Document 5b1ej0K0NNZLa60a7Mqvy6vJJ

(QL O <U> 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS BEAUMONT DIVISION CECIL SCOTT, ET AL v. MONSANTO COMPANY ] ] No. B-84-1103-CA ] VIDEOTAPE DEPOSITION OF WILLIAM GAFFEY June 3, 1987 1300 Post Oak Boulevard Houston, Texas Jerry Kelley, Court Reporter Nell McCallum & Associates Inc. 2900 Smith, Suite 104 Houston, Texas 77006 (713) 523-3767 NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020205 LAWYER'S NOTES HARTOLDMON0020206 1 APPEARANCES 2 3 For the Plaintiffs: 4 5 Michael Pohl 6 Attorney at Law 7 Gilpin, Pohl & Bennett 8 Allied Bank Tower, 23rd Floor 9 1300 Post Oak Boulevard 10 Houston, Texas 77056 11 12 For the Defendant: 13 14 Stephen S. Andrews 15 Attorney at Law 16 Woodard, Hall & Primm 17 4700 Texas Commerce Tower 18 Houston, Texas 77002 19 20 Video operator: 21 22 Sue Morgan 23 24 25 2 NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020207 3 1 Videotape Deposition of William Gaffey, taken 2 on June 3, 1987, at 1300 Post Oak Boulevard, Houston, 3 Texas, between the hours of 9 a.m. and 2 p.m., before 4 Jerry Kelley, CSR No. 2004 and Notary Public in and for 5 the State of Texas. 6 7 8 9 10 11 12 - VIDEO OPERATOR: This video deposition is 13 being taken in Cause No. B-84-1103-CA and is filed in 14 U. S. District Court, Eastern District, Beaumont 15 Division. The style of the case is Cecil Scott, et al, 16 versus Monsanto. For identification purposes, the video 17 technician is Sue Morgan of the firm Executive Service 18 Groups,.and the certified court reporter present today 19 is Jerry Kelley of the firm Nell McCallum & Associates. 20 Today's date is June 3rd, 1987, and the time is 21 approximately 9:45 a.m. We are here today to take the 22 oral and video deposition of the witness, Dr. William R. 23 Gaffey, and we are located at the Law Offices of Gilpin, 24 Pohl & Bennett, 1300 Post Oak, Houston, Texas. We are 25 now ready to begin the deposition. Will counsel please I ; NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020208 4 1 state their appearances for the record? 2 MR. POHL: My name is Mike Pohl. I'm one of 3 the attorneys for the plaintiffs. 4 MR. ANDREWS: I'm Steve Andrews. I represent 5 Monsanto. 6 VIDEO OPERATOR: Will the court reporter 7 please swear in the witness? 8 9 10 11 12 WILLIAM GAFFEY, 13 being duly sworn, testified as follows: 14 15 EXAMINATION BY 16 ' MR. POHL: 17 Q Dr. Gaffey, my name is Mike Pohl. As the 18 court reporter just indicated, I am one of the attorneys 19 for the plaintiffs in this case. We have never met 20 before, have we? 21 A No, we have not. 22 Q And you are generally familiar with the 23 process of giving a deposition? 24 A Yes, I am. 25 Q Okay. And you understand that your testimony NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020209 5 1 is under oath today and that it may be offered in 2 evidence at the time of trial? 3 A I understand that, yes . 4 Q Good. I'd like to have a couple of 5 agreements with you, if we could, before we proceed 6 further with your deposition. First of all, I would 7 appreciate your answering audibly to each question, that 8 is, do not answer by a shrug of the shoulders or a nod 9 of the head. Can we have that agreement? 10 A Yes. 11 Q Okay. If for some reason my question is not 12 clear to you or for some reason you do not understand my 13 question, I would like you to stop me and ask me to 14 repeat the question, to rephrase the question, to slow 15 down or to speak up, whatever the case may be, so that 16 we1 re sure that you understand each question that you 17 attempt to answer. 18 A I understand. 19 Q Okay. If at any time you desire to take a 20 break or consult with your attorney, if you will let me 21 know, we will take a recess at your convenience. Okay? 22 A Very well. 23 Q How are you currently employed? 24 A I am Epidemiology Director for the Monsanto 25 Company. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020210 6 1 Q Is that in the medical department? 2 A Yes. 3 Q Who do you report to? 4 A Dr. George Roush. 5 Q How long have you reported to Dr. Roush? 6 A Since July of 1979. 7 Q When were you first employed by Monsanto? 8 A In July of 1979. 9 Q With whom did you interview for that job? 10 A With Dr. Roush; I believewith Dr.Tillman, 11 who was then one of the occupational physicians; with - 12 Mr. Oliver De Garmo, who has subsequently retired; and I 13 had lunch with a group of the people from the operating 14 companies, who individually I don't remember, but they 15 were directors of environmental operations for the 16 operating companies. ' 17 Q Okay. 18 . Is your specialty, that of epidemiology, a 19 subdepartment in the medical group at Monsanto? 20 A Yes, it is. 21 Q How many people are in your group? 22 A There are sixpeople, plus myself. 23 Q Are all the six, plus yourself, 24 epidemiologists? 25 A No. Three of them are master's level NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020211 7 1 epidemiologists, plus myself. Of the others, one is a 2 computer programmer, one is a data clerk, and one is a 3 secretary. 4 Q All right. So you have a total of seven 5 people in the epidemiology department at Monsanto today? 6 A That is correct. 7 Q Okay. And has that grown significantly over 8 the last few years? 9 A No. In fact, it has grown since 1980 by, I 10 believe, two people. 11 Q So in 1980 you had five people in your ~ 12 department? 13 A That's the best of my recollection, yes. 14 Q Now, does your department work side by side 15 with the toxicology department? 16 A I'm afraid I don't understand exactly what 17 you mean. 18 .Q Okay. How many other departments are in the 19 medical department? 20 A Toxicology, industrial hygiene, occupational 21 medicine, quality assurance, and an information service. 22 Q And do each of those subgroups in the medical 23 department report to Dr. George Roush? 24 A Yes. 25 Q Okay. And physically are all of the groups NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020212 8 1 that report to Dr. Roush located in the same building or 2 on the same premises? 3 A They are located on two different floors of 4 the same building. 5 Q Is that in St. Louis? 6 A Yes. 7 Q That1s the headquarters of Monsanto? 8 A That is correct. 9 Q And is the medical department that's located 10 at the headquarters in St. Louis the medical department 11 that issues all the guidelines and reports on - 12 toxicology, epidemiology and so forth for all of 13 Monsanto 1s American operations? 14 A To the best of my knowledge, yes. 15 Q Okay. 16 Have you worked with Dr. Levinsksas? 17 A Yes. 18 .Q Is he head of the toxicology department? 19 A Not at thepresent time. 20 Q Has he been in the past? 21 A Yes. 22 Q Okay. And did you work with any of the 23 people in the toxicology department that reported to 24 Dr. Levinsksas? 25 A From time to time I have worked briefly with NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020213 9 1 one or the other of some three or four toxicologists in 2 that group, yes. 3 Q Okay. Who are they? 4 A Dr. Rashmi Nair, Dr. Michael Stevens, Dr. 5 Bruce Hammond, Dr. Wright, Dr. Levinsksas himself. 6 Q These are people in the toxicology department 7 that you can recall today having worked with? 8 A That is correct. 9 Q Okay. And Dr. Wright's first name is Paul? 10 A Paul, yes. I forgot that. 11 Q Okay. - 12 And you1ve done studies on PCBs while 13 employed by Monsanto, have you not? 14 A No, I have not. 15 Q Okay. You haven't researched the literature 16 and made reports with regard to the possible effects of 17 Monsanto s Aroclor products on human beings? 18 A No. 19 Q Okay. Was that work done before you joined 20 Monsanto? 21 A I have done no work on Monsanto's products 22 specifically. 23 Q Okay. Do you mean that when you studied PCBs 24 you studied those produced by Monsanto as well as those 25 that may have been produced by some foreign NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020214 10 1 manufacturer? 2 A I conducted no studies of PCBs. 3 Q Okay. 4 In the work that you have done as an 5 epidemiologist, have you reviewed any animal 6 toxicological reports on Aroclor products? 7 A No, I have not. 8 Q Have you read any at all? 9 A No, I have not. 10 Q Okay. 11 " In any epidemiological studies in which you12 may have participated regarding the effect of PCB 13 exposure on human beings, did you consider it not to be 14 important to review animal studies? 15 A I haven't participated in any studies of PCBs 16 in human beings. 17 Q Okay. 18 Regarding your educational background, 19 Doctor, you received your Ph.D. in 1955? 20 A That is correct. 21 Q The University ofCalifornia atBerkeley? 22 A That's correct. 23 Q And your undergraduate degree was in 24 psychology? 25 A That's right. NELL MC CALLUM & ASSOCIATES. INC. HARTOLDMON0020215 11 1 Q 1948? 2 A That's correct, 3 Q Okay, And you did not obtain a master's 4 degree? 5 A No, I did not. 6 Q Okay. 7 Now, your science, that is, the science of 8 epidemiology, is a science that has been around for 9 quite a long time. Is that correct? 10 A Yes. 11 Q And epidemiologists were people who first _ 12 studied epidemics? 13 A That is correct. 14 Q They studied epidemics of infectious 15 diseases. Is that correct? 16 A Yes. ' 17 Q And how far back does that go? The first 18 thing that comes to my mind as a layman, Doctor, are 19 some of the plagues that existed in medieval Europe. 20 Does your profession go back that far? 21 A Yes. John Snow, who was involved in a 22 cholera epidemic in London, is usually thought of as one 23 of the earliest epidemiologists. 24 Q Okay. And this epidemic in London that Mr. 25 Snow was involved in, when did it occur, as best you can NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020216 12 1 recall? 2 A As best I can recall, it was sometime in the 3 16th century. 4 Q In your work as an epidemiologist, you use 5 statistics, do you not? 6 A Yes. 7 Q And that's a large part of what you do. Is 8 that correct? 9 A A fairly large part, yes. 10 Q Okay. Let me see if I understand this 11 correctly. What you look at in the statistics is you - 12 take a certain group that you want to study and you try 13 to find if there's any statistically significant result, 14 is that correct, or effect? 15 A That's essentially correct, although the 16 process is somewhat more complicated than you've 17 suggested. 18 .Q I'm speaking very, very basically or very 19 simply. Epidemiology is not a profession whereby you 20 examine the individual who has been exposed to the 21 particular chemical under study. Is that correct? 22 A Generally speaking, that's correct. 23 Q And it's not a situation where you look at 24 individual effects in individual human beings, generally 25 speaking, but rather you would look at the average or NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020217 13 1 the statistically significant effect, if any, on the 2 group. Is that correct? 3 A That is correct. 4 Q And you're not qualified by your background 5 to express an opinion one way or another on the cause or 6 effect with regard to a particular illness and a 7 person's exposure to a chemical, are you? 8 A Could you clarify that? I'm not quite sure 9 what you mean. 10 Q Sure. Let me back up and approach it this 11 way. - 12 For one, you don't have a medical degree? 13 A No, I do not. 14 Q And you've never taken, in your studies, any 15 courses in anatomy? 16 A No, I have not. ' 17 Q And no courses in infectious diseases? 18 A No. 19 Q No courses in biochemistry? 20 A No. 21 Q No courses in pharmacology? 22 A No. 23 Q And in terms of the type of study you do, you 24 look at statistics, but not at the individual cause-and- 25 effect relationship between a chemical and the potential NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020218 14 1 adverse effects in a given individual in terms of trying 2 to diagnose whether or not the chemical caused the 3 effect in that person? 4 A That is correct. 5 Q Okay. 6 Now, in the past, you've testified for 7 Monsanto several times, have you not? 8 A I have -- yes, I have given depositions and I 9 have testified. 10 Q All right. And you've testified in cases 11 involving benzene as well as PCBs? ~ 12 A I have given a deposition in such a case. 13 Q Okay. And you've also testified in cases 14 involving alleged environmental contamination as a 15 consequence of PCBs. Is that correct? 16 A I testified in one such case. 17 Q That's the Outboard Marine case? 18 A No. I gave a deposition in that case. 19 Q Okay. I'm referring generally to giving 20 testimony -- 21 A Yes. 22 Q -- either by deposition, like you are doing 23 today, or in the actual courtroom. 24 And you testified in a case that involved an 25 alleged benzene exposure in Beaumont, Texas. Is that NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020219 15 1 correct? 2 A Yes. 3 Q Okay. And that was where a workman had sued 4 Monsanto and some others claiming that he had been 5 injured by exposure to benzene? 6 A I believe that is correct. 7 Q And you've done research and studies, as an 8 epidemiologist, on benzene, have you not? 9 A I have done one study which could be 10 interpreted as having implications for benzene exposure. 11 Q Okay. And there's been quite a lot of TM 12 literature about benzene over the last few years, has 13 there not? 14 A I believe there has been. 15 Q Okay. Have you tried to keep yourself up to 16 speed or up to date on that literature? 17 A I have tried to keep myself current on the 18 epidemiology studies of human exposures to benzene, yes. 19 Q Okay. And have you tried to keep yourself 20 current on the human exposure studies with regard to 21 PCBs? 22 A Yes, I have. 23 Q Okay. And when is the last time you tried to 24 read anything, any literature about PCBs? 25 A Approximately September of 1986. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020220 16 1 Q Okay. And in what connection was that? 2 A Two studies were completed which were updates 3 of earlier studies of -- I beg your pardon. You're 4 talking -- would you repeat thatquestion,please? 5 Q Sure. 6 A I'm a bit confused. 7 Q Yes. I'm trying to find out when is the last 8 time you made any study of the literature with regard to 9 PCBs -- 10 A Yes. ' 11 Q -- and what the reason for that study was. - 12 A There were two studies that were updates of 13 earlier studies of PCBs. I read the updates because the 14 earlier studies had left some unfinished business that 15 was completed or at least enlarged on by the updates. 16 Q Was one of those studies Dr. Levinsksas's 17 study? 18 .A Dr. Levinsksas has done no human studies, to 19 the best of my knowledge. 20 Q His review of the literature. 21 A In connection with that review, I looked at 22 the updates that I have discussed. 23 MR. PHOL: Okay. 24 Would you mark this? 25 [Exhibit 1 marked] NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020221 17 1 MR. POHL: 2 Q Your attorney has handed to me this morning a 3 document which Monsanto has provided, and it's a memo 4 addressed to George Levinsksas, dated December 18, 1986, 5 purports to have your signature, with an attachment. 6 Can you tell me -- Can you identify this document? 7 A Yes. To the best of my recollection. Dr. 8 Levinsksas was preparing a review of recent data on PCBs 9 and came upon some human health studies which he asked 10 me to comment on. 11 Q And did you do so? - 12 A Yes, I did. 13 Q And are your comments this handwritten memo, 14 or are your comments the typewritten attachment? 15 A My comments are the two typewritten 16 attachments which bear my name. 17 Q Okay. If you'11 look at the handwritten 18 memo, which is the first page of Exhibit No. 1 to your 19 deposition, do you see your signature at the bottom of 20 that page? 21 A Yes, I do. 22 Q And do you recognize that as being your 23 signature? 24 A I do. 25 Q And was your memo prepared on or about NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020222 18 1 December 18, 1986? 2 A To the best of my recollection, yes. 3 Q The last three lines of your memo, would you 4 read those to me, starting with this word? 5 A "I think we can ignore the melanoma issue 6 because the paper was withdrawn." 