermal 0247 1 or inhalation is just as important, then we would 2 ask for a study there. And we ask for a 3 mutagenicity battery, three studies. Then we ask 4 for some environmental studies, a fish LC50 5 study, an aquatic invertebrate LC50, and a bird 6 LD50. That's primarily for labeling and for 7 information in case there's an accident or a 8 spill. 9 Q Okay. 10 A And we ask for a hydrolysis study. And that's 11 for a typical indoor -- you know, a product 12 that's used with an indoor use pattern. If it's 13 used outdoors, such as a wood preservative or an 14 antifoulant, then the environmental studies are 15 going to be far more extensive, and some of the 16 toxicity studies more -- a tier two type of study 17 would be required. 18 Q Okay. Now, if the active ingredient was already 19 previously registered, what do you call that in 20 the process? How do you register that? 21 A We call that an old chemical, if it's been 22 previously registered. You know, if it's 23 currently registered. You're talking -- 24 Q Currently, not canceled? 25 A Yeah, if it's currently registered in a product, 0248 1 yes. 2 Q Okay. And -- 3 A Now, when I said that, I talked about, you know, 4 for the active ingredient, because there are 5 product-specific requirements also. 6 Q Okay. What do you mean by product-specific 7 requirements? 8 A Well, again, on the product that we actually get 9 to register, we would ask for chemistry on that, 10 we would ask for acute studies on that. And then 11 depending on the claims, we would ask for product 12 performance or efficacy data, if they're making 13 public health claims, or even for some nonpublic 14 health if they're making some type of unique or 15 exotic claim that we felt we needed data to 16 support. 17 Q That's relating to an old chemical, correct? 18 A That would be for an old chemical, or that would 19 be for a new chemical. 20 Q Okay. I understand. Okay. Now, you mentioned 21 public health claims, if they're being made. 22 What additional data would be required if public 23 health claims are being made? 24 A Well, for a new chemical if we're talking public 25 health, and we're talking in, say, in a food 0249 1 handling establishment, then we would ask for 2 additional generic data on that in order to make 3 an assessment that any residue that might occur 4 in or on a food item wouldn't cause unreasonable 5 adverse effects. And then the biggest piece we 6 would ask for is product performance or efficacy 7 data to demonstrate that the product does meet 8 its intended function. 9 Q Okay. And why is this additional data needed 10 when there are public health claims made? 11 A Again, because you can't see the organisms that 12 you're intending to control, and you want to 13 insure that the product works. 14 Q Mr. Edwards, you've used the word efficacy a 15 couple of times. Can you explain what you mean 16 by that? 17 A Well, again, EPA has a hierarchy for claims, 18 starting off with sterilant, then disinfection, 19 then sanitization. And then once you get below 20 that, then we're kind of in another category 21 which is unique, requiring a separate product and 22 a -- a separate method and a separate performance 23 standard. For the three tiers that I talked 24 about, sterilant, disinfectant, sanitizer, there 25 are established test methods that an applicant 0250 1 must use in order to generate their efficacy 2 data. 3 Q And who reviews that efficacy data? 4 A We have a branch called the Product Science 5 Branch that looks at that. 6 Q All right. And what can happen if a pesticide 7 making public health claims is not actually 8 effective in controlling the pests it claims to 9 control? 10 A Well, if the product is not effective, then at 11 the very least you could end up with 12 cross-contamination, with whatever the public 13 health organism is, going from one site to the 14 other. And then the worst, you could end up with 15 somebody at some point getting sick. 16 Q Okay. We talked about labeling just a little bit 17 ago, and I would like to come back to that area 18 for a second. What types of information, just 19 generally, are required on a typical accepted 20 label, one that's accepted by EPA? 21 A Well, we start off with the front panel. We ask 22 for the product name to be on there. We look at 23 product names to make sure, again, that they're 24 not false or misleading in terms of the name 25 implying that the product does more than what it 0251 1 actually does. We require a signal word. We 2 require a child hazard warning, keep out of the 3 reach of children, because it is a pesticide 4 product. We require an ingredient statement with 5 the active ingredients, pesticide, along with the 6 percentage. And then they have to also 7 characterize the inerts in terms of either inert 8 ingredient or other ingredient, and it adds up to 9 a hundred percent. 10 We would want to see the 11 precautionary statements starting off with 12 hazards to humans. Again that language is 13 determined by the acute toxicity studies that the 14 company conducts. There are ranges in terms in 15 specified language associated with certain 16 toxicity values. 17 We would want to see first aid 18 directions if somebody is exposed from the oral, 19 dermal, inhalation, skin or eye route. 20 Q Okay. 21 A And if it's an outdoor use, we would want to see 22 an environmental hazard in terms of is it toxic 23 to fish, birds and wildlife? Then if it were, 24 say, an aerosol, we would want to see physical 25 chemical hazards, is it flammable? 0252 1 Then we move over to the directions 2 for use, which would then describe where the 3 product is going to be used, how it's going to be 4 applied, when it would be applied, getting into 5 contact time, the specific site surfaces, the 6 organisms, you know, what type of product it is. 7 And then anything, you know, unique. If they can 8 make other claims such as being a cleaner or a 9 deodorizer, they would have to provide directions 10 for that. 11 Q Does the label have to identify what 12 microorganisms are being targeted by the product? 13 A Yes, it does. 14 Q And does it -- what about EPA numbers, are there 15 any EPA numbers that are required on it? 16 A You will find some labels with an ATCC number, 17 which identifies the specific strain of the 18 organism that was tested. You'll also see 19 something like E.coli, there are various strains 20 that would be placed on the label if they tested 21 for that organism. 22 Q I'm sorry. I guess I wasn't clear in my 23 question. My question was -- although that was 24 helpful, thank you -- is there an EPA 25 establishment number that is required? 0253 1 A Yeah, there is an EPA establishment number that's 2 either on the label or on the container. And it 3 doesn't have to be on the label. It actually 4 has -- the requirement is that it be on the 5 container of the product so that the purchaser or 6 someone else that wants to know where the product 7 was manufactured, they know how to go back. 8 Q Well, you answered my next question, which is 9 what is an establishment number? 10 What about an EPA registration 11 number, is that required? 12 A Yes. We wouldn't get it on a draft label, but on 13 a final label of a product that's actually 14 marketed, it's a requirement, yes. 15 Q And you mentioned signal words. What do you mean 16 by that? 17 A I would start off with the signal word of danger, 18 warning, caution, or there's the potential to not 19 have a signal word depending on the toxicity of a 20 product. 21 Q And you talked about use direction. Can you give 22 an example? 23 A Well, if the product is going to be used in an 24 institutional area, such as hospitals, then it 25 would say for use in hospitals. It would tell 0254 1 you where to apply the product in the hospital, 2 what type of surface, and it would verify the 3 contact time, the organism, and whatever the 4 company has applied to register the product for 5 use. 6 Q Okay. And can you give an example of a first 7 aid -- first aid information on the label? 8 A Well, it can be -- one, it would be, if 9 swallowed, if on skin, if inhaled. And it could 10 be anything like, if swallowed to drink one or 11 two glasses of water and call a physician. 12 Q Now, are you familiar with what an MSDS is? 13 A Yes. 14 Q Materials Safety Data Sheet. 15 A Yes. We do get MSDS sheets, especially to 16 characterize inert ingredients in products. 17 Q Okay. And is a label still needed if there is an 18 MSDS sheet that's been -- that's, let's say, for 19 a final product been provided? 20 A An MSDS sheet is not an EPA form nor a 21 requirement. It's something that the Department 22 of Labor, the OSHA requires. What we have is, we 23 have a pesticide registration notice that was 24 issued several years ago saying that an MSDS 25 sheet must be consistent with a label in terms of 0255 1 precautions and all. 2 Q Okay. Can it ever substitute for a label? 3 A No. 4 Q Why not? 5 A It would not have anywhere near the kind of 6 information on it that we require for a pesticide 7 label. 8 Q Okay. Let's talk about -- you mentioned earlier 9 that you provide guidance to your staff. Do you 10 get inquiries from people seeking advice or 11 guidance on antimicrobial pesticides? 12 A Do I personally? Yes, I get phone calls and 13 e-mails daily -- 14 Q Okay. 15 A -- from people wanting information. 16 Q Can you tell us who might call you or your branch 17 to seek advice or guidance relating to 18 antimicrobial pesticides and FIFRA compliance? 19 A Well, from a simple standpoint, it could be 20 someone from the public that's actually using the 21 product that wants some information in terms of 22 any hazards associated with that product. Going 23 from there, we interact with the pesticide 24 industry, both from a company, as well as 25 consultants that are representing companies. We 0256 1 talk with states in terms of information that 2 they need especially interpretations about some 3 of the use sites or directions on the product to 4 EPA regions, interacting with them if they need 5 more information or if they want to know what's 6 registered for a certain active ingredient. We 7 talk with other federal agencies, FDA probably on 8 a routine basis, often CDC, USDA, again seeking 9 information or trying to clarify, you know, what 10 might be out in terms of what's registered. 11 Q Okay. And might you ever get questions regarding 12 if registration is required? 13 A Yes, yes. We -- not only I, but I have an 14 ombudsman that answers those types of questions 15 on a daily basis -- 16 Q Okay. 17 A -- again, from providing of information in terms 18 of, does it require registration, or is it 19 eligible, say, for a treated article exemption. 20 Those are very routine. 21 Q And might you get questions about whether label 22 amendments are appropriate? 23 A Yes. 24 Q Can you explain what a label amendment is, 25 please? 0257 1 A A label amendment is where a company has modified 2 part of the label, whether it be the 3 precautionary statements, whether it be the use 4 directions. A very simple label amendment would 5 be where they're rearranging and adding text to a 6 label. A little more complicated one would be 7 where they're adding an additional organism, and 8 they have to submit efficacy data to support 9 that, provide possibly some additional use 10 directions. 11 Q Okay. Now, what guides your branch in making 12 these types of decisions when you're answering 13 these questions, or even determining whether 14 something needs to be registered or not? 15 A Well, we typically, where we can, fall back on 16 the regulations in 40 CFR. We also use the Label 17 Review Manual, which is out on the web site, was 18 developed many years ago to take the regulations, 19 and where it can be, to provide more guidance in 20 terms of the information that's in our 21 regulations, because often they're kind of cut 22 and dried, and the Label Review Manual will go 23 into much more detail. We use pesticide 24 registration notices which are issued every year, 25 and have been for the last close to 50 years. 0258 1 Q Do you rely on any agency guidance? 2 A We rely on standard operating procedures that the 3 antimicrobials division has, and we rely on 4 expertise that we have developed simply from 5 reviewing these types of application and 6 answering these questions. 7 Q Does your staff rely on you for guidance? 8 A I talk daily with various team members on either 9 problems that they're having with a particular 10 application or what type of answer that they 11 might have to provide back to an inquiry, whether 12 it be e-mail or by telephone. 13 Q Okay. Now, you mentioned earlier that you get 14 inquiries about whether registration is required 15 or not. Can you give an example of such an 16 inquiry? 17 A We routinely get questions from companies that 18 want to know if certain claims that they're 19 making, if they're considered to be a pesticide 20 claim. Right now silver is a very popular active 21 ingredient, and there are a lot of questions that 22 have come in from companies wanting to make 23 certain claims or not possibly make claims, just 24 the way that they've structured their label or 25 their marketing information, and they ask, you 0259 1 know, if I say this, do I need to get registered? 2 If I don't say this, is it not considered to be a 3 pesticide product? 4 Q Okay. How many inquiries of these types do you 5 get in a year? 6 A We literally get hundreds of that type of 7 request. 8 Q Okay. In the past, Mr. Edwards, has your branch 9 ever told a member of the public that they do not 10 need to register a product with FIFRA because 11 they believe that FDA has sole jurisdiction over 12 it? 13 A Have we? Yes. 14 Q Yes. And can you give an example? 15 A If somebody has come in, and they have a product 16 that is going to be applied specifically to 17 living man or animal, such as a hand sanitizer, 18 that would be exclusively FDA's. Or if somebody 19 has come in, and they've got a product that's 20 going to be applied in or on processed food, 21 we've told them that they would need to go to FDA 22 and get their approval. 23 Q I'm just seeing if I can move through some of 24 this. 25 How many applications for 0260 1 registration does your branch handle 2 approximately in a year? 3 A For registration of new products, we handle a 4 couple of hundred a year. 5 Q Okay. And how many other types of applications 6 does your branch handle in a year, other than 7 registration of new products? 8 A Last year we handled approximately 1200 9 applications. 10 Q Okay. Does your branch handle the registration 11 of antimicrobial pesticides that are also food 12 additives under FDA? 13 A Yes. 14 Q And can you give an example of that, please? 15 A Probably the most common example is an 16 application where a company is applying a product 17 to water to control bacteria, slime buildup in 18 the water, and the water is used to manufacture 19 pulp and paper. And that pulp and paper 20 ultimately is going to come in contact with 21 processed food, so we would require a letter 22 from -- if the company obtained a letter from the 23 FDA, or that they point out to us an existing 21 24 CFR citation that shows that FDA clearance has 25 been obtained for that active ingredient. 0261 1 Q Now, you were in the room when Mr. Rybicki 2 testified yesterday, correct? 3 A Yes. 4 Q Okay. And you heard what he said about 5 sanitizers at the Acme facility? 6 A Yes. 7 Q And can you tell us what the intended purpose of 8 a sanitizer like the one he mentioned -- I think 9 he said they were Eco Lab products -- what the 10 purpose of those are? 11 A If I remember his testimony, he talked about the 12 sanitizers being used on food contact surfaces so 13 they would have to be registered as a food 14 contact sanitizer product, they'd have to have 15 EPA tolerance exemptions, so they would have to 16 be listed in 180.940, 40 CFR 180.940. And the 17 purpose behind a sanitizer is it's intended to 18 reduce public health organisms to a level that is 19 acceptable for public -- or by public health 20 officials. 21 Q And, Mr. Edwards, could the sanitizers 22 Mr. Rybicki described migrate into food? 23 A Yes. I mean, they're being applied to a food 24 contact surface. You certainly will have 25 indirect residues that might occur in a food 0262 1 item. 2 Q And are these required to be registered by EPA? 3 A Yes, they are. 4 Q We talked a little bit about label amendments, 5 and can you tell us approximately how many 6 inquiries regarding label amendments does your 7 branch handle in a year? 8 A Out of the 1200 applications we got last year, we 9 probably -- 900 to 950 were some type of label 10 amendment, which includes notification. 11 Q All right. And you also mentioned that you get 12 calls from regions and states. How many of those 13 types of calls do you handle in a year? 14 A We handle hundreds of those on a yearly basis. 15 Q All right. And you mentioned earlier that -- you 16 mentioned some agency guidance and PR notices and 17 the Label Review Manual that guides your branch. 18 How familiar are you with those different things 19 that guide your branch in making the decisions 20 that you make on a daily basis? 21 A I am very familiar. I certainly don't know the 22 wording like I used to because I don't have to 23 look at them in a sense and use them on a daily 24 basis, but I do know where to go to look and 25 where to find the information and where to direct 0263 1 people. 2 Q Were you involved in helping write or peer review 3 any of these? 4 A I have -- we are currently revising the Label 5 Review Manual. 6 Q Uh-huh. 7 A So I am on a label consistency review committee, 8 and one function of that is to review all of the 9 Label Review Manual chapters as they are 10 prepared. 11 Q And are you trained in determining when a product 12 needs to be registered under FIFRA? 13 A Yes. 14 Q And I'm going to ask you the obvious question. 15 Why? 16 A Just simply that's what I've been doing for 32 17 years. 18 Q Are you familiar with the exemptions set forth 19 under FIFRA and its implementing regulations 20 regarding registration? 21 A You mean -- yes. 22 Q Thank you. Was that question clear? 23 A No. I mean, if you're talking about exemptions 24 -- if you're making a pesticide claim, you're 25 either going to be exempt or you have to be 0264 1 registered. There are very few exceptions. 2 Q And you're familiar with those exemptions? 3 A Yes. 4 Q And I'll ask you again the obvious question. Why 5 are you familiar with those exemptions? 6 A Again, been doing it for 30-some years, and I end 7 up having to make those types of decisions 8 almost, you know, every day in one way or the 9 other. 10 Q Well, we've talked about your very impressive 11 career. Let's talk about your education for a 12 little bit. Can you tell us where you received 13 your undergraduate degree? 14 A I received the undergrad degree at Clemson 15 University. 16 Q And in what field? 17 A I have a bachelor of science in pre medicine. 18 Q Okay. And when did you receive it? 19 A 1972. 20 Q And did you also receive a master's degree? 21 A Yes, I have a master's of science in entomology. 22 Q And where was that? 23 A At Clemson also. 24 Q And when was that? 25 A 1975. 0265 1 Q Do you conduct any training on behalf of the EPA? 2 A Yes. 3 Q Can you tell us to whom, and on what topics, if 4 it's easier to do both at the same time? 5 A Okay. I guess, simply starting out, I train new 6 branch members when we receive them as somebody 7 retires or leave. I'm also involved in training 8 new members to the division in terms of -- they 9 may be in another branch, but explaining our 10 labeling requirements and standard operating 11 procedures to them. I have participated in 12 what's called prep -- and I'm not sure I can 13 remember what it's called -- but it's a group 14 forum that the agency supports where they bring 15 in the states and provide overviews of our 16 registration process -- actually going at the end 17 of April -- and providing an overview of the 18 antimicrobial division. I represent the division 19 at any number of workshops and forums that 20 consulting law firms hold within D.C. 21 Q Okay. And over the course of your career, how 22 many training courses would you say you've 23 conducted? 24 A Probably more than 50. 25 Q And I'm going to direct your attention to 0266 1 Complainant's Exhibit 24. I believe it's in 2 Volume 1. It's in Volume 2. Sorry. 3 JUDGE GUNNING: No, it's Volume 1. 4 MS. O'MEARA: Oh. Sorry. 5 BY MS. O'MEARA: 6 Q Can you tell the Court what this is? 7 A This is a curriculum fact sheet that I prepared. 8 Q All right. 9 MS. O'MEARA: Your Honor, the parties 10 have stipulated that this exhibit is admissible, 11 and I'd ask that it be moved into the record at 12 this time. 13 MR. MCILNAY: No objection. 14 JUDGE GUNNING: I believe pursuant to 15 the stipulations, it's already marked as 16 received. But, yes. Mark Exhibit 24 as 17 received, please. 18 MS. O'MEARA: Thank you. 19 BY MS. O'MEARA: 20 Q All right. Thank you for going through that with 21 us, Mr. Edwards. Let's talk about Behnke 22 Lubricants now, if we may. Let's start with 23 physical evidence that we've already talked about 24 previously. I'm going to show you what has 25 already been marked as Complainant's Exhibit 38. 0267 1 May I approach the witness, Your 2 Honor? 3 JUDGE GUNNING: Yes. 4 BY MS. O'MEARA: 5 Q Can you tell the Court what this is please? 6 A This is a tube of POLY-Guard FG-2. 7 Q All right. And can you review the label, please? 8 A Can I take it out? 9 MR. MCILNAY: I have no objection to 10 that. 11 MS. O'MEARA: I think one of them is 12 leaking, and I believe it's that one. 13 THE WITNESS: That's all right. 14 BY MS. O'MEARA: 15 Q Can you see it all right, Mr. Edwards? Is there 16 anything on that label that concerns you? 17 A They've got the statement, anti-wear NSF H1 food 18 machinery grease with PTFE and Micronox 19 antimicrobial. 20 Q Okay. Anything else? 21 A It says, JAX POLY-Guard FG grease with PTFE 22 provides greatly enhanced protection in the 23 highest -- that's not -- 24 Q Take your time. 25 A The statement, the bonus is an H1 lubricating 0268 1 grease with Micronox JAX exclusive antimicrobial 2 chemistry possessing true knockdown capabilities. 3 Q All right. Anything else? 4 A The statement, added step-in microbial protection 5 program. And then they've got the statement, 6 powerful antimicrobial performance. 7 Q Okay. Now, why do these statements concern you? 8 A They're a concern because they appear to be 9 making pesticide claims for this tube of grease. 10 Q Okay. Given the fact that they concern you 11 because of the pesticidal claims as you state, is 12 there something on the label that isn't there 13 that concerns you? 14 A They're not registered. 15 MR. MCILNAY: I'm going to object to 16 the last question. It mischaracterizes his 17 testimony. He said, it appears they're making 18 pesticidal claims. 19 THE COURT: Okay. I can't hear you 20 at all. You're going to have to start over. 21 MR. MCILNAY: I'm sorry. I'm having 22 trouble hearing the witness, too, and I was going 23 to ask the court reporter to mark this testimony. 24 JUDGE GUNNING: You're fading off 25 again. 0269 1 MR. MCILNAY: Your Honor, first of 2 all, my objection, it mischaracterizes his 3 testimony. I just heard him say, it appears to 4 make pesticidal claims. Counsel said it made 5 pesticidal claims. 6 The other issue is, I can't hear. 7 JUDGE GUNNING: Okay. 8 MR. MCILNAY: And, you know, over a 9 break I would certainly like to get maintenance 10 in here, see if we can do something. Because I 11 was going to ask you to mark those so you can 12 read back to me on cross, what he said was 13 concerns of his on the label. I'm just having a 14 heck of a time. 15 JUDGE GUNNING: Well, why don't we go 16 off the record for a few minutes and see if we 17 can make sure all the microphones are working. 18 MS. O'MEARA: Okay. 19 JUDGE GUNNING: Then maybe counsel 20 can get together with the court reporter to 21 review what was said in the last few minutes. 22 MR. MCILNAY: That would be great. 23 JUDGE GUNNING: Okay. And so we'll 24 take a ten-minute recess. 25 (A recess was taken.) 0270 1 JUDGE GUNNING: Shortly before the 2 break there were a couple of objections, in part 3 based upon the system, microphone system that we 4 have here. And the two parties were going to get 5 together with the court reporter and review some 6 of the testimony. And has that occurred. 7 MR. MCILNAY: Your Honor, the court 8 reporter indicated -- is my mike working? 9 JUDGE GUNNING: Well, you need to 10 hold down the button. You may want to take it 11 out so it doesn't strain your hand. 12 MS. O'MEARA: Your Honor, I think the 13 way we resolved it is I would just go back 14 through the question, because the court reporter 15 had trouble hearing the labeling, what he had 16 read, what Mr. Edwards had read off the tube. 17 JUDGE GUNNING: So we will go back. 18 MS. O'MEARA: And I will withdraw 19 that question and start again. 20 JUDGE GUNNING: All right. If there 21 are any problems in the future hearing anything, 22 just let me know, and we'll stop and make sure we 23 get it. 24 MR. MCILNAY: Thank you, Your Honor. 25 MS. O'MEARA: Is that working? 0271 1 MR. MCILNAY: I'm not sure. 2 JUDGE GUNNING: It's working. 3 THE WITNESS: I assume you can hear 4 me. 5 MR. MCILNAY: I can now. 6 THE WITNESS: The same microphone. 7 MS. O'MEARA: Complainant's 8 Exhibit 38, Mr. Edwards, if you could please look 9 at it and tell us again if you have any concerns 10 with that label on Complainant Exhibit 38. 11 A The tube? 12 Q Sorry? 13 A The tube or in here? 14 Q No, it's not in there. It's on the tube. 15 A All right. I have a concern with the statement 16 advanced anti-wear NSF H1 food machinery grease 17 with PTFE and Micronox antimicrobial; with the 18 sentence, the bonus is an H1 lubricating grease 19 with Micronox JAX exclusive antimicrobial 20 chemistry possessing true knockdown capabilities; 21 with the statement powerful antimicrobial 22 performance; and the statement added step-in 23 microbial protection program. 24 Q Okay. And can you tell the Court why you are 25 concerned with these four statements you just 0272 1 read? 2 A I have a concern because they are pesticide 3 claims, and this is not a registered pesticide 4 product. 5 Q And based on that answer, are there things on the 6 label that you are concerned with that aren't 7 present? 8 A Well, when I went over what goes on a label, one, 9 that there is no ingredient statement, so you 10 really don't know what the antimicrobial active 11 ingredient is. There is no signal word, there is 12 no child hazard warning. There may be some 13 precautionary statements, but they're certainly 14 not of the type and the amount that we would 15 require. There's certainly no use directions in 16 terms of how you would use this as an 17 antimicrobial product. The organisms, the 18 contact time, in terms of what you're attempting 19 to control and how long it takes to control the 20 organism from an antimicrobial standpoint aren't 21 on the label. I don't see storage and disposal, 22 I don't see first aid. I mean, from a FIFRA 23 labeling standpoint, it's quite deficient. 24 Q Are there any EPA establishment registration 25 numbers on there? 0273 1 A No, there is no establishment number and no EPA 2 registration number. 3 Q Thank you. I'm going to ask you to now look at 4 Complainant's Exhibit 39. 5 MS. O'MEARA: May I approach the 6 witness? 7 JUDGE GUNNING: Yes. 8 MS. O'MEARA: Thank you, Your Honor. 9 BY MS. O'MEARA: 10 Q And this has been previously admitted as well, or 11 received. Can you please identify what -- can 12 you tell the Court what that is? 13 A The name of this is HALO-Guard FG-2. 14 Q All right. And can you review it and tell us if 15 there is any language on there that concerns you? 16 A There's the statement, JAX HALO-Guard FG-2 17 provides Micronox microbial knockdown 18 performance. 19 Q If you're done, let me know, and we'll -- okay. 20 Is there -- can you tell the Court why that 21 statement, JAX HALO-Guard FG-2 provides Micronox 22 microbial knockdown performance, why that 23 statement concerns you? 24 A Again, this is a pesticide claim on a product 25 that is not registered, or at least no EPA 0274 1 registration number or establishment number or 2 anything else that would be a typical EPA label 3 on the product. 4 Q So you just testified about POLY-Guard FG-2 and 5 the concerns you had with that label -- lack of 6 labeling, rather. Do you have the same concerns 7 here? 8 A Yes, it would be the same concerns. 9 Q All right. 10 MS. O'MEARA: May I approach the 11 witness? 12 JUDGE GUNNING: Yes. 13 MS. O'MEARA: Thank you. 14 BY MS. O'MEARA: 15 Q Let's talk about some of the advertising and 16 marketing materials, if we may. Let's talk about 17 JAX POLY-Guard FG-2 with Micronox first. I'm 18 going to direct your attention to Complainant's 19 Exhibit 1, Bates number 21. And we do have that 20 in an enlarged version. And if it's easier, we 21 can move that closer. Why don't we do that. 22 JUDGE GUNNING: I want to remind the 23 witness when reading a label to make sure that 24 the court reporter is able to capture all of the 25 words. 0275 1 MS. O'MEARA: Okay. So slowly, I 2 guess. 3 THE WITNESS: You said 21? 4 MS. O'MEARA: Yes, EPA 21. And 5 that's in Complainant's Exhibit 1. 6 And Your Honor, just for the record, 7 this has already been received, this particular 8 exhibit, Complainant's Exhibit 1. 9 BY MS. O'MEARA: 10 Q Can you please review that? Let me know when 11 you're ready. 12 A Okay. 13 Q Can you please tell the Court what this is? 14 A This is literature on POLY-Guard FG-LT, FG-2. 15 Q Okay. If you want to pull the microphone a 16 little closer -- 17 MS. O'MEARA: Bruce -- 18 MR. MCILNAY: I'm okay so far. 19 BY MS. O'MEARA: 20 Q Just trying to think of the easiest way. Would 21 it be easier for you to look at that or -- I'd 22 like you to point out if there is any language on 23 the large exhibit, so everybody can see, that 24 concerns you. And you have a pointer there, so 25 you can use that if that helps. Or if you need 0276 1 to approach the chart, let us know, or the 2 exhibit. 3 A All right. I have a concern with the phrase 4 advanced anti-wear NSF H1 food machinery grease 5 with PTFE and Micronox, specifically the term 6 Micronox. 7 Q Okay. 8 A And then at the top on the right I have concern 9 with the sentence, since June 1, 2001, JAX 10 POLY-Guard FG contains Micronox providing 11 antimicrobial protection for the product. JAX 12 Micronox has proven especially effective in 13 protecting -- again it's right in there. 14 MS. O'MEARA: Your Honor, I'm sorry, 15 just logistically can I ask if Mr. Edwards can 16 get out of his seat and go to the enlarged 17 exhibit? 18 JUDGE GUNNING: That would be fine. 19 MS. O'MEARA: I think it probably 20 would be easier. You can take the pointer with 21 you if you wish. 22 JUDGE GUNNING: As long as the court 23 reporter can pick up the voice. 24 MS. O'MEARA: Absolutely. Let us 25 know. 0277 1 BY MS. O'MEARA: 2 Q All right. 3 A It started off with the sentence, since June 1, 4 2001, JAX POLY-Guard FG contains Micronox 5 providing antimicrobial protection for the 6 product. JAX Micronox has proven especially 7 effective in protecting JAX POLY-Guard greases 8 against Listeria, E. Coli and Salmonella over 9 extended lubrication intervals. There's the 10 statement powerful antimicrobial performance, and 11 the statement added step-in microbial protection 12 programs. And then at the very beginning we 13 talked about the advanced anti-wear NSF H1 food 14 machinery grease with PTFE and Micronox, the term 15 Micronox. 16 Q All right. And is there -- are any of these 17 claims that you've just read public health 18 claims? 19 A The statement, JAX POLY-Guard greases against 20 Listeria, E. Coli and Salmonella over extended 21 lubrication intervals is a public health claim. 22 The statement, since June 1, 2001, JAX POLY-Guard 23 FG contains Micronox providing antimicrobial 24 protection for the product is an implied public 25 health claim in that it's not qualified in terms 0278 1 of what's meant by protection. 2 Q Okay. 3 A Powerful antimicrobial performance, you know, 4 could be construed, if you're taking the fact 5 that it's already saying it's effective against 6 Listeria, Salmonella and E. Coli, and the fact 7 that added step-in microbial protection programs, 8 again, it's not qualified. So take the whole 9 phrase -- all the phrases together, and it's 10 certainly implying public health protection. 11 Q Okay. Why don't you go ahead and have a seat and 12 we can continue talking. 13 MS. O'MEARA: I'm going to grab this 14 and get this out of Mr. Olson's way, if I may. 15 JUDGE GUNNING: Yes. 16 BY MS. O'MEARA: 17 Q Why do these claims that you just reviewed 18 concern you? 19 A Because they're making, one, public health claims 20 for a lubricant that we have not -- one, they're 21 pesticide claims, so it should be registered. 