Document zz9ZRqbYa9gV6egd31j9qg9RB
IN THE COURT OF COMMON PLEAS PHILADELPHIA COUNTY
IN RE:
PAOLI RAILROAD YARD PCB LITIGATION
) ) Master File No. 90-0609-C-6
) )
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE:
PAOLI RAILROAD YARD PCB LITIGATION
)
) ) Master File No. 86-2229 ) Relates to All Actions
DEPOSITION OF GEORGE ROUSH, JR., M.D. Taken on behalf of Plaintiffs April 22, 1992
WALLER REPORTING, INC. 515 Olive Street, Suite 1506
St. Louis, Missouri 63101 (314) 621-2571
HARTOLDMON0030560
IN THE COURT OF COMMON PLEAS PHILADELPHIA COUNTY
IN RE:
PAOLI RAILROAD YARD PCB LITIGATION
) ) Master File No. 90-0609-C-6
) )
IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
IN RE:
PAOLI RAILROAD YARD PCB LITIGATION
)
) ) MasterFile No. 86-2229 ) Relates toAll Actions
DEPOSITION OF GEORGE ROUSH, JR., M.D., produced, sworn and examined on behalf of Plaintiffs, on April 22, 1992, between the hours of eight o'clock in the forenoon and five o'clock in the afternoon of that day, at the office of Brown & James, 705 Olive Street, 11th Floor, St. Louis, Missouri 63101, before TINA M. STUMPF, a Certified Shorthand Reporter and a Notary Public.
APPEARANCES
The Plaintiffs were represented by Mr. Arnold E. Cohen of the law firm of Klehr, Harrison, Harvey, Branzburg & Ellers, 1401 Walnut Street, Philadelphia, PA 19102 and Mr. Martin J. D'Urso of the law firm of Kohn, Nast & Graf, P.C., 1101 Market Street, Suite 2400, Philadelphia, Pennsylvania 19107.
The Defendant SEPTA/PCC was represented by Mr. Paul J. Giordano of the law firm of Blank, Rome, Comisky & McCauley, Four Penn Center, Philadelphia, Pennsylvania 19103.
The Defendant General Electric was represented by Mr. Eric A. Kuhl of the law firm of Williams & Connolly, 839 Seventeenth Street, N.W., Washington, D.C. 20006.
The Defendant Monsanto and Dr. Roush were represented by Mr. Michael H. Malin, 1650 Market Street, Philadelphia 19103.
The Defendant The Budd Company was represented by Mr. Willard R. Burns of the law firm of Kelly, McLaughlin & Foster, 260 S. Broad Street, 1700 Atlantic Building, Philadelphia, Pennsylvania 19102.
HARTOLDMON0030561
INDEX OF EXAMINATIONS
Direct Examination by Mr. Cohen . . 0 0 0 0 0 0 Cross-Examination by Mr. Maiin . . 0 0 0 0 0 0 Redirect Examination by Mr. Cohen . 0 0 0 0 0 0 0
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Recross-Examination by Mr. Maiin . 0 0 0 0 0 0 0
Direct Examination by Mr. D' Urso
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INDEX OF EXHIBITS MARKED
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INDEX OF EXHIBITS ENCLOSED
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1 IT IS HEREBY STIPULATED AND AGREED by and between 2 Counsel for the Plaintiffs and Counsel for the Defendants, 3 that this deposition may be taken in shorthand by TINA M. 4 STUMPF, a Certified Shorthand Reporter and Notary Public, and 5 afterwards transcribed into typewriting, and then read and 6 signed by the witness. 7 o-O-o 8 GEORGE ROUSH, JR., M.D., 9 a witness, being produced, sworn and examined on the part of 10 the Plaintiffs, deposes and says: 11 DIRECT EXAMINATION 12 QUESTIONS BY MR. COHEN: 13 Q. For the record, sir, can we have ;your full name? 14 A. George Roush, R-O-U- S-H, Jr. 15 Q. And you're a medical doctor, sir? 16 A. Yes. 17 Q. Where do you reside? 18 A. In Ladue. 19 Q. Ladue? 20 A. L-A-D-U-E, Missouri. The address is 10 Babler 21 Lane, B--A-B-L-E-R Lane, 63124. 22 Q. What is your date of birth, sir? 23 A. April 30th, 1921. 24 Q. My name is Arnold Cohen. With me is Martin 25 D'Urso. We are, together, co-counsel for plaintiffs in
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1 certain actions pending in the United States District Court 2 for the Eastern District of Pennsylvania and in the Court of 3 Common Pleas of -- What is it now? 4 MR. MALIN: Chester County. 5 Q. Chester County, Pennsylvania, your counsel says 6 with a small smile. We're going to be asking you some 7 questions here today. If during the course of this 8 examination at any time you don't hear a question that I ask 9 you, would you be kind enough to indicate that to me? 10 A. I'11 try to remember that. 11 Q. All right. If at any time during this 12 examination you don't understand the question that I put to 13 you, would you be kind enough to tell me that? 14 A. Yes. 15 Q. In both instances I'll either repeat or have the 16 reporter repeat or I will restate the question as is 17 necessary, because as for myself I'm going to assume that 18 every question you answer you will have both heard and 19 understood; would that be a fair assumption? 20 A. I think so. 21 Q. Now, doctor, I'm a layman. If I should misstate 22 any technical term or medical term and you recognize that I 23 have misstated or misused the term or even mispronounced the 24 term, would you be kind enough toindicate that tome? 25 A. Yes.
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1 Q. I want to be sure that I understand the question 2 I'm asking and that you understand the question I'm asking 3 and that I understand your answer. That way we'll have a 4 nice clean record. You understand, sir, that all of your 5 responses must be made in a verbal fashion? 6 A. Yes. 7 Q. Have you had the occasion to testify before? 8 A. Yes. 9 Q. Can you tell me how many times you've testified 10 in the past in any type of matter whatsoever? 11 A. Including workman's comp? 12 Q. Sure. 13 A. Many workman comp cases. 14 Q. When you say many, is that somewhere between five 15 and 10 or 50 and 100? 16 More than 10. 17 Would it be more than 50 times? 18 No. 19 So somewhere between 10 and 50 times? 20 Yes. 21 Q. And you have testified, what, as the employer's 22 physician or in some other capacity? 23 A. Or as an expert witness. 24 Q. Can you tell me the entities who have had 25 occasion to call you as an expert witness in workers
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1 compensation cases? 2 A. Lead poisoning. 3 Q. Without regard to what the alleged substance was, 4 can you tell me the names of the employers who have called 5 you? 6 A. No, I don't rememberthem. 7 Q. You don't remember? 8 A. No. I think cases rather than people or 9 companies. 10 Q. Okay. Then why don't you tell me, if you can, to 11 the best of your ability, the substances then that were 12 involved in various workers compensation cases where you 13 appeared and testified as an expert witness. 14 A. A number of lead poisoning cases or alleged lead 15 poisoning cases. 16 Q. Any other substance? 17 A. Carbon disulfide. Boranes. 18 Q. Bor -- 19 A. B-O-R-A-N-E-S. PCB's. Dioxin. That's -- Many 20 of them were lead. 21 Q. Many of them were lead? 22 A. Yes. 23 Q. Now, other than in workers compensation cases. 24 Have you had occasion to testify? 25 A. On the Boranes and on workman's comp.
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1 Q. I'm sorry. You said on the Boranes? 2 A. Boranes. You have it on the list there. That 3 was a non-workman's comp. 4 Q. Any other cases that you can recall where you 5 testified either as a fact or expert witness other than in a 6 workers compensation proceeding? 7 A. And in dioxin. 8 Q. You've testified in civil cases involving dioxin? 9 MR. MALIN: I'll make it easy. He testified in 10 the Sturgeon case involving dioxins. 11 MR. COHEN: Sturgeon? 12 MR. MALIN: What was the full name of that case? 13 MR. COHEN: Kemner? 14 MR. MALIN: Kemner, yes. He testified in the PCB 15 cases for Monsanto. Brewer was one. 16 MR. COHEN: Do you mind if I get the testimony 17 from the witness. What you have to say is not testimony, 18 counsel. If you want to supply me with a list that the 19 witness can sign as being a listing of the cases -- 20 MR. MALIN: I was just trying to save time. 21 MR. COHEN: I'm not trying to waste time. I'm 22 trying to get the information. 23 MR. MALIN: Sure. 24 Q. (By Mr. Cohen) So, you testified in Kemner? 25 A. Yes.
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1 Q. You were on the stand for 30 days? 2 A. Yes. 3 Q. That was a case involving dioxin? 4 A. Alleged dioxin at least. 5 Q. Alleged dioxin, PCB cases. You testified in PCB 6 cases or just workers compensation claims? 7 A. Workman's -- They were not workman's comp. They 8 were other than workman's comp. 9 Q. Civil cases? 10 A. Yes. 11 Q. When you testified in PCB cases that were civil 12 cases, were you testifying as a fact witness or an expert 13 witness or both? 14 A. Representing Monsanto. 15 Q. So, you werespeaking onbehalf of Monsanto? 16 A. Yes. 17 Q. Had Monsanto called you to testify and to offer 18 opinions on their behalf? 19 MR. MALIN: I object to the form of the question. 20 If you understand that, doctor, go ahead. 21 A. I don't think I understand the question. 22 Q. Do you understand the difference between an 23 opinion and a fact? 24 A. No. 25 Q. So in the past, you've been called to testify as,
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1 what you believe to be, an expert witness and you offered 2 testimony, but you don't know whether what you were offering 3 was a fact or opinion? 4 A. Yes. 5 Q. That's correct? 6 A. Yes. 7 Q. You were employed by Monsanto? 8 A. Yes. 9 Q. When were you last employed by Monsanto? 10 A. '88. 1988. April 30th. 11 Q. And you retired four years ago? 12 A. Yes. 13 Q. I gather your retirement.was something that you 14 wanted to do? 15 A. Yes. 16 Q. Are you a shareholder of Monsanto or any Monsanto 17 entity? 18 A. No. 19 Q. Have you ever been a shareholder of Monsanto? 20 A. Yes. 21 Q. And did you divest yourself of shares in that I 22 guess? 23 A. Yes. 24 Q. When was that? 25 A. When I retired.
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1 Q. Did you have some sort of employee incentive plan 2 that gave you shares in the company? 3 A. No. I had options to buy stock that have been 4 issued to me in my name. 5 Q. And when you retired you got rid of all that? 6 A. Yes. I still have some that I haven't exercised 7 options yet. 8 Q. Since your retirement, have you testified on 9 behalf of Monsanto? 10 A. On PCB's. 11 Q. When was that? 12 A. I don't know. I don't remember. I have no basis 13 of thinking of that way. 14 Q. You retired four years ago? 15 A. Yes. 16 Q. Did you testify on behalf of Monsanto -- and I'm 17 excluding today because I don't know about your appearance 18 here today -- at all in 1992? 19 A. I don't remember when I testified. I'm sorry. 20 Q. Well, we're three and a half months into 1992. 21 A. I understand. 22 Q. Did you have occasion to> appear this year? 23 A. No. 24 Q. How about in 1991? 25 A. I don't recall.
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1 Q. You have no recollection of whether you 2 testified? 3 A. I have nobasis for it. 4 Q. Do you know the names of the cases -- 5 A. No. 6 Q. -- in which you testified regarding PCB's since 7 April 30th, '88? 8 A. No. 9 Q. Do you have a record of what those cases were? 10 A. No. 11 Q. Do you keep files on the cases in which you are 12 asked to testify? 13 A. No. 14 Q. When you were asked to testify, do you then have 15 a file, whether you keep it after you're finished or not? 16 A. I'm not sure what you mean by a file. 17 Q. Does anyone give you information either in 18 documentary form or orally that you reduce to a document that 19 you then retain so that you'11 have information about the 20 case in which you're appearing and testifying? 21 A. No. 22 Q. So, you just go in and testify and answer 23 whatever questions are put to you? 24 A. Yes. 25 Q. Has that always been the case when you testified
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1 regarding PCB's other than during your employment with 2 Monsanto? 3 A. Yes. 4 Q. So, you've never had any files on any cases? 5 A. No. 6 Q. Now, you're appearing here today. Are you 7 appearing here on behalf of Monsanto? 8 A. Yes. Well, I was being subpoenaed. 9 Q. Are you appearing here as a result of having been 10 served with a subpoena? 11 A. Yes. 12 Q. Do you have a copy of that subpoena? 13 A. No. 14 Q. Who served you with the subpoena? 15 A. I don't know. Somebody came to the door and gave 16 it to me. 17 Q. Did it ask you to bring anything? 18 A. Yes, but I just took it to Monsanto. 19 Q. Who did you take it to at Monsanto? 20 A. Mr. Bistline. 21 Q. Mr. Bistline? 22 A. Yes. 23 Q. He's in their legal department? 24 A. Yes. 25 Q. Do you know his title?
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1 A. No. 2 Q. Did Bistline tell you that you had to bring any 3 documents or anything to the deposition? 4 A. No. 5 Q. Did he tell you that you didn't have to bring 6 anything to the deposition? 7 A. No. He showed me a form that said I should bring 8 what information I have. 9 Q. And what did you bring? 10 A. Nothing. 11 Q. Because you didn't have anything? 12 A. I don't have anything. 13 Q. Youdon't have any documents, materials, any 14 information at allregardingPCB's? 15 A. It's at Monsanto if I do have. I didn't take 16 anything from Monsanto. 17 Q. In other words, you had materials when you were 18 there up to April 30th, '88, or at least access to materials 19 up until April 30th, '88, but since that time, you have 20 nothing? 21 A. That's correct. 22 Q. Mr. Malin said he's your counsel; is that 23 correct? 24 A. Yes. 25 Q. He represents you here today?
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1 A. Yes. 2 Q. Who's compensating you for yourappearance here 3 today? 4 A. We haven't discussed that. 5 Q. So, you neither discussed thatwith Mr.Bistline 6 nor Mr. Malin? 7 A. No. 8 Q. What's your usual fee for appearing and 9 testifying on behalf of Monsanto? 10 A. $1500 a day. 11 Q. And you expect to get paid that for your 12 appearance today? 13 A. We haven't discussed it. 14 Q. Are you paying Mr. Malin anything for 15 representing you here today? 16 A. No. 17 Q. You haven't discussed that either? 18 A. We haven't discussed that. 19 Q. But you don't expect to? 20 A. No. 21 Q. Did Mr. Bistline tell you that they would supply 22 you with counsel? 23 A. Yes. 24 Q. And is that how you engaged Mr. Malin's services? 25 A. I'm not sure. Mr. Bistline introduced me to him.
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1 Q. When was that? 2 A. Yesterday. 3 Q. Was that the first time you met Mr. Malin? 4 A. Yes. 5 Q. Had you spokenwith himby phone prior to that 6 time? 7 A. No. 8 Q. Did youprepare forthisdeposition? 9 A. I looked over a book that I've got on toxicology 10 of occupational things. The title is Patty's, P-A-T-T-Y, 11 Textbook. 12 Q. Patty's? 13 A. Yes. 14 Q. Textbook? 15 A. Of Industrial Medicine, Industrial Hygiene. 16 Q. Is that a one volume text? 17 A. It's three volumes. 18 Q. And do you know the date of publication? 19 A. No. 20 Q. Do you know the date of revision or whatever 21 update you were looking at? 22 A. It's the most recent one is all I can answer. 23 Q. Who owns that book? 24 A. I don't know. You mean now? 25 Q. The one you looked at.
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1 A. I own it. 2 Q. You own it? 3 A. Yes. 4 Q. Do you have that at home? 5 A. Yes. 6 Q. But you didn't bring it here today? 7 A. Yes --- No. 8 Q. Does it have a section on PCB's? 9 A. Yes. 10 Q. For what purpose did you look at Patty's 11 Textbook? 12 A. Historically, that's what I do when I talk about 13 any chemical in terms of health effects. 14 Q. You reference Patty's Textbook to see what's been 15 reported? 16 A. Yes. 17 Q. How large is the section on PCB's in Patty's 18 Textbook? 19 A. Five, 10 pages. 20 Q. Do you consider it to be a comprehensive review 21 of the subject? 22 A. Reasonably so. 23 Q. Do you have other sources of information 24 regarding the health effects of PCB's other than Patty's 25 textbook?
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1 A. I have Zenz Textbook of Occupational Medicine. 2 Q. Zenz? 3 A. Z-E-N-Z. 4 Q. Z-E? 5 A. N-Z. 6 Q. Textbook of occupational medicine? 7 A. Yes, volume 2. 8 Q. That has a section on PCB's? 9 A. Yes. 10 Q. And how large is that section? 11 A. Two pages. 12 Q. Do you consider that a comprehensive review of 13 the subject? 14 A. Reasonably so. 15 Q. Any other source? 16 A. No. 17 Q. Would it be fair to say that prior to April 30th, 18 '88, you had more information regarding the health effects of 19 PCB's available to you than you have now? 20 A. Yes. 21 Q. What did you have available to you prior to April 22 30th, '88? 23 A. On PCB's? 24 Q. Yes. 25 A. I had no reason for looking at them, looking for
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1 the information. 2 Q. But you had, I gather, some repository of 3 information available to you at that time? 4 A. Yes. 5 Q. Can you describe that repository for me? 6 A. We have a library. 7 Q. You have a library at Monsanto? 8 A. Yes. 9 Q. Did that library to your knowledge contain the 10 published scientific literature on PCB's? 11 MR. MALIN: I object to the form of the question. 12 He's asking him did it contain all -- Apparently he's asking 13 if it contains all of the published scientific literature. 14 If you can answer that, answer. 15 Q. Just tell me to the best of your ability what you 16 believe this library at Monsanto contained regarding 17 scientific information on PCB's. 18 A. It has a good representation. How complete it 19 is, I can't answer that. 20 Q. And you said earlier you had no reason to look at 21 it; is that right? 22 A. That's right. 23 Q. Was that during your employment you had no reason 24 to look at it or now you have no reason to look at it? 25 A. When I was working I had reason for looking at
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1 it. 2 Q. During the course of your employment, you did, 3 from time to time, reference that library but you do not now? 4 A. Yes. 5 Q. Do I take it that you have not gone to that 6 library since April of '88 to look up any information 7 regarding PCB's? 8 A. I looked at the library to see if there was 9 anything that was apparent, but I didn't have any reason for 10 looking at anything. I didn't look at anything. 11 MR. COHEN: Could I have that answer read back, 12 please? 13 (Reporter read back as requested.) 14 MR. MALIN: I think your question was directed to 15 after he left Monsanto. Wasn't it? 16 MR. COHEN: Yes. 17 Q. (By Mr. Cohen) After you left Monsanto, did you 18 have any occasion to go back and look at that library, that 19 reference material on PCB's? 20 A. I did go back and look at the library. 21 Q. How recently? 22 A. Since this deposition came up. 23 Q. What did you look for in particular? What were 24 you looking for? 25 A. Whether I wanted -- Just to see in general what
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1 they had in way of reference books.
2 o. Was there anything there that caught your eye?
3 A. No.
4 Q. See anything new there since you left in April
5 '88?
6 A. I didn't look for something new.
7 0. When was it that you actually went to the
8 Monsanto reference library to see what was there?
9 A. Monday.
10 0. Day before yesterday?
11 A. Tuesday.
12 o. I'm sorry. Monday or Tuesday?
13 A. Tuesday.
.
14 o. Yesterday?
15 A. Monday.
16 0. Day before yesterday?
17 A. Yes.
18 0. Today is Wednesday.
19 A. That helps.
20 0. Two days ago?
21 A. Yes.
22 0. Was that prior to your meeting with Mr. Malin?
23 A. Yes.
24 0. Did you see if they have for example the report
25 of the Banberry Conference, report 35?
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1 A. No, I didn't look. I didn't see it. 2 Q. Do you know if they have any reports ofthe 3 Banberry Conference? 4 A. I didn't attempt to find out. 5 Q. Do you know what the Banberry Conference is 6 about? 7 A. No. 8 Q. Did you review any other materials other than 9 going into the library on Monday? Did you review any other 10 materials in preparation for this deposition? 11 A. No. 12 Q. What did Mr. Malin tell you about the Paoli case? 13 MR. MALIN: I'11 object to that question. That's 14 attorney-client. 15 Q. Let's ask it a different way. What do you know 16 about the Paoli case? 17 A. What I wastoldyesterday. 18 Q. Okay. What doyou know about the Paoli case? 19 A. In the Philadelphia area, I have to guess where, 20 there is a trial involving workers exposed to PCB's in 21 railroad as well as inhabitants living in close proximity to 22 where the explosion of PCB's could have occurred. That's, I 23 think, reasonable. 24 Q. Did anybody show you any photographs of the 25 facility?
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1 A. No. 2 Q. Anybody show you any drawings or maps of the 3 facility? 4 A. No. 5 Q. Did anybody give you a description of the 6 facility? 7 A. No. 8 Q. Do you know that it's a rail yard? 9 A. I knew that we talked about it being a rail yard. 10 Q. Do you know that it contains a car repair shop, a 11 rail car repair shop? 12 A. I don't remember. 13 Q. Do you know how long PCB's were allegedly used at 14 that railroad yard and car shop? 15 A. No. 16 Q. Do you know when they were last used? 17 A. No. 18 Q. Do you know anything about the levels of 19 contamination that were found outside on the rail yard 20 property but outside the car shop? 21 A. No. 22 Q. Do you know anything about the levels of 23 contamination that were found inside the car shop? 24 A. No. 25 Q. Do you know anything about the levels of
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1 contamination, if any, that were found on any of the
2 residential properties surrounding the rail yard?
3 A. No.
4 Q. No one gave you any information about that at
5 all?
6 A. No.
7 Q. Did youask for it?
8 A. No.
9 Q. Did youhave any interest in knowing it?
10 A. No.
11 Q. Were you told anything about anything, any of the
12 ailments or injuries that any of the plaintiffs claim that
13 they have as a result of their exposure to PCB's?
14 MR. MALIN: Same objection. That's
15 Attorney-c1ient. Do you want to ask him a different way?
16 Ask him what he knows.
17 Q. Do you have any information about any of the
18 ailments or injuries the plaintiffs claim they have as a
19 result of the PCB's?
20 A. No.
21
Q.
So, youdon't know what thesepeople
contend
22 happened to them as a result of exposure to PCB's?
23 A. We talked about that they said their health
24 effects were affected by their exposure to PCB's.
25 Q. What information did you have when you went to
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1 any of the references, reference sources that you described 2 somewhat earlier regarding any of the health effect claims? 3 A. Nothing. 4 Q. What were you looking for? 5 A. Information that would supplement what I had, 6 these two references I had at home. 7 Q. Do those references discuss adverse health 8 effects from exposure to PCB's? 9 A. Yes. 10 Q. What does Patty's discuss as adverse health 11 effects observed from exposure to PCB's? 12 A. They talk about the syndrome that wecall 13 poisoning by PCB's. 14 Q. What is that syndrome? 15 A. Pardon? 16 Q. What is that syndrome? 17 A. It consists of chloracne, plus involvement 18 irritation of the eye, nose, upper respiratory tract, liver 19 involvement, and a peripheral neuropathy. 20 Q. Anything else? 21 A. And I can't tell which one of these books it is, 22 but they talk about an immunologic reaction. 23 Q. Specifically what? 24 A. Some effect on thelymphocytes called T cells. 25 Q. What is the effect on the T cells?
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1 A. Some suppression of the levels of T cells. 2 Q. Anything else? 3 A. No, I think that's it. 4 Q. What do they refer to when they talk about liver 5 involvement? 6 A. Enzyme effects. 7 Q. Specifically what enzyme effects? 8 A. SGOT, SGPT. 9 Q. Those are the enzymes; but what happens to them? 10 A. They are elevated and gamma glutamyle pepaidase 11 is the fourth one. 12 Q. Also elevated or suppressed? 13 A. Elevated. 14 Q. What adverse health effects are believed to be 15 caused by elevation of liver enzymes that you know of? 16 A. Nothing. 17 Q. What adverse health effects are related to the T 18 cell suppression that you know of? 19 A. Nothing. 20 Q. Absent PCB exposure, do you know of any adverse 21 health effects that are reported from elevation of liver 22 enzymes? 23 A. Many diseases are associated with the effect on 24 the liver. It's a liver respondent. 25 Q. You want to describe some of those disease for
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1 me? 2 A. Hepatitis, alcohol, viral diseases. 3 Q. You're telling me about diseases now that cause 4 elevation of liver enzymes? 5 A. Yes. 6 Q. Okay. So, you were answering my question, what 7 disease or health effects are associated with elevation of 8 liver enzymes; is that right? 9 A. Isn't that the question you asked me? 10 Q. Yes. That's the answer you were giving? 11 A. Yes. 12 Q. And you were describing for me the disease 13 hepatitis and alcohol? 14 A. Alcohol. 15 Q. Anything else? 16 A. Some exposure to chemicals. 17 Q. Other than PCB's? 18 A. Yes. 19 Q. Anything else? 20 A. I think that's it. 21 Q. Do any of these references refer to the results 22 of animal studies? 23 A. I'm sure they do, but I didn't look at them. 24 Q. You didn't look at, what, the reference or the 25 animal studies?
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1 A. What you had asked me to look at, what I had 2 looked at. We talked about, what are the agents that affect 3 the liver? That includes mostly infections, but it includes 4 drugs, medical drugs; and so I listed those. 5 Q. Yes. Let me back up. I'll ask you a different 6 question now, sir. I'11 ask you whether the reference books 7 you looked at -- You named two; Zenz and Patty's -- whether 8 those reference books refer to animal studies of the effect 9 of the toxic properties of PCB's? 10 A. That wasn't the question I thought you asked me. 11 Q. That's all right. Let's forget about that other 12 question. Let's talk about that question. 13 A. Ask the question again, please. 14 Q. Sure. Do these texts, speaking of Patty's and 15 Zenz now, and anything else that you looked at, discuss the 16 results of animal studies that were directed toward 17 determining the toxic effect of PCB's? 18 A. Yes. 19 Q. And what do they report in animal studies? 20 A. With big doses. 21 Q. That's a qualification. 22 A. Yes. With big doses. There will be an effect on 23 the liver and it produces an obvious effect on the appearance 24 of the liver and this is associated with a relatively large 25 exposure on the order of 50 parts per million, ppm.