7 Q Okay. What melanoma issue are you making 8 reference to? 9 A A paper was published sometime in the -- I 10 beg your pardon. A letter was written to a medical 11 journal sometime in the late 1970s alleging the - 12 occurrence of two deaths from melanoma in a population 13 allegedly exposed to PCBs. A more detailed description 14 of the work done in that letter was submitted to NIOSH 15 to be included in a criteria document for PCBs, and then 16 was withdrawn because question had arisen in the ' 17 author's mind as to whether the people were accurately 18 characterized as being exposed. 19 Q And who authored this paper? 20 A A Dr. Anita K. Bahn, that's B a h n, of the 21 University of Pennsylvania. 22 Q Did you ever review Dr. Bahn's paper? 23 MR. ANDREWS: Are we talking about a paper 24 here, or a letter? 25 MR. POHL: Either one. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020223 19 1 A I looked at the letter, and I have looked at 2 the references to her study in the NIOSH criteria 3 document. 4 MR. POHL: Okay. 5 Q And what did you conclude from that 6 examination? 7 A That not enough detail was provided to be 8 able to decide whether the population was selected 9 because they were exposed or because there had been 10 occurrences of melanoma. If the former was the case, ' 11 then the study would be a bona fide description of risk- 12 subject to many problems of interpretation. If the 13 latter is the case, then it's impossible to decide what 14 significance, if any, the observations have. 15 Q You indicated a moment ago that one of the 16 things you did was review the text of a report that 17 pertained to PCBs. Is that correct? 18 .A I reviewed several individual papers at 19 Dr. Levinsksas's request. I believe that's what I said. 20 Q And were any of these human studies, or were 21 they all animal studies or all reviews of the 22 literature? 23 A They were -- the studies I'm referring to 24 were all human studies. And I have never reviewed any 25 animal studies nor, to the best of my recollection, have NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020224 20 1 I reviewed any reviews of the literature. 2 Q Okay. So that we can understand what we're 3 talking about, then, you on one or more occasions have 4 reviewed reports by Dr. Levinsksas pertaining to human 5 studies? 6 MR. ANDREWS: Now -- 7 A No. I have provided Dr. Levinsksas with 8 reviews of human studies for inclusion in documents 9 which he was forwarding to other places. 10 MR. POHL: 11 Q Okay. I'm confused. Because what you did 12 then was you provided data or information -- 13 A I provided information and evaluation of 14 human studies to Dr. Levinsksas. 15 Q Okay. I think I understand. And on how many 16 occasions did you do that? 17 A I'm trying to recall. To the best of my 18 knowledge, on this one occasion. I do not recall that I 19 did anything of this kind on any other occasion. 20 Q Okay. 21 On what Monsanto products have you done 22 epidemiological studies? 23 A On 2,4,5-T, acrylonitrile, and -- no others. 24 Q And were these studies of Monsanto's worker 25 population? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020225 21 1 A Yes, they were. 2 MR. ANDREWS: Can we take about a ten-minute 3 break? I recognize that we got started early and we 4 haven't gone too far, but I need to take about a 5 ten-minute break. 6 MR. POHL: Sure. Let's do. 7 VIDEO OPERATOR: We're off the record. 8 [Recess] 9 VIDEO OPERATOR: We've been off the record 10 for a short break. We're now back on the record. The 11 time is 10:14 a.m. ~ 12 MR. POHL: 13 Q Dr. Gaffey, the 2,4,5-T, that's dioxin, is it 14 not? 15 A No. 16 Q What is it?' 17 A 2,4,5-T is a weed killer produced by -- at 18 that time by Monsanto. 19 Q Okay. And what is the name of that product 20 commercially? 21 A I don't know what the commercial name of the 22 product was nor do I know that it was sold commercially. 23 Q Okay. 24 Now, in connection with your review of a 25 Monsanto epidemiological study involving PCBs, did you NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020226 22 1 visit the Monsanto Krummrich plant? 2 A No, I did not. 3 Q Okay. Do you know where the Krummrich plant 4 is? 5 A Yes. 6 Q Is that outside of St. Louis? 7 A Yes. 8 Q In Sauggt? 9 A That is correct. 10 Q Okay. Do you have any knowledge of an 11 epidemiological study that involved Monsanto workers who 12 worked at the Krummrich plant and who may have been 13 exposed to PCBs? 14 A Yes. 15 Q Okay. Who conducted that study? 16 A Mrs. Judith Zack and a Dr. David Musch, 17 M u s c h. 18 Q And did they publish a draft of their report? 19 A I'm not aware that any report was published. 20 Q Okay. By publish, I don't mean published in 21 final form in the official literature, but I mean 22 prepared in typewritten form. 23 A Yes. 24 Q They did do that? 25 A Yes. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020227 23 1 Q And they submitted a copy of that to you? 2 A Yes. 3 Q And you reviewed it? 4 A Yes. 5 Q Okay. And did that report deal with workers 6 at Monsanto who had been exposed for one or more years 7 to PCBs? 8 A That is the best of my recollection, yes. 9 Q And were these workmen all hourly workmen? 10 A Yes, they were. 11 Q And were these all the types of workmen who- 12 were provided with all the normal safety equipment and 13 safety gear that Monsanto would have provided to its own 14 workmen during those times? 15 A I have no knowledge one way or the other of 16 that. ' 17 Q Any reason to believe that the workmen 18 involved in the Zack and Musch study did not receive the 19 benefits of Monsanto1s normal safety program? 20 A I have no knowledge about them, because these 21 events occurred before I came to Monsanto. 22 Q Okay. And it's not the type -- and data with 23 regard to safety precautions provided by the employer 24 for these PCB workers is not the type of data that would 25 have been included in the files pertinent to this NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020228 24 1 report? 2 A I don't know whether it was included or not. 3 Q You didn't read the file? 4 A No, I did not. 5 Q Okay. You just read the typewritten report? 6 A That is correct. 7 Q Okay. Do you recall from your reading of the 8 report whether any foremen or management-level employees 9 were included within the study? 10 A To the best of my recollection, they were 11 not. - 12 Q Do you know whether all the workers included 13 in this study were male? 14 A I believe they were. 15 Q Do you know whether this study attempted to 16 include any workers who might have been indirectly 17 exposed to PCBs, that is, not exposed in the actual 18 process of manufacturing PCBs, but exposed in the 19 shipping department as a truck driver, as a rail car 20 worker? 21 A To the best of my knowledge, such people were 22 not included. 23 Q Okay. And in connection with the report of 24 this study by Zack and Musch, did you learn the length 25 of exposure of the workmen who were studied? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020229 25 1 A If I did, I cannot now remember it. 2 Q Okay. Do you recall what the dose of 3 exposure was with regard to those workmen? 4 A No, I do not. 5 Q Do you recall if the study even attempted to 6 measure the dose of exposure? 7 A I don't recall that it did. 8 Q And do you recall whether or not the study 9 attempted to differentiate between different routes of 10 exposure? 11 A To the best of my knowledge, it did not. 12 Q Okay. And you understand what I mean when I 13 say route of exposure, don't you? 14 A Yes, I believe I do. 15 Q Okay. And that can be exposure through 16 inhalation, skin contact or any number of other means. 17 Is that correct? 18 A That is my understanding. 19 Q Okay. 20 Now let me talk to you again about another 21 very general concept in epidemiological studies, and 22 that is the more complete the study in terms of 23 information gathered with regard to the group under 24 study, then the more reliable the results are likely to 25 be as a general rule? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020230 26 1 A No. 2 Q Okay. Would you agree thatwithin reason the 3 larger the size of the group that's being studied, the 4 more reliable the results would be statistically? 5 A All other things being equal, yes. 6 Q Okay. And in fact groups can become so small 7 that the results achieved from the epidemiological study 8 would be very questionable at best from a statistical 9 point of view. Is that correct? 10 A Not necessarily. 11 Q Okay. So there's no limit on the size of the 12 group in terms of smallness of numbers? 13 A Not from the point of view of the issues that 14 you have raised. 15 Q Okay. Well, as a layman maybe I've 16 inartfully worded it. Let's assume that of all the 17 workmen that Monsanto has that participated in its 18 production, distribution, sales of PCB products someone 19 chose to study ten workers at a plant. Would that be a 20 statistically valid study? 21 A Depending on the design of the study, yes, it 22 could be. 23 Q Okay. And if these were just ten people from 24 the general population of workers exposed to PCBs as 25 opposed to ten who had had a particular type of NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020231 27 1 purported adverse effect, would it still be 2 significantly valid, statistically valid? 3 A Yes. Statistical validity has nothing to do 4 with sample size. 5 Q Okay. And how does sample size affect the 6 validity of an epidemiological study? 7 A Sample size has no effect on the validity of 8 the study. 9 Q Okay. 10 Now, in trying to understand how a 11 statistical study would work of people who were exposed 12 to PCBs, are there different types of groups that can be 13 studied, such as groups who were exposed occupationally, 14 groups who are fish eaters and exposed because they eat 15 fish out of rivers or streams that have been polluted by 16 PCBs, groups who live near landfills that have been 17 contaminated by PCBs, or groups that are salvagers who 18 salvaged copper out of capacitors or transformers and 19 thus exposed their skin to the PCBs? 20 A The question was rather long. Could you 21 please repeat the beginning of that? 22 Q Sure. 23 MR. ANDREWS: I think the problem was it 24 wasn't a question, it was a statement. So if he will 25 make it a question, maybe you can answer it. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020232 28 1 MR. POHL: 2 Q Are these the types of groups that can be 3 studied by an epidemiologist? 4 A Yes. 5 Q Okay. 6 Now, the human literature that you indicated 7 earlier that you had read, let me refer back to that, 8 please, Doctor. Does the human literature demonstrate 9 that PCBs cause adverse liver effects? 10 A No. ' 11 Q Okay. Does the human literature demonstrate 12 effects of PCBs on liver enzymes? 13 A Yes. 14 Q Does the human literature demonstrate adverse 15 skin effects? 16 A Yes. ' 17 Q And does the human literature demonstrate 18 melanoma? 19 A No. 20 Q Does the human literature demonstrate 21 increases in blood pressure as a consequence of PCB 22 exposure? 23 A No. 24 Q Does the human literature demonstrate adverse 25 pulmonary function as a consequence of PCB exposure? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020233 29 1 A No. 2 Q Does the human literature demonstrate 3 leukemia as a consequence of PCB exposure? 4 A No. 5 Q Does the human literature suggest any of 6 those that you have said no to? 7 A Would you please tell me what you mean by 8 suggest? 9 Q Give indication of. For example, adverse 10 liver effects resulting from PCB exposure. ' 11 A I know of none. - 12 Q Does the human literature demonstrate or 13 suggest arthritis as a result of PCB exposure? 14 A No. 15 Q And by the literature I mean literature -- 16 any literature that you have read, including any change. 17 Okay? 18 .A [Moving head up and down] 19 Q Okay. 20 Now, does the literature demonstrate malaise 21 as a consequence of PCB exposure? 22 A No. 23 Q Does the human literature demonstrate effects 24 on children born of parents exposed to PCBs? 25 A No. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020234 30 1 Q And have you studied the European, American 2 and Japanese literature? 3 A Yes. 4 Q Does the literature demonstrate early 5 abortion as one of the consequences of PCB exposure? 6 A No. 7 Q Does itsuggest that? 8 A No. 9 Q Have you studied paint workers exposed to 10 Aroclor products? 11 A No, I have never studied any PCBexposures.~ 12 Q I'm asking you now ifyou've studied paint 13 exposures which included Aroclor products. 14 A No, I have not. 15 Q Okay. And did you conduct a study or 16 participate in a study of solvents, the solvents used in 17 paint? 18 .A Not specifically. 19 Q In what way did you conduct such a study or 20 participate in such a study? 21 A I participated in a study of persons employed 22 in the manufacture of paints and coatings. 23 Q And do those paints and coatings include 24 solvents such as Aroclors? 25 A They include solvents. I do not know whether NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020235 31 1 they include the Aroclors or not. 2 Q And when did you participate in this study? 3 A To the best of my recollection, approximately 4 in 197 -- '76 or '77. 5 Q And who sponsored this study? 6 A The National Painting and Coating 7 Association. 8 Q And did you find any incidence of human 9 effects, health effects, resulting from exposure to 10 these products? ' 11 A I don't recall specifically what we found. - 12 Q Did you reduce your report to writing? 13 A The report was reduced to writing after I had 14 left the organization that did the study. 15 Q Okay. And was that report published? 16 A Yes. ' 17 Q And can you give us the citation so we can 18 find that? 19 A The citation is in mycurriculumvitae. I 20 don't have a copywith me. I don't recallin which 21 journal it was, but there were multiple authors. The 22 senior author, I believe, was a Dr. Robert Morgan. 23 Q Can you furnish us a copy of your CV? 24 A Yes. 25 Q Okay. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020236 32 1 Are you familiar with a study by C r y e s, 2 Cryes? 3 A Cryes, I believe, yes. 4 Q Cryes. And it pertained to Aroclor products? 5 A I thought it was a study of fish eaters. 6 Q Wasn't it a study of fish eaters who ate fish 7 that were contaminated by PCBs? 8 A Yes. 9 Q Okay. And where did these fish eaters live? 10 A In the town of Treana, Alabama. ' 11 Q And that' s near Anniston, Alabama? -r' 12 A I have no idea of the location. 13 Q It's a town by a river? 14 A So I've been told. 15 Q Okay. And does Monsanto now have or has it 16 ever had a plant in Alabama that manufactures PCBs? 17 A I've been told that Monsanto did have, yes. 18 .Q What plant was that? 19 A I've been told that it's the Anniston plant. 20 Q In Alabama? 21 A In Alabama. 22 Q Okay. And what were the results of Cryes' 23 study of the fish eaters who had eaten fish contaminated 24 by PCBs? 25 A Her principal finding was that the most -- NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020237 33 1 the facts most strongly associated with PCB blood levels 2 were age, sex, and amount of fish consumed. Among the 3 other factors that she investigated were cholesterol 4 levels and blood pressure. The first of these was found 5 to have been unassociated with PCB levels, the second 6 one appeared to be associated. This has not been 7 duplicated in any other study. 8 Q Okay. So what Dr. Cryes found was that 9 people who ate fish contaminated by PCBs had an effect 10 on their blood pressure as a consequence of eating these 11 contaminated fish? -r* 12 A There was an association between average 13 blood pressure level and the level of blood PCBs, to the 14 best of my recollection. 15 Q And so I can understand that. Doctor, are you 16 telling me that the higher the level of PCBs in the 17 blood of one of the fish eaters, the higher that 18 person's blood pressure might be? 19 A On the average, yes. 20 Q Okay. And again, as I think we established 21 at the outset of your deposition, what you deal with as 22 an epidemiologist is the, quote, average? 23 A That is correct. 24 MR. ANDREWS: May I ask a question? Because 25 I'm a little confused here. I'm not sure that I'm NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020238 34 1 following the testimony. 2 It's my understanding that you were 3 responding to questions about the levels of PCBs in 4 someone' s blood. But the last question had to do with 5 blood pressure. Am I just not following the testimony, 6 or have we got a mixture of apples and oranges here? 7 THE WITNESS: My understanding is that we 8 were talking about the relationship between blood levels 9 of PCBs and blood pressure. 