22 It's not registered. And I have no way of 23 knowing that the product works, and I have no way 24 of knowing that what level -- what they're trying 25 to imply in terms of control. My opinion, a 0279 1 lubricant is going to provide very little control 2 in terms of the public health control that you 3 need in a food processing plant. So I would look 4 at it as possibly being either false and/or 5 misleading to the purchaser in terms of what the 6 product does. 7 Q Okay. You mentioned that that first sentence 8 right there didn't talk about where -- it didn't 9 qualify. Can you explain that, or the sentence 10 wasn't qualified, what did you mean by that? 11 A Well, for this type of product, not so much 12 lubricants, but in general I would expect that 13 the antimicrobial additive is in there to protect 14 the article, and that the claims would then be 15 more consistent with the treated article 16 exemption, that it's in there solely to protect 17 the lubricant from breaking down due to bacterial 18 activity. And I'd want to see that in terms of 19 its protecting it from -- you know, typically you 20 see staining or you see odor control or you see 21 deterioration as phrases that are used to qualify 22 this type of product. Because antimicrobial 23 additives are used in paints, they're used in 24 photographic solution, they're used in 25 practically any and every aqueous solution 0280 1 manufactured to prevent microbial growth. 2 Q And in this case when you say article, do you 3 mean the lubricant itself? 4 A I'm talking about the lubricant. 5 Q Okay. Moving on to JAX HALO-Guard FG-2 and FG-LT 6 with the Micronox antimicrobial technology, can 7 you please turn to the same exhibit, but Bates 8 number 23? 9 Q And I'll have you stay in your seat. Can you 10 review that? Let me know when you're ready, 11 Mr. Edwards. 12 A Okay. 13 Q All right. Is there anything on -- first of all, 14 can you tell us what that is, what you're looking 15 at? 16 A It's again literature for HALO-Guard FG greases. 17 Q Okay. And is there anything on this particular 18 page that concerns you? 19 A The right-hand column towards the bottom or 20 maybe -- antimicrobial performance, the paragraph 21 there. 22 Q Okay. Could you read it? 23 A JAX HALO-Guard FG grease incorporates JAX new 24 proprietary antimicrobial additive technology 25 Micronox to provide antimicrobial protection for 0281 1 the product. A first in food-grade lubricant, 2 JAX Micronox has proven especially effective in 3 protecting JAX HALO-Guard FG greases against 4 Listeria, E. Coli, and Salmonella over extended 5 lubrication intervals. 6 Q And why does this language concern you? 7 A It concerns me for the same reasons as for the 8 other product and the fact that there -- that 9 the -- this particular -- these greases are 10 making public health claims. I don't have any 11 data to support the fact that they either -- that 12 they work. I don't know what the performance 13 standard, I don't know what the method. 14 Q Okay. And you said they're making public health 15 claims. 16 A Right. 17 Q What specifically are you talking about? 18 A Well, they're making claims against Listeria, E. 19 Coli and Salmonella. 20 Q Okay. 21 A And these are not claims that -- these are 22 organisms that are pathogenic to man. I mean, 23 you don't -- the grease itself doesn't need to be 24 protected against these organisms. People don't 25 get sick from these -- people get sick from these 0282 1 organisms, not grease. 2 Q Okay. And does this particular paragraph you 3 just read indicate where the microorganisms are 4 being targeted? 5 A It says that it's providing antimicrobial 6 protection for the product in the first sentence. 7 Q Okay. And would you consider these claims to be 8 implicit or explicit? 9 A They're explicit. 10 Q Now I'm going to direct you to Magna-Plate 74 11 with Micronox, and that is just two pages later 12 at 25, Complainant's Exhibit 1 at Bates 25. Can 13 you review this while we put it up. Let me know 14 when you're ready, please. 15 A Okay. 16 Q All right. Is there any language on -- first of 17 all, can you again identify what it is that 18 you're looking at? 19 A Again, this is literature for Magna-Plate 74. 20 Q All right. And can you tell us if there is any 21 language on there that concerns you? 22 A Left column, second paragraph, JAX Magna-Plate 74 23 incorporates JAX new proprietary antimicrobial 24 additive technology Micronox for enhanced 25 antimicrobial protection for the product against 0283 1 a wide variety of microbial agents, including 2 yeast, molds and gram-positive and gram-negative 3 bacteria. A first in food-grade lubricant, JAX 4 Micronox has proven especially effective 5 protecting the product against Listeria, E. Coli 6 and Salmonella. 7 Q All right. Anything else? 8 A The statement, powerful antimicrobial performance 9 and -- 10 Q Is that in the bullet points? 11 A That's in the left in the bullets. And then on 12 the right down at the bottom in the bullets, 13 added step-in microbial protection programs. 14 Q Okay. And on the right-hand side of this 15 particular page is there any mention of Micronox 16 there? 17 A The right-hand column, second paragraph, Micronox 18 antimicrobial technology to provide antimicrobial 19 protection for the product. 20 Q Okay. And does this language, just for brevity, 21 it concern you for the same reasons you already 22 discussed for the previous two exhibits that 23 we've looked at? 24 A Yes, it does. 25 Q Okay. And are there public health claims being 0284 1 made here as well? 2 A Yes. 3 Q Does this particular page discuss where the 4 microorganisms are being targeted? 5 A Well, the last statement in terms of Micronox 6 antimicrobial technology to provide antimicrobial 7 protection for the product. So in one place it's 8 saying for the product, and yet over on the 9 left-hand column it also talks about protecting 10 the product. 11 Q So on both sides it talks about it? 12 A Yes. 13 Q Are these implicit or explicit claims? 14 A No. They're explicit claims. 15 Q All right. Let's move to Magna-Plate 78, which 16 is at Complainant's Exhibit 8a, Bates number -- 17 that's the number at the bottom, Mr. Edwards -- 18 at 208. And we'll put that up. 19 MS. O'MEARA: And just to note for 20 the record, this exhibit has also been received. 21 MR. CHA: I believe it's CX 8a at 22 page Bates number EPA 0208. 23 BY MS. O'MEARA: 24 Q Just review that, and let me know he when you're 25 ready. 0285 1 A Okay. 2 Q Is there any way -- can you tell us, first of 3 all, what this is, Mr. Edwards? 4 A This is literature for MAGNA-Plate 78 fluids. 5 Q Okay. Is there any language that concerns you on 6 this particular piece of advertising? 7 A Up at the top right hand, advanced anti-wear 8 extreme pressure food machinery oil with 9 Micronox. 10 Q All right. 11 A And then on the right-hand top side, third 12 paragraph, both products incorporate JAX new 13 proprietary antimicrobial additive technology 14 Micronox for enhanced product protection against 15 a wide variety of microbial agents, including 16 yeast, mold, gram-positive and gram-negative 17 bacteria. The fourth paragraph on the right-hand 18 column, a first in food-grade lubricants JAX 19 Micronox provides significant knockdown 20 performance and has proven especially effective 21 against Listeria, E. Coli and Salmonella on 22 contact and over extended lubrication intervals. 23 Q Can you see the bullet points or do you need to 24 approach this to look at the bullet points? 25 A Since they're in yellow, I'd like to come up, 0286 1 yeah. The statement, powerful antimicrobial 2 performance. 3 Q And that's the -- what bullet point? Can you 4 just identify where it is? 5 A One, two, three, four, five, six -- one, two, 6 three -- fourth bullet on the left-hand column. 7 Q Okay. 8 A And then the fourth bullet on the right hand, 9 added insurance for antimicrobial protection. 10 Q Okay. If there is nothing else, you can have a 11 seat. Thank you. Does this language concern you 12 for the reasons you just stated for the last 13 three exhibits you've looked at? 14 A Yes. Again they're making pesticide claims for 15 unregistered pesticide products. 16 Q Okay. And are there public health claims made 17 here as well? 18 A Yes, when they talk about again effective against 19 Listeria, E. Coli, and Salmonella, those are 20 explicit claims. And also the fact that they 21 talk about that it provides enhanced product 22 protection against a wide variety of microbial 23 agents, including yeasts, molds, gram-positive 24 and gram-negative bacteria. Again, there's no 25 qualifying in terms of what gram-positive and 0287 1 gram-negative are. So I would assume that 2 they're all bacteria. I mean, they're either 3 going to be gram-negative or gram-positive. 4 Q Okay. And does it indicate where the 5 microorganisms are being controlled? 6 A Again, it talks about enhanced product 7 protection, both in the third paragraph -- the 8 fourth paragraph talks about effective against 9 Listeria, E. Coli and Salmonella on contact and 10 over extended lubrication intervals. So it 11 certainly implies that it's protecting the 12 lubricant. But also the fact that it's killing 13 these organisms wherever the lubricant may come 14 in contact with them, but it's not clear where 15 that might be. 16 Q Okay. I'd like you to, I'm sorry, turn back to 17 Complainant's Exhibit 8, Bates 187. 18 Complainant's Exhibit 8. 187 is the Bates label. 19 And we'll put that up, if you would review it in 20 the meanwhile. 21 A Okay. 22 Q Okay. Can you please tell us what it is before 23 you talk about it? 24 A This is again literature for Magna-Plate 78 25 fluids. Appears that it's providing various 0288 1 types of information about the fluids. 2 Q All right. Is there any language that concerns 3 you on this? 4 A Down towards the bottom where it talks about 5 antimicrobial protection, colony-forming units 6 per gram. Then it lists listeria, E. Coli, 7 Salmonella, and it further talks about in terms 8 of a comparison of Magna-Plate 78 versus 9 competitor A for all three organisms at week one, 10 week two, week three, and week four. 11 Q Okay. Is there any language at the bottom of 12 that that concerns you? 13 A Then it talks about listeria was inoculated at a 14 level of 80,000 colony-forming units per gram; E. 15 Coli, you know, at 100; and Salmonella at 120,000 16 colony-forming units per gram. 17 Q All right. And, Mr. Edwards, can you please tell 18 the Court why this language concerns you? 19 A Well, again, the literature is -- trying to get 20 the right wording -- the literature is showing 21 that the product is effective against these three 22 organisms against competitive products, but, you 23 know, it doesn't tell you anything about the 24 performance method that was used, the contact 25 time or really anything that would let you see 0289 1 just how valid the study is that they got these 2 numbers from. 3 Q Okay. And on the upper portion of this exhibit 4 it lists different methods. Is there a method 5 listed that they used to determine the 6 antimicrobial properties here and its 7 effectiveness? 8 A I don't see any method that I would recognize as 9 an efficacy method. 10 Q Okay. Thank you. Well, let's then talk about 11 just JAX Micronox antimicrobial technology 12 generally. I'm going to ask you to please turn 13 to Exhibit 8b, Bates 249. Exhibit 8b, 249. Also 14 previously been received into the record. And 15 review it while we put it up for you. Let me 16 know when you're ready. 17 A Okay. 18 Q Can you please first identify what it is that 19 you're looking at? I should note that only half 20 of this exhibit is up. So please feel free to 21 identify whatever you need to, to identify that 22 page. 23 A Well, again, it's literature on JAX Micronox 24 technologies. On the left-hand column, which 25 isn't up, there's a letter from USDA, and 0290 1 underneath it talking about JAX pioneered USDA 2 authorized lubricants. And then on the right, 3 which is up there, there are a number of 4 pesticide claims that are made. 5 Q Okay. And can you please share with us the 6 language that concerns you on the portion that is 7 blown up, which is Page 15 of Bates 249? 8 A All right. The sentence, independently 9 engineered and field tested by JAX, the Micronox 10 additive system is a groundbreaking advance that 11 promises to enhance antibacterial capabilities in 12 food and beverage plants nationwide. Micronox 13 will provide immediate and significant knockdown 14 capabilities and will be an active participant in 15 any food or beverage plant program designed for 16 enhanced antimicrobial protection. 17 Q Okay. 18 A The sentence, through laboratory testing of 19 competitive food-grade lubricants, no other 20 lubricants in the industry have demonstrated 21 comparable knockdown performance. This 22 distinction is important if a bacteria, yeast or 23 mold colony is already established. FDA/USDA/NSF 24 approved competitor lubricants will inhibit the 25 growth of the colony, but to actually kill the 0291 1 colony will require a sanitization process, or 2 the use of JAX food-grade lubricants which 3 incorporate Micronox technology. And then, 4 finally, you've got independent lab results where 5 they list a number of public health organisms and 6 compare JAX to competitor A, B. 7 Q And does it identify in that chart what product 8 is being compared? 9 A It says POLY-Guard FG, so I'm assuming that's the 10 one that's compared. 11 Q Okay. And what, about this language, concerns 12 you, Mr. Edwards? 13 A Well, in the first paragraph it talks about, to 14 enhance antibacterial capabilities in food and 15 beverage plants. Antibacterial from EPA's 16 standpoint is a public health claim, so -- 17 And then it talks about if a 18 bacteria, yeast or mold colony. And again 19 bacteria is certainly not qualified in terms of 20 its -- so I would interpret that to be any and 21 all the bacteria that this product -- that 22 competitive lubricants will inhibit the growth, 23 but the last sentence says, implies that, you 24 know, to actually kill the colony, you require a 25 sanitization process, use of a sanitizer, or you 0292 1 could use this product. And I fail to see how 2 you could -- a lubricant is going to in any way 3 substitute for sanitizing. 4 Q Okay. 5 A So if you just use this product, you would not 6 get the kind of control that you need in a food 7 processing plant. 8 Q All right. And can you just give me what you 9 believe knockdown means or if it's significant to 10 you? 11 A Knockdown to me would mean that it's inhibiting, 12 it is killing, I assume reducing the colony by a 13 certain log reduction. But I don't know what 14 that is. 15 Q You don't know what -- 16 A It's an unqualified term from my standpoint. 17 Q So you don't know what it is? 18 A I don't know the performance that is actually -- 19 I mean, you've got the chart here, but again 20 whether -- for a food contact sanitizer our 21 efficacy standard is that the product would show 22 a five log reduction in 30 seconds. And I have 23 no way to know if this product meets that 24 standard or not. 25 Q Is there any other language that concerns you, 0293 1 because I stopped you to talk about knockdown for 2 a second. 3 A Well, I mean, you've got the chart showing that 4 this product is providing some level of kill or 5 inhibition for three organisms, and you've got a 6 comparison to the competitor products. Again, 7 these are public health organisms that would be 8 pathogenic to man in some way if they were 9 exposed to them. 10 Q Would you say these are implicit or explicit? 11 A These are explicit claims. 12 Q And does this tell -- this particular exhibit 13 tell you where the microorganisms are being 14 controlled? 15 A The first sentence certainly doesn't. I'm not 16 sure where the microbial knockdown is occurring. 17 It just says, will be an active participant in 18 any food or beverage plant program designed for 19 enhanced antimicrobial protection. So I don't 20 think it's products. 21 Q Is that what you mean by unqualified when you 22 referred to that previously? 23 A Right. I mean, I'm assuming it's talking about 24 the entire plant and not just in this case this 25 stuff, the grease or fluid. 0294 1 Q Okay. 2 A And then otherwise it talks about the lubricants 3 demonstrating comparable knockdown performance. 4 Again, with the last sentence, talking about the 5 use of JAX food-grade lubricants which 6 incorporate Micronox technology, as implying that 7 it might substitute for a sanitization process. 8 Well, you're going to sanitize hard surfaces, 9 which implies that this will control them on hard 10 surfaces. But then this is not intended, the 11 grease is not intended to be applied to 12 countertops or all of the hard surfaces that 13 you're talking. It's there to lubricate 14 machinery. 15 Q Okay. Mr. Edwards, based on this exhibit, can 16 you rely on the lab results that are depicted in 17 that chart right there for purposes of 18 registration under FIFRA? 19 A Could I? No. 20 Q Why? 21 A Well, the type of data that we would get would be 22 far more extensive than this. It would be done 23 according to an established efficacy method that 24 requires certain -- an SOP in terms of how the 25 study was conducted, it would require the raw 0295 1 data to be provided, it would require that the 2 study be done under good laboratory practices. 3 Q Okay. 4 A And, again, we have a performance standard that 5 it would have to meet, and I have no way of 6 telling from this if it meets that performance 7 standard or not. Certainly there's no indication 8 of the fact that it works within a 30-second 9 period. 10 Q And why would that be important for this 11 particular exhibit? 12 A Because it's implied that you could use this 13 product as a sanitizer, and a food contact 14 sanitizer is required to work in 30 seconds or 15 less. 16 Q Okay. And just turning back to this one 17 momentarily, which is Complainant's Exhibit 8, 18 Bates 187. Could you rely on these results? 19 A Not to support a registration of a product. 20 Q Okay. 21 A Again, for the same reasons. 22 Q All right. Thank you. Mr. Edwards, based on 23 everything you've reviewed, despite the results 24 of any of these lab tests that we're talking 25 about, would the products still need to be 0296 1 registered? 2 A Yes, they would. 3 Q Why? 4 A Based on the claims that are being made, and the 5 claims that are being made is that the Micronox 6 is in the lubricant to protect the lubricant. 7 Q Okay. 8 A That's a pesticide claim. 9 Q So despite the efficacy? 10 A Well, you've got the fact that claims are being 11 made that it will protect the lubricant, and then 12 also it's making public health claims, and public 13 health claims automatically from our standpoint 14 require registration, depending on where the 15 product is being used. 16 Q Okay. I'm going to now direct you to 17 Complainant's Exhibit 8(c), Bates 256. And we'll 18 put that up as you turn to it. 8(c), Bates 256, 19 which has already been previously received into 20 the record. And let me know when you're ready. 21 A All right. 22 Q All right. Before I -- if you recall, Mr. Bonace 23 did testify about this particular letter, so I 24 won't have you read the entire letter in. But if 25 you could just highlight for us if any of these 0297 1 claims concern you, and why? 2 A Well, the letter starts out talking about 3 antimicrobial usage in JAX food-grade products. 4 Then it goes on to talk about that the Behnke 5 Lubricants incorporate a proprietary mix of 6 antimicrobial agents to provide enhanced 7 protection. 8 Q And where is that, Mr. Edwards? 9 A That's the first sentence of the letter. 10 Q Okay. 11 A And, again, I -- it's -- with that sentence, it 12 certainly does not state what they're intending 13 to protect, whether they're intending to protect 14 the lubricant -- 15 JUDGE GUNNING: Excuse me. Let me 16 interject. There is something in the background 17 that is difficult. 18 MS. O'MEARA: Yeah, some buzzing. 19 JUDGE GUNNING: Something in the 20 system. But if you go just start back where you 21 were, because not everyone could heard it. 22 THE WITNESS: All right. The first 23 sentence where it talks about Behnke Lubricants 24 incorporate a proprietary mix of antimicrobial 25 agents to provide enhanced protection, it's 0298 1 certainly not specific as to what the 2 antimicrobial agents are intended to protect, 3 whether it's the lubricant or whether it's 4 broader. 5 BY MS. O'MEARA: 6 Q Okay. 7 A And then they list a number of materials and talk 8 about it meeting the FDA's Generally Recognized 9 As Safe, or GRAS specification. And then it 10 talks about benzoates exhibit broad spectrum 11 antimicrobial activity against gram-positive and 12 gram-negative bacteria, yeast and molds. 13 Again, based on the first sentence, I 14 don't know, you know, what these products are 15 intended to -- what the antimicrobial components 16 are intended to protect, whether it's the 17 lubricant or whether it's broader. I would 18 interpret it as being at least the lubricant, and 19 possibly broader. 20 Q Okay. And does the fact that they discuss GRAS 21 impact your assessment at all? 22 A For EPA? 23 Q Yes. 24 A No. EPA does not have a GRAS list. EPA requires 25 the products to be -- the active ingredients to 0299 1 be registered. 2 Q Okay. I forgot to ask you if you could just 3 identify what the letter is entitled and who 4 signed it? 5 A The letter is entitled What Is JAX Micronox 6 Technology, and it's signed by Troy Paquette, who 7 is technical director at Behnke Lubricants. 8 Q And can you just read the what it's regarding, on 9 the second line there of the letter? 10 A Antimicrobial usage in JAX food-grade products. 11 Q All right. You discussed the first paragraph. 12 Is there anything in the second paragraph that 13 concerns you? 14 A Well, I mean, the second paragraph talks about 15 the fact that the antimicrobial agents that are 16 being used in the JAX products are authorized by 17 FDA and are used at FDA allowable levels. But, 18 again, it talks about the fact that the -- no 19 other food-grade lubricant in the industry has 20 demonstrated comparable knockdown performance. 21 The bacteria, yeast or mold colony is already 22 established, FDA/USDA/NSF approved competitor 23 lubricants will inhibit the growth of the colony, 24 but to actually kill the colony will require a 25 sanitization process or the use of JAX food-grade 0300 1 lubricants which incorporate Micronox technology. 2 Q That's the same language that was here, correct? 3 A That's correct. And I would have the same 4 concern in that they're certainly implying that 5 you could use the lubricant as a substitute for a 6 sanitization process that the company may have, 7 should have established -- 8 Q Okay. 9 A -- and be using. 10 Q Just so the record can be clear, when I said the 11 same language as is here, I was referring to 12 Bates 249. 13 Is there anything in the third 14 paragraph that concerns you? 15 A Well, I mean, again it's just advertising in a 16 sense or marketing that the JAX -- these grease, 17 fluid products contain Micronox that enhance 18 antibacterial capabilities in food and beverage 19 plants, and that they provide immediate and 20 significant knockdown capabilities, and will be 21 an active participant in any food or beverage 22 plant program. I would interpret these are 23 pesticide claims made for a product, that they're 24 intended -- since these are lubricating products 25 for -- you know, as a grease or a fluid to 0301 1 lubricate machinery, that they're in there -- 2 because in the past they've talked about they're 3 in there to enhance or provide protection of the 4 product, that they're pesticide claims, and this 5 is not a registered product. 6 Q Okay. 7 A And when they talk about the fact that they're 8 enhancing antibacterial capabilities, again, as I 9 said before, we would interpret that to be a 10 public health claim. 11 Q And that last sentence, is there anything of 12 significance of the fact that it says immediate 13 and significant knockdown capability, to you? 14 A Well, again, if an organism -- if the lubricant 15 comes in contact with an organism, it's certainly 16 saying or implying that there is an immediate 17 kill of the organism. 18 Q Okay. 19 A Don't have the data to support those types of 20 claims. 21 Q Okay. And anywhere in this letter does it 22 indicate where the microorganisms are being 23 controlled? 24 A No. This letter is very broad in that regard. 25 Q Okay. Are the claims in this letter implicit or 0302 1 explicit? 2 A I would say that they're explicit claims in that 3 they talk about knockdown, they talk about 4 enhancing antimicrobial performance. 5 Q I'm going to direct you to Complainant's 6 Exhibit 8c, Bates 270. We'll put that up for you 7 as you review it. Let me know when you're ready. 8 Let the record reflect that this 9 Exhibit 8c has been received. 10 A All right. 11 Q All right. Can you tell us, first, what it is? 12 A Well, it's a piece of literature that's titled 13 Plant Microbial Knockdown Results. 14 Q And is there anything on this particular exhibit 15 that concerns you? 16 A Well, there's a chart starting with dates going 17 from July 31st to October 15th, and it says 18 coli -- I'm assuming it's E. Coli -- and then 19 yeast and mold, and it's showing, I would assume, 20 some type of inhibition of these organisms. 21 Q Okay. 22 A And it talks about test results of coli, yeast 23 and mold counts taken on existing grease from 24 bearing cavity prior to the introduction of JAX 25 POLY-Guard FG-2. 0303 1 Q Okay. 2 A And then it talks about POLY-Guard FG-2 3 introduced to the bearing, expelling the existing 4 grease, tests were run on the mixture of both 5 greases. Due to the large size of this 6 particular bearing, antimicrobial control took 7 about ten weeks. Smaller bearings will purge 8 much quicker. And at the bottom it talks about 9 tests were run on JAX POLY-Guard FG-2 only. New 10 bearings were installed and packed with JAX 11 POLY-Guard FG-2. 12 Q All right. Are there any public health claims 13 made on this? 14 A The E. Coli, possibly the yeast, and we certainly 15 have concern -- molds have been implicated as 16 being of public health significance. 17 Q All right. And does this particular piece of 18 literature from Behnke's product line identify 19 where the microorganism is being controlled? 20 A It doesn't specifically -- I don't think it 21 specifically says, but it certainly appears that 22 counts are taken from existing grease, so I have 23 to assume it's from the POLY-Guard FG-2. 24 Q So -- 25 A Whether it's in the equipment or out, I do not 0304 1 know. 2 Q Okay. So it's not explicit in this case. Can 3 you rely on these results? 4 A No, not for registration. I wouldn't even know 5 how to begin to interpret these. 6 Q Okay. And is there anywhere on this that 7 indicates what testing standards they might have 8 used? 9 A In terms of the method and all, no. 10 Q Okay. I'm going to then ask you to turn to 11 Complainant's Exhibit 36, please. 12 This, too, has been admitted or 13 received into the record. 14 Before you turn to any particular 15 page, if you would just tell me, the first page 16 of Complainant's Exhibit 36, can you tell us what 17 this is? And if you need to turn a page to 18 figure out what it says, that's fine because the 19 first page might be a certification. 20 A The first page says United States District Court, 21 and it says it certifies that the attached is a 22 true and full copy of the original. 23 Q Okay. Turn to the next page if you could, 24 please. 25 MR. MCILNAY: Your Honor, in the 0305 1 interest of time, we'll stipulate that on or 2 about -- 3 JUDGE GUNNING: Speak up. Please. 4 MR. MCILNAY: On or about March 22, 5 2006, Respondent filed a lawsuit against NSF 6 International in the Eastern District of 7 Wisconsin, District Court, seeking, among other 8 things, a restraining order and interpretation, 9 declaratory judgment action regarding the issues 10 presented in this case, among others. It's 11 authenticated. It's been received. 12 MS. O'MEARA: Thank you. 13 BY MS. O'MEARA: 14 Q All right. Then if you could turn to Page 751, 15 Bates 751 in that exhibit, please. And let me 16 know when you've had a chance to review 17 Paragraph 5 of that particular Page 751. When 18 you're ready, let me know. 19 A Okay. 20 Q You can, of course, turn to the next page if you 21 want to look at the rest of it. 22 A Thank you. All right. 23 Q I would ask you, Mr. Edwards, to please read the 24 first three full sentences of Paragraph 5. 25 A Behnke also formulates an antimicrobial additive 0306 1 for industrial lubricants identified as Micronox, 2 which Behnke incorporates into some of its 3 food-grade lubricants. All of the ingredients in 4 the Micronox product meet all relevant regulatory 5 guidelines, including those of the United States 6 Food and Drug Administration and the United 7 States Department of Agriculture. The Micronox 8 product has antimicrobial properties which no 9 competing product contains. 10 Q Go ahead and read the next two lines. 11 A These properties extend the useful lives of the 12 food-grade lubricants containing Micronox. It 13 does this by retarding bacterial growth in the 14 lubricants, which bacterial growth otherwise 15 would degrade the lubricants and make them 16 potential harbors for bacteria. 17 Q Okay. And does this language concern you at all? 18 A Well, the last two sentences are pesticide claims 19 for the product. 20 Q Okay. And if these particular claims were 21 brought to you for registration, how would you 22 handle that situation? 23 A We would require either the Micronox additive to 24 be registered or the lubricant to be registered. 25 Q Okay. Why the Micronox additive? 0307 1 A Because it's the Micronox additive, based on all 2 the literature that I've looked at, that's 3 providing the antimicrobial efficacy. 4 Q And would there be a particular section in 40 CFR 5 that would address -- would address if the 6 Micronox additive was being registered? 7 A 152.15, which talks about what is a pesticide. 8 Q Okay. Does this particular language, the last 9 two sentences as you stated, tell you anything 10 about Respondent's intent regarding the 11 antimicrobial properties in the lubricant? 12 A Well, they're intending to market the lubricants 13 and make claims that the lubricants contain an 14 additive which kills or protects the lubricant. 15 I mean, they're making pesticide claims for the 16 lubricant. 17 Q Okay. I'm going to have you look at one further 18 exhibit, and that is Respondent's Exhibit 9. And 19 I don't believe you have that book. We'll just 20 provide that to you. 21 MS. O'MEARA: Do you have exhibits, 22 Bruce? That's okay. We'll just provide it. 23 BY MS. O'MEARA: 24 Q We've turned it to Respondent's Exhibit 9 for 25 you. We'll put it up. If you would just review 0308 1 it. Let me know when you're ready, please. 2 A Okay. 3 Q Okay. If you would please identify what this is? 4 A Again, it's literature for Magna-Plate 78 fluids. 5 Q Okay. 6 MS. O'MEARA: Before we get into any 7 language, Your Honor, we have previously 8 stipulated that it's authentic, and we would now 9 stipulate that it is also relevant, and we'd ask 10 that Respondent's Exhibit 9 be moved in as 11 received to the record. 12 MR. MCILNAY: No objection. 13 JUDGE GUNNING: Okay. I also have it 14 already as received. 15 MS. O'MEARA: Oh, I'm sorry. Okay. 16 Good enough. 17 MR. MCILNAY: That might be a 18 mistake. But that's all right. 19 JUDGE GUNNING: I have it 20 specifically by 9. 21 MS. O'MEARA: Okay. 22 BY MS. O'MEARA: 23 Q Could you tell us if there is any language on 24 this particular exhibit that concerns you? 25 A At the top right, it talks about advanced 0309 1 anti-wear/extreme pressure food machinery oil 2 with Micronox, the term Micronox. And then on 3 the right-hand column third paragraph, Micronox 4 technology, both products contain a performance 5 benefit of Micronox technology that provides 6 preservative protection for the product. A first 7 in food-grade lubricant, JAX Micronox has 8 provided especially -- JAX Micronox has proven 9 especially effective in protecting JAX 10 Magna-Plate 78 fluids over extended lubrication 11 intervals. 12 Q Okay. And why does this language concern you? 13 A Again, that's a pesticide claim that the Micronox 14 additive has been put into the lubricant to 15 protect, preserve the lubricant, and that's a 16 pesticide claim. 17 Q Okay. Is that consistent with the language 18 you've just read previously if the NSF lawsuit? 19 A Yes. 20 Q Okay. And are there public health claims being 21 made here? 22 A Not in this particular. 23 Q Okay. And does the exhibit, does this particular 24 advertising indicate where the microorganisms are 25 being controlled? 0310 1 A It talks about preserving or protecting the 2 product. 3 Q Okay. 4 A So it's in the products, in the lubricant. 5 Q All right. That's the -- what is the 6 significance of the word preserve here? 7 A It's intended to in some way help the product 8 from being broken down from the bacterial 9 contamination or that might degrade the 10 lubricant. 11 Q Okay. And are these claims implicit or explicit? 12 A Provides preservative protection? That's to me 13 an explicit claim. 14 Q Okay. All right. Well, let's move on to talking 15 briefly about the formula. 16 MS. O'MEARA: I will note, Your 17 Honor, for the record I do recognize that there 18 is CBI in the information we have received 19 recently, and we won't talk about the specific 20 ingredients unless we have to. 21 MR. MCILNAY: Your Honor, I would 22 have no objection. Perhaps if we get to that 23 point, we could have the court reporter merely 24 mark this part of the transcript. 25 JUDGE GUNNING: Absolutely. 0311 1 MS. O'MEARA: May I proceed? 2 JUDGE GUNNING: Yes. At any time 3 where it becomes obvious, I want the record to 4 reflect that both parties have identified the 5 people in the courtroom at this time and that 6 there is no one here who is not privileged with 7 regard to CBI. In other words, everyone here is 8 either working for the EPA and is qualified to 9 deal with Confidential Business Information and 10 is credentialed as such, or Respondent waives 11 such with regard to his own people. 