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1 Q. And what is the obvious effect on the appearance 2 of the liver? 3 A. A nodule response and some fibrosis associated 4 with it. 5 Q. Any other health effects in animals associated 6 with exposure to PCB's? 7 A. I don't recall. 8 Q. Do you recall whether there are any reports in 9 animal data reflecting that PCB's have caused neoplastic 10 changes? 11 A. That's part of it. To me, that's the 12 continuation of the response I was talking about. 13 Q. So when you were talking about -- 14 A. This nodule response can be included. Cancer in 15 some of PCB exposure, not all. 16 Q. In some PCB exposure, not all? 17 A. Yes. 18 Q. What organs in animal tests have shown neoplastic 19 changes specifically cancer, from exposure to PCB's? 20 MR. MALIN: I object to the form of the question. 21 If you understand that, doctor, answer. 22 THE WITNESS: Would you ask it again? 23 MR. COHEN: You want to read it back? If it's 24 not understandable, 111 ask you a different question. 25 (Reporter read back as requested.)
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1 A. The liver. 2 Q. Any other organ that you know of? 3 A. Not that I recall. 4 Q. How about kidney? 5 A. No. 6 Q. Gastric tube? 7 A. Pardon? 8 Q. Gastric tube. 9 A. No. 10 Q. Brain? 11 A. No. 12 Q. Lung? 13 A. No. 14 Q. Bones? 15 A. No. 16 Q. Skin? 17 A. No. 18 Q. Only the liver that you recall? 19 A. Yes. 20 Q. And are these results reported in Patty's and 21 Zenz to your knowledge? 22 A. I'm not sure it was both of them because I looked 23 at them both. I couldn't tell you what was in one and what 24 was in the other, but it is mentioned in one of them at 25 least; and these --
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1 Q. I'm sorry? 2 A. About it causing liver cancer. 3 Q. And as I understand it, these are the only 4 reference materials that you looked at in preparation for 5 this deposition? 6 A. Yes. 7 Q. And the only materials you looked at in 8 preparation for this deposition? 9 A. Yes. 10 Q. Did you look at any testimony from any of the 11 witnesses in this case? 12 A. No. 13 Q. Are you aware of other Monsanto witnesses who 14 have testified in this case? 15 A. It was mentioned yesterday. 16 Q. What was mentioned? 17 A. One man. 18 Q. Who? 19 A. Kaley, is that how you pronounce his name? 20 MR. MALIN: Kaley. 21 Q. Do you know Dr. Kaley? 22 A. I know the name. 23 Q. Have you ever worked with Dr. Kaley? 24 A. No. 25 Q. Do you know if he is a medical doctor?
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1 A. No, he is not. 2 Q. You know he is not? 3 A. (Witness nodded). 4 Q. You nodded your head. 5 A. No, he is not. 6 Q. So, your answer is, no, he is not? 7 A. That's right. 8 Q. Do you know what position Dr. Kaley holds with 9 Monsanto? 10 A. No, I do not. 11 Q. Were you told that Dr. Kelly testified? 12 A. Yes. 13 Q. Were you told a Mr. Papageorge testified? 14 A. Yes. 15 Q. Do you know Mr. Papageorge? 16 A. Yes. 17 Q. You worked with Mr. Papageorge? 18 A. I don't know what the definition of worked with 19 him is. 20 Q. Well, you were both working for Monsanto at the 21 same time? 22 A. Yes. 23 Q. But you were not necessarily working in the same 24 department; is that fair to say? 25 A. That's right.
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1 Q. How about Dr. Kelly? Did you work with Dr. 2 Kelly? 3 A. I worked for him when I first came to Monsanto. 4 Q. Did you subsequently succeed him? 5 A. Yes. 6 Q. When did you first start with Monsanto? 7 A. 1973. 8 Q. In what capacity, sir? 9 A. Associate director, medical director. 10 Q. And the medical director at that time was Dr. 11 Kelly? 12 A. Yes. 13 Q. I gather 1973 was not when you graduated from 14 medical school; is that fair to say? 15 A. That's correct. 16 Q. So let's start with your graduation from college 17 and tell me about your educationalbackground. 18 A. I went to the University of Wisconsin from 1940 19 to 1943. Then I had an interruption with the service and I 20 came out in '45 and went back to the University of Wisconsin; 21 and in 1947, I went to the Washington University Medical 22 School, 1947, and graduated in 1951. 23 Q. Did you receive a agree from the University of 24 Wisconsin in 1947? 25 A. No.
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1 Q. No degree. 2 A. I wrote to them later and said please send me a 3 degree, and they did. I don't recall when that was. It was 4 just some time in the time while I was in medical school that 5 I got that. 6 Q. So you had accumulated sufficient credits to 7 obtain a degree, but you did not actually obtain it while you 8 were still there. 9 A. It was part of that interruption with the service 10 that made a difference. 11 Q. What degree did you receive from Washington 12 University Medical School? 13 A. M.D. 14 And that was in 1951? 15 A. Yes. 16 Q. Did you have further formal education? 17 A. I don't know whether you would call an internship 18 formal, but it really is. 19 Q. Let's talk about your internship then. Where was 20 that? 21 A. Milwaukee County Hospital. That was the 22 Marquette Teaching Hospital. 23 Q. Marquette University? 24 A. Yes. 25 Q. How long was your internship?
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1 A. One year.
2 Q. Rotating?
3 A. Yes.
4 Q. You saw all services that year?
5 A. Yes. From there, I went to the University of
6 Pittsburgh, School of Public Health; and I got an MPH in
7 occupational medicine.
8 Q. What year?
9 A. That was in '53. And the next year, I had a
10 fellowship with the National Heart Institute on metabolism of
11 the heart.
12 Q. Metabolism of the heart?
13
A.
Yes. Then I went --
.
14 Q. Where was that service?
15 A. It was at the University of Pittsburgh, School of
16 Public Health.
17 Q. And when did you complete that fellowship?
18 A. One year.
19 Q. 1954?
20 A. Yes. The next year I went to the National Cancer
21 Institute, National Institute of Health; and that was in
22 clinical cancer. I was a clinical associate.
23 Q. And that was 1955?
24 A. Yes.
25 Q. You were there one year?
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1 A. Yes. 2 Q. Then what? 3 A. Then I went to theStatenIsland MarineHospital 4 as a resident in medicine; then backto theUniversity of 5 Pittsburgh. 6 Q. You say a resident in medicine. Was that the 7 study of internal medicine? 8 A. Yes. 9 Q. Was that a one year residency? 10 A. Yes. 11 Q. 1956, then, are we up to? 12 A. Yes. 13 Q. And then what? 14 A. Then back to theUniversity of Pittsburgh, 15 Department of Medicine, residency in medicine, internal 16 medicine, one year. 17 Q. So, you had back to back residencies in internal 18 medicine? 19 A. Yes. 20 Q. Two years total; is that right? 21 A. Yes. 22 Q. And then? 23 A. Then I went on the staff of the School of Public 24 Health and Occupational Medicine as assistant professor. 25 Q. In Pittsburgh?
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1 A. Yes, and in the department of medicine as 2 instructor. 3 Q. And how long did you stay there? 4 A. I also was medical director of Callery, 5 C-A-L-L-E-R-Y Chemical Company in Pittsburgh. 6 Q. What products did they manufacture? 7 A. The Boranes. Then in 1962, I went to the 8 University of Louisville where I had a fellowship in 9 cardiology. 10 Q. How long was that? 11 A. One year. 12 Q. Next? 13 A. University of Cincinnati, Department of 14 Preventive Medicine. 15 Q. Department of Preventative Medicine? 16 A. Preventive Medicine. 17 Q. Preventive. 18 A. And I was an Associate Professor of Occupational 19 Medicine; 1968, Tulane Medical School, Associate Professor of 20 Medicine and then professor of medicine; and then in 1973, I 21 came to Monsanto. 22 Q. Other than your residencies, did any of these 23 various positions involve the practice of medicine? 24 A. Only within the clinics. And then the Boranes -- 25 At the Callery Chemical Company, I was responsible for the
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1 health of those workers.
2 Q. Did you render professional service to those
3 workers at Callery as a physician?
4 A. Yes.
5 Q. And what was that?They had some sort of
6 infirmary or some other sort of medical office there?
7 A. I had a clinic.
8 Q. You had a clinic?
9 A. Yes (nodded).
10 Q. Any in-patient facilities?
11 A. No.
12 Q. What sort of injuries or ailments did you treat
13 there at Callery?
.
14 A. Exposure to the Boranes.
15 Q. What did it cause?
16 A. One of the Boranes was called diborane, produces
17 an acute respiratory response with tightness in the chest of
18 short duration, non-progressive, non-continuing, no increase.
19 Exposure to decaborane produces some change in liver function
20 tests.
21 Q. Any long-term effects from them?
22 A. No.
23 Q. So how did you treat these people?
24 A. Take them off of exposure. When they were
25 exposed to the diborane, we gave them oxygen; and with time,
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1 plus oxygen, they were able to go back to work when we said 2 that there was no evidence of any long-term effect. 3 Q. Tell me about the other clinical experience you 4 had practicing medicine. 5 A. I operated in the clinic at the University of 6 Pittsburgh; and with the medical students, we would work up 7 patients and decide what was going to be done and treatment. 8 Q. Was that -- Let's see what period that would have 9 been. 10 A. '57 to '62, I think, something like that. 11 Q. '57. That was your residency in internal 12 medicine or -- 13 A. No, that's after. 14 Q. I'm sorry. I apologize. When you were on the 15 staff of the School of Public Health and Occupational 16 Medicine; is that right? 17 A. And instructor of medicine. 18 Q. Right. Department of medicine as an instructor. 19 A. Yes. 20 Q. So you had clinical practical experience at that 21 time? 22 A. Plus I would see any consultations on the wards 23 that they thought I should see. 24 Q. And that was '57 to '62? 25 A. Yes.
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1 Q. And that was coincided with your experience at 2 Callery? 3 A. Yes. 4 Q. So during that five year period, 1957 for '62, 5 you had clinical experience both at the University of 6 Pittsburgh and at Callery Chemical? 7 A. Yes. 8 Q. And the clinical experience that you described. 9 A. Yes. 10 Q. Did you ever treat a patient at any time with 11 alleged PCB intoxication? 12 A. No. 13 Q. How about dioxin? 14 A. No. 15 Q. What were your duties as assistant medical 16 director of Monsanto Chemical Company? 17 A. To assist in the clinic on examinations of the 18 employees who worked at the headquarter site. 19 Q. What is headquarters called? 20 A. I think it's called Headquarters of Monsanto. 21 Q. Where's the plant located? 22 A. Here in St. Louis. 23 Q. That's not Queeny or Krummrich or anything like 24 that? 25 A. No.
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1 Q. They're all different places. 2 A. Yes. 3 Q. Is there a factory at the headquarter site? 4 A. There was a research facility. 5 Q. Just a research facility? 6 A. Yes. 7 Q. Was that a pilot type plant or just a laboratory? 8 A. Laboratory. 9 Q. So, you were seeing people then who might have 10 had some sort of illness or ailment while working in the 11 laboratory? 12 A. Yes. 13 Q. How many people worked in that laboratory during 14 that time period you were assistant director? 15 A. I can't answer that. I wouldn't even guess. 16 Q. You have no idea? 17 A. No. 18 Q. How big was a clinic? 19 A. What do you mean how big was the clinic? 20 Q. What kind of physical facility was it? Was 21 10 bed hospital? 22 A. Not a hospital. It is a place where we see 23 workers either bring in their non-occupational problems to 24 decide whether they can go on to work or whether they should 25 see their doctor, things like that, making decisions for
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1 them, and doing examinations on them in a periodic basis. 2 Q. Did you actually render medical treatment to them 3 at that time? 4 A. Only for non-occupational, we did not. For 5 occupational, we would treat them if it was appropriate. 6 Q. So if a fella got burned in the laboratory with a 7 Bunsen burner, he'd come around to see and you'd dress the 8 wounds and take care of it? 9 A. Yes. 10 Q. What type of ailments and illness did you see 11 while you were assistant medical director in the clinic? 12 A. Non-occupational problems. 13 Q. And then you would refer them to their family 14 physician if appropriate? 15 A. Yes. 16 Q. What sort of occupational problems did you see? 17 A. Didn't see any occupational problemsbesides 18 injuries. 19 Q. Injuries such as I described, a fella burned 20 himself on a Bunsen burner or something like that? 21 A. Yes. 22 Q. How many people worked in the clinic when you 23 were assistant medical director? 24 A. Dr. Kelly and I, and four or five nurses, and a 25 receptionist.
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1 Q. Now, did you say that you also did some studies
2 on these employees?
3 A. No.
4 Q. Did you do periodic health exams on them?
5 A. Yes.
6 Q. What were they for?
7 A. To tell them about the state of their health.
8 Q. Just to provide them with routine physical exam?
9 A. Yes.
10
Q. Did you
keep records on that?
11 A. Yes.
12 Q. You were not studying them at any time in these
13 periodic health exams to determine if they had any exposure
14 to anything?
15 MR. MALIN: We're talking about the period of
16 time when he was associate medical director.
17 MR. COHEN: Yeah, assistant associate director.
18 THE WITNESS: And afterward.
19 Q. I'm justtalking about when you were assistant.
20 Were you studying them to determine if they had any adverse
21 health effects from occupational exposure?
22 A. There could be a question about a man saying,
23 "Was I exposed to a chemical or not, and how much? Was it a
24 health effect?" Being exposed to a gas or a vapor, and he
25 got a whiff of it and come over and say that. That's typical
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1 of the kind of things we would do. 2 Q. These are folks that were working at the 3 laboratory in the headquarters place? 4 A. Yes. 5 Q. What sort of things did they complain about? 6 A. I just said it usually would be a vapor of some 7 kind that would catch them unaware instead of putting it in 8 the hood like he should. 9 Q. But never anything on an organized basis, you 10 were never directing any sort of a study on them; is that 11 correct? 12 A. No. 13 Q. Did Dr. Kelly to your knowledge direct any such 14 studies? 15 A. I don't know. 16 Q. How long were you assistant or associate medical 17 director at headquarters? 18 A. About a year and a half. 19 Q. Then what happened? 20 A. Then Dr. Kelly retired. 21 Q. That would have been 1974 some time? 22 A. Yes. 23 Q. And you became medical director? 24 A. Yes. 25 Q. How did your duties change?
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1 A. I'm now responsible for all the employees of 2 Monsanto at all sites; and I was responsible for those people 3 that had reported to Dr. Kelly, like the industrial hygiene 4 section, the toxicology section, the medical section. 5 Q. Okay. Let's talk about the industrial 6 hygienists. What were your responsibilities with respect to 7 them? 8 A. Their responsibility was to look at all the work 9 sites and to observe the work place exposure and to gather 10 whether they were in some level of safe exposure, so there 11 would not be an adverse health effect. 12 Q. During this time period 1974 to 1988, did 13 Monsanto have established levels of exposure for PCB's? 14 A. Yes. 15 Q. Did they have establishedlevels of exposure that 16 they considered safe for dioxins? 17 A. No. 18 Q. Did they have anestablished safe level of 19 exposure to furans? 20 A. No. 21 Q. Did they have anestablished safe level of 22 exposure to benzene? 23 A. Yes. 24 Q. Did they have establishedsafe levels of exposure 25 to chlorinated benzene?
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1 A. I don't recall, but if it was in the work place, 2 I'm sure we did. 3 Q. Did they have established safe levels of exposure 4 to tin tetraphenyl? 5 A. I don't know, but I'm sure we did. We had 6 exposure limits set for everything that we could use to 7 evaluate their exposure. 8 Q. Was there a publication that would contain this 9 information that was available to you? 10 A. We used the government standards where they were 11 available. 12 Q. Prior to the time government standards were 13 available, what did you use? 14 A. I wasn't with Monsanto before there were 15 government standards. 16 Q. So, your recollection is, is that as long as 17 you've be with Monsanto, there was established levels for 18 exposure to all of those compounds; and these levels were 19 established by the government and that's what you used? 20 A. That's right, except for things like dioxin and 21 furans. 22 Q. Why is that? 23 A. Because there wasn't ones established. 24 Q. What do you consider the safe level of exposure 25 to dioxins?
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1 A. The dioxin issue was no longer a realistic one 2 when I came to Monsanto and -- 3 Q. You want to tell me why? 4 A. Well, no studies had been done. When they first 5 did the studies on the effects of dioxin in animals, then we 6 went back to see what the level of exposure of our people 7 was. 8 Q. Okay. When was that first study that you know 9 about? 10 A. I don't recall, something like 1975. 11 Q. Who did the study? 12 A. The study was done by Dow. 13 Q. Dow Chemicals? 14 A. Yes. 15 Q. Dow chemical was a manufacturer of dioxins at the 16 time? 17 A. Yes -- Well, no, they didn't make dioxin on 18 purpose. It was a byproduct. 19 Q. They manufactured products that contained 20 dioxins; is that correct? 21 A. Yes. 22 Q. And you say they didstudies onanimals. Do you 23 know who the author was of the study? 24 A. I don't recall. 25 Q. Do you know theanimals that they used?
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1 A. I just recall -- And I'd say rats and mice and 2 I'd probably be right. 3 Q. In other words, that's your assumption today. 4 You're not sure. 5 A. Yes, but that's almost a routine for it. 6 Q. And then as I understand it, your industrial 7 hygienists who would have been working under your direction 8 would have went back and studied the exposure levels that 9 your employees may have had to dioxin? 10 A. We were out of the dioxin business almost at that 11 time. 12 Q. So are you saying that by the time this first 13 study on dioxins came about, some time in '75, Monsanto was 14 basically out of the dioxin business? 15 A. Yes. 16 Q. What business was it in that involved the 17 manufacture or the potential exposure by employees to dioxin? 18 A. AgentOrange. 19 Q. Was that the only product that you know that 20 Monsanto manufactured that would have generated dioxins? 21 A. Yes. 22 Q. And that would have been as a byproduct? 23 A. Yes. 24 MR. MALIN: I object to the form of that 25 question. He's answered. That's all right.
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1 Q. When did Monsanto manufacture Agent Orange?
2 A. It started early 50's, 1955, something like that.
3 Q. And where was it manufactured?
4 A. Nitro, West Virginia.
5 Q. And was it at that plant that you went back with
6 your industrial hygienists to determine the levels of
7 exposure?
8 A. We were working on trying to establish a level of
9 exposure, but these are contaminants, they're not something
10 that's easily measured. These are contaminants at a very low
11 level.
12 Q. Would you consider dioxin a very dangerous
13 compound?
.
14 MR. MALIN: I object to the form of the guestion.
15 You can answer if you understand it.
16 THE WITNESS: I didn't hear.
17 MR. COHEN: You can answer.
18 MR. MALIN: I object to the form of the guestion.
19 If you think you understand that guestion or if you can
20 answer it in a meaningful way --
21 THE WITNESS: Would you ask the guestion again?
22 Q. (By Mr. Cohen) Do you consider dioxin a dangerous
23 compound?
24 A. I didn't know at that time whether it was
25 dangerous.
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1 Q. We're sitting here in 1992. What do you do you 2 know now. 3 MR. MALIN: Object to the form of the question. 4 If you think you can answer that easily, you can answer it. 5 A Back in 1955, they were studied in some depth 6 the workers who were making the Agent Orange, and they 7 developed a skin rash; and they were studied in depth in 8 1955, and then they started to -- Because of that, they 9 worked to control exposure, but it was done methodologically 10 rather than scientifically because they didn't know what the 11 material was that was causing the rash. 12 Q. Let me see if I understand your testimony. 13 You're relating to me an incident that occurred in 1955 while 14 Monsanto was manufacturing Agent Orange; is that correct? 15 A. Yes (nodded). 16 Q. You're nodding yourhead. Is that a yes? 17 A. Yes. 18 Q. These were employees atNitro, WestVirginia? 19 A. Yes. 20 Q. Any other plant? 21 A. Some of the work on finishing up that product was 22 done in Queeny Plant here in St. Louis. 23 Q. Did you study those employees at the Queeny 24 Plant? 25 A. This was before I came to Monsanto.
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1 Q. All right. Let me withdraw that question. The 2 employees at the Nitro, West Virginia plant in 1955 began to 3 develop a rash while working on the production of Agent 4 Orange; is that correct? 5 A. Yes. 6 Q. Work on Agent Orange was also done during the 7 same time period at the Queeny Plant? 8 A. Not the same process, but it was a part of the 9 development and production of that material. 10 Q. Were employees exposed to Agent Orange at the 11 Queeny Plant? 12 A. Exposed to Agent Orange? 13 Q. Yes. 14 A. Yes. 15 Q. To yourknowledge, did employees atthe Queeny 16 Plant also develop the same type of rash that was seen on the 17 employees at the Nitro Plant? 18 A. Not in the same degree. 19 Q. In other words, they had it but not as bad? 20 A. I'm not sure how much they had, but it was not 21 much. 22 Q. Was that skin rash of chloracne type? 23 A. Yes. 24 Q. Was it chloracne? 25 A. Yes -- Well, some of the rashes they had were.
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1 There was a rash, what we call chloracne, that took place
2 there, but they had other rashes from exposure to chemicals.
3 Q. Which rash were you interested in, the chloracne
4 type rash?
5 A. This was before me.
6 Q. Which rash was it that caused concern in the
7 50's, the chloracne?
8 A. The chloracne.
9
Q.
Chloracne is also arash thatdevelops
from
10 exposure to PCB's; is that right?
11 MR. MALIN: Object to the form of the question.
12 A. It can.
13 MR. MALIN: Answerit if youthink you understand
14 it.
15 Q. I'11 ask the question again. I think you said,
16 "It can." Was that your answer?
17 A. Exposure to -- When we say exposure to PCB's, are
18 we talking about PCB's or something bigger? It's not the
19 same thing. I talk about dioxin when I'm talking about Agent
20 Orange. It's not the same. The PCB's and the association of
21 chloracne is not the same because we didn't have exposure.
22 We didn't have chloracne with PCB's.
23 Q. Whether or not you had it, would you agree that a
24 reported effect of exposure to PCB's is chloracne?
25 MR. MALIN: I object to the form of the question.
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1 What do you mean by reported? 2 Q. In the scientific literature, doctor, would you 3 agree that a reported effect in the scientific literature 4 from PCB's is chloracne? 5 A. I'm not sure that's right. 6 Q. You do not believe that its report that exposure 7 to PCB's causes chloracne? 8 A. Sometimes people exposed to PCB's will have 9 chloracne. 10 Q. And do you believe that's because of the PCB's or 11 something else? 12 A. It's something else. 13 Q. What is that something else? 14 A. I don't know. 15 Q. Do you believe that exposure to Monsanto's 16 dielectric fluids is associated with chloracne? 17 MR. MALIN: I object to that question. You're 18 asking for his opinion. He's hear as a fact witness, not an 19 expert witness. Doctor, I'm going to advise you that you 20 don't have to give opinions unless they're opinions that you 21 held when you were a medical director of Monsanto, but you 22 don't have to give medical opinions unless you're compensated 23 as an expert; and you're not named as an expert in this case. 24 The deposition is not being taken as an expert witness, it is 25 a fact witness deposition. Obviously, you're entitled to do
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1 what you wish on the issue. 2 Q. (By Mr. Cohen) Do you have an opinion today, sir, 3 whether exposure to dielectric fluids manufactured by 4 Monsanto could produce chloracne? 5 A. Monsanto doesn't make it. 6 Q. Not now. 7 A. It hasn't -- 8 Q. But it did make it? 9 A. It hasn't since -- 10 Q. I don't know. 'll, somewhere around there? 11 A. Yes. 12 Q. But they did make it? 13 A. Yes. 14 Q. I'm asking you whether you have an opinion today 15 as to whether an exposure to dielectric fluids manufactured 16 by Monsanto during the time they were manufacturing those 17 fluids could produce chloracne? 18 A. I don't think so. 19 Q. When you were medical director of Monsanto or 20 associate medical director, did you have an opinion about 21 that subject? 22 A. That was when I was not associated with it, never 23 saw it, never had any experience with it. During that time, 24 it was not producing -- making chloracne. It was not 25 producing chloracne.
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1 Q. So you're saying to me during the time period you 2 were associate medical director or assistant associate 3 medical director of Monsanto, you were not having reports 4 from employees exposed to dielectric fluids manufactured by 5 Monsanto having incident of chloracne? 6 A. That's right. 7 Q. Do you know whether the scientific literature 8 reports chloracne as a potential effect from exposure to 9 dielectric fluids manufactured by Monsanto? 10 MR. MALIN: I object to the form of the question. 11 If you think you can answer the question, doctor, you may 12 attempt to answer. 13 A. Monsanto, when it was producing PCB's, did not 14 have a problem with chloracne. 15 Q. That's not my question, sir. 16 A. People who were handling PCB's other places, 17 people who used them, did have chloracne from time to time. 18 Now, the cause of that chloracne is not clear. 19 Q. Is not clear in your mind; is that right? 20 A. That's right. 21 Q. So, you're saying you're not sure whether it was 22 because of dielectric fluid contained other compounds other 23 than PCB's? 24 A. We knew that there were mixtures and we didn't 25 know what those mixtures were.
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1 Q. Is this your own products you're speaking of? 2 A. I think that's true of all products. 3 Q. Well, let's focus on your products for a moment. 4 Are you saying you did not know what the mixtures were? 5 A. That's right. 6 Q. Now, you also blended, assembled, whatever, 7 products for other manufacturers such as G.E. and 8 Westinghouse. 9 A. Yes. 10 Q. They were intended to contain substances other 11 than PCB's; is that right? 12 A. I don't know. 13 Q. Well, do you know the name Inerteen? 14 A. Yes. 15 Q. Do you know what it's made of? 16 A. No. 17 Q. Do you know the product Pyronol? 18 A. Yes, but I don't know what it is. 19 Q. Do you know if it contains chlorobenzenes? 20 A. No. 21 Q. Do you know if it contains tin tetraphenyl? 22 A. No. 23 Q. Do you know if it contains Aroclor? 24 A. Yes. 25 Q. It does contain Aroclor?
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1 A. Yes (nodded). 2 Q. Do you know that Monsantoblended and sold 3 products called Pyronol and Inerteen? 4 A. No. 5 Q. They did not? 6 A. When you give me the names, I would say yes, but 7 I wouldn't be able to -- I don't know it well enough to tell 8 you that. 9 Q. So you recognize the fact when I tell you that 10 they sold it, that they did sell it? 11 A. Yes. 12 Q. Were you aware during the time period that 13 Monsanto was blending and selling that product? 14 A. No. 15 Q. Are you aware of the fact that dielectric fluid 16 can in use form furans and dioxins? 17 MR. MALIN: I object to the form of the question. 18 Answer it if you think you understand it. 19 THE WITNESS: Could I hear the question, again, 20 please? 21 (Reporter read back as requested.) 22 MR. MALIN: I object to the form of the question. 23 A. I know that they can produce cloracne and the 24 assumption is that it's something in there that apparently 25 was not there when it was made, so there can be a contaminant
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1 there that is not causing the chloracne. It's something
2 that's formulated. The one that they always talk about is
3 overheating that could cause it.