10 MR. POHL: That's correct. 11 Q And your indication, I believe, was -- so wgr 12 oan clear the record up, if there's any confusion, was 13 that Dr. Cryes, in her study, found a relationship 14 between the level of PCBs in a fish eater' s blood and 15 that person's blood pressure. Is that correct? 16 A That is correct. 17 Q Okay. 18 As a general rule, epidemiologists do not 19 concern themselves with animal studies. Is that 20 correct? 21 A That is correct. 22 Q Okay. 23 In the study of the literature which you said 24 that you conducted, you indicated first of all that you 25 looked at the worldwide literature. Is that correct? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020239 35 1 A All of it that was included in the major data 2 bases maintained by the National Library of Medicine. 3 Q Okay. And did you look at all the 4 literature, no matter how early or how late, or did you 5 look at specific time periods? 6 A I looked at all the literature that involved 7 epidemiology studies, no matter when those studies were 8 done. 9 Q Now let me ask you something about the nature 10 of your job and about why companies like Monsanto hi re 11 people of your profession. First of all, Doctor, why 12 would a company want to sponsor an epidemiological study 13 of its workers? What is the company's motivation for 14 doing that? 15 A I really can't state what the company's 16 motivation is. I can only state what has been told to 17 me in connection with these studies. 18 Q And what is that? 19 A They start for various reasons. Sometimes 20 there are indications in the animal literature that a 21 substance might be worth studying, sometimes there are 22 indications from industrial hygiene measurements that a 23 study of exposure or a study of certain plants should be 24 done. 25 Q So if a company sees an indication in the NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020240 36 1 animal literature, for example, that a product may cause 2 carcinomas in rats, then that is the kind of impetus 3 that could result in an epidemiological study by one 4 such as yourself? 5 A It could, yes. 6 Q Okay. Or if an industrial hygienist who 7 works for a company notices that a number of employees 8 who work around a particular product have an adverse 9 health effect such as chloracne, that could be another 10 impetus for another epidemiological study. Correct? ' 11 A Yes, that is correct. -- 12 Q And since you've been employed by Monsanto, 13 Monsanto has never conducted an epidemiological study of 14 PCBs that you' ve been involved in. Is that cor rect? 15 A That is correct. 16 Q Okay. 17 And prior to the time that you were hired by 18 Monsanto, did Monsanto have an in-house epidemiologist? 19 A Yes. 20 Q Who was that? 21 A Mrs. Judith Zack. 22 Q How long had she been in Monsanto's employ? 23 A I am told that she was hired in 1977. 24 Q And when did she leave? 25 A To the best of my recollection, it was NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020241 37 1 approximately 1982 or '83. 2 Q What was her title when she left? 3 A Epidemiologist. 4 Q Okay. And did she report to you while y'all 5 worked at Monsanto together? . 6 A Yes. 7 Q Okay. Prior to the time that you were 8 employed by Monsanto, and while she was there, do you 9 know whether or not there was anyone in Monsanto's 10 employ who was an epidemiologist besides Judith Zack? 11 A I don't know. - 12 Q Prior to the time that you joined Monsanto, 13 did Judith Zack or anyone else at Monsanto conduct an 14 epidemiological study of Monsanto's PCB workers? 15 A I'm told that she did. 16 Q Did you ever read her study? 17 A Yes. 18 Q What were her conclusions? 19 A That there were no observable carcinogenic 20 effects associated with exposure to PCBs. 21 Q Did she attempt to define any other effects? 22 Or identify any other effects? 23 A I'm afraid I don't understand your question. 24 Q You say she concluded there were no 25 observable carcinogenic effects. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020242 38 1 A The study was a study of mortality from all 2 causes. But the concern of the authors, I believe, was 3 primarily for cancers. 4 Q Do you know whatprecipitated Monsanto's 5 sponsoring of this epidemiological study? 6 A No, I do not. 7 Q Did you ever confer with Mrs. Zack about this 8 study? 9 A I conferred with her about some of the 10 details of the study report. 11 Q Was the report concluded in final form before 12 you were employed by Monsanto? 13 A I don't know. 14 Q What I'm getting at, Doctor: Did you help in 15 any way to put the report in final form? 16 A Yes. ' 17 Q Okay. 18 Other than the report or the study that was 19 done by Judith Zack, were there any other Monsanto- 20 sponsored epidemiological studies pertinent to PCBs? 21 A No. 22 Q Okay. 23 Are you familiar with what's known as the 24 latency period? 25 A Yes. NELL MC CALLUM & ASSOCIATES. INC. HARTOLDMON0020243 39 1 Q And certain chemicals have a latency period, 2 such as asbestos, benzene, even PCBs. Is that correct? 3 MR. ANDREWS: Doctor, I want to object just 4 for purposes of the record to that question as being 5 compound. And I just ask you to listen to his question, 6 and when he asks you a question like the last one that 7 is really three questions in one, it might be 8 appropriate to have him break it down. 9 A I wonder if you could repeat the question, 10 please. 11 MR. POHL: Sure. 12 Q I was asking you if various chemical 13 products -- and I identified three, asbestos, benzene, 14 PCBs -- have a latency period. 15 A Only if they are carcinogens. 16 Q Okay. Is there a latency period for 17 asbestos? 18 .A I've been told there is. 19 Q What is your understanding of that latency 20 period? 21 A That in the case of some of the asbestos 22 effects it can be as long as 40 years. In the case of 23 some of the other asbestos effects, it can be as short 24 as, I believe, 10 or 15 years. 25 Q What is the latency period for leukemia NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020244 40 1 resulting from a significant or substantial exposure to 2 benzene? 3 MR. ANDREWS: Doctor, if you know the answer 4 to these questions, then you ought to give them, of 5 course. But I'd make an objection as to relevancy. 6 We' re here to discuss PCBs, not other chemicals. To the 7 extent, however, that you have personal knowledge of 8 these matters, I want to permit you to answer them. But 9 I hope we don' t intend to go down this trail too far, 10 because I don't see any relevancy. 11 A I don't know the answer to your question. -- 12 MR. POHL: Okay. 13 Q What is the latency period for PCBs as a 14 cause of cancer? 15 A PCBs do not cause cancer. 16 Q Okay. So you wouldn't be familiar with any 17 latency period for PCBs, then? 18 .A None exist, to the best of my knowledge. 19 Q Okay. 20 And just so we can be sure that we have an 21 understanding the court and jury can comprehend with 22 regard to latency period, tell us in your own words what 23 you mean by latency period. 24 A The interval from the time the exposure began 25 until death from the particular cause that is under NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020245 41 1 discussion. 2 Q And do you know whether or not PCBs are the 3 type of chemical that accumulate in the body? 4 A I have been told that they do, but I do not 5 know of my own knowledge. 6 Q Okay. Is that something that would be 7 significant to an epidemiological study? 8 A It could be. 9 Q Would it be particularly significant if you 10 were trying to do a chronic study? 11 A [No reply] 12 Q Let me approach the question this way. I 13 think you indicated earlier today that the duration of 14 exposure is an important factor to consider. Is that 15 correct? 16 A I meant -- 17 MR. ANDREWS: Iobject to that as a 18 mischaracterization of his testimony. I that he was 19 quite clear that it has an awful lot to do with the 20 design of the study and the purpose of the study, and 21 there were a whole series of variables that were 22 discussed earlier this morning. That's a 23 mischaracterization of what he said. 24 MR. POHL: 25 Q I understand yousaid severalother things. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020246 42 1 But one of the things you said was the duration of the 2 exposure. Is that correct? 3 A All other things being equal, one would 4 expect duration to be a relevant factor, if there is an 5 effect. 6 Q And so far as you know there's been no -- 7 there is no accepted latency period for PCBs in your 8 profession. Is that correct? 9 A There is no accepted belief that PCBs are 10 causes of cancer, and therefore no opinions or 11 statements about latent periods. -- 12 Q All right. So the answer to my question is 13 no? 14 A No. 15 Q Now, PCBshave beendeclared to be 16 carcinogenic in animals by variousgovernmental 17 agencies, have they not? 18 A I don't know what has been done in animal 19 work. I've been told so. 20 MR. ANDREWS: Excuse me. Doctor. For 21 purposes of this deposition, this gentleman wants to 22 know what you have knowledge of. And he may want to 23 expand on that or he may not want to expand on that, but 24 you should try to answer the questions on what you know. 25 MR. POHL: NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020247 43 1 Q So there will be no confusion, I want you to 2 tell me the whole truth. And if somebody has told you 3 something and that1s one of the things you know as an 4 epidemiologist and a Ph.D. and a researcher for 5 Monsanto, I want to know these other sources of 6 information as well, Doctor. Okay? 7 A Okay. 8 MR. ANDREWS: The problem with that 9 instruction, Doctor, is two-fold: First of all, I, too, 10 want you to be as truthful as you possibly can. And I 11 know you are trying to do that. But to the extent that" 12 you start testifying as to what other people have told 13 you, then you sometimes get in an awkward position about 14 vouching for the veracity of what somebody else has 15 done. And I don11 want you to do that, because you are 16 under oath, and I want you to be careful and truthful. 17 MR. POHL: 18 Q Now, you are aware, are you not, Doctor, that 19 the International Agency for Research on Cancer has , 20 declared PCBs to be carcinogenic in animals, are you 21 not? 22 A That is not true. 23 Q What is your understanding of that? 24 A I beg your pardon. You -- What you said is 25 correct. ' NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020248 44 1 Q Okay. 2 And you are aware, are you not, Doctor, that 3 the manufacture and sale of PCBs is banned by law? 4 A I am aware of that. 5 Q And you are aware, are you not, that the 6 Toxic Substances Control Act states that PCBs are a 7 carcinogen. Is that correct? 8 A I am aware that the act so states. 9 Q Okay. And I take it from what you've 10 testified to already today as an epidemiologist you 11 disagree with the Toxic Substance Control Act statements 12 that PCBs are a carcinogen. Is that correct? 13 A I disagree with the statement that they are a 14 human carcinogen. 15 Q Okay. Are you expressing an opinion one way 16 or the other as to whether or not they are a carcinogen 17 in animals as found by the International Agency for 18 Research on Cancer? 19 A I have no opinion on that matter. 20 Q Okay.That's because you don't concern 21 yourself with the animal studies. Is that correct? 22 A I'm not an expert inanimal studies. 23 Q Okay. 24 What contaminants, if any, do Monsanto's 25 Aroclor products contain? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020249 45 1 A I have no idea. 2 Q Okay. And did that ever come up in any of 3 the -- or was it ever revealed in any of the literature 4 which you read regarding the human PCB studies? 5 A No, it was not. 6 Q So then that's not something you can comment 7 on? 8 A That is correct. 9 Q Okay. 10 Are you able, Doctor, to rule out PCBs as a 11 possible cause of human cancer? 12 A Yes. 13 Q And what enables you to do so? 14 A The results of four studies of human exposure 15 to PCBs and the resulting mortality experience of those 16 people. 17 Q Okay. And which four studies are those? 18 A 1. An unentitled study by Anita K. Bahn 19 which was the subject of a letter to the New England 20 Journal of Medicine. 21 2. A study of mortality in capacitor workers 22 by a David Brown and a Mr. Jones from the National 23 Institute for Occupational Safety and Health. 24 3. A study of Monsanto workers employed in 25 the manufacture of PCBs by Judith Zack and David Musch. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020250 46 1 And a study of Italian capacitor workers by a 2 group of authors headed by a man named Bertazzi. That' s 3 Bertazzi. 4 Q And are there any studies which -- the 5 results of which is contrary to these four upon which 6 you rely? 7 A No, there are no other studies that are 8 contrary. 9 Q Okay. And so it's the consensus among 10 epidemiologists, and your opinion as well, that you can ' 11 rule out PCBs as a possible cause of cancer in humans? -- 12 A It is my opinion, and I believe that it is a 13 consensus among epidemiologists. ' 14 Q Okay. 15 Have you made any efforts to reconcile your 16 opinion with the animal toxicology studies that have 17 been conducted on PCBs? 18 A I have not looked at the toxicology studies 19 that have been done. 20 Q Did youread any of them? 21 A No, I did not. 22 Q Okay. 23 In your discussions with Dr. Paul Wright at 24 Monsanto, did you discuss his studies or his 25 participation in studies of Monsanto's Aroclor products? NELL MC CALLUM & ASSOCIATES. INC. HARTOLDMON0020251 47 1 A No, I did not. 2 Q Did you ask him any questions about what he 3 had observed in his studies of Monsanto's Aroclor 4 products? 5 A No. 6 Q Are there any -- Is there any published 7 literature that -- suggesting that there is a direct 8 relationship between PCB exposure and a particular type 9 of cancer? 10 A I know of none. 11 Q Okay. Even in the four that you have cited-- 12 to us, they don't document any particular type of cancer 13 resulting from exposure to PCB in human populations? 14 A None of them agrees as to the site of cancers 15 that are found. 16 Q Well, do they separately note different sites 17 of cancer in the populations they studied? 18 A Yes. 19 Q For example, what are some of the types of 20 cancers which they separately found? 21 A The study by Bahn found two deaths from 22 melanoma, which were found in none of the other studies. 23 Q Is melanoma a skin cancer? 24 A It is a skin cancer, yes. 25 Q Is it generally considered to be a serious NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020252 48 1 form of skin cancer? 2 A Yes. 3 Q Okay. So Bahn found melanoma, but none of 4 the other three studies found melanoma in the human 5 populations exposed to PCBs. Correct? 6 A That is correct. 7 Q What about the study by Brown and Jones? 8 What cancers, if any, did they find in the worker 9 studies that they conducted? 10 A They found nonstatistically significant 11 excess of liver cancer which was largest -- the excess-- 12 was largest in the group with the shortest exposure. 13 Q They found lesions in the livers of humans 14 exposed to PCBs? 15 A No. They looked at cause of death and they 16 found that the risk of death from liver cancer was ' 17 lowest in the people with the longest exposure to PCBs 18 and highest in the people with the shortest exposure to 19 PCBs. 20 Q So, in the study conducted by Brown and 21 Jones, they found that an acute exposure of PCBs rather 22 than a chronic exposure of PCBs was more likely to 23 result in liver cancer. Is that correct? 24 A They passed up several opportunities to say 25 that, and therefore I do not believe that they concluded NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020253 49 1 that. 2 Q Would that being a reasonable assumption, 3 based on their study, to you as an expert? 4 A No. 5 Q Okay. 6 Now, what type of cancer did Zack and Musch 7 find? 8 A The -- They found lung cancer. 9 Q And again that was a type of cancerfound by 10 Zack and Musch that was not found by the authors of the 11 other three studies that you have cited to us this -- 12 morning. Is that correct? 13 A That is correct. 