12 JUDGE GUNNING: All right. Also let 13 the record reflect in the audience is my staff 14 attorney Robyn Hanson from the Office of 15 Administrative Law Judges, and she is also 16 approved for handling CBI, as we -- it's the 17 acronym for Confidential Business Information. 18 MR. PETER: I'm a little sensitive 19 about it, because my attorney had to pull my 20 teeth to get me to give it to him, so I just want 21 to make sure that it is treated as such. 22 MS. O'MEARA: And I will respect 23 that. And, again, we'll do our best not to even 24 mention the specific ingredients. We'll talk 25 about it generally. 0312 1 JUDGE GUNNING: And it will be 2 redacted from any decision if it's even necessary 3 to refer to it. I try to avoid it at all costs, 4 and then it's treated as CBI. 5 MS. O'MEARA: We'll do our best to 6 avoid it. It would be a lot easier. 7 If I may proceed? 8 JUDGE GUNNING: Yes. 9 BY MS. O'MEARA: 10 Q Mr. Edwards, we've received a list of ingredients 11 regarding lubricants just recently. Have you 12 reviewed the list? 13 A Yes, I have. 14 Q Okay. Does the list that was provided -- 15 JUDGE GUNNING: Excuse me just a 16 moment. By any chance, is your cell phone on? 17 Is everyone's turned off? Okay. 18 MR. MCILNAY: Due to the 19 interruption, Your Honor, could we take a brief 20 break? 21 JUDGE GUNNING: Yes. We can take a 22 short break. It's 11:10. 23 (A recess was taken.) 24 JUDGE GUNNING: I just want to remind 25 the witness that he's still under oath. And 0313 1 we'll resume direct. 2 MS. O'MEARA: Okay. Thank you. 3 BY MS. O'MEARA: 4 Q Mr. Edwards, we were talking about the list of 5 ingredient for these lubricants. And you have 6 reviewed them; is that correct? 7 A Yes. 8 Q Okay. And does the list identify which 9 antimicrobial lubricant the ingredients are 10 identified for? 11 A The list that I saw was just a list of 12 ingredients. 13 Q Was it marked with any heading? 14 A I'd have to take a look at it again. I don't 15 recall if it had a heading or not. 16 Q Okay. I'm going to let you take a look at it. 17 MS. O'MEARA: May I approach the 18 witness? 19 JUDGE GUNNING: Yes. 20 MS. O'MEARA: Thank you. 21 BY MS. O'MEARA: 22 Q Okay. Is there a heading on it? 23 A It just says ingredient, and then over to the 24 right it says cast number. 25 Q In your experience, Mr. Edwards, would this list 0314 1 of ingredients be acceptable if the Respondent 2 was submitting an application for registration 3 under FIFRA? 4 A It would be a start, but in and of itself it 5 would not be sufficient for registration. 6 Q What is missing? 7 A Well, first, we would want to see, as has been 8 provided, a list of all the ingredients, but we 9 would want to know the function of each 10 ingredient, and we would need to know the 11 percentage of each ingredient that's in the 12 formula. 13 Q Why is the percentage important? 14 A The percentages is important in order for us to 15 make a determination whether or not we have 16 registered -- if that particular ingredient 17 happened to be the active ingredient, whether 18 we've registered it at that level or not. 19 Q Okay. 20 A It relates back to the data and all that's 21 required to be submitted with the application. 22 Q Okay. And without identifying any of the 23 ingredients, are any of the listed ingredients 24 potential actives that can be used for pesticidal 25 purposes? 0315 1 A There are five ingredients in here that we have 2 assigned what we call a PC code, a product 3 chemistry code, as an active ingredient. Two of 4 them there's currently no registered product that 5 contain them as an active. Two of them there 6 are -- two of the ingredients are currently 7 contained in registered pesticide products as 8 active ingredients. And one ingredient was 9 registered in the past as an active ingredient in 10 a couple of products, but those products have 11 since voluntarily canceled. 12 Q Okay. Two more questions and then we'll just put 13 this away. One is, the first one is, is there an 14 ingredient -- again, without identifying it -- on 15 that list, where you really don't have all the 16 information you need? 17 A There are -- there is at least -- there is one 18 ingredient that says it's proprietary. 19 Q So if you were registering this product, you 20 would need more information on that particular 21 ingredient as well? 22 A Right. We would ask the company to go back to 23 their supplier and have the supplier send us the 24 complete identity of that ingredient. 25 Q Okay. Now you said that there were five 0316 1 ingredients that were potential actives and two 2 were known -- were registered pesticides or used 3 in registered -- 4 A Two are in currently registered products. 5 Q Okay. And can you just inform the Court on what 6 the significance is of two possible ingredients 7 or more mixing together and how that would affect 8 things? 9 A Well, there are potentially five ingredients in 10 here -- 11 Q Okay. 12 A -- that could be active ingredients. It's quite 13 possible that it takes all five in some sort of 14 combination acting in synergy in order to make 15 the product work. 16 Q Okay. 17 A I don't know, but just based on the fact that 18 five of them have -- two are in registered 19 products. One is in -- was registered, and then 20 two others are potential, without the percentages 21 and all, it's very difficult to make any other 22 determination. 23 Q And is that because you don't have enough 24 information at this time? 25 A That's right. 0317 1 Q Okay. I'm going to take that from you. 2 MS. O'MEARA: May I approach the 3 witness? 4 JUDGE GUNNING: Yes. 5 MS. O'MEARA: Thank you. 6 BY MS. O'MEARA: 7 Q And that will be the end of that particular 8 discussion with respect to the ingredients. I'm 9 just going to put this away. 10 Mr. Edwards, in reviewing 11 Respondent's claims in the exhibits we've looked 12 at, how do you determine if registration is 13 needed or is not needed? 14 A In looking at the claims, how do I determine? 15 Q Yes. 16 A Partly based on experience and partly based on 17 our regulations. 18 Q Okay. And based on their claims, can you infer 19 intent? 20 A Sure. 21 Q And can you explain why intent plays a role in 22 whether something needs to be registered as a 23 pesticide or not? 24 A Intent plays a role because you look at how, what 25 the purpose -- you look at the claims and based 0318 1 on the claims and the usage of the product, 2 you're making a determination based on that, that 3 the product is either being sold with the 4 intended purpose as a pesticide product or not. 5 And based on the claims that are being made, 6 it's -- these are pesticide claims, so the intent 7 is that it be used as a pesticide product. 8 Q Okay. And you said you rely on regulations and 9 guidance. Is there a particular regulation that 10 discusses intent? 11 A 152.15 talks about, in 40 CFR, what pesticide 12 products need to be registered. 13 Q Okay. 14 A And it defines what's considered to be a 15 pesticide, and then it goes into intent with the 16 claims and all. 17 Q All right. And what does 152.15 state? And if 18 you need me to hand you the regulation to refresh 19 your recollection, that's fine. 20 A I can tell you what a pesticide product -- you 21 know, but the rest of it I would need to -- 22 Q Okay. 23 MS. O'MEARA: Your Honor, may I 24 approach the witness? 25 JUDGE GUNNING: Yes. 0319 1 MS. O'MEARA: Thank you. 2 BY MS. O'MEARA: 3 Q I'll give you the regulation, 40 CFR, parts 150 4 to 189. If you could find that particular 5 section that you were referring to, please. 6 A Okay. 7 Q Okay. Without reading what it says into the 8 record, if you could just give us a summary of 9 what 40 CFR 152.15 states regarding intent? 10 A All right. The title of it is Pesticide Products 11 Required to be Registered. And I think the -- 12 probably most important part is where it talks 13 about a substance is considered to be intended 14 for pesticidal purpose if the person who 15 distributes or sells the substance claims, states 16 or implies by labeling or otherwise that it can 17 or should be used as a pesticide. 18 Q Okay. And is there also agency guidance that 19 discusses this? 20 A There's guidance out with the Label Review Manual 21 that's out on our web site and also a reference 22 material that the reviewers have. 23 Q Okay. I'd ask you to turn to Complainant's 24 Exhibit 50, please. Let me move some of these 25 things out of your way, and I can hand them back 0320 1 to you if you need them. 2 What is this exhibit, please? 3 A It is the third edition of the Label Review 4 Manual. 5 Q And does it discuss intent? I can actually refer 6 you to EPA 924, EPA Bates number 924 of CX 50. 7 A It talks about intent in Chapter 2. 8 Q Okay. And what does it say about intent, just 9 generally? You don't have to read the language 10 if you don't need to. 11 A It very closely mirrors what's in 151.15, which 12 talks about, you know, products are considered to 13 be pesticides if they're intended for preventing, 14 destroying, repelling or mitigating any pest. 15 Q And that was on Bates EPA number 924? 16 A Yes, it is. 17 Q Okay. 18 MS. O'MEARA: Your Honor, at this 19 time I would -- this particular exhibit, I 20 believe -- I just checked -- has been previously 21 agreed as authentic, and I'd ask that it be 22 admitted or received as we've already 23 demonstrated its relevance with respect to the 24 discussion of intent. 25 MR. MCILNAY: Your Honor, I have no 0321 1 objection. 2 JUDGE GUNNING: Please mark Exhibit 3 No. 50 as received. 4 MS. O'MEARA: Thank you. 5 BY MS. O'MEARA: 6 Q Based on your review of the labels and the 7 advertising materials and the marketing materials 8 for the JAX lubricants with Micronox 9 antimicrobial technology, what is your 10 understanding of intent in this case? 11 A Well, there are pesticide claims being made when 12 you look at the fact that it specifically states 13 in the literature that it's to control E. Coli, 14 Salmonella and Listeria public health organisms. 15 It talks about the fact that the Micronox is in 16 to preserve the product. I mean, it is intended 17 to be used as a pesticide. There are pesticide 18 claims being made. 19 Q Okay. 20 A Even though it's a lubricant. 21 Q Okay. Thank you. And earlier you mentioned that 22 you're familiar with the exemptions found in 23 FIFRA and its regulations, correct? 24 A That's right. 25 Q All right. What exemption in particular deals 0322 1 with on or in processed food in FIFRA or its 2 implementing regulations? 3 A 40 CFR 152.5 defines what we can consider to be a 4 pest. 5 Q Okay. And what does it state? And if you want 6 to look at the regulations, I'm happy to pass 7 them to you. 8 A I mean, in general it goes through and defines a 9 number of items as being a pest, and then it gets 10 specific into microorganisms and talks about 11 microorganisms, specifically bacteria, viruses 12 and fungi are considered to be a pest, and then 13 there's an exception. 14 Q Okay. 15 A And then it says, except when they occur in or on 16 living man or animal, processed animal feed, 17 processed food, and then drugs, cosmetics or 18 beverages. 19 Q Okay. Focusing -- 20 A So those are excluded. 21 Q Okay. Focusing on the portion that talks about 22 on or in processed food, what is your 23 understanding of when this exemption applies? 24 A When the product is to be applied directly to, in 25 or on processed food, directly. 0323 1 Q All right. And what is your understanding of the 2 purpose of this exemption? 3 A The purpose of the exemption is the fact that 4 processed food is adequately regulated by another 5 agency, FDA, and EPA does not need at that point 6 to regulate materials that are applied to 7 processed food. 8 Q Can you give us an example of when the exemption 9 does apply, the on or in processed food 10 exemption? 11 A When? 12 Q Yes. 13 A There was in the last several years, a Proctor & 14 Gamble product called Fit that was sold. 15 MR. MCILNAY: I'm sorry. What was 16 the name? 17 THE WITNESS: F-I-T. And it was 18 intended to be applied to, specifically used in 19 restaurants and all, and they would go out -- 20 actually go out and treat the lettuce and other 21 commodities in the salad bar. But they weren't 22 treating the counter or the hard surface, but 23 actually treating the salad, tomato, cucumber, 24 whatever the ingredients were in that salad. 25 That specifically would be for antimicrobial 0324 1 purposes. 2 BY MS. O'MEARA: 3 Q Okay. 4 A Whether it be, you know, public health or 5 spoilage, bacteria. 6 Q All right. Is there any guidance that discusses 7 the on or in processed food exemption in context 8 of 40 CFR 152.5 (d)? 9 A The Label Review Manual discusses it. 10 Q Okay. Let's turn back then to the Label Review 11 Manual, and I will direct you to EPA Bates 924 12 again, please. And on that page, Item 6, can you 13 please read that? 14 A The title of number 6 is antimicrobial products 15 used solely in processed foods or feeds, in 16 beverages or in pharmaceuticals. Cracking, 17 milling, grinding, and other processes that cause 18 a physical change in the commodity are methods 19 that meet the definition of process. Substances 20 used in these processes against microbes in or on 21 the processed food are not pesticides under 22 FIFRA, and are regulated by FDA, not EPA. 23 Drying, husking and shelling do not meet the 24 definition of process, so that the products used 25 during these processes are FIFRA pesticides and 0325 1 are regulated by EPA under FIFRA. Cosmetics and 2 pharmaceuticals -- cosmetics are pharmaceuticals 3 regulated by FDA. It says, see 40 CFR 152.5(d). 4 Q Okay. Thank you. And is there anything else 5 that guides you and your staff on what -- how on 6 or in processed food applies? 7 A There's a document that was prepared back in 8 1998 -- 9 Q Okay. 10 A -- when we were working with FDA to figure out 11 jurisdiction over and the microbials, shortly 12 after the passages of the Food Quality Protection 13 Act. 14 Q All right. I'm going to direct you to that 15 document. That's Complainant's Exhibit 20. 16 Could you please turn to that, and I'll confirm 17 that that is the document you are referring to. 18 Complainant's Exhibit 20. And I'll direct 19 you -- I'll let you get to it first. I'm sorry. 20 Is this the document you were referring to? 21 A This is one of the documents. There is also 22 another one. 23 Q Are you talking about a Federal Register or piece 24 of guidance? 25 A I'm talking about a Federal Register. 0326 1 Q Okay. All right. I'm sorry. That's 2 Complainant's Exhibit 19. Will you tell me if 3 that is the document that you're referring to? 4 A Yes. 5 Q Okay. I apologize. So Complainant's Exhibit 19, 6 I'm going to direct you to 523, Bates 523. 7 MR. MCILNAY: If I could interrupt, I 8 didn't hear what you called Exhibit 19. 9 MS. O'MEARA: I haven't asked him 10 yet. 11 MR. MCILNAY: He referred to it. He 12 said there's a -- and I missed what he said. 13 THE WITNESS: I think I just said 14 there's another document. This is a Federal 15 Register notice. 16 MR. MCILNAY: Okay. 17 BY MS. O'MEARA: 18 Q Can you tell us, before you turn to 523, what the 19 title of that document is? 20 A It's a Legal and Policy Interpretation of the 21 Jurisdiction Under the Federal Food Drug and 22 Cosmetic Act of the Food and Drug Administration 23 and Environmental Protection Agency Over the Use 24 of Certain Antimicrobial Substances. And it's a 25 notice. 0327 1 Q And so is this a jointly issued document by EPA 2 and FDA? 3 A That's right. 4 Q All right. Does it discuss EPA's interpretation 5 of on or in processed food? 6 A Yes, it does. 7 Q All right. Now, directing you to 523, Bates 523. 8 Is there -- does it discuss EPA's interpretation 9 of on or in processed food on -- in that -- on 10 that page? 11 A On the -- there are three columns. The left-hand 12 column towards the top, actually the second full 13 paragraph, it talks about, in applying this 14 exclusion, EPA has historically interpreted the 15 words processed food and processed animal feed as 16 they are commonly understood -- food that has 17 undergone processing and is intended to be 18 consumed immediately or after some further 19 processing or preparation. 20 Q Okay. Now, having reviewed these marketing and 21 labeling and advertising claims, would you say 22 that Behnke's Lubricants fit into this particular 23 exemption, on or in processed food under 40 CFR 24 152.5(d)? 25 MR. MCILNAY: I'm going to object, 0328 1 Your Honor, as to the qualification of this 2 witness to give essentially the -- what's the 3 providence of the Court, the legal conclusion 4 that's at the very heart of this case. 5 MS. O'MEARA: Your Honor, if I may 6 respond. 7 JUDGE GUNNING: Yes. 8 MS. O'MEARA: Mr. Edwards is a -- 9 he's just finished testifying that he's an 10 expert, he's been doing this for 32 years at EPA. 11 He's offering his understanding of how that 12 exemption applies based on his experience, based 13 on historical interpretation of the EPA to inform 14 the Court. And certainly, of course, it is the 15 Court's decision at that point to determine if 16 the exemption -- his interpretation is correct. 17 And of course the Court will then draw the legal 18 conclusion and make its decision. But I would 19 submit that his informed testimony is relevant 20 here. 21 MR. MCILNAY: With that limitation 22 and understanding, Your Honor -- I didn't 23 understand the question that way -- but with that 24 part of the record, I'll withdraw my objection. 25 JUDGE GUNNING: Okay. As it's 0329 1 expressly stated by counsel for the EPA, I will 2 allow it with qualifications and limits that I 3 will be drawing the legal conclusion; however, 4 we'll admit the testimony of the expert witness 5 that can inform that decision, but it is an 6 expert opinion. 7 MS. O'MEARA: Thank you, Your Honor. 8 BY MS. O'MEARA: 9 Q You need me to ask the question again? 10 A Yes. 11 Q Okay. Based on the labeling, marketing and 12 advertising claims made by Behnke that we've 13 reviewed and you've reviewed, is it your opinion 14 that the on or in processed food exemption under 15 152.5(d) applies to the lubricants? 16 A It would be my opinion that that exemption does 17 not apply to these products. 18 Q Can you tell us why? 19 A First, in reviewing the literature that has been 20 provided, nowhere are there any directions for 21 these lubricants to be applied directly to, in or 22 on processed food. They are intended as 23 lubricants. They're intended to lubricate 24 machinery. If they do become a part of processed 25 food, it is through incidental contact. And I 0330 1 think there was testimony from one of the earlier 2 witnesses that if a lubricant were to drip onto 3 meat, that that would -- where it dripped, it 4 would be cut out and disposed of. So there are 5 no use directions. 6 In looking at the claims, some of the 7 claims being made, the claims are being made that 8 the antimicrobial substance is in there to 9 protect the lubricant. The intent seems to be 10 with some of the other claims that the lubricant 11 is killing, they're making claims to kill 12 microorganisms, but they would be on the surface 13 that the lubricant would come in contact with, 14 which would be typically a hard surface, be the 15 machinery, be whatever it's being used to 16 lubricate. 17 Q Okay. And is this with regard to all five 18 products? 19 A Yes, it is. 20 MS. O'MEARA: Your Honor, before I 21 forget, I would ask to have Complainant's 22 Exhibit 19 received. We've already stipulated to 23 its authenticity. I would submit that it is 24 relevant and ask that it be moved into the 25 record. 0331 1 MR. MCILNAY: No objection. 2 JUDGE GUNNING: Please mark 3 Exhibit 19 as received. And as previously noted 4 on federal register notices, it is somewhat moot, 5 because I would take administrative notice of 6 federal register notices. But it makes for a 7 cleaner record if it's in the record. 8 MS. O'MEARA: Thank you, Your Honor. 9 BY MS. O'MEARA: 10 Q Mr. Edwards, can you tell us what your opinion is 11 as to whether the Respondent's antimicrobial 12 lubricants, all five of them that we've been 13 discussing, are only targeting microorganisms 14 coming from or -- coming from on or in processed 15 food? Would that then exempt them? 16 A No, it would not exempt them. The claims vary 17 all over the place in a sense. I mean, in one 18 place they talk about that the Micronox is 19 intended to preserve the product. In another 20 place it's suggested that it could substitute as 21 a sanitizer. In other places it's very vague, 22 and it doesn't specify why the Micronox is in the 23 product. It talks about enhanced antibacterial 24 protection, but it doesn't really specify where. 25 It talks about, in a sense, throughout the plant, 0332 1 so it could be from any. But for us to apply 2 that exemption, for me to consider that these 3 aren't pesticide products, that they are 4 regulated exclusively by FDA, I would need to see 5 some directions that talk specifically about the 6 fact that they are applied directly to processed 7 food. 8 Q Okay. 9 A Not through an incidental -- possibly an 10 incidental contact. 11 Q Is it your opinion that the lubricants are food, 12 processed food? 13 A No. They're intended to be lubricants. That's 14 the whole -- I mean, if you look at most of the 15 literature, that's was probably 60, 70 percent of 16 the description provided. 17 Q Okay. Now, you talk about indirect foods, and 18 Respondent does claim that its lubricants are 19 indirect food additives under FDA. In your 20 opinion, does that have any effect on whether the 21 lubricants have to be registered under FIFRA? 22 MR. MCILNAY: I'm going to object to 23 the foundation and qualification of this 24 client -- or this witness to interpret FDA 25 regulations. 0333 1 MS. O'MEARA: May I respond? 2 JUDGE GUNNING: Please. 3 MS. O'MEARA: Thank you. I'm not 4 actually asking Mr. Edwards to interpret the FDA 5 regulations. What I'm asking is, when he is 6 determining whether registration is appropriate 7 or not, does he consider the fact that FDA has 8 deemed the particular product an indirect food 9 additive, does it have any impact on his decision 10 at EPA? 11 MR. MCILNAY: I'll withdraw the 12 objection with that qualification. 13 THE WITNESS: I think I earlier 14 talked about the fact that we do handle 15 applications for registration for a variety of 16 products where FDA and indirect food additive 17 regulation is required, but an EPA registration 18 is also required because of where the product is 19 intended to be used. I think I gave as an 20 example application to water, where in the 21 manufacture of pulp and paperboard, where you're 22 applying it to water to control pests, bacteria, 23 slime in the water, the residue in the water is 24 going to end up being a component of pulp and 25 paperboard which would come in contact with 0334 1 processed food. So the residue in that case is 2 regulated by FDA, and they've actually got a 3 citation in 21 CFR, I think it's 176.300 for 4 slimicides. We've registered many other products 5 for other types of uses, such as coatings. We've 6 even registered a product intended for 7 application as in-tube lubricants, where FDA 8 indirect food additive was required, but an EPA 9 registration is also required because the purpose 10 is that it's intended to preserve the lubricant, 11 and lubricant is not processed food. 12 BY MS. O'MEARA: 13 Q And with respect to these particular lubricants, 14 the fact that they may or may not be indirect 15 food additives under FIFRA, does that have any 16 impact on your deciding whether registration is 17 appropriate under FIFRA? 18 A No. FIFRA -- I mean, what we would do is we 19 would require an indirect food additive 20 regulation be established or required to show us 21 where one has been established, or we would not 22 register the product. 23 MS. O'MEARA: Okay. I had some 24 questions -- Your Honor, if I may just direct the 25 question to you before I go into these questions, 0335 1 regarding Section 2(mm). And I just want to seek 2 clarification whether I need to even ask these 3 questions. I was not clear yesterday whether the 4 defense regarding 2(mm) still exists. And I do 5 have seven questions. Maybe I can just dispense 6 with it by asking them. 7 JUDGE GUNNING: Okay. Assuming they 8 don't call for legal conclusions. 9 MS. O'MEARA: Absolutely not. 10 JUDGE GUNNING: Okay. 11 BY MS. O'MEARA: 12 Q Mr. Edwards are you familiar with Section 2(mm) 13 of FIFRA? 14 A Yes, I am. 15 Q All right. And can you tell the Court what 2(mm) 16 says? And I can hand you your statute book if 17 you would like to take a look at that. 18 A If you'd like me to read it. I mean, in general 19 2(mm) defines what is considered to be an 20 antimicrobial pesticide. 21 Q Okay. I'll just hand it to you in case you need 22 it, but go ahead. I'm sorry. 23 A The whole purpose behind 2(mm). 24 MR. MCILNAY: Is there a question? I 25 didn't hear you ask him about the purpose of it. 0336 1 MS. O'MEARA: Okay. 2 BY MS. O'MEARA: 3 Q What is the purpose of 2(mm)? 4 A The purpose of 2(mm) is simply to define what 5 applications that we receive are subject to the 6 time frames in Section 3(h) of FIFRA. There is 7 no other purpose behind it. It defines which 8 applications are subject to the time frames, and 9 then it also lists several types of applications 10 that are not subject to the time frames. 11 Q Okay. Does Section 2(mm) in your opinion create 12 any sort of an exemption under FIFRA for purposes 13 of registration of antimicrobial pesticides? 14 A No. What it does in there is it says that 15 application for registration of wood 16 preservatives, antifoulants and food uses, both 17 food uses that involve a 409 tolerance or a 408 18 tolerance, are not considered to be antimicrobial 19 pesticides, and therefore are not subject to the 20 time frames listed in 3(h). They still require 21 registration. 22 Q Okay. Thank you, one last question on that. In 23 your opinion does Section 2(mm) allow the 24 Respondent to escape FIFRA jurisdiction for its 25 JAX lubricants? 0337 1 MR. MCILNAY: I'm going to object, 2 Your Honor. This clearly is a legal conclusion. 3 JUDGE GUNNING: Sustained. 4 MS. O'MEARA: Thank you. 5 BY MS. O'MEARA: 6 Q Mr. Edwards, does FIFRA exempt indirect food 7 additives as defined in -- I'm going to strike 8 that question. I'm sorry. 9 MS. O'MEARA: Give me just one 10 minute, Your Honor? 11 JUDGE GUNNING: Yes. 12 BY MS. O'MEARA: 13 Q Mr. Edwards, does FIFRA exempt from registration 14 microbial products, in your opinion, that target 15 only the food and beverage industry? 16 A No. I mean, it would exempt antimicrobials that 17 are applied directly to beverages and directly to 18 processed food. But if you're not applying it 19 directly to, in or on that, no. 20 Q Okay. Let's -- I'm going to move on to talking 21 about some of the products you were talking 22 about, the slimicides and the coatings and the 23 like. I'm going to direct your attention to 24 Complainant's Exhibit 18a, 18a. And when you 25 have had a chance to review it, please let me 0338 1 know. 2 A Okay. 3 Q Can you please tell the Court what this is? 4 A This is an EPA registered product where the 5 active ingredient which is a silver sodium 6 hydrogen zirconium phosphate, is registered as a 7 product that is applied, can be incorporated into 8 a number of substrates. 9 Q Okay. Can you tell the Court what the -- on the 10 first page, the title of the product we're 11 talking about is? 12 A It is called antimicrobial AlphaSan RC 5000. 13 Q All right. And is this an antimicrobial product 14 covered both by FIFRA and the Federal Food Drug 15 and Cosmetics Act? 16 A Yes. 17 Q How do you know that? 18 A If you look on the label of the product, you'll 19 see under the directions -- well, I guess if you 20 look, first of all, on the top of the left hand 21 it talks about -- 22 Q What page? I'm sorry. 23 A All right. Page EPA 501. 24 Q Okay. 25 A If you look at the left-hand column up at the top 0339 1 under the name, you'll see that it's an 2 antimicrobial additive especially designed to 3 withstand high temperatures in the manufacture of 4 plastics, films, fibers, polymeric materials, and 5 ceramics. 6 Q On the right-hand side is there a -- 7 A Right. And then you move over to the right-hand 8 side, and you'll see both food contact, and then 9 underneath drinking water and nonfood contact 10 directions. 11 Q Okay. 12 A The food contact directions talk about it being 13 an antimicrobial additive in polymeric 14 manufactured products, plastics, coatings, films. 15 And, you know, these can be products that will 16 come in contact with processed food. 17 Q Okay. And can you read the language under Food 18 Contact Uses? Perhaps -- I know it's difficult 19 to read -- perhaps the first paragraph? 20 A Antimicrobial AlphaSan RC 5000 may be used as an 21 antimicrobial additive in the polymeric 22 manufactured products listed below that are used 23 for manufacturing, packing, packaging, 24 transporting, handling and/or holding food if 25 such use is not intended to have antimicrobial 0340 1 effect in the food itself. Do not incorporate 2 antimicrobial AlphaSan RC 5000 into any food 3 contact polymer unless that food contact polymer 4 and use conditions are approved and listed in 21 5 CFR 164 through 186, inclusive, or in the United 6 States Food and Drug Administration's food 7 contact substance notification system. Any 8 incorporation of alpha -- antimicrobial AlphaSan 9 RC 5000 into any food contact substance other 10 than in an approved and listed food contact 11 polymer is prohibited. 12 Q Okay. Could this -- based on what you've just 13 read, could this antimicrobial AlphaSan RC 5000 14 migrate into food? 15 A Yes, it could. 16 Q And why do you say that? 17 A Because it's part of the polymer, and it will 18 migrate to the surface. And as such, small 19 amounts will likely become a part of any food 20 item that would be -- come in contact with that 21 substance. 22 Q Is there any indication on this label what type 23 of microorganism this antimicrobial pesticide is 24 intended to control? 25 A It says at the top under the -- top right, 0341 1 Directions For Use. 2 Q Yes. 3 A The second sentence, it is designed to be 4 incorporated into materials during the 5 manufacturing process to impart antimicrobial 6 activity to manufactured products. Antimicrobial 7 AlphaSan RC 5000 suppresses the growths of 8 bacteria, algae, fungi, mold and mildew. If 9 microbial activity in the manufactured product 10 could lead to unpleasant odors, discoloration or 11 deterioration of the product, then such a claim 12 may be made for the manufactured product. 13 Manufactured products incorporating antimicrobial 14 AlphaSan RC 5000 may not make any public health 15 claims relating to antimicrobial activity without 16 first obtaining an EPA registration for the 17 manufactured product which permits such claims. 18 When incorporated into manufactured products, 19 antimicrobial AlphaSan RC 5000 does not protect 20 users of any such manufactured product or others 21 against foodborne or disease-causing bacteria, 22 virus, germs or other disease-causing organisms. 23 Q Thank you. Is there a Direction For Use on this 24 label? 25 A Are there directions? 0342 1 Q Yes. 2 A Yes. 3 Q Where are they? 4 A Under the paragraph that I just read. 5 Q Oh, okay. You mean the next sentence? 6 A Yes. It talks about antimicrobial AlphaSan RC 7 5000 may be used in materials that may be 8 incorporated into manufactured products listed 9 below. The final article are finished coating 10 for all users -- uses, I guess, requiring coating 11 type applications may contain from 0.1 percent to 12 2 percent, by weight, this product, except as 13 specifically noted. 14 Q Okay. So that whole two paragraphs you read were 15 Directions For Use, correct? 16 A Yes. 17 Q Is this product an example of an antimicrobial 18 pesticide that's subject to both FIFRA 19 requirements and FDA requirements? 20 A Right. 21 MR. MCILNAY: I'm going to object, 22 Your Honor. Well -- I am going to object. It 23 speaks for itself, and specifically the document 24 says, if used in a certain fashion, it must be 25 FDA regulated. I guess I'd -- I don't think it's 0343 1 clear from the testimony that it is subject to 2 both necessarily. 3 JUDGE GUNNING: That would be 4 something you could cover on cross. 5 MR. MCILNAY: All right. 6 JUDGE GUNNING: Okay. 7 BY MS. O'MEARA: 8 Q Go ahead and answer the question. 9 A It is subject to dual jurisdiction. 10 Q Okay. 11 A Because it's being used to treat articles that 12 will come in contact with processed food, an FDA 13 indirect food additive regulation is required. 14 Because it's being used as a pesticide, it's 15 being incorporated in the article to protect the 16 article from bacteria, mold, whatever the listed 17 organism, that's a pesticide claim and requires 18 it to be registered as a pesticide product. 19 Q Is this a good example of the type of labeling 20 information that would be needed for 21 antimicrobial pesticides? 22 A It covers the basic components of a label. If 23 you look at the top, you've got the name, you've 24 got the ingredient statement, you've got a signal 25 word, you've got the child hazards, you've got 0344 1 precautionary statements, you've got first aid, 2 you've got storage and disposal, and then you've 3 got the Directions For Use -- 4 Q Okay. 5 A -- as to where, when and how it's to be applied. 