4 Q. What do you know about the presence of
5 chlorinated benzenes on the formation of furans and/or
6 dioxins in dielectric fluid in use?
7 A. I don't know that.
8 Q. So, you don't know anything about that chemical
9 process, whatever it is?
10 A. No.
11 Q. Now, do I understandthat youassume that it's
12 something different that's causing the chloracne because
13 Monsanto's experience with its production workers, who were
14 working with PCB's, is that they did not develop chloracne?
15 A. Yes.
16
Q.
So it's not baseduponscientificliterature
per
17 se reporting that people developed chloracne, but rather on
18 the empirical data that you had in-house?
19 A. Yes.
20 Q. Let's go backto thesituation in 1955. This Dow
21 Chemical study came out in the mid 70's reporting dioxin is a
22 byproduct of Agent Orange and reporting the results of animal
23 studies involving, you believe, rats and mice?
24 A. Yes.
25 Q. As aconsequence, someone lookedback to seewhat
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1 had happened in the Nitro, West Virginia Plant in 1955 or
2 thereabouts when Agent Orange was being manufactured?
3 A. Yes.
4 Q. And apparently there werereports ofemployees at
5 Nitro having chloracne?
6 A. Yes.
7 Q. Were there reports of employees at Queeny having
8 chloracne?
9 A. When?
10 Q. In the 10's, when you looked back at the
11 historical manufacture of Agent Orange.
12 A. Are we talking about in the 70's having chloracne
13 or looking back further?
14
Q.
Looking backat thehistoricalmanufacture
of
15 Agent Orange, whenever that was.
16 A. They had a reaction thatwas calledchloracne.
17 Q. Do you indicate to me that you did not believe it
18 was chloracne?
19 A. No, I didn't know what it was. We had an expert
20 witness on chloracne who came there and had seen the first
21 cases and followed up on them.
22 Q. Who was that expert?
23 A. A man from the University of Cincinnati. His
24 name slips my mind.
25 MR. COHEN: Well, can you help me out, Mr. Malin?
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1 MR. MALIN: I think Dr. Kelly testified that it 2 was a man named Suskind. 3 Q. (By Mr. Cohen) Does that refresh your 4 recollection? 5 A. Yes. 6 Q. Was he a medical doctor? 7 A. Yes, Dermatologist. 8 Q. Dr. Suskind came down. Was he studying records? 9 A. No, studying people. 10 Q. When was that? What year? 11 A. At that time in 1955. 12 Q. Suskind came down and studied people in the 50's 13 and he diagnosed chloracne. 14 A. Yes. 15 Q. Both at Nitro and Queeny? 16 A. He didn't come to Queeny. 17 Q. Who diagnosed the chloracne at the Queeny Plant? 18 A. There wasn't much in the way of chloracne problem 19 there. It was very small if there was any. 20 Q. Did you tell me a few minutes ago that people had 21 chloracne at Queeny? 22 A. I told you that I have difficulty because it was 23 such a small problem, if it was any, and that you're talking 24 about before my time in terms of bringing it up to the 25 present time; and I can't do it.
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1 Q. I'm not trying to argue with you, doctor. I'm 2 trying to found out who made the determination -- however 3 many people it was, one, three, a hundred, how many people, I 4 don't know -- who had chloracne. 5 MR. MALIN: You're asking him to testify to 6 something in which he has no personal knowledge. 7 MR. COHEN: I don't care whether he has personal 8 knowledge, Mr. Malin, but he had records available to him at 9 the time. He knew that Suskind went to Nitro. 10 Q. (By Mr. Cohen) Who went to Queeny? 11 A. I'm not even sure when -- They didn't make Agent 12 Orange. I told you there's a different process at Nitro than 13 there was at Queeny, and so that the hazard of it and the 14 production of it would be quite different in terms of the 15 likelihood of producing chloracne; and so the definition of 16 what they had could have been made by a local doctor rather 17 than having Suskind come to Queeny. 18 Q. I understand, sir. All I'm trying to find out is 19 who did make the determination of the employees at Queeny. 20 Was it a local doctor? 21 MR. MALIN: If you know, doctor. 22 A. I don't know. 23 Q. But someone apparently reported that employees at 24 Queeny, during some time period during the manufacture of 25 Agent Orange, had experienced chloracne; is that right?
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1 A. I don't know. 2 Q. You don't know. Okay. What happened in the mid 3 70's when you looked back at the employees at Nitro and 4 perhaps Queeny? Did you do further studies? 5 A. Yes, we had Suskind come back and examine them 6 again. 7 Q. And did Suskind write up his studies? 8 A. Yes. 9 Q. Did he issue a report on what happened? 10 A. Yes. 11 Q. What did hereport? 12 A. That therewas persisting cloracne lesions in the 13 people who had the exposure back in 1955. 14 Q. And were these people no longer exposed to the 15 Agent Orange? 16 A. That's right. 17 Q. So from an exposure in the past, almost 20 years 18 in the past, they were having persistent chloracne? 19 A. Some of them. Less than 50 percent. There were 20 some of them that had persisting lesions. 21 Q. Did he study any other health effects other than 22 the chloracne? 23 A. Yes. 24 Q. What? 25 A. He had a general examination. He had a
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1 neurologist; and I think that's it.
2 Q. Did they do liver function studies?
3 A. Yes, as part of the general examination.
4 Q. Did they find any change in liver enzymes?
5 A. Allthat hadcleared up.
6 Q. Howabout back inthe 50's? Did he do liver
7 function studies?
8 A. Yes.
9 Q. Did he find elevation of liver enzymes?
10 A. In some.
11 Q. Did he do any other studies, any serum studies,
12 plasma, body fat, to see if any substance was being stored?
13 A. No.
.
14 Q. By the mid 70's did he know that the exposure was
15 to dioxins when he came back?
16 A. Yes.
17 Q. Was that as a result of the work that Dow had
18 done?
19 A. I don't know how we'd say what the basis of that
20 knowledge was.
21 Q. But by the mid 70'sMonsanto knew that dioxin was
22 a byproduct of the manufacture of AgentOrange?
23 A. Yes.
24 MR. MALIN: I object to the form of the question.
25 It is a contaminant not a byproduct; and that's what he
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1 testified to.
2 MR. COHEN: No. His exact word was a byproduct. 3 Q. (By Mr. Cohen) Were they not, doctor? I wrote it 4 down when you said it. A byproduct. 5 MR. MALIN: Just tell us what's correct. 6 Q. (By Mr. Cohen) You tell me, doctor. 7 A. I don't know the difference. 8 Q. Do you believe you used the word byproduct 9 earlier in this deposition? 10 A. I'd have to assume I did. 11 Q. So when you say byproduct, that is equal to, in 12 your mind, contaminant? 13 A. Yes. 14 Q. Were any further studies made of these folks at 15 Nitro? 16 A. The people from Mt. Sinai came. 17 Q. Up in New York? 18 A. Yes. 19 Q. Who were those people? 20 A. I don't recall. It wasn't done for us. It was 21 done for the union.
22 Q. You don't know their names?
23 A. No.
24 Q. If I said some names, would you recognize them?
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1 Q. Schecter? 2 A. No, Schecter's not from there. 3 Q. Selikoff? 4 A. It was from Selikoff's department, but it wasn't 5 he. 6 Q. Wolf? 7 A. No. 8 Q. Nicholson? 9 A. No. It wasa woman. 10 MR. COHEN: I'11 think of it on the plane on the 11 way home, and I'll give you a call. 12 Q. (By Mr. Cohen) What other studies did Monsanto 13 perform on these folks? 14 MR. MALIN: When are we talking about? 15 MR. COHEN: Nitro, West Virginia. Folks exposed 16 to Agent Orange. 17 Q. (By Mr. Cohen) What other studies were done? 18 A. There was, as a part of the Nitro lawsuit, the 19 same population was studied by the West Virginia Medical 20 School Department of Medicine. 21 Q. Who was directing Suskind's work on these folks 22 at Nitro? 23 A. No one was directing, but what he had planned to 24 do he gave us to look at, and we agreed with what he was 25 going to do.
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1 Q. Who's we?
2 A. Primarily me.
3 Q. 4 time?
You were the medical director of Monsanto at that
5 A. Yes.
6 Q. Suskind came to you, told you what his plans were
7
8 A. No. He came and asked -- He said he would like
9 to do an examination to see.
10 Q. Was Suskind working alone on this? 11 A. He brought with him a team from the University of
12 Cincinnati to do the exam.
13
Q. Who's J. A. Zack?
14 A. Who?
15 Q. J. A. Zack. 16 A. She worked for Monsanto.
17 Q. She's an employee of Monsanto? 18 A. Yes, she was.
19 Q. She was? 20 A. Yes.
21 Q. Industrial hygienist?
22 A. No, no.
23 Q. What was her job? 24 A. Epidemiologist.
25 Q. What department did she work in when she was
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1 working there? 2 A. Department of medicine. 3 Q. Was that your department? 4 A. Yes. 5 Q. Was she an employee of yours? 6 A. Yes. 7 Q. What's her full name? 8 A. Judy. Judy Zack. 9 Q. Where does she live? 10 A. She doesn't live in St. Louis. She moved away. 11 She was married to a resident in medicine and they went 12 someplace else. 13 Q. How long did she work at Monsanto? 14 A. A short time, three, four, five years. 15 Q. What were the inclusive dates of her employment? 16 A. I don't know. 17 Q. Mid 70's? 18 A. Yes. 19 Q. Is that correct? 20 A. I think so. I don't know. 21 Q. Was it about this time that Suskind came back and 22 talked to you and told you what he wanted to do? 23 A. Yes. 24 G. Did Ms. Zack work with Dr. Suskind? 25 A. Yes.
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1 Q. Didn't they together investigate these employees 2 at Nitro? 3 A. Yes. 4 Q. Did they investigateemployees anywhereelse? 5 A. No. 6 Q. Ms. Zack was anepidemiologist. Did she have a 7 Ph.D.? 8 A. No. 9 Q. Masters? 10 A. Yes. 11 Q. Do you know from what institution? 12 A. Michigan, I think. 13 Q. What is epidemiology? 14 A. Epidemiology, it is a study of epidemics. 15 Q. And today what do epidemiologists do? 16 A. Yes. 17 Q. What do they do? 18 A. They study epidemics. 19 Q. They study epidemics. What was she studying with 20 Dr. Suskind? 21 A. Whether there was an epidemic effect from the 22 exposure to the dioxin. 23 Q. Epidemic of what? 24 A. An epidemic. Any epidemic. 25 Q. Oh. I'm sorry. An epidemic effect, is that what
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1 you said? 2 A. Yes. 3 Q. In other words, a broad population of individuals 4 afflicted with some ailment? 5 A. To see if there was an affliction of some type. 6 Q. And what did they determine? 7 A. That there was a persisting effect on the skin, 8 and that was it. 9 Q. Did they study anything else? 10 A. Oh, they did the complete medical workup as you 11 would any other person; and the specific test was to look at 12 the skin by Dr. Suskind. 13 Q. And Dr. Suskind, hewas a medicaldoctor? 14 A. Dermatologist. 15 Q. Was there report andepidemiological study? 16 A. Yes. An epidemiological study can be either a 17 lifetime study or it can be a vertical study in terms of what 18 affects the population. They're both a part of epidemiology. 19 Q. What was this? 20 A. What was what? 21 Q. This study that Zack and Suskind did. 22 A. It was a vertical study. 23 Q. What was it called? 24 A. What was it called? 25 Q. The study.
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1 A. I've forgotten. 2 Q. Was it published? 3 A. Yes. 4 Q. Was it called a cancer risk specific dose 5 estimate for 2,3,7,8-TCDD? 6 A. That was one of the studies, yes. 7 Q. How about the mortality experience of workers 8 exposed to tetrachlorodibenzodioxin in a trichlorophenal 9 process accident? 10 A. Yes. 11 Q. Is that one of the studies? 12 A. Yes. 13 Q. What's trichlorophenal? 14 A. It's one of the substances they used to make 15 Agent Orange. 16 Q. Is that what you were manufacturing at Nitro? 17 A. Yes. 18 Q. Was there an accident? 19 A. Yes. 20 Q. In the 50's? 21 A. Yes. 22 Q. What happened? 23 A. It's like all chemistry in a chemical company is, 24 they have a large reactor as big as this room and the 25 chemicals that are reacting together are put in these large
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1 vessels and they have a release valve on top of it someplace 2 and that release valve is, if the pressure builds up in 3 there, so they don't have an explosion, that it releases. 4 That's what took place. There was a release of material 5 inside that reactor and it coated the inside of the building 6 where this reactor was; and they went in afterward and 7 cleaned it up off the walls of the reactors and other places. 8 Q. So it was the workers who did the cleanup work 9 who developed the chloracne? 10 A. Yes. 11 Q. Any other workers develop the chloracne? 12 A. Only those that worked there either for a long 13 period of time or a short period of time. Not all of them 14 developed it. 15 Q. But you're saying that individuals who worked for 16 a short period of time developed chloracne and individuals 17 who worked for a long period of time developed chloracne. 18 A. Yes. 19 Q. As part of this study, were they trying to 20 determine if there was any other ailment caused by the 21 exposure other than the chloracne? 22 A. They were looking to see what the state of their 23 health was at the time they did the examination. 24 Q. Did they make an analysis to determine if there 25 was any cancer as a result of the exposure?
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1 A. Yes. 2 Q. What did they report? 3 A. There was no excess of cancer. 4 Q. Was that true? 5 A. There was no excess of cancer? 6 Q. Yes. 7 A. What do you mean is it true? 8 Q. Was it true? 9 A. The studies showed there was no excess of cancer. 10 Q. Do you believe that that is the fact, that there 11 was no excess of cancer? 12 A. On what would I base it? 13 Q. I didn't ask you that. I asked you if you 14 believed it was true. 15 MR. MALIN: He's asking for your opinion again. 16 A. Based on that study, there was said there was no 17 cancer effect. 18 Q. And was that your only source of information, the 19 study itself? 20 A. At that time. 21 Q. Did you subsequently learn that the study was 22 perhaps flawed? 23 A. No. 24 Q. Did you subsequently learn that the study may 25 have been fraudulent?
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1 A. No. 2 Q. Has it been reported that the study was 3 fraudulent? 4 A. No, not to my knowledge. 5 Q. Has anyone from the environmental protection 6 agency ever spoken to you about that study? 7 A. No. 8 Q. Has anyone ever told you that the Environmental 9 Protection Agency has issued a memorandum in which they 10 allege that that study was fraudulent? 11 A. I haven't seen it. 12 Q. Did you testify about this study on the Kemner 13 case? 14 A. Yes. 15 Q. Has anyone ever suggested to you that that 16 research was altered? 17 A. That what? The study was altered? 18 Q. Uh-huh (yes). 19 A. No. That Suskind's studywas altered? 20 Q. Uh-huh (yes). 21 A. No. 22 Q. What was the nature of therelationship between 23 Suskind and Monsanto Company when this study was performed at 24 Nitro? 25 MR. MALIN: I object to the form of the question.
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1 If you can understand that question, you can attempt to 2 answer that. 3 THE WITNESS: Could you ask the question again, 4 please? 5 (Reporter read back as requested.) 6 THE WITNESS: Which study? 7 MR. COHEN: The one that was performed by Suskind 8 and Zack in the mid 70's on the Nitro employees. 9 MR. MALIN: Was it more than one study? Did we 10 establish that? 11 Q. (By Mr. Cohen) All right. Let's get it clear. 12 How many studies did Zack and Suskind together perform? 13 A. They did the lifetime study. 14 Q. And that was what, the mortality experience of 15 workers exposed to tetrachlorodibenzodioxin in a 16 trichlorophenal process accident? 17 A. Yes. 18 Q. Do you know where it was published? 19 A. I think it was in the -- No, I don't. 20 Q. In the Journal of Occupational Medicine? 21 A. Yes. 22 Q. Number 22? 23 A. Yes. 24 Q. In 1980? 25 A. I don't know.
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1 Q. Did they do another study?
2 A. Suskind did another study. That was the lifetime
3 -- I mean the vertical study.
4 Q. What was that study called?
5 A. I don't know.
6 Q. Do you know when that was published?
7 A. No. That was A.M.A., though.
8 Q. A.M.A.?
9 A. That was published in the A.M.A.
10 Q. Journal of the American Medical Association?
11 A. Yes.
12 Q. J.A.M.A.?
13 A. Yes.
14
Q.
Was that after the 1980
study?
15 A. I don't know.
16 Q. Now, when the mortality study was done, what was
17 the relationship between Monsanto and Dr. Suskind?
18 MR. MALIN: I object to the form of the question.
19 If you think you understand that question, you can attempt to
20 answer it. What do you mean? Do you mean financial
21 relationship? Did he know the chairman of the board?
22 MR. COHEN: I don't know.
23 Q. (By Mr. Cohen)Were you working together? What
24 was it?
25 A. I have a problem with the nature of the
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1 relationship. 2 Q. Do you know the relationship? Was there a legal 3 relationship that was established? 4 A. No. 5 Q. Did you enter into a contract with Suskind? 6 MR. MALIN: Do you mean a written contract, oral 7 contract? 8 MR. COHEN: I really don't know and don't care. 9 I just want to know if they had a contract or a relationship. 10 MR. MALIN: Doctor, tell us how you came to hire 11 them and what he was supposed to do. I think that's what 12 he's looking for here. 13 A. The study that Suskind did in looking at the 14 health of the people who were still working at that plant and 15 those who had worked at the plant was done based on the need 16 for information on the long-term health effects of dioxin 17 exposure; and that was done as a result of a conference over 18 in Italy, and he came back and said, "I'd like to do a study 19 on these people." And based on that meeting, we said, "Go 20 ahead." Now, the contract. Was there a contract, as who 21 paid to help to get it done? I'm sure Monsanto paid part of 22 it; and he had some money of his own for research that he 23 could use. 24 Q. Plus you supplied an employee? 25 A. Yes.
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1 Q. Ms. Zack? 2 A. To help to do it, yes. 3 Q. Did she do the epidemiological part of the study? 4 A. Yes. 5 Q. Or did they do that together? 6 A. She did the epidemiologic parts. 7 Q. What did Suskind do, the medical exams? 8 A. He went over and talked about who was there in 9 the exposure and helped to define what the people were. 10 Q. How many people were involved? 11 A. I don't know. The people who are part of the -- 12 This was a study of people with chloracne; and there was 13 something on an order of a hundred people involved in that 14 study. 15 Q. Does 121 sound right? 16 A. Could well be. 17 Q. And there was analysis to determine whether there 18 was an excess of cancer deaths; is that right? 19 A. Their goal was to determine what had happened and 20 what it was, the mortality experience of that population. 21 That was what they did. 22 Q. And was one of the conclusions dealing with an 23 excess of cancer deaths? 24 A. That would be one of the conclusions. It 25 wouldn't follow always on the mortality studies.
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1 Q. And the report was that there was not; is that 2 correct? 3 A. That's right. 4 (A short recess was taken.) 5 Q. To your knowledge, has Ms. Zack ever obtained a 6 Ph.D.? 7 A. I don't know. She left while she was -- while 8 she was talking about it, going on. I knew she was talking 9 about it, but whether she did -- 10 Q. Are you aware of the fact that Dr. Zack had done 11 an earlier or predecessor study on the same group of people 12 prior to the time that she worked with Dr. Suskind? 13 MR. MALIN: I object to the form of the question. 14 You mean on the Nitro people? 15 MR. COHEN: Uh-huh (yes). Yes, on the Nitro 16 people. 17 MR. MALIN: You're talking about things I don't 18 know anything about, so I'11 withdraw my objection. 19 A. I don't know. 20 Q. You don't know anything about that? 21 A. I don't recall anything. 22 Q. Has it ever been suggested to you that Dr. Zack 23 had omitted five deaths from the exposed group and put them 24 into the category as unexposed? 25 A. No.
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1 Q. Let me restate that. Had it ever been alleged to 2 you that she had knowingly omitted five deaths from the group 3 exposed to dioxins? 4 MR. MALIN: Are we talking about the Nitro study 5 then? 6 MR. COHEN: Yes. 7 MR. MALIN: Answer the guestion if you can. 8 A. The crux of all such discussions would be whether 9 the people in the epidemiology study put them in the right 10 category or not; and the question is, did she have some that 11 she moved from one category to another? 12 Q. Yes. 13 A. And if she did, it was because there was a basis 14 for that interpretation that I took that person from here 15 because they thought we were there, when, in fact, they 16 worked over here. That's a terrible problem in occupational 17 epidemiology in deciding which cohort are you talking about. 18 Q. So you're saying that it'spossible that she had 19 some people in the wrong group? 20 A. I think it's true of any epidemiology study. 21 Q. I didn't ask you that. Is it possible she had 22 some people in the wrong group? 23 A. It's possible. 24 Q. Do you know that shehad somepeople in the wrong 25 group?
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1 A. No. 2 Q. Wasthere another incident in 1949 different than 3 the incident in 1955? 4 MR. MALIN: I object to the form of that 5 question. Are we talking about another incident? 6 A. I think we're all talking about the same one. 7 This is -- The 1949/1955 is my problem in saying when that 8 episode took place. 9 Q. So there was one 1949 accident that you're aware 10 of. When you said '55, you were talking about the same 11 thing. 12 A. Right. 13 Q. And that's theincident thatwe're talkingabout 14 that involved this -- what was it called here -- this 15 trichlorophenal accident? 16 A. Yes. 17 Q. Do you know that five persons who died were 18 omitted from the group that was considered to be the exposed 19 group in that 1949 accident? 20 A. No, I don't know that. 21 Q. Do you know that four workers who had been 22 exposed were categorized as unexposed? 23 MR. MALIN: I object to the form of the question. 24 I mean you're stating something categorically that's not in 25 evidence information and the doctor wouldn't necessarily know
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1 the answer, and he already testified to that. But if you 2 think you can answer the question, go ahead. 3 A. I don't recall any of this. 4 Q. Were you asked the same exactquestions in your 5 testimony in the Kemner case? 6 A. Pardon? 7 Q. Were you asked these questions in theKemner 8 case? 9 A. I was asked so many questions, I can't answer 10 that question. 11 Q. So you're saying you don't know whether you were 12 asked about that? 13 A. No. 14 Q. Were you asked aboutZack and Suskind'swork when 15 you testified in Kemner? 16 A. Yes. 17 Q. Were you asked whetherthe classifications made 18 by Dr. Zack were accurate? 19 A. I told you I don't recall that. That's a 20 different thing. 21 MR. MALIN: Wait a minute. He's asking you if 22 you were asked that in the Kemner case, not whether or not 23 you know they were accurate. 24 THE WITNESS: I don't recall that. 25 MR. MALIN: Okay. That's his answer.
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1 Q. Is it my understanding of your testimony that the
2 possible classification of individuals for a cohort group in
3 any epidemiological study can lead to the possibility of
4 error in classification?
5 MR. MALIN: Objection. He said occupational
6 epidemiological studies.
7 Q. (By Mr. Cohen) Is that correct, sir? Is that
8 what you said?
9 A. Yes.
10 Q. So you're referring to occupationally exposed 11 individuals?
12 A. Yes.
13 Q. And you are saying that it's possible that any 14 such epidemiological study can contain such errors in 15 classification?
16 A. Yes.
17 Q. Is it your experience that they do contain such 18 errors?
19 A. No.
20 Q. Do you have any experience to tell you whether
21 they do or do not?
22 A. No.
23 Q. On what do you base your testimony that it is 24 possible that that error can occur?
25
A.
I know howthey are putintocohorts.
They get
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1 this from as many different sources as possible and that's a 2 general statement. When we talk about that looking at those 3 people with chloracne, that was an easier definition that, in 4 fact, this cohort was, in fact, a group that had chloracne. 5 Now, if they didn't have chloracne, then they wouldn't go 6 into a group with chloracne. 7 Q. Has Monsanto ever, to your knowledge, used the 8 results of the Zack and Suskind study, mortality study? 9 MR. MALIN: I object to the form. Used for what 10 purpose? 11 MR. COHEN: Any purpose. 12 MR. MALIN: If you understand the question, try 13 to answer it, doctor. 14 A. Not that I know of. 15 Q. Has Monsanto ever relied upon that study to show 16 that the only health consequence of exposure to dioxin was 17 chloracne? 18 A. I don't know that. 19 Q. Did you ever, as medical director of Monsanto, 20 rely upon that study? 21 A. Rely on it for what? 22 Q. Anything, advising customers, advising scientists 23 who inquired, anyone. 24 A. No. 25 MR. COHEN: Mark this as an exhibit.