14 Q And was there any particular type of lung 15 cancer that Zack and Musch found in their study of human 16 beings exposed to PCBs? 17 A No. 18 Q Okay. 19 Now, you mentioned another -- the fourth that 20 you mentioned was a man named Bertazzi. Is that 21 correct? 22 A That is correct. 23 Q Did the Bertazzi study find any cancers in 24 the human beings that they studied? 25 A Yes. They found an excess mortality from all NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020254 50 1 cancers. In fact, in the group studied by Bertazzi, 2 most of whom were women, he found an excess mortality '3 from all causes of death among the women. And examining 4 the study makes it seem very probable that the excess 5 existed because the standard rate against which he 6 compared his people was too low. 7 Q Okay. So in Bertazzi's study of a human 8 population exposed to PCBs he found an excess of all 9 types of cancers. Is that correct? 10 A Yes. And in women he found an excess of all ` 11 types of mortality. -- 12 Q All right. Now -- 13 A From all causes. 14 Q Okay. And so I can understand this, are you 15 telling me, then, that in Bertazzi's study, where he 16 found an excess of all types of cancers in the worker 17 populations exposed to PCBs, that would have included 18 things like the melanoma found by Bahn, the liver cancer 19 found by Brown and Jones, and the lung cancer found by 20 Zack and Musch? 21 A I don't remember specifically what Bertazzi 22 found, because I don't believe he listed the cancers 23 with any degree of detail. So there was no reference to 24 melanomas, no reference to liver cancer, and, to the 25 best of my recollection, no reference to lung cancer. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020255 51 1 Q So, to summarize then. Doctor, in the four 2 studies that you have cited to us in your deposition 3 today by name, there was a finding of skin cancer in one 4 study, liver cancer in another study, lung cancer in yet 5 -another study, and an increased risk of all forms of 6 cancer in the fourth study of workers exposed to PCBs. 7 Is that correct? 8 A That is correct. 9 Q Okay. 10 In conducting an epidemiological study' 11 generally of people exposed to PCBs, what would it mean* 12 to you as a Ph.D. epidemiologist if one of the 13 particular persons under study had an increased level of 14 PCBs in his blood? 15 A I can't evaluate what that would mean, 16 because I wouldn1t study a person in the course of doing 17 a study, I would study a group of people. 18 Q Okay. I understand. That was my mistake, 19 because we cleared that up before. You don't study 20 individuals in the type of work you do. Is that 21 correct? 22 A That is correct. 23 Q Okay. Well, let's assume there's a group of 24 people and this is your study group. What could you 25 conclude if you found that nine out of the ten people in NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020256 52 1 your group had at least a moderately high level of PCBs 2 in their blood? 3 A I would conclude that they had probably been 4 exposed to PCBs. 5 Q Okay. And if you had a fat sample taken from 6 the people in this same study group and that fat showed 7 that these people had PCBs in their fat, what would you 8 conclude from that? 9 A Again, that they had probably been exposed to 10 PCBs. ' 11 Q If people show PCBs in their fat, would -- 12 that -- would those PCBs be generally distributed 13 throughout the body? 14 A That I don't know. 15 MR. POHL: Okay. 16 Would you number these next four documents as 17 the next numbered exhibits? 18 [Exhibit 2 marked] 19 [Exhibit 3 marked] 20 [Exhibit 4 marked] 21 [Exhibit 5 marked] 22 MR. POHL: Would you also mark this document 23 as the next numbered exhibit? 24 [Exhibit 6 marked] 25 MR. POHL: NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020257 53 1 Q As an epidemiologist, Dr. Gaffey, if a 2 manufacturer makes a statement that, "At ordinary 3 temperatures Aroclors have not presented industrial 4 toxicological problems," is that the type of general or 5 blanket representation that can be made in the absence 6 of an epidemiological study? 7 A Yes. 8 Q Okay. And you would agree that that's a 9 proper procedure? 10 A I agree that that sort of statement can be 11 made whether or not an epidemiology study has been dons'. 12 Q Okay. So a manufacturer of a product can 13 draw conclusions such as that Aroclors have not 14 presented industrial toxicological problems without 15 conducting an epidemiological study upon which to base 16 that conclusion. Correct? 17 A Would you read the particular sentence to me 18 again, please? 19 Q Yes, sir, I will. It reads: "At ordinary 20 temperatures, Aroclors have not presented industrial 21 toxicological problems." 22 A That seems to me to be an observation on the 23 physical nature of the substance, and as far as I can 24 see has nothing to do with health effects or 25 epidemiology. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020258 54 1 Q Industrial toxicological problems doesn't 2 make any reference to health effects, in your opinion? 3 A Neither in my opinion nor anybody else's. 4 Q Okay. The bottom line, then, is that as an 5 epidemiologist you would have no problem with a 6 manufacturer making that representation without 7 conducting an epidemiological study upon which to base 8 it. Is that correct? 9 A I would have no trouble with that particular 10 representation. 11 Q Let me read to you another representation. 12 I'm reading from Gaffey Deposition Exhibit 2, which has 13 previously been identified as Plaintiff's Exhibit 172. 14 This will be under the caption on Page 4 of that 15 document entitled "Use Ordinary Personal Precautions." 16 Let me read this to you, Doctor. "Transformer Askarel 17 has been made, handled, and used for over 30 years 18 without causing toxic or other ill effects. It can be 19 handled with only minor precautions." Did you 20 understand that? 21 A Yes. 22 Q Okay. Now, is that the type of 23 representation or comment that can be made by a 24 manufacturer without having an epidemiological study 25 upon which to base that statement? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020259 55 1 A That's a statement about industrial hygiene 2 levels and could be made by reference to an industrial 3 hygiene establishment, yes, that can be made without 4 reference to epidemiological studies. 5 Q Okay. But no question in your mind that the 6 statement that I read you, when it speaks of ill 7 effects, is talking about health effects. Is that 8 correct? 9 A I understand that to mean health effects, 10 yes. 1 11 Q And because it talks about personal - 12 precautions, you understand that this refers to health 13 effects in human beings? 14 A I assumed that it did. 15 Q Okay. 16 Let me read to you a small segment from 17 Plaintiff 1s Exhibit No. 124 and Gaffey Deposition 18 Exhibit 3. It reads as follows: "Aroclor is the 19 registered trademark for a range of chlorinated 20 polyphenols manufactured by Monsanto. These compounds 21 are manufactured in this country and have been used 22 safely in industry throughout the world for 30 years." 23 Did you understand that? 24 A Yes. 25 Q Okay. Is that the type of comment that can NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020260 56 1 properly be made by a manufacturer without the support 2 of an epidemiological study? 3 A Would you read the statement again, please? 4 Q Yes, I'll be happy to, Doctor. "Aroclor is 5 the registered trademark for a range of chlorinated 6 polyphenols manufactured by Monsanto. These compounds 7 are manufactured in this country and have been used 8 safely in industry throughout the world for over 30 9 years." . 10 A That's a question of fact which has nothing 11 to do with health effects and therefore has nothing to- 12 do with epidemiology. 13 Q Okay. And when the statement contained in 14 Plaintiffs' No. 124 refers to used safely in industry 15 throughout the world for over 30 years, in your opinion 16 that has nothing to do with health effects? ' 17 A Nothing to do with health effects other than 18 what might be found in an acute situation. 19 Q Is this statement somehow limited to acute 20 exposure, since it talks about the effects of 30 years? 21 A Well, I don't know what was in the minds of 22 the people who wrote that. I have no problem myself 23 with it. 24 Q Okay. That's all I'm trying to establish, 25 Doctor. You have no problem with a company properly NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020261 57 1 making this type of representation and drawing this type 2 of conclusion without first conducting an 3 epidemiological study upon which to base this 4 conclusion. Is that correct? 5 A I think that would depend very much on when 6 the statement was made. But in general, yes, that is my 7 position. 8 Q Okay. 9 Doctor, I'm going to refer to Plaintiffs' 10 Exhibit No. 196 and what has been marked as Deposition 11 Exhibit 4 to your deposition. Let me read to you the ~ 12 following statement found on Page 002532 of that 13 document. I'm quoting: "Askarel fluids have been 14 manufactured, handled, and used for over 30 years 15 without encountering toxic or ill effects." Did you 16 understand that statement? 17 A Yes. 18 .Q And is that the type of statementthat could 19 be properly made by a manufacturer without first 20 conducting an epidemiological study? 21 A In common with the other statements of this 22 kind that you have read to me, they are statements which 23 are true. I have no problem with them because I do not 24 believe that PCBs or any trade name or label for them 25 constitute a health problem. The statement that's made NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020262 58 1 there is, to the best of my belief, a true statement. 2 Q Okay. And is not the kind of statement that 3 would require the support of an epidemiological study 4 before the manufacturer could make such a 5 representation? 6 A I cannot say about that. But the existence 7 of the epidemiology studies proves that the statement is 8 true. 9 Q I'm not asking that question, though, Doctor. 10 I just want to find out, as I did in these other 11 instances when I quoted from documents, whether or not 12 in your opinion the manufacturer would have to first 13 conduct an epidemiological study before it could 14 properly make such a representation. 15 A Not in the context in which these are being 16 mentioned here, no, I do not believe so. 17 Q Okay. 18 And I've got one more document to look at. I 19 want to ask you the same question. But before I do, in 20 one of your immediately-preceding responses you said 21 that in your opinion PCBs have no -- or did you say that 22 PCBs, in your opinion, have no adverse human health 23 effects? 24 A That is what I said. 25 Q Okay. Then that's your opinion as an NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020263 59 1 epidemiologist working for Monsanto? 2 A No. I would have to qualify that by saying 3 that PCBs have been shown to be associated with 4 dermatitis at high levels. 5 Q Okay. 6 And would you then disagree with the 7 testimony of anyone who said that severe exposure to 8 PCBs could cause problems with the liver or problems 9 breathing, problems with the gastrointestinal tract? 10 A I would disagree with all of those 11 statements. - 12 Q Okay. 13 And would you disagree with the statement 14 that PCBs in high levels of exposure or severe exposure 15 can cause loss of hair? 16 A I disagree with that statement. 17 Q Okay. 18 . Would you disagree with the statement that 19 PCB exposure at high levels can cause skin 20 discoloration? 21 A Yes, I disagree with that. 22 Q And would you disagree with the statement 23 that PCB exposure at high levels can cause a hardening 24 or turning under of the fingernails? 25 A I disagree with that also. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020264 60 1 Q Okay. 2 And let me turn to Plaintiffs' Exhibit 3 No. 197, which has been marked as Exhibit 5 to your 4 deposition. This is a statement similar to that 5 contained in some of the other Monsanto documents I've 6 already quoted to you. But let me cover this one as 7 well. It reads as follows, and I'm quoting: 8 "Transformer Askarel has been made, handled, and used 9 for over 30 years without causing toxic or other ill 10 effects." Again, is this the type of statement that can 11 be properly made by the manufacturer of such a product 12 without first conducting an epidemiological study? 13 A I think --yes, I think it is. 14 Q Okay. 15 Doctor, speaking generally again about 16 epidemiological studies -- and let's assume that we're 17 studying a group of workers, two groups of workers who 18 are involved in handling PCB products, and let me ask 19 you if the following fact which I'm going to relate to 20 you would cause a difference in the result of such a 21 study. Okay? 22 A Okay. 23 MR. ANDREWS: Let me ask a question for my 24 own clarification. Are you now going to ask him a 25 series of questions about cause and effect of variables? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020265 61 1 Because I think you've established quite clearly that 2 he's not qualified to answer those questions, he's 3 qualified to answer questions about studies. 4 MR. POHL: This is about studies, Steve. 5 Q Are you ready to proceed? 6 A Yes. 7 Q Okay. 8 Let's assume that in one study the workers 9 who are handling the PCBs have various types of 10 protections provided to them by their employer and those 11 protections include but are not limited to protective ~ 12 clothing, skin creams, bathing, including hand-washing 13 and face-washing facilities, rubber booties or rubber 14 shoes and other things. And let's assume that the other 15 group of workers who handle PCB product are provided 16 with no protective clothing, with the possible exception 17 of white cotton gloves. Would you expect that the 18 results of your epidemiological studies would vary as 19 between these two groups? _ 20 A No. 21 Q Let me try to reconcile that, Doctor, with 22 your prior testimony today. We've talked about a number 23 of the factors that you considered. I asked you a 24 question a few moments ago, as well as did your lawyer, 25 about the duration of the exposure, and while it wasn't NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020266 62 1 the only factor, it was one of them. 2 MR. ANDREWS: I object to the form of the 3 question in that it contains a statement that the 4 testimony has to be reconciled. I don' t think it has to 5 be reconciled at all. His testimony has been clear and 6 unequivocal, and it wasn't an answer -- it wasn't a 7 question, it was a statement. 8 MR. POHL: 9 Q And one of the other factors that we talked 10 about earlier this morning was the amount of the 11 exposure. Correct? - 12 A Yes. 13 Q And wedetailed thatsomewhat because we 14 talked about dose and we talked about route of exposure 15 and so forth. Do you recall that testimony? 16 A Yes. 17 Q Okay. 18 Now, let's assume that in the firstgroup 19 that I have described to you, the group that was 20 provided the protective clothing, the rubber shoes, the 21 gloves, the skin cream, that the amount of exposure was 22 significantly less because the workmen just simply 23 didn't get it on their bodies, that is, the protective 24 clothing or the barrier creams or other safety 25 precautions prevented that type of exposure; and let's NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020267 63 1 assume in the second group that there was substantial 2 exposure and that the men had no safety equipment or 3 clothing or, alternatively, extremely minimal safety 4 equipment or clothing. Are you telling me that in those 5 two instances there would be no variance or significant 6 difference between the results to be achieved from an 7 epidemiological study of those two groups? 8 A I don't think that was the question you asked 9 me earlier. I wonder if I could hear the earlier 10 question back. Because I think what you asked me was 11 whether there would be a difference between the results 12 observed in the studies. 13 Q Okay. Maybe I've misstated it. Ignore the 14 first question, then, and just answer the latter 15 question I've just asked. 