6 Q Okay. Now, when you read the Directions For Use, 7 it specifically stated, can't make public health 8 claims. What kind of efficacy data was required 9 for this antimicrobial pesticide prior to 10 registration? 11 A We did not require efficacy data to be submitted 12 with this application, because there are no 13 public health claims being made. What we expect 14 is the company has efficacy data, that they 15 perform the studies in accordance with proper 16 test guidelines, under good laboratory practice 17 standards, and that that data is available in 18 their files, and should we see a need to ask for 19 it, then they will be able to submit it. 20 Q So theoretically speaking, it should be available 21 in the AlphaSan? 22 A Yes. But no data was required up front because 23 there are no public health claims being made. 24 Q Okay. 25 MS. O'MEARA: Your Honor, at this 0345 1 time I would ask that this Exhibit 18a be entered 2 into the record. It has already previously been 3 stipulated as authentic. I would submit that it 4 is also relevant, and ask that it be received. 5 MR. MCILNAY: Your Honor, I would 6 like to reserve for cross my objection on 7 Exhibit 18a. Time permitting, I could voir dire 8 the witness a little bit on it right now to make 9 a determination on relevancy. 10 MS. O'MEARA: Your Honor, if I may 11 just get through the rest of the testimony. 12 JUDGE GUNNING: Yeah. I think for 13 time-wise it would probably be better to stay 14 with this, and then we'll revisit that objection. 15 I do not have -- with regard to 16 Complainant's Exhibit 20, was that proffered? 17 MS. O'MEARA: I do need to, yes, 18 proffer that. I apologize. Complainant's 19 Exhibit 20, I started to do it, I apologize, I 20 kind of dropped the ball there. 21 JUDGE GUNNING: That is a guidance 22 document, food labeling guidance; is that 23 correct? 24 MS. O'MEARA: Yes. Actually if I 25 could just ask for some testimony on that real 0346 1 quickly. 2 BY MS. O'MEARA: 3 Q If you would turn to 20, and tell the Court what 4 the title of that guidance is, please? 5 A The title is Antimicrobial Food Additives 6 Guidance, and it's a notice that the Food and 7 Drug Administration put together after passage of 8 the Antimicrobial Technical Corrections Act in 9 '98. 10 Q Okay. And in the interest of time, does Page 541 11 discuss processed food and the definition of 12 processed food? 13 A Yes. 14 Q And does it state in the second sentence that EPA 15 and FDA have agreed to certain things being 16 processed food and not being processed food? 17 A Right. 18 Q All right. And in the item above it, which says 19 food additive uses subject to pesticide 20 registration under FIFRA, is there a discussion 21 about FIFRA registration in that paragraph? 22 A There is a discussion of FIFRA. 23 Q Okay. 24 MS. O'MEARA: This, Your Honor, I 25 would ask be admitted into the record, received 0347 1 into the record as well. It has been previously 2 agreed that it is authentic. 3 MR. MCILNAY: I have no objection. 4 JUDGE GUNNING: Okay. Please mark 5 Complainant's Exhibit 20 as received. 6 MS. O'MEARA: Thank you. 7 BY MS. O'MEARA: 8 Q Now going back to 8b, EPA number 508, and this is 9 relating to antimicrobial AlphaSan RC 5000. 10 Quickly, if you could tell the Court what this 11 document is? 12 A Are you talking 18b? 13 Q Yes, 18b. I'm sorry. Thank you. 14 A It is a document that the Food and Drug 15 Administration puts out that lists their 16 inventory of food contact substances that have 17 been submitted through their Food Contact 18 Substance Notification Program. 19 Q Is this particular product on that list? 20 A This product is number one on that list. 21 MS. O'MEARA: I would ask again that 22 this particular Exhibit 18b, we have previously 23 agreed that it is authentic, I would submit given 24 the testimony that Mr. Edwards just gave with 25 respect to 18a, it is too relevant, and ask that 0348 1 it be received into the record. 2 MR. MCILNAY: I would also like to 3 reserve. 4 JUDGE GUNNING: Okay. 5 BY MS. O'MEARA: 6 Q Okay. Mr. Edwards, can you please turn to 7 Complainant's Exhibit 18c, which can be found at 8 EPA 510. 9 A Okay. 10 Q And can you please tell us what product this 11 particular exhibit covers? 12 A This is for an EPA registered product named 13 Tolcide TS352C. 14 Q Okay. And if you would turn to Page 511, please. 15 What is the title of that page? 16 A It's the first page of a draft label that we 17 accepted, and called Tolcide PS352C. 18 Q Okay. And what is the purpose of this 19 antimicrobial pesticide? 20 A This material is intended as a preservative for 21 various -- either as a preservative in products, 22 or it's intended to be applied to, in some case, 23 the industrial processes to control slime. 24 Q All right. 25 A Or bacteria. 0349 1 Q Okay. Are there any food contact uses for this 2 product in this label? 3 A On page EPA Page 512. 4 Q All right. And can you tell us where that is? 5 A If you look, it's down toward the bottom under 6 Directions For Use, there's a section called 7 paper and paperboard manufacturing, and then 8 you've got a), and then if you look under 1) 9 you've got dosing, intermittent dosing, 10 continuous dosing. And then you have b), and 11 then it says under b), for use as a slimicide 12 in the manufacture of paper and paperboard 13 products that may contact food. 14 Q For what types of organism -- I'm sorry -- 15 microorganisms does this antimicrobial -- or is 16 this antimicrobial pesticide intended to control? 17 A Again, this product's intended to control 18 microorganisms that are nonpublic health in 19 nature. It's a preservative, or it's intended to 20 kill bacteria that grows in water. 21 Q And does it say that under Directions For Use? 22 I'm going to direct your attention to paper and 23 paperboard manufacturing on top before a, in 24 parentheses. Do you see that? 25 A Yeah. It just says for control of bacteria, 0350 1 fungi and algae. And then it says further under 2 a) as a slimicide, which is the same thing it 3 says under b), as a slimicide. 4 Q Okay. 5 A So again it's to control bacteria that will 6 affect the manufacturing process of the pulp and 7 paper. 8 Q Is this another example of a product -- 9 antimicrobial pesticide that is subject to both 10 FIFRA requirements and FFDCA requirements? 11 A Because the pulp and paperboard could be made 12 into products such as your Saran wrap, your meat 13 containers, your absorbent materials on the 14 bottom of a meat package that would come into 15 contact with processed food, then any residue 16 that would result in that processed food is 17 subject to FDA jurisdiction. So we would require 18 an indirect food additive regulation from FDA 19 before we would register this product. Again, 20 it's being applied to water to control bacteria 21 in the water. 22 Q Okay. 23 A So it's a pesticide product. 24 Q And does it require registration with EPA? 25 A It requires registration, and is registered. 0351 1 Q Was there efficacy data that was required for 2 this antimicrobial pesticide? 3 A Again, it's like the other product. It's making 4 no public health claims, so no data is required 5 to be submitted, but it's expected to be 6 available. 7 Q Okay. Could you please turn to Complainant's 8 Exhibit 8d (sic), EPA 516, EPA number 516. And 9 if you would review this and tell us what it is? 10 A In the middle column this is -- 11 Q First, if you would just tell us what the 12 document is? 13 A All right. This is a Federal Register notice 14 that the Food and Drug Administration issued that 15 established an indirect food additive regulation 16 for this Tolcide material -- 17 Q Okay. 18 A -- to be applied -- or for residues that could 19 occur in pulp and paper from a pesticide 20 application. 21 Q Okay. And you were going to say in the column, 22 and I forget what column you said. 23 A Well, the middle column talks about that. 24 Q Okay. All right. And what does it state? 25 A Under summary, it says the Food and Drug 0352 1 Administration, FDA, is amending the food 2 additive regulations to provide for the safe use 3 of tetrakis(hydroxymethyl)phosphonium sulphate as 4 a slimicide for use in the manufacture of paper 5 and paperboard that contact food. 6 Q And is this the same product we were just talking 7 about, the Tolcide? 8 A Yes. 9 Q Okay. 10 MS. O'MEARA: Your Honor, at this 11 time I would ask that 18c and d also be received 12 into the record. 13 MR. MCILNAY: I would like to reserve 14 on those as well. 15 MS. O'MEARA: All right. 16 BY MS. O'MEARA: 17 Q Directing your attention then to Complainant's 18 Exhibit 8e. And I'm going to put up a large 19 size. 20 JUDGE GUNNING: 18. 21 MS. O'MEARA: Sorry. I keep messing 22 that up. 18. Thank you. 23 BY MS. O'MEARA: 24 Q I'm going to put up a larger version of EPA 518, 25 EPA 518. Just review it. Can you tell the Court 0353 1 what this is? 2 A This is again a label that EPA accepted for a 3 pesticide product, for an antimicrobial product 4 that's intended to be applied to food-grade 5 lubricants as a preservative. 6 Q What is the title of this particular page, 518? 7 A The name of the product is MICROL Preservative. 8 Q Can you read the next sentence? 9 A An antimicrobial preservative for industrial use 10 in food-grade lubricating oils. 11 Q Okay. I'm going to ask you to turn to Page 519, 12 the next page. And I'll have a large version of 13 that as well, up. Please review it. When you're 14 ready please, let me know. 15 A Okay. 16 Q All right. Could you please read under 17 Directions For Use where it starts with the word 18 MICROL? 19 A MICROL Preservative should be added to the 20 mineral oil component of lubricants compliant 21 with 21 CFR 178.3570 at a maximum level of one 22 percent in order to prevent decomposition and 23 odors in the lubricant caused by microorganisms. 24 Add MICROL Preservative at any convenient time 25 during the mixing process. 0354 1 Q All right. And then if you would read the next 2 paragraph underneath that, please? 3 A No finished products containing MICROL 4 Preservative may make any public health claims 5 relating to antimicrobial activity without EPA 6 pesticide registration. When incorporated into 7 lubricants, this product does not protect users 8 of any such treated article or others against 9 foodborne or disease-causing bacteria, viruses, 10 germs or other disease-causing organisms. 11 Q Okay. And if you'd read that last sentence 12 underneath that paragraph you just read, please. 13 A This product is compliant with 21 CFR 184.1021. 14 Q Is that a FDA regulation? 15 A That's an FDA regulation. 16 Q Okay. Is this an antimicrobial product that is 17 covered by both EPA under FIFRA and the Federal 18 Food, Drug and Cosmetics Act? 19 A Yes, it is. 20 Q What is the purpose of this antimicrobial 21 pesticide based on this accepted label? 22 A Again, it's intended to preserve the lubricant. 23 To control -- as it says, to prevent 24 decomposition and odors in the lubricant caused 25 by microorganisms. 0355 1 Q Does it have food contact uses? 2 A It could. It could have both food and nonfood. 3 Q Okay. Could this antimicrobial MICROL migrate 4 into food? 5 MR. MCILNAY: Objection, foundation. 6 JUDGE GUNNING: Sustained. 7 BY MS. O'MEARA: 8 Q Okay. What type of microorganisms is this 9 antimicrobial pesticide intended to control based 10 on the label? 11 A Microorganisms that cause odor and deterioration, 12 decomposition. 13 Q Okay. Explain why EPA has jurisdiction over this 14 antimicrobial pesticide under FIFRA. 15 A Because it's being applied to an inanimate 16 object, in a sense, the lubricant, for the 17 purpose of preserving the lubricant or 18 controlling odors or decomp -- bacteria that 19 might cause decomposition. Those are pesticide 20 claims that require a product to be registered. 21 Q Okay. And, I'm sorry, I can't remember if I 22 asked you if it specifies where the antimicrobial 23 preservative targets microorganisms? 24 A It targets them in the lubricant. 25 Q And directing your attention to Complainant's 0356 1 Exhibit 8f, which is EPA -- 18f which is EPA 520. 2 Can you review that? And when you are ready, 3 please tell us what it is. 4 A Yes. This is a citation found in 21 CFR, 5 specifically 184.1021, for benzoic acid. 6 Q And going back to EPA 518, can you identify the 7 active ingredient in the MICROL preservative 8 product? 9 A The active in MICROL is found on EPA Page 518, 10 and it's benzoic acid. 11 Q So the active is -- 12 A It's the same active ingredient, that's right. 13 MS. O'MEARA: Your Honor, at this 14 time -- 15 MR. MCILNAY: Excuse me. Could you 16 read back -- I don't think -- they kind of talked 17 over each other, and that was an important 18 question and answer. I want to make sure you got 19 that. 20 MS. O'MEARA: Is the active 21 ingredient also generally recognized as safe? Is 22 that the question? 23 MR. MCILNAY: It was just the last 24 question and answer. 25 (The testimony was read as follows:) 0357 1 A The active in MICROL is found on EPA Page 518, 2 and it's benzoic acid. 3 Q So the active is -- 4 A It's the same active ingredient, that's right. 5 MR. MCILNAY: That's not what I 6 heard. Could you repeat the question? 7 MS. O'MEARA: Sure. I'll go back two 8 questions. 9 BY MS. O'MEARA: 10 Q Going to EPA -- turning to EPA 520, can you 11 please tell us what 18f, Complainant's 12 Exhibit 18f, at 520 is? 13 A It is a copy of a citation in the Food -- in 21 14 CFR, 184.1021 for benzoic acid, which is listed 15 as a substance affirmed as Generally Recognized 16 As Safe, GRAS. 17 Q Okay. 18 A And it is the same substance, benzoic acid, 19 that's also contained in the EPA registered 20 product called MICROL. 21 Q So turning back to EPA 518, what is the active 22 ingredient in MICROL Preservative? 23 A If you look under the active ingredient statement 24 up at the top of the label, it says benzoic acid 25 at 99.98 percent. 0358 1 Q Is that the same benzoic acid as what you just 2 described? 3 A It's the same benzoic acid. 4 Q And is the benzoic acid on 520 identified as 5 Generally Regarded As Safe? 6 A Yes. 7 Q Going back to EPA -- 8 A By FDA, not EPA. 9 Q By FDA. Thank you. 10 A By FDA. 11 Q And going back to EPA Bates 518, is this product 12 also registered with benzoic acid that's 13 Generally Regarded As Safe with EPA under FIFRA? 14 A Yes, it is. 15 MS. O'MEARA: Your Honor, at this 16 time I would ask to have Complainant's 17 Exhibits 18e and 18f received. 18 MR. MCILNAY: I have no objection to 19 those two, Your Honor. 20 JUDGE GUNNING: Please mark 21 Complainant's Exhibits 18e and 18f as received. 22 MS. O'MEARA: Your Honor, I see that 23 it is 12:37. And I do have a little bit more, 24 and I know that the cafeteria closes at 1:30. 25 Would this be a good time to break? 0359 1 JUDGE GUNNING: Well, depending on 2 how much longer you think. 3 MS. O'MEARA: Into lunch. I mean, it 4 won't be enough time to probably get everybody to 5 the cafeteria. 6 JUDGE GUNNING: Well, then this would 7 be a good place to break for lunch. How about if 8 we try to keep it approximately 45 minutes. So 9 we'll start back here at 1:30 sharp. 10 (A recess was taken.) 11 JUDGE GUNNING: Okay. 12 MS. O'MEARA: This shouldn't take 13 much longer. 14 JUDGE GUNNING: Excellent. 15 BY MS. O'MEARA: 16 Q Mr. Edwards, continuing. Good afternoon. I want 17 to talk about briefly, you mentioned previously 18 the treated article exemption. If you could just 19 tell us what that is? 20 MR. MCILNAY: Your Honor, if I could, 21 we're not making a claim to fall under the 22 treated article exemption, and so if it would 23 save time not to go through the details of what 24 the treated article exemption means, that would 25 be fine with us. 0360 1 MS. O'MEARA: Your Honor, I believe 2 it's defense number six that, although they don't 3 say the actual words treated article exemption, 4 they certainly are arguing treated article 5 exemption. And what I would like to do is 6 essentially get PR notice 2000-1 in, which talks 7 specifically about some of this language that has 8 been used, if I need to argue it in a post brief. 9 MR. MCILNAY: Is that Exhibit 21? 10 MS. O'MEARA: Exhibit 21. 11 MR. MCILNAY: I'll stipulate to its 12 submission. 13 JUDGE GUNNING: Is that agreeable? 14 MS. O'MEARA: Thank you. Yes. 15 JUDGE GUNNING: Please mark 16 Complainant's Exhibit 21 as received. 17 BY MS. O'MEARA: 18 Q Okay. Then moving on, we really don't have much 19 more to go. Mr. Edwards, in your opinion, based 20 on Respondent's labeling, advertising and 21 marketing claims, what is the intended purpose of 22 the five lubricants we have been discussing? 23 A I think it's -- based on the literature and all, 24 that it's clear they're intended to function as 25 lubricants, but they also make antimicrobial 0361 1 claims and, therefore, should be registered as 2 pesticide products. 3 Q Okay. Based on your opinion, does the on or in 4 processed food exemption apply in any way to the 5 five products? 6 A No, it does not. 7 Q And in your opinion -- strike that. In your 8 opinion, if these five antimicrobial lubricants 9 were to be registered under FIFRA, would EPA 10 allow the types of claims that have been made 11 here? 12 A Some of the claims might be allowed if there were 13 adequate supporting data that would show that the 14 products performed as the claims indicated. 15 Certainly if they were to come in and apply for 16 registration as a preservative, to be applied to 17 lubricants as a preservative, then they could 18 make that application along with whatever the 19 supporting data are as needed. 20 Q Okay. I'm going to direct your attention to 21 Complainant's Exhibit 8b for a second, and it's 22 249, the second half of that page. Specifically 23 with respect to the statement that says, if a 24 bacteria, yeast or mold colony is already 25 established, FDA/USDA/NSF-approved competitor 0362 1 lubricants will inhibit the growth of the colony, 2 but to actually kill the colony will require a 3 sanitization process or the use of JAX food-grade 4 lubricants which incorporate Micronox technology. 5 Would you allow that claim? 6 A We would not allow a sanitization claim without 7 supporting data. 8 Q Based on your -- based on the labeling, 9 advertising and marketing claims that have been 10 made by Behnke with respect to the five 11 lubricants, what is your opinion as to whether 12 each of these lubricants should have been 13 registered with FIFRA? 14 A Based on the claims on the literature that we 15 discussed, all five products should be 16 registered. 17 MS. O'MEARA: Thank you, Your Honor. 18 I have no further questions. 19 JUDGE GUNNING: Now, if it would be 20 helpful, if counsel would like to stay at his 21 seat, with the microphone, if you think that 22 would work better, I don't have an objection. 23 MS. O'MEARA: I don't have an 24 objection. 25 MR. MCILNAY: The only difficulty is 0363 1 I can't see the witness very well, and that's why 2 I prefer podium. 3 If I don't speak loudly enough, 4 Phyllis, just give me a shout. 5 JUDGE GUNNING: And I want to make 6 sure Mr. Peters can also see the witness through 7 counsel. 8 MR. PETER: Thank you. 9 MR. MCILNAY: Let me put on the 10 record that our prehearing submission, we did 11 provide both the tribunal and opposing counsel 12 with exhibits we intend to use, but we had those 13 separately bound for purposes of the hearing. 14 And we added Bates stamp numbers to the pages so 15 that it would make it easy to direct the witness 16 within the particular exhibit. I have given two 17 volumes to EPA's counsel during the lunch break, 18 and I have two volumes for you. 19 JUDGE GUNNING: Thank you. 20 MR. MCILNAY: There were some 21 references made during Mr. Edwards' initial 22 testimony involving some of our exhibits, so I 23 will place two volumes on the witness stand as 24 well for ease of reference. 25 JUDGE GUNNING: Now, maybe this will 0364 1 confuse matters, but at some point in the hearing 2 I'm going to have to get it straightened out. 3 Normally we have the court reporter take charge 4 of the copy, the official copy, which is then 5 transmitted to the regional hearing clerk and 6 becomes the file, the record on file. We 7 normally attach stickers indicating whether the 8 document has been received into the record or 9 not, thereby precluding a substitution of 10 pages -- not attaching any evil purpose on anyone 11 on intent, but that's just the best course of 12 action. So what I would like to do is, before we 13 close, we will leave with instructions to the 14 court reporter to go back and label all of the 15 documents whether accepted or rejected, etc., and 16 that both parties be afforded an opportunity to 17 go over the list, and then she will just do that 18 at a later date. 19 MR. CHA: Yes, Your Honor. Just for 20 the record, just for clarification, as far as the 21 Complainant's exhibits are concerned, the binders 22 which the witnesses will be working with, we've 23 been treating those as the official versions. So 24 those are intended to stay with the court 25 reporter and ultimately be sent back to the 0365 1 regional hearing clerk. 2 JUDGE GUNNING: Right. It usually 3 saves on paper, effort, etc. So I assume what 4 you just gave to this witness will also become 5 the court record. 6 MR. MCILNAY: With one possible 7 exception, Your Honor. The -- I don't recall 8 your acronym for business records. 9 JUDGE GUNNING: Oh, CBI. 10 MR. MCILNAY: CBI. The CBI is 11 unfortunately in there without being -- I 12 couldn't figure out how to separately seal it and 13 bind it and get it out. So perhaps -- 14 JUDGE GUNNING: We need to do that. 15 There is a method identified in the regulations 16 for the treatment of CBI. 17 MR. CHA: If we could find a 18 letter-size envelope, we can include it in that, 19 seal it, and mark it with the exhibit number and 20 the case caption and indicate it is CBI and have 21 it sealed. 22 JUDGE GUNNING: Okay. 23 MR. MCILNAY: So I would need to 24 extract that one from the volumes that are in 25 front of the witness now. 0366 1 JUDGE GUNNING: So I need to remind 2 the witness not to mark in these books at all. 3 Because they will become the official court 4 record. 5 MS. O'MEARA: And, Your Honor, just 6 for the record, we do not have again any CBI 7 stuff in our binders. So I want to assure 8 Mr. Peter that it is under lock and key, in my 9 control at all times. 10 JUDGE GUNNING: Okay. And that needs 11 to be cut out, separated from Respondent's 12 exhibits. 13 MR. MCILNAY: Thank you. 14 EXAMINATION 15 BY MR. MCILNAY: 16 Q Good afternoon, Mr. Edwards. I guess I'd like to 17 start out with a better understanding of -- we 18 went through on your direct examination a lot of 19 claims that you found objectionable. As I 20 understand it, your testimony, it's because of 21 the unlimited nature of the claims and that -- 22 let me start over. 23 Not all microbes -- microbicides are 24 pesticides, correct -- 25 A Right. 0367 1 Q -- under FIFRA? And one of the determinants of 2 whether or not it is a pesticide is the use for 3 which the product is to be made; is that correct? 4 A That's right. 5 Q Can you speak up just a little bit? 6 A Yes. 7 Q Okay. So, for example, an application that is 8 intended to act as an antimicrobial on human 9 hands would not be a pesticide if that was the 10 only use that was claimed, because those aren't 11 pests under FIFRA, correct? 12 A That's right. 13 Q And as I understood your direct testimony, an 14 antimicrobial that is applied directly to 15 processed food for purposes of controlling the 16 microbes on or in the food would also not be a 17 pesticide if that was its sole use, correct? 18 A If it's applied directly to, yes. 19 Q Okay. Can you point me to the portion of FIFRA 20 that requires that the application be directly to 21 the food product? 22 A In 152.5 when it talks about the definition of 23 pests, it says that any fungus, bacteria, virus 24 or other microorganism is considered a pest 25 except, then it says, and those on or in 0368 1 processed food. 2 Q Okay. And that is from 40 CFR 152.5, correct? 3 A .5(d). 4 Q And that is the EPA's regulation promulgated 5 under the authority of FIFRA, the statutory, 6 congressional statutory act, correct? 7 A That's right. 8 Q Okay. I'm asking you, within the statute, can 9 you refer me to a section that indicates that the 10 product must be applied directly to the processed 11 food? 12 A I don't believe, if I remember, that there is 13 anything specifically in the statute. Let's see 14 what it says in terms of what's considered a 15 pesticide. 16 Q The definition of pest is found in Section 2 B of 17 FIFRA, I think? Consult my sheet. 18 A All right. In FIFRA under Section 2 T, it talks 19 about pests, and then it talks about any other 20 form of terrestrial or aquatic plant or animal 21 life or virus, bacteria or other microorganism, 22 except viruses, bacteria, other microorganisms 23 living on living man or other living animal. So 24 it certainly doesn't there exclude processed 25 food. It's in our regulations. 0369 1 Q And do you know, after 32 years of experience 2 with the agency, why the EPA chose to exclude 3 microbes found in or on processed foods from 4 pesticide registra -- from the definition of 5 pests? 6 A Just looking to see if it's in 152.6, because 7 it's my understanding that they're excluded 8 because they are adequately regulated by another 9 federal agency. 10 Q And what you've read into the record on 152.1 -- 11 or .5(d), says microbes found in or on processed 12 foods are not pests; is that right? 13 A That's right. 14 Q Okay. So, in short, the agency has then 15 interpreted that language -- and by the agency I 16 mean the Environmental Protection Agency -- to 17 mean that an antimicrobial that's applied 18 directly to processed food to control those 19 microorganisms found in or on the food is not a 20 pesticide because it's not aimed at controlling 21 pests? 22 A That's right. 23 Q That's the logic. 24 A That's right. 25 Q From whence did the interpretation of in or on 0370 1 processed food, meaning that the product had to 2 be applied directly to the processed food, from 3 where did that come? 4 A I think that's consistent with the interpretation 5 or the definition that's in there under the pest 6 when it talks about in or on living man, living 7 animal. And then the 5(d) is expanded not just 8 to cover processed food, but also drugs, 9 cosmetics and beverages. Again, we're talking in 10 or on. Because all of those items are adequately 11 regulated by another federal agency. 12 Q In that regard I believe it was exhibit -- this 13 is Complainant's Exhibit 18a. Could you turn to 14 that? 15 A Okay. 16 Q Would you remind the Court that is the E 17 registration information relative to what 18 product? 19 A This is the AlphaSan RC 5000 product. 20 Q Now, we spent a lot of time on direct examination 21 going over the label and so on. The proposed 22 label in there has described uses above and 23 beyond food contact; isn't that true? 24 A That's right. 25 Q And whether or not it had a food contact use that 0371 1 was FDA approved, it would require EPA 2 registration as a pesticide because of these 3 other uses; would you agree? 4 A That's right. 5 Q The slimicide that's Exhibit 18c, I believe, 6 could you turn to that? And 18c is -- what's the 7 name of that product? 8 A It's called Tolcide PS352C. 9 Q Okay. And in one application, namely use in 10 water made in the paper and pulp industry where 11 the paper may ultimately contact the food, it 12 might have to be FDA compliant, correct, this 13 product? 14 A That's right, yes. 15 Q However, that's not the only use for that 16 product; is it? 17 A No. There are other registered uses on the 18 label. 19 Q Okay. That are nonfood contact, wouldn't 20 require -- 21 A That's right. 22 Q -- FDA approval? 23 A That's right. 24 Q The MICROL, that would be 18e, I believe, that is 25 registration by what company? 0372 1 A Petro Canada. 2 Q And that particular product is specific to 3 food-grade lubricants? 4 A Yes, it is specific to food-grade lubricating 5 oils. 6 Q And so part of the registration, the labeling, 7 refers to it being compliant with an FDA 8 regulation; is that right? 9 A That's right. 10 Q Okay. However, the only use claim made with 11 respect to MICROL is as a preservative of the 12 lubricant, correct? 13 A I think it's preservative and odor control. 14 Q Odor from microbes growing within the product? 15 A That's right. 16 Q Right. And preservative, as commonly used in the 17 treated article, that is also to protect against 18 the product becoming -- taking on an odor; is it 19 not, from the microorganisms? 20 A It depends. I mean, I think the fabric, that 21 would be fair. Here, yes, there are probably 22 some uses that you may be more concerned with 23 staining or deterioration where you may not be 24 concerned with odor. 25 Q With regard to Petro Canada's product then, the 0373 1 label that is 18e has been approved by the EPA? 2 A Yes, it has. 3 Q Okay. With that registration, should Petro 4 Canada have made a claim that its product, when 5 used for its intended purpose in the food 6 processing industry, would resist or knock down 7 microbes, as I understand your opinion, that 8 wouldn't fall within that registration. That 9 advertising would be an unapproved claim; is that 10 correct? 11 MS. O'MEARA: Your Honor, I'm just 12 going to ask Mr. McIlnay to restate the question. 13 14 MR. MCILNAY: Could you read it back? 15 (The question was read.) 16 MS. O'MEARA: Your Honor, I'm going 17 to object. I think that the question is 18 confusing. I also think that he's asking Mr. -- 19 MR. MCILNAY: I'll rephrase. 20 JUDGE GUNNING: Okay. It will be 21 rephrased. 22 BY MR. MCILNAY: 23 Q Given the registration of MICROL, MICROL could 24 advertise that its lubricants containing MICROL 25 have that antimicrobial property to protect the 0374 1 product, the lubricant itself, correct? 2 A MICROL can sell lubricants that make a claim that 3 it contains an antimicrobial additive to inhibit 4 the growth of odor-causing bacteria or bacteria 5 that cause deterioration in the lubricant. 6 Q Correct. 7 A Yes. 8 Q If the claims were to go beyond that, that it 9 would knock down microbes found in the food 10 processing plant generically, generally, that 11 would fall outside the registration? 12 A We would ask that the lubricant be registered. 13 Q Okay. Now, let's shift gears a little bit and go 14 back to the beginning. With respect to each one 15 of the products at issue in this case, Attorney 16 O'Meara asked you your opinion as to whether or 17 not those products were pesticides requiring 18 registration. Do you recall that? 19 A Yes, I do. 20 Q I just was looking for my list of those products. 21 The first one I have is JAX POLY-Guard FG-2. 22 Your opinion that you gave the Court this morning 23 is based solely on the claims made either in the 24 labeling or the various advertising we've seen; 25 is that true? 0375 1 A That's right. 2 Q Have you had any occasion to go and see in 3 industry how POLY-Guard, JAX POLY-Guard FG-2 is 4 actually used? 5 MS. O'MEARA: Objection, Your Honor. 6 I'm going to object as the question being 7 immaterial. 8 JUDGE GUNNING: I'll allow it. 9 MR. MCILNAY: Thank you. 10 THE WITNESS: Have I seen how? 11 BY MR. MCILNAY: 12 Q Yes. 13 A No, I have not. 14 Q Okay. Would the same answer be true for all 15 products that are listed here? 16 A That's right. 17 Q You sat in the courtroom when Mr. Rybicki 18 testified yesterday and made reference to his 19 testimony earlier today; is that right? 20 A A portion of it, yes. 21 Q Yes. And specifically you made reference to his 22 statement that if lubricant gets on a carcass, 23 they cut it out. Do you recall that? 24 A That's right. 25 Q Okay. How many years experience do you have in 0376 1 the beef processing industry? 2 A How many years? 3 Q Yes. 4 A I don't have any experience, other than I have 5 been in, you know, years ago, in and around such 6 facility. 7 Q All right. Then you have no understanding as to 8 whether or not those beef processors can catch 9 each and every instance where these lubricants 10 might contaminate a carcass? 11 MS. O'MEARA: Your Honor, I'm going 12 to object. This line of questioning seems to 13 mischaracterize what Mr. Edwards stated. All he 14 stated was he heard Mr. Rybicki say that the -- 15 once the lubricants hit the carcasses, they were 16 cut off. And that's all he said. 17 MR. MCILNAY: And the only reason -- 18 MS. O'MEARA: He didn't imply 19 anything beyond that. 20 MR. MCILNAY: The only reason he said 21 it was to say these aren't part of the food and 22 aren't edible. And I'm just attacking his 23 credibility and trying to impeach the witness as 24 to whether -- if that's the only basis on which 25 he thinks the lubricants never become part of 0377 1 food, is that little bit of testimony from 2 Mr. Rybicki yesterday. 3 JUDGE GUNNING: Since this is the 4 crux of the matter before us, I'm going to allow 5 Counsel to fully explore the area and flesh it 6 out. 7 MR. MCILNAY: Thank you. 8 BY MR. MCILNAY: 9 Q Do you need the question read back, please? Do 10 you need it read back? 11 A Yes. 12 (The question was read.) 13 THE WITNESS: Do I know whether or 14 not that the processors capture any and all 15 lubricant that might inadvertently drop onto the 16 carcasses? No. 17 BY MR. MCILNAY: 18 Q Okay. 19 A However, I do believe these are intended as 20 lubricants. 21 Q Well, let's talk about that a moment. 