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1 (Reporter marked Plaintiff's Deposition (Roush) Exhibit 1.) 2 Q. Have you ever seen this document before? 3 A. No. 4 Q. So, this is the first time you've seen this 5 memorandum? 6 A. Yes. 7 Q. Has anyone ever discussed this document with you 8 before? 9 A. No. 10 Q. Were youunaware of its existence prior to it 11 being shown to you just a few moments ago? 12 A. I was unaware of thisdocument. 13 MR. MALIN: In order to understand, this is a 14 document that we're talking about is Exhibit 1, dated 15 February 23, 1990, from Cate Jenkins to Raymond C. Loehr, 16 Ph.D., which is apparently based upon a plaintiff's brief in 17 the Kemner case. Is that what we're talking about? 18 MR. COHEN: We're talking about a document that 19 is dated February 23rd, 1990, from Cate Jenkins to Raymond C. 20 Loehr. It's been marked Exhibit l. You can characterize it 21 any way you want to for any purpose you like. 22 Q. (By Mr. Cohen) Now, let me ask you this, doctor, 23 when you retired in April of 1988, was there, to your 24 knowledge, any ongoing investigation, litigation claim of any 25 kind between EPA's Office of Research and Development or any
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1 other division of EPA and Monsanto? 2 A. No. 3 Q. You're unaware of any case that was in existence 4 at that time? 5 A. That's right. 6 Q. So where it says in the last paragraph on the 7 last page, "I request that the SAB on its own, or by way of 8 direction to EPA's office of Research and Development obtain 9 the full files from the ongoing case against Monsanto," you 10 have no idea what they're talking about? 11 A. No. 12 Q. Is that correct, you have no idea? 13 A. Yes. 14 Q. Now, is it true, to your knowledge, from records 15 that Dr. Suskind testified on behalf of Monsanto before the 16 Workers Compensation Commission in 1955? 17 MR. MALIN: I object to the form of the question. 18 What Workers Compensation Commission? What state? What? 19 Q. Without regard to what state, are you aware of 20 that, sir? 21 A. No. 22 Q. You're unaware of that. 23 A. (Witness nodded). 24 Q. You've never seen anything to indicate whether or 25 not Dr. Suskind ever testified on Monsanto before a Workers
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1 Compensation Commission? 2 A. In 1955, about? 3 Q. We're talking about in 1955. 4 A. No, I do not. 5 Q. Are you aware -- 6 MR. MALIN: The doctor has testified that he came 7 to Monsanto in 1973. Is that 18 years? 8 MR. COHEN: Thank you for that. I appreciate 9 that, Mr Malin. I'm asking him from records. 10 Q. (By Mr. Cohen) From any other source, are you 11 aware of Dr. Suskind having testified on behalf of Monsanto 12 before a Workers Compensation Commission? 13 A. No. 14 Q. Are you aware of whether any of the employees at 15 the Nitro, West Virginia Plant ever made claims for workers 16 compensation benefits as a result of harm they allege 17 occurred from their exposure at that facility? 18 A. No. 19 Q. And I'm referring specifically to the 1949 20 trichlorophenal accident. 21 A. No. 22 Q. You're unaware of any claim before the workers 23 compensation? 24 A. That's right. 25 Q. So where it says in this document on the third
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1 page, "In addition, it was alleged that in November of 1955, 2 Dr. Suskind colluded with Monsanto to conceal findings of 3 psychoneuroses in the exposed workers from the Workers 4 Compensation Commission." You have no information to tell 5 you whether or not that's true or not? 6 A. No. 7 Q. And you are unaware of Dr. Suskindever having 8 offered any testimony, or any reports, any information, to 9 any Workers Compensation Commission? 10 A. That's right. 11 Q. And let's move away fromtestimony fora moment. 12 Did Dr. Suskind, to your knowledge, from records or otherwise 13 ever offer any reports or affidavits or statements of any 14 kind to any Workers Compensation Commission regarding these 15 employees? 16 A. I'm not sure what the question is, but I know the 17 subject. What was the question? 18 (Reporter read back as requested.) 19 MR. MALIN: I object to the form of the question. 20 That's very confusing. I'm not sure what you're asking. Are 21 you asking, do you know from records whether or not he did 22 it? Well, I think you're asking him, do you know from any 23 records that you have seen while you were at Monsanto, 24 whether Dr. Suskind ever offered any testimony with respect 25 to any of the Nitro workers for any workman's compensation
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1 boards? Is that what you're asking? 2 MR. COHEN: No. 3 Q. I'm asking the doctor, from any source of any 4 information whatsoever available to you, whether you were 5 aware that Dr. Suskind offered either testimony, reports, 6 affidavits or statements of any kind before any Workers 7 Compensation Commission regarding the employees at Nitro, 8 West Virginia? 9 A. No. 10 Q. Are you aware of whether there was ever any 11 litigation brought by any of the workers or their survivors 12 against Monsanto or anyone as a result of injuries that they 13 allege occurred at that trichlorophenal explosion? 14 A. No. 15 Q. There has been no such litigation? 16 A. No, I don't know. 17 Q. You don't know whether there has been or not? 18 A. That's right. I have no knowledge about the 19 subj ect. 20 Q. Now, it states here in this document again, on 21 page 3, "An earlier, predecessor study performed by Dr. Zack 22 was alleged to have deliberately and knowingly omitted 5 23 deaths from the group exposed to dioxins in the 1949 24 accident." And it goes on. Are you aware of any predecessor 25 study performed by Dr. Zack?
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1 A. No. 2 Q. Second full paragraph, on that page, starts off, 3 "The Monsanto study performed by Dr. Suskind on workers 4 exposed to dioxins" -- 5 A. I'm not with you. 6 Q. On page 3. 7 A. The same page. 8 Q. "The Monsanto study performed by Dr. Suskind on 9 workers exposed to dioxins in the 1949 accident, published in 10 1980 in the Journal of the American Medical Association and 11 the same year, in the Journal of Occupational Medicine with 12 Dr. Zack as co-author" -- and there's a parenthetical phrase 13 -- "was also alleged to be fraudulent." Are you aware of Dr. 14 Suskind having published a study in 1980 in J.A.M.A. 15 regarding that 1949 accident? 16 A. Yes. 17 Q. Are you aware that that is the same study that 18 was also published in the Journal of Occupational Medicine? 19 A. No. 20 Q. It is not, to your knowledge, the same study? 21 A. Not the same study. 22 Q. They are separate studies? 23 A. Yes. 24 Q. Is Dr. Zack a participant in any way in both 25 studies?
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1 A. No. 2 Q. She was a participant in one study only; is that 3 correct? 4 A. In the J.O.M. study. 5 Q. And that's the study that we discussed earlier, 6 the mortality experience of workers exposed to 7 tetrachlorodibenzodioxin in a trichlorophenal process 8 accident? 9 A. Yes. 10 Q. What is the study that was published in J.A.M.A.? 11 What was that about? 12 A. That was a medical study. That's the vertical 13 study. That's looking at -- 14 Q. That was not an epidemiological study? 15 A. That's a vertical epidemiologic study. That's a 16 study of a population rather than the person. That makes an 17 epidemiological study. 18 Q. And that is the 1980 study? 19 A. Yes. 20 Q. In J.A.M. A. ? 21 A. Yes. 22 Q. And that was performed by Dr. Suskind alone? 23 A. And people with him at Cincinnati. 24 Q. Now, in either of these studies, are you aware of 25 any allegations of knowing or unknowing misclassifications of
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1 participants? 2 A. No. 3 MR. MALIN: He's answered that question several 4 times already. 5 MR. COHEN: We're trying to get it clear. 6 Q. (By Mr. Cohen) Have you ever had occasion to talk 7 to Dr. Suskind about either of these studies since you 8 testified in the Kemner case? 9 A. No. 10 Q. Have you ever talked to Ms. Zack about either of 11 these studies? 12 A. No. 13 Q. We had started talking about your 14 responsibilities as a medical director. You had said that 15 you had had industrial hygienists working for you and you 16 looked at work sites in order to determine whether the levels 17 of exposure were safe levels. Do you recall that? 18 A. Yes. 19 Q. And you started to tell me about the incident in 20 1955 at Nitro. Did you make any other determinations 21 regarding the exposure of workers at any Monsanto plant for 22 any of the substances that by that time the government had 23 published exposure levels for? 24 MR. MALIN: I object to the form of the question. 25 If you think you understand it, you can try and answer it.
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1 Q. You had told me that you had no published levels 2 for dioxins prior to that time. Do you recall that? 3 A. Yes. 4 Q. Thats how we got on this whole discussion. 5 A. Yes. 6 Q. Until this Dow report. Didyou make 7 determinations at that time in the mid 70's regarding the 8 exposure levels of employees in Monsanto plants to other 9 substances? 10 A. Yes. 11 Q. Where are thoseresultsof those analyses? 12 A. In our industrial hygiene section. They keep 13 records of those. 14 Q. And thosewere the work ofthe industrial 15 hygienists? 16 A. Yes. 17 Q. When you found levels of exposure beyond what the 18 government had published as so-called safe levels of 19 exposure, what did you do? What was it your responsibility 20 to do? 21 A. Determine whether, infact, they were elevated; 22 and if they were elevated, either to give them some 23 protective gear or to change the ventilation in the area in 24 order to get it down to a level where it is at a safe level. 25 Q. Who made the determination as to what was the
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1 appropriate step to take? 2 A. Well, appropriate step to take about what? 3 Q. What measures you were going to do to bring the 4 exposure levels down. 5 A. That's the responsibility of the plant together 6 with industrial hygiene that, in fact, met the goal. 7 Q. And ultimately was it your determination as to 8 what was to be done or did you just supervise this? 9 A. Just supervised. 10 Q. Other than the industrial hygienists, what other 11 responsibilities did you have as medical director? 12 A. Supervise the toxicology section. 13 Q. And what were their activities? 14 A. To do appropriate studies to insure we knew 15 enough about our chemicals to say that they can be handled 16 safely, as well as what safety device would probably be 17 effective. 18 Q. Handled safely by whom? 19 A. The workers. 20 Q. Your own workers? 21 A. Yes. 22 Q. Was any of the work of the toxicology section 23 directed toward the handling of your products by persons 24 other than workers of Monsanto? 25 MR. MALIN: I object to the form of the question.
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1 He's testified what his responsibility was. His 2 responsibility was as medical director to supervise the 3 health of workers at the Monsanto facilities. I don't think 4 he described any other. 5 MR. COHEN: Are you coaching him now, or are you 6 instructing him not to answer? 7 MR. MALIN: I'm describing what he has described 8 as his duties; and you haven't established that he has or 9 would have any such knowledge. 10 MR. COHEN: I don't believe I have to establish 11 anything. This is a discovery deposition. I'm trying to 12 find out what he knows. 13 MR. MALIN: I object to the form of the question. 14 If you can understand the question, answer it. 15 MR. COHEN: I think we probably both forgot the 16 question. Do you want to hear it back? 17 (Reporter read back as requested.) 18 A. The toxicology section had the responsibility to 19 define how a product should be handled safely; in other 20 words, if the product is not toxic, then it can be a 21 relatively non-specific safety procedure, but if in fact it 22 was a more toxic material, they would say something needs to 23 be done in addition to that. 24 Q. When you say how to handle the product safely, 25 are we speaking strictly of Monsanto employees or are we
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1 speaking of the world at large? 2 A. Our customers. 3 Q. So this went beyond then trying to protect your 4 own workers? 5 A. Yes. 6 MR. COHEN: What time do you want to break for 7 lunch? Off the record. 8 (A recess was taken for lunch.) 9 Q. When we had brokenoff,doctor, we weretalking 10 about the work of the toxicology section; and I believe you H said that they had the responsibility to determine how to 12 handle a product safely. And that was, as I understood it, 13 for your customers; is that right? 14 A. Yes. 15 Q. Now, when you say your customers, do you mean 16 just those people who buy the product, how it should be 17 handled safely, or was it intended to determine its safe 18 handling throughout its useful life and perhaps beyond that, 19 on through salvage? 20 MR. MALIN: If you understand that question, 21 doctor, you may attempt to answer it. 22 A. Their responsibility was to write out how they 23 think it should be handled to be handled safely. 24 Q. What was the duration of their intended scope of 25 instruction?
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1 A. That it would appear as a label on the product 2 for use. 3 Q. So would it be fair to say then that their job 4 was to provide appropriate labeling for the product? 5 A. Yes. 6 Q. What was that labeling to inform whoever received 7 the product? What information was it to give them? 8 A. To explain to them what they must do to protect 9 themselves. 10 Q. From the product itself? 11 A. Yes. 12 Q. Now, at the time that you came there in 1973 -- 13 A. Yes. 14 Q. -- did you have any responsibility toward the 15 toxicology section? 16 A. Yes. 17 Q. Were they thesameresponsibilities -- 18 A. Between '74, I became responsible for them. 19 Q. So it was after Dr. Kelly left? 20 A. Yes. 21 Q. What did you do at that time to determine that 22 the toxicology section had prepared appropriate labeling for 23 the products? 24 A. I don't understand the question. 25 Q. Did you do anything to determine whether the
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1 labeling of the products was appropriate when you took over 2 the role of medical director? 3 A. Indirectly. 4 Q. What do you mean indirectly? 5 A. Dr. Levinskas was responsible for the labeling. 6 Q. And who was Dr. Levinskas? 7 A. He's the head chief toxicologist. 8 Q. Was he in your department? 9 A. Yes. 10 Q. Did you supervise him? 11 A. Yes. 12 Q. Would he have been the individual who was head of 13 the toxicology section? 14 A. Yes. 15 Q. When you took over as medical director, did he 16 report to you on the status of his work? 17 A. Yes. 18 Q. What did he tell you? 19 A. On what? 20 Q. Anything. 21 A. Tell me about the products, if he had any concern 22 for them, whether there should be more studies done on them. 23 Q. Do I take it then that the toxicology section did 24 some sort of work in order to determine whether the labeling 25 was appropriate?
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1 A. Yes. 2 Q. What sort of work did they do? 3 A. Do animal studies. 4 Q. Animal studies? 5 A. Yes. 6 Q. Why did they do animalstudies? Can you tell me? 7 A. To observe what biologic effects of the chemical 8 are onthat species. 9 Q. Yes. Is that it? 10 A. Yes. 11 Q. Now, I gather that your principal concern was not 12 the biological effects on the species that you were testing; 13 is that fair to say? 14 A. That's right. 15 Q. What species were you primarily concerned with? 16 A. With man. 17 Q. Why was it that you did animal studies then? 18 A. It's a way to get information that will provide 19 some understanding of the biologic effects of such chemicals. 20 MR. COHEN: Could I get that last answer again? 21 (Reporter read back as requested.) 22 Q. Biologic effects of those chemicals on any 23 species oron man or on animals? 24 A. Where appropriate. 25 Q. What does that mean?
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1 A. If it was for man, then we would establish and 2 write the safe handling procedure for man. If it's a cow 3 exposed to a chemical, then it will be responsible to the 4 farmer to take care of him or whatever. 5 Q. Did you do testing on cows? 6 A. No, but if we did have, we would do that. We 7 would do a study that would be appropriate to the use of that 8 chemical. 9 Q. Did you have any products that you were writing 10 labels for at that time in a toxicology section where the 11 intended user or the individual exposed was a species other 12 than man? 13 A. I don't recall, but it could well be. 14 Q. Was that sort of feeds and that sort of thing? 15 A. Pardon? 16 Q. Feeds, animal feeds? 17 A. Sure. 18 Q. You were manufacturing feeds during that time, 19 were you? 20 A. No. 21 Q. So are wetalking hypothetically then? 22 A. All I'msaying is there could be some chemicals 23 in Monsanto that are being used in a farm where an animal 24 could be exposed and we wanted to handle that animal properly 25 if there was an exposure.
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1 Q. Can you give me an example? 2 A. I cannot, but all I'm saying is we would do it 3 if, in fact, there was one. 4 Q. During the time that you were there as medical 5 director from '74 to '88, did you have an occasion where you 6 were worried about the exposure of some species other than 7 man on the particular project? 8 A. I don't recall. 9 Q. In a 14 year period, you don't recall whether 10 there was one product where the potential exposure was to a 11 species other than man? 12 A. No, I do not. 13 Q. Do you believe that theresults of animal 14 studies, that is the observed biologic effect of the chemical 15 on that species, can be translated into an expected biologic 16 effect on man? 17 A. It's a procedure by which it'sdone. 18 Q. Well, I don't think I asked you that. I asked 19 you whether you believed that you could translate that 20 biologic effect observed in one species to man? 21 A. Yes. 22 MR. MALIN: I object to the form of the question. 23 Go ahead. Answer the question. 24 MR. COHEN: On what basis do you object? What is 25 it about the form that you object to?
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1 MR. MALIN: The question you asked is, do you 2 believe that you can translate an observed effect in an 3 animal to man; and that's too vague in terms of the words 4 translate. It's too vague, too general. For the question to 5 have any meaning, it would have to deal specifically with the 6 kind of tests, dosage, animals used, etc. It's far more 7 complex than that. 8 MR. COHEN: Are you testifying then? Are you 9 testifying now, Mr. Malin? 10 MR. MALIN: That's not testifying. 11 MR. COHEN: All right. In any event, the witness 12 answered the question. Do you have the witness's answer? 13 THE REPORTER: His answer was "Yes." 14 Q. (By Mr. Cohen) Would it be fair to say, doctor, 15 excepting if you will for a moment, the possible odd exposure 16 to an animal such as a farm animal, which you don't even 17 recall if it occurred, excepting that category for a moment, 18 you were doing research in animals to observe biologic 19 effects with the intention of determining potential biologic 20 effects in man. 21 A. Yes. 22 Q. Do you believe that animal studies of PCB's and 23 their byproducts, such as you alluded to earlier -- Strike 24 that. Do you believe that animal studies to observe the 25 biologic effects of PCB's and their byproducts can be used to
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1 determine biologic effects of the same compounds in men?
2 MR. MALIN: I object to the form of the question.
3 If you think you understand that question, answer it.
4 A. The animal studies are not done to give a
5 one-on-one interpretation. The studies are done to determine 6 whether there is an inhalation hazard; and if there's an
7 inhalation hazard, how to handle it. It can be you don't get
8 it on your hands because of something, and make sure you
9 don't get it in your mouth, don't breathe it. All of these
10 things can be brought up; and it's not on a one-on-one basis,
11 but to answer those questions, I just cited that's what the
12 test is for.
13 Q. In other words to determine if there's the
14 potential danger from exposure to whole skin, you will not
15 test humans, but test an animal to see if it absorbed through
16 the skin?
^
17 A. Or produce an effect on the skin.
18 Q. All right. To see if there's an adverse effect
19 on the skin of the animal or if a transdermal route of
20 absorption is possible; is that fair to say?
21 A. Yes.
22 Q. Would you look for --
23 A. And that's acute effect.
24 Q. Your animal studies were looking for acute
25 effects?
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1 A. The ones we have been discussing are acute 2 studies. 3 Q. You didn't do chronic studies? 4 A. We did chronic studies when they were indicated. 5 Q. If you saw an acute effect, were you doing 6 chronic studies? 7 A. No. 8 Q. What would be an indicator for a chronic study, 9 doctor? 10 A. An observation in man; another chemical is quite 11 similar to it; something reported. In other words, there's a 12 whole host of collections, could be, would influence whether 13 we did chronic studies. 14 Q. Did Monsanto ever of its own initiative determine 15 to do chronic animal studies in order to observe chronic 16 long-term adverse effects from exposure to PCB's in animals? 17 A. Yes. 18 Q. Can you give me some examples during your tenure 19 as medical director? 20 A. There was a lifetime study done with PCB's. 21 Q. What species? 22 A. Rats and mice. 23 Q. And again was the goal to determine biologic 24 effects of potential chronic long-term exposure in man? 25 A. If there are any.
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1 Q. I don't know what you mean. What do you mean if 2 there are any? 3 A. There may not be any chronic lifetime effects. 4 Q. In other words, you would do chronic long-term 5 studies in animals to see if there are any adverse effects 6 from such exposure? 7 A. But you don't do it on all chemicals, lifetime 8 studies. 9 Q. You did do it on PCB's? 10 A. Yes. 11 Q. When you say you did it on PCB's, were you using 12 Monsanto product? 13 A. That was before me. 14 Q. So the test you're alluding to now occurred prior 15 to your tenure? 16 A. Yes. 17 Q. Was it prior to your employment with Monsanto? 18 A. What was before? Did they do the study before? 19 Q. Yes. 20 A. Yes. 21 Q. So it wasn't just before you became medical 22 director, it was before you even worked there? 23 A. Yes. 24 Q. I know there was only a short time period between 25 the time you joined and became medical director. What were
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1 the results of those chronic long-term studies? 2 A. There was cancer in one of the species that was 3 studied of the PCB's. 4 Q. Now, again, was the product that was being used 5 in that study, which I know was before your employment, 6 Monsanto product, that is, an Aroclor? 7 A. Was it -- I'm not sure I got the question out of 8 that. Restate it. 9 Q. Sure. A chronic long-term study was done prior 10 to your employment to determine long-term adverse health 11 effects from exposure to PCB's? 12 A. Right. Yes. 13 Q. I'm trying to determine if the product that was 14 being tested for adverse health effects was a Monsanto 15 product, specifically an Aroclor. 16 A. I'm sure it was. 17 Q. In other words, you don't have the study in front 18 of you but you believe they used Aroclor? 19 A. Yes. 20 Q. Was it production grade or production quality 21 Aroclor? 22 A. Again, as, I'm sure it was. 23 Q. Do you know if it contained the byproducts that 24 we had discussed earlier, like dioxins? 25 MR. MALIN: Objection. He never testified that
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1 PCB's contained dioxins. 2 Q. Let me back up then. Do you believe that your 3 production grade Arodors in this time period when this test 4 was done, whenever it was done prior to your employment, 5 contained anything other than PCB's? 6 A. It's like all chemicals. It's not 100 percent 7 3 8 Q. What else did it contain, to your knowledge? 9 A. I don't know. 10 Q. Did it contain furans? 11 A. If it did, they wouldn't have known it because 12 they didn't know what furans were back then. 13 Q. I understand that, but I'm asking you, do you 14 believe it contained furans? 15 A. I said before, I don't think that furans were 16 present in this or dioxins were present in these products. 17 Q. You do not believe that the Monsanto product 18 contained furans? 19 A. That's right. 20 Q. Do you know what stereo chemicals are? 21 A. No. 22 Q. Do you know whatcoplanar PCB's are? 23 A. No. 24 Q. You never heard of that? 25 A. No.
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1 Q. It was not a subject that was ever discussed 2 during your tenure of employment? 3 A. No, it was not. 4 Q. Do you know the name James Mieure, M-I-E-U-R-E? 5 A. No. 6 Q. A Dr. James Mieure? 7 MR. MALIN: It's pronounced Mieure. 8 WITNESS: Mieure. I know Mieure. 9 Q. Do you know James Mieure? 10 A. I know Mieure. 11 Q. I'm sorry. 12 A. Yes. 13 Q. He apparently had a business address of 800 North 14 Lindbergh in St. Louis. Do you know that address? 15 A. I know about where it is, yes. 16 Q. Is that where you worked? 17 A. Yes. 18 Q. Is that where your office was? 19 A. Yes. 20 Q. In '74? 21 A. Yes (nodded). 22 Q. Is Mieure a medical doctor? 23 A. No. 24 Q. Ph.D.? 25 A. I'm sure.
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1 Q. What department was he in in '74? 2 A. I don't know. 3 Q. Did you have any dealings with him at that time? 4 A. Casually, I'm sure I did. 5 Q. Were you made aware of the fact that apparently 6 some scientists by the name of Roach and Pomerantz in 1974 7 contended that they had found contaminants, dibenzofurans, 8 chlorinated dibenzofurans in certain PCB's? 9 A. No. 10 Q. Are you saying you don't recall that today or you 11 never knew it? 12 A. No. Isn't that the same answer? That's the same 13 answer to me. 14 Q. Back in the early 70's, did you have any dealings 15 with Dr. Kaley? 16 A. No. 17 Q. He did not report to you on his activities? 18 A. No. 19 Q. Do you know when Monsanto first got gas 20 chromatography? 21 A. No. 22 Q. Do you know what gas chromatography is? 23 A. Sort of. 24 Q. Would youagree that gaschromatography is what 25 enabled Monsanto to detect these byproducts or contaminants
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1 in their product? 2 A. I'm not a chemist. 3 Q. So, you don't know? 4 A. I have an idea, but I don't know. 5 MR. COHEN: Mark this as Roush Exhibit 2. 6 (Reporter marked Plaintiff's Deposition (Roush) Exhibit 2.) 7 Q. Have you had a chance to look at the document? 8 A. It's a chemistry document, though. 9 Q. Have you ever seen it before? 10 A. No. 11 Q. This is dated December -- Am I looking at the 12 write document? It's dated December 23rd, '74. 13 A. Yes. 14 Q. And it refers to an AOAC meeting presentation 15 from October, '74. 16 A. Whatever that is. 17 Q. Whatever that is. But you see on the first page 18 here of the report itself, it says, "In this paper, we report 19 the finding of chlorinated dibenzofurans in production lots 20 of Aroclor 1254, 1242 and 1016 that were manufactured in 21 1973 . " 22 A. Do you see that? 23 A. Yes. 24 Q. Did you see the attachments here? They have been 25 stamped with the numbers PRR 4369, 4370, 4371, 4372.
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1 A. Yes. 2 Q. Theyrefer toAroclorproducts. 3 A. Yes. 4 Q. Would it be fair to say about this time in 1974 5 was when you became aware of the fact that the product 6 contained furans? 7 MR. MALIN: Objection to the form of the 8 question. I don't think he ever testified that he became 9 aware that the product contained furans. 10 MR. COHEN: I'm asking him that. 11 A. No, Ididn't know that. 12 Q. Did you ever know that it contained furans? 13 A. No. 14 Q. So through 1988, were you aware of the fact that 15 the product contained furans? 16 A. No. 17 Q. Did you ever see anydata subsequent to this in 18 '74 that indicated that the product did not contain furans? 19 A. No. 20 MR. MALIN: Off the record. 21 (Colloquy held off the record.) 22 MR. COHEN: Mark Exhibit 3. 23 (Reporter marked Plaintiff's Deposition (Roush) Exhibit 3.) 24 Q. Have you had a chance to look at the document, 25 sir?
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1 A. Yes, but not in depth as I should because it's 2 pretty deep for me. 3 Q. It's a little heavy. 4 A. Yes, it is. 5 Q. You'll agree with me, however, on the first page 6 it is a handwritten memo from the desk of R. E. Keller dated 7 11/11/71, that the document appears to be a typewritten memo 8 with attachments sent to a number of people within the 9 Monsanto organization including Mr. Mieure and, again, it is 10 directed to W. R. Richard, but appears to be, again, from R. 11 E. Keller; is that right? 12 A. Yes. 13 Q. Now, this predates your employment with the firm. 14 I understand that. Were you aware of the existence of this 15 document when you came to the medical department? 16 A. No. 17 Q. Do you see that there are on page 2 of the memo 18 dated October 28th, '71, questions for medical? 19 A. Yes. 20 Q. Would that have been your department, that is, at 21 that time Dr. Kelly's department? 22 A. Yes. 23 Q. Were you aware that these questions were raised 24 in 1971 in the medical department? 25 A. No.
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1 Q. Are you aware of any test that was done to 2 determine the toxicity of furans in 1971? 3 A. No, I'm not sure that they would have known how 4 to do it at low levels. 5 Q. Do you know if the medical department either had 6 done or had access to information regarding the toxicity of 7 what are called impurities, chlorinated naphthalenes, 8 anthracene, phenanthrene? Do you know if you had any of that 9 information in that time period? 10 A. No -- I don't recall it if I did. 11 Q. Do you know if the PCB product Aroclor that 12 Monsanto manufactured during that time period contained any 13 of these impurities such as chlorinated naphthalenes? 14 A. Not for sure. 15 Q. At any time prior to your employment in 1973, are 16 you aware of any acute toxicity studies having been done on 17 chlorodibenzofurans? 18 A. No. 19 Q. That's either inside, in-house, or paid for by 20 Monsanto, sponsored by Monsanto, or otherwise? 21 A. Right. 22 Q. You're unaware of any? 23 A. No (nodded). 24 Q. And the answer is no? You shook your head. 25 A. No. Right.