16 A I would want to study people with a ' 17 substantial exposure in order to evaluate the effects of 18 the substance that I was concerned with. 19 Q Okay. So if in the first group that we've 20 hypothesized the exposure was either minimal or 21 virtually none as a consequence of protective clothing 22 or other safety precautions provided by the 23 manufacturer, then that would not be the type of group 24 you would want to study to determine the effects of 25 exposure? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020268 64 1 A All other things being equal, I would prefer 2 a more heavily-exposed group. 3 Q Okay. So what you would prefer as an 4 epidemiologist, if you were trying to conduct a study to 5 determine the effects of exposures of human beings to 6 PCBs, would be a group that was actually exposed in that 7 it got the PCBs on their skin or inhaled them. Is that 8 correct? 9 A Not quite. If I were interested in the 10 question of whether exposure to PCBs could cause a 11 health problem, I would want to look at heavily-exposed 12 people. If I wanted to ask the question "Does exposure 13 as it currently occurs constitute a health problem," I 14 would look at people who have the protections that are 15 ordinarily given to workers. 16 Q I think I understand that. 17 Now, when you deal in averages, as we've 18 discussed in your epidemiological studies, the actual 19 effect of a chemical on an individual worker may vary 20 from your average. Is that correct? 21 A That is usually the case, yes. 22 Q Okay. And what I'm getting to, Doctor, is 23 that some people -- and you know this as an 24 epidemiologist -- some people are going to be affected 25 more adversely by exposure to a chemical than other NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020269 65 1 people. 2 A That's generally agreed upon, yes. 3 Q And what you do in your epidemiological 4 studies is you look to the average of the effects of the 5 exposures of these people to a particular chemical? 6 A That is essentially correct. 7 Q And the fact that the average person exposed 8 to a particular chemical has a certain result doesn't 9 mean that a particular individual might not have a 10 different or more severe effect from exposure to a 11 chemical. Is that correct? - 12 A Epidemiology studies don't make statements 13 about individuals, they make statements about groups of 14 people measured, if you will, by the mean of something. 15 Q I understand. My question, I think, was a 16 little simpler than that, and that is that while the 17 average effect as found by one of your epidemiological 18 studies resulted from exposure to a particular chemical 19 may be a certain type of health effect, that does not 20 mean that an individual worker might not have a 21 different and even a more severe health effect in his 22 individual case. 23 A That is true. But it would also have to mean 24 that that was balanced by a worker who had less effect 25 in order to create the average that I would get. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020270 66 1 Q Exactly. So -- and I think that -- I'm glad 2 you stated that, Doctor. So that what you have is, in 3 an epidemiological study, an average, and individuals 4 may vary from that average either by a small amount or 5 by a great amount. Is that correct? 6 A One can't rule out that possibility. 7 Q Okay. And so because you've concluded in an 8 epidemiological study that PCBs do or don't cause a 9 particular type of adverse health effect, that does not 10 rule out that an individual exposed to PCBs may or may 11 not have a certain health effect resulting from exposure 12 to PCBs? 13 A That can never be ruled out by any 14 epidemiology study. 15 Q Okay. 16 Now, also in an epidemiological study, if a 17 worker hadn't gone through the latency period applicable 18 to a particular chemical product, then you wouldn't 19 expect in that particular study that that worker's case 20 would demonstrate causation? 21 A That iscorrect. 22 Q Okay. 23 Now, are you familiar with a study done of 24 Mobil Oil Company workers in Trenton, New Jersey? 25 A I believe that's the study by Professor Bahn. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020271 67 1 Q Okay. 2 A The one that we discussed earlier involving 3 melanomas. 4 Q Okay. And you indicated, I believe, that her 5 study was not published. 6 A That is correct. 7 Q Okay. And, again, what type of cancers did 8 Bahn find in the Mobil Oil Company workers? 9 A She stated that she found two deaths from 10 melanomas. 11 Q Okay. That's the skin cancer? - 12 A That is correct. 13 Q Is it possible, Doctor, that even though an 14 epidemiological study does not show a statistically- 15 significant health effect in the group of individuals 16 who were studied that an educated professional such as a 17 company doctor or an industrial hygienist might 18 nevertheless observe adverse health effects in 19 individual workers? 20 A An industrial hygienist doesn't look at 21 health effects, he looks at the level of exposure. 22 Whether an astute company doctor could find something 23 out, I do not know. 24 Q You wouldn1t be able to express an opinion on 25 that one way or the other? NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020272 68 1 A I would not. 2 Q Okay. 3 Are you familiar with the epidemiological 4 studies that have attempted to compare smoking and lung 5 cancer? 6 A Yes. 7 Q Okay. And I take it you are aware, then, 8 that there are studies which have concluded that there 9 is a link between smoking and lung cancer. 10 A I am aware of those studies, yes. ' 11 Q Studies conducted by competent - 12 epidemiologists? 13 A Yes. 14 Q Are you also aware that there are studies 15 conducted by epidemiologists working for cigarette 16 manufacturing companies that have found no link between 17 smoking and lung cancer? 18 .A No. I am not aware of that. 19 Q All right. So are you indicating to me that 20 as among epidemiologists there is no longer any 21 disagreement between whether or not smoking in the human 22 population can result in lung cancer? 23 A No, I'm not indicating that. 24 Q Okay. Is there still disagreement? 25 A I believe there is. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020273 69 1 Q Okay. And are some epidemiologists taking 2 the position that in their studies smoking appears to 3 result in lung cancer? 4 A There are epidemiologists who are taking that 5 position, yes. 6 Q Are there epidemiologists who take the 7 contrary position? 8 A Yes. 9 Q Okay. So there are areas in epidemiology 10 where trained professionals can have a disagreement? 11 A Yes. - 12 Q And, in the case of cigarette smoking, rather 13 pronounced disagreement. Correct? 14 A Yes. 15 Q Okay.So that reasonable people or 16 reasonable minds could disagree about the results of 17 epidemiological studies. Correct? 18 A No onewho disagrees wouldcharacterize 19 himself as unreasonable. So I suppose I must agree with 20 you. 21 Q Okay. 22 Now, other than the variables that we've 23 talked about earlier today about the duration of 24 exposure, the route of exposure, and so forth, are there 25 any other -- and the size of the group being studied. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020274 70 1 what other variables are there that you can tell me that 2 might affect the outcome of an epidemiological study, 3 generally speaking? 4 A The duration of follow-up. 5 Q Anything else, Doctor? 6 A That's about the only one I can think of. 7 MR. POHL: Okay. 8 Steve, it's 11:30. Can you check the office 9 to see if you've got those documents ready for me? 10 Maybe, if you do, we could just take a very short lunch ' 11 break, grab a sandwich, then we can just finish this up-. 12 I don't have much more, Doctor. I can be through in 13 another half hour at the outside. 14 MR. ANDREWS: I've got a phone message here 15 from Jon. It's likely that's what he's calling about. 16 So why don' t we take a break here and I' 11 call him and 17 see what's going on. 18 MR. POHL: Okay. I'll just wait here till 19 after you've talked to him. 20 VIDEO OPERATOR: Off the record. 21 [Recess] 22 VIDEO OPERATOR: This is the continuing 23 deposition of Dr. William R. Gaf fey. We've been off the 24 record for a lunch break. The time is 12:39 p.m. and 25 the date is June 3rd, 1987. We' re back on the record. NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020275 71 1 MR. POHL: 2 Q Doctor, this is the continuation of your 3 deposition following the lunch break. Before we get 4 started, I understand that there are some documents 5 pertinent to the deposition that are going to be 6 unavailable today, but you and your attorney and I have 7 talked about that off the record and we will try to 8 review those documents as soon as we can, if necessary, 9 resume your deposition at a time convenient to all 10 parties. And place. 11 A I understand. -- 12 MR. ANDREWS: I don' t know, just for purposes 13 of the record, whether or not the documents are 14 pertinent to his deposition. We were just simply 15 requested to produce them, and we've been unable to do 16 so. But I agree with you that, if necessary, we will 17 reconvene the deposition, hopefully when we're in 18 St. Louis doing other matters. 19 MR. POHL: Would you mark this as the next 20 numbered exhibit, please? 21 [Exhibit 7 marked] 22 MR. POHL: 23 Q .Dr. Gaffey, you've had an opportunity to 24 review Gaffey Exhibit No. 7, have you not? 25 A Yes, I have. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020276 72 1 MR. POHL: Okay. 2 MR. ANDREWS: May I look at it just for a 3 second? I was out of the room when he was looking at 4 it. 5 . _ MR. POHL: Sure. 6 Q One of the items that this document discusses 7 is the medical department1s attention to support 8 business group efforts. What does that mean to you? 9 A I have no idea. This is three, four years 10 before I joined the company. I have no idea what it 11 means. -- 12 Q Okay. 13 The second paragraph of this document notes 14 that questions from outside Monsanto have required the 15 organization of epidemiological studies. Are those -- 16 To your knowledge, were there more than one 17 epidemiological study conducted? 18 A Not to my knowledge, no. 19 Q Okay. The documentconcludes with the 20 sentence: "We will have to do much more epidemiology in 21 the future although clear-cut conclusions are almost 22 impossible." What is Dr. Roush implying or stating when 23 he says that clear-cut conclusions are almost 24 impossible? 25 MR. ANDREWS: Excuse me. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020277 73 1 A I have no idea. 2 MR. POHL: 3 Q Does Dr. Roush have any training in 4 epidemiology himself? 5 A I don't know whether he has had formal 6 training or not. 7 Q Now, you indicated earlier today that you 8 helped review or contribute information towards 9 Dr. Levinsksas's rather lengthy paper on PCBs. Is that 10 correct? 11 A Yes. - 12 Q Okay. And that paper, I believe, was done 13 during the time that you were employed by Monsanto. Is 14 that correct? 15 A Yes. 16 Q At the time that youcontributed information 17 towards Dr. Levinsksas's paper, were you the head of 18 epidemiology at Monsanto? 19 A Yes. 20 Q And at the same time was Dr.Levinsksas the 21 head of toxicology at Monsanto? 22 A I believe he may have been retired at that 23 time. We're talking now about September of 1986, I 24 believe. 25 Q Was there also a paper that he had done in NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020278 74 1 1981? 2 A I'm not aware of any. 3 Q Okay. But Dr. Levinsksas,immediately before 4 his retirement, had been the head of the toxicology 5 department at Monsanto? 6 A That is correct. 7 Q Okay. So you and hewere coequal inthat you 8 were both in subsections or subdepartments of the 9 medical department. Correct? 10 A That is correct. 11 Q And you both reported to Dr. Roush, who was- 12 the chairman of the medical department? 13 A Yes. 14 Q Okay. 15 Now, we talked very briefly right before 16 lunch about your study of a product known as 2,4,5-T. 17 A Yes. 18 .Q I asked you if there was a name for that, or 19 commercial name, and you didn't recall any? 20 A That's correct. 21 Q Okay. What was the purpose of that study? 22 A An earlier study had shown no effects 23 resulting from short-term, high-level, acute exposure. 24 We wanted to look at the effect of long-term, low-level 25 exposure to 2,4,5-T. And to do that, we conducted the NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020279 75 1 mortality study that I referred to. 2 Q Okay. Is this a study that Monsanto 3 sponsored itself, or was it a study that was done in 4 conjunction with other manufacturers of the same 5 product? 6 A Monsanto did this on its own. 7 Q Okay. What was the name of the study that 8 you were comparing? What study did you refer to in your 9 prior answer? 10 A The initial study was done by Judith Zack and' 11 Raymond Suskind. I forget the title, but it appeared i-n 12 the January 1980 issue of the Journal of Occupational 13 Medicine. 14 Q At the time that you did your study of 15 2,4,5-D -- sorry, T, did you understand that dioxins 16 were a part of or contaminant of 2,4,5-T? 17 A I understood that they were a possible 18 contaminant at some times in the past, yes. 19 Q At the time that you reviewed the literature 20 of the possible human health effects of exposure to 21 PCBs, did you understand what the contaminants of PCBs 22 were or might have been? 23 A I understood from my reading on the Yusho 24 case what some of the contaminants of the Japanese PCBs 25 might have been. NELL MC CALLUM & ASSOCIATES. INC. HARTOLDMON0020280 76 1 Q And the Japanese PCBs are known as Kanechlor? 2 A I believe so. 3 Q Okay. And you understood that Kanechlor had 4 some contaminants? 5 A Yes. 6 Q Okay. And what were they? 7 A By the time the product was consumed by 8 Japanese, there were dibenzofurans and another class of 9 chemicals whose name I forget. 10 Q Okay. But in the Japanese studies which you 11 read as part of your review of the PCB issue, you were12 aware that dibenzofurans were a contaminant of the PCB 13 product which the Japanese and the Taiwanese people were 14 exposed? 15 A I became aware of that as -- in the course of 16 my reading, yes. 17 Q Okay. Did you do any reading on the 18 contaminants that might be contained in Monsanto's 19 Aroclor product as compared to the Japanese Kanechlor 20 product? 21 A No. My interest in the Japanese product was 22 because the issue was raised by the Japanese 23 investigators who were looking at the Yusho incidents. 24 I made no attempt to investigate further than what I 25 found in the Japanese accounts. NELL MC CALLUM & ASSOCIATES. INC. HARTOLDMON0020281 77 1 Q From your reading of the Japanese accounts, 2 were you able to determine or draw any conclusion 3 whatsoever as to whether or not it was the PCBs or the 4 dibenzofurans that were causing the illnesses reported 5 in the Japanese literature? 6 A The Japanese investigators ended up 7 concluding a decade or so after the event that the Yusho 8 incident was probably primarily caused by contaminants, 9 most likely dibenzofurans. This evidence came from 10 assorted studies that they had done. 11 Q And the Japanese studies concluded that ther-e 12 were various effects, human health effects, from the 13 exposure of these PCB products and these contaminants, 14 dibenzofurans, such as early abortions, respiratory 15 problems, arthritis and others as well. Is that 16 correct? 17 A I'm aware that such problems were reported, 18 yes. 19 Q Okay. And in your opinion, then, the 20 conclusion that you draw from that is that those human 21 health effects were more likely caused by the 22 dibenzofurans as opposed to the PCBs themselves? 23 A I accept the conclusion of the Japanese 24 investigators that that is the case. 25 Q Okay. And you have no opinion one way or NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020282 78 1 another as to whether or not the Monsanto Aroclor 2 products contained dibenzofurans as an acknowledged 3 contaminant thereof? 4 A I have no opinion or knowledge one way or the 5 other. 6 Q So no study or investigation that you did and 7 no review of the literature that you did would enable 8 you to opine on Monsanto's Aroclor products as a human 9 health hazard to the extent that such product contained 10 dibenzofurans as a contaminant? 