22 MR. MCILNAY: If I could get a little 23 help from Counsel. Maybe they could help me 24 identify the exhibit. The page is EPA 0021. 25 MS. O'MEARA: Complainant's Exhibit 0378 1 No. 1. 2 MR. MCILNAY: Plaintiff's Exhibit 3 No. 1. 4 BY MR. MCILNAY: 5 Q Could you read under application the first 6 paragraph, please? 7 A JAX POLY-Guard FG greases are revolutionary USDA 8 H1 food-grade greases compounded with 9 state-of-the-art, food-grade, antiwear chemistry, 10 PTFE and an exclusive new antimicrobial additive 11 for lubrication of high-speed and 12 high-temperature meat, poultry, vegetable, fruit, 13 and beverage-processing machinery. 14 Q Okay. And USDA H1, does that mean anything to 15 you sir? 16 A USDA H1? No. 17 MR. MCILNAY: One minute, Your Honor? 18 JUDGE GUNNING: Yes. 19 BY MR. MCILNAY: 20 Q Mr. Edwards, are you familiar with Kenji Yano? 21 A I have talked to him in the past, yes. 22 MS. O'MEARA: Your Honor, I'm going 23 to object. This is beyond the scope. 24 MR. MCILNAY: Your Honor -- 25 JUDGE GUNNING: Where are we going 0379 1 with this? 2 MR. MCILNAY: It will become 3 apparent. I'll tie it up. But I believe that 4 Mr. Edwards has had conversation with Dr. Kenji 5 Yano and my client discussing H1 lubricants in 6 the past, and I would like to ask him some 7 questions about that. 8 JUDGE GUNNING: Okay. First off, who 9 is Ken -- 10 MR. MCILNAY: Kenji Yano, Y-A-N-O. 11 He formerly was associated with the NSF, the NGO 12 that does the H1 certifications. They also 13 contract with the EPA for other services. 14 JUDGE GUNNING: Okay. 15 MR. MCILNAY: I'll withdraw the 16 question. 17 BY MR. MCILNAY: 18 Q Mr. Edwards, have you ever met Mr. Peter before 19 this hearing started? 20 A Not to my recollection. 21 Q Have you ever attended any Petroleum Institute 22 expositions? 23 MS. O'MEARA: Your Honor, I'm going 24 to object. This is beyond the scope of direct. 25 MR. MCILNAY: Your Honor, I just 0380 1 asked him about USDA 1, H1, and he denied any 2 knowledge of it. I think -- I can cover this 3 with Mr. Peter. I'll withdraw the question. 4 BY MR. MCILNAY: 5 Q Before that colloquy -- no, let me take -- I 6 remember now. EPA Bates Stamp 00023, would you 7 turn to that, please? It should be in the same 8 exhibit, Complainant's Exhibit No. 1. This is 9 the HALO-Guard product; is that correct? 10 A That's right. 11 Q If you could, would you read into the record the 12 last sentence of the first paragraph with regard 13 to application? 14 A This technology is combined with the new 15 high-speed viscosity partially synthetic 16 food-grade based fluid to make JAX HALO-Guard FG 17 a true high-performance, food-grade grease for 18 heavily-loaded applications. 19 Q Do you know what the reference to food-grade 20 grease is about? 21 A It's my understanding that it would have to be 22 food-grade in order to be used in a food 23 processing facility. 24 Q Do you have an understanding as to why? 25 MS. O'MEARA: Your Honor, I'm going 0381 1 to object. This is not relevant material to the 2 issue, and it's beyond the scope of direct. 3 JUDGE GUNNING: I'm going to allow 4 it. I don't know where we're going with it, and 5 I'll allow some latitude. It is cross. If we 6 could see the light, but -- 7 MR. MCILNAY: We'll get there. 8 JUDGE GUNNING: Okay. 9 So if you could reread the question, 10 and if you could answer it, please. 11 (The question was read.) 12 JUDGE GUNNING: Do you need 13 background on that, Mr. Edwards? 14 THE WITNESS: No. I'm not quite sure 15 how to answer the question in a sense that, from 16 EPA's standpoint whether it's food-grade or not, 17 I don't care. What I care about is whether or 18 not FDA has an indirect food additive regulation 19 if it were going to be used in such food 20 processing facilities. So the food-grade is 21 their requirement, and I don't know why they 22 require food-grade. 23 MR. MCILNAY: Could you read back 24 that answer? 25 (The answer was read.) 0382 1 BY MR. MCILNAY: 2 Q I want to understand. You do care whether or not 3 there is an FDA food-grade requirement? 4 A That's right. If it's going to be used in a 5 facility and making claims in that facility, that 6 it will be used on equipment or will come in 7 contact potentially with food in some way -- 8 Q Uh-huh. 9 A -- then I need -- we need to ensure that there is 10 a regulation in effect that would cover such use. 11 Q So that is part of your review process to 12 determine whether or not the product that you're 13 reviewing for pesticide registration does have a 14 food contact use? 15 A We require the company to tell us. Are we 16 required to label, such as a pulp and paper, if 17 we go back to Tolcide, you'll see in their 18 Directions For Use for manufacture of pulp and 19 paper that will not come in contact with food. 20 And what we've done is take that even a step 21 further and have them specify nonfood contact 22 pulp and paper, such as newsprint, you know, 23 photography, corrugated cardboard, and put the 24 restriction so it's very clear it's not intended. 25 Q Mr. Edwards, would you turn to Complainant's 0383 1 Exhibit CX 19? 2 A All right. 3 Q And, first of all, would you identify for the 4 record what exhibit, Claimant's Exhibit 19 is? 5 A This is a Federal Register notice of EPA and FDA 6 issued on the Legal and Policy Interpretation of 7 Jurisdiction Under the Food, Drug and Cosmetic 8 Act. 9 Q And the issuance was on October 9, 1998; is that 10 correct? 11 A That's right. 12 Q And it's a joint publication of the FDA and EPA, 13 correct? 14 A That's right. 15 Q And the Food Quality Protection Act was enacted 16 and became effective on August 3, 1996? Let me 17 direct your attention to EPA 0522, the first 18 sentence after the summary. 19 A August -- okay. I couldn't remember whether it 20 was August 3rd, 5th or 6th. 21 Q Let me ask you this. Did you have any 22 involvement in the authorship of this document? 23 A Yes and no. 24 Q Okay. Let's take, yes, first. 25 A I did look at parts of it when it was written. 0384 1 Q Okay. 2 A You know this is somewhat obsolete in that the 3 Antimicrobial Technical Corrections Act modified 4 parts of it. 5 Q I'm very aware of that, Mr. Edwards. 6 A Okay. 7 Q But your counsel saw fit to put this into the 8 record, so I have some questions about it. It's 9 not entirely obsolete; is it? 10 A No. I mean, we agreed in here -- it defines what 11 is considered to be processing in the sense of a 12 raw agricultural commodity that's being treated 13 that's going on through processing and, you 14 know -- yeah, parts of it are still -- 15 Q All right. Let me direct your attention first of 16 all to -- back to that summary. The FQPA, 17 Federal Quality -- the Food Quality Protection 18 Act, amended both FIFRA and the Food, Drug and 19 Cosmetic Act. Is that what it says? 20 A Yes, uh-huh. 21 Q Okay. And it does say that one of the things it 22 did was to change some of the regulatory 23 authority between the FDA and the EPA regulation 24 of pesticide -- regarding the regulation of 25 pesticide residues on food; is that correct? 0385 1 A That's right. 2 Q Okay. Then I'd like to direct your attention to 3 the last sentence of that paragraph, the very 4 last phrase, and for. This is a discussion of 5 what's going to be discussed in this publication. 6 Could you read that briefly to yourself. 7 A Now which one are we talking about? 8 Q First paragraph under summary -- let's back up. 9 It starts up above. This is a very long 10 sentence, obviously written by -- 11 JUDGE GUNNING: Is this 0522? 12 MR. MCILNAY: 0522, left-hand column. 13 JUDGE GUNNING: Okay. 14 MR. MCILNAY: Under Summary, it's one 15 of these lawyer sentences that goes on and on. 16 It says this notice, colon, and then there are 17 one, two, three, four. Do you see that, sir? 18 THE WITNESS: Yes. 19 BY MR. MCILNAY: 20 Q Okay. Number four, the very last phrase there 21 says, and for those that EPA proposes to return 22 to FDA's regulatory authority through EPA rule 23 making, take your time and read and refresh your 24 recollection if you need to. Do you know to what 25 that refers, what was being returned to the FDA's 0386 1 regulatory authority? 2 A Well, at the time FQPA was passed, what happened 3 was all regulatory authority for regulating 4 antimicrobial residues on -- for antimicrobials 5 was transferred to EPA. And there were, over 6 probably at least a year or so, a number of 7 discussions with FDA and with the affected 8 industry at returning the regulatory authority 9 back to FDA, by some mechanism, that FQPA had 10 turned over to EPA. We were keeping and have 11 kept sanitizer use. 12 Q Okay. I'd like to turn your attention now to the 13 next page. Actually it probably makes sense to 14 have you read under Roman numeral A (sic), 15 subparagraph A, where it says EPA Jurisdiction 16 and Authorities Under FIFRA. Do you see that? 17 Starting on 00 -- 0522. I apologize. There's 18 Roman numeral I, Legal Background, and then A, 19 Jurisdiction and Authorities Under FIFRA. 20 A So what do you want me to do? 21 Q Could you read that -- let me ask you some 22 questions about part of this. Under A, about 23 halfway through the first paragraph on 0522, do 24 you see the sentence that says, As a result of 25 these broad definitions, EPA regulates as FIFRA 0387 1 pesticides a wide variety of chemical substances 2 marketed for a diverse array of uses. For 3 example, EPA regulates as pesticides substances 4 used to control weeds and fungi on crops and 5 microorganisms that may be present on permanent 6 or semi-permanent surfaces such as countertops 7 and food processing equipment that may come into 8 contact with food. It should be noted that FIFRA 9 defines fungus as any non-chlorophyll-bearing 10 thallophyte, as for example, mildew, mold, yeast 11 and bacteria. But the definition specifically 12 excludes those organisms when, quote, on or in 13 processed food, beverages or pharmaceuticals. 14 FIFRA Section 2(k). Further, EPA has broadened 15 this statutory exclusion in its FIFRA regulations 16 at 40 CFR 152.5(d). Specifically under this rule 17 an organism is not considered a pest if it is a 18 fungus, bacteria, virus or other microorganism on 19 or in processed food or processed animal feed, 20 beverages, drugs and cosmetics. 21 Did I read that correctly? 22 A No. I mean -- 23 Q I read it correctly? 24 A That's right. 25 Q Okay. Going on, it states, In applying this 0388 1 exclusion EPA has historically interpreted the 2 words processed food and processed animal feed as 3 they are commonly understood--food that has 4 undergone processing and is intended to be 5 consumed immediately or after some further 6 processing or preparation. Because the commonly 7 understood meaning of these terms applies to 8 edible food articles, EPA has not considered food 9 contact items such as paperboard or ceramic ware 10 to be processed food within the meaning of that 11 term in FIFRA and EPA's implementing regulations. 12 Did I read that correctly? 13 A That's right. 14 Q All right. Thus, EPA has regarded any 15 antimicrobial substance used in or on paper, 16 paperboard or other food contact items as a 17 pesticide under FIFRA. 18 Did I read that correctly? 19 A That's right. 20 Q All right. In your mind, is there a distinction 21 between a food contact item and a food additive? 22 A A food contact item and a food additive? 23 Q Correct. 24 A Yes. 25 Q Okay. And is that relevant to you in making your 0389 1 decisions as to whether or not a product -- 2 whether it's a food additive or a food contact 3 item, is that relevant to making your 4 determination whether the product need be 5 registered as a pesticide? 6 A Well, if you have an antimicrobial applied to a 7 hard surface, such as a countertop, as a 8 sanitizer -- that is a food contact or food 9 processing equipment, as a sanitizer, those are 10 EPA -- that is EPA's jurisdiction, and it 11 certainly requires registration. 12 Q Okay. We have no dispute there. 13 A All right. 14 Q Food additives? 15 A Food additives? Again, if you're talking about 16 your application directly to or on processed 17 food, then that is not subject to EPA. It is 18 FDA's, and a registration is not required. If it 19 is applied to a substance that will indirectly 20 come in contact with processed food, then a food 21 additive may be required, a registration would be 22 required because you're not applying it directly 23 to that food commodity, but to an inanimate 24 surface. And if that food commodity comes in 25 contact and there is a transfer of residue, then 0390 1 a food additive is likely to be required. 2 Q Is that true regardless of the claims that are 3 made with regard to the food additive, 4 antimicrobial claims? 5 A To the food additive. 6 Q Right. You're an expert witness. 7 A You're talking about claims made that's being 8 applied directly to that. If it's not being 9 applied to it, then I'm not sure what you're 10 talking about in terms of claims. 11 Q Let me clear it up. 12 A You need to clarify it. 13 Q Okay. Hypothetically, if the claim were limited 14 to this product when it is -- becomes a food 15 additive, resists and even mitigates microbes 16 found in or on the food to which it becomes an 17 additive, would that have required registration? 18 A These lubricants? 19 Q I'm asking generically, a product that made just 20 that claim. 21 MS. O'MEARA: You're Honor, I'm 22 having trouble understanding the question. I 23 would ask that it be clarified. 24 JUDGE GUNNING: Okay. 25 MR. MCILNAY: Sure. 0391 1 THE WITNESS: Again, I -- 2 JUDGE GUNNING: Why don't we wait for 3 clarification. 4 BY MR. MCILNAY: 5 Q The product I'm describing -- let's not limit it 6 to lubricants -- states in advertising or 7 labeling that it may reasonably be expected to 8 become part of the food in the processing. And 9 if it should do so, it would mitigate or control 10 microbes in or on the processed foods. Would 11 that require registration? 12 A It depends. 13 Q Okay. On what? 14 A I think the first thing would be, look at what 15 the intended use is. In the case -- let's take 16 the lubricants as an example. If it's being used 17 to treat the lubricant, and the lubricant is 18 intended to lubricate equipment, would such 19 claims still require registration? Yes. 20 Because, again, there's an implied pesticide 21 claim in there. If it's going to control 22 microbes in or on processed food should it come 23 in contact, it's going to control microbes that 24 it may come in contact as a lubricant, 25 lubricating machinery. 0392 1 Q It doesn't state that. So where is the 2 implication -- 3 A I can't ignore that. 4 Q Okay. 5 A All right? I would not be able to ignore the 6 fact that there is the possibility -- and if 7 you're making a claim as a lubricant that it's 8 going to get in food, in the absence of 9 directions to be applied to food, and it's 10 intended, it seems like to me it's a rather 11 spurious claim to begin with, to make. And it 12 doesn't make any sense to make, because I don't 13 understand how it's going to work. And just to 14 put the words up there -- 15 Q That seems to be the heart of the matter, is you 16 don't understand how it's going to work. 17 MS. O'MEARA: Objection, Your Honor. 18 That's argumentative. 19 BY MR. MCILNAY: 20 Q Mr. Edwards, I apologize. I'd like to direct 21 your attention back to EPA 0524. It's still part 22 of Exhibit 19. I'd like to direct your attention 23 to the middle of the column, second paragraph. 24 FQPA also amended the definition of 25 food additive, under the FFDCA Section 2019(s). 0393 1 The FQPA amendments did not affect the primary 2 definition of food additive. As before, this 3 term food additive is defined broadly and 4 includes any substance, the intended use of which 5 results or may reasonably be expected to result 6 directly or indirectly in its becoming a 7 component or otherwise affecting the 8 characteristics of any food. 9 Did I read that correctly? 10 A Yes, sir. 11 Q I'd like to turn your attention to EPA 0525. In 12 the allocating the jurisdiction, this document 13 indicates that -- this is under Background, first 14 paragraph, is Roman numeral II, about halfway 15 down that first paragraph, you see sentence that 16 begins, Principally? 17 A Okay. 18 Q It says, Principally, the two agencies have 19 concluded that the jurisdiction under the FFDCA 20 for antimicrobial substances should be allocated 21 in a way that promotes protection of public 22 health and uses limited public resources. And 23 then there is a description of Promotion of 24 Public Health. Do you see that under A? 25 A Uh-huh. 0394 1 Q It states, In recent years, the scientific 2 community has identified the contamination of 3 food by pathogenic microbes as both a serious and 4 growing problem affecting the overall safety of 5 the food supply. The Federal government work 6 being through multiple agencies such as the FDA, 7 EPA and the Department of Agriculture, Food 8 Safety and Inspection Service, is using its 9 resources and regulatory authorities to address 10 this problem in a concerted fashion. 11 MS. O'MEARA: Your Honor, I'm going 12 to object at this point. The last couple of 13 questions have just been Mr. McIlnay reading 14 things into the record without actually asking a 15 question, and they all appear to be immaterial to 16 the issue. 17 MR. MCILNAY: I will get there, Your 18 Honor. I'm laying the groundwork. 19 JUDGE GUNNING: I'm going to allow a 20 fair amount of latitude. This is cross. My own 21 request is maybe slow it down a little bit for 22 the court reporter. 23 MR. MCILNAY: Okay. 24 BY MR. MCILNAY: 25 Q Where with I left off it says, Some of the more 0395 1 significant initiatives are FDA's Hazard Analysis 2 and Critical Control Point, HACCP -- is the 3 acronym, H-A-C-C-P -- program for the seafood 4 industry, USDA'S HACCP program for the meat and 5 poultry industry, and the possible expansion by 6 FDA of HACCP to other segments of the food 7 industry. 8 Are you familiar with any of those 9 HACCP programs, Mr. Edwards? 10 A Only very limited from discussions almost ten 11 years ago with FDA at the time of working through 12 jurisdictional issues. I mean, it's an FDA 13 voluntary program, doesn't have any impact on 14 EPA. There's certainly no EPA labeling required 15 or -- 16 Q I'm sorry. You said there's no -- 17 A EPA labeling, nor would we probably allow it if 18 it's an FDA initiative. 19 Q I'd like to direct your attention to EPA 0527. 20 At the bottom of that page, the left-hand column, 21 last paragraph, could you read that, through that 22 entire paragraph to yourself? 23 JUDGE GUNNING: Beginning with, The 24 agencies believe? 25 MR. MCILNAY: Yes. 0396 1 JUDGE GUNNING: Okay. 2 BY MR. MCILNAY: 3 Q Have you had a chance to read the paragraph, 4 Mr. Edwards? It states, The agencies believe 5 that it makes little sense to have the same 6 antimicrobial substance require both a 7 section 408 tolerance and a section 409 food 8 additive regulation when the food, whether raw or 9 processed, is undergoing the same activity. 10 Mr. Edwards, do you have an 11 understanding what a 408 tolerance is? 12 A Yes. 13 Q And what is a 408 tolerance? 14 A A 408 tolerance is a level at which a pesticide 15 may appear on a raw agricultural commodity, at or 16 below, for that residue level to be considered 17 safe. 18 Q Okay. And that is issued by -- 19 A That is issued by EPA. 20 Q Okay. And section 409, food additive regulation, 21 do you know what that is? 22 A Do I know the definition? I'd have to look at 23 it. 24 Q Okay. That's not an EPA -- 25 A No. That is an FDA. EPA used to, but they no 0397 1 longer do. 2 Q Okay. And the next paragraph, Facilities, goes 3 on to talk -- I believe this is consistent with 4 what you said this document was about. It helps 5 define the difference between processed and 6 unprocessed foods; is that correct? 7 A That's right. 8 Q All right. And it makes reference to facilities 9 where foods are processed as opposed to 10 restaurants and whatnot; is that correct, or food 11 vending machines? 12 A That's right. 13 Q Okay. 14 A Again, that's their jurisdiction. 15 Q Correct. So the FDA's jurisdiction over 16 antimicrobials that are used in processed food in 17 those locations remained unchanged, and remain 18 subject to regulation as food additives under 19 section 409. Is that what it says? 20 A Well, it says that food processing facility 21 includes locations where food is prepared, packed 22 or held, except in the field, where that is 23 considered at that point to be a raw agricultural 24 commodity. 25 Q Uh-huh. 0398 1 A So then it talks about includes slaughtering, 2 manufacturing facilities and all that. That's 3 right. 4 Q Okay. But that last sentence then, FDA's 5 jurisdiction over antimicrobials that are used in 6 processed foods in such locations remains 7 unchanged by the Food Quality Protection Act. 8 Such antimicrobials remain subject to regulation 9 as food additives under section 409 of FFDCA. 10 A And that's not true. 11 Q It's not true? 12 A Well, a food contact substance used on a food 13 contact surface, such as a countertop, in a food 14 processing facility is EPA's, and subject to 408, 15 not 409. 16 Q And that would be that sanitizer? 17 A That's the sanitizer. If you've got the use in a 18 facility in or on directly to processed food, 19 that is FDA. If you've got it used on an 20 inanimate surface, and it comes in contact with 21 that, that's going to be EPA and require 22 registration. It may require an indirect food 23 additive, but it's going to require registration. 24 Q I'd like to direct your attention to the third 25 column on Page 0527, and specifically the 0399 1 paragraph, first full paragraph in that column, 2 the one that begins, In summary, FDA and EPA 3 agree that. 4 A Uh-huh. 5 Q Could you read through that, please? 6 A You want me to read through it or read it aloud? 7 Q Read it to yourself. 8 A All right. 9 Q Now, this particular paragraph also discusses the 10 division of jurisdiction between the FDA and EPA 11 over antimicrobials used in food processing 12 facilities, including those used in process water 13 contacting edible food regardless of whether the 14 food is processed as that would not be FIFRA. 15 A Again, some of that changed. 16 Q Okay. 17 A All right. 18 Q I understand. 19 A All right. If you apply a pesticide or a 20 substance to water for the purpose of controlling 21 a pest in the water, that is EPA, and a 22 registration is required. If you're applying it 23 to water, and the water is just used as a vehicle 24 to carry that substance to processed food, that 25 is FDA. So there is a distinction on whether or 0400 1 not you're controlling a pest in the water or 2 simply using the water as a carrier to get it to 3 processed food. 4 JUDGE GUNNING: And I must ask here. 5 You say it changed. 6 THE WITNESS: The Antimicrobial 7 Technical Corrections Act -- 8 JUDGE GUNNING: I just wanted to -- 9 THE WITNESS: -- passed October 18th, 10 or I don't remember the exact date, just within a 11 couple of weeks after this. It's unfortunate 12 because -- one of our lawyers wrote this, spent a 13 lot of time on it, and a good bit of it was taken 14 care of through the Antimicrobial Technical 15 Corrections Act, so it's no longer applicable in 16 many cases. 17 JUDGE GUNNING: Okay. So you're 18 saying this specific provision was changed. 19 THE WITNESS: When they talk about 20 process water. 21 MR. MCILNAY: Water. 22 THE WITNESS: Yeah, when they talk 23 about water. And actually what we agreed on out 24 of this is, treatment of a RAC, and the RAC is 25 going to be further processed, is FDA. Treatment 0401 1 of a RAC where it's just -- a Raw Agricultural 2 Commodity -- where it's just intended to -- 3 you're going to take the leaves off, you're going 4 to wash it, you're not going to do anything of 5 substance, no further processing. It's just 6 going to go then on to a grocery store, or 7 wherever it's going to go, that's EPA's 8 jurisdiction. And that was clarified. Parts of 9 this remain applicable. Parts are gone due to 10 the Antimicrobial Technical Corrections Act. 11 BY MR. MCILNAY: 12 Q Let me ask you if this part has changed. This is 13 on EPA 0529, middle column, first full paragraph, 14 the last sentence reads, antimicrobials used to 15 kill microbes on processed food are not 16 pesticides; therefore, FDA retains authority over 17 food packaging impregnated with an antimicrobial 18 that is intended to kill microbes on the 19 packaged, processed food. 20 Has that changed? 21 MS. O'MEARA: I'm sorry. Where is 22 that, Mr. McIlnay? 23 MR. MCILNAY: EPA 0529, middle 24 column, first full paragraph, the last sentence 25 of that paragraph. 0402 1 MS. O'MEARA: Thank you. 2 THE WITNESS: No, that has not 3 changed. But note that an EPA registration is 4 required if you're treating the materials that go 5 into the food packaging. So you may need a -- 6 and you likely will need an indirect food 7 additive for the food packaging, but you're still 8 going to need an EPA registration for treating 9 the components of that food packaging. 10 BY MR. MCILNAY: 11 Q Mr. Edwards, I'd ask you to read to yourself, and 12 I'm going to ask you some questions about it, 13 subsection E, begins on EPA 0529, and it's 14 entitled, Antimicrobial Substances Incorporated 15 into Food-Contact Articles, Other Than Food 16 Packaging, with No Pesticidal Effect in the 17 Finished Article. Would you please read that to 18 yourself, and then I would like to ask you some 19 questions about that. 20 A All right. 21 Q Have you had a chance to read that section? 22 A Yes. 23 Q First of all, help me understand what is a -- 24 what kind of claim or pesticide is discussed 25 here, one that has no ongoing effect on the 0403 1 finished product? 2 A It's basically what we would refer to now as 3 treated article claims. 4 Q Okay. 5 A They're in there to preserve the article. 6 Q But this says there's no claim of antimicrobial 7 effect on the finished food contact article. 8 That's why I'm trying to understand. Is this 9 distinguished from the treated article? 10 A It depends on whether somebody wants to make a 11 claim or not. Again, most aqueous solutions made 12 have an antimicrobial added. Paint has an 13 antimicrobial. Very few paint products say that 14 they have an antimicrobial. They don't have to 15 make a claim. 16 Q Okay. I understand. 17 A And if they make a claim, then it's a pesticide 18 product. All right? 19 Q I understand if they don't make the claims, they 20 don't need to register. 21 A All right. 22 Q This particular section though, E, I'm trying to 23 understand. It's titled Antimicrobial Substances 24 Incorporated into Food-Contact Articles, Other 25 Than Food Packaging, with No Pesticidal Effect in 0404 1 the Finished Article. 2 A Right. Such as a cutting board, all right? A 3 cutting board, where the cutting board is made up 4 of various components that may have an 5 antimicrobial that's been used to preserve those 6 components, you end up with a finished article 7 being a cutting board, there is no claim made. 8 Q Of an ongoing pesticide. 9 A Of an ongoing -- the cutting board is not killing 10 an organism, all right? But the cutting board is 11 composed -- can be composed of components that 12 have been treated to protect, preserve those 13 components, and they're going to come in contact 14 with food. 15 Q Uh-huh. Yes. Okay. Stop there. That's what 16 this section is discussing, those kinds of 17 products? 18 A Right. 19 Q And as I read the section, the proposal was made 20 that in that case they would be regulated as food 21 additives and not as pesticides under FIFRA. Did 22 I understand that section correctly? 23 A A food additive is required, a registration is 24 still required, because you're treating 25 components that go into that cutting board. 0405 1 Q Well, let me ask that, because that's where I'm 2 confused. 3 A All right. 4 Q Down at the bottom of Page 0529, the last 5 sentence of the last paragraph states, The result 6 of such a rulemaking would be that products for 7 uses in this category would no longer be 8 pesticides under FIFRA and would be subject to 9 regulation as food additives under the FFDCA, 10 section 409, instead of as pesticide chemicals 11 under section 408 of FFDCA. 12 A All right. And it depends on what the cutting 13 board -- and there are cutting boards out there 14 that say that they have been treated. Again, 15 part of this was affected by the Antimicrobial 16 Technical Corrections Act in terms of giving 17 jurisdiction over residue back to FDA, where it 18 had been transferred at some point with the Food 19 Quality Protection Act to EPA. It depends on 20 whether the cutting board makes a claim. If the 21 cutting board makes a claim, it's a pesticide 22 product. 23 Q If it makes a claim to have an ongoing microbial 24 effect -- 25 A Technical effect. If it says that if you lay 0406 1 chicken on it and it's going to kill, you know, 2 bacteria that may lead to spoilage and all, then 3 it's a pesticide product and requires 4 registration. But we're still, I think, 5 discussing the components. Again, whatever the 6 components are of the cutting board -- let's say 7 it's a plastic cutting board. 8 Q Okay. 9 A All right? You've got an antimicrobial that's 10 added to the plastic for the purpose of 11 protecting the plastic, preserving the plastic. 12 That's a pesticide claim. It goes into to a 13 cutting board. Food additive is needed, because 14 of the residue that might occur, or transfer from 15 that plastic to a processed food item. 16 Q Solely if the cutting board manufacturer makes 17 that claim. 18 A No. Outside of it. If the manufacturer makes a 19 claim, then it's very possibly going to, 20 depending on the claim, require that the cutting 21 board be registered. If it were a public health 22 claim, the cutting board would have to be 23 registered. 24 Q Understood. Let me -- 25 A Again, you've got it added to the plastic for the 0407 1 purpose of protecting the plastic, of which the 2 cutting board is made from. That is a pesticide. 3 Q Let me finish reading this section, and then 4 maybe you can help me understand that. The 5 reasons for this proposed action are similar to 6 those described above for antimicrobial 7 substances used in or on food packaging material. 8 JUDGE GUNNING: Slow down. 9 MR. MCILNAY: Okay. 10 BY MR. MCILNAY: 11 Q With no intended ongoing antimicrobial effect in 12 the finished packaging. Again, these substances 13 are part of the formulations of materials used to 14 produce food-contact articles. Regulations of 15 these substances as food additives, along with 16 other adjuvants -- can you help me with that? 17 What does that word mean? 18 A An adjuvant is something that's not making a 19 direct claim, but it's used -- we don't regulate 20 adjuvants. 21 Q Okay. 22 A I'm not sure I can tell you what the definition 23 is. California does, but EPA doesn't. 24 Q All right. And components would result in a more 25 efficient use of government resources. Further, 0408 1 these antimicrobial substances have no intended 2 ongoing antimicrobial effect in the finished food 3 contact article. Therefore, no claims for 4 antimicrobial activity, i.e., pesticidal effect, 5 which would be under the jurisdiction of EPA are 6 made for the finished food contact article. 7 A Okay. So let's talk about food packaging. I 8 think for the slimicide in pulp and paper is 9 quite appropriate. You're applying it to 10 water -- that's a pesticide use -- to control 11 pests in water. The water becomes a component of 12 paper or paperboard because it's used in the 13 manufacture of that. The pulp and paper are made 14 into all sorts of objects, Saran wrap, a meat 15 container. Again, an FDA indirect food additive 16 regulation is required because of the possible 17 transfer of a residue from pulp and paper from 18 the -- to the processed item. Same thing on food 19 packaging. Again, it can transfer to whatever 20 the item might be. But an EPA registration is 21 required because you're ultimately applying it to 22 water, which is an inanimate object. 23 Q So the registration is for the additive put in 24 the water? 25 A Right, to control the pest in the water. 0409 1 Q All right. Now, that ultimately is used to make 2 Saran wrap. Ultimately we've taken that water, 3 we've used it to make Saran wrap. 4 A Right. 5 Q And the Saran wrap is going to be used as food 6 packaging. 7 A Right. 8 Q My question to you now is, absent some other 9 public health claim, must the Saran wrap which 10 was made with the water which was treated with 11 the pesticide, be registered? 12 A Must Saran wrap be registered? No. 13 Q Okay. 14 MR. MCILNAY: Would this be a good 15 time to take a break? 16 JUDGE GUNNING: That would be fine. 17 MR. MCILNAY: Move on to a different 18 area now. 19 JUDGE GUNNING: Yes. 20 (A recess was taken.) 21 JUDGE GUNNING: I want to remind the 22 witness he's still under oath. 23 BY MR. MCILNAY: 24 Q Thank you, Mr. Edwards. I hope I won't be much 25 longer. Counsel for the EPA asked you a number 0410 1 of questions about your interpretation of intent 2 based on the -- what amounts to advertising for 3 the various JAX products or Behnke products at 4 issue in this case. Do you recall that? 5 A Yes, I do. 6 Q And I think it was your answer in each case that 7 you interpreted the language as making a claim 8 for a pesticidal use. Is that accurate? 9 A Yes. 10 Q I forget your testimony on your background. Did 11 you go to work for EPA immediately upon receiving 12 your advanced degree? 13 A Within about six, seven months. 14 Q Okay. You've never been a consumer of any of the 15 products that were discussed, true? 16 A Have I bought the products or used the product? 