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1 Q. See down in the last paragraph, it says "I 2 suggest that the only immediate analytical work would be to 3 firm up furan data for remaining PCB/PCT products with 4 existing methodology." See that sentence? 5 A. Yes. 6 Q. What's PCT? 7 A. I don't know. 8 Q. Would you turn, sir, to the page marked 4245, 9 dated June 13, '72, apparently from J. R. Savage, St. Louis. 10 It is to W. R. Richard. Do you see that page? 11 A. Yes. 12 Q. Do you see that symbol T3A -- 13 A. Yes. 14 Q. -- under the name? 15 A. Yes. 16 Q. What's that mean? 17 A. That's his location. 18 Q. And would B2SL likewise be a location? 19 A. Yes. 20 Q. Now, it says, "Cumming Paton has asked that we 21 develop a history on chlorodibenzofuran content of our PCB 22 products. The plant has no methods for this analysis. If we 23 just need to screen a few current batches, this is perhaps 24 better done in Research, but if we want to develop a 25 continuing history, of say every fifth batch as we did with
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1 Dioxins and Penta, we should have a method developed," etc.,
2 etc. Were you aware as to whether or not there was a
3 continuing program to test product for Dioxins and Penta,
4 whatever that is?
5 A. No.
6 Q. Do you know whatproductsthey're talking about
7 they would have been testing for Dioxins and Penta?
8 A. I have to guess. I'd say they're talking about
9 PCB's.
10 Q. The memo refers to PCB's in the same paragraph.
11 A. Yes.
12 Q. As director of the medicaldepartment atMonsanto
13 Company, wouldn't you have had access to information
14 regarding the content of the product?
15 A. Not necessarily. They could give it and we could
16 talk about PCB's and we would test PCB's and we would include
17 that as a contaminant of it.
18 Q. You're assuming that the testing of PCB's was on
19 production grade material; is that right?
20 A. Yes.
21 Q. In other words, I'mdistinguishing from
22 laboratory grade that could be made to a higher degree of
23 refinement.
24 A. Yes.
25
Q.
So, youthink thatwhatever
thetests would show
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1 it would include whatever was in there? 2 A. Yes. 3 Q. And again, I asked you earlier, you have no 4 information as to what effect there is on having the 5 chlorinated benzenes in there with respect to the formation 6 of dioxins and furans? 7 A. No. 8 (Reporter marked Plaintiff's Deposition (Roush) Exhibit 4.) 9 Q. Have you ever seen this memo before? 10 A. No. 11 Q. You see it refers to apparently a memo or some 12 communication between the same two individuals. HSB, I 13 assume, is H. S. Bergen. Do you know who that is? 14 A. I know the name, but I don't know him. 15 Q. WRR is W. R. Richard. Do you know who that was? 16 A. Yes. 17 Q. Copies were sent again to Mieure and Munch. 18 Munch, did he work for you? 19 A. No. 20 Q. The memo does however refer to Dr. Levinskas? 21 A. Yes, it does. 22 Q. In May '75, he worked for you? 23 A. Yes. 24 Q. He was head of toxicology? 25 A. Yes.
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1 Q. Again a report of the presence of dibenzofurans 2 in Monsanto product; is that correct? 3 A. Yes. 4 Q. You were not aware of this at that time? 5 A. I don't recall it at least. 6 Q. Do you see in the fourth paragraph there's a 7 reference to a case against Dow, "The case was never brought 8 to trial vs. Dow because of lack of evidence." 9 A. Yes. 10 Q. Do you know what they're talking about? 11 A. I can only surmise what it is. 12 Q. Which is? 13 A. The tetrachlorodibenzodioxin -- 14 Q. Right. 15 A. -- was a subject of interest to Dow. Dow was 16 working on dioxin and the fact that they had difficulty in 17 analyzing some form, there's a reason that Dow was never 18 brought in. 19 Q. Do you know anything about a lawsuit against Dow 20 in that time period regarding dioxin? 21 A. I don't think there would be a lawsuit. I think 22 they're talking about what regulations they would be pushing 23 on them. 24 Q. You see the sentence, "The case was never brought 25 to trial vs. Dow because of lack of evidence."
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1 A. Yes. 2 Q. You don't think that refers to a lawsuit? 3 A. That one sentence isn't very much for me. 4 MR. MALIN: Doctor, please don't speculate. 5 Either you know or you don't. 6 Q. Let's go to the next sentence. First sentence, 7 of the next paragraph. "In our case the argument is about 8 chlorinated dibenzofurans." Do you know anything about a 9 lawsuit against Monsanto in May of '75 regarding chlorinated 10 dibenzofurans? 11 A. No. 12 Q. And you have no recollection of Dr. Levinskas 13 discussing this situation with you? 14 A. No. 15 (Reporter marked Plaintiff's Deposition (Roush) Exhibit 5.) 16 Q. Have you had a chance to look at the memo, 17 doctor? 18 A. Yes. 19 Q. Now, this apparently is a memo that was sent to, 20 it looks like Mr. Papageorge, although his name appears to 21 have been crossed out, from David Wood. Did you know Mr. 22 Wood? 23 A. Yes. 24 Q. And apparently a copy of this document went to 25 you?
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1 A. Yes. 2 Q. Your address was A2SA? 3 A. Yes. 4 Q. Do you recall this situation with Dr. Allen 5 calling about furans and dioxins? 6 A. No. 7 Q. You don'trecall? 8 A. No. 9 Q. Does looking at the memo refresh your 10 recollection at all about this event? 11 A. No. 12 Q. Does this memo refresh your recollection that you 13 were aware that furans were being reported as being found in 14 Ar odors? 15 A. No, I do not recall it. 16 Q. You see where it refers to a Risebrough paper? 17 A. Yes. 18 Q. Do you know that paper? 19 A. No, I do not. 20 Q. Have you ever read it? 21 A. No. 22 Q. Do you know what the subject matter is? 23 A. No. 24 Q. Between the time of this memo in August of '75 25 and the time you retired in April of '88, did you ever
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1 receive information that indicated that furans were present 2 in Aroclor products, in Monsanto products? 3 A. I don't recall. 4 Q. Did you ever discuss with Dr. Levinskas what you 5 should do about warning labels for PCB's as a result of the 6 reported presence of furans? 7 A. I don't recall. 8 Q. You were aware during that time period, however, 9 that furans can be formed in certain operations that involve 10 dielectric fluids? 11 A. Yes. 12 Q. Now, you knew throughout this time period in '74 13 to '88 that there was an awful lot of dielectric fluids that 14 Monsanto manufactured and sold; didn't you? 15 A. Yes. 16 Q. And you knew certainly as of some time in '77 17 that there was a general market trend to get those dielectric 18 fluids containing PCB's out of transformers; didn't you? 19 A. I knew that they were to stop putting them in, 20 but I don't think they were told to take them out. 21 Q. Well, were you aware at any timeprior to April 22 30, 1988, that industry was generally trying to get the 23 dielectric fluids containing PCB's out of the transformers? 24 A. I didn't know how broad it was. 25 Q. But you did know that there were efforts to take
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1 dielectric fluids containing PCB's out of transformers? 2 A. Yes. 3 Q. Were you aware of what's called frequently cross 4 contamination, where mineral oil transformers were 5 contaminated with dielectric fluids containing PCB's? 6 A. Yes. 7 Q. Were you aware that therewas industry developing 8 ways to remove those PCB's from those mineral oil 9 transformers? 10 A. No. 11 Q. Were you aware that there were substitute 12 dielectric fluids coming to market during that time period to 13 replace the dielectric fluids containing PCB's? 14 A. Yes. 15 Q. What did you know or believe was happening to the 16 dielectric fluid containing PCB's? 17 MR. MALIN: I object to the form of the question. 18 If you can understand it, answer it. 19 Q. Did you understand it, doctor? 20 A. Would you say it again? 21 Q. I'm trying to understand, doctor, sometime in the 22 late 70's people started taking dielectric fluid containing 23 PCB's out of transformers; is that right? 24 MR. MALIN: I object to the form of that 25 question.
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1 Q. You already answered that, didn't you, doctor? 2 A. Yes. 3 Q. You know that'strue; don't you? 4 A. Yes. 5 Q. What did you knowor believe was happening to 6 that PCB fluid? 7 MR. MALIN: You mean the PCB fluid that was being 8 taken out of transformers? 9 MR. COHEN: Yeah. 10 MR. MALIN: Answer the question if you think you 11 understand it, doctor. 12 A. I understand the question, but I don't know. I 13 wasn't a part of that. 14 Q. So you don't know what was happening to it? 15 A. No. 16 Q. But you knew at least as of the late 70's it was 17 coming out of transformers in the field? 18 A. I didn't know how broad it was. I knew they were 19 talking about it. 20 Q. When did you know that under certain operating 21 conditions dielectric fluids in transformers could develop 22 furans and dioxins? When did you have that information? 23 A. I don't know. 24 Q. Did you have it by the late 70's? 25 A. I don't know.
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1 Q. Well, I believe there's a report by Hudsinger. 2 Is that his name? Are you familiar with that paper? 3 A. No. 4 Q. Have you ever seen any of the studies of the 5 Binghamton fire, the Binghamton office building fire? 6 A. I knew about the fire and I've seen discussions 7 of it, but not in any depth. 8 Q. That goes back into the 70's, doesn't it, doctor? 9 A. I'm sure it does. 10 Q. And furans and dioxins were all detected in the 11 suit from the transformer fire; isn't that right? 12 A. Furans were. I don't know whether dioxins were. 13 Q. So at least some time during that time period in 14 the late 70's to early 80's you were aware that furans were 15 being formed under certain conditions in dielectric fluids in 16 the field? 17 A. I wasn't sure that it wasn't by leaks and some 18 other exposure but not in the transformer itself. 19 Q. You were unaware that the fluid could form furans 20 in the fluid itself still in the transformer? 21 A. That's right. 22 Q. Doctor, let me show you an article from 23 Environmental Health Perspective Volume 60. I can't read the 24 date. It looks like 1980 something. It's an article by 25 Hudsinger, Chaldry, Chittam, and Johnston, a Formation of
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1 Polychlorinated Dibenzofurans and Dioxins During Combustion, 2 Electrical Equipment Fires and PCB Insineration. Have you 3 ever seen this before? 4 A. No, and I can't tell you anything about this. 5 Q. You have no recollection of having seen it 6 before? 7 A. No. 8 MR. MALIN: Mr. Cohen, I think you may be under 9 the impression that Dr. Roush worked for Dr. Kaley as an 10 analytical chemist as opposed to being a medical doctor. I 11 think he told you what the medical director does. 12 Q. Do you believe or did you believe while you were 13 a medical director of Monsanto Chemical Company that 14 dibenzofurans were a toxic substance? 15 A. Yes. 16 Q. Did you believe that they could cause adverse 17 health effects in man? 18 A. Depends on -- 19 MR. MALIN: I object to the form of the question, 20 unless you're talking about dose. 21 A. Depends upon dose. 22 Q. Do you believe that at some dose, that could form 23 and cause adverse health effects in man? 24 A. I don't think there was an experiment done to 25 talk about that, but it has to do with how much of a dose
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1 could be out there. 2 Q. You're familiar with the Yusho and Yucheng 3 incidents? 4 A. Yes. 5 Q. They involve, I think it is now believed, furans? 6 A. Yes. 7 Q. People developed very significant adverse health 8 effect from ingesting rice oil containing -- 9 A. I sure did. 10 Q. -- dielectric fluids that contained, amongst 11 other things, furans. You're familiar with those studies? 12 A. Yes. 13 Q. When were you familiar with those studies? 14 A. '75. 15 Q. Between 1975 and 1988what, if any,instructions 16 did you give to Dr. Levinskas in the toxicology department to 17 inform customers and others of the dangers of furans? 18 A. If we did anything, it would be to put it on the 19 label of something. 20 Q. You said, if we did anything. Did you do 21 anything? 22 A. I would have to talk to Levinskas to see what was 23 done. 24 Q. You have norecollection of what you instructed 25 Levinskas to do?
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1 A. That's right. I do not.
2 Q. You were Levinskas's boss?
3 A. Yes.
4 Q. Do you know, as you sit here today, whether you
5 ever put warnings, on the labels of PCB containers going out,
6 of the dangers of furans?
7 A. You'll have to go back. We're still talking
8 about dose. The question is how much of this was present.
9 Q. I'm asking you, doctor, if you ever did anything
10 to change those labels?
11 MR. MALIN: He's answering your question.
12 MR. COHEN: Mr. Malin, can I please have the
13 witness's testimony?
14 MR. MALIN: Tell him to give you an answer and
15 explain his answer.
16 Q. Sure. Explain your answer, please, feel free,
17 but tell me the answer.
18 A. It was a contaminant of PCB's and the
19 concentration was very low; and the people who had been
20 exposed to PCB's in Yusho were exposed to concentrations that
21 were in the thousands of ppm; and they're the ones who got
22 the chloracne. And when we come back from that, we're
23 talking about chloracne being related, there's no evidence
24 that there was chloracne associated with PCB's unless it was
25 in part of a fire or an explosion.
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1 Q. What, if anything, to your knowledge did the 2 medical department of Monsanto Company do between 1974 and 3 1988 to warn people in the field that were taking dielectric 4 fluid out of transformers that that fluid could be 5 contaminated with furans or dioxins? 6 MR. MALIN: He hasn't testified that he believed 7 it could be contaminated with benzofurans or dioxins. 8 MR. COHEN: I didn't ask him that. I asked him 9 what he did. 10 MR. MALIN: Well, you premised it on its being 11 contaminated or possibly being contaminated. He never 12 testified to that. 13 MR. D'URSO: He just said furans were present in 14 PCB products and -- 15 MR. COHEN: You also said under certain 16 circumstances in the field. 17 MR. MALIN: In the field, not necessarily in the 18 transformer as a result of operations in the transformer. 19 MR. COHEN: I'm still asking him what he did. 20 Q. (By Mr. Cohen) What did you do? If the answer is21 nothing, tell me nothing. 22 A. It's nothing. 23 Q. Thank you. Is it your contention that people in 24 Yusho and Yucheng only developed chloracne? 25 A. No.
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1 Q. What other ailments did they develop allegedly as 2 a result of their exposure to this dielectric fluid? 3 A. There was an irritation of upper respiratory 4 tract, of the eyes, nose. There were liver effects. There 5 were enzyme effects in the liver; and there was a sensory 6 neuropathy. 7 Q. Anyone develop cancer? 8 A. There were several who developed cancer. 9 Q. Anyone develop birth defects? 10 A. Yes, but it wasn't a true -- It was a birth 11 defect, but it went away with time, which makes it different. 12 Q. Which was -- What was the birth defect that went 13 away with time? 14 A. The pigmentation went away, and the eye effects. 15 Q. It was Cola Baby Syndrome? 16 A. I don't remember that. 17 Q. You don't remember that phrase? 18 A. No, but they -- Most of these things disappeared 19 on the babies born with this defect, so it was not a 20 permanent effect. 21 Q. Were the cancers that developed associated with 22 exposure to the dielectric fluids? 23 A. There's no indication that they were. There was 24 only a couple of them. 25 Q. Were any of the cancers that developed neoplastic
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1 -- I'm sorry -- a metastatic disease? 2 A. I don't think that there's any evidence about 3 spread, but cancers do spread. That's a characteristic of 4 them. 5 Q. Now, in the lesions that you referred to earlier 6 as developing in animal studies from exposure to PCB's -- 7 A. Yes. 8 Q. -- were they metastatic lesions? 9 A. No. 10 Q. They were non-metastatic? 11 A. That's right. 12 Q. Were any of the animals allowed to live long 13 enough after the neoplasms developed to develop metastasis? 14 A. I don't recall that. 15 Q. So, you don't remember whether the sacrifices of 16 the animals occurred prior to the time that any metastasis 17 would have been detected? 18 A. The studies by Colandra would have done that. 19 Q. Colandra was with IBT? 20 A. Yes. 21 Q. Were you atMonsanto when the investigation of 22 IBT took place? 23 A. Yes. 24 Q. And were you there when Keplinger was prosecuted? 25 A. I was there when that lawsuit took place. I was
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not privy to what took place at that time. Q. When you say the lawsuit, he was prosecuted
criminally; wasn't he? A. I don't know. Q. You were not aware that he was convicted of
altering or faking animal studies? A. I don't know. Q. You're aware that whatever the charges were, they
arose out of studies that were being done for Monsanto? A. No. Q. You're not aware of that? A. No. MR. MALIN: If you're aware of that, we'd like to
know about it. MR. COHEN: Well, they weren't PCB's. I'11 agree
with that. Q. (By Mr. Cohen) Did you ever order any studies
done to determine any adverse health effects that would result from the combination of chemicals that was used in the product Pyronol or Inerteen?
A. No. Q. You were aware however that you were manufacturing and selling a product called Pyronol? A. Yes. Q. And another productcalled Inerteen?
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A. Yes. Q. Do you know the ingredients of those products? A. No.
MR. MALIN: The question has been asked and answered. He said before he didn't know the ingredient.
MR. COHEN: I was trying to refresh his recollection.
(Reporter marked Plaintiff's Deposition (Roush) Exhibit 6.) A. I don't understand it. Q. You don't understand the document? A. No. MR. COHEN: What have we marked it as, as 6? THE WITNESS: Six. Q. You do see that there are a number of compounds
contained in these various product numbers for Pyronol, and apparently it varied year by year. Do you see that, sir?
A. I see something. Yes. Q. Do I understand that you never ordered any tests done on the combination of Arodors and chlorinated benzenes? A. I don't recall. Q. Do you know what the scientific literature is with respect to the toxic properties of chlorinated benzenes? A. No. Q. Do you know if they're toxic?
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A. I don't know. MR. COHEN: At any dose. MR. MALIN: Everything is toxic at a dose. MR. COHEN: Only if you gag on it.
Q. (By Mr. Cohen) Do you know if chlorinated benzenes are more or less, at the same dose, more or less toxic than chlorinated biphenyls?
A. I don't know. Q. Do you know ifchlorinated benzenes are more or less toxic at the same dose than benzene? A. No, I do not know. Q. Do you know anything about the toxicity of tin tetraphenyl? A. No, I do not. Q. Do you know anything about epoxide dicyclo-diepoxy carboxylate? A. No. Q. Do you know anything about 3,4-Epoxycyclohexylmethyl-3,4 epoxycyclohexane carboxylate? A. No, I do not. Q. Are you aware of any literature indicating that certain epoxide compounds, known Epoxide 201 was a known carcinogen? A. No. Q. Do you know whetheryour product, that's product
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manufactured by Monsanto Chemical, contained at any time
Epoxide 201?
A. No, I do not.
Q. Would it be fair to say you never directed Dr.
Levinskas or anyone to issue any warnings to customers or
anyone regarding Epoxide 201?
A. No, I do not.
Q. How about tin tetraphenyl?
A. No.
Q. How about chlorinated benzenes?
A. I don't recall.
Q. How about benzene?
A. We do for benzene.
Q. But not part of PCB products; is that right?
A. If it were benzene itself, it would have been.
Q. I'm talking about PCB's now. Did your warnings
for PCB's contain any warnings about the toxic effects or
toxic interaction between PCB's and benzene?
MR. MALIN: I object to the form of the question.
He hasn't testified there is any toxic interaction.
A. I don't think there was benzene as such in
Aroclor.
Q. Have you ever heard it claimed that PCB's may
have a promotional effect on the carcinogenicity of other
compounds?
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A. I've heard it said, yes. Q. Do you believe it? A. I don't know. The whole idea about promoters is not well understood. It's still in the stage of thinking and trying to understand. Q. Do you believe that benzene is a carcinogenic agent in humans? A. Yes. Q. You'll agree with me that benzene is a fairly common industrial compound? A. Yes. Q. You'll agree with me that people who work in industry can have exposure to benzene on an ongoing basis? A. But their exposure should be protected. Q. But they can have exposure, you'11 agree with that? A. But at low levels. Q. Benzene is a common ingredient in motor fuels? A. Yes; and not all, but in some it is. Q. Do you believe that long-term chronic exposure to benzene can cause leukemia? A. The circumstances under which it produces leukemia is not well understood. If you keep it down below one ppm, that is largely protective. To say absolute is a very difficult subject.
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Q. You say below one ppm, you mean on a -- what do
they call it -- TEL?
A. No. TLV.
Q. TLV, right. Is that what we're referring to?
A. Yes.
Q. One ppm TLV. TLV is -- What is TLV time?
MR. MALIN: Threshold limit --
A. Threshold limit value.
Q. Threshold limit value. A government term.
A. And an industry term. ACGIH does that. American
Conference of Governmental Industrial Hygienists by and large
do the rating of TLV's.
Q. You're not an epidemiologist; is that right?
A. No.
Q. You've never designed an epidemiological study;
have you?
A. No.
Q. Is that the work of your toxicology department?
A. When Zack came, then we had an epidemiology
section.
Q.
And when did she come there again?
A. Early 70's.
Q. And when did she leave?
A. I don't know. 75, '76, something like that.
Q. Was she your epidemiology section?
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A. For a while.
Q. When she left, did you have others?
A. Yes.
Q. Their names?
A. Bill Gaffey.
Q. Gaffey?
A. G-A-F-F-E-Y.
Q. Anyone else?
A. He had a couple of people with Master's degrees working for him.
Q. Was he a Ph.D.?
A. Yes.
Q. By the way, have you ever published anything?
A. A couple of things.
Q. Do you have a CV?
A. Yes.
Q. Is it available?
A. Yes.
Q. Could you supply it to counsel?
A. Sure. MR. COHEN: Would you be kind enough to supply
the witness's CV? MR. MALIN: Sure.
Q. (By Mr. Cohen) Is there any resource that you could go to enable us to find out the names of the court
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terms and numbers of cases in which you testified?
A. I can work out and come up a lot closer than we
have thus far. Q. So in other words, if you had enough time and
gave it enough thought, you could probably think of most of
them?
A. I hope so. Q. You know the phrase low dose extrapolation?
A. Yes.
Q. What does it mean?
A. That largely refers to a riskassessment
procedure for evaluating a carcinogen. Q. Is that something that you do from animal
studies?
A. Yes. Q. You make risk assessments to the population at
large?
A. And what you do is you take a place where you see
an effect and go back to zero. Q. Other than low dose extrapolation and risk
assessment activities, do you think that animal studies can
be used in order to determine a biologic effect in man?
MR. MALIN: This question has been asked and
answered. And if you want to try to answer it again, doctor,
go ahead?
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THE WITNESS: Would you say that again for me? MR. COHEN: Would you like to take a break? THE WITNESS: Yes.
(A short recess was taken.) MR. COHEN: Go ahead and read back the last question.
(Reporter read back as requested.) A. No, not directly at least. Q. What do you mean by that, doctor? A. There's a study in man -- an animal, and then you look at a population and you may see an association or you may not. Now, that can be metabolically or pharmacologic handling of it or it can be the metabolic activity of the animal and its response to that chemical. Q. How about if the particular substance causes the same metabolites in both animals in tests and in man?
MR. MALIN: I object to the form of that question.
Q. Do you understand the question, doctor? A. Ask it again, please.
(Reporter read back as requested.) MR. MALIN: I don't know if I understand the question. Is this question, will the biological effect be the same in animals as in man if the substance being tested produces the same metabolites in man as it produces in
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animals? MR. COHEN: That's a good question. MR. MALIN: Or will it produce the same effect in
both? MR. COHEN: Yes. That's a good question. MR. MALIN: Is that the question? MR. COHEN: That's a good question. MR. MALIN: Do you understand the question? THE WITNESS: Yes. It is a very complicated
question. The understanding of man from animal is most difficult; and there are very few examples where the studies in animal have been seen in man, but as you do more and more things to make it the same metabolic activity, which is quite hard to do and do it with different doses and make it different, and then have the same lesion appear would be quite unusual. To say it could happen or not, I think it can -- could happen.
Q. How about if the substance attacks the same target organ in both animals and in man?
A. At the same dose? Q. Well, I can't say at the same dose, doctor. I don't know that you have humans getting the same dose. It may be a different dose but attacks the same organ. A. Practically all studies are done at doses that are multiples of what man is exposed; and they do that to try
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to take into account the fact that we don't have many animals
exposed. But the fact is, we do the studies to see what we
think may happen in man, but the interpretation of it is most
complicated.
Q. But you would agree not impossible?
A. Yes.
Q. Are you aware of any government documents that
indicate with respect to PCB's that there is a high degree of
concordance between animal studies and epidemiologic studies
in man?
A.
No.I think that's
not correct.
Q. So, you disagree with that?
A. Pardon?
Q. You disagree with that?
A. I disagree with that.
Q. You're not aware of any such government documents
that say that?
A. I know there's lots of written reports that talk
about that, and that there's no association.
Q. Have you ever had a chance to talk to Dr. Kelly
about this particular subject, that is, the translatability,
if you will, of the effects in animal studies to man?
A. No.
Q. Would you agree or disagree that in animal
studies and in epidemiological studies, PCB's -- whatever
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PCB's means whether it includes those contaminants or not -- A. Yes. Q. -- have attacked the same target organ? MR. MALIN: I object to the form of that
question. If you think you understand that -- I don't think he testified that he knows that PCB's have attacked any target organ in man at the levels in animals.
A. We have an effect with big doses. We do get an effect on the liver and they're enzymatic responses primarily and in the animal, but the dose is so different. They haven't done at the same dose level in the animal as we've done on man.
Q. What dose levels are you assuming in man? MR. MALIN: I object to the form of the question.
For what purpose? MR. COHEN: He's talking about dose levels in
man. I'm asking him what he's referring to? MR. MALIN: Dose levels to do what? For what
effect? MR. COHEN: Mr. Malin, please. I'm asking him. MR. MALIN: I object to the form of that question
on the grounds that it's unclear. If you think you understand that, doctor, go ahead.
MR. COHEN: I'm asking the witness what he's referring to when he says dose levels in man.