11 A That is correct. - 12 Q Okay. 13 Now, we talked very briefly about 14 environmental effects of PCBs, and I asked you about 15 some cases you had worked on, and you mentioned the one 16 about -- up in Oregon, I believe it was, in the -- where 17 EPA had filed a lawsuit against Monsanto and others in 18 the Outboard Marine case. Is that correct? 19 A I gave a deposition in connection with that 20 case, yes. 21 MR. POHL: Okay. 22 MR. ANDREWS: Excuse me, Doctor. Was that in 23 Oregon? 24 THE WITNESS: I'm sorry, it was in -- 25 MR. POHL: NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020283 79 1 Q Where was that? 2 A In fact, the deposition was given in Chicago. 3 The issue was, I believe, concerning the Waukegan 4 Harbor, Waukegan, Illinois. 5 Q All right. 6 Doctor, do you know what the background or 7 environmental exposure levels of PCBs are? 8 A Would you please -- Could you be more 9 specific by what you mean by background? 10 Q Sure. What is the -- is there -- Are there 11 PCBs that have contaminated the environment? ~ 12 A Yes. 13 Q Okay. And thereare PCBsfloating around out 14 there in rivers and in lake beds and soil, so forth? 15 A They've been found in a large number of 16 places. 17 Q They've been found in fish, they've been 18 found in mothers1 milk, they've been found in animal 19 tissues. Correct? 20 A That's correct. 21 Q Okay. And is there a level or isthere a 22 body burden of PCBs for the population generally? 23 A There are detectable levels of blood PCBs in 24 most people. I don' t know what the level is, because 25 the value you get depends a little bit on what NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020284 80 1 analytical technique you use. It could be anywhere up 2 to 30 parts per billion, I suppose, depending on where 3 you are, how old you are, how much fish you eat, and 4 what analytic method was used. 5 Q Okay. What would be the range, then, of 6 that? The body burden. 7 A That I really don't know. I have read or 8 been told that figures can range up to about 30 parts 9 per billion, but I don' t know any more about the 10 variability than that. 11 Q Okay. And at the 30 parts per billion, is 12 that any particular group of people such as the fish 13 eaters in Alabama or the people who resided adjacent to 14 landfills contaminated with PCBs? 15 A I don't know what groups of people were 16 referred to in getting that figure. 17 Q All right. 18 Do you have any idea what the -- You're from 19 St. Louis? 20 A Yes. 21 Q Okay. What would be the average body burden 22 of your typical St. Louis, Missouri, office worker? 23 A I have no idea. 24 Q Okay. Would you have any idea what the body 25 burden of PCBs would be of the typical resident in NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020285 81 1 mid-America? 2 A No. No. 3 Q At what level are you as an epidemiologist 4 able to distinguish between the body burden that someone 5 would have just as an ordinary member of the population 6 from that which might be caused by exposure to PCBs in 7 the workplace? 8 A I know that workplace studies have shown 9 values which frequently run above one or two hundred 10 parts per billion, up possibly to eight or nine hundred 11 parts per billion, but I can't be more precise than - 12 that. 13 Q Okay. And how many parts per million would 14 100 to 200 parts per billion? 15 A It would be .2 parts perbillion. 16 Q .20 -- .02? ' 17 A 0.2. 18 Q Okay. So 100 to 200 parts per billion of 19 PCBs in the blood would be 0.2 parts per billion. Is 20 that correct? 21 A 200 parts per billion would be 0.2 parts per 22 million. 23 Q Okay. And the high that you described is 800 24 to 900 parts per million. How many parts per million 25 would that be of PCBs in the blood? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020286 82 1 A That would be . 8 to .9 parts per million. 2 Q And again these levels, 0.2 to 0.9, would be 3 levels of PCBs in the blood of the individual that would 4 indicate to you, Doctor, occupational exposure to this 5 chemical? 6 A Those levels have been found in 7 occupationally-studied populations. 8 Q Okay. Anddo you accept that? 9 A Yes. 10 Q Okay. 11 The PCBs that you have described that are 12 generally in the environment that are in the blood of 13 the population generally, do you know as an 14 epidemiologist how that has affected the rate of cancer 15 in this country generally? 16 A I know that during the time when this sort of 17 contamination was increasing the mortality from cancer 18 other than lung has been decreasing. I know nothing 19 more than that. 20 Q Okay. Well, I'm notasking about the 21 mortality. I'm really asking, Doctor, about the 22 incidence of cancer. Has that been decreasing? 23 A I don't know. 24 Q So, from what you know as a Ph.D. in 25 epidemiology and from all the literature you've read, NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020287 83 1 the worldwide literature about PCBs, you don't know what 2 the effect of PCBs in the blood of the general 3 population has on the incidence of human cancer in this 4 country? 5 A Either it has no effect or it has an effect 6 which is hiding a rather spectacular decrease. My point 7 is that in a period in which the exposures to these PCBs 8 are increasing, mortality has been decreasing. 9 Q Okay. And by mortality you mean the deaths 10 resulting from -- 11 A That is correct. - 12 Q -- a case of cancer? 13 A [Moving head up and down] 14 Q Okay. You are not intending to imply by that 15 that somehow PCBs are what's curing people of cancer? 16 A No. Also, in the last 20 or 30 years the 17 trends in survivorship from cancer have not changed 18 much. 19 Q So in the last 20 or 30 years the various 20 medical techniques that are used in curing or abating 21 cancer have not resulted in any significant medical 22 gains in that regard? 23 A That is correct. 24 Q Okay. 25 A Generally speaking. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020288 84 1 [Exhibit 8 marked] 2 MR. POHL: 3 Q Dr. Gaffey, I've made a xeroxed copy for the 4 court reporter of this little pamphlet you gave me. Is 5 this pamphlet that I'm showing you -- let me pass it to 6 you -- is that a chapter or part of a larger work? 7 A Yes. This is a chapter from a book which 8 represents the proceedings of a symposium. 9 MR. ANDREWS: Excuse me. I know we haven't 10 been back on the record very long, but I would like to 11 take just a very short break at this point. - 12 MR. POHL: Certainly. 13 VIDEO OPERATOR: We're off the record. 14 [Recess] 15 VIDEO OPERATOR: We've been off the record 16 for a short break. We're back on the record. The time 17 is now 1:02 p.m. 18 . MR. POHL: 19 Q What symposium was this. Doctor? 20 A It was a symposium held by the Michigan State 21 University on, I believe, health problems in the 22 environment. 23 Q Were you the only one who presented a paper 24 on PCBs at that particular symposium? 25 A I can't recall. I can't recall. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020289 85 1 Q And was this a one-day symposium or one-week 2 symposium or -- 3 A I believe it was a one- or two-day symposium. 4 Q Okay. Who sponsored the symposium? 5 A I believe it was sponsored by EPA. 6 Q And are they the ones that requested that you 7 attend and speak? 8 A I believe I was requested to attend by the 9 organizers of the symposium. 10 Q The EPA? 11 A The people who organized the symposium with12 EPA funds. 13 Q Who were they? 14 A I'm trying to remember their names. One of 15 them was named D'ltri, D ' I t r i. I forget the name 16 of the other person. 17 Q And what was the date of the symposium? 18 A I can't remember, but I believe it was in 19 1982 sometime. 20 Q This was after Monsanto had stopped 21 manufacturing PCBs? 22 A Yes. 23 Q Okay. And why was Monsanto interested in 24 having you participate in a symposium on PCBs in 1982? 25 A I don't know whether Monsanto was interested NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020290 86 1 or not. 2 Q Was this something that was done outside the 3 scope of your employment at Monsanto? 4 A No. 5 Q And did you obtain clearance for your 6 presentation at this seminar from Dr. Roush or anyone 7 else at Monsanto? 8 A I informed Dr. Roush of the request and my 9 interest in accepting it. 10 Q And he concurred? 11 A He concurred. ~ 12 Q All right. And then you proceeded at that 13 point to publish this paper that has been marked as an 14 exhibit to your deposition? 15 A I proceeded to give the paper at the 16 symposium. ' 17 Q And was the paper prepared especially for the 18 symposium? 19 A No. 20 Q Well, why had the paper -- had a paper 21 already been prepared at the time you were asked to 22 speak at the symposium? 23 A Yes. 24 Q Okay. And when had the paper beenprepared? 25 A The main outlines of the paper had been NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020291 87 1 prepared about a year or a year and a half before, to 2 the best of my recollection. 3 Q Okay. And why had this paper on the 4 epidemiology of PCBs been prepared a year earlier? 5 A I received a call from a person named Fawcett 6 from the American Chemical Society who was organizing a 7 session on epidemiology for the annual meeting of that 8 society. The members had expressed interest in hearing 9 about chlorinated organic compounds, and he had come in 10 some way upon my name and asked me if I would be willing 11 to talk about them. And it occurred to me that a good12 and easy topic to prepare would be one on PCBs. In the 13 process of doing it, I found a great deal more 14 literature than I had thought, and so I proceeded to do 15 a rather complete review based on that literature, in 16 addition to the rather brief presentation that I made at 17 the meeting. 18 Q All right. I note in your paper, on 19 Page 285, the page numbered 285, under Table 3, the 20 following sentence, which commences with the first full 21 paragraph on that page: "In summary, body burdens of 22 PCBs are clearly related to the level of exposure to 23 environmental PCBs." Do you find that, Doctor? 24 A Yes, I see that. 25 Q Okay. What do you mean by that? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020292 88 1 A I mean that people who are exposed generally 2 have higher blood levels of PCBs than people who were 3 not exposed. 4 Q Okay. Well, here you're talking about 5 exposure to environmental PCBs. Are you talking about 6 the general PCBs that exist in some of our waterways, in 7 fish or meat that we might eat or in milk that we might 8 drink? 9 A No. I'm referring to the measurements of 10 exposure that occurred in the studies that I reviewed. 11 Q Then are you referring to some of the -- 12 measurements, for example, that the Swedish published 13 noting the persistence of PCBs in the environment? 14 A No. Because those were not epidemiology 15 studies. 16 Q Okay. Well, are you making reference, then, 17 to occupationally-exposed persons? 18 A I'm making reference to the series of studies 19 which I reviewed in this particular paper, some of which 20 were occupational and some of which were not. 21 Q Okay. And those that were not, were they 22 environmental exposures? 23 A Yes. 24 Q Okay. And by environmental exposures do you 25 mean some concentrated exposure that exists in the NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020293 89 1 environment because individuals were members of groups, 2 for example, that lived adjacent to landfills 3 contaminated by PCBs, or do you mean just the population 4 in general? 5 A Neither of those groups was represented in 6 any of the studies that I looked at here. 7 Q Okay. Well, I'm trying to figure out what 8 you mean by the exposure to environmental PCBs. What 9 groups are you referring to? 10 A To one study of a population which included 11 people who used fertilizer made from sewage sludge which 12 contained PCBs; a second study of sports fishermen who 13 ate fish whose PCB levels were unusually high. 14 Q All right. And the sports fishermen who ate 15 fish that had high levels of PCB, were these saltwater 16 fish or freshwater fish? 17 A These were freshwater fish. 18 Q All right. And the people that you talked 19 about who used sludge contaminated with PCBs, was that 20 the study where people used sludge from a local 21 community that was contaminated with PCBs and used it as 22 fertilizer for their gardens? 23 A Yes. 24 Q Okay. And they then ate the vegetables, 25 tomatoes and radishes, that grew in that garden and NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020294 90 1 ingested PCBs. Correct? 2 A That is correct. - 3 Q Okay. Were there any adverse health effects 4 found in the group that ingested the tomatoes and 5 radishes and whatever else there might be that had been 6 grown as a consequence of PCB-contaminated sludge 7 fertilizer? 8 A No adverse health effects were found in that 9 group. 10 Q Was there any evidence of adverse health 11 effects, even though none were concluded? ~~ 12 A No. None is reported in the reported study. 13 Q Okay. And how many people were studied in 14 that particular study? 15 A I don't know. I would have to look and see 16 whether I've included it in my review. 17 Q Okay. Do you recall the name of the study? 18 I know you -- 19 A The senior author was Baker. 20 Q Okay. That's the second study on your list? 21 A That is the second study in my Table 4. 22 Q All right. It says under physiological 23 parameters -- it has the letter Y. What does that mean? 24 A That means that physiological parameters were 25 looked at and an association was found with blood levels NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020295 91 1 or some other measure of exposure to PCBs. 2 Q Okay. And what was the specific finding in 3 that study? 4 A I would have to look at what I've got here to 5 see. I classified them in various categories which I 6 can't now recall. 7 Q Okay. Could you do that just briefly? 8 A The study in question found no abnormalities 9 in liver function, no relationship of cholesterol to 10 blood PCBs, no relationship with the number of symptoms 11 such as weight loss, anorexia, fever, headache, eye -- 12 irritation, cough, shortness of breath, nausea, 13 vomiting, diarrhea, abdominal pain, arthralgia, and 14 persistent rash. 15 Q Was that found in some of the other studies? 16 A Some of those were found in the Yusho study. 17 Q Okay. And that's the one that you 18 distinguished because the literature indicates to you 19 that it was -- that the contamination of the PCBs by 20 dibenzofurans played a large part in that incident? 21 A That is correct. 22 Q Okay. 23 Have you found the part yet you were looking 24 for on Baker? 25 A I am looking for the part on physiological NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020296 92 1 parameters, and -- Ah. Baker found an increase in 2 triglyceride levels with increasing blood PCBs. 3 Q And what is the effect of an increase in the 4 triglyceride level? 5 A I am unable to say. I'm aware that it's a 6 physiological parameter whose difference was found. I 7 do not know what, if any, is the effect. 8 MR. POHL: Okay. 9 Would you mark this? 10 [Exhibit 9 marked] 11 MR. POHL: - 12 Q Let me pass to you now Exhibit No. 9 to your 13 deposition and ask you to look at this letter from you 14 to David Brown, as well as the accompanying report, and 15 see if you can identify these documents. 16 MR. ANDREWS: I'11 look over your shoulder 17 here, Doctor , if you don't mind. 18 THE WITNESS: You may. 19 MR. ANDREWS: Would you like him to look 20 through the report that's attached to it as well? 21 MR. POHL: Sure. 22 Q Do you want to thumb through it, Doctor -- 23 A Okay. 24 Q -- and see if you can identify it? 25 MR. ANDREWS: Doctor, if Mr. Pohl intends to NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020297 93 1 ask you some questions about that report, and I assume 2 that he does, I would rather that you not thumb through 3 it but take whatever time you feel is necessary to be 4 able to respond to his questions accurately. 5 THE WITNESS: All right. 6 I want to verify that, as far as I can tell, 7 it's indeed the study that we've been talking about as 8 the Zack and Musch study. It appears to be, yes. 9 MR. POHL: Okay. 10 Q Is that a study that you reviewed while you 11 were employed at Monsanto? -- 12 A Yes. 13 Q Okay. And this is one that was done by 14 Judith Zack? 15 A That is correct. 