17 Q Yes, sir. 18 A That's right. No, I have not. 19 Q I didn't think so. We are going to have to pull 20 it out of the version you have ultimately, but 21 for these purposes today, Respondent's Exhibit 22 68 -- 23 May I approach the witness? 24 JUDGE GUNNING: Yes. 25 BY MR. MCILNAY: 0411 1 Q -- is in this bound volume with Exhibits 51 2 through 71. Would you turn to Exhibit RX 68? 3 JUDGE GUNNING: That's 68? 4 MR. MCILNAY: 68. 5 JUDGE GUNNING: Okay. 6 BY MR. MCILNAY: 7 Q This is the list of ingredients that you were 8 questioned about during direct examination. 9 A Okay. 10 Q And I believe you testified that five of the 11 ingredients listed here are active ingredients; 12 is that correct? 13 A That's right. 14 Q Okay. What I'd like to do is, begin with the 15 first ingredient as number one on the list, and 16 would you count down from that being number one, 17 and just indicate by where it lies on the list 18 what number ingredients are active? 19 A Number 2. 20 Q Okay. 21 A Number 4, number 15. And I would have to consult 22 some notes to remember the other two. 23 Q Okay. Do you know without consulting your notes, 24 out of 2, 4 and 15 which, if any of them, are 25 currently used, would not be new chemicals? 0412 1 A All three of them would not be new chemicals. 2 A See these are the ones that either have never 3 been registered in the end use or were registered 4 in end use, but are no longer. 5 A You said which ones are not new chemicals? 6 Q Correct. 7 A These three are not new chemicals. 8 Q Right. Oh, okay. So if I understood your 9 definition of new chemicals, these three are -- 10 A Are in currently registered products. So, 11 therefore, they would not be at this time 12 considered to be new, active ingredients. 13 Q Okay. 14 A If you use the definition that a new active 15 ingredient is one that is not in any currently 16 registered product. 17 Q Okay. 18 A I can't say these might not be new uses. 19 Q I understand. 20 A All right. But they're not new. 21 Q If you refer to Claimant's Exhibit 18e, the 22 labeling for MICROL -- 23 MR. CHA: Your Honor, I -- first, I 24 apologize for speaking, because this is not an 25 objection. I just want to make sure that the 0413 1 record reflects the correct terminology. The EPA 2 is considered Complainant, and I'm not sure -- it 3 sounded like Counsel used the word Claimant. I 4 want to make sure that the transcript correctly 5 reflects that if Counsel is referring to EPA, 6 which I believe in context he was, that the 7 correct word is Complainant. 8 JUDGE GUNNING: Okay. 9 BY MR. MCILNAY: 10 Q The active ingredient in 18e, the MICROL, is 11 benzoic acid; is that correct? 12 A That's right. 13 Q If I count down to number 12, I don't know, is 14 that the same chemical? 15 A I couldn't tell you -- 16 Q Okay. 17 A -- just looking at it. 18 Q You went through a number of different 19 registration issues that can come up. One would 20 be the new chemical registration. 21 A That's right. 22 Q All right. And that would be a registration 23 required every time a chemical is not currently 24 being used in a registered product. Is that a 25 yes? 0414 1 A That is -- I mean, you only get classified a new 2 chemical once, because as soon as you're 3 registered, then you're an old chemical. 4 Q Right. 5 A Yeah. 6 Q However, if you were an old chemical, but then 7 it's -- 8 A Then somebody voluntarily canceled, and they were 9 in no products, then the next application that 10 comes in, you're a new chemical. 11 Q A new chemical again. 12 A Right. 13 Q And then there was the new use registration. 14 A That's right. 15 Q Okay. If it's a new use for an old chemical, by 16 a different manufacturer -- can the old chemicals 17 be found on an EPA web site or publication? 18 A Probably not. 19 Q All right. 20 A I don't think we've ever published a list of 21 active ingredients. We have now published a list 22 of inert ingredients, but not active. Although, 23 MPIRS, M-P-I-R-S, it's a data base that Purdue 24 University operates, you can go to them, and for 25 a fee they'll print you out a list of all EPA 0415 1 active ingredients. 2 Q Okay. Bear with me. That was a diversion. If I 3 have a new use for an old chemical, but I'm a 4 different manufacturer from its current use, does 5 that speed up the registration process any? 6 A Well, the timeline -- if you're a new chemical, 7 the shortest timeline you're going to be given is 8 15 months in terms of review process. And if 9 it's a food use, then it's going to be 18 months. 10 I may have those -- I don't think I brought that, 11 but we could certainly look it up on our web 12 site. But somewhere in the 15 to 18-month 13 period. If it is a new use of an old chemical, 14 again, it depends on whether it's a food use or 15 nonfood, the timeline will be shortened. 16 Q Let's assume that it is a food use, and it's an 17 old chemical. What's the shortest time frame? 18 A 15 months. 19 Q Is it shorter for a nonfood use? 20 A Yes. 21 Q And what would that be? 22 A Nonfood use, nine months. 23 Q Does that include the pre-application conference? 24 A No. I mean, the pre-application is encouraged so 25 that the application comes in complete, so that 0416 1 once the review is complete, we can reach a 2 positive decision. I mean, all that timeline 3 does is guarantee you that by that -- within that 4 certain amount of time, we will make a decision. 5 It may be that, no; it may be, yes; it may be we 6 need more information, of which then the timeline 7 is going to be extended. 8 Q Very good. I just want to clear up, make sure I 9 understand your earlier testimony. When you were 10 asked about MICROL and efficacy testing, you said 11 there was no efficacy testing done, as I 12 understood it, because there were no health 13 claims made, human health claims made. 14 A We did not require efficacy data to be submitted 15 with the application for registration because no 16 public health claims were being made. That's 17 right. 18 Q But you do anticipate that they will have such 19 data on file? 20 A That's right. 21 Q Okay. Are there requirements as to the quality 22 and quantity of the data that they have to have 23 on file? 24 A There are guidelines, our subdivision g provides 25 guidelines in terms of test methods and all that 0417 1 are available for testing. And in terms of 2 quality we expect any testing to be done under 3 Good Laboratory Practice, GLP procedures. 4 Q And that can be subcontracted out to 5 nongovernmental labs; is that correct? 6 A The efficacy studies are often -- you're talking 7 about our review or you're talking -- 8 Q I'm talking about the data that must be retained 9 by -- 10 A Sure, you can go to anyone you want, or you can 11 do it in-house, as long as you -- the studies are 12 done under GLP and an established method. 13 Q Okay. Your efficacy testing, is that sometimes 14 contracted out? 15 A Yes. 16 Q Would one of those independents be NSF? 17 A No. 18 Q One last area I want to cover, Mr. Edwards, so I 19 really understand your testimony and your opinion 20 about the JAX advertising and/or labeling that 21 you had seen to form your opinion. And I'm just 22 going to use EPA 0021 as an example. As I 23 understood your testimony, certain of the 24 statements made in 0021 you interpreted to be 25 indirect claims because you were taking them 0418 1 within the context of the entire advertising, 2 which does refer to Listeria, E.coli and 3 Salmonella. Did I properly understand what you 4 intended to say? 5 A I think what I said is those were direct claims. 6 Q Those are direct claims. 7 A Right. 8 Q But then certain other claims, you were asked 9 whether they were human health claims, and as I 10 understood it -- let me find an example if 11 there's one on here. In the first paragraph, you 12 refer to this, and an exclusive new antimicrobial 13 additive for lubrication of high-speed and 14 high-temperature meat. In and of itself, the 15 exclusive new microbial additive, absent anything 16 else in the document, would that make a health 17 claim? 18 A Would it? It would -- we would ask you to 19 qualify it. 20 Q Very good. 21 A All right. In terms of insuring that it is 22 non-public health. Odor, deterioration, some way 23 to qualify it. 24 Q Okay. Good, good. So but within the context of 25 this piece read as a whole -- 0419 1 A Right, taking all that together, then I would 2 consider that to be a public health, an implied 3 public health claim because you've directly 4 mentioned the three organisms. 5 Q Okay. Now, absent that context, and with 6 qualification, do you have an opinion as to 7 whether or not the trademarked name Micronox 8 makes public health claims? 9 A I would consider that trademark name to be a 10 pesticide claim. 11 Q A pesticide claim? 12 A And, depending on how it's used, but if it were 13 up there -- I mean, I would interpret Micro to be 14 microorganisms, and I would interpret the nox to 15 be knockdown. So I consider that to be a 16 pesticide claim, and it's certainly not 17 qualified. Again, in the context of the claims 18 made, I would consider all of that to imply 19 public health. 20 Q I agree, that it's -- within that context. So 21 let me narrow this down. Micronox, outside that 22 context, inappropriately qualified, you would 23 still interpret just that term as a pesticidal 24 claim? 25 A Yes. 0420 1 Q And knockdown, what about the term knockdown 2 leads you to the opinion that it's pesticide, a 3 pesticide? 4 A Well, if I'm knocking down microorganisms, I'm in 5 some way inhibiting, I'm killing, I'm doing 6 something to that organism. I'm mitigating it, 7 you know, repelling it, doing something in 8 context of what a pesticide is. 9 Q Okay. So breaking down the lexicology here, 10 micro means microorganism? Is that a yes? 11 A That's right. 12 Q And nox means knockdown in your interpretation. 13 A That's right. 14 Q You're mitigating it? 15 A That's right. 16 Q Okay. But not all microorganisms are pests, 17 correct? 18 A That's rights. 19 MR. MCILNAY: Thank you, Mr. Edwards. 20 No further questions. 21 JUDGE GUNNING: Okay. Would EPA like 22 a very brief recess before redirect? 23 MS. O'MEARA: That's fine. I can go 24 ahead and start my redirect if that's okay. 25 JUDGE GUNNING: Okay. 0421 1 MS. O'MEARA: Thank you for the 2 offer, though. 3 JUDGE GUNNING: Now, even though a 4 great deal of latitude was accorded on cross, as 5 we go into redirect and recross, if necessary, 6 now we'll be a little more strict on focusing as 7 to the prior testimony. 8 MS. O'MEARA: Thank you. 9 EXAMINATION 10 BY MS. O'MEARA: 11 Q Mr. Edwards, can you imagine a nonfood use for 12 these lubricants with the antimicrobial claims on 13 it? 14 MR. MCILNAY: Objection, Your Honor. 15 It's not relevant. 16 MS. O'MEARA: I think it is relevant. 17 MR. MCILNAY: No suggestion has been 18 made that we have a nonfood use. 19 JUDGE GUNNING: Okay. I'm having a 20 problem -- 21 MR. MCILNAY: There's no -- there's 22 been absolutely no evidence that this is used in 23 a nonfood use, and no claim has -- in all of the 24 literature we've gone through today, Your Honor, 25 every single one of them mentions food use. 0422 1 MS. O'MEARA: Your Honor, if I may 2 respond. I would suggest that there is a lot of 3 suggestion in these labeling and advertising and 4 marketing claims that there is nonfood use. It 5 is on the equipment, for example. And 6 Mr. Edwards has testified that it could kill 7 microorganisms on the equipment, and equipment is 8 a nonfood item. It could hit the floor as easily 9 as it could hit food, which is nonfood as well. 10 JUDGE GUNNING: Well, all of that, 11 but not as asked. 12 MS. O'MEARA: Okay. 13 JUDGE GUNNING: If you could give 14 additional background, that's fine. Define 15 certain testimony. 16 MS. O'MEARA: Okay. 17 BY MS. O'MEARA: 18 Q Mr. Edwards, can you imagine any other uses for 19 the antimicrobial lubricant? 20 A For this particular -- 21 Q Yes. 22 A I don't know, just looking at the advertising, 23 that it's restricted to sale only to use in food 24 processing -- 25 Q Okay. 0423 1 A -- circumstances. I mean, if it were used in a 2 nonfood, I see nothing -- I've seen nothing with 3 the advertising or other literature that would 4 prevent it. In fact, some companies might be 5 willing to pay more for this type of lubricant 6 knowing that it is intended for food, and they 7 might use it in nonfood situations. 8 Q Okay. Could you imagine that perhaps lubricant 9 could fall on the floor in a food processing 10 facility? 11 A Sure. 12 Q And would it, according to the claims that you 13 read, kill microorganisms on that floor? 14 MR. MCILNAY: Objection, Your Honor. 15 This is speculative at best. I mean, it could. 16 MS. O'MEARA: May I respond? 17 JUDGE GUNNING: Yes. 18 MS. O'MEARA: The claims that have 19 been made over and over again is that the 20 lubricants contain Micronox in it, that they're 21 part of, incorporated in the -- I'm sorry -- the 22 lubricants, yes, contain the Micronox in it, and 23 they're incorporated in the lubricant. So as a 24 result, Micronox is going to go along with the 25 lubricant wherever the lubricant will fall. So I 0424 1 don't think there is much speculation based on 2 these claims to answer that question. 3 JUDGE GUNNING: I'll allow that 4 question. 5 THE WITNESS: I mean, it certainly 6 could. We would consider the floor to be a 7 nonfood use. 8 BY MS. O'MEARA: 9 Q I'm sorry. Say that again. 10 A We would consider the floor to be a nonfood use. 11 Q Okay. And in the claims and advertising that you 12 reviewed, were there some claims that were 13 unqualified, and didn't specify where the 14 microorganisms were being targeted? 15 A That's right. There were some. 16 Q Now, Mr. MCILNAY talked to you about MICROL a 17 little bit. Can you tell the Court if there is 18 any similarity between MICROL, the Petro Canada 19 product in 18e of Complainant's exhibits, and 20 Micronox, the products we're talking about today, 21 the lubricants containing the Micronox? 22 A Well, I mean MICROL contains benzoic acid, and 23 it's registered to be -- it can be incorporated 24 into food-grade lubricants. Micronox is 25 incorporated into food-grade lubricants. MICROL 0425 1 makes no public health claims. It's in there to 2 preserve the lubricant, to control odors in the 3 lubricant. While the Micronox makes public 4 health claims for the lubricants. 5 Q Okay. 6 A So there are similarities, and there are 7 differences. 8 Q Now, if MICROL were to make public health claims, 9 would the additive have to be registered or would 10 the actual lubricant have to be registered? 11 A If the lubricant made any reference to a public 12 health claim, then the lubricant would have to be 13 registered. 14 Q Thank you. 15 A MICROL could -- yeah, it could submit efficacy 16 data, and they could demonstrate that they 17 control public health. But, again, you take that 18 and add it to a lubricant, the lubricant could 19 not make a public health claim without being 20 registered. 21 Q Mr. McIlnay had you read some of, for example, 22 Complainant's Exhibit 21, I think he did -- I'm 23 sorry -- Complainant's Exhibit 1, EPA number 21, 24 which is up on the board, and I think he did it 25 also with 23, which is right there by that first 0426 1 microphone. And he had you read the lubricant 2 portion of the descriptions; is that correct? 3 A That's right. 4 MS. O'MEARA: Give me just one 5 second, Your Honor? 6 JUDGE GUNNING: Yes. 7 MS. O'MEARA: Thank you. 8 BY MS. O'MEARA: 9 Q In determining -- when you're determining if 10 registration is required for an antimicrobial 11 product, do you only consider one -- only one use 12 or the primary use of that product? 13 A No. We look at the full set of directions in 14 terms of where the product is going to be used. 15 Q Okay. So you look at everything in its entirety? 16 A Right. 17 Q Now, there was a lot of discussion about 18 Complainant's Exhibit 19, and I just want to 19 clarify that briefly. Does EPA have some 20 involvement in the Federal Food, Drug and 21 Cosmetics Act? 22 A EPA sets tolerances or tolerance exemptions under 23 section 408 of the Food, Drug and Cosmetic Act. 24 Q Okay. And then section 409 -- 25 A Section 409 is there for food additives, which 0427 1 EPA used to use, but no longer, because we 2 reclassified Raw Agricultural Commodities and all 3 of the associated by-products as Raw Agricultural 4 Commodities, so we no longer needed to set 5 tolerances under 409. 6 Q Okay. So 408 is EPA? 7 A And 409 is FDA. 8 Q And this is all under the Federal Food -- 9 A Right. 10 Q -- Drug and Cosmetics Act, correct? 11 A That's right. 12 Q And much of this discussion in Complainant's 13 Exhibit 189 in that Federal Register is really 14 regarding EPA's and FDA's jurisdiction in the 15 Federal Food, Drug and Cosmetic Act; isn't that 16 correct? 17 A That's right. 18 Q Did any of that discussion that occurred with 19 Mr. MCILNAY change your opinion as to whether 20 these particular lubricants need to be registered 21 under FIFRA? 22 A No, not based on the claims that are on the 23 literature. 24 Q And Mr. McIlnay asked you a question about Saran 25 wrap, and he was trying to understand how water 0428 1 that has an antimicrobial additive into it and 2 then makes Saran wrap. Do you remember that 3 discussion? 4 A Yes. 5 Q Okay. And one of the questions he asked you was 6 regarding whether the Saran wrap needed to be 7 registered. Do you remember that? 8 A Yes. 9 Q And if the Saran wrap -- your answer was, it 10 didn't need to be registered, correct? 11 A That's right. It does not. 12 Q If the Saran wrap made antimicrobial claims on it 13 that were public health nature or not, I don't 14 think it would make a difference, would it 15 require registration then? 16 A Yes. The Saran wrap at that point would need to 17 be registered. 18 Q Under FIFRA? 19 A Under FIFRA. 20 Q Okay. And he also talked to you about the word 21 Micronox, and whether it implied claims anti -- 22 pesticidal claims. It seems to me he was trying 23 to ask you some questions. Would you be willing 24 to talk to Behnke if they had questions about 25 registration? 0429 1 A Sure. 2 Q Is that something you commonly do? 3 A Yes, meet with companies and talk on the 4 telephone every week, potential, perspective 5 registrants. 6 Q Okay. And when you look at the word Micronox, do 7 you put it into context with everything that's 8 already out there in the advertising and 9 marketing world? 10 A Yes. You have to. And for these products, yes. 11 Q And just so I am clear on this, can something be 12 a food additive under the Federal Food, Drug and 13 Cosmetics Act and still require FIFRA 14 registration? 15 A Yes, it can. 16 Q And, in fact, there is an FDA piece of guidance 17 that talks about that; isn't that correct? 18 A That's right. 19 Q I'm going to ask you to turn to Complainant's 20 Exhibit 20, and when you get there, to Page 541, 21 EPA 541. 22 A Okay. 23 Q Okay. Under the heading -- under heading 6, Food 24 Additive Uses Subject to Pesticide Registration, 25 under FIFRA, do you see that? 0430 1 A Yes, I do. 2 Q Okay. I wonder if you could please read for the 3 Court -- let me make sure I have you reading 4 everything you need to read. Actually, why don't 5 you read the entire paragraph, please. I'm 6 sorry. 7 A By definition, a substance that is a pesticide 8 chemical under Section 201(q) is a pesticide 9 within the meaning of FIFRA. And then it's got 10 (Section 201(q)(1)(A) of FFDCA, as amended by 11 ARTCA), and not a food additive. Such pesticide 12 chemicals are subject to pesticide registration 13 under FIFRA. As discussed earlier, there are 14 exceptions to the definition of a pesticide 15 chemical under Section 201(q)(1)(B), which 16 exceptions are subject to regulation as food 17 additives under section 409. However, under 18 Section 201(q)(1)(B) of FFDCA, as amended by 19 ARTCA, such substances that are excepted from 20 pesticide chemical are not excepted from the 21 definition of a pesticide under FIFRA. 22 Consequently, such substances that still meet the 23 definition of a pesticide under FIFRA (even 24 though, under FDCA, they may be regulated as food 25 additives), are subject to registration under 0431 1 FIFRA. 2 Q Thank you. Does this clarify this whole 3 discussion in Complainant's Exhibit 19? 4 A Well, it just means that depending on where a 5 product is applied and what the claims are, that 6 you may need a food additive in addition to being 7 considered a pesticide product, with the 8 exception being under the definition of pest, 9 where you're specifically applying it to living 10 man, living animal, processed animal feed, 11 processed food, drugs, cosmetics or beverages. 12 And if you're specifically applying it there, an 13 antimicrobial, then you do not need to be 14 registered. 15 Q Is this one of the circumstances, these 16 lubricants that can be a food additive can also 17 be a pesticide under? 18 A Yes, there could -- there certainly would be dual 19 jurisdiction here. 20 Q Mr. McIlnay asked you at the end of his 21 cross-examination if all microorganisms are 22 pests. And your answer -- can you tell us what 23 your answer was? 24 A I said they are pests -- I mean, I said they are 25 not all pests. 0432 1 Q Okay. Is E.coli a pest? 2 A Yes, E.coli is a pest. 3 Q How about Salmonella? 4 A Salmonella is a pest. 5 Q How about Listeria? 6 A And Listeria. 7 Q How about references to gram-positive and 8 gram-negative, would that be pests as well? 9 A Yes. 10 Q Is there anything else on the language that you 11 reviewed that I have missed that -- 12 A Well, mold is a pest. Yeast would be considered 13 a pest. 14 Q Yes. Okay. Anything else that I missed? 15 A I'd have to go back and look, but I -- you know, 16 I think they reference bacteria, not just 17 gram-positive and negative. 18 Q Yes, they do. 19 A But just bacteria in general. That would be a 20 pest. 21 MS. O'MEARA: May I have a minute, 22 Your Honor? 23 JUDGE GUNNING: Yes. 24 MS. O'MEARA: Thank you. 25 I have no further questions, Your 0433 1 Honor. 2 MR. MCILNAY: I don't know if it's 3 appropriate to have a sidebar or just do this on 4 the record. 5 Your Honor, in the nature of cross 6 and rebuttal, I didn't anticipate the questions 7 about whether he could foresee another use, a 8 nonfood use for the lubricants. And I have an 9 exhibit here that wasn't identified prehearing, 10 and I propose to mark this as exhibit -- 11 Respondent's Exhibit 72. Certainly Counsel is 12 free to review it. But in response to that 13 question, I didn't -- which I didn't anticipate, 14 I would like to add this to my list. 15 MS. O'MEARA: Your Honor, I would 16 object. I would object for a number of reasons. 17 One, is there has been ample time -- this is the 18 first time I've seen this exhibit. It 19 certainly -- prehearing exchange was closed. The 20 ability to do that at this late moment, I haven't 21 had a chance to confer with my client or look at 22 this. 23 MR. MCILNAY: Let me withdraw it. We 24 have Exhibit 70, which has been submitted. 25 JUDGE GUNNING: Okay. We're not 0434 1 getting everything on the record. 2 MR. MCILNAY: I'm sorry. We have 3 Exhibit 70. I'm withdrawing the request to add a 4 new exhibit. We have Exhibit 70, which was 5 submitted prehearing, at least the label was. 6 This is the actual physical object, similar to 7 the tubes of grease. And what I guess I'd like 8 to do perhaps is if the court reporter has an 9 exhibit sticker, this is our Exhibit 70. It was 10 submitted. Have her mark this as the actual 11 exhibit. 12 JUDGE GUNNING: Okay. I understand 13 that, but I'm trying to relate it to this 14 witness. 15 MR. MCILNAY: It has to do with the 16 questions that were asked about whether he could 17 foresee a nonfood use for our product. 18 JUDGE GUNNING: Okay. 19 MS. O'MEARA: I am trying to 20 understand it as well. Mr. McIlnay is holding a 21 bottle of not lubricant. 22 MR. MCILNAY: Absolutely. 23 MS. O'MEARA: And I'm not sure what 24 it has do -- 25 JUDGE GUNNING: Okay. I have no 0435 1 problem asking this witness -- we'll see what the 2 question is -- but to use this witness to lay the 3 foundation to introduce this document into the 4 record, that I don't understand. 5 MR. MCILNAY: Okay. 6 JUDGE GUNNING: Okay. In other 7 words, you could ask the witness to review the 8 label and maybe tie it to the questions that were 9 raised on recross. 10 MR. MCILNAY: Yes. I wasn't going to 11 offer the exhibit as -- to be admitted. 12 JUDGE GUNNING: Okay. 13 MR. MCILNAY: It was purely for 14 identification. 15 JUDGE GUNNING: Fine. Okay. 16 MR. MCILNAY: And because it has been 17 previously marked as 70, I'd just as soon use 18 that number. 19 JUDGE GUNNING: Okay. 20 MR. MCILNAY: Okay. 21 JUDGE GUNNING: So you're going to 22 show this to the witness. 23 MR. MCILNAY: Right. 24 JUDGE GUNNING: But in terms of -- 25 it's for identification purposes only at this 0436 1 stage. 2 MR. MCILNAY: Yes, yes. 3 JUDGE GUNNING: Okay. 4 (RX Exhibit No. 70 was marked.) 5 EXAMINATION 6 BY MR. MCILNAY: 7 Q I'm going to try to speed this up, Mr. Edwards. 8 With the Court's permission, I'm going to show 9 you what's been marked for identification 10 purposes as Respondent's Exhibit 60. And I will 11 state to you this is bottle of Listerine -- 12 JUDGE GUNNING: 60 or 70? 13 MR. MCILNAY: 70, I'm sorry. 14 JUDGE GUNNING: Okay. 15 BY MR. MCILNAY: 16 Q And I will state to you, for the record, this is 17 a bottle of Listerine. Reviewing that label, 18 that is not an EPA-registered pesticide, correct? 19 A That's right, it's not registered. 20 Q Because it's used to kill germs on human beings, 21 which are excluded from the definition of pests. 22 A That's right. 23 Q So it comes under FDA jurisdiction as a drug 24 product. 25 A That's right. 0437 1 Q And has drug facts on it. 2 A That's right. 3 Q Can you imagine another use for Listerine? 4 MS. O'MEARA: Objection, Your Honor. 5 It's absolutely not material to the issue of the 6 lubricant. 7 BY MR. MCILNAY: 8 Q It claims to kill germs, correct? 9 JUDGE GUNNING: Okay. Hold on. If 10 you could respond to the objection. 11 MR. MCILNAY: I'll withdraw the 12 question. 13 BY MR. MCILNAY: 14 Q It claims to kill germs on that label, correct? 15 A Yes. 16 Q If I spilled some on the floor, might it kill the 17 germs on the floor? 18 A I don't know. 19 Q Oh, okay. Thank you. 20 MS. O'MEARA: May I see that bottle? 21 MR. MCILNAY: Sure. 22 BY MR. MCILNAY: 23 Q How is it that you know if we spilled some 24 lubricants on the floor it would kill germs? 25 A Because of claims that are made. 0438 1 Q I see. In the Saran wrap case, you were asked if 2 Saran wrap made an antimicrobial claim as to the 3 product, would it need to be EPA registered, and 4 your answer was, yes. 5 A That's right. 6 Q What if it made no claim as to ongoing 7 antimicrobial impact on the Saran wrap, but 8 simply that it would have an antimicrobial impact 9 on the food in which it was wrapped? 10 A So you're saying that the Saran wrap itself is 11 killing organisms on processed food? 12 Q Correct. 13 A That's a very good question. I would say offhand 14 that we would probably talk with FDA and sort 15 through and figure out jurisdiction over that 16 before we would make any commitment one way or 17 the other. 18 Q I just don't know the answer to this, and I want 19 to understand it. When you were asked E.coli, 20 Salmonella, certain bacteria, whether those are 21 pests, are they always pests regardless of where 22 they're located? 23 A They wouldn't be considered pests if they're on 24 processed food or living man, living animal. But 25 I think you have to ask, are they going to occur 0439 1 in places like that? 2 Q I agree. But the answer is, they're not always 3 pests? 4 A They're not always pests, depending on where 5 they're found. That's right. 6 MR. MCILNAY: Thank you. 7 MS. O'MEARA: I have just two or 8 three redirect, re -- whatever. 9 JUDGE GUNNING: Okay. 10 EXAMINATION 11 BY MS. O'MEARA: 12 Q Before I forget the last question, let me ask 13 that first. You just testified that they're not 14 always considered pests. For example, Listeria 15 if on or in processed food, it wouldn't be 16 considered a pest. 17 A Right. 18 Q Is that in the context of FIFRA? For purposes of 19 FIFRA, is that why they're not considered pests? 20 A That's right. 21 Q Okay. 22 A It all comes down to whether under FIFRA, because 23 that's -- that's right. 24 Q Okay. Now, you looked at this bottle. 25 MS. O'MEARA: May I approach the 0440 1 witness, Your Honor? 2 JUDGE GUNNING: Yes. 3 BY MS. O'MEARA: 4 Q If the label said right there at the bottom that 5 it kills Listeria, E.coli and Salmonella on the 6 floor if it spills on the floor, would it have to 7 be registered with EPA? 8 A Yes. 9 MS. O'MEARA: Thank you. No further 10 questions. 11 MR. MCILNAY: Nothing for me, Your 12 Honor. 13 JUDGE GUNNING: Okay. Now, does the 14 EPA wish to retain this witness or reserve this 15 witness? 16 MS. O'MEARA: Yes. 17 JUDGE GUNNING: Okay. Sir, thank you 18 very much for your testimony today, but 19 unfortunately you're not released. 20 MR. MCILNAY: Could we take a brief 21 break? 22 JUDGE GUNNING: Yes. We have -- I 23 just want to get a feel for what we're -- we have 24 left today. 25 MR. CHA: Your Honor, we have one 0441 1 more witness. I have been trying to streamline 2 testimony. That is Dr. Blackburn. I would like 3 to push on and get her finished today, because we 4 have nine Respondent's witnesses, judging from 5 the descriptions. I would like to hold out hope 6 that we can get finished this week. So I don't 7 know how late we're allowed to stay here, but I 8 would like to press on until we're done with this 9 witness. 10 JUDGE GUNNING: Well, it would be 11 great if we could get a large amount under our 12 belt. So why don't we take a very brief break? 13 MR. CHA: Can we strictly limit it to 14 five minutes, Your Honor? 15 MR. MCILNAY: Well, let me ask this. 16 I'll put this on the record. I started this 17 hearing with a question about having a settlement 18 discussion, settlement questions. I quite 19 honestly don't know, given the nature of the 20 complaint that's made, and a description of what 21 this witness is to testify to in this case, quite 22 frankly how it's relevant or what purpose it has 23 to the issue of whether or not the claims made in 24 the labeling and the literature require us to 25 settle registration. I certainly understand that 0442 1 she's going to discuss toxicology and the types 2 of testing done for toxicology of pesticides, but 3 that's not part of the complaint that's been made 4 in this case. 5 MR. CHA: Your Honor -- 6 MR. MCILNAY: Excuse me. I'm sure 7 she'll give you time to discuss this. 8 Part of the reason we're here, Your 9 Honor, is -- and I said during my opening 10 statement, we crossed the line in some of this 11 advertising. We have not, despite the 12 representations that have been made here today, 13 had success in talking to the EPA about what 14 would be permissible. And much of my 15 cross-examination of Mr. Edwards, much of my 16 examination of Mr. Bonace, was directed at 17 finding out for us going forward what we can and 18 cannot do with the labeling. And if my 19 understanding is that it's EPA's position that, 20 but for certain claims within the advertising, 21 that we can continue to sell our product and not 22 require FIFRA registration, then that's where we 23 want to get. And I know there's public health 24 concerns. We wouldn't be doing this -- we heard 25 Mr. Rybicki say that the reason they want this 0443 1 and paid a little bit more for our product than 2 others is because of the food safety concerns. 3 We're concerned about it, too. That's what we're 4 trying to accomplish. And so I don't know, I 5 feel bad that the good doctor has been back there 6 for two days. I'm willing to listen to her 7 testimony, but I guess I just don't understand 8 how it's relevant to the labeling claims that 9 have been made and are the subject of this 10 complaint. 11 JUDGE GUNNING: All right. 12 MR. CHA: Your Honor, there are two 13 separate issues. I'm going to let Ms. O'Meara 14 handle the topic of settlement discussions. This 15 is her case. I don't want to intrude on her. 16 She is lead counsel. 17 As far as the relevance of 18 Dr. Blackburn's testimony, Respondent has made an 19 issue, has raised a defense that their products 20 are, quote, strictly regulated by the FDA. 21 Despite that, Respondent has provided no document 22 or evidence to show there was any review of these 23 products' efficacy. Dr. Blackburn will talk 24 about what the efficacy review requirements are 25 under EPA's FIFRA pesticide registration process, 0444 1 what each of those requirements are, and she will 2 explain why following those requirements to 3 demonstrate a product's efficacy is important. 4 Contrary to Counsel's understanding, 5 she isn't going to talk about the toxicology. 6 She's talking about the efficacy review process 7 and why it is important to subject products which 8 make claims the Respondent has made for its 9 products, why products that make those public 10 health claims must be subjected to an efficacy 11 evaluation. This goes both to the importance of 12 the regulation involved and to the importance of 13 regulating these products as pesticides under 14 FIFRA and also to the gravity of the violation 15 committed, which goes to penalty. It's directly 16 relevant. 