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Q. (By Mr. Cohen) What are you referring to, sir? A. Either the levels of exposure in Yusho; and coming back to occupational exposure, occupational exposure is in milligrams. Q. Milligrams what? A. Per day. Q. For how many days? A. In the animal? Q. No, no. Occupational exposures. A. In occupational exposure? Q. What's the longest occupational exposure you're aware of at milligram per day level? A. I'd have to have the epidemiologic studies to see what those were. Q. So it varies from study to study, depending on how long they were studying the individuals -- A. And the dose. Q. -- and how long the individuals were employed? In fact, there was no particular dose you can refer me to in any study for man; is that right? A. All I can tell you is that man has been exposed in the work place at least a milligram per day; and there's no evidence that they get liver cancers from that. Q. You have no information about the exposure at Paoli; is that right?
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A. No. Q. Would you agree that it is possible that human beings in the work place ingest PCB's?
MR. MALIN: I object to the form of the question. It is possible. Anything is possible. Anything is possible. The distance of the Norse gods is possible. The question is too vague.
MR. COHEN: We have your objection. I'm not asking you about the Norse gods. I'm asking you about ingesting PCB's.
THE WITNESS: Please? (Reporter read back as requested.)
A. Yes. Primarily it comes from them using -- wiping it off from their hands and putting it in their mouth.
Q. You would agree that individuals that have PCB's on their hands may then go ahead and either smoke a cigarette, for example, and inhale the fumes and perhaps even consume products of the PCB's, or perhaps may eat their lunch and actually consume the PCB's then?
A. Yes. Q. May wipe their face and consume the PCB's from their hands? A. Yes, but they shouldn't be doing that. Q. I understand that. That the PCB's may be on the skin on their face and they may sweat and swallow the sweat?
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A. Yes.
Q. In fact, these are all rather recognized modes of ingestion of PCB's in the work place; would you agree?
A. Yes, that's the source of the level that they've
got.
Q. Then, of course, they may have dermal absorption
besides ingestion; is that right?
A. What kind of?
Q. the skin.
Dermal, from their skin, actually going through
A. Dermal. I thought you were saying thermal.
Q. No, sir. I'm sorry. We have the window open a little bit and that may affect. I'll try to speak up.
Dermal absorption through the skin.
A. Yes.
Q. That's another means of absorption of PCB's in
the work place?
A. Yes.
Q. It's recognized; isn't it?
A. Yes.
Q. And, in fact, there is some level of inhalation absorption from fumes and airborne particles on dust and the
like. That's also recognized; would you agree?
A. Yes.
Q. So all of these are methods of absorbing PCB's in
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the work place? A. But they all can be protected from all of those. Q. I understand that, but what I'm saying is that
these are all recognized methods of absorption. A. Of exposure. Q. Of exposure. Are you aware if in the studies
that you have seen on work place exposure, an effort was made to quantify on a daily basis the level of absorption through these various routes of exposure?
A. No, but I've seen the blood levels reported for such workers.
Q. Do you think that blood levels are a good measure of absorption?
A. Yes. Q. You would agree with me that if the person had an acute short-term exposure that shortly after that acute exposure, they may show a high blood level of PCB's? A. I'm not sure how soon, but it will reflect it. Q. Would you agree that after a long period of time they may show a low blood level of PCB from one acute exposure? A. I think that it will follow after, with no further exposure. Q. And what causes it to fall from the blood level? Why does the blood level go down?
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A. We know that it appears in the urine and feces.
Q. Are you saying it's excreted?
A. Yes.
Q. Anything else cause the blood level to drop?
A. It can be metabolized, but metabolism isn't well
understood.
Q. Do you think it's going to be transported and
stored in any of the other cells in the body other than the
blood?
A. In the fatty tissues primarily.
Q. So would you agree after an acute exposure, some
of the PCB's will be excreted, some maybe metabolized and
some will be stored in fatty tissues?
A. And it's all in equilibrium.
Q. So that you believe that the blood level after
the storage process will then again reflect the entire body
level?
A. Yes. Not instantaneously, but it willreflect
it.
Q. How about with chronic long-term exposures?
A. The same will be true in terms of the equilibrium
may be changed and he may put something into another depot.
Q. Like fat cells?
A. Another fat depot because they're not all equally
available.
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Q. So, you may fill up the fat cells in the liver
and then fill up the fat cells in another organ and fill them
up in another organ, etc.; is that correct?
A. Yes.
Q.
And you still believe that thelevel in
the blood
will be reflective in equilibrium that the body burns?
A. If you give it time.
Q. How much time?
A. I don't know. It depends on what the level is
compared to where it's going to.
Q. What's the difference betweentesting serum and
plasma?
A. I don't know. Serum has more relative fat than
does --
Q. Serum what?
A. The serum has more fat in it than does the --
Q. Plasma?
A. Yes (nodded).
Q. Would it then belikely to report a higher level
or a lower level?
A. I don't know, but I would say it would reflect a
higher level.
Q. Do you think there's any disagreement in the
scientific and/or medical community about the utility of
animal data for determining an ailment or illness in an
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individual human being? MR. MALIN: I object to the form of that
question. If you think you understand it, doctor, you may attempt to answer it. I think it also has been asked and answered several times.
MR. COHEN: No, I think this is different. THE WITNESS: Ask it for me again, please.
(Reporter read back as requested.) A. There is no question about the value of doing animal studies, both given an estimation how it is metabolized, how it's handled, and then you do it within man to see if it handles the same. But the obvious one if I got something very irritating or toxic and I give it to the animal and it drops dead, I've learned a great deal in terms of what the implication of that is, so that's the acute or the easy one. That more difficult one is the long life time because there the differences become more apparent and it's difficult. Nevertheless, we do animal studies lifetime to understand what is a possible effect rather than saying we know what the effect is. Q. Other than animal studies, if you as a medical doctor are evaluating an individual who has an ailment and you know has been exposed to a particular substance, what other information would you want to have? A. Do I understand that at all, his problem? Is
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this the first time I've ever seen it?
Q. Right.
A. First time I've ever seen it?
Q. First time you've everseen this person.
A. Have I seen the chemical before and its action in
man?
Q. Are you asking me?
A.
I want to know if that'sanother
--
Q. I'm trying to understand. Let me ask you this.
In making a diagnosis about a particular individual, would
you be interested in looking at the scientific literature of
the effects on man or animals of similar compounds, related
compounds?
A. If I didn't have it on that chemical, I'd welcome
any material that I could use.
Q. With respect to PCB's, what similar or related
compounds would you look at?
A. I'm not enough of a chemist, but I would look and
see some closely related chemical that I may know something
about.
Q. Would you have any interest in looking at
polybrominated biphenyls?
A. Yes.
Q. How about chlorinated naphthalenes?
A. Yes, but I'm not sure that it would be the same
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as this, as PCB's.
Q. How about dioxins?
A. No.
Q. Furans?
A. No.
Q. Chlorinated benzenes?
A. I don't know that.
Q. How about other chlorinated hydrocarbons?
A. But there's a big range on chlorinated hydrocarbons that you can't take --- You have to look over the whole gamut before you decide.
Q. Would it be fair to say that you would look at all of these other possibilities with which you were familiar in order to see what they're known to cause in making a diagnosis in this person?
A. Yes. MR. COHEN: You want to mark this, please.
(Reporter marked Plaintiff's Deposition Exhibit (Roush) 7.) Q. Did you ever see this document before? A. It's got my name on it. Q. You notice that down at the bottom there are two
series of numbers, SCM77226 andPRR43367? A. Yes. Q. Notice that the next page is numbered SCM77227
and PRR 43368, and the next page is again numbered in
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sequential order? A. Yes. Q. Now, do you also notice that the first page ends
in the middle of a sentence, and it doesn't start again on the second page?
A. Yes. Q. Do you think that was the condition of the document when you got it back in 1975? A. I don't recall. Q. Do you recall receiving this document? A. No. Q. Do you recall having a meeting to discuss the results of a rat feeding study completed by Dr. Kimbrough? A. I know we talked about her study, but I'm not sure I did it in the presence of all these. Q. P. L. Wright, is that Paul Wright? A. Paul Wright. Yes. Q. Is he the chap who worked first for Monsanto and then for Industrial Bio-Test and then came back to Monsanto again? A. Yes. Q. He had worked for Monsanto prior to the time Monsanto gave research work to Industrial Bio-Test? A. That was before my time. Q. When he was here, at this time in '75, was this
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after he returned from Industrial Bio-Test? A. Yes. Q. Was he supervising any of the work at Industrial
Bio-Test for Monsanto while he was there? A. I don't know. Q. Did you ever review any of the work done by
Industrial Bio-Test to see if he had supervised that work or participated in any way in that work while he was there?
A. Levinskas was the one who was supervising the Bio-Test studies.
Q. Where is Levinskas now?
A. He's retired.
Q. Do you ever see him?
A. Yes.
Q. Do you know where he lives?
A. Close to Monsanto.
Q. Do you have an address for him?
A. I don't have his address. We can get it.
Q. Is he in the white pages?
A. I'm sure it is.
Q. What's his first name, George?
A. George.
Q. And does he live in the City of St. Louis?
A. No, he lives in Creve Coeur. It's a suburb of St. Louis.
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Q. What's it called? A. Creve Coeur. Broken Heart. Q. How old a man is -- Is it Dr. Levinskas? A. Yes. Q. Medical doctor? A. No. Ph.D. Q. Ph.D.? A. Yes (nodded). Q. How old is he? A. He just retired a short time ago. Q. Is he about 65? A. 67, I think. Q. Do you remember that cancerous cells were observed in a certain number of Dr. Kimbrough's laboratory animals? A. Yes. ' Q. You see the page that's marked as page two? A. Yes. Q. According to this document, you had a number of responsibilities here. A. Yes, I did. Q. Item 1 is, "Publish the results of the Monsanto studies conducted by Industrial Bio-Test Laboratories." What was the purpose in doing that; do you know? A. To get the information out of the data that had
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been gathered by Calandra. Q. He's the chap at Industrial Bio-Test; right? A. Right. Q. Was. As of 1975, how old were those studies; do
you know? A. A couple of years. Q. Had you ever published them before? A. No, they were Bio-Test studies. They were the
ones who had to publish it. Q. Had they published it before? A. They had published other things, but they didn't
publish this. Q. So they had not prior to 1975 published their
studies? A. This study. Q. That's right. This study referred to on page 1,
similar studies; is that right? Similar to Dr. Kimbrough's studies?
A. Yes. Q. So they had notpreviously published it andnow you wanted it published; is that right? A. That's right. Q. Was that in anattempt tocounter theresults of Dr. Kimbrough's study? A. It was to get the information out to the public.
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Q. Item 2, "Obtain services of cancer specialists to review both studies and interpret significance to current PCB applications." Did you do that?
A. Yes. Q. Who did you get? A. Dr. Pour, P-O-U-R, from the University of Nebraska. Q. And did he do a study? A. No. No, he wasn't supposed to. He was supposed to interpret these studies. Q. Were the results that he -- Were his results ever compiled in a document? A. Yes. Q. Where is that document? A. They were given to the Washington scene. They were given to FDA. Q. EPA? A. EPA. Q. What were Dr. Pour's results? A. That there was cancer found, but they weren't the same, exactly the same as those of Kimbrough. Q. Now, whose study was he interpreting, Kimbrough's? A. IBT's as well as Kimbrough's. Both. Q. Now, do I understand that the IBT interpretation
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was that cancer was not found? A. No, no. They found cancer. Q. So in other words, both the IBT study as
interpreted by IBT and as interpreted by Dr. Pour showed cancer in animals fed?
A. One species. Q. Sherman rats? A. I don't know whichrat it was. Q. The species of ratsdeveloped cancer? A. Yes. Q. And then Dr. Kimbrough, in her studies, found in a species of rats cancer, but a different lesion? A. She had found cancer in the same species. I don't recall what more than that in way of an interpretation. Q. Where are those results of Pour's work now; do you know? A. No, I don't, but they were given -- We took them to the Cancer Institute as well and talked to different agencies. Q. Were any of those lesions metastatic? A. No. Q. Were any of the animals allowed to survive long enough to see if the disease would metastasize? A. I can't answer it without qualification. Q. Tell me your qualifications.
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A. I think it was long enough to do that. Q. You think the animals were allowed to live long enough to have allowed the disease to metastasize if it was going to metastasize? A. Yes, and that's kind of the way the liver acts. That's the way the liver acts. Q. What? A. It doesn't metastasize very much. Q. It does not metastasize very much? A. Right. Q. And is that in any kind of cancer to your knowledge? A. Liver cancer. Q. Does not metastasize very much. A. Yes (nodded). Q. And that's in man andanimals? A. I can't answer that in all animal species. I don't know. Q. In man, though? A. That's right. And it was also true in the 1260 study. Q. And how about the study done by IBT, was that a 1260 study? A. That was all species. There were other Arodors besides 1260.
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Q. So IBT tested other Aroclors besides 1260 to see if it would develop cancer. Did all of the Aroclors that they tested produce cancer?
A. No. Q. Which Aroclors did? A. 1260. Q. How about 1254? A. I don't think so. Q. Was it tested? A. I can't answer that. Q. How about 1248? A. I can't tell you which ones were tested. Q. So, you don't recall? A. No. Q. But the 1260 did produce cancer? A. Yes. Q. And it was the same species of rat as used by Dr. Kimbrough? A. I can't answer that. Q. You don't know, but you do know that the lesions were different? A. No, I didn't say that. Q. I'm sorry. I thought you did. A. No (nodded). Q. Same lesions as found in Dr. Kimbrough's study?
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A. I think so. Q. What was the difference then in the results between Kimbrough's study and IBT's study? A. I don't know, but there were differences. Q. Was it the difference in frequency percentage? A. I can't answer the question.
Q. But you do know that Pour's work was reduced to
writing and apparently -- A. And transmitted.
Q. -- to the National Cancer Institute?
A. To agencies, right.
Q. How about EPA?
A. EPA.
Q. Where's the National Cancer Institute located?
A. National Institute of Health?
Q. No, no. National Cancer Institute.
A. That's part of the National Institute of Health. It's all in Bethesda.
Q. Item 3, "Obtain National Cancer Institute interpretation." You were supposed to do that?
A. Did that.
Q. Did you?
A. Didn't get a reply that was helpful.
Q. What was their reply?
A. I don't recall.
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Q. When you say not helpful, not helpful to whom, Monsanto?
A. Didn't give us any interpretation of the two studies.
Q. Do you believe that the results obtained by Dr. Kimbrough in that study and by IBT in their study are good results?
A. Yes. Q. So you believe that in the dosage that was utilized in those studies of Aroclor 1260, that Aroclor 1260 will cause cancer of the liver in that strain of rats? A. Yes; and the dose that was used was in the order of 50 ppm. Q. In both your study and in Kimbrough's study? A. Yes. Q. Did you and Mr. Pappageorge and someone by the name of Easley discuss these tests with NIOSH, OSHA, EPA, and FDA? A. That's what I just said. Q. I'm sorry. I was referring to the National Cancer Institute interpretation. A. Yes. Q. So you did both? A. Yes. Q. You talked to National Cancer Institute, and you
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talked to NIOSH, OSHA, etc.?
A. Right.
Q. How about number 5, did you discuss these tests
with your key customers?
A. I didn't.
Q. You did not?
A.
Q.
it?
No. It was designated as your task, but you didn't do
A. That's right.
Q. Who did do it?
A. I don't know, but I would suspect it was
Papageorge or Gossage.
Q. T. L. Gossage, who's that?
A. One of the people with business.
Q. Not in Papageorge's department?
A. No.
Q* Who were the key customers? Do you know who they
were referring to?
A. No.
Q. Would they have been the G.E.'s and
Westinghouses?
A. I'm sure it was.
Q. Is it your belief that some time in 1975 G.E. and
Westinghouse was advised of the results of both Dr.
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Kimbrough's studies and the IBT studies?
A. Yes.
Q. Next was 6, "Complete WGK" -- That's the
Krummrich plant?
A. Yes.
Q. "Employee exposure study." Did you do that?
A. Yes.
Q. Who worked on that?
A. That's Johansen.
Q. Johansen?
A. Yes, before Zack joined us.
Q. And who was Johansen?
A. A toxicologist.
Q. Not an epidemiologist?
A. No.
Q. Johansen, is that a man or woman?
A. Man, Fred Johansen.
Q. Was it an epidemiological study that he was
doing?
A.
Q.
studies?
Yes. Had he had experience doing epidemiological
A. No.
Q. Did you look over his work?
A. Yes.
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Q. Were you satisfied with his work? A. We had difficulty interpreting. Q. In other words, you didn't know what the results meant? A. We did some work and I've forgotten what it was with them. Q. What did the results show? A. I don't recall. Q. Where is that test? A. I don't know. Q. Where's the raw data?
MR. MALIN: Do you know the answer to his guestion, where's the raw data?
A. I don't know. MR. MALIN: The answer is no. He doesn't know.
Q. Do you think any of those classification errors that we discussed earlier this morning in connection with Dr. Zack's work on the Nitro, West Virginia plant occurred in Johansen's studies of Krummrich?
MR. MALIN: Objection to the form. He didn't admit that there was ever -- there were any such classification errors or that there were any at all.
MR. COHEN: I didn't say that he did. I said that we discussed in connection with. I was giving that to him as a reference. Would you like me to rephrase that,
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doctor?
A. Could you now? Yes, please.
Q. Do you recall this morning we discussed the possibility of classification error in epidemiological
studies between cohort groups and other groups?
A. Yes.
Q. And we discussed that in connection with Dr.
Zack's work at the Nitro, West Virginia plant.
A. Yes.
Q.
Did you detect any sucherrors in the
work done
by Johansen?
A. No, we did not.
Q. Do you recall that Johansen's studyshowed four
deaths attributable to lung cancer out of 23 deaths with an
expected rate of 1.24 deaths attributable to lung cancer from
the 1969 U.S. Male population?
A. Yes. Q. Did you think that was statistically significant?
A. It's very difficult to interpret lung cancer in
the population without knowing smoking, without having
background levels in that immediate area. We had an excess
of lung cancer in that area anyway; and there is in that
Krummrich area an excess of lung cancer. Q. You're saying that the population of Krummich had
an excess of lung cancers anyway?
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A. All I'm saying is there were things that made us
have difficulty in interpreting the lung cancer problem and
then we struggled with that and wished we had an
epidemiologist.
Q. Did you ever publish the results?
A. No.
Q. I think I asked you, you don't know where the raw
data is anymore?
A. I don't know.
Q. Did you work with Johansen -- Was it Dr.
Johansen?
A. Yes.
Q. Ph.D.?
.
A. Yes.
Q. Did you work with Johansen in an effort to rule
out the other confounding factors like smoking and that sort
of the thing?
A. Yes.
Q. Did you have any success?
A. I'm not sure how we went to the next stage, but
we continued on.
Q.
Let me showyousomething.
Tell meif you recall
it.
(Colloquy held off the record.)
(Reporter marked Plaintif's Deposition (Roush) Exhibit 8.)
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Q. Have you had a chance to take a look at Exhibit
8?
A. Yes.
Q. What is he referring to when he says highly
significant . . . cni X squared?
A. That's --
MR. MALIN: It's chi squared. It is a standard
statistical method for determining significance of some kind.
MR. COHEN: Can I have the testimony from the
witness, please?
MR. MALIN: It's not cni.
MR. COHEN: It looks like cni.
THE WITNESS: The top of the "h" is cut off some
way.
Q.
(By Mr. Cohen) Okay. Chi X squared. What does
that mean? Do you know?
A. It is a test of significance.
Q. Does this indicate statistical significance?
A. Yes, that's what it says. In excess of lung
cancer. Q. A.
Was that conclusion of this study by Johansen? I think we did something else. There should be
another sheet of paper after this. Q. You sent this out for evaluation by an outside
contractor?
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A. I don't remember what we did. We did something
with it.
Q. Were you satisfied with these results or not
satisfied with these results?
MR. MALIN: I object to the form of the question.
I don't know what you mean by satisfied.
Q. Did you think that this was a well done, well
conceived, well carried out study that had results that are
worth relying upon?
A. No, that population is too small. Any time you
have a population as small as 23, you're going to have
movement one way or another; and it's difficult to interpret
by itself. We really have to take another population that's
equal to it and study it.
Q. Well, the actual population was 311; wasn't it?
A. Yes.
Q. And then you ruled out all those people who
worked there for less than six months?
A. Right.
Q. That left you a population of 140?
A. Right.
Q. Of which you had 23 deaths?
A. Yes.
Q. That's what you werereferring to as the 23?
A. Yes.
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Q. Of which there were actually six who died but two
were ruled out. Was that right?
A. Yes.
Q.
So that left you with
four?
A. Yes.
Q. And your conclusion is that that was too small of
a population to rely on this study?
A. Well, we didn't know what to do with it because
it was so small. (Reporter marked Plaintiff's Deposition (Roush) Exhibit 9.)
Q. Doctor, let me show you another document. Have
you had a chance to look at this document 9?
A. Yes.
Q. Did you have any participation in the preparation
of this document?
A. No.
Q. Had you ever seen it before?
A.
I don'tthink
so.
Q. You neverrecall seeing it prior to today?
A. No.
Q. So, it would be fair to say if I asked you if
this was ever used, you wouldn't know?
A. That's right.
MR. MALIN: He was the medical director. He
didn't sell PCB's, and he wasn't in the business department.
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And this is a contract provision, so I think it's fair to assume it's not in his area of responsibility or knowledge. (Reporter marked Plaintiff's Deposition (Roush) Exhibit 10.)
THE WITNESS: What about the date of these two? MR. COHEN: The date of this is September 17, '75. THE WITNESS: Yes. MR. COHEN: The date of the other one? THE WITNESS: Yes. MR. COHEN: You said you didn't know anything about it. THE WITNESS: I'm trying to see. MR. MALIN: He's not asking you a question. Q. (By Mr. Cohen) Your counsel made this nice speech, but if you don't know anything about it, I'm not going to ask you anything about it. Have you had a chance to look at number 10? A. Yes. Q. What can you tell me, sir -- Strike that. You're the author of number 10; correct? A. I'm the one who signed it. Q. Did you write it? A. No. Q. Who wrote it? A. I can't answer that.
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Q. Down here where it says, "GR/ln," doesn't that indicate you dictated it?
A. That says the things that will be done in the second paragraph, I will do that. This up here I didn't write that.
Q. Did you normally sign your name to things that you hadn't written?
A. Yes. If I was in agreement with it and the fact that I would have to -- the effort that's required in the second paragraph is ours, the medical department's.
Q. I see. So the first paragraph was information that was supplied to you; is that right?
A. Yes. Q. By someone on your staff? A. No. Q. Someone outside of Monsanto? A. No, no, in Monsanto. Q. Oh, but outside of the medical department? A. Right. Q. And you incorporated it into your memo? A. That's right. Q. What if any activities did you have or anyone in the medical department under your direction or control have with respect to any state or federal agency in formulation of legislation controlling PCB's?
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A. My department had no responsibility with contact. Q. So, you did nothing? A. Did nothing. Q. With respect to EPA or FDA, NIOSH, anybody? A. No. Q. You did not participate in any way in efforts to change or modify proposed Toxic Substances Control Act or anything else? A. That's right. Q. What did you mean by, "We will have to do much more epidemiology in the future although clear cut conclusions are almost impossible." A. The workers in our plant had not had any epidemiology studies done on them, and there were a number of them which we could be talking about to make sure we don't have some long-term health effects that we were missing; and this is only a demonstration. Q. Well, you said you were doing long-term health effects -- I'm sorry. Strike that. Questions from outside Monsanto about the long-term health effects of chemicals used in two Monsanto plants on the workers in the plants have required organization of epidemiological studies. What studies are you referring to? Was one of them the Johansen study? A. Yes.
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Q. Any others that you can think of?
A. I don't recall.
Q.
You don't recall. You say,"We will
have to do
much more epidemiology in the future although clear cut
conclusions are almost impossible." What did you mean
although clear cut conclusions are almost impossible?
A. The statistics of epidemiology make it difficult
to explain small variations that appear big on small
populations?
Q.
I see. And that's an inherentlimitation
in
epidemiology itself?
A. Yes. MR. COHEN: Thank you. Anybody wish to examine
the witness?
MR. BURNS: No.
MR. GIORDANO: I have no questions.
MR. KUHL: I have no questions.
CROSS-EXAMINATION
QUESTIONS BY MR. MALIN:
Q. I just have a few to clear up some questions.
Doctor, after you came to Monsanto in 1973, could you give us
an estimate of how much of your time you spent on issues
involving PCB's if that's possible?
A. A very small portion of my time.
Q. Could you break it down any better than that,
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less than five, less than 10? A. Less than five. Q. And why was that? A. I had responsibilities to do and many things I
assigned out to be completed by someone else. Q. Well, you had otherresponsibilities besides
PCB's; is that correct? A. That's right. Q. What other responsibilities did you have? What
other types of chemicals or divisions did you have responsibility for? What other types of chemicals or divisions did you have responsibility for?
A. We were involved in the Keller trial as a major project.
Q. Anything else? A. Some efforts with the ag products. Q. Monsanto makes agreat manyagricultural chemicals; does it not? A. Right. Q. And you had responsibilities in all those areas? A. That's right. Q. Approximately how many other products were there for which you had responsibilities, if you recall? A. I can't answer that. Q. Well, during your tenure as medical director of
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Monsanto, were you aware of any adverse health effects among Monsanto PCB workers?
A. No, none. Q. Do you believe that you as medical director during the period of time that you were there, that '73 to '88, did everything that was reasonable to determine if Monsanto's workers who worked on PCB products experienced any adverse health effects? A. Yes. Q. During your tenure as medical director, were you aware of any reports of adverse health effects from people outside of Monsanto who were the users of PCB fluids? A. I don't recall. Q. Well, do you recall receiving any reports of adverse health effects? A. On Monsanto products? Q. From Monsanto PCB products. A. On PCB's, the question of people being exposed to the product and wanting to know whether they're going to be adversely affected or not. Q. Were there actually reports of actual adverse effects, of people sick? A. No. Q. Doctor, do you now consider PCB's to be a human carcinogen?
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A. No.
Q.
Did the -- Strikethat.
DidMonsanto follow
your
recommendations for determining whether or not Monsanto
workers, in fact, had any adverse health effects from
producing PCB's?
A. Yes.
Q.
Werethere ever anyrecommendations that
you made
for studies or otherwise that they did not follow?
A. No.
Q. Do you know of a single case of PCB poisoning
during your entire tenure as medical director, either inside
Monsanto or outside Monsanto?