16 Q And she's not a Ph.D., is she? ' 17 A No, she is not. 18 Q Okay. What was the purpose of this report 19 prepared by her? 20 A I don't know, since it originated before I 21 came to Monsanto. My concern was with the quality of 22 the resulting report. 23 Q Okay. Well, I notice that one of the things 24 she does is she reviews some of the literature like 25 Yucheng, she reviews Yusho, starting, for example, on NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020298 94 1 Page 3 of her report. 2 A Yes. 3 Q Okay. So she reviews some of the literature, 4 then she goes on to talk about a study of 2,567 5 capacitor plant workers exposed to PCBs. Is that 6 correct? 7 A It's correct that she makes a reference to 8 such a study, yes. 9 Q And in her reference, which has been marked 10 as Exhibit No. 9 to your deposition, she says in 11 connection with that study that there were excesses of12 liver and rectal cancer deaths. Is that correct? 13 A She does say that, yes. 14 Q Then she goes on to conclude that even though 15 there were such deaths she doesn't consider them 16 statistically significant. Is that correct? 17 A I don't believe she said she did not consider 18 them. I think she said they were not statistically 19 significant. 20 Q What she writes is that they were not 21 statistically significant? 22 A Yes. 23 Q Then she goes on to note on Page 5 another 24 study of 1,310 workers from a capacitor-manufacturing 25 plant with at least six months employment. Do you see NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020299 95 1 that? 2 A Yes. 3 Q She says there that a statistically- 4 significant excess of deaths from all cancer in males 5 was found. Is that correct? 6 A That's what it says, yes. 7 Q Okay. And she says that thestudy suggested 8 but did not find statistically-significant excesses in 9 deaths due to digestive system cancers in males. Is 10 that correct? 11 A She does say that, that is correct. ~ 12 Q And malignancies of lymphatic andhemato -- 13 what? 14 A Hematopoietic. 15 Q Tissue. Is that correct? 16 A It does say that, yes. 17 Q And what is hemato, whatever you called it, 18 tissue? 19 A The blood-forming organs, essentially. 20 Q Okay. And what are malignancies of that 21 organ? What does that mean in layman-like terms? Is 22 that like a malignancy of the lymph node or of the bone 23 marrow, or what? 24 A Yes, it's a -- it's a type of cancer. 25 Q Okay. Usually when I think of cancer, people NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020300 96 1 tell you you've got cancer of the skin or cancer of the 2 liver or cancer of the lungs. What is that a cancer of? 3 A The tissues that produce blood. 4 Q Okay. Is that inside the bone, in the bone 5 marrow? 6 A I don't know. 7 Q Okay. And what about malignancies of the 8 lymphatic tissues? Is that the lymph glands? 9 A It is the lymph glands. 10 Q Okay. 11 And Judith Zack, in her study, looked at------1 12 believe these are Monsanto PCB workers, are they not, 13 this group that she's referring to on the bottom of 14 Page 6 of her study? 15 A That is correct. 16 Q Okay. In her studyof the Monsanto PCB 17 workers, she states on Page 7 that she found diseases of 18 the circulatory system which accounted for almost half 19 of the deaths. Is that correct? 20 A That's correct. 21 Q And she excludedfrom that arteriosclerotic 22 heart disease. Is that correct? 23 A That's correct. That's what shesays, yes. 24 Q Okay. And did she also find among the same 25 worker population at Monsanto that lung cancer accounted NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020301 97 1 for 75 percent of the deaths due to malignant neoplasms? 2 A That's what she says, and I assume that is 3 correct. 4 MR. POHL: Let me show you what's been 5 previously marked as Plaintiffs' Exhibit 574, and let me 6 also ask the court reporter to mark it as the next 7 numbered exhibit to this deposition. 8 [Exhibit 10 marked] 9 MR. ANDREWS: While he ' s doing that, Mr. 10 Pohl, would you hand me the last exhibit that you were 11 looking at? ~ 12 MR. POHL: Certainly. 13 Q Can you identify this letter dated December 14 14, 1981? 15 A I haven't seen this -- I saw this yesterday 16 in Mr. Andrews1 office, but I had not seen it 17 previously. 18 Q Okay. And what do you know about this 19 letter, if anything? 20 A Nothing. 21 Q Okay. 22 Prior to looking at Exhibit No. 10 yesterday 23 in Mr. Andrews1 office, did you know that information 24 with regard to your paper on the epidemiology of PCBs 25 had been transferred to the Environmental Protection NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020302 98 1 Agency? 2 A Yes. 3 MR. POHL: I'11 pass the witness. 4 5 EXAMINATION BY 6 MR. ANDREWS: 7 Q Dr. Gaffey, I have a few questions for you 8 this afternoon. First of all, I'd like you to locate 9 Exhibit No. 8, if you would. 10 A Yes, I have Exhibit No. 8. 11 Q And just forconsistencywithin the r 12 deposition, would you identify what that document is 13 again? 14 A It says "Chapter 20, the Epidemiology of 15 PCBs, William R. Gaffey, Monsanto Company, St. Louis, 16 Missouri , 63167 . " 17 Q All right. Now, did you write that document? 18 .A Yes, I did. 19 Q And as far as you cantell from your 20 examination of it, is it a true and correct copy of the 21 document that you wrote on or about the date indicated? 22 A With one trivial difference. In the original 23 document that I wrote, there were -- oh, I beg your 24 pardon. No, this is a correct copy. This is exactly 25 the same. Exactly the same. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020303 yy 1 Q Is there a date on that document? 2 A No, there is not. 3 Q Can you tell me approximately when you wrote 4 the document? 5 A It would have been in 1980 or '81, I believe. 6 Q Now, what was the purpose of your undertaking 7 a review of the literature so as to write this document? 8 A I originally intended to give a much rather 9 brief review of the literature with respect to cancer, 10 because I knew that that collection of documents was 11 small and manageable and would be appropriate topic for 12 a 15-minute talk before a chemical group. 13 Q All right. Now, this was in response to the 14 request -- 15 A It was in response to a request from a 16 Mr. Fawcett, who was a session organizer for the 17 American Chemical Society. 18 Q Now, what did you do in response to that 19 request? 20 A I started out to search the literature for 21 PCS studies of cancer, and as a by-product turned up 22 with a rather long list of studies of all kinds of 23 health effects of PCBs. I prepared the presentation 24 that I gave to the American Chemical Society, and at the 25 same time took advantage of the literature search to NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020304 100 1 prepare a comprehensive review, which included the work 2 that I had done for the American Chemical Society. 3 Q Now, I notice that there's a bibliography 4 attached to this exhibit. 5 A Yes. 6 Q And what does that include? 7 A That includes health studies -- pardon me. 8 It includes epidemiology studies of the relationship 9 between PCB exposure and various measures of ill health, 10 it includes a couple of studies which I included as 11 examples of the kind of thing I was not going to put in, 12 and one or two technical references. 13 Q How many articles are represented in the 14 bibliography? 15 A I don't have a count here, but there were 16 about 22 studies, I believe; and there are probably some 17 26 or 27 references, because some of them included, as I 18 say, things that I gave as examples of things that I was 19 not going to include. 20 Q Did you make an attempt to do a comprehensive 21 review of the status of the literature in order to write 22 this paper? 23 A Of the literature of studies of human beings, 24 yes. 25 Q Now, Mr. Pohl asked you some questions NELL MC CALLUM St ASSOCIATES, INC. HARTOLDMON0020305 101 1 earlier about some of the studies that you have reported 2 in this paper. 3 A Yes. 4 Q Specifically,he asked you afew questions 5 about the Brahn study. Do you address the Brahn study 6 in Exhibit No. 9? 7 A Are you referring to the study which reported 8 two melanomas? 9 Q Yes, sir. 10 A The Bahn study, yes, I doaddress it here. 11 And -- r 12 Q Would you turn to that section of your paper,I 13 please? 14 A I address it on Page 292 in that study. 15 Q Now, specifically, what did that study show? 16 A It showed 3 cases of melanoma out of 92 17 workers in a research and development position in a 18 refinery where there was thought to be exposure to PCBs. 19 Q Now, was that study ever published? 20 A No, it was not; in fact, it was withdrawn. 21 Q Now, why was it withdrawn? 22 A The reason was that doubt had arisen as to 23 the accuracy of the exposure classification of the 24 subjects. In other words, people weren't sure whether 25 they really had a group of people exposed to PCB or not. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020306 102 1 Q Is that type of information important in 2 understanding the validity of a scientific study? 3 A Yes, it is, if the study alleges a positive 4 result. 5 Q I take it by your earlier response that, 6 because of the question surrounding whether or not the 7 individuals were actually exposed, this paper was 8 withdrawn. Is that correct? 9 A That is correct. 10 Q In your mind, does that cast doubt on the 11 validity of the findings? r 12 A It does. I have other reasons to question 13 the validity of this particular finding. 14 Q What other reasons do you have? 15 A It's not clear either from the original 16 letter to the New England Journal of Medicine or from 17 the discussion in the NIOSH criteria document whether 18 this group of workers was being studied because they 19 were exposed or because they had an excess of melanoma. 20 If it was the second case, then the author is in the 21 position of saying "There1s too much melanoma; let's go 22 look and see if there's too much melanoma." I'm not 23 suggesting that shouldn't be done, I'm simply suggesting 24 that any of the usual calculations about statistical 25 significance go by the board if you looked at a NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020307 103 1 population because they were sick rather than because 2 they were exposed. 3 Q Were there questions raised about the reason 4 for the study? 5 A I'm not aware that any questions were raised. 6 Q You were also asked some questions about the 7 Brown and Jones study. 8 A Yes. 9 Q Do you also address that in your paper? 10 A Yes, I do. There are two comments about the 11 Brown and Jones study. One of them, of course, is that 12 the excess was not statistically significant. 13 Q Now, what excess are we talking about? 14 A We1 re talking about the excess of liver 15 cancers, which is frequently talked about as the main 16 finding of the Brown and Jones study. 17 Q All right. Now, when you use the phrase that 18 the liver cancer findings were not statistically 19 significant, what does that phrase mean? 20 A Because the population that we're studying is 21 a finite number, the number of deaths from liver cancer 22 that we see will be subject to some random variation. 23 And when we say that a result is not statistically 24 significant, we mean essentially that the number that's 25 observed is within the range that could be expected as a NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020308 104 1 result of chance variation. 2 Q Now, with that definition in mind, how does 3 that impact on the scientific validity of a study? 4 A It certainly weakens the validity of the 5 study. And in fact it was given by Brown as a reason 6 for updating the study several years later. 7 Q Now, in addition to the statistical 8 insignificance of the finding, was there also another 9 finding in the Brown and Jones study that was of note to 10 you? 11 A Yes. The fact that the observed excess of ^ 12 liver cancer deaths was greatest in people with the 13 shortest exposure. In other words, it violated the 14 usual ground rules for inferring occupational 15 association, which is that if a little bit is bad, a lot 16 is worse. And here we find a situation in which the ' 17 deaths occurred more often in people with short exposure 18 than in people with long exposure. 19 Q From that relationship, are 20 epidemiologists -- or can epidemiologists make a 21 conclusion as to whether or not the exposure to the PCBs 22 were causing disease? 23 A The pattern of -- of liver cancer deaths here 24 is not consistent with PCBs as a causal factor. It 25 might conceivably be consistent in slight extent with NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020309 105 1 PCBs as a protective factor. 2 Q Let's turn now to the Bertazzi study that 3 Mr. Pohl asked you about earlier. I think there was an 4 indication or you testified earlier that in that study 5 there was an indication of excess mortality from all 6 causes of death. Is that correct? 7 A That is correct. 8 Q Now, would that also include cancer? 9 A It included cancer, heart disease, accidents, 10 infectious diseases, all causes. My first reaction was 11 that the news was too bad to be true in the sense thatr^ 12 typical experience in occupational studies is that if 13 there is an occupational cancer it will generally be 14 lung cancer or a group of closely-allied cancers, and 15 it's not at all uncommon to find people even like 16 uranium miners who have a substantial excess mortality 17 from a particular cause, lung cancer, whose overall 18 mortality is not much different from what you would 19 expect. Here we have a group whose every -- overall 20 mortality was more than double what was expected. No 21 such cohort has ever been seen in the history of 22 occupational epidemiology. 23 Q Sometimes, Doctor, you use terms that are 24 very familiar to you but are not very familiar to those 25 of us who are not epidemiologists. Could you tell the NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020310 106 1 jury what the term "cohort" means? 2 A Yes. A cohort is a group of people who are 3 identified as having been exposed at a particular time 4 and who are then followed to see whether disease 5 develops in that population. 6 Q During the course of time that you were 7 reviewing the Bertazzi studies, did you make any 8 comparisons of his mortality rate with other cohorts or 9 known populations? 10 A Yes, I did. 11 Q What was the purpose in doing that? ^ 12 A It was my belief, based on what I've seen of 13 Bertazzi's work, that he himself is a capable and 14 competent epidemiologist. I therefore speculated that 15 the excesses that he found, which were, as I say, 16 suspiciously universal, might have been due to some 17 problem with the comparison group that he used, the 18 group against which he compared. So what I did was I 19 looked at the mortality rates in the comparison group 20 that Bertazzi used. This was a group the mortality 21 rates among Italian women in a nearby city. And I 22 compared them with mortality rates for white males in 23 the United States. And the average rate that Bertazzi 24 got for his study was equal to the rate for females age 25 15 to 19 in the United States. In other words, if NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020311 107 1 Bertazzi had done his study in the United States, in 2 order to get those results, his work force through the 3 entire course of their working would have had to have 4 been under the age of 20. I concluded, therefore, 5 either: 6 A. The mortality of Italian women is 7 spectacularly lower than that of United States white 8 females, or 9 B. The Italian public health authorities are 10 not as diligent in identifying deaths as Dr. Bertazzi 11 was for the group in his study. ^ 12 Q Now, based on those conclusions and the 13 defect that you observed in the mortality rates, what 14 does that lead you to conclude about the study insofar 15 as it purports to find an excess of mortality for all 16 causes? 17 A I doubt that it really exists. The 18 difficulties I pointed out are true for the rates for 19 females, but females are the majority of Bertazzi's 20 cohorts. And until that doubt is cleared up, I'm 21 skeptical of the reality of the excess mortality. 22 Q All right. Now, if, as you have suggested, 23 there is this excess mortality for all causes, what 24 impact does that have on any relationship between 25 exposure to PCBs and disease? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020312 108 1 A If that excess is real, it's the only finding 2 of its kind in existence. And I don't know what it 3 means. It certainly -- it's a spectacular finding, 4 because, if my recollection is correct, these women had 5 something over twice the expected mortality from all 6 causes. That excess sticks out like a sore thumb. And 7 it's inconceivable that one would find it there and not 8 find it in any other studies. 9 I think in summary there's another 10 characteristic of these studies which is not a 11 characteristic of any one of them particularly, and that 12 is that the studies among themselves show no 13 consistency; that is, the -- . 14 Q Well, let me ask you a couple of questions 15 about that. Is consistency of findings from one study 16 to another important in validating a scientific theorem 17 or a scientific hypothesis? 18 A It's certainly important in the case of 19 epidemiology studies. 20 Q Why is that? 21 A Because the studies themselves are not 22 experimental, so that one cannot control the conditions 23 of observation precisely, as one can, for example, in 24 toxicology studies. Therefore, the next best thing is 25 to try and rule out the effect of various complicating NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020313 109 1 biases by looking at the studies -- looking at different 2 studies done under different circumstances at different 3 times. And that issue of consistency has been brought 4 up, has been listed as one of the essentials for 5 inferring causal relationship by the International 6 Agency for Research in Cancer and by two or three 7 epidemiologists. These groups differ from one another 8 slightly in the details of what they present as their 9 requirements, but they all agree on consistency. 10 Q Doctor, if exposure to PCBs in fact had no 11 effect on human health, what would you expect these 12 studies that we've been discussing by Bahn, Brown and 13 Jones, Zack, and Bertazzi to show? 14 A I'd expect them to show pretty much what they 15 did show. In other words, in any -- if one does a study 16 of a group with no particular exposure and no particular 17 excess risk, and if, as is typically the case in these 18 follow-up studies, one looks at all causes of death, 19 then one expects that a certain number of these deaths 20 will occur in apparent excess. And if I found a study 21 that showed no excesses from any cause of death, I 22 wouldn't believe it. Because I would say chance 23 requires that some of these be greater. And that' s just 24 what we have here. We have a sporadic excess, no excess 25 that occurs in one study is found in any of the others. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020314 110 1 Q And is that the lack of consistency from 2 study to study that you were referring to earlier? 3 A Precisely. 4 Q And what does that lack of consistency 5 demonstrate to you as an epidemiologist? 6 A I think that what we're seeing here is the 7 noise level that one would expect in a study of groups 8 of people with no particular hazard. 9 Q What does noise level mean? 10 A The random variation that results from the 11 fact that sample sizes are not infinitely large. ^ 12 Q Do the results of all the studies that we've 13 been talking about -- are those results consistent with 14 an hypothesis that PCBs are having no effect on human 15 health? 16 A Absolutely. 17 Q Have any epidemiological studiesever shown 18 any relationship between PCB exposures and cancer? 19 A No. 20 Q Mr. Pohl asked you somequestions earlier 21 about individuals as opposed to averages. And I think 22 you will recall your testimony about epidemiologists 23 dealing with averages. 24 A Yes. 25 Q ' If a study shows -- an epidemiological study NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020315 in 1 shows that there is no evidence of a link between PCBs 2 and disease, is it likely that an individual who' s 3 exposed to PCBs will develop any disease? 4 A No, it is not likely. 5 Q Mr. Pohl asked you some questions about the 6 Zack study, which has been marked as Exhibit No. 9, 7 insofar as it related to heart disease. Do you recall 8 those questions? 9 A Yes, I do. 10 Q Was there any attempt in the Zack study to 11 correlate those findings with known risk factors of 12 heart disease? 13 A No. 14 Q What are those factors? 15 A Well, certainly smoking, cholesterol level, 16 weight, blood pressure. I think there is -- there are 17 some ethnic differences, but I'm less sure about them. 18 Q Without an attempted correlation of those 19 items, is the finding of heart disease statistically 20 significant? 21 A Well, it may be statistically significant, 22 but it's not substantively significant, it's not 23 important. 24 Q Can you explain the difference between those 25 concepts? NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020316 112 1 A The -- when we talk about the statistical 2 significance of something, we're talking about whether a 3 difference is real. When we talk about the substantive 4 significance, we're saying: Is the difference big? 5 A difference can be real and yet be so small that nobody 6 would have any particular concern about it or any worry 7 about it. I think the difficulty we have here also is 8 that with four deaths we can't really --- we can't answer 9 the questions that we would like to have answered about 10 the pattern of mortality. All we can say is it' s big. ' 11 We really can' t say anything about latency/ anything r12 about duration. 13 Q Does that have to do with the sample size? 14 A Yes. 15 MR. ANDREWS: I'11 pass the witness. 16 17 FURTHER EXAMINATION BY 18 MR. POHL: 19 Q You just mentionedlatency, didn't you? 20 A Yes. 21 Q Didn't you tell me this morning that in your 22 opinion there was no latency period as it affected PCBs? 23 A That's right. 24 Q Okay. Have you ever testifieddifferently 25 under oath? NELL NIC CALLUM & ASSOCIATES, INC. HARTOLDMON0020317 113 1 A No. - 2 Q Okay. You are sure you haven't testified 3 that the latency period for PCBs was 15 to 20 years? 4 A Not that I can recall. 5 Q Do you recall when you testified in the 6 Bad Axe case? 7 A I recall that I gave testimony there, yes. 8 Q Do you recall that Mr. Jungerheld examined 9 you in that case? 10 A Yes, I remember Mr. Jungerheld. 11 Q Do you recall when Mr. Jungerheld asked you-' 12 the question: How long a latent period do you think we 13 need to look at for PCBs as a cause of cancer? 14 A That's a different question. 15 Q Why is that question different? 16 A Because you asked me if there were a latent 17 period for PCBs. In order for there to be a latent 18 period, one must assume that PCBs are a carcinogen. 19 What Mr. Jungerheld was asking was: How long a period 20 would I require to elapse in order to investigate the 21 issue of whether or not PCBs were a carcinogen. 22 Q So the question I asked you about the latency 23 period for PCBs and the question I asked you more 24 specifically this morning about the latency period for 25 PCBs as a cause of cancer is different than the question NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020318 114 1 that Mr. Jungerheld asked you at trial? 2 A Yes. Your question presupposes the 3 assumption that PCB is a carcinogen. His question is: 4 What would it take for you to investigate whether or not 5 it was a carcinogen? 6 Q Well, in response to his question of what was 7 the latency period, about how long a latency period do 8 you think we need to look at for PCBs as a cause of 9 cancer, what is your answer? 10 A If I wanted to find out whether or not PCBs 11 were a cause of cancer, I would have to -- I would want 12 to look at a latent period of 15 to 20 years. 13 Q All right. And then, as an epidemiologist, 14 for you to determine whether or not a group of workers 15 had a statistically-significant increase in cancer as a 16 cause of exposures to PCBs, you would have to look at 17 those workers after the latency period. Correct? 18 A That is correct. 19 Q Okay. So if you looked at the workers 20 earlier than this 15- to 20-year period you just 21 testified about, that would jeopardize the validity of 22 the examination, would it not? 23 A If you lumped all those data together, it's 24 possible that your effect would be diluted by the 25 short-term observations. Those people with a latency NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020319 115 1 period of less than 15 years or whatever. 2 Q And why is the latency period for the 3 possible cause of cancer of people by PCBs so long? 4 A I made that estimate because that is typical 5 of latent periods for cancers that are supposed to be 6 chemical in origin. 7 Q In other words, that's a typically-accepted 8 latency period? 9 A A study with a shorter latency period would 10 be criticized by most people because there could be a 11 longer latent period. ~ 12 Q Remember when we talked this morning about 13 benzene exposure? 14 A I recall that we did, yes. 15 Q Okay. In your opinion, Doctor, from the 16 epidemiology work that you have done as a Ph.D., can 17 benzene exposure in large amounts lead to leukemia? 18 A Are you asking me on the basis of studies 19 that I have done? 20 Q On the basis of any knowledge that you have 21 in your head. 22 A I believe that large doses of benzene can 23 cause leukemia. 24 Q Okay. 25 Are you familiar with a product known as NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020320 116 1 Kanechlor? 2 A Yes, yes. 3 Q Is Kanechlor a product that, to your 4 knowledge, could be contaminatedwithdibenzofurans? 5 A I know Kanechlor as the trade name for a 6 Japanese PCB. And I know from reading the Yusho studies 7 that people have stated that it's been contaminated with 8 dibenzofurans. 9 Q All right. 10 Now, you indicated in regard to the Bahn 11 study that Monsanto' s attorney asked you about a moment" 12 ago that the fact that paper was never published, and I 13 believe you said even withdrawn, cast doubt on the 14 validity of the findings. Is that correct? 15 A Yes. 16 Q All right. And are you telling the court and 17 jury that you wouldn't rely on a study whose validity 18 might be undermined? 19 A I wouldn't rely on a study whose validity had 20 been undermined. 21 Q Okay. What are some of the other things that 22 in your professional opinion could undermine the 23 validity of a study? 24 A Bias in the selection of the exposed 25 population, and, more often than one would think, NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020321 117 1 statistical errors in the analysis. 2 Q Now, in talking about the Brown and Jones 3 study that pertained to liver cancer, do you recall 4 that? 5 A Yes, I do. 6 Q All right. Would it be important to you as 7 an epidemiologist that the finding of liver cancer in 8 humans by Brown and Jones was independently confirmed in 9 animal studies? 10 A No. Because there are too many other 11 variables involved. ~ 12 Q All right. Would it be important to you in 13 determining whether or not the Brown and Jones study was 14 accurate or correct to know if a manufacturer's own 15 experiences with a particular product had demonstrated 16 liver dysfunction as a result of exposure? 17 A Not unless that manufacturer had done a study 18 of the risk as opposed to simply observation that there 19 was or was not a dysfunction of the liver. 20 Q And in the case of Monsanto's Aroclor 21 products, were you familiar with the very early 22 literature that Monsanto generated with regard to the 23 problems experienced with its own local populations? 24 A No, I am not familiar with any of that. 25 Q Okay. That's not some of the material that NELL MC CALLUM & ASSOCIATES, INC, HARTOLDMON0020322 118 1 you read or studied in drawing your conclusions that 2 PCBs are not harmful to human beings? 3 A No, it is not. 4 Q Okay. 5 Are you familiar with a study that was 6 sponsored by Monsanto with Dr. Drinker? 7 A I -- no, I'm not. 8 Q And you're not familiar with a report, then, 9 that was published by Dr. Drinker in 1937? 10 A No. 11 Q Okay. ~ 12 Would it affect you one way or the other that 13 Monsanto had known since the ' 30s and 1940s that its 14 workers who were exposed to PCBs had a demonstrated 15 yellow dystrophy of the liver as a consequence of such 16 exposure? 17 A I do not know that this is the case, but if 18 it was, it was never -- there's been no published data 19 showing this in any population that I'm aware of. 20 Q Okay. At least none that you have read? 21 A None that I have read. 22 Q And nobodyfromMonsanto has ever come and 23 told you as Monsanto' s chief epidemiologist that in the 24 1930s, for example, they were having problems with 25 yellow dystrophy of the liver in connection with workers NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020323 iy 1 who were contaminated by PCBs? 2 A Nobody has come and told me, and, as of this 3 moment, without seeing the studies, I cannot say whether 4 or not this is true. 5 Q Okay. And my question was simply that nobody 6 from Monsanto has come and told you that in their early 7 working with PCBs Monsanto was experiencing yellow 8 dystrophy of the liver in its workers? 9 A Nobody has come and told me that. 10 Q Has anybody at Monsanto ever come and told 11 you that in Monsanto's early experiences with PCBs its12 workers were developing chloracne? 13 A No. 14 Q Okay. 15 Are you familiar with Krotosky's study? 16 A No, I'm not. 17 Q The study of 1310 workers? 18 A I'm not familiar with the study at all. 19 Q Okay. 20 Have there been any comparison studies, 21 Doctor, that would compare the effects on humans of 22 exposure to various potentially toxic chemicals such as 23 DDT, 2,4,5-T or PCB? 24 A I am aware of no studies of exposure to any 25 of these except separate studies. NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020324 120 1 Q If workmen in the 1930s had been diagnosed as 2 having yellow dystrophy of the liver as a consequence of 3 their exposure to PCBs, that would be inconsistent with 4 your statement today that PCBs cause no adverse human 5 health effects. Is that correct? 6 A That iscorrect. 7 Q Okay. 8 Does the medical department at Monsanto keep 9 records of its early findings in regards to the workers 10 who were exposed to PCBs in the 1930s and 1940s? 11 A I don't know. ~ 12 Q Have you eversearched those records to see 13 if Monsanto had documented any adverse health effects 14 resulting from the exposure of workers to PCBs? 15 A No. Because I'm not aware that the records 16 exist. 17 MR. POHL: Okay. 18 I'll pass the witness. 19 MR. ANDREWS: I don't have anything further . 20 MR. POHL: Subject to our stipulation that we 21 made right after lunch, I'11 pass the witness. 22 23 24 25 NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020325 121 1 CORRECTIONS 2 Page Line Change Reason for Change 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020326 122 1 SIGNATURE OP WITNESS 2 3 I, William Gaffey, solemnly swear or affirm, 4 under the pains and penalties of perjury, that the 5 foregoing 120 pages contain a true and correct 6 transcript of the testimony given by me at the time and 7 place stated, with the corrections, if any, and the 8 reasons therefor noted on a separate sheet of paper and 9 attached hereto, and that I am signing this before a 10 Notary Public. 11 12 13 14 William Gaffey 15 16 THE STATE OF 17 18 Subscribed and sworn to before me, the 19 undersigned authority, by the said William Gaffey on 20 this the day of , 1987. 21 22 23 24 Notary Public in and for 25 the State of NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020327 123 1 THE STATE OF TEXAS] 2 CERTIFICATE 3 I, Jerry Kelley, a Certified Shorthand 4 Reporter, hereby certify that the foregoing testimony 5 was given before me after the witness had been duly 6 sworn. 7 I further certify that the foregoing is a 8 true and correct copy of the transcript of the 9 proceedings. 10 I further certify that I am neither 11 attorney for, related to nor employed by any of the ~ 12 parties or any attorney of record in this cause, nor do 13 I have a financial interest in the matter. 14 Witness my hand in Houston, Texas, on June 15 8, 1987. 16 17 18 19 20 21 2900 Smith, Suite 104 22 Houston, Texas 77006 23 713/523-3767 24 *My Certificate Expires 25 December 31, 1988 NELL MC CALLUM & ASSOCIATES, INC. HARTOLDMON0020328