17 MR. MCILNAY: Your Honor, if 18 that's -- and that's not how I understood it 19 after listening to Attorney O'Meara's opening 20 statement, what she was here to testify to. If 21 that is the issue, I'm more than happy to listen 22 to her. I would hope, given that discussion, 23 that we could certainly finish by six with this 24 witness. I would certainly hope. 25 JUDGE GUNNING: Does that 0445 1 anticipate -- now, I realize we're eating into 2 that time somewhat, but that would give us an 3 hour and a half. 4 MR. CHA: We'll do our best, Your 5 Honor. 6 JUDGE GUNNING: Okay. 7 MR. MCILNAY: Here's -- I'm trying 8 to -- I would stipulate that these made public 9 health claims, so if we need to go back through 10 this to say, are those public health claims and 11 therefore require efficacy testing, I'll concede 12 that if we can shorten up the testimony and focus 13 on why they request the -- why they want the 14 efficacy testing. 15 MR. CHA: I can try, Your Honor. 16 JUDGE GUNNING: Okay. Now, the other 17 issue in light of the developments, I think it 18 was quite apparent that you have attempted to 19 isolate the type of language that would or would 20 not be acceptable in labeling, and I think 21 everyone here is starting to get a feel for that. 22 However, I don't know if that will resolve this 23 problem. And I am very willing to allocate some 24 time tomorrow for you all to have some settlement 25 discussions. At this stage, however, if either 0446 1 party does not want to participate, that is 2 strictly up to them, and I certainly wouldn't 3 pressure anyone to engage in that. But I think 4 at this stage it would be best if we got through 5 this witness, and then allocate some time 6 tomorrow morning or before lunch, some time when 7 the parties would like to get together. 8 MR. MCILNAY: That is certainly 9 acceptable to us. 10 JUDGE GUNNING: Okay. So my 11 suggestion is we take a five-minute bathroom 12 break now, and we come back and start in on this 13 witness, with the primary goal to discuss this 14 within the context of the gravity component of 15 the penalty. 16 MS. O'MEARA: Your Honor, I'd be 17 remiss to not complete the record on this issue. 18 We have had discussions on these very things that 19 we just talked about with Mr. Edwards, with 20 Mr. Bonace, and myself present, with Mr. 21 Paquette, with Mr. McIlnay, and with Mr. Peter. 22 And, therefore, I'm not very optimistic. I'm 23 just being realistic. 24 JUDGE GUNNING: Okay. Well, there 25 are two aspects that would have to be covered. 0447 1 One would be future labeling or current labeling, 2 and then, of course, the penalty enforcement 3 action. So both issues would have to be 4 resolved. I think it's always worth a shot. 5 Sometimes when a hearing occurs, issues 6 crystallize. And I probably have a 35 percent 7 settlement rate during the course of the hearing. 8 And I encourage it, maybe for selfish reasons, I 9 don't have to write this up. But also I think 10 it's still preferable if it can be done that way. 11 But I'll let the parties decide that. Sleep on 12 it tonight, and see what you can come up with 13 tomorrow. Okay? 14 MR. MCILNAY: Hope springs eternal. 15 JUDGE GUNNING: Yes. And the sun is 16 out. Okay. A quick five-minute break. 17 (A recess was taken.) 18 MR. CHA: Your Honor, for the record, 19 James Cha representing Complainant in this 20 matter. Our last and final witness is Dr. Tajah 21 Blackburn. 22 JUDGE GUNNING: Okay. 23 MS. O'MEARA: Your Honor, I'm sorry, 24 before we -- I apologize. Before we move on to 25 Dr. Blackburn -- please go ahead and take a seat. 0448 1 There were a number of exhibits that were 2 reserved. I apologize. Thank you, Mr. Olson, 3 for reminding me. I believe it as 18a, b, c, and 4 18d. 5 MR. MCILNAY: Yes, Your Honor. And I 6 believe that after cross-examination, the weight 7 to be given to those is the appropriate issue, 8 and I would have no objection to their being 9 received. 10 JUDGE GUNNING: Okay. Thank you. So 11 let the record reflect that Complainant's 12 Exhibits 18a, 18b 18c, 18d are received. 13 Any other documents? 14 MS. O'MEARA: I think that should 15 cover it. Thank you. 16 JUDGE GUNNING: Okay. Thank you. 17 Dr. TAJAH BLACKBURN, called as a 18 witness herein, having been first duly sworn on 19 oath, was examined and testified as follows: 20 EXAMINATION 21 BY MR. CHA: 22 Q Thank you, Your Honor. 23 Dr. Blackburn, could you please state 24 your full name and spell your name for the 25 record? 0449 1 A Tajah Lynette Blackburn; that's T-A-J-A-H, middle 2 name is Lynette, L-Y-N-E-T-T-E, last name is 3 Blackburn, B-L-A-C-K-B-U-R-N. 4 Q Dr. Blackburn, in what city and state do you 5 live. 6 A I reside in Alexandria, Virginia. 7 Q I'd like to begin with a few questions about your 8 educational background. Do you hold any 9 educational degrees? 10 A Yes, I do. 11 Q What degrees do you hold? 12 A I hold a BA in biology from DePauw University, I 13 hold a Ph.D. in biomedical sciences, with a 14 concentration in microbiology, immunology. 15 Q Okay. And focusing on your Ph.D., did you have 16 an area of specialty? 17 A Yes, my area of specialty was enteric pathogens. 18 Q Okay. Now, in general terms what is the field of 19 biomedical sciences? 20 A Biomedical sciences is a very unique field. It's 21 kind of novel in theory, but what it does is it 22 takes a lot of the pathologies and complications 23 that we see in a hospital setting and translates 24 that to an academic requirement where testing is 25 done to understand the mechanisms of disease, the 0450 1 pathologies associated with it, and the 2 immunology as well. 3 Q Thank you, Doctor. And what is the field of 4 microbiology? 5 A The field of microbiology is the study of 6 microbes, and that includes bacteria, viruses, 7 prions, fungi, etc. 8 Q And just for the record, what is a prion? 9 A A prion is an abnormally folded protein. The 10 cases that we've seen with prions, I guess, 11 recently would concern Mad Cow Disease or any 12 other BSE. 13 Q Thank you. And what is the field of -- strike 14 that. You mentioned that your area of specialty 15 was enteric pathology? 16 A Yes. 17 Q What kind of pathogens did you study? 18 A Enteric pathogens are basically microbes that 19 live in the GI of -- the gastrointestinal tract 20 of animals, and that would include E.coli, that 21 would include some Salmonella species, some 22 Listeria as commensal organisms. My area of 23 specialty was Helicobacter pylori, and it's a 24 bacterium that lives in the stomach. 25 Q You used the word commensal. Could you explain 0451 1 what that term means? 2 A Commensal organisms are organisms that impart 3 some protection to their host in which they live. 4 For example, in our gastrointestinal tract we 5 have several organisms that live there, and they 6 impart protection from pathogenic organisms. 7 They may become pathogenic when they increase in 8 number, but theoretically when they're maintained 9 in certain ranges, then they actually impart some 10 protection to other pathogenic organisms that may 11 come into that area. 12 Q And what type of courses did you take to earn 13 your Ph.D. degree? 14 A Well, I went to a medical school, so I -- 15 actually, for the first two years I followed the 16 main course of a medical student. I took gross 17 anatomy, histology, physiology, and some other 18 statistical courses, some ethics courses as well. 19 After the first two years of study, the 20 coursework divides, and the Ph.D. students go 21 into the laboratory component and take additional 22 classes, and the medical students go into the 23 hospital environment for their rotation. 24 And for my specialty, I did -- I took 25 microbiology courses that consisted of 0452 1 bacteriology, virology, mycology, as well as the 2 physiology of these microbes as well. 3 Q Okay. And so this question probably calls for an 4 obvious answer, but did you perform any 5 analytical work? 6 A Yes, I did. 7 Q And was this in the laboratory? 8 A Yes. 9 Q And what kind of laboratory work did you perform? 10 A As a component of the Ph.D. it's a requirement 11 that you do two laboratory rotations before you 12 select your field of study. My first laboratory 13 rotation was in a biotech lab, and my second 14 laboratory rotation was in an immunology, 15 microbiology laboratory. 16 Q Okay. Focusing on the second rotation, were 17 microorganisms involved in the work you did? 18 A Yes. 19 Q And what kinds of microorganisms? 20 A For the second rotation I studied Helicobacter 21 hepaticus, and it is the microbe that infects the 22 liver of mice. And mice basically they're in 23 colonies, and to further understand the pathology 24 associated with that infection, I would observe 25 the development of carcinomas associated with 0453 1 contamination or infection with this microbe. 2 Q Thank you, Doctor. Now, moving away from 3 education and towards the employment realm. Have 4 you performed any laboratory work in the 5 employment setting? 6 A Yes, I have. 7 Q Okay. And did any of this laboratory work 8 involve microorganisms? 9 A Yes, it did. 10 Q And where was this? 11 A D Square Biotechnology. That was a biotech 12 company that was involved in the development of 13 diagnostic kits. We also developed kits for DNA 14 isolation and RNA isolation. 15 Q And other than that particular laboratory work, 16 did you subsequently work in a laboratory in any 17 other employment setting? 18 A Yes, I did. 19 Q And where was that? 20 A I worked for Earthgrains and Nestle, the 21 refrigerated dough production plant. 22 Q And what kind of dough was produced? 23 A They were responsible for producing cookie dough, 24 biscuit dough, English muffins, etc. 25 Q Okay. And what were your responsibilities? 0454 1 A I was a microbiologist and a QA inspector, and I 2 was responsible for doing the rotation of the 3 production floor to insure that during the 4 sanitization process that the equipment had been 5 thoroughly cleaned, and that using the system 6 called IDEXX, which basically emits light if 7 microbes are present, using that system 8 attempting to quantify quantitatively -- 9 qualitatively, excuse me, the microbes that were 10 present, and then translating that to a 11 quantitative analysis using plate counts. 12 Q And what are plate counts? 13 A Plate counts typically in that setting refer to 14 colony-forming units per milliliter. And they 15 allow you to determine or quantitate the level of 16 contamination in a facility. 17 Q And by contamination do you mean bacteria? 18 A Bacterial contamination, yes. 19 Q Okay. Did you do any analytical work inside the 20 laboratory? 21 A Yes. 22 Q Okay. And were microorganisms involved? 23 A Yes, they were. 24 Q What kinds of lab work did you do involving 25 microorganisms? 0455 1 A A lot of plate counts were conducted and a lot of 2 analysis to determine what the source of 3 contamination was. Those identification 4 techniques that we used would involve the 5 identification of E.coli, Salmonella, Listeria, 6 streptococcus in some situations, staph aureus, 7 it just really depended. But it allowed you to 8 observe a broad spectrum of microbes. 9 Q Okay. Now, Doctor, do bacteria such as 10 Salmonella, E.coli and Listeria exist naturally 11 in bread or cookie dough? 12 A No, they do not. 13 Q Okay. Do any of these bacteria exist naturally 14 in the yeast that's used to make this dough? 15 A No. 16 Q Okay. Then where would the -- where would these 17 bacteria come from if they came to contaminate a 18 bread or cookie dough? 19 A They would come from cross-contamination, that is 20 the transfer of microorganisms from another 21 entity into these actual products. 22 Q Dr. Blackburn, have you ever published any 23 articles? 24 A Yes, I have. 25 Q Okay. What kind of articles have you published? 0456 1 A I have published scientific research articles as 2 a result of research that I've conducted, and 3 I've also published -- well, they've been posted 4 for publication, some agency documents. 5 Q Okay. Focusing on the first set of documents 6 that you described, could you briefly describe 7 the general subject matter? 8 A These articles were in response to research that 9 I conducted while in undergrad school, conducting 10 an internship at Indiana University, Purdue 11 University. And this research focused on 12 applying essential fatty acids to cells to 13 protect them against oxidant injury. 14 Q Okay. Were any of the articles which you've 15 published peer reviewed? 16 A Yes. 17 Q And what does the term peer reviewed mean? 18 A Peer reviewed is considered the highest level of 19 evaluation for published articles in the 20 scientific arena. It involves experts in the 21 field that critically evaluate the data that's 22 generated, the nature of the article that's 23 written, and they provide comments and feedback 24 to better their argument if need be. And if it 25 passes this level of scrutiny, then the article 0457 1 is published. 2 Q Now, I believe you mentioned agency guidance 3 documents as well? 4 A Yes. 5 Q And were any of these guidance documents 6 subjected to any form of peer review? 7 A Internal peer review, yes. 8 Q And in general terms what were the subjects of 9 these agency guidance documents? 10 A There was an agency document generated to address 11 the issue of avian influenza and how the agency 12 was going to deal with products that were 13 registered against avian influenza regarding 14 label claims and label guidance. 15 And the second document was regarding 16 pedicure spas and the outbreak of infections that 17 were occurring at that time and how to mitigate 18 infections in those scenarios. 19 Q Thank you, Doctor. Now, Dr. Blackburn, are you 20 currently employed? 21 A Yes, I am. 22 Q And where are you currently employed? 23 A I am employed with the United States Public 24 Health Service Commission Corps as a lieutenant, 25 and I'm also employed with the Environmental 0458 1 Protection Agency as a microbiologist and 2 efficacy evaluator team leader. 3 Q And within the Environmental Protection Agency do 4 you work with a particular office? 5 A Yes, I do. 6 Q Which office? 7 A I work in the Office of Pesticide Programs. 8 Q Okay. And do you work within the Office of 9 Pesticides Programs within a division or branch? 10 A Yes, the antimicrobials division. 11 Q And I guess further, within the antimicrobial 12 division, do you do work within another office or 13 branch? 14 A Yes, I work in the product science branch and on 15 the efficacy evaluation team. 16 Q And approximately how long have you been employed 17 with the product science branch of the 18 antimicrobials division? 19 A I have been employed for four and a half years. 20 Q Okay. Dr. Blackburn, do you hold a particular 21 title or position within the product science 22 branch? 23 A Yes. 24 Q What is that? 25 A I'm the efficacy evaluation team leader. 0459 1 Q Okay. Now, in very general terms, what is an 2 efficacy evaluation? 3 A An efficacy evaluation is a critical review of 4 data that's generated to determine the efficacy 5 or the product performance, the performance of a 6 product that makes pesticide claims. 7 Q Okay. Now, assume that a company applies for 8 FIFRA registration of an antimicrobial product. 9 For purposes of conducting an efficacy 10 evaluation, what items of information will make 11 the application complete? 12 A The application is complete from an efficacy 13 standpoint when there is first a letter from the 14 registrant detailing what the intended purpose of 15 the submission is. So in that letter it details 16 what the source of the product is, what claims 17 they intend to make, and what data has been 18 submitted. 19 In addition to that, the proposed 20 labeling is included. And that proposed labeling 21 pretty much follows the -- to some degree the 22 registrant's letter in that what the product is 23 going to do, the use directions, if there is a 24 dilution rate, how the product should be diluted, 25 and the appropriate contact time. That proposed 0460 1 label is supported by efficacy data that's 2 generated. 3 Q Okay. Just briefly, what does the phrase contact 4 time refer to? 5 A Contact time is the exposure time in which the 6 product has to be in contact with that surface to 7 impart efficacy. 8 Q Okay. And by efficacy, what do you mean 9 specifically? 10 A By efficacy, in that the product must perform at 11 a certain level in order to have a certain 12 pesticide classification level. 13 Q And is that performance as an antimicrobial? 14 A Yes. 15 Q Now, what are the requirements for a person to 16 become a team leader of the efficacy evaluation 17 team? 18 A The qualifications is -- will be training or a BA 19 in biology, courses in microbiology, laboratory 20 experience, and I think a master's, a Ph.D. in 21 microbiology is required as well. 22 Q Okay. And I forget if I asked this before, but 23 how long have you been an efficacy evaluation 24 team leader? 25 A I have been a team leader for about a year and a 0461 1 half. I acted first in that capacity, and then I 2 was promoted. 3 Q And how long were you acting as a team leader? 4 A I acted for about nine months. 5 Q And as a team leader, what are your 6 responsibilities? 7 A My responsibility is to critically evaluate the 8 efficacy reviews that are generated by my staff, 9 either as primary reviews, secondary reviews, or 10 tertiary reviews. I provide feedback to the team 11 as to how to better the efficacy reviews, and I 12 also provide feedback to the team regarding novel 13 scientific methods that come into the agency and 14 any dynamic changes that are occurring in the 15 science arena that may impact what we do as far 16 as microbes, or microbes we should be looking out 17 for, new organisms in a sense, or even new 18 sources for organism acquisition. 19 Q Okay. You mentioned a term, primary review. 20 What does a primary review mean? 21 A A primary review is the first, I guess, take at 22 the actual efficacy review. The efficacy 23 evaluations go through multiple tiers. Typically 24 there is a primary review and a secondary review. 25 And then I conduct the final review to ensure 0462 1 that all the pieces of the puzzle are indeed 2 there and the product -- the statements that we 3 are dictating in our reviews are indeed accurate 4 based on proposed claims and how the product is 5 intended to be used. 6 Q Okay. Now, Dr. Blackburn, prior to being a team 7 leader, either now permanent or acting position, 8 were you employed? 9 A Yes. 10 Q And in what position? 11 A I was an efficacy evaluator. 12 Q Dr. Blackburn, are there guidelines -- well, let 13 me ask you first. How long were you an efficacy 14 evaluator? 15 A Three years. 16 Q Dr. Blackburn, are there guidelines for 17 conducting efficacy evaluations? 18 A Yes. 19 Q Okay. And how familiar are you with these 20 guidelines? 21 A Very. 22 Q Okay. And do you know which office developed 23 these guidelines? 24 A The registration division generated most of the 25 guidelines that are referred to as disinfectant 0463 1 technical science section documents. 2 Q Okay. Do you know, just in general terms, how 3 the guidelines were developed? 4 A They were developed based on approved scientific 5 methods that have already been validated and peer 6 reviewed, based on scientific knowledge, 7 scientific expertise. 8 Q Okay. And what is the purpose of these 9 guidelines? 10 A These guidelines ensure that a product will 11 perform to the level at which it's going to be 12 registered. So if the product is a sterilizer, 13 which is the highest level of pesticide that we 14 encounter, that it will perform at the level of a 15 sterilizer, disinfectant, or the lowest tier, 16 sanitizer. 17 Q Okay. And how often have you followed these 18 guidelines? 19 A Every day, which I conduct reviews. 20 Q And approximately how many times do you conduct 21 some form of efficacy evaluation? 22 A Daily. 23 Q Okay. And I guess over your entire time working 24 for the Environmental Protection Agency, do you 25 have a rough number as to how many efficacy 0464 1 evaluations you've conducted? 2 A I would say in excess of 300, 3 to 5. 3 Q Thank you. And do you still currently conduct 4 efficacy reviews yourself? 5 A Yes. 6 Q Dr. Blackburn, have you provided training or 7 other educational presentations on the subject of 8 efficacy evaluations? 9 A Yes, I have. 10 Q Okay. And have you given any formal 11 presentations outside of the Environmental 12 Protection agency? 13 A Yes. 14 Q When was this? 15 A I participated in the antimicrobials workshop 16 that was conducted last year, did a presentation 17 to our stakeholders. It was basically open to 18 the public. And I've also presented at numerous 19 conferences, The Center for Biomedical 20 Engineering, etc. 21 Q Okay. And focusing on the antimicrobials 22 workshop, who composed the audience? 23 A The audience was the general public, consisted of 24 stakeholders, registrants, testing labs, other 25 scientists. 0465 1 Q And could you explain, what are registrants? 2 A Registrants are -- well, I guess it's the title 3 that we give to individuals that submit 4 applications to our office for registration. 5 Q And is that registration as a pesticide under 6 FIFRA? 7 A Yes. 8 Q And what are stakeholders? 9 A Stakeholders would be other interested parties in 10 the registration process. Registrants can fall 11 under that heading as well, but consultants and 12 even testing labs. 13 Q Okay. At the present time, Dr. Blackburn, do you 14 hold any other positions within the federal 15 government? 16 A Yes. 17 Q What position do you hold? 18 A I'm a Lieutenant in the United States Public 19 Health Service Commission Corp. 20 Q Okay. And what is the United States Public 21 Health Service? 22 A The United States Public Health Service is the 23 uniformed service that supports the surgeon 24 general. Our mission is to promote, prevent, and 25 to advance public health. 0466 1 Q And how long have you held that position? 2 A I have been in the Public Health Service for a 3 year and two months. 4 Q And what are your duties? 5 A My duties initially would be to promote, advance 6 Public Health Service in any capacity in which 7 I'm charged to do. I'm actually employed with 8 the EPA as an extension of that, but if public 9 health issues arise nationally, then it's my 10 responsibility -- or I'm usually deployed to 11 these areas in order to mitigate whatever the 12 case may be relating to public health. 13 Q Have you conducted any work recently as a 14 Lieutenant in the commissioned corps of the U.S. 15 Public Health Service? 16 A Yes, I have. 17 Q What work was that? 18 A I was recently deployed to Louisiana to 19 communicate the result of formaldehyde testing to 20 the occupants of the trailers, FEMA trailers. 21 Q Okay. And could you explain what the -- just 22 briefly, what the formaldehyde testing was for? 23 A The formaldehyde -- well, formaldehyde is being 24 off-gassed in the trailers in which the survivors 25 of hurricane Katrina and Rita have been living 0467 1 for an extended period of time. And as a result 2 of this exposure, this prolonged exposure to 3 formaldehyde, a lot of the occupants have been 4 experiencing respiratory complications. So with 5 this increased incidence in infection -- or not 6 infection -- in exposure, the CDC and FEMA 7 initiated a study where they went out and tested 8 random trailers to observe the levels of 9 formaldehyde in these trailers. And it was our 10 responsibility as officers to go out to each 11 trailer and sit down with the occupants of the 12 trailer and communicate the results of that 13 testing and the potential health effects 14 associated with it, mitigation strategy, and just 15 pretty much add some comfort to the anxiety 16 that's come about concerning this. 17 Q Thank you, Doctor. Dr. Blackburn, are you a 18 member of any professional organizations? 19 A Yes. 20 Q Which ones? 21 A I'm a member of the Association of Analytical 22 Chemists, and I'm a member of the American 23 Society of Microbiology. 24 Q Okay. What is the Association of Analytical 25 Chemists? 0468 1 A That's an association of -- it used to be 2 chemists in the past, but now it's basically 3 broadened to many different areas of -- of 4 science areas. But it's an association that is a 5 standard setting body in which they publish 6 protocols, and they propose or include 7 performance standards within those protocols to 8 address disinfectant efficacy, sanitizer 9 efficacy, sterilizer efficacy, and it's many 10 different areas in which they generate protocols. 11 Q Okay. And how did you become a member? 12 A I was actually appointed by my peers. 13 Q Okay. And who nominated you? 14 A Some scientists that I work with actually 15 nominated me to participate in AOAC, and more 16 specifically the subcommittee M, which is the 17 microbiology methods committee. 18 Q Okay. And what do you do as a member of this 19 subcommittee? 20 A As a member of this subcommittee I am responsible 21 for evaluating protocols that are generated, data 22 that's generated via validation studies, insuring 23 that comments that are acquired when the 24 protocols are released for public usage, looking 25 at the comments, ensuring that the methods are 0469 1 indeed sound and that the standards set are 2 indeed representative of mitigation strategies. 3 Q Okay. And what kinds of methods do you review? 4 A I have reviewed methods for sterilizers or 5 sporicides. I've reviewed methods for 6 disinfectant activity, as well as sanitization 7 activity. 8 Q Okay. And are these methods intended to 9 determine the effectiveness of antimicrobials? 10 A Yes, they are. 11 Q Dr. Blackburn, are you familiar with Salmonella 12 typhimurium? 13 A Yes, I am. 14 Q I'm going to use just the shorthand Salmonella 15 from now on. 16 A Okay. 17 Q How did you become familiar with Salmonella? 18 A I became familiar with this organism via my 19 studies in undergrad and both graduate school and 20 my work in a production -- a plant food 21 production facility, as well as my studies 22 with -- or my continuing employment with EPA. 23 Q Okay. And what is Salmonella? 24 A Salmonella is a gram-negative bacterium. 25 Typically if it colonizes the -- it colonizes the 0470 1 lower gastrointestinal tract of a lot of animals 2 and mammals, including birds, and it's the 3 leading cause of gastroenteritis. 4 Q Okay. First, what does the term gram-negative 5 refer to? 6 A Gram-negative refers to the bacterial cell wall. 7 Different organisms -- well, gram-negative 8 organisms have a certain type of cell wall where 9 they have a substance present called 10 lipopolysaccharide, and the shortened version of 11 that is LPS. And there's a different immune -- 12 or there's immune responses associated with 13 gram-negative bacteria, and the identifying 14 feature is the LPS. 15 Q And are there diseases associated with 16 Salmonella? 17 A Gastroenteritis is typically associated with 18 Salmonella. It's the leading cause. 19 Q Okay. And what is gastroenteritis? 20 A Gastroenteritis is inflammation of the 21 gastrointestinal tract, and symptoms associated 22 with that would be abdominal cramps, fever, 23 diarrhea, epigastric discomfort, basically a 24 feeling of just stomachache in a sense. 25 Q Okay. And how serious is this disease? 0471 1 A It's very population dependent. In healthy 2 populations the -- depending on the amount of 3 bacteria that's present, the infection or 4 symptoms can be self-limiting. But in 5 compromised populations, such as the elderly, 6 infants, immunocompromised and immunosuppressed 7 individuals, they can have these pathologies for 8 a very long period of time, and even succumb to 9 death in some situations. 10 Q And are you familiar with a bacteria called 11 Escherichia coli? 12 A Yes, I am. 13 Q And I'm going to use the shortened version, 14 E. coli. 15 A Sure. 16 Q How did you become familiar with E. coli? 17 A I became familiar with E. coli through my 18 undergraduate studies, my graduate studies, and 19 my work with the Environmental Protection Agency. 20 Q And in general terms, what is E. coli? 21 A E. coli is also a gram-negative bacterium. It is 22 what we consider in the microbiological world, 23 the indicator of fecal contamination, and it 24 tends to colonize the lower GI tract as well, and 25 it's kept at a very moderate level where it does 0472 1 not impart pathology typically. But when those 2 levels increase or a virulent strain, that is a 3 strain that causes pathology, is introduced into 4 that environment, then it can have very severe 5 pathologies as well. 6 Q Okay. So are there diseases associated with E. 7 coli? 8 A Yes. 9 Q And what diseases? 10 A Individuals that have E. coli -- and E. coli runs 11 the gamut -- can have gastroenteritis as well, 12 from mild to severe cases. They can have 13 gram-negative pneumonia, meningitis, septicemia, 14 mastitis, and urinary tract infections. 15 Q Okay. What is septicemia? 16 A Septicemia is basically a systemic response to 17 the presence of toxins released by bacteria. 18 Q Okay. And what are some of the symptoms? 19 A Some of the symptoms ultimately would be -- if an 20 individual evolves to septicemia, they will 21 usually die, if it comes to that. 22 Q Okay. And what is meningitis? 23 A Meningitis is inflammation of brain lining. 24 Q Okay. And how serious is meningitis? 25 A It really depends on the populations that have 0473 1 meningitis. In some individuals an antibacterial 2 agent can help remedy the situation. But in 3 other individuals, since it impacts the nervous 4 system, then you can have very prolonged and, you 5 know, in some cases even death associated with 6 that infection. 7 Q And who is most at risk among the human 8 population from diseases associated with E. coli? 9 A Again, that would be the infants, elderly, 10 immunocompromised, immunosuppressed individuals,. 11 Q And, Dr. Blackburn, finally, are you familiar 12 with Listeria monocytogenes? 13 A Yes, I am. 14 Q I'm going to use Listeria. And how did you 15 become familiar with Listeria? 16 A Through my studies, undergrad work, graduate 17 work, and my employment with the EPA. 18 Q Okay. And what is Listeria? 19 A Listeria is a gram-positive organism, and it -- 1 20 to 10 percent of the human population are 21 considered to be carriers, so they actually 22 commensal strains of Listeria present in their GI 23 tracts as well. And some mammalian species have 24 Listeria present as well in their 25 gastrointestinal tracts. 0474 1 Q And what does the term gram-positive mean? 2 A Gram-positive also refers to the bacterial cell 3 wall, and in bacteria that have -- that are 4 classified as gram-positive, they tend to have a 5 thick peptidoglycan layer, and that's actually 6 the exterior layer of the bacteria. And it has 7 certain immune responses associated with it as 8 well. 9 Q Okay. And are there diseases associated with 10 Listeria? 11 A Yes. 12 Q What diseases? 13 A Gastroenterology, again septicemia, meningitis, 14 and in pregnant women in their second or third 15 trimester they can actually have spontaneous 16 abortions if they are infected with Listeria 17 monocytogenes. 18 Q Okay. And can these diseases be fatal? 19 A Yes. 20 Q Okay. Do you have any idea what the mortality 21 rates are? 22 A The mortality rate associated with meningitis is 23 about 70 percent. With septicemia it's about 24 50 percent. And with neo -- no, I'm sorry -- 25 with the intrauterine abortions it's about 0475 1 80 percent. So it's pretty high. 2 Q Okay. Focusing on Listeria, how many bacteria 3 will produce disease? 4 A In healthy populations, less than a thousand can 5 cause disease. In vulnerable populations, such 6 as the elderly, infants, immunocompromised, 7 suppressed individuals, it can take less than 8 that. 9 Q And how persistent is the bacteria Listeria in 10 terms of its ability to survive? 11 A It is quite persistent. It can withstand 12 dryness, freezing, refrigeration conditions. 13 It's associated a lot of times with deli meat and 14 cheeses, so it can stand a huge range, a broad 15 spectrum of environmental conditions. 16 Q Dr. Blackburn, are you familiar with bacteria 17 which break down oils and greases? 18 A Yes, I am. 19 Q Okay. Turning to the three bacteria we've been 20 discussing, Salmonella, Listeria, and E. coli, do 21 any of these three bacteria have an effect on 22 petroleum, greases or oils? 23 A No, they do not. 24 Q Okay. Do any of these three bacteria, again, 25 Salmonella, Listeria and E. coli, do any of these 0476 1 three have an effect on metal objects? 2 A No, they do not. 3 Q Okay. Dr. Blackburn, have you ever observed a 4 plant or facility where animal parts were 5 processed? 6 A Yes. 7 Q What kind of such facility have you personally 8 observed? 9 A I've observed a swine facility and a bovine, a 10 cattle slaughter house. 11 Q And which stages -- in each of these facilities, 12 which stages of the slaughtering process did you 13 observe? 14 A The entire process. 15 Q Okay. And would that include from when the 16 animals were alive to when they were -- 17 A From when the animal entered until when the 18 products leave. 19 Q Okay. How do bacteria such as Salmonella, 20 E. coli, and Listeria first enter a facility 21 where animals are slaughtered and processed? 22 A The most common route of entry would be the 23 actual animal. Cattle in particular are 24 surrounded by their waste, their feces. And they 25 can track their feces, or they track their feces 0477 1 into the establishment. The fecal matter is on 2 their hide, on their hooves, on their tails. 3 They can pretty much be covered in it, 4 macroscopically as well as microscopically. 5 Also, the workers of the facilities can bring 6 these organisms into the plant as well. 7 Q Okay. And how would workers bring the organisms 8 into the plant? 