A. No.
MR. COHEN: I object to the form. I object to
your leading your own witness.
MR. MALIN: We're not leading our own witnesses.
He's a subpoenaed witness.
MR. COHEN: Not only is he your witness, he
testified that you represent him. I don't know how much more
of your witness he can be. Q. (By Mr. Malin) Do you consider that Monsanto was
|
adequately staffed to handle any inquiries that were made from the outside on PCB health effects or PCB usage?
j
MR. COHEN: I object. Same objection.
Q. You may answer the question.
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A. Yes. Q. What kind of a staff did you have? Would you describe the staff, its size, and its composition with the extent you can remember? A. Well, the industrial hygiene had gone to the place where we could monitor what was taking away of exposure in each one of our plants. We have got it recorded. We set up a medical surveillance program and got it so that we could record the data and have it transmitted electrically into headquarters, so we could look at the data in a relative PC form. We set up and put together a toxicology laboratory and had something of the order of a hundred people or more working in that facility, doing the studies that was within their province of being able to do, because a lot of toxicology is very specific and people who do it only do one little precise study. And we also developed our epidemiology to a reasonable form under Dr. Gaffey. Q. Do you believe that it's possible to extrapolate from one species of animal studies to determine human causation with respect to any disease if we assume that the animal studies are from especially sensitive animals; they are high dose, and -- well, all right -- especially sensitive animals; and they are high dose?
MR. COHEN: Objection. I object not only to the form of the question, but I object to it being a hypothetical
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and assuming a whole bunch of facts that may not have any relevance to anything in this case.
MR. MALIN: You may answer the question. A. We had the facilities developed so that we could do the animal studies and we could follow the workers with their exposure to see whether they're responding the same. So we knew quite well whether the animal data was related to human exposure or not and we could make the judgment based on what we got. Q. Did youmake any such judgment? A. Lots of times.
MR. COHEN: Same objection. Q. You have not been hired as a consultant by Monsanto in this case; have you?
MR. COHEN: I object to the form. A. No,I have not been hired. Q. And you don't have the authority to speak on behalf of Monsanto in this case; do you? A. No.
MR. COHEN: Object to the form. Q. You're hear as a subpoenaed witness. Doctor, you were asked whether or not you knew of trace levels of impurities such as anthracenes, naphthalenes, phenanthrenes, polychlorinated dibenzofurans in PCB's during the 70's. Would it have made any difference to anything that you had
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done had you known about the existence of those impurities? MR. COHEN: I object to the form.
Q. You may answer the question. A. We have looked at the history and the data that's available on human poisonings, primarily Yusho, and we did not see anything there, but we did say that we had to have some other effect besides PCB and the dioxin to be causing the Yusho incident. The workers exposed to PCB's did not show that they had any response to PCB's at the levels of presence in the work place. Q. So therefore, even if we assume that these impurities were there, they made no difference.
MR. COHEN: I object to the form. A. In terms of the fact that if there was sporadic cases of chloracne, and those sporadic cases of chloracne occurred where there was a possibility of some other contaminants that was producing the effect. Q. Were there any cases of chloracne while you were with Monsanto? A. No.
MR. COHEN: Object to the form. Q. Do you yourself know of any cases of chloracne that occurred while you were medical director of Monsanto anywhere?
MR. COHEN: Object to the form.
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A. No.
MR. MALIN: I have no further questions for this
witness.
REDIRECT EXAMINATION
QUESTIONS BY MR. COHEN:
Q. Earlier, doctor, in response to a question put
to you by your counsel, you said that you do not presently
consider PCB's to be a carcinogen; is that correct?
A. Human carcinogen.
Q. Is that what you were limiting it to?
A. Yes.
Q. Do youbelieve it to be an animalcarcinogen?
A. Yes.
.
Q. Is that onlyin certain specialstrains of
animals?
A. Yes.
Q. Do you believe those to be animals that were bred
to be particularly susceptible to this particular toxin?
A. No.
Q. Then what makes them a special strain?
A. They're responding to this and the others did
not.
Q. So it's just that they did respond. You don't
know that they were bred or have any particular genetic
predisposition to?
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A. That's right. There's something else that makes that one respond to dose.
Q. And it happened in that particular animal? A. That's right. Q. Now when you said that you don't consider PCB's to be a carcinogen, are you speaking of just the PCB's or are you talking about the commercial production grade compound that you were selling, such as 1248, 1254, 1260? A. Commercial grade. Q. That includes then whatever it is that's in there. You don't consider it to be carcinogenic in humans. A. That's right.
MR. COHEN: I have no further questions. RECROSS-EXAMINATION
QUESTIONS BY MR. MALIN: Q. Just one last question, doctor. With respect to
animal carcinogenicity, do you believe that all PCB mixtures are animal carcinogens in this special species of animal or rat or whatever it is, that is whether it's 1016, 1242, 1254, or 1260?
MR. COHEN: I'11 object. I don't think he said that at any time. He said -- I think he said 1260 was the one which proved to be carcinogenic.
THE WITNESS: Yes. Q. It's only 1260; isn't it?
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A. Yes. MR. COHEN: Object to the form of the question.
DIRECT EXAMINATION QUESTIONS BY MR. D'URSO:
Q. Doctor, you mentioned the attempts to improve the data collection, epidemiology and toxicology efforts that
were made under tenure. All these efforts --
A. Yes.
Q. they not?
A.
were designed to protect Monsanto workers; were
MR. MALIN: I object to the form of the question. Yes. But also to understand the chemical because
we do have a responsibility to a customer. That was one of
my assignments.
MR. D'URSO: Thank you, doctor. MR. COHEN: I want the witness to read and sign.
I want all exhibits attached.
GEORGE ROUSH, JR., M.D. Subscribed and sworn to before me this ________________ day of , 1992. My commission expires .
Notary Public
(TMS/PAOLI RAILROAD YARD PCB LITIGATION)
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HARTOLDMON0030739
NOTARIAL CERTIFICATE STATE OF MISSOURI)
) CITY OF ST. LOUIS)
I, TINA M. STUMPF, a Certified Shorthand Reporter and a duly commissioned Notary Public, within and for the State of Missouri, do hereby certify that there came before me at the offices of Brown & James, 705 Olive Street, 11th Floor, St. Louis, MO 63101,
GEORGE ROUSH, JR., M.D., who was by me first duly sworn to testify to the truth and nothing but the truth of all knowledge touching and concerning the matters in controversy in this cause; that the witness was thereupon examined under oath and said examination was reduced to writing by me; and that this deposition is a true and correct record of the testimony given by the witness.
I further certify that I am neither attorney nor counsel for, nor related or employed by, any of the parties to the action in which this deposition is taken; further, that I am not a relative or employee, of any attorney or counsel employed by the parties hereto or financially interested in this action.
IN WITNESS WHEREOF, I have hereunto set my hand and seal this day of , 1992.
My commission expires February 1, 1994.
Notary Public
HARTOLDMON0030740
T BY'.KOHN. SAVETT. KLfciNWiKAri nri UNHID STATES ENVIRONMENTAL PROTECTION AGENCY Washington. ox. amo
, j* tcu3^*t'r a*o fvi<il*.ev
date?
rterumry IS, 1990
SUBJECTi
mom
Newly Revealed Fraud toy Monsanto in an Epideoiological
SbuOy Used to? EM to Xiiua Huun Health Effects I tom
Dioxins
.
Cat Jenkins, PhD. ' Chesiit, Huia omr^rmimtlm Branch ids ssii Characterisation and Xoaeement Division
TOs Haymnd e, tmhr, Chair, Executive mmiimm Science Mvieory SMra (A 101) ofMe of tut toihiitrmte?
On tfovesoer 21, 1119 you transmitted to tilt Administrator a reviw oy the science Advisory tort (SABI* of x Cancer Wrtspecific tot Estimate for i.J^.S-TCOD.** This review concluded that th existing epitolologic studies vtrs conflicting* and did not provide definitive data on mum health effects of dioxins, and thus ESA should continue to utiiin wimi toxicologic data as a basis for diwdn risk aaaeaaaentsa
A key epideniolefical study leading to dill eensAUtisn was performed by fimmmm corporation* This stu^ vsMlaad medical records were tRiaiiiai of wployves pOM to diOXlna IfOm ft 1949 explosion of l*4,l~triebirepim0l MmUKtdriiif process, eM
1 U.S. EPA, Soic&ei Advisory to!, M Ees pioidjt Panel (HovBtoir 21, IfII | BwfiM of Draft Don menu * cancer Mskiptcific to# EMdmta for i,a,7,i-fSBB and "sntlaaclag Exposure to 2,3 ?*8a,1CDDa
* tf.3. EH, Office of Bonltb and Bttviroxwmt&i Assetiimeut <June* LSll) X cancer Risk-specific Doee Batlsme for 2,3,7,S rau,m Publication Bo. EPA/flOO/a-ee/0071U,
M*K
E* Dibit i2-
HARTOLDMON0030741
ui rwniii yAVu ii r\wuAiyfvnj i i~ i i~oi * iwtw
4.W V (WWW
tmiM no statistically iignifleant axceu cancsr dsatlu.J The Monsanto study was ii^orxaitt, since although the exposed population w* rau (lZl workers), exposure to dioxins was claariy escabilsned bsciuae the workers experienced chloracne. other studies were confounded by the fact that exposure to dioxins was not so denonstrsted.
in Appendix i of A csnesr Risk-Specifle Dose estimate for 2,3,7,8-TCDD" this Monsanto study is discussed in juxtaposition with other studies on snail populations where excess cancer morbidity and mortality were in fact found, as a result tnt studies where excess cancers wers observed were rendered suspect. Por axanple, B, discussed in the mam wmxmm tbe fact itfuit although the studies by mtoea t ai. and imuot et si.3 reported statistically significant excuses of itoaacn cancer* tnt study by ttonsrot did not* OK dmeuiMa the fact that significantly elevated levels Of cancers (a^ot prostate, nonHcdfkia* lywphona, connective tissue, soft tUsm sarcoras, reumun ceil sarcom, kidney ctactr, etc.) had been found in other iloMln-expOMd populations* The study by Monsanto, however, either did not find m such emeus, or the emeiri observed were not statistically significant.
This study by ustsanto apparently ham mmi Iseen sbeua to be a fraud. Attached is a brief filed by the plaintiffs in a case where dtmaees are being sought rasuiting from a spill of dioxlncontinat@fl paaticblornpnawl mod preservative by Monsanto. This study a behalf of Moment is daegfitotd, where it is
1 zoh, J.a. and i.i. ouaxind Uteos me Mortality kKporimo of iforkero boosed to fetraQU-oroillbiismodioxiii in a Trichiorophenoi process xceiamt. j. oceup, Med. Z2(l)ili*i4*
4 Thleas, A.H,, i. rrentsei-Beyne, and x. Unk mill Mortality study ot Person* exposed to Dioda in a Tricfaiorophenoi-Prociti ftecldrat that Oewtrred in the nor xo on Noveabtr 17, 1983. Xa. J. lad. Med* 3*179-119.
5. mmlsmio 0. 11911, Ja*u 21) Mobobtals of the final deport on Cmmm bar tbn loyal coMlaslon en tie de and Bfieots of Chmicai ipomta on Australian pericmol la Vietnam. DeparMnt . of Occupetlrraol IMloine, university Hospital, Oniversitetet Lintoplaf, Liakeping, awodsn*
1 Plalmtiffs-ftppeileea* Brief (October 3, 1919) franca* . Samar, an_ai. j* ftsnaanti ceaptsy, Appeal fro* the Circuit court of it. Clair county, Illinois, No. I0-L-970, filed by Ux Carr, CAM, MB, TOLM, ili( HHOr, 031 6 MOOD, 411 Missouri Avenue, mm it. Lduii, tt ftZ201 i&d Mram N, . Seigfriea. SXUntXlS, BUBGE, LEOKMETX fOBUOm, P.O. BOX ISO, 123 Bast Jocrnm St. ( Mexico, MD 52*5-0110.
2
HARTOLDMON0030742
BT fSUMNi ahvei ii ALeAn&ufWi /-1 /-o i i iw*i
few V IW*
alleged tSiafe the record aenenstreted a. deliberate course' of
conduct by Monsanto through "altered* rttue& to prove to the world that the only health oonsoquanct of dioxins vu Ctt relatively harmles*, revereible condition of chloracne. The cross examination of Dr. Roush ttedleal Director of Monsanto, was caid to clearly eotmblleh the fraudulent nature of tno cancer, mortality study by Dr. Sack, a Monsanto e^loytt, mm. an "Independent* researcher, Dr. dusking, described as Having performed "joint" studies with tsonaanto.
to tar liar, predecessor study performed by Or. lack ism
alleged to have deliberately and movingly omitted 5 deaths from
the group exposed to dioxins in the 1141 accident, while removing
4 workers who hid bam imosed and putting thast workers in the
untJTOied group, serving to provide tn appimt incraen the
cancer death rate in the unexpond group. At menJJL canoar
death rate was alleged to have actually been ii% ffittii in the
exposed population, with 141% higher lung cancers, 109% higher
genitourinary cancers, *% higher bladder cancers, end 92%
higher lymphatic cancers.
The Monsanto study performed by 0f auilisfl Oh vomers . expoaad to dioxins in the 1949 accident, puDlilhed In 1980 in the
journal of the Mericsn medical Association mi the atm year. In
me journal of occupational Medicine with Dr. lack u eo^anttsot
(this vis the study wan reviewed by DAI, was nine alleged to he
fraudulent, it vu claiirad that the actual medical records
rtva&itd gross miselassifieatimas and eniaiiou. me correct
classification was said to have been 21 esnear in the exposed
group compared t miv 2 in the imaxpoitd group* Mskind reported
14 cancers in the
grot and I in the miimpased group. In
addition, it was alleged that In novestber of lfll, Dr. susklnd
colluded .with mmmto to conceal, findings of peyoheneurosei In
the exposed workers fra the Workers eemptnaatioii dtwission.
Dr. fusklnd um alleged teo hive felseiy stated that workers"
nervous eyetta mm liver problem had disappeared by 1S3, with
tli stated intention by Suskino to sni tM world Milov that
only a IIV of tbs wrtfUV COUtlmed to htff pfOblOIS, Df.
Sanmina, was reported m acttwtaedfihf to tM Court that the world
and tM scientific coMnuty were intended to, and Indeed tad,
rtiied'tpn his reports of no adverse cmeir affects from toam
exposures to diimifiae
It la a cowaly bandied Mage that tai5siu have asi hem dasnonttratid to Im cammed esm In taws, despite exposures. Perhaps tMm My m been mm m ytt another 'elfi industry tale1 in light of the fend allegedly cossilttad by tensanto in contactlap its research on its worttra exposed to dioxin!. it could be ttat otter studies on t|oM populations m similarly flame* tad subject to frsd.
3. ate.
HARTOLDMON0030743
X request that the ttl on It own, or by way of direction co EA'i Office of Research ana Development, obtain thi full flies iron the ongoing cast against Moannoe to dewnairi* whether definitive ooociittiona m? now be drawn regartinf th evidence establishing a eauaai link between dioxins mat ntma cancar in the Monsanto population. X believe that an audit of other dioxin-related Hainan epideniologleal Studies should bo ptrfOfmd, to detarmlno whether alacisaaif lcation of nodical records ft other errors hu resulted in itmUtriy flawed conclusions. Studies that would be particularly prone to bias would be then periaraw by any manufacturing fin on its om wloyees, or In conjunction with an outside ressarcfcsr, since s positive finding of @xom cancer mortality or morbidity would result in the financial liability of that firm.
cat Donald a. bsxnes, 7R.O. Director, science Wiiory Board (R 101) Office of tm AAlAlstrator Hugh itoUanm, Ph.D. Director, Hunsa Health MHaasit mop tm iiS Office of Research and Devaiopsesat Peter H. freuse, m.D. Cbtimsa, Interoffice Iterlifrettfi for a cmnrnt Risk-tpeaific Dose Setiste for
4
HARTOLDMON0030744
DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE
Puaue HEALTH SERVICE
FOOO and drug administration WASHINGTON. O C. WW
December 23, 1974
Dr. Jems Hi sure Monsanto Company 800 North Lindbergh St. Louis, Missouri
63166
Dear Dr. Mieuret .
In response to your recent request made te John Roach, I am enclosing a copy ef the presentation made at the October 1974 AOAC Meeting, entitied "Finding of Chlorinated Dibenzofurans in Aroclor PCB's of Recent Manufacture." Additional work to determine the levels of chlorinated dibenzofurans in the Aroclers is now underway in ear laboratory.
You are probably aware that evidence for chlerlnated dibenzofuran contaminants has been reported for PCB's made in France and Germany, by Vos, and in Japan, by Reach and Pemerantz, prior to our recent findings in the 1200 Series Aroclors. Yeu may have considered, as we have, possible means by which the chlerinated dibenzefurans are
formd. Can you please tell us whether the parent dibenzofuran has been looked for or found in the starting biphenyl? Are hydroxylatsd, chlorinated biphenyls, conceivable precursors to the dibenzofurans, present in the Aroclors? Are they formed in a base treatment step (lim or alkali) after chlorination? Perhaps there are alternative explanations for which you have seam experimental support.
Your discussion of these points would be welcome and I leak forward to your response.
Sincerely,
Mtsloatife
We s
anaD*
Director
Division of Chemical
Bureau of Foods
Technology
(HFT-420
pRR 004361
HARTOLDMON0030745
2
Th procedure used in the current work was a considerably modified version of that applied earlier to the analysis of Kanechlor 400. Th current procedure used three types of adsorbent columns for sample preparation.
Call for Slide 1. (Flow chart of sample preparation)
Th alumina column was SO g of WOELM W-200 alumina which was eluted
with 400 ml of 17.
methylene chloride/hexan followed by 400 ml of 20Z methylene chlorid;
hexane. The 207. eluate containing the material of interest was then
concentrated to less than one ml prior to addition to an alumina micr:
column.
.
Th micro columns were disposable plpets of roughly 5 mm bore into vh a small wad of glass wool had been inserted to retain the aluminum ox W0ELM W-20) alumina was poured into the columns to a depth of 2.5 cm. micro eolutns were eluted with 10 ml of 1Z methylene chloride/hexcr.e and 6 ml of 20Z methylene chloride/hexane ,
Prior to th Fldrisil column, eluates from two, 100 mg Aroclor portio:
ach being lass than one ml, wer combined. Th Florisil
column was 8 g of 60/100 mesh PR grade Florisil which was eluted with
1 of hexane and 100 ml of 5Z ethyl ether/hexane. The latter eluate
was concentrated to less than 20 microliters and was never permitted
go to dryness.
,^
PRR 00*3t
HARTOLDMON0030746
-3-
All for Slldo 1, The concentrated cluatcs were analyzed by conbined gas chromatography/.-- s c spectrometry using a Finnigan 1015 quadrupole mass spectrometer interfaced thru a Gohlke all-glass jet separator to a six-foot by two millimeter bore 3% OV-101 column at 200C with a helium carrier gas flow of twenty milliliters per minute. Mass spectra of authentic chlorinated dibenzofurans were obtained under identical operating conditions using a mixture of mono-, di-, tri-, and tetra- chlorodibenzofurans kindly provided by Dr. Albert Pohland of FDA. A summary of the results for each Aroc lor sample analyzed is given in the following slides. In each ease, the mass spectral data obtained for the chlorinated dibcncofurans included the parent ion uad fragment ions derived from losses of CO + Cl. Taken together, these data are considered characteristic for the chlorinated dibenzofurans. Each analyzed extract also gave eviden of soon chlorinated biphenyls indicating the column separation procedure uaed did not completely separate Cl-DBF from the chlorinated biphenyls.
PRR 00^3'
HARTOLDMON0030747
-4-
In each Aroclor found Co contain Cl-DCF, the level of contamination was estimated to be in the ppm range. Studies are now under way to obtain more meaningful quantitative data on the level of Cl-DBF contamination.
Call for Slide 2. along
Sis, 200 mg replicates of an Aroclor 1254 sample were analyzed^with a re blank. Tetra- and pentachlorodlbcnzefurans were found in all six extracts. Hexa- and heptachlornaphthalene were also found. None of these compounds was found in a reagent blank equivalent in size to a 200 mg sample.
Call for Slide 3.
Tun *nn mo
n*- , fkTnf ior i '/wA a*nm i e were anaivzeu. J J. . <-l i.
tetrachlorodlbcnzofurans were detected in both. In addition, tetra- ,
pents- and hexachloronaphthalens, a trichloroterphenyl, and three
unidentified halogenated compounds were letected. The unidentified
halogenated compounds may form a homologous series differing from
one another only in their degree of chlorination. The tentative
molecular weights of these unidentified components were 278 (possible
4 chlorines), 312 (5 chlorines) and 346 (possible 6 chlorines).
These may haye_J>een methylchloronaphthalenes or chlorophenyl eyelopentadlones, However, their only observed fragmentation was a loss of one chlorine atom. The data for these unidentified compounds was therefore too sparse to permit identification. ,
PRR 004365
HARTOLDMON0030748
-5
Call for Slide A. Tvo, 200 mg replicaCes of an Aroclor 1016 sample were analyzed. Dichlo: dibcnzofuran was found in each of the samples.
Call for Slide 5.
.
Initially, 2, 200 mg replicates of an Aroclor 1221 sample and a rcagcr.-. were analyzed. No Cl-DBF were detected. Sensitivity of the instrunar.r for the molecular ions of lower Cl-DBF was then enhanced by limiting the mass scan to roughly 170 to 290 a.m.u. and a third 200 mg sample was analysed. The results were again negative for Cl-DBF. Mono-, di- and tzichlorobiphenyls were the only halogenated species detected : the sample extracts. The reagent blank analyzed with this lot contain: a barely detectable trace of dichlorobiphenyl. Another reagent blank was then prepared and was found to be free of halogenated materials.
Call for Slide 6. (flow chart of recycle experiment)
'
a
To inveatigate the possibility that the observed chlorinated dibentn-
ftirens stay
be artifacts produced in the sample analytical
PAR 004366
HARTOLDMON0030749
6
procedure, duplicate experiments with Aroclor 1254 were carried out lu all eluates normally discarded in the procedure were retained and pooled. The pooled sample eluates were then concentrated and re subjected to the sample preparation procedure. Hie original samples I and the samples prepared from the pooled eluates were examined by combined gas chromatography/nnss spectrometry on the same day under identical operating conditions. No chlorinated dibenzofurans were | detected In the samples resulting from the pooled eluates that had been resubjected to the sample preparation procedure. If we had found a significant level of chlorinated dibenzofurans in the pooled samples, this would have suggested that the procedure it self was capable of making chlorinated dibenzofurans from one or
more oonstl ftiene* et the
In summary, we have shown the presence of chlorinated dibenzofurans as trace contaminants in recent production lots of Aroclor 1254, 1242. and 1016 but not in Aroclor 1221 when samples of comparable size were analyzed. No dibenzofurans were detected in reagent and equipment blanks run with the samples. The procedure itself dees not appear to produce chlorinated dibenzofurans as an artifact of analysis.
The authors wish to acknowledge the technical assistance of Tom Lyon
a
and Linda Ladarach in the preparation of these samples for analysis.
PRR 004367
HARTOLDMON0030750
100 MG AROCLOR
100 MG AROCLOR IN PARALLEL PREPARATION
50 G ALUMINA COLUMN
}______________________
I
20% METHYLENE CHLORIDE IN HEXANE-
2 ALUMINA MICRO COLUMNS
T--1
2tJ METHYLENE CHLORIDE IN HEXANE
COMBINE EXTRACTS FROM 230 MG AROCLOR
I
8 G FLORISIL COLUMN L_ 5% ETHYL ETHER IN HEXANE
I
i
J
GC-/MS
PRR co^3&a
HARTOLDMON0030751
Prr 004369
mima.
prj *jction date 10/73
SAMPLES ANALYZED.' 6 SAMPLE SIZE: 200 ISG
FOUND: TETRA- AW PENr/OTXWBIBENZCRfWIS CHJ0RINA1H) NMfTHALENES
. WIW'T
HARTOLDMON0030752
PRR 0 0 4 3 7 0
AROCLOR 1?JQ
ir ducticn date 9/75
SAMPLES ANALYZED: 2 SAMPLE SIZE: RG MG
FOUND: DI~, IRl-j MB TETR/CltJORCDIBENZDFURANS
CHLORINATED LAWHALENES TO5CHLCR0TERPHHNYL UNIDENTIFIED HUDGENATED OTTOtOS
i> ip v
HTT . ..... .... 1!........ - ........................................................................... .... . imirijnijriimiiiunirnjirnwriii.~inr mi !
HARTOLDMON0030753
MQCL(K1P16.
to cxticn date 10/73
SAMPLES ANALYZED: 2 SAMPLE SIZE! 2MN3
FOUM): DICHLORODIBENZt FURAN
PRR 0 0 4 3 7 1
i
I
HARTOLDMON0030754
PRR CC^* 3 7 2
AROTIOR 1221
fRcduction date 6/73
SAWLES ANALYZED: 3 SAWLE SIZE: 2C.0 MG
No CHLORINATED DIBENZCITJRANS DETECTED
my JJII uw III T Ui^n"
i ................ "iV
yww
'""tf ...........umium
HARTOLDMON0030755
pRR 00^373
HARTOLDMON0030756
p '
itmm tkg dttk of
//- n-')/
7<*~
^W
.,
^WWm4
9- SUloy-L*,<6 /v*. |i A-
cmMsus #aiJCi ^
^iUvir
J
&****
PRR QC1 <2VJ
HARTOLDMON0030757
Monsanto INDUSTRIAL chemicals company rM. ,.<*^cTt'O^R. E. Keller - South Second Street - St. Louis
October 28/ 1971
..
ALLEGED DIOXINS AND BENZOFURANS IN PCB'S - INPUTS FOR REPORT
HSB 10-22-71 Memo to REK/WRR
TO ;W. R. Richard General Offices
"CC. W. Roos - Res. 1 T. M. Patrick - Res. 1
M. W. Dietrich - Res. 2 J. P. Mieure - Res. 2
E. s. Tucker - Res. 2
The attached reports and summary data table for furans cover informatien in hand on the above subject.
Overall, we should be able to meet predicted regulatory agency maximum permissible levels of chlorodibenzofurans in our PCB/PCT products. Data in hand show that Areclor 1242/ 1254 / 1260 and MCS 1016 contain no detectable (<2 ppm)4 furans (or chlorodiber.zop-dioxins). Aroclor 5442 contains no detectable (<S ppm) furans.