9 A They can bring these organisms in by having 10 contact with animals before they enter the plant, 11 as well as not following proper hygiene practices 12 when they go to the restroom, for an example. 13 Q Okay. And you used a couple of terms. You said 14 that the fecal matter could be present on cattle 15 macroscopically. What does that mean? 16 A Well, when I toured the facility, a 17 slaughterhouse, for example, there were actually, 18 I want to say mounds of fecal matter attached to 19 the hide, and it had solidified in some places, 20 so they were pretty much covered in it. And that 21 can be a seasonal variation as well, but during 22 that time I think when I toured that facility 23 there were lot of freeze/thaw episodes, and so 24 the waste had pretty much hardened onto the 25 actual -- the animal's hide. 0478 1 Q And when you said that the fecal matter could be 2 present on an animal microscopically. Could you 3 explain what that means? 4 A Even though fecal matter cannot be seen, in a 5 sense, the remnants or traces of that can be 6 present as well, where I'm not able to visualize 7 that with the naked eye. 8 Q Now, Dr. Blackburn, are there ways that equipment 9 can become contaminated with these bacteria other 10 than by direct contact either with people or with 11 the animals to be slaughtered? 12 A Yes. 13 Q And how could the equipment be contaminated in 14 this manner? 15 A The equipment can become contaminated via 16 aerosolization of the microbes via blood 17 splatter, via fecal splatter. 18 Q Okay. What does the term aerosolization mean? 19 A Aerosolization is when these particles, or the 20 fecal matter and the microbes contained within 21 the fecal matter, can be transferred or carried 22 in the air to a lesser degree, or to a greater 23 degree, on water vapors, or when particles are 24 moved, shifted, and it generates some air volume, 25 a flow of air, then the particles can be 0479 1 aerosolized at that time. 2 Q Okay. And can each of these three bacteria we've 3 been discussing, Listeria, Salmonella, and 4 E. coli become aerosolized in this way? 5 A Yes, they can. 6 Q Okay. Now, within the water vapor droplets, will 7 they usually be in organic matter? 8 A Yes. 9 Q And will the bacteria be in the organic matter? 10 A Yes. 11 Q In a slaughterhouse, what is the most prevalent 12 or most common form of organic matter that will 13 be found in water vapor droplets? 14 A I would say feces, from my observation, because 15 the volume of waste there is immeasurable. It's 16 copious, it's ubiquitous, it's everywhere. And 17 that would be the source. 18 Q Now, in what kind of organic matter will 19 Listeria, E. coli, and Salmonella be most 20 concentrated? 21 A In fecal matter. 22 Q Let's talk briefly about vegetable processing. 23 How can a vegetable become contaminated with the 24 three bacteria we've been discussing? 25 A They can become contaminated via manure that's 0480 1 used to fertilize the actual plants, from using 2 untreated water, from cross-contamination, that 3 is the transfer of microbes from the individual 4 that's handling those microbes to the actual 5 vegetable or fruits, etc. 6 Q Do any of these three bacteria exist naturally 7 inside a vegetable? 8 A No. 9 Q Dr. Blackburn, you testified earlier about 10 efficacy evaluations. I'd like to direct your 11 attention to Complainant's Exhibit 51. 12 JUDGE GUNNING: Okay. Now, I think 13 at this moment, even though she may not need it, 14 I'd liked to give the court reporter just a 15 little break. And we could use that time to 16 maybe isolate the CBI information that is in 17 Respondent's exhibits. I have some here if 18 someone would like to use mine. I want to make 19 sure those pages are ripped out and placed in the 20 envelope and secured before we adjourn for the 21 evening. 22 (A recess was taken.) 23 MR. CHA: I'm going to try to do this 24 quickly. 25 0481 1 BY MR. CHA: 2 Q Dr. Blackburn, I'd like you to look at what's 3 going to be four documents. Could you please 4 take a look at the document identified as 5 Complainant's Exhibit 51. Do you recognize this 6 exhibit? 7 A Yes. 8 Q And what is it? 9 A This is the product performance efficacy test 10 guidelines. 11 Q Okay. And do you use this document in your work? 12 A Yes. 13 Q And how often? 14 A Whenever an efficacy evaluation is conducted, 15 this document is one of the reference tools. 16 Q Okay. And do you know whether other 17 microbiologists who perform efficacy evaluations 18 also use this document? 19 A Yes. 20 Q Okay. And I guess I should ask, do these other 21 microbiologists, in fact, use this document? 22 A Yes, they do. 23 Q Okay. 24 JUDGE GUNNING: Mr. Cha, can you keep 25 your voice up a little bit? 0482 1 MR. CHA: I apologize Your Honor. 2 JUDGE GUNNING: Thank you. 3 BY MR. CHA: 4 Q What is the purpose of this document? 5 A This document provides guidelines for products 6 that make pesticides claims. Initially it 7 defines what a public health use versus a 8 non-public health use is, and it has associated 9 test methodologies, as well as, if required, the 10 required contact times and performance standards 11 as well. 12 Q Okay. And if I could have you look at 13 Complainant's Exhibit 54. 14 A Can you give me the page number, too, as well so 15 that I can be exact? 16 MR. CHA: May I approach the witness? 17 JUDGE GUNNING: Yes. 18 BY MR. CHA: 19 Q Do you recognize the documents that comprise 20 Complainant's Exhibit 54? 21 A Yes. 22 Q In general terms, what are these documents? 23 A These are the disinfectant technical science 24 section document referred to as DIS/TSS document. 25 Q And what is the purpose of these documents? 0483 1 A These documents also provide a reference for 2 conducting efficacy evaluations. 3 Q And do you use these documents in your work? 4 A Yes. 5 Q Now, just in general terms, what subjects do 6 these particular documents cover? 7 A There are, I think, a total of 16 of these 8 documents, and they cover a broad range of 9 disinfectant or pesticide classifications from 10 sterilants to disinfectants to sanitizers, and 11 they also include label guidelines as well. 12 Q Okay. Now, if I could have you look at 13 Complainant's Exhibit 55? I believe it's -- I'm 14 sorry. It's in the next volume to your right. 15 Do you recognize Complainant's Exhibit 55. 16 A Yes. 17 Q And what is it? 18 A This is the SOP for conducting the efficacy 19 evaluations. 20 Q And by SOP, what does that acronym stand for? 21 A Standard operating procedures. 22 Q Okay. And do you use this -- these standard 23 operating procedures in your work? 24 A Yes. 25 Q Okay. Again, how often? 0484 1 A Whenever an efficacy evaluation is conducted. 2 Q Okay. What is the purpose of standard operating 3 procedures? 4 A The purpose of these procedures is to create a 5 template or standard in which you would conduct 6 the evaluations so that all the evaluations are 7 consistent, and they are scientifically sound. 8 Q And what subjects are covered by the standard 9 operating procedures? 10 A These -- this document covers the purpose of the 11 SOP, the scope of the SOP, the background 12 information that's required, the components of 13 the data package. 14 Q Okay. And by data package, is that the data 15 package which an applicant for registration of a 16 pesticide must submit? 17 A Yes. 18 Q If you could look at finally Exhibit 56, do you 19 recognize this exhibit? 20 A Yes. 21 Q What is it? 22 A This exhibit consists of test methodologies that 23 are approved and published by the Association of 24 Analytical Chemists. 25 Q And how familiar are you, Dr. Blackburn, with 0485 1 these test methodologies? 2 A Very. 3 Q And how reliable are these test methodologies? 4 A Very reliable. 5 Q And do you use this particular document in your 6 work? 7 A Yes. 8 Q Okay. Dr. Blackburn, what kinds of antimicrobial 9 products are required to undergo an efficacy 10 evaluation? 11 A All antimicrobial products that make pesticide 12 claims should undergo an efficacy evaluation on 13 the public health claims that they make or 14 non-public health claims. 15 Q Now, what makes an antimicrobial claim a public 16 health claim? 17 A A public health claim references those pathogens 18 that are considered to be directly infectious to 19 man. 20 Q Could you give us some example of what a public 21 health claim would be? 22 A A public health claim would be, for an example, 23 kills 99.999 percent of E. coli on food contact 24 surfaces. 25 Q And what are some other examples of specific 0486 1 microorganisms that if mentioned in a claim would 2 make the claim a public health claim? 3 A Listeria monocytogenes, E. coli, Salmonella 4 typhimurium, staphylococcus aureus, klebsiella 5 pneumonea, bacillus anthracis, clostridium 6 sporogenes. 7 Q Okay. I think we have enough of a sample. How 8 is the level of the stringency of review 9 different for a product which makes public health 10 claims as opposed to one which does not make a 11 public health claim? 12 A Well, for public health claims, there are set 13 protocols and there are set performance standards 14 that the agency follows. For nonpublic health 15 claims -- and that data for the public health 16 claims must be submitted to the agency for 17 review. 18 For non-public health claims a 19 standard method should be used and efficacy 20 should be demonstrated, but the agency reserves 21 the right to request that data on a case-by-case 22 basis. 23 Q Now, focusing on antimicrobial products for which 24 a public health claim is made, are there 25 different categories of these kinds of products? 0487 1 A Yes. 2 Q And what are these different categories? 3 A The highest level of pesticide or antimicrobial 4 pesticide that we register are sterilants. The 5 next tier underneath are disinfectants, and 6 disinfectant can be subclassified into limited 7 disinfectants, broad spectrum disinfectants or 8 hospital disinfectants. And the tier after that 9 would be sanitizers, and sanitizer are registered 10 based on whether or not they're food contact 11 sanitizer or non-food contact sanitizer. 12 Q Now, are the claims that are made for an 13 antimicrobial product important? 14 A Yes. 15 Q Okay. And why is it important to review the 16 claims that are made for a product? 17 A Well, the claims are the guide in which the end 18 user uses the product, and if the claims aren't 19 clear, concise, and if they don't communicate 20 properly what the product is intended to do, then 21 we have done the consumer a disservice by not 22 adequately addressing that. 23 Q Okay. Let's focus on sanitizers. You mentioned 24 two different kinds of sanitizers, and I want to 25 focus on one of them. What is a food contact 0488 1 sanitizer? 2 A A food contact sanitizer would be those 3 registered for use on food contact surfaces. 4 Q Okay. And what must be demonstrated -- let me 5 start again. In order to have a product 6 registered under FIFRA as a sanitizer, a food 7 contact sanitizer, what must be demonstrated in 8 terms of product efficacy? 9 A For product efficacy three lots must be tested 10 against E. coli and Staphylococcus aureus, and 11 the test that's done is the AOAC germicidal 12 detergent sanitizing method. And using this 13 test, the product must demonstrate a five-log 14 reduction in 30 seconds. 15 Q Okay. First, you used the phrase three lots. 16 What does that refer to? 17 A Three lots of production are the production lots, 18 so three different batches, three different 19 batches have to be tested. 20 Q Okay. And what does a five-log reduction mean? 21 A A five-log reduction, for example, is if you 22 start with million cfu's per mill, in order to 23 demonstrate a five-log reduction, at the end of 24 that test you must only have ten -- at the 25 greatest, ten organisms left remaining. So 0489 1 that's a five-log reduction, or a 99.9999 percent 2 reduction. 3 Q And you used the acronym cfu. What does that 4 refer to? 5 A Colony-forming units. And that's basically how 6 we determine what -- or how me measure viable 7 bacteria. 8 Q Okay. Are certain claims in your experience 9 associated with food contact sanitizers? 10 A Yes. 11 Q What are some examples of kinds of claims that 12 are associated with food contact sanitizers? 13 A The five-log reduction, or the statement kills 14 99.9999 percent of E. coli on food contact 15 surfaces. 16 Q Okay. Dr. Blackburn, assume that a product makes 17 a claim that it will inhibit or kill a particular 18 microorganism, let's use Listeria as an example. 19 Does the applicant for registration need to 20 provide efficacy data? 21 A Yes. 22 Q And does the efficacy data need to include proof 23 of -- that is proof that the product's 24 effectiveness tested against Listeria 25 specifically? 0490 1 A Yes. 2 Q And why is it important to test the product's 3 effectiveness against the particular 4 microorganisms that are identified in the claim? 5 A It's important for organisms to be listed 6 because, as I mentioned before, that's the end 7 user's template, that's their guide. And they -- 8 in order to use a product, it's important to have 9 that information disclosed on the label so that 10 they will know to which organisms this product is 11 indeed efficacious against. 12 Q Okay. And if a product is not tested for 13 efficacy or effectiveness against the particular 14 microorganisms identified in the claim, is there 15 any potential danger to the public? 16 A Yes. 17 Q What potential danger is there? 18 A Well, the end user doesn't know to what organisms 19 the product is efficacious, and so, for example, 20 if they work in a day care setting, and there is 21 an outbreak of, let's say, E. coli, for example, 22 and they use a product that doesn't have -- has 23 not demonstrated efficacy again E. coli, then to 24 use that product will not impart the level of 25 efficacy that they expect the product to impart. 0491 1 Q Okay. Turning briefly to disinfectants. You 2 mentioned different kinds of disinfectants? 3 A Yes. 4 Q Okay. And what are the -- what different kinds 5 of disinfectants are there? 6 A There are three different types of disinfectants. 7 The first one is a limited disinfectant. For a 8 limited disinfectant efficacy has to be 9 demonstrated for either a gram-positive, which 10 would be Staph aureus, or gram-negative organism, 11 which would be Salmonella. 12 Q Okay. 13 A For broad spectrum disinfectants efficacy has to 14 be demonstrated against both a gram-positive and 15 gram-negative organism. And finally for a 16 hospital disinfectant, efficacy has to be 17 demonstrated against the two organisms that were 18 tested for the broad spectrum disinfectant, as 19 well as Pseudomonas aeniginosa. 20 Q And finally for sterilizers, what performance 21 standard must be approved for a product to 22 qualify as a sterilizer? 23 A For a sterilizer there has to be complete kill 24 when tested against Clostridium sporogenes and 25 Bacillus subtilis, using the AOAC sporicidal 0492 1 activity test. 2 Q Okay. Now, Dr. Blackburn, what kinds of data on 3 a product's efficacy do you need in order to 4 perform an efficacy evaluation? 5 A The data that's required for our review involves 6 the test method that was used, the study conduct, 7 that is, what controls were involved in the test 8 method, how the test method was performed in 9 general, the contact time or exposure time, the 10 organisms that were tested, including the ATCC 11 designation numbers, and the data is presented in 12 a tabular fashion, and all the studies must be 13 conducted under good laboratory practices. 14 Q What does ATCC designation refer to? 15 A ATCC designation number refers to the American 16 Tissue Culture Collection, and it's basically a 17 collection agency of different microbes. And 18 they're stored properly so that they impart the 19 virulence factors or they're representative of 20 virulence factors that are representative of the 21 organisms when they're actually encountered in 22 these settings. So ATCC has a controlled setting 23 in which they store these organisms and can 24 provide a standard organism associated with each 25 of the required organisms that we look for in our 0493 1 test methods, for our test methods. 2 Q So is the source from which -- assume that there 3 was a test on the antimicrobial effectiveness or 4 efficacy of a product. Is the -- and assume that 5 in this efficacy test certain microorganisms were 6 used. Is the source from which the 7 microorganisms were obtained important? 8 A Yes. 9 Q And why? 10 A Depending where the organism is isolated from and 11 depending on how the organism is stored, it has 12 different characteristics associated with it. 13 So, for example, if an organism was isolated 14 from, let's say, a countertop, and it wasn't 15 stored properly, over time that organism loses 16 its virulence factors, so it's not truly 17 representative of an organism that could cause 18 pathology because it has no need to express those 19 virulence factors because it's not subjected to 20 environmental conditions that force it to express 21 those genes. So by requiring that organisms are 22 purchased from a standard collection agency that 23 has rigors in place and controls in place that -- 24 in which these organisms are stored, we are 25 confident that when these organisms are tested, 0494 1 that the efficacy is consistent across the board. 2 Q Thank you, Doctor. Now, who is responsible for 3 demonstrating the efficacy of an antimicrobial 4 product within the FIFRA pesticide registration 5 process? 6 A The registrant is responsible. 7 Q Okay. And how would an applicant for 8 registration or a registrant make this 9 demonstration? 10 A They would make this demonstration by generating 11 efficacy data in a GLP environment. 12 Q And by GLP, what does that mean? 13 A Good laboratory practices. 14 Q Okay. Dr. Blackburn, what are the basic elements 15 of an efficacy study? 16 A The efficacy study involves the test method that 17 was followed, the organisms that were tested, 18 including the source in which they were purchased 19 from, the contact time, other environmental or 20 laboratory conditions, in that if the organism 21 was tested under stringent conditions, organic 22 soil load or water hardness, that information is 23 included as well. If the product was diluted, 24 the dilution rate is included. And the diluent, 25 that is what it was diluted in, was included. 0495 1 The study conduct is important, and that study 2 conduct includes how the test was performed, what 3 controls were present, internal controls, 4 positive controls, neutralizer controls, all that 5 information is included, as well as the actual 6 raw data presented in tabular form. 7 Q Okay. Now, you mentioned good laboratory 8 practices. What is required under good 9 laboratory practices? 10 A Good laboratory practices or good laboratory labs 11 are certified labs that have undergone an audit 12 in which their storage conditions have been 13 certified as acceptable, their equipment has been 14 validated or calibrated on a regular schedule, 15 and their employees, their documentation is 16 present, and they're considered to be GLP 17 certified if they meet certain qualifications, 18 and as well as the study conduct of different 19 tests that are performed, all that information is 20 stored and is considered part of the audit. 21 Q Okay. And are good laboratory practices required 22 by a federal regulation? 23 A Yes, they are. 24 Q Which regulation? 25 A 40 CFR 160. 0496 1 Q Thank you, Doctor. Now, Dr. Blackburn, based on 2 your education and your experience as a 3 microbiologist, how important are efficacy 4 evaluations when reviewing an antimicrobial 5 product? 6 A They're critical. 7 Q And why do you consider them critical? 8 A They're critical because these organisms are 9 public health organisms. We know that they 10 directly impact man, are infectious to man, 11 they're pathogenic towards man. And it's 12 important that we have the confidence that these 13 products will work against these pathogenic 14 organisms before they're registered by evaluating 15 the data that's generated. 16 Q Are there situations in which an efficacy 17 evaluation is particularly important? 18 A I think in all situations, but more importantly 19 in your hospital settings, and also in your food 20 processing areas. 21 Q And why is an efficacy evaluation particularly 22 important in a food processing situation? 23 A Well, in the food processing establishment your 24 end product is going to be something that's going 25 to be ingested, and it's important that proper 0497 1 products are used to mitigate public health 2 organisms from getting in the food, from causing 3 the diseases associated with food and by 4 addressing the efficacy at the beginning of the 5 process and knowing that the products that are to 6 be used in these facilities are indeed 7 efficacious, you can mitigate a lot of these 8 infections or these pathologies. 9 Q Thank you, Doctor. I'd like to turn to the 10 specific claims at issue in this case. I'm going 11 to use the large exhibits because I think it 12 might go a little bit faster. Dr. Blackburn, I'm 13 going to show you a couple of exhibits. 14 For the record, these have already 15 been admitted. They are Complainant's Exhibit 1, 16 pages are Bates stamp EPA 0021 and EPA 0023. 17 May I approach the witness, Your 18 Honor? 19 JUDGE GUNNING: Yes. 20 BY MR. CHA: 21 Q Now, I'm just going to read a couple of 22 sentences. First, on page EPA 0021, on the upper 23 right side of this document there's the 24 statement, since June 1, 2001, JAX POLY-Guard FG 25 contains Micronox providing antimicrobial 0498 1 protection for the product. JAX Micronox has 2 proven especially effective in protecting JAX 3 POLY-Guard greases against Listeria, E. coli and 4 Salmonella over extended lubrication intervals. 5 And the next statement I want you to 6 focus on, Dr. Blackburn, is on page EPA 0023, 7 near the bottom right-hand corner, under the 8 heading Antimicrobial Performance. The sentence 9 reads, JAX HALO-Guard FG greases incorporate JAX 10 new proprietary antimicrobial additive 11 technology, MICRONOX, to provide antimicrobial 12 protection for the product. The second sentence 13 reads, a first in food-grade lubricant, JAX 14 MICRONOX has proven especially effective in 15 protecting JAX HALO-Guard greases against 16 Listeria, E. coli and Salmonella over extended 17 lubrication intervals. 18 Dr. Blackburn, you've seen these 19 exhibits before today? 20 A Yes. 21 Q And that was as part of your work on this case? 22 A Yes. 23 Q Okay. If advertising literature such as this 24 makes these specific claims, do you have any 25 concerns? 0499 1 A Yes. 2 Q And what are your concerns? 3 A I would be concerned, first of all, because these 4 are public health organisms. I know the 5 pathology associated with it, I know the stats 6 associated with infection, and I would be 7 concerned if these products weren't registered 8 and they were making these claims because it has 9 not been proven that they are indeed efficacious 10 against these organisms. 11 Q Okay. Would you require an efficacy evaluation 12 then? 13 A Yes. 14 Q I'd like you to turn -- and this is going to be 15 Complainant's Exhibit 8, Bates page EPA 0186. 16 This will be in the first volume. Dr. Blackburn, 17 do you recognize this particular document? 18 A Yes. 19 Q Is this a document you reviewed as part of your 20 work on this case? 21 A Yes. 22 Q For the record, what product is discussed on this 23 particular document. 24 A Magna-Plate 78 Fluids. 25 Q Now I'd like you to turn to the next page that's 0500 1 Bates stamped EPA 0187. 2 MR. CHA: Your Honor, again this was 3 previously admitted into the record, and I have 4 an enlarged version. 5 I should ask the witness if she can 6 even see this. Are you able to see the enlarged 7 exhibit? 8 THE WITNESS: Yes. 9 BY MR. CHA: 10 Q Dr. Blackburn, does this document -- well, first, 11 what product or products is discussed on this 12 page? 13 A MAGNA-Plate 78 Fluids. 14 Q Okay. And focusing on the lower half of this 15 page, what information appears on that part of 16 this page? 17 A It appears to be some data collected from the use 18 of the Magna-Plate 78 product versus the 19 competitor. 20 Q Dr. Blackburn, does this document provide you 21 with sufficient data to be able to conduct an 22 efficacy evaluation for this product? 23 A No. 24 Q Why not? 25 A First of all, I don't know the test that was 0501 1 conducted to generate this data. I don't know if 2 the test was conducted under GLP. I don't know 3 the -- it appears that the starting inoculums 4 vary, but for where this product is intended to 5 be used, in a food production plant, the middle 6 inoculum or your control carrier is 75 million, 7 and none of these starting inoculums represent 8 that. From this diagram I can't determine what 9 the contact time is, how long the product was 10 indeed exposed to the surface, whatever surface 11 that is, for what period of time. I don't know 12 the source of the microorganisms. Were they 13 obtained from a reputable source and are they 14 representative of the organisms that are 15 encountered in those facilities. I don't know 16 what internal controls were conducted to generate 17 this data. So there are a lot of deficiencies. 18 Q Dr. Blackburn, why is it necessary for an 19 applicant to satisfy the requirements you've just 20 described? 21 A It's required that you satisfy those requirements 22 because that is representative of sound 23 scientific data based on the standards that are 24 set forth by the agency. 25 Q Okay. And is this level of stringency necessary 0502 1 to protect human health? 2 A Yes. 3 Q I'd like you to turn to the page that's Bates 4 stamp EPA 0188. And that is -- just to verify -- 5 Complainant's Exhibits 8 as well. Did you review 6 this document as part of your work in this case? 7 A Yes. 8 Q Okay. And for the record, what product is being 9 discussed? 10 A Magna-Plate 74. 11 Q Now, Dr. Blackburn, are there any statements on 12 this document that are of any concern to you? 13 A Yes. 14 Q Could you identify which statements those are? 15 A You want me to read them or just -- 16 Q If you could first point out where on the page 17 they are, and then go ahead and read them. 18 A They're on the page stamped 0188, and it's the 19 first column, the second paragraph. The claims 20 to -- the second column, the second paragraph, 21 item number 2. 22 Q Okay. And the first -- could you read the first 23 set of claims that you've identified? 24 A Okay. JAX Magna-Plate 74 incorporates JAX new 25 proprietary antimicrobial additive technology 0503 1 Micronox for enhanced antimicrobial protection 2 against a wide variety of microbial agents, 3 including yeasts, molds, and gram-positive and 4 gram-negative bacteria. A first in food-grade 5 lubricant, JAX MICRONOX provides significant 6 knockdown performance and has proven especially 7 effective against Listeria, E. coli, and 8 Salmonella on contact and over extended 9 lubrication intervals. 10 Q Dr. Blackburn, what concerns do you have with 11 this particular language? 12 A I'm concerned primarily with the use of the 13 organisms. There's reference to a wide variety 14 of yeasts, molds, gram-positive and gram-negative 15 bacteria, for which efficacy data was not 16 submitted to the agency, and these claims have 17 not been substantiated adequately. 18 The second paragraph that actually 19 lists the organisms, Listeria, E. coli, and 20 Salmonella. And, furthermore, I'm concerned 21 about "on contact" because that implies or it 22 explicitly states that as soon as the product 23 makes contact with the surface that the level of 24 efficacy can be demonstrated. 25 Q If this product had come in to you for an 0504 1 efficacy evaluation, would you ever have approved 2 a label with this language? 3 A No. 4 Q Okay. And why not? 5 A Well, if efficacy data was generated, and it 6 supported the use of the organisms, the specific 7 organisms, that is Listeria, E. coli, and 8 Salmonella, I would ask first that they include 9 the ATCC designation numbers to determine which 10 organisms were actually tested. The broad 11 mention of gram-positive and gram-negative 12 bacteria, yeasts and molds, they would have to 13 qualify which organisms were actually tested in 14 order to support those claims. And I would never 15 accept the claim "on contact" because none of the 16 products that are tested and registered with the 17 agency impart efficacy immediately. There is 18 usually a period of time associated with the 19 product or exposure time associated before that 20 product can impart efficacy. 21 Q Thank you, Doctor. I'd like to direct your 22 attention to another large exhibit. This is 23 Complainant's 8a, and the Bates stamp number is 24 EPA 0208. For the record, Dr. Blackburn, what 25 product is discussed on this exhibit? 0505 1 A Magna-Plate 78 Fluids. 2 Q And do you have any concerns with the language on 3 this particular document? 4 A Yes, similar language as with the other document. 5 Q Okay. And so I take it you would not approve a 6 label with this language? 7 A No. 8 Q Okay. I'd like to direct your attention to CX 9 8a, and I believe the page number is EPA 0211. 10 Dr. Blackburn, what product is discussed on this 11 page? 12 A Magna-Plate 74. 13 Q Okay. Now, there appears to be a chart or table 14 in the upper half of this page. If you could 15 look at the last row, which appears to be titled 16 MICRONOX Antimicrobial. And the third column to 17 the right there appears to be a column with 18 spaces in which to identify a method. Is there a 19 test method identified for Micronox 20 Antimicrobial? 21 A No. 22 Q And do you find this omission significant? 23 A Yes. 24 Q And why so? 25 A Well, if they're making these claims, I would 0506 1 like to see what test method was used and how the 2 data was generated to support these claims. 3 Q Okay. Dr. Blackburn, just generally in your work 4 in this case, have you seen the claims that were 5 made for all of the Behnke Lubricant products 6 that are at issue in this case? 7 A Yes. 8 Q And would you require an efficacy evaluation for 9 all of these products -- 10 A Yes. 11 Q -- if they came in for registration? 12 A Yes. 13 Q Thank you. Dr. Blackburn, I would like to show 14 you another exhibit. It's Complainant's 15 Exhibit 8c, and the page is EPA 0256. And I do 16 have an enlarged version if that's easier for 17 you, Dr. Blackburn. Do you recognize this 18 exhibit? 19 A Yes. 20 Q And is this a document you reviewed as part of 21 your work in this case? 22 A Yes. 23 Q Now, for the record, what is being discussed on 24 this particular page? 25 A The JAX Micronox Technology. 0507 1 Q Now, are there any statements on this particular 2 document that are of concern to you? 3 A Yes. 4 Q Which statements? 5 A The reference again to the product exhibiting 6 broad-spectrum antimicrobial activity against 7 gram-positive and gram-negative bacteria, yeasts 8 and molds. The statement in general that, all 9 the antimicrobial agents utilized, the reference 10 to knockdown performance, and lastly, the 11 statement, if a bacteria, yeast or mold colony is 12 already established FDA/USDA/NSF-approved 13 competitor lubricants will inhibit the growth of 14 the colony, but to actually kill the colony will 15 require a sanitization process or the use of the 16 JAX food-grade lubricants which incorporate 17 Micronox technology. 18 Q And in particular, the final statement, why is 19 that claim of concern to you? 20 A It's concerning to me because it implies or 21 directly implicitly states that this product can 22 be used as a substitution for the sanitization 23 process. 24 Q And if a product came in for your review, would 25 you ever approve a label with this language? 0508 1 A No. 2 Q Would you require an efficacy evaluation for this 3 Micronox technology? 4 A Yes. 5 Q Okay. And I take it you believe an efficacy 6 evaluation is important for this technology? 7 A Yes. 8 Q And why do you consider it important? 9 A Again, there are public health claims being made 10 here, and what's really disheartening to me is 11 the statement about the sanitization process and 12 how a lubricant can replace that process. And 13 that process is -- having worked in a food 14 production facility and seeing how extensive that 15 process is and the volumes of water and sanitizer 16 that have to be used, substituting that process 17 with a lubricant is alarming. 18 Q Now, does this document provide you with 19 sufficient information to conduct an efficacy 20 evaluation? 21 A No, it does not. 22 Q Okay. 23 JUDGE GUNNING: I think this may be 24 an ideal place to break. I know you're not done 25 and would like to finish, but we have to be 0509 1 realistic. And we're allocated a fair amount of 2 time for this hearing, and hopefully we can 3 accomplish it all by Friday. But the parties 4 requested additional time, and I'm willing to go 5 with that if that's what it takes. But I think 6 any time -- unless you were to wrap it up in five 7 minutes, I don't want to pressure you. 8 MR. CHA: Probably not five minutes, 9 Your Honor. 10 JUDGE GUNNING: Okay. Then I think, 11 one, we have an obligation to the court reporter. 12 And I think everyone is pretty much exhausted, so 13 I think we should call it a day. 14 MR. CHA: Thank you, Your Honor. 15 MR. MCILNAY: Thank you, Your Honor. 16 JUDGE GUNNING: Thank you. 17 (The proceeding was adjourned at 5:55 18 p.m.) 19 20 21 22 23 24 25 0510 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