The above position is based on the belief that higher levels
would be permitted for furans because of lower toxicity compared
to dioxins. The data shown or. the confidential attachment from a
European manufacturer shows that tetrachlorodibonzo-p-dioxin has'
an acute toxicity to rabbits at least 3OX that for tetrachloro-
dibenzofuran. Regulatory agencies, including the EPA, are
.
currently imposing 0.1 ppm max. for tetrachlorodibenzo-p-dioxin
in 2,4/5-T and hexachlorophene. On this basis, a 2 ppm max.
level should be acceptable for furans.
'
If we are required to pusli the detection to 0.1 ppm, we will need to synthesize furans and develop more sensitive methods.
This will be costly, and difficult technically, especially for PCT products.
Based on experimental work in our ewn laboratories and in part at the University of Utrecht -
We Know
1. Monsanto Aroclor 1242, 1254, 1260 and MCS 1016 centam no
detectable (<2 ppm) chlorodibenzofurans (I) or chlorodiber.ro-
p-dioxins (II) of the type below. Aroclor 5442 also contains
no detectable (<5 ppm) chlcrodibenzefurans or chlorodibenzc-
p-dipxins.
.
Cl 1-8
(I) (ID
Cl 1-8 *0n a per component and not total furan basis.
PRR 004241
HARTOLDMON0030758
Dr* W. R. Richard
October 28, 1971
Page two
2. Competitive products - Prodelc and Bayer chlorinated biphenyl* similar in composition to Aroclor 1260 contain detectable furens (up to 30 ppm) and no dioxins (<2 ppm). Japanese product from Shizuki similar to Aroclor 1242 contains no detectable (<2 ppm) furans or dioxins.
3. All the above PCB products contain chlorinated naphthalenes at ppm levels. Aroclor 5442 contains either chlorinated anthracene or phenanthrene.
Don't Know or Limited Information Only
1. Biodegradability of furans - " Toxicity to bacteria may be a problem for biodegradation studies.
2. Photodegradation of furans -
Work by the USDA indicates that photodegradation of dioxins under conditions in which water is the solvent is probably extremely slow in the natural environment.
" ,
3. Existence of furans (or dioxins) in the environment or as biological residues -
Methodology normally applied to analysis of environ mental materials will not make this detection.
Questions for Medical
*
1. Toxicity of other impurities -
.
Chlorinated naphthalenes, anthracene and/or phenanthrene
found in above commercial products?
.
2. Acute toxicity or teratogenic effects of chlorodibenzofurans relative to dioxins? Availability-of published data in the public domain for reference purposes?
3. Based on tho above - the odds that 2 ppm max. for chlorodibonzofurans will be put on our products?
Z suggest that the only immediate analytical work would be to firm up furan data for remaining PCB/PCT products with existing method ology. Out of this, we should decide what minimum monitoring is needed to insure that our manufacturing process produces no furans in our final products. Additional analytical method development work should be done only if lower detections are needed, based on
inputs such as adverse toxicity findings from others.
.* db
R. E. Keller
"'
PRR 004242
HARTOLDMON0030759
GC/MS ANALYSIS DATA FOR TOXIC COMPOHEHTS IH PCB/PCT PRODUCTS
LABGRATORY/PRQDUCTS
Voa, et al University of Utrecht
Prodelec Phenoclor DPS (Composition similar to
Aroclor 1260)
Bayer Clophen A60( Lot 912434 (Composition similar to
Aroclor 1260)
Monsanto Aroclor 1260, Lot AX-3
CIILORODIBENZOFURANS FOUND
'.
<4 "Cl/mol
rWn^T----------------------rgl/sSl - .
ND (<1 ppm)
Detected (1-20 ppm) Detected (1-20 ppm)
ND (<1 ppm)
Detected (1-20 ppm) Detected (i-5 ppm)
ND (<1 ppm)
ND (<1 ppm)
ND (<1 ppm)
Applied Sciences Monsanto Industrial Chemicals
Prodelec Phenoclor DPS
ND .(<2 ppm)
Prodelec Phenoclor DPS
ND (<2 ppm)
Bayer Clophen A60, Lot 931134
ND (<2 ppm)
Kaneclor KC-300 Shizuki, July 1970 (Composition similar to Aroclor 1242)
ND C<2 ppm)
Monsanto Aroclor 1242, Lot AK-255 Monsanto Aroclor 1254, Lot AK-38 Monsanto Aroclbr 1260, Lot AK-3 Monsanto MCS 1016, Drum B Monsanto MCS 1016, KA-708
ND (<2 PP) ND (<2 ppm) ND (<2 ppm) ND (<2 ppm) ND (<2 ppm)
Monsanto Aroclor 5442, Lot AI-9
ND (<5 ppm)
'
Detected Detected Detected
ND (<2 ppm)
ND (<2 ppm) ND C<2 ppm) ND 2 ppm) ND C<2 ppm) ND (<2 ppm) ND (<i ppm)
Detected(15-30 Detected(15-30
Detected
ND (<2 ppm)
ND (<2 ppm) ND (<2 ppm) ` ND (<2 ppm) ND (<2 ppm) ND (<2 PP) ND (<5 ppm)
PRR 004243
HARTOLDMON0030760
2,4,5-Iricklorphe2.l
.'j_Uhl3------_____
Clyr^OH Cl-VAl
M
1 ,2,4,5-Tatrachlorkanaol
oiOci
1,0
Pentachlorpheaol
Cl^^Cl
ci-'V^i 6s
0,5
0,2
| "S ^ c2ire..'ic" 1
0/3 0/
0/5 i/
0/2 0/2 2/2
Sfx&ehlornaphtSiaiia' ' ' cKOS1^
?fstcsh.lerdi jhsayl '
,O-Q012
. 0,1
0,05 0,01 0,003
6,05 0,005
* 2/2 +. 2/4 + 1/4
0/2
0/1 0/2
3/4 0/2 0/1 C/2
2sptastley-44 *-diexyiiphenyl
30-AJVE
0,05
0/2
0/2
2'petrachlor-2, -diory-
r~.* iiphenyl i..;
'
I i ?etraehler-4,4*-dioryiiphenyl
U.: *
ft.-.
J?ri chi or-2,2' -di oxy- .
iijhanyl
*
Scxaehl ordiphcnyloaoxyd
{Pant'achl ordiphenyl ea.ozyd
1
?etreehlordiphenolen-
&ryd
. Srichiordipk eny1eaoxyd
Ectracklordiphsaylea-
dioxyd
'
0,05 0,05
0/2 ' 0/2; 0/2 0/2
0,05
0/4
C/4
C1<XOC13 >
0,005 0,001 0,0003 0,000.1
-* 2/2 4- 3/4 4 1/7
0/2
2/2
3/4 3/7 j. 0/2
"sCgO1* " 0,001 + 5/S
# ( Cl<XOCI!
6,0003 + 1/2 ro.ooo; 4. I/ll
0,001
2/2
0,0003 4 1/2
0,000.1 0/2
3/4 2/2 11/11
2/2 2/2 2/2
*
Gl^ o^^ci
C^JC^OCqi-*
0,005 ) 2/2 0,001 4* 6/20
0,0003 4-4/9 0,000.1 0/2
*
0,000.' ;+ 4/4 0,020: ?* 5/5 0,0000 0,0000 3 0/3''
l/l S/2C S/9 2/2
3/>// "*
PRft 004244
HARTOLDMON0030761
Jim 13# 1972 ChXorodibanxofuraa
< G..-' J. R. Savage - St. Louis - B2SL
C. futon
V. Uo Mds4
T3A
.
Cuming M tea aakoi tlmt vs derslop a histosy an chlorodlbamofuran extant of our PCS products Tim plant has no methods for this analysis. Zf va Just nasd to aer a few currant batch* *, this Is perhaps b@itr dans in Reaaarch, but if wo want to dswslop a continuing history# of say tvery fifth batch as wo dM with DiaadLna and Feata, vs should havs a method deralepod that is suitable for routim plaint uss Let me knew ham jm, would Uka to proesod
J. 8 Earn#
Ai
PRR 004245
HARTOLDMON0030762
Monsanto *
r.OM ,n...i cocat.on, gggg Gumming Paton
May 23i 1972 Dielectric Aroclor
TO : B2SL J. R. SAVAGI
A,
cc B2SL T3A 1760
B2S0 B2NK
T. L. Qossage W. R. Richard R. H. Munch P. 0. Bonlgnus W. B. Papageorge
Jim, at our presentation to the PCS Task Force In Washingto: on May 15 we presented the composition of Aroclor 1016 as containing 1$ pentachloroblphenyl and higher homologs and 0.1$ hexachlorobiphenyl and higher homologs. By now I think the Idea that Aroclor 1016 has under 0.4# pentachloro and higher homologs Is pretty well established. The fact that methodology Is Involved In making distinctions Is not going to be of Immediate significance to many people. In order to prevent more of a credibility problem I think we need to know what current Aroclor 1016 Is running as far as penta-chloro and higher homologs and hexachloro and higher by our latest analytical techniques. We should have avail able evidence to show that our May 15 numbers can be sub stantiated.
The second point concerns chlorodlbenzofurans. At our meeting the FDA showed concern regarding getting definite proof that chlorodlbenzofurans were absent from our PCBs. I suggest we have several current batches of Aroclor 1016, 1242 and 1254 screened. I think we need to have this data ' available.
Gumming Pato^
cs
iK.ie psv li ft
PRR 004246
HARTOLDMON0030763
Monsanto
'v-VV'
nA' /
fees imamc ft uocfttio*i M. w. Dietrich - Teghnalggy_Dfi.aflrtnia
-Sfijcrmd- .^f-rpp
January 27, 1971
W. B. Papageorge - GO
M. W. Farrar - Res. 1
DIBEN20FURANS IN AROCLOR PRODUCTS
H. S. Bergen - GO
R.E.Keller Memo to W.B.Papageorge 10/20/70
E. P. Wheeler - GO E. S. Tucker - Res. 2 E. M. Emery - Res. 2
TO
W. R. Richard
Co
General Offices
(aJ
&
R. E. Keller - Res. 1 R. H. Munch - Res. 2
Q* E* Thompson - GO
R%>J` p* Mieur - Res 2
A--
We initially reported that Aroclor 5442 (Lot AI-9) contained
1-3 ppm tetrachlorodibenzofuran. Additional work by Dr. Mieure has shown that this identification is not conclusive; tetrachloromethylbiphenyl cannot be distinguished from the above dibenzofuran. Since Dr. Mieure has`also found methylbiphenyl in Santowax R, chlorinated methylbiphenyls could be expected in Aroclor 5442.
High resolution mass spectrometry at the Physical Sciences Center has been unsuccessful in distinguishing between these materials. We have explored several other approaches to make this identification and feel none have reasonable odds of success. At this time, we plan no additional work on this problem.
Recipients of this memo are asked to delete the identification
of "1-3 ppm tetrachlorodibenzofuran in Aroclor 5442/ lot AI-9" (memo JPM to REK, 10/20/70) and replace it with 1-3 ppm unidentified tetrachloro compound with molecular weight of 304 (based on Cl 35.0). The other analyses in that memo in cluding that of 15-30 ppm pentachlorodibenzofuran in Pheneclor
DP 6/ Prodelec are unchanged. At this higher 15-30 ppm level, an unambiguous identification is possible.
If it becomes necessary to quote a figure for oxygenated
impurities in Aroclor 5442, a figure of less than 5 ppm should
be safe based on our analyses.
.
M. W. Dietrich db
PRR 00<24 HARTOLDMON0030764
Monsanto
twicer
i
TO
W. R. Richard - T3A May 29, 1975
DIBENZOFURANS IN AROCLOR HSB/WRR 5/23/75
H. S. Bergen - B2SL
\ .y
\
ec/ j. p, Mieure
R. H, Munch
T2F - TIB
Bob Haley attended "5th Annual Symposium on Recent Advances in Analytical Chemistry of Pollutants", May 19-21. Irwin Pomerantz of FDA presented a paper claiming 1 to
several ppm chlorinated dibenzofurans in Aroclor 1016,
Aroclor 1242, none in Aroclor 1221. No technical proof was
presented - just a claim.
Haley and Mieure have done more work. They are still not
convinced chlorinated benzofurans are present; possible level
10X less than Pomerantz claim. Papageorge and Mieure are to
call on Pomerantz to discuss analytical methods next week.
Mieure does report 0.3 ppm benzofuran in biphenyl. We have
speculated that we could have 0.3 ppm of chlorinated benzo
furan present in Aroclor.
.
Munch has not tackled Levinskas on the biological significance
of 0.3 ppm. This is the level of argument for tetrachlorodibenzodioxin in 2,4,5-T. The case was never brought to trial ,vs. Dow because of lack of evidence.
In our case the argument is about chlorinated dibenzofurans. The toxicity should be lower and the chlorination level should be lower than tetra if they are present in Aroclor 1016. Fractional distillation at the same chlorination level as biphenyl should concentrate any chlorinated dibenzofurans in the still pot.
Will tackle Levinskas and see what comes out of PapageorgeMieure visit before doing more work.
Coft-
W. R. Richard
/is
PRR 0CH382
HARTOLDMON0030765
Monsanto
t eor He * .0 : * '
WS*<C"
<
e<rfe*ei
TO :
David Wocd-St. Louis-B2SD August 29, 1975 TELBPB3ME CALL "'0,W6 2 8/29/75
B2SK
fHH
eC H. 8. Bergen-B2SL
C. Paton/T. L. Oosssg.B2SC G. Roush-A28A Q. L*vinakas-A2IC R. Keller-TIB J. f. Misure-T2B W. R. Richard/R. B. Munch-T W. w. Withara-B2SA
CALL FROMs ftp. J. B. Allan Univarsity of wiscons in (608)263-3524
Dr. Allen called about Dibensylfurana and Dioxins in Chlorinated Biphsnyls m a rasult of his rssding ths Risebrough paper* Hs is concerned about lsvsls of those compounds in ths Arodors which hs is using for his U. of Wisconsin fssding studies sines hs is unclssr ss to potsntisl intsrfsrsncss in rssults which can bs ascribed to PCB per ss or contaminants in PCB.
Bs askad if ws could chock samplss to bo ussd in his studies to dotormina positivoly if contaminants wars or wars not prosont in thoss spocific samples. I said that I did not bs1ievo our analytical techniques wore fully developed to ths stage where we ware confident that we could properly consider ourselves able to mast his need. 1 told Dr.
week.
/deb
in . ts
* *
ow a-t-i
PRR 074856
HARTOLDMON0030766
PYRANOL" COMPOSITIONS
GENERAL ELECTRIC COMPANY 1932 - 1976
* GE Specification - 1488, 1467, 1470, A13B3B. (1497 - A13B3B), A50P5.. # ASTM 0 2283 Type (_), Annual Book of Standards, Vol. 10.03. 1242, 1254, 1260 - Aroc lor" PCB mixtures - Monsanto Chemical T3 4C8 - tri- & tetra-chlorobenzenes - Hooker Chemical Sni4 - tin tetraphenyl - Hooker Chem1cal(1944-1957),
Metal & Thermite Corp
EDOC - epoxide dlcyclo-dlepoxy carboxylate - ERL 4221, Union Carbide 6 CY-179, Clba-Gelgy
PITTSFIELD. MA
1932-NOV 1944 1488*
60% 1260 40% T3CB
NOV 1944-APR 1952 1467
60% 1260 40% T3CB 0.125% Sn*4
APR 1952-MAR 1963 1470
45% 1260 40% T3CB 15% T4C8 0.125% Sn4
APR 1972-NOV 1973 A13B3B2 (FI 45% 1254 40% T3CB 15% T4C8 0.125% EDDC
NOV' 1973--FEB 1974 A50P559
65% 1254 23% T3CB 12% T4CB 0.125% EDDC
MAR 1963-APR 1972 A13B3B (Bl# 45% 1260 40% T3C8 15% T4CB
0.125% EDOC
JAN 1974-END A13B3B3 (G) 60% 1254 40% T3CB
0.125% EDDC
1953 - 1963 1470
45% 1260 40% T3C8 15% T3C8 0.125% Sn#4
1970 - 1972 A50P559 _ 65% 1254 23% T3CB 12% T3C8
0.125% EDDC
ROME. GA
1963 - 1965 A13B3B (B) 45% 1260 40% T3C8 15% T4CB 0.125% EDDC
1965 - 1970 A50P524 (Cl
80% 1242 13% T3CB
7% T4C8 0.125% EDDC
1972 - 1974 A13B3B2 (F)
45% 1254 40% T3C8 15% T4C8 0.125% EDDC
NOV 1973--FEB 1974 A50P559 65% 1254 23% T3CB 12% T4C8
0.125% EDDC
SEP 1969 - OCT 1970 A13B3B f B1
45% 1260 40% T3C8 15% T4C8 0.125% EDDC
MAR 1974-END A50P570
40% 1254 60% T3CB 0.125% EDDC
--jjlC&PRLu. NC & SHREVEPORT. LA Pyranol - never used
/3800B
tor 12-29-87
GEP 000654
HARTOLDMON0030767
W. B. Pipage#rge February 10* 1975 AROCLOR 1260 - HEW STUDIES
H. S. Bergen - B2SL
B2SX
D. R. Blihop - C2SA 0. L. Bratach - 33HA K. V. Eaaley - 1S20 P. J. Fitzgerald - B3SA T. L. Ooasage - B2SL 0. J. Levinakai - A2SC C. Pi ton - B2SC W. R. Richard - T3A 0. Rouah - A2SA E. Tillman - A2SA W. W. Withers - B2SA P. L. Wright - A2SC
Shs fallowing met on fhmrsday* February 6 to review th# result* of a rat feeding study recently completed by Br. R#nat@ Kiabreuj Center for Dlaeaa# Control, HEW 1
T. L. Coaaage 0. J. Levinakas 2. B. Papageorge C. Paton
W. R. Richard 01. Rouah 1. Tillman W. W. Withers
P. L. Wright
Qeorg Levinskas stucarited a meeting held at th Rational
Cancer Institute* Washington, D. C. #n January 31# at which
sections, of liver tlaaue from Sr. Kimbrough's study wore
'
reviewed. Siacuaalon relating to interpretstien# aignificance
and required aation followed. The following conclusion*
were drawn1
.
1. Cancerous- liver oella were observed, in approximately 8f . of the rata exposed to Ar-oelor 1260 in Hr. Kimbrough's study.
2. Otis effect was not observed in similar studies conducted . for Monsanto Cempany by Industrial Bio "Test Laboratories.
3. This difference in observed effects oo&ld be due to th difference in rat strains used in the two studies.
-
A. Dr. Kimbrough will in all probability present and/or publish
her findings as soon.aa she can.
.
.
y--.' . " .. . 'J.
% HOffl has Br. Kimbrough's data and certainly* following
publictien of this informstlon and in tha absence of any
eentrediefcing reports* the regulatory agenda will be
pressured Into reviewing their policies and regulations
relating to polychlorinated biphenyls. Aa in the past there
will very likely be limited attempts made to distinguish -
between typea of commercial mixtures of polychlorinated ~
biphenyls. The canesr cell formation observed in Dr.
"
Kimbrough's study with Aroclor 1260 under cenditions unique
to that test will in all probability be.quickly and without
acienflfle basis assumed to occur with all polychlorinated
SCM
077226
PRR 043367
HARTOLDMON0030768
rC
i
-2
Ih# following lotion plan use developed and la recommended for adoptions
Action
Responsibility
Dates Start _ Complete
Katina ted Coat
1. fublieh tii results of
0. Roush
tha Monsanto atudlas
'* J(f, Stapleton
oonduatod by Industrial
Bio-Test laboratories.
2. Obtain aarvicas of
.V Q. ROush
cancar apaolallat to '
review both studies and
'.
. lnterprat significance to '
current fCB applications. ' ,
. '
,,
Ieaedlately July 1, 1975
Immediately
April 1, 1975 |2000 - |5000
1
t
3. Obtain national Cancar
i. Roush
' Institute interpratatlon.
Following 2 above.
A. Discuss with RI03S, OSHA, DA, RFA.
0. Roush K.V. Esslsy H.B. Fapageorg
Immediately following 2 and 3 above.
5. Discuss with hay qua toman
a. Roush T.L. floatage W.B, Fspegeorg
Coincident with % above.
6. Complete WAX plant
employe expoaura
study.
0. Roush .
lamedlately April 1. 1975
7. Conduct study of
. 0. Rouah
Aroclor 1260 with rata
to determine effeot
at 2k months when
o , exposure la withdrawn '
2 * at 18 menths.
Isaadlataly lafsh, 1977
| 70.000C
2 tf. Conduct study of Aroclor 1260 with second epeciea * | {hamstart) to astabllah
if species difference
1 * f.
0. Rouah .
Immediately
' 4 70,000
PRR 0 4 3 3 6 8
HARTOLDMON0030769
r'
,C
Action
' ' . -3"
*t
Responsibility -
Dates
'
Start
Complete
9. Conduct 2-year rat
feeding study Mlfeh
Aroolor 1016,
`
0, Housts
.
10. Revleu rat liver sections
froa Monsanto t-12%2 study,
Q. Rousts ..
laaedlataly
* ' ** .
.
Estimated Cost
| 85*000 _ '
$2000 - $5000
ij
v-
HARTOLDMON0030770
i f \ \\
t'
>
r:
,v
*S
sp
Iw
n
Monsanto
om iNAMt*location* Qept. of Medicin* & Environment!! Health . F.R. Jonannsen, A2SC
0ATt; August 27, 1976
subjct epidemiology
'
*^siwc: ^ruiBia7ica Plant ..
TO 3. Aoush ` ' A2SA
" '
\.
.CC; .
A group of 311 present/former W.G. Krummrich Plant employees
nave been compiled. Each of the 311 is known to have worked in Dept. 246, cased on work history records. Information on the causa of death has been obtained on SO former employees
from this group. Evaluation of death certificates attribute 6 of those deaths to lung cancer.
A review of this population, omitting all those who worked in
Dept. 246 for less than 6 months, yielded the following sub population!
total number of employees identified deaths (all cases) deaths attributed to lung cancer
- 140 - 23 -4
-
When compared to the 1969 U<S. male population, this group of 23 deaths would be expected to contain 1.24 cases attributable to lung cancer. Statistical comparison of the observed lung cancer versus the expected lung cancers yielded a highly significant cni X2 value of 7,1. This number is even more significant tnan the value (cni X* 6.8) obtained following evaluation of the full
50-person mortality population.
Frederick ft. Johannaen alw
CM K
: i'c*
iN-tiW- l8/f
PRR . 034870 SCH 068365
HARTOLDMON0030771
Monsanto
MON8AJTTO INOUiTmM. CHIMICAU CO. (00 N lni4l,,|lt 8teva,(
St Iouiq, Mittcu/i Hill
014) (84.1000
SPECIAL UNDERTAKING BY PURCHASERS OF POLYCHLORINATED BIPHENYLS
Monsanto Company ("Monsanto") manufacture* certain poly chlorinated biphenyl products ("PCB ' s") which_______
("Buyer") desires to purchase. While Buyer desires to purchase PCB's because of certain desirable flam* resistant and insulator properties. Buyer acknowledges that it is aware and has been advised by Monsanto that PCB's tend to persist in the environment; that care is required in their handling, possession, use and disposition; that tolerance limits have been or are being established for PCB 's in various food products.
Monsanto has therefor* adapted certain restrictive policies with respect to its further production, sal* and delivery of Pda' s, including the receipt of undertakings from its customers as set.ferth below, and Buyer is willing to agree to such undertakings with respect to sales and/or deliveries of PCB's by Monsanto to Buyer.
Accordingly, Buyer hereby covenants and agrees that, with
respect to any and all PCB's sold or delivered by or on
behalf of Monsanto to Buyer on or after the date hereof
and in considaratien of any such sal* or delivery. Buyer
shall defend, indemnify and hold harmless Monsanto, its
present, past and future directors, officers, employes and
agents, from and against any and all liabilities, claims,
damages, penalties, actions, suits, losses, costs and
expenses arising out of or in connection with the receipt,
purchase, possession, handling, use, sale or disposition of
such PCB's by, through or under Buyer, whether alone or in
combination with other substances, including, without implied
limitation, any contamination of or adverse effect on humans,
marine and wildlife, food, animal feed or the environment by
reason of such PCB's.
u**t MMunii Cm0ny
PRR 043740 SCM 016437
HARTOLDMON0030772
'1 X
/ -2-
All existing contracts for th sals of PCB's by Monsanto .
to Buyer are hereby amended to contain the provisions set
forth above*
.
Nothing herein shall create or imply any duty or obligation of Monsanto to sell or deliver any PCB'a to Buyer. No condi tions. understandings or agreements purporting to modify or vary the terms hereof shall be binding unless hereafter made in writing specifically referring to this agreement and signed by the party to be bound and no modification or variance of the above undertaking shall be effected by tho acknowledgment or acceptance of any sale document, purchase order, shipping instruction or other forms containing terms or conditions at variance herewith*
r
_________________________ ________ ; 1 (Buyer)
BY > ._______________ ____________ __
TITIS 8
BATS 8
MONSANTO COMPANY BY* _______ _
! i
PRR 043741 SCM 016436
HARTOLDMON0030773
Monsanto
9 isl
e,*M**C4 TO :
; e .
'
George Roush, Jr.# H. D.
7''-!: >!?`- *. v'.- ;
September 17, 1975
* '
monthly comments - medical department
Corporate Administrative Conalttea
CONFIDENTIAL
l
t
t ikt
t
Stat and federal agency activities related to PCB ' s
.
continue to require Medical Department attention to
support business group efforts. Recent public
hearings in Wisconsin served as a forum for Mr. Schweitzer#
of EPA's Toxic Substances Office#to mate his pitch again
in support of the Toxic Substances Control Act now being .
considered in Congress. Between now and the end of
November, FDA, EPA, and N10SH will conduct hearings on
various aspects of the*PCB*s in foods and the environ-
raent.
Questions from outside Monsanto about the long-term
health effects of chemicals used in two Monsanto plants
on. the workers in the plants have required organization
of epidemiological studies. These require acquisition
of data on individual work assignments within the plant
tover long periods of time# collection of death certificates
of deceased employees, and comparison of causes of death
with frequency of cause to some segment of the general
population. We will have to do much more epidemiology in
the future although clear cut conclusions are almost
Impossible.
.
GR/m
K D.
EXHIBIT UKJ'
PRR 073526